Nova Scotia Formulary Updates

Transcription

FEBRUARY 2012 • VOLUME 12-01
PHYSICIANS’ EDITION
Nova Scotia Formulary
Updates
New Products
New Diabetic Products – PRP
New Products
The following product was reviewed by the Canadian Drug Expert Committee
(CDEC), and will be listed as a benefit, effective February 2, 2012.
New Exception Status Benefits
Calcitonin Intranasal Criteria Code
Non-Insured Products
Changes to the Nova Scotia
Formulary on the Pharmacare
Website
PRODUCT
STRENGTH
DIN
Twynsta®
(telmisartan/
amlodipine)
40/5mg Tab
40/10mg Tab
80/5mg Tab
80/10mg Tab
02371022
02371030
02371049
02371057
Decision
Highlights


PRESCRIBER
DNP
DNP
DNP
DNP
BENEFIT
STATUS
MFR
SF
SF
SF
SF
BOE
BOE
BOE
BOE
Telmisartan is an angiotensin II receptor blocker and
amlodipine is a calcium channel blocker.
Telmisartan/amlodipine fixed dose combination (FDC), at
both the lowest and highest recommended doses, was
demonstrated to be bioequivelant to the same doses of its
individual components given separately.
The following products are new listings to the Nova Scotia Formulary,
effective February 2, 2012. The benefit status within the Nova Scotia
Pharmacare Programs is indicated.
PRODUCT
STRENGTH
AC Girlz
Chamber
(replacing
AeroChamber
AC-Girlz)
AC Boyz
Chamber
(replacing
AeroChamber
AC-Boyz)
ASATAB
325mg EC
Tab
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
96899963
DNP
FC
TMI
96899962
DNP
FC
TMI
02352427
DNP
SFC
ODN
PAGE 2 OF 9
VOLUME 12-01
New Products continued…
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
BENEFIT
STATUS
MFR
Bisacodyl-ODAN
5mg Tab
02273411
DNP
C
ODN
Chloral hydrate -ODAN
Citrodan (magnesium
citrate)
100mg/mL Syr
02247621
DNP
SFC
ODN
50mg/mL O/L
80001809
DNP
C
ODN
Diamicron® MR
60mg Tab
02356422
DNP
SFD
SEV
Erythromycin Opthalmic
Ointment
0.5%
02326663
DNPMO
SF
SGQ
JAMP-K8
(potassium chloride)
600mg (8mEq)
SR Tab
80013005
DNP
SFC
JPC
JAMP-K20
1500mg
(20mgEq) SR
Tab
80013007
DNP
SFC
JPC
ODAN K-20
1500mg
(20mgEq) SR
Tab
80004415
DNP
SFC
ODN
The following products are new listings to the Nova Scotia Formulary, effective February 2, 2012. The
benefit status within the Nova Scotia Pharmacare Programs is indicated.
PRODUCT
DIN
PRESCRIBER
BENEFIT STATUS
MFR
CO Valsartan 40mg Tab
02337487
DNP
SF
COB
Sandoz Valsartan 40mg Tab
02356740
DNP
SF
SDZ
Teva-Valsartan 40mg Tab
02356643
DNP
SF
TEV
Diovan® 40mg Tab
02270528
DNP
SF
NVR
valsartan 40mg tab
PAGE 3 OF 9
VOLUME 12-01
New Diabetic Products
The following products are new listings to the Nova Scotia Formulary, effective February 2, 2012. The
PRODUCT
DIN/PIN
PRESCRIBER
BGStar® Test Strips (50)
97799464
DNP
BENEFIT
STATUS
SFD
BGStar® Test Strips (100)
97799465
DNP
SFD
SAV
BGStar® Lancets (100)
97799466
DNP
SFD
SAV
MFR
SAV
The following products were reviewed by the Atlantic Expert Advisory Committee (AEAC) and will be listed
as exception status benefits, with the following criteria, effective February 2, 2012.
PRODUCT
STRENGTH
DIN
PRESCRIBER
CO Etidronate
200mg Tab
02248686
DNP
BENEFIT
STATUS
E (SFC)
MYLAN-Etidronate
200mg Tab
02245330
DNP
E (SFC)
MYL
CO Etidrocal Kit
400mg/500mg Tab
02263866
DNP
E (SFC)
COB
Etidrocal Kit
400mg/500mg Tab
02353210
DNP
E (SFC)
SAS
MYLAN-Eti-Cal Carepac
400mg/500mg Tab
02247323
DNP
E (SFC)
MYL
Novo-Etidronatecal Kit
400mg/500mg Tab
02324199
DNP
E (SFC)
TEV
Didrocal® Kit
400mg/500mg Tab
02176017
DNP
E (SFC)
WNC
Criteria 


Decision Highlights 
MFR
COB
for the treatment of osteoporosis associated with documented fragility fracture
when alendronate, risedronate and raloxifene are not tolerated or are
contraindicated
for the treatment of osteoporosis without documented fragility fracture when the
patient is at high 10 year fracture risk (>20% major osteoporotic fracture over 10
years) as indicated by the radiologist on a BMD report, and alendronate,
risedronate and raloxifene are not tolerated or are contraindicated
other requests reviewed on a case by case basis
The committee recommended that etidronate be listed with the same criteria as
calcitonin as there is very little evidence of benefit and it is not a first line agent.
PAGE 4 OF 9
VOLUME 12-01
New Exception Status Benefits continued…
PRODUCT
DIN
PRESCRIBER
Novo-Methylphenidate ER-C 18mg Tab
02315068
D
BENEFIT
STATUS
E (F)
02315076
D
E (F)
TEV
02315084
D
E (F)
TEV
Novo-Methylphenidate ER-C 54mg tab
02315092
D
E (F)
TEV
Criteria 


MFR
TEV
for patients 6-25 years of age diagnosed with attention deficit
hyperactivity disorder (ADHD) who require 12-hour continuous
coverage due to academic and/or psychosocial needs, and who
meet the following:
- patients who demonstrate significant and problematic
disruptive behaviour or who have problems with inattention
that interfere with learning AND
- prescribed by or in consultation with a specialist in pediatric
psychiatry, pediatrics, general practitioners or other
prescribers with expertise in ADHD AND
- have been tried on immediate release or slow release
methylphenidate with unsatisfactory results
The Committee recommended that generic methylphenidate
extended release be added to the formulary with the same restrictive
criteria as Biphentin®.
Both products are once daily methylphenidate alternatives and
generic methylphenidate ER is not more expensive than Biphentin®.
It was recommended to increase the upper age limit to 25 years to
allow for psychosocial needs as patients transition into adulthood.
PAGE 5 OF 9
VOLUME 12-01
The following products were reviewed by the Atlantic Expert Advisory Committee (AEAC), and will be listed
with the following new criteria, effective February 2, 2012.
BENEFIT
MFR
STATUS
Biphentin®
10mg Cap
02277166
D
E (F)
PFR
(methylphenidate)
15mg Cap
02277131
D
E (F)
PFR
20mg Cap
02277158
D
E (F)
PFR
30mg Cap
02277174
D
E (F)
PFR
40mg Cap
02277182
D
E (F)
PFR
50mg Cap
02277190
D
E (F)
PFR
60mg Cap
02277204
D
E (F)
PFR
80mg Cap
02277212
D
E (F)
PFR
Criteria  for patients 6-25 years of age diagnosed with attention deficit hyperactivity disorder
(ADHD) who require 12-hour continuous coverage due to academic and/or
psychosocial needs, and who meet the following:
- patients who demonstrate significant and problematic disruptive
behaviour or who have problems with inattention that interfere with
learning AND
- prescribed by or in consultation with a specialist in pediatric psychiatry,
pediatrics, general practitioners or other prescribers with expertise in
ADHD AND
- have been tried on immediate release or slow release methylphenidate
with unsatisfactory results
Decision Highlights
 It was recommended to increase the upper age limit to 25 years to allow for
psychosocial needs as patients transition into adulthood.
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
PAGE 6 OF 9
VOLUME 12-01
The following product was reviewed by the Canadian Drug Expert Committee (CDEC), and will be listed with
the following new criteria, effective February 2, 2012.
PRODUCT
STRENGTH
DIN
PRESCRIBER
Aclasta® (zoledronic acid)
5mg/100mL Inj
02269198
DNP
BENEFIT
STATUS
E (SFC)
MFR
NVR
Criteria


for the treatment of Paget’s disease
for women with postmenopausal osteoporosis for whom bisphosphonates are
contraindicated due to hypersensitivity or abnormalities of the esophagus
(e.g., esophageal stricture or achalasia) and have at least two of the following:
- age > 75 years
- a prior fragility fracture
- a bone mineral density (BMD) T-score ≤-2.5
Decision Highlights


Aclasta® (zoledronic acid) is an injectable bisphosphonate agent.
There is insufficient evidence that zoledronic acid offers a therapeutic
advantage over oral bisphosphonates, including alendronate.
The cost of zolendronic acid is approximately five times that of generic
alendronate.
There may be a small proportion of women who are otherwise eligible for
funding of oral bisphosphonates but who are unable to take oral
bisphosphonates and who may benefit from annual intravenous
bisphosphonate therapy.


The following products were reviewed by the Atlantic Pharmacare Review Committee (APRC) and will be
listed as exception status benefits, with the following criteria, effective February 2, 2012.
PRODUCT
Saizen®
(somatropin)
BENEFIT
MFR
STATUS
6mg/cartridge
02350122
DNP
E (SF)
EMD
12mg/cartridge
02350130
DNP
E (SF)
EMD
20mg/cartridge
02350149
DNP
E (SF)
EMD
Criteria
 For the treatment of growth hormone deficiency in patients with Turner
Syndrome, upon the request of an endocrinologist or prescriber with a
specialty in endocrinology
STRENGTH
DIN
PRESCRIBER
PAGE 7 OF 9
VOLUME 12-01
Calcitonin Intranasal Criteria Code
Please note that effective immediately, Criteria Code 90 is available for use for calcitonin intranasal, for the
following criteria only:

for the treatment of pain associated with osteoporotic fragility fractures, bone metastases or
pathological fractures (short term up to 3 months)
The code will be limited for use to a maximum of 3 months, once per year. The prescriber may submit a
request to the Pharmacare office for consideration for beneficiaries who require therapy beyond 3 months.
The following products were reviewed by the Atlantic Pharmacare Review Committee (APRC), and were not
recommended to be listed as insured benefits under the Nova Scotia Pharmacare Programs.
PRODUCT
ASATAB
Ferodan
(ferrous sulphate)
Ferodan Infant Drops
(ferrous sulphate)
PEG 3350 (polyethylene
glycol 3350)
Ni-ODAN (nicotinic acid)
Lidodan Endotracheal
(lidocaine)
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
02280167
N/A
Not Insured
ODN
00758469
N/A
Not Insured
ODN
02237385
N/A
Not Insured
ODN
100% powder
for solution
500mg ER Tab
02358034
N/A
Not Insured
MSC
00779806
N/A
Not Insured
ODN
10mg/ACT
liquid
02231147
N/A
Not Insured
ODN
STRENGTH
80mg Chewable
Tab
150mg/5mL
Syrup
75mg/mL
The following products were reviewed by the Atlantic Expert Advisory Committee (AEAC) and were not
recommended to be listed as benefits under the Nova Scotia Pharmacare Programs.
BENEFIT
MFR
STATUS
Niaspan FCT®
500mg ER Tab
02309254
N/A
Not Insured SNV
(nicotinic acid)
750mg ER Tab
02309262
N/A
Not Insured SNV
1000mg ER Tab
02309289
N/A
Not Insured SNV
Decision Highlights
 Niaspan FCT® (nicotinic acid) is more expensive than other alternatives
without demonstrated superiority.
PRODUCT
STRENGTH
DIN
PRESCRIBER
PAGE 8 OF 9
VOLUME 12-01
Non-Insured Products continued…
The following products were reviewed by the Canadian Drug Expert Committee (CDEC) and were not
recommended to be listed as benefits under the Nova Scotia Pharmacare Programs.
BENEFIT
MFR
STATUS
Revolade®
25mg Tab
02361825
N/A
Not Insured GSK
(eltrombopag olamine)
50mg Tab
02361833
N/A
Not Insured GSK
Decision Highlights
 Eltrombopag olamine is a thrombopoietin receptor agonist.
 In the three double-blind, randomized placebo-controlled trials of patients with
chronic immune thrombocytopenic purpura (ITP), the primary outcome was
platelet response, which the Committee considered less clinically relevant
than bleeding events.
 There are no head-to-head randomized controlled trials comparing
eltrombopag with individual comparator treatments for ITP.
PRODUCT
STRENGTH
DIN
PRESCRIBER
PRODUCT
STRENGTH
DIN
PRESCRIBER
Abstral®
(fentanyl citrate)
BENEFIT
STATUS
Not Insured
Not Insured
Not Insured
Not Insured
Not Insured
MFR
100mcg SL Tab
02364174
N/A
PAL
200mcg SL Tab
02364182
N/A
PAL
300mcg SL Tab
02364190
N/A
PAL
400mcg SL Tab
02364204
N/A
PAL
600mcg SL Tab
02364212
N/A
PAL
Decision Highlights
 Fentanyl is a µ-opioid receptor antagonist.
 There are no randomized controlled trials directly comparing fentanyl citrate
sublingual tablets with other less costly opioids available for the management
of breakthrough cancer pain.
 The cost of fentanyl citrate sublingual tablets greatly exceeds the costs of
other available oral opioids.
PAGE 9 OF 9
VOLUME 12-01
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
D
N
P
M
O
S - Seniors’ Pharmacare
F - Community Services Pharmacare
- Under 65-Long Term Care Pharmacare
- Family Pharmacare
C - Drug Assistance for Cancer Patients
D - Diabetes Assistance Program
E - Exception status applies
BOE
- Physician / Dentist
- Nurse Practitioner
- Pharmacist
- Midwife
- Prescribing Optometrist
COB
EMD
GSK
JPC
MSC
MYL
NVR
ODN
PAL
PFR
SAS
SAV
SEV
SDZ
SGQ
SNV
TEV
TMI
WNC
- Boehringer Ingelheim
(Canada) Ltd.
- Cobalt Pharmaceuticals
Company
- EMD Serono Canada Inc.
- GlaxoSmithKline Inc.
- Jamp Pharma Corporation
- Medisca Pharmaceutique
Inc.
- Mylan Pharmaceuticals Inc.
- Novartis Pharmaceuticals
Canada Inc.
- ODAN Laboratories Ltd.
- Paladian Labs Inc.
- Purdue Pharma
- Sanis Health Inc.
- Sanofi-Aventis Canada Inc.
- Servier Canada Inc.
- Sandoz Canada
Incoporated
- Sterigen Inc.
- Sunovion Pharmaceuticals
Canada Inc.
- Teva Canada Ltd.
- Trudell Medical
International
- Warner Chilcott Canada
Co.
.
Changes to the Nova Scotia Formulary on the Pharmacare Website
Beginning February 2, 2012, the Nova Scotia Formulary will be available on the Nova Scotia Pharmacare
website (www.nspharmacare.ca) only in PDF file format. It will continue to be updated monthly.
To view PDF files, you need to have Adobe Acrobat Reader installed on your computer. This software is
free from the Adobe Web Site. Instructions to download the software, as well as how to search for text in
PDF documents, will be provided on the Formulary link.
MARCH 2012 • VOLUME 12-02
Updates
OxyContin®/OxyNEO®
Communication
Palliative Home Care Drug
Coverage Program
Exception Status Drugs
New Products
Changes to the Nova Scotia
Formulary on the Pharmacare
Website
Included with this
Bulletin
Palliative Home Care Medication
Authorization Form
OxyContin®/OxyNEO® Communication
The Atlantic Expert Advisory Committee (AEAC) has reviewed OxyNEO® and
recommended that it not be listed on the Nova Scotia Pharmacare Formulary.
Effective March 1, 2012, under the Nova Scotia Pharmacare Programs, there will
be no new starts for OxyContin® or OxyNEO®. Nova Scotia Pharmacare
beneficiaries who are currently receiving OxyContin ® (who have received
coverage in the 3 months prior to March 1, 2012) will be eligible to receive
coverage of OxyNEO®.
The Nova Scotia Pharmacare Program will consider requests for long acting
oxycodone (OxyContin® or OxyNeo®) on a case-by-case basis for cancer or
palliative pain when other alternatives on the Formulary have failed or are not
appropriate.
OxyNEO® is not interchangeable with OxyContin®. Nova Scotia Pharmacare
beneficiaries changing to OxyNEO® will require a new prescription if their
physician deems it appropriate to continue, but will not need a new Exception
Status Drug Request as their approved coverage for OxyContin® will apply to
OxyNEO®. As well, all existing part-fill prescriptions for OxyContin® will have to
be rewritten for OxyNEO® for patients who are currently on OxyContin® once the
supply of OxyContin® is depleted.
A comprehensive review of oxycodone is being done. The results of this study will
address the appropriate place in therapy for oxycodone products for pain
management.
Palliative Home Care Drug Coverage Program
Coverage of palliative care symptom control medications helps to ensure
individuals who choose end-of-life care at home are able to do so. As a
result, effective February 1, 2012, the province has introduced the
Palliative Home Care Drug Coverage (PHCDC) Program. This program
will cover the full cost of drugs intended for use in end-of-life care at home
with no conditions or restrictions.
PAGE 2 OF 5
VOLUME 12-02
Pallative Home Care Drug Coverage Program Continued…
In order to be eligible for the program, patients must meet the following eligibility criteria:
 reside in Nova Scotia and have a valid Health Card Number
 diagnosed by a physician with a life-threatening illness
 accepted into a DHA/IWK Palliative Care Program
 assessed by the DHA/IWK Palliative Care Program Team to be within six months of anticipated death
 living at home, where home is defined as wherever the person is living, whether in their own home, living
with family or friends, or living in a supportive living residence, but does not include a hospital setting or a
palliative care unit
Once patients are approved for coverage, a nurse or physician from the DHA/IWK Palliative Care Team will
complete a Medication Authorization Form and forward to the community pharmacist. This form lists all of the
approved medication classifications that will be covered under the program for the patient.
Only those classes of medications included on the form are eligible. A valid prescription is required for
medications that can be purchased over the counter. A copy of the form is included with this bulletin. The
program covers the list of drugs recommended for coverage in the Pan-Canadian Gold Standards in Palliative
Home Care, a national standard that includes recommendations for palliative drug coverage.
The form provides authorization for the pharmacy to bill the cost of the approved medications, and is valid for six
months from the date of issue. The pharmacy will bill the Department of Health and Wellness directly for all
approved medications. There will be no cost to the patient for approved medications. The program does not
cover non-drug costs, including supplies for drug administration.
A webinar about the program will be available on the Department of Health and Wellness website in the future.
For pharmacy related inquiries, please contact Palliative Home Care Drug Coverage Program, Pharmaceutical
Services, Department of Health and Wellness at 902-424-1596. For all other inquiries, contact Primary Health Care Branch, Department of Health and Wellness at 902-424-5859.
Exception Status Drugs
Certain drugs are only eligible for coverage under the Pharmacare Programs when an individual meets criteria
developed by the Atlantic or Canadian Expert Advisory Committees. A list of drugs is included in the Nova Scotia
Formulary as Appendix III, “Criteria for Coverage of Exception Status Drugs” and they are indicated by “E” in the
benefit status column of the Formulary.
Copies of the standard exception status drug (ESD) request form, Pharmacist ESD request form, and special forms
for specific drugs are included in the Formulary, and can also be found on the Nova Scotia Pharmacare website at
www.nspharmacare.ca.
PAGE 3 OF 5
VOLUME 12-02
Exception Status Drugs Continued…
Requests for Coverage
To request coverage, the prescriber should mail or fax a completed request form or letter to the Pharmacare office.
Pharmacists may complete an exception status form on behalf of the beneficiary; however, the form must be signed
by the prescriber. Prescribers may also contact the Pharmacare office and speak directly to an Exception Status
Drug Analyst or a Pharmacist Consultant to request coverage. The prescriber must provide the following
information as part of the request:





beneficiary identification, including Nova Scotia Health Card number
diagnosis
drug requested
criteria met
other pertinent information
The request must include all of the above, as well as clearly indicate:
 the Physician’s name and CPNS license number
 the mailing address (for written confirmation of response)
Coverage for non-benefit drugs may also be considered for coverage in exceptional circumstances following a
written request from the prescriber. Prescribers may also contact the Pharmacare office and speak directly to a
Pharmacist Consultant to request coverage.
Notification
Beneficiaries are notified only if the request is approved. Beneficiaries may bring this letter to the pharmacy to
verify that coverage has been approved or the Pharmacist may simply bill the claim on-line for immediate
response. The prescriber is notified in all cases (if coverage is authorized, if the request is refused because the
criteria for coverage is not met, or if more information is required). The notification will include the name and
strength of the drug approved as well as the term for coverage.
Billing
Once authorization is approved, the claim for the exception status drug is billed on-line to the Pharmacare
Programs. Usual copayment and deductible rules apply. If the beneficiary has received the drug while awaiting
authorization and the request is eventually approved, the beneficiary can seek reimbursement if the original
receipt is forwarded to the Pharmacare Office within six months of the date purchased. Likewise, coverage may
also be backdated to a maximum of three months or the first of the month of registration (whichever is less).
PAGE 4 OF 5
VOLUME 12-02
New Products
The following products are new listings to the Nova Scotia Formulary, effective February 27, 2012. The benefit
status within the Nova Scotia Pharmacare Programs is indicated.
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
BENEFIT
STATUS
MFR
Botox®
50 unit/vial Inj
00999443
DNP
E (SF)
ALL
Hydromorph Contin®
4.5mg Cap
02359502
D
SFC
PFR
Hydromorph Contin®
9mg Cap
02359510
D
SFC
PFR
pms-Mirtazepine
15mg Tab
02273942
DNP
SFC
PMS
pms-Quetiapine
50mg Tab
02361892
DNP
SF
PMS
Synthroid®
0.137mg Tab
02233852
DNP
SF
ABB
The following products were reviewed by the Atlantic Expert Advisory Committee (AEAC) and were not recommended to
be listed as benefits under the Nova Scotia Pharmacare Programs.
PRODUCT
STRENGTH
DIN
PRESCRIBER
TOBI®
300mg/5mL Sol
02239630
N/A
BENEFIT
STATUS
Not Insured
TOBI® Podhaler®
28mg Cap
02365154
N/A
Not insured
Decision Highlights



MFR
NVR
NVR
Current available evidence does not clearly show superiority of any one
formulation over another with regards to efficacy or safety
TOBI is approximately ten times the cost of IV tobramycin
A well designed comparative trial is required to justify the increased cost of
TOBI compared to the IV tobramycin formulation
PAGE 5 OF 5
VOLUME 12-02
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
D
N
P
S
F
ABB
ALL
NVR
- Pharmacist
C
E
- Seniors’ Pharmacare
- Community Services Pharmacare
- Family Pharmacare
- Drug Assistance for Cancer Patients
- Exception status applies
PFR
PMS
- Abbott Laboratories Inc.
- Allergan Inc.
Inc.
- Purdue Pharma
- Pharmascience Inc.
Changes to the Nova Scotia Formulary on the Pharmacare Website
Beginning February 2, 2012, the Nova Scotia Formulary will only appear on the Nova Scotia Pharmacare
website (www.nspharmacare.ca) in Portable Document Format (PDF). It will continue to be updated monthly. In
order to view PDF files, you need to have Adobe® Reader installed on your computer. Instructions to download
this free software is provided on the Formulary site.
To search for specific text and page content in the PDF version of the Formulary you can:
 Right click the document and choose “Find” from the pop-up menu. In the upper right of the window,
enter your search term and click the arrows to navigate to each instance.
 Perform a more complex search for whole words, phrases, comments, and other options by doing
either of the following:
 In a web browser, click the binoculars at the left of the window. If the binoculars are not there,
right click the document and choose “Show Navigation Pane Buttons”
 In the Adobe® Reader application, choose Edit > Advanced Search
PALLIATIVE HOME CARE DRUG COVERAGE
MEDICATION AUTHORIZATION
Client Information
Name
HCN
DOB
Address
Community Pharmacy Information
Name of Pharmacy
Phone
Contact Person
Fax
Address
Billing Instructions
Bill the Department of Health and Wellness for the out of pocket costs for following
medications ONLY:
Analgesics
Dermatological Agents
Respiratory Agents
opioid analgesics, NSAID,
acetaminophen
corticosteroids, antifungal,
antipruritic, antibiotic
cough preparations, bronchodilators,
antihistamines
Gastrointestinal Agents
CNS Agents
Cardiovascular Agents
antidiarrheal, antiemetic (including
octreotide), antispasmodic, laxatives,
PPI, H2 blockers
anticonvulsants, antidepressants,
antipsychotics, stimulants,
sedatives and hypnotics
antiarrythmics, nitrates, beta blockers,
calcium channel blockers, diuretics, ACE
inhibitors, ARB
Corticosteroids
Coagulating Agents
Anti-infective Agents
for dermatologic and systemic use,
inhaled corticosteroids
warfarin, heparin, LMWH
(for dermatologic and systemic use)
antibiotics, antivirals, antifungals
Hemorrhoid Therapy
Diabetes Agents
Bone Metabolism Regulators
bisphosphonates
This authorization is valid for SIX MONTHS from the date written. Any medications
after that date or additional medications will require a new authorization form.
Authorized by
DHA
(Palliative Care Nurse or Palliative Care
Physician-Print Name)
Date
Phone
Fax
Please submit invoices with original prescription receipts and a copy of this
Authorization to:
Palliative Care Drug Program
Pharmaceutical Services, Department of Health and Wellness
1690 Hollis Street PO Box 488 Halifax NS B3J 2R8
Phone: 902 424-1596
NOVA SCOTIA PROVINCIAL PHARMACARE PROGRAMS
First Request for Cholinesterase Inhibitor
Please provide the following to support your request for initial 4 month coverage of a cholinesterase inhibitor
PATIENT INFORMATION
PATIENT SURNAME
PATIENT GIVEN NAME
HEALTH CARD NUMBER
DATE OF BIRTH
PATIENT ADDRESS
DIAGNOSTIC INFORMATION- COMPLETE ALL
The cause of the patient’s dementia is (check as appropriate):
 Probable Alzheimer’s Disease
 Possible Alzheimer’s Disease with vascular component
 Possible Alzheimer’s Disease with Lewy bodies
 Possible Alzheimer’s Disease with other – specify: _________________________
MMSE Score ___________
Date ___________
FAST Score _________
Date __________
FAST Stage
Functional Impairment due to cognitive deficit (NOT PHYSICAL DEFICIT)
4 Mild
IADLs: needs assistance (Instrumental Activities of Daily Living include complex tasks such as managing money and
medications, shopping, cooking, driving, housekeeping, using telephone)
5 Moderate
Re-wearing clothes; requires assistance in such basic tasks of daily life as choosing proper clothing. Assistance is
required for independent community living.
6 Severe
ADLs: needs hands-on assistance, especially with dressing and bathing, due to cognitive impairment; eventually
experiences urinary and fecal incontinence (Activities of Daily Living include dressing, washing, toileting, feeding, mobility)
7
Very Severe
(End Stage)
Non-verbal, non-ambulatory
Only patients with a FAST score of 4 or 5 are eligible for coverage for cholinesterase inhibitors.
Adapted from: Reisberg, B. Functional Assessment Staging. Psychopharmacology Bulletin. 1988.
CHOLINESTERASE INHIBITOR
Has this patient been on a cholinesterase inhibitor before?
 YES since ___________
Is this a switch to a different agent due to intolerance?
If “YES”, please describe the intolerance:
 YES
 NO
 NO
A switch to a second cholinesterase inhibitor agent will only be considered for reimbursement during the first four month approval period.
Cholinesterase inhibitor requested and starting dosage
 Donepezil (Aricept®)
Dosage: _______________________________
 Galantamine (Reminyl ER® and generics)
Dosage: _______________________________
 Rivastigmine (Exelon® and generics)
Dosage: _______________________________
PHYSICIAN NAME & ADDRESS:
CPSNS #
PHYSICIAN SIGNATURE
DATE
If you need assistance, please contact the Pharmacare Office at (902) 496-7001 or 1-800-305-5026
Please Return Form To: Nova Scotia Pharmacare Programs
P.O. Box 500, Halifax, NS B3J 2S1
Fax: (902) 468-9402
03/2012
Request for Renewal of a Cholinesterase Inhibitor
Please provide the following to support your request for renewal of a cholinesterase inhibitor
PATIENT INFORMATION
PATIENT SURNAME
PATIENT GIVEN NAME
HEALTH CARD NUMBER
DATE OF BIRTH
PATIENT ADDRESS
MMSE & FAST (complete both)
MMSE Score ___________
Date ___________
FAST Score _________
Date __________
FAST Stage
Functional Impairment due to cognitive deficit (NOT PHYSICAL DEFICIT)
4 Mild
IADLs: needs assistance (Instrumental Activities of Daily Living include complex tasks such as managing money and
medications, shopping, cooking, driving, housekeeping, using telephone)
5 Moderate
Re-wearing clothes; requires assistance in such basic tasks of daily life as choosing proper clothing. Assistance is
required for independent community living.
6 Severe
ADLs: needs hands-on assistance, especially with dressing and bathing, due to cognitive impairment; eventually
experiences urinary and fecal incontinence (Activities of Daily Living include dressing, washing, toileting, feeding, mobility)
7
Very Severe
(End Stage)
Only patients with a FAST score of 4 or 5 are eligible for coverage for cholinesterase inhibitors.
Adapted from: Reisberg, B. Functional Assessment Staging. Psychopharmacology Bulletin. 1988.
EVIDENCE OF BENEFIT
Only for initial re-assessment. Not required for subsequent annual re-assessments.
Is the patient benefitting from this drug?
Please describe:
 YES
or
 NO
* benefit can be based on caregiver report or cognitive testing; consider cognitive, functional,
behavioural, social and leisure domains
If MMSE <10 OR FAST ≥6 (not eligible for coverage) OR
there is no initial improvement after 3-6 months of drug therapy OR
the patient has a rapid decline in cognitive or functional symptoms OR
rapid decline in MMSE (>3points in 6 months) or FAST
When is it time to consider
discontinuing the cholinesterase
inhibitor?
CHOLINESTERASE INHIBITOR
Cholinesterase inhibitor being continued and current dosage
 Donepezil (Aricept®)
Dosage: _______________________________
 Galantamine (Reminyl ER® and generics)
®
 Rivastigmine (Exelon and generics)
Dosage: _______________________________
Dosage: _______________________________
CPSNS #
PHYSICIAN SIGNATURE
DATE
Fax: (902) 468-9402
03/2012
APRIL 2012 • VOLUME 12-03
Updates
Cholinesterase Inhibitors (ChEI)
Exception Status Criteria and
Process Revisions
Cholinesterase Inhibitors (ChEI) Exception Status Criteria
and Process Revisions
Understanding Generic Drugs
Included with this
Bulletin
This bulletin is to advise of changes to the exception status criteria and process
for reimbursement of ChEI under the Nova Scotia Provincial Pharmacare
Programs. These changes will be effective April 1, 2012.
New ChEI Request Forms
Generic Drugs:
Your Questions Answered
Exception Status Criteria Change
Similarities and Differences
Between Brand Name and Generic
Drugs
A review of the ChEI was undertaken in order to ensure that the exception status criteria
are in line with the current medical evidence. As a result, several changes to the current
exception status criteria were recommended. Effective April 1, 2012 the exception status
criteria will change to the following:
What are Bioavailability and
Bioequivelance?
Donepezil, Galantamine, Rivastigmine
For the treatment of mild to moderate probable Alzheimer’s disease or possible
Alzheimer’s disease with vascular component, with Lewy bodies who meet the following
criteria:
• a Mini-Mental State Examination (MMSE) score of 10 to 30 AND
• a Functional Assessment Staging Test (FAST) score of 4 to 5
Initial requests for reimbursement will be considered for a maximum 4 month
approval; subsequent requests may be considered for a maximum 12 month
approval. Requests to switch from one agent in the class to another will not be
considered beyond the initial 4 month approval
The following qualitative information will also be requested:
At initial re-assessment:
• Is this patient benefitting from drug therapy?
Yes / No
Please Describe
At subsequent re-assessment:
• Is the patient benefitting from drug therapy?
Yes / No
PAGE 2 OF 4
VOLUME 12-03
Exception Status Criteria Change Continued…
Switching Agents
Currently Nova Scotia Pharmacare accepts requests to change from one agent to another at any point in
therapy; however, the literature demonstrates that intolerance to an agent is identified early in therapy.
Therefore switching will only be permitted during the first four month approval period. It was noted that there
is no definitive evidence that these drugs, when given at equipotent doses, will have differences in their
adverse effects.
Target Symptoms
Target symptoms will no longer be required; however physicians will be asked at the initial and subsequent
reassessments if, in their opinion, the patient is benefiting from drug therapy.
Exception Status Forms
Please note that the ChEI request forms have been updated, with the number of forms reduced from four to
two, with one for initiation of therapy and one for continuation of therapy. PATIENT SPECIFIC RENEWAL
FORMS WILL NO LONGER BE AUTOMATICALLY MAILED TO THE PHYSICIAN’S OFFICE. It will be
the responsibility of the physician to acquire and complete a renewal request form.
Requests must be submitted on the appropriate exception status request form. Copies are attached to this
bulletin and are also available under “Exception Status Drugs” on the website at www.nspharmacare.ca.
Functional Assessment and Staging Tool (FAST)
The Functional Assessment and Staging Tool (FAST) score is a measure of a patient’s functional ability.
FAST STAGE
4
Mild
5
Moderate
6
Moderately
Severe
7
Severe
FUNCTIONAL IMPAIRMENT DUE TO COGNITIVE DEFICIT (NOT PHYSICAL)
IADLs: needs assistance (Instrumental Activities of Daily Living include complex tasks
such as managing money and medications, shopping, cooking, driving, housekeeping,
using telephone)
Re-wearing clothes; requires assistance in such basic tasks of daily life as choosing
proper clothing. Patient can no longer function independently.
ADLs: needs assistance, especially with dressing and bathing (i.e. unable to bathe
properly; inability to handle the mechanics of toileting); eventually experiences urinary
and fecal incontinence
(Activities of Daily Living include dressing, washing, toileting, feeding, mobility)
Adapted from: Reisberg, B. Functional Assessment Staging (FAST). Psychopharmacology Bulletin 1988;24(4):653-9
PAGE 3 OF 4
VOLUME 12-03
Stage 4: Patients with mild Alzheimer’s disease may demonstrate problems with recent memory,
which impairs their ability to manage their instrumental activities of daily living (IADL).
 These patients may still be quite capable of managing their own basic activities of daily living
(ADL).
 This would be associated with a FAST of 4.
Stage 5: Patient exhibits deficient performance in such basic tasks of daily life such as choosing
proper clothing, and assistance is required for independent community living. Functional
Impairment is due to cognitive deficit and not a physical deficit.
•
•
•
•
The caregiver must help the patient choose appropriate clothing for the occasion or season.
(e.g. the patient will wear incongruous clothing)
Over the course of this stage some patients may begin to forget to bathe regularly, unless
reminded.
Patients at this stage are still capable of putting on their clothing properly, once it has been
selected for them. They are also capable of bathing themselves although they may have been
reminded to bathe.
This should represent a change from previous behaviour.
Note: Patients with moderate Alzheimer’s disease will have more difficulty with their IADL and may
require cueing to manage their basic ADL (e.g., assistance to choose proper clothing) but are able to
complete the task with some degree of independence. This would be associated with a FAST of 5.
Stage 6: Decreased ability to dress, bathe, and toilet independently
Substage 6(a): Decreased ability to put on clothing properly. Patient requires actual physical
assistance in putting on clothing properly. As the illness advances, increasing assistance from
caregivers is needed to help the patients clothe themselves properly (e.g. putting on clothing in the
proper sequence, putting shoes on proper feet, buttoning or zipping clothing).
Substage 6(b): Decreased ability to bathe independently. Ability to properly adjust the bathwater,
enter and exit the bath, wash properly, and completely dry oneself declines. Patient may have a fear of
bathing.
Substage 6(c): Decreased ability to perform mechanics of toileting independently. Patients at this
stage begin to forget to flush the toilet. They may also begin to forget to wipe themselves or wipe
themselves improperly when toileting. The caregiver begins to assist the patient in the mechanics of
toileting.
Substage 6(d): Urinary incontinence and 6(e): Fecal Incontinence. This is in the absence of
infection or other genitourinary tract, or gastrointestinal, pathology. The patient has episodes of
incontinence.
Note: If there is a reason unrelated to Alzheimer’s dementia that a patient meets the criteria for a score
of 6 on the FAST scale (e.g., they have urinary incontinence secondary to pre-existing stress
incontinence, or dressing difficulties due to arthritis), that criterion should be ignored when determining
the patient’s FAST stage.
Adapted from: www.calgaryhealthregion.ca/.../e02form102591functionalassessmentstaging.doc and Sclan and Reisberg,
International Psychogeratrics Vol4. Supp 1. 1992.
PAGE 4 OF 4
VOLUME 12-03
The Canadian Agency for Drugs and Technologies and Health (CADTH) has developed handouts for both
patients and health professionals, which help to answer common questions about generic drugs. You can
access these handouts through the following links:
http://www.cadth.ca/resources/generics
Generic Drugs: Your Questions Answered:
http://www.cadth.ca/en/resources/generics/your-questions-answered
Similarities and Differences Between Brand Name and Generic Drugs:
http://www.cadth.ca/en/resources/generics/similarities
What are Bioavailability and Bioequivelance?:
http://www.cadth.ca/media/pdf/Generic_prof_supplement_en.pdf
For your convenience, copies of these handouts have been included with this bulletin.
Request for Coverage of Dabigatran (Pradax®)
PATIENT INFORMATION
PATIENT SURNAME
PATIENT GIVEN NAME
HEALTH CARD NUMBER
DATE OF BIRTH
PATIENT ADDRESS
DOSE REQUESTED
 Pradax® 110mg bid
DIAGNOSTIC INFORMATION
DIAGNOSIS
*Only insured for non-valvular atrial fibrillation (AF) in patients with a CHADS2 score of ≥ 1
 Non-valvular atrial fibrillation (AF)
 CHADS2 score: ___________________
*The CHADS2 score is an algorithm for predicting the risk of stroke in patients with AF. The score assigns points for various risk factors, as follows:
1 point for congestive heart failure, hypertension, age ≥ 75 yrs, and diabetes; 2 points for history of stroke or TIA. The score = sum of points
(range 0-6)
Renal Function Tests:
Serum creatinine [SCr]: ___________________ µmol/L
Date: ___________________
Creatinine clearance [CrCl]: ___________________ mL/min
Date: ___________________
Recommended Dosing in AF (Refer to monograph for complete dosing information):
CrCI < 30mL/min: Pradax® use is contraindicated
CrCI 30-49mL/min: Pradax® 110mg bid
CrCI ≥ 50mL/min: Pradax® 150mg bid
Age > 80 years: Pradax® 110mg bid
MEDICATION HISTORY
Agents tried:
Dose, length of therapy, and outcome: (i.e. inadequate anticoagulation*, etc.)
 Warfarin
_________________________________________________________
 Other ______________________________
_________________________________________________________
* Please provide the percentage of INR testing results that are outside the desired INR range.
If warfarin has not been tried, please indicate the reason why:
 Warfarin contraindicated _____________________________________________________________________________________________
 Other ____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
CPSNS #
PHYSICIAN SIGNATURE
DATE
Fax: (902) 468-9402
06/2012
PRADAX® (dabigatran) INFORMATION
INDICATION:
On October 26, 2010, Health Canada approved dabigatran for the prevention of stroke and
systemic embolism in patients with atrial fibrillation (AF). Dabigatran etexilate (Pradax®) is the
first of a new class of oral anticoagulants to reach the market. It is a direct thrombin inhibitor.
With a more targeted mechanism of anticoagulation, dabigatran offers several potential clinical
advantages over warfarin therapy, including obviating the need for routine monitoring; a faster
onset and offset of action; no required dietary restrictions for patients; and few drug interactions.
Anticoagulation agents are associated with a risk of bleeding complications. Bleeding in patients
treated with warfarin can be managed with the administration of vitamin K but for the new
anticoagulants there is no established specific antidote for reversal of the anticoagulation effect.
CDEC RECOMMENDATION:
On June 22, 2011, CADTH released the CDEC recommendation on dabigatran for the
prevention of stroke and systemic embolism in patients with non-valvular AF. The Canadian
Drug Expert Committee (CDEC) recommends that dabigatran be listed for the prevention of
stroke and systemic embolism in patients with atrial fibrillation meeting one of the following
criteria:
-
-
Patients in whom warfarin is indicated but who fail to achieve adequate international
normalized ratio (INR) control, despite monitored warfarin treatment, such as with:
regular INR testing, dosage adjustment according to a validated nomogram, and
patient education. Patients who fail to achieve adequate INR control should be
referred to an anticoagulation management service, if available. Or
Patients who have a history of a serious hypersensitivity reaction to warfarin.
PRECAUTIONS:
Bleeding is typically the main safety issue of concern with all anticoagulants, including
dabigatran. In RE-LY, the major randomized controlled trial (RCT) comparing dabigatran with
warfarin, the risk of severe bleeding was reduced with the lower 110mg dose of dabigatran
compared with adjusted-dose warfarin, but there was no such reduction with the higher,
150mg dose. However, there was evidence that in elderly patients there was no reduction in
severe bleeding risk at either dose versus warfarin, and in the post-marketing period there
was some evidence from case reports that elderly patients and/or those with severe renal
impairment are at risk for serious bleeding events.
MONITORING:
Kidney function should be assessed in all patients prior to beginning dabigatran therapy.
Patients with severe kidney impairment (i.e. CrCL<30 mL/min) should not take dabigatran.
While on treatment, kidney function should be assessed in clinical situations where a decline
in kidney function is suspected. Such situations include low blood volume, dehydration and
when certain medications are taken at the same time.
In elderly patients (> 75 years) or in patients with moderate kidney impairment, kidney
function should be assessed at least once a year.
®
NOTE: The Exception Status Drug Request Form for Pradax is available on the Nova Scotia
Pharmacare website at: www.gov.ns.ca/health/Pharmacare/info_pro/exception_status_drugs.asp
JUNE 2012 • VOLUME 12-05
Updates
Criteria Updates: Xeloda®,
Gleevec®
Legend
Included with this
Bulletin
Request for Coverage of Dabigatran
(Pradax®) Form
Pradax® Information Sheet
The following products were reviewed by the Canadian Drug Expert Committee
(CDEC) and will be listed as exception status benefits, with the following criteria,
effective June 1, 2012.
Product
Banzel®
(rufinamide)
Criteria
Decision
Highlights
Benefit
MFR
Status
100mg Tab
02369613
DNP
E(SF)
EIS
200mg Tab
02369621
DNP
E(SF)
EIS
400mg Tab
02369648
DNP
E(SF)
EIS
 For the adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome for patients who meet all of the
following criteria:
- Are under the care of a physician experienced in
treating Lennox-Gastaut syndrome-associated
seizures, AND
- Are currently receiving two or more antiepileptic
drugs, AND
- In whom less costly antiepileptic drugs are
ineffective or not appropriate
 The mechanism by which rufinamide exerts its antiepileptic
effect is unknown. It is structurally unrelated to other
currently available antiepileptic drugs.
 Rufinamide has a Health Canada indication for the
adjunctive treatment of seizures associated with LennoxGastaut syndrome in children aged four years and older,
and adults.
Strength
DIN
Prescriber
PAGE 2 OF 5
VOLUME 12-05
Strength
Pradax®
(dabigatran)
Criteria
110mg Cap
02312441
DNP
BOE
150mg Cap
02358808
DNP
BOE
 Inclusion Criteria:
At-risk1 patients with non-valvular atrial fibrillation (AF) who require dabigatran for
the prevention of stroke and systemic embolism AND in whom:
- Anticoagulation is inadequate2 following a reasonable trial3 on warfarin;
OR
- Anticoagulation with warfarin is contraindicated or not possible due to
inability to regularly monitor via International Normalized Ratio (INR)
testing (i.e. no access to INR testing services at a laboratory, clinic,
pharmacy, and at home)

DIN
Prescriber
Benefit
Status
E(SF)
E(SF)
Product
MFR
Exclusion Criteria:
Patients with impaired renal function4 (creatinine clearance or estimated
glomerular filtration rate < 30 mL/min) OR ≥ 75 years of age and without
documented stable renal function5 OR hemodynamically significant rheumatic
valvular heart disease6, especially mitral stenosis; OR prosthetic heart valves
1. At risk patients with non valvular atrial fibrillation are defined as those with
2.
3.
4.
5.
6.
a CHADS2 score of ≥ 1.
Inadequate anticoagulation is defined as INR testing results that are
outside the desired INR range for at least 35% of the tests during the
monitoring period (i.e. adequate anticoagulation is defined as INR test
results that are within the desired INR range for at least 65% of the tests
during the monitoring period).
A reasonable trial on warfarin is defined as at least two months of
therapy.
Since renal impairment can increase bleeding risk, renal function should
be regularly monitored. Other factors that increase bleeding risk should
also be assessed and monitored (see Pradax® (dabigatran) Product
Monograph).
Documented stable renal function is defined as creatinine clearance or
estimated glomerular filtration rate that is maintained for at least three
months (i.e. 30-49 mL/min for 110 mg twice daily dosing or ≥ 50 mL/min
for 150 mg twice daily dosing).
There is currently no data to support that dabigatran provides adequate
anticoagulation in patients with rheumatic valvular disease or those with
prosthetic heart valves, so dabigatran is not recommended in these
populations.
*Please Note: Patients starting dabigatran should have ready access to appropriate
medical services to manage a major bleeding event.
PAGE 3 OF 5
VOLUME 12-05
Decision Highlights
-
The anticoagulant activity of dabigatran is through direct inhibition of thrombin.
There is no reversal agent for dabigatran if there is a major bleed.
Since renal impairment can increase bleeding risk, renal function should be
regularly monitored.
In a pre-planned subgroup analysis the benefit of dabigatran 150 mg twice daily,
compared with adjusted dose warfarin, was primarily observed in centres that
failed to achieve adequate INR control.
Criteria Updates: Xeloda®, Gleevec®
The following products were reviewed by the Cancer Systemic Therapy Policy Committee (CSTPC) and will
be listed with the following new criteria, effective June 1, 2012.
Product
Xeloda®
(capecitabine)
Criteria
Benefit
MFR
Status
150mg Tab
02238453
DNP
E(SFC)
HLR
500mg Tab
02238454
DNP
E(SFC)
HLR
 As a single agent or in combination with HER2 directed therapy (e.g. lapatinib or
trastuzumab) as one line of therapy in patients with advanced or metastatic breast
cancer (MBC) who have an ECOG performance status of 0-2. For any one
patient, a capecitabine-based regimen may only be used as one line of therapy for
the treatment of MBC
 As a single agent in patients who have documented evidence of metastatic
colorectal cancer, with an ECOG performance status of 0-2, who choose not to
receive combination chemotherapy (5-FU/LV/irinotecan) and/or are unable to
tolerate first line therapy. This includes patients who are chemotherapy naive or
who have progressed 6 months after completion of adjuvant 5-FU/LV therapy
 For adjuvant treatment of patients with stage III (Dukes’ C) colon cancer and
ECOG status 0-1 when prescribed by an oncologist
 Requests must be from an oncologist or a prescriber with a specialty in oncology,
and approval will be granted for three months, to be reviewed as required; in stage
III colon cancer, coverage approved for 6 months
Strength
DIN
Prescriber
PAGE 4 OF 5
VOLUME 12-05
Criteria updates continued…
Product
Gleevec®
(imatinib)
Criteria
Benefit
MFR
Status
100mg Tab
02253275
DNP
E(SFC)
NVR
400mg Tab
02253283
DNP
E(SFC)
NVR
 As a single agent for adult patients with a histological diagnosis of localized
primary Gastrointestinal Stromal Tumors (GIST) (KIT(CD-117)-positive) following
surgical complete resection and at a high risk of recurrence
- Risk of recurrence is dependent on location, size, and mitotic rate.
Specific parameters for considering adjuvant treatment after resection of
GIST along the gastrointestinal tract may include but are not limited to:
o Gastric: any tumor >3cm where the mitotic rate is >5/50 high
powered fields (HPFs). Adjuvant treatment could be considered
where the mitotic rate is <5HPFs and tumor >10cm
o Duodenal, small bowel, peritoneal, colorectal: any tumor where
mitotic rate is >5HPFs; any tumor >5cm in size
o Coverage duration: 36 months
 For the treatment of chronic myelogenous leukemia (CML), as a single agent, in
patients who have documented evidence of Philadelphia chromosome positive
CML, with an ECOG performance status of 0-2 and who:
- Are in blast crisis, accelerated phase, or chronic phase OR
- As a secondary treatment in patients who demonstrate a hematologic
relapse or cytogenetic progression after interferon-alpha (INF-a) therapy
- Coverage duration: 1 year
 Requests for other indications will be reviewed on a case by case basis
 Written request of an oncologist required
Strength
DIN
Prescriber
The following products were reviewed by the Canadian Drug Expert Committee (CDEC), and were not
Product
Toctino®
(alitretinoin)
Decision Highlights
Benefit
MFR
Status
10mg Cap
02337630
N/A
Not insured
ACT
30mg Cap
02337649
N/A
Not insured
ACT
 Alitretinoin is an immunomodulator and anti-inflammatory agent.
 Alitretinoin is associated with a risk of teratogenicity and adherence to the Toctino
Pregnancy Prevention Program in the drug monograph is important.
 In one double-blind, RCT in patients with severe hand eczema refractory to topical
corticosteroids, the percentage of patients achieving a physician global
assessment of “clear” or “almost clear” was statistically significantly higher for
alitretinoin 30mg compared to placebo.
Strength
DIN
Prescriber
PAGE 5 OF 5
VOLUME 12-05
Non-Insured Products continued…
The following product was not recommended to be listed as a benefit, however, will be funded through the
Cystic Fibrosis (CF) Clinic at the IWK and the QEII Health Sciences Centre, effective June 1, 2012.
DIN
Prescriber
Benefit
Status
Not insured
Product
Strength
MFR
Cayston®
(aztreonam)
Decision Highlights
75mg/vial
02329840
N/A
GIL
Inhalation Sol
 Aztreonam is a monobactam antibiotic. Aztreonam for inhalation has a Health
Canada indication for the management of CF patients with chronic pulmonary
Pseudomonas aeruginosa infections.
 Aztreonam for inhalation solution is approved for the treatment of chronic
pulmonary Pseudomonas aeruginosa infections when used as cyclic treatment (28
day cycles) in patients with moderate to severe cystic fibrosis (CF) and
deteriorating clinical condition despite treatment with inhaled tobramycin.
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
D - Physician / Dentist
N - Nurse Practitioner
P - Pharmacist
- Family Pharmacare
ACT
BOE
EIS
GIL
HLR
NVR
- Actelion Pharmaceuticals
Canada Ltd.
- Boehringer Ingelheim
(Canada) Ltd.
- Eisai Limited
- Gilead Sciences Inc.
- Hoffmann-LaRoche
Limited
Canada Inc.
JULY 2012 • VOLUME 12-06
Updates
Criteria Update: Xarelto®
Criteria Update: Sutent®
effective July 3, 2012.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Visanne®
(dienogest)
2mg Tab
02374900
DNP
E(SF)
BAY
Criteria 
Decision 
Highlights 

For the management of pelvic pain associated with
endometriosis in patients for whom one or more less costly
hormonal options are either ineffective or cannot be used
Dienogest is a progestin.
Dienogest has a Health Canada indication for the
management of pelvic pain associated with endometriosis.
In two randomized controlled trials (RCTs) included in the
systematic review, dienogest was superior to placebo
(study A32473), and non-inferior to leuprolide (study
AU19), in reducing pelvic pain in patients with
endometriosis.
PAGE 2 OF 5
VOLUME 12-06
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
Xgeva®
(denosumab)
120mg/1.7mL Sol
02368153
DNP
Criteria 

BENEFIT
STATUS
E(SFC)
MFR
AGA
As a single agent for the prevention of skeletal related events (SREs) for
metastatic castrate resistant prostate cancer (CRPC) patients with one or more
documented bone metastases and ECOG performance status (PS) 0-2
Xgeva® (denosumab) is a human lgG2 monoclonal antibody that binds to human
RANKL, a transmembrane (soluble protein) essential for the formation, function,
and survival of osteoclasts, the cells responsible for bone resorption.
In three double-blind randomized controlled trials (RCTs) in patients with bony
metastases secondary to solid tumours, denosumab was superior (study 103 and
study 136) or non-inferior (study 244) to zoledronic acid for outcomes related to
skeletal-related events (composite of fracture, spinal cord compression, and the
need for surgery or radiation therapy of symptomatic bone metastases).
The following product was reviewed by the Pan-Canadian Oncology Drug Review (pCODR) and will be
listed as an exception status benefit, with the following criteria, effective July 3, 2012.
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
Votrient®
(pazopanib)
200mg Tab
02352303
DNP
Criteria 

BENEFIT
STATUS
E(SFC)
MFR
GSK
As an alternate single agent first line treatment for patients with documented
evidence of histologically confirmed advanced or metastatic clear cell renal cell
carcinoma (RCC) who have an ECOG performance status (PS) of 0 or 1 and are
unable to tolerate sunitinib
Pazopanib is an orally administered, multi-target tyrosine kinase inhibitor.
The pCODR systematic review included one double-blind, randomized controlled
trial (Study VEG105192, Sternberg 2010) comparing pazopanib with placebo in
patients with advanced and/or metastatic renal cell carcinoma who were treatment
naïve or who had received one prior cytokine-based systemic therapy.
PAGE 3 OF 5
VOLUME 12-06
Criteria Update: Xarelto®
The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed with
the following new criteria and applicable criteria codes, effective July 3, 2012.
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
Xarelto®
(rivaroxaban)
10mg Tab
02316986
DNP
Criteria 

BENEFIT
STATUS
E(SF)
MFR
BAY
For the prophylaxis of venous thromboembolism following total knee replacement
surgery for up to 14 days, as an alternative to low molecular weight heparins
[Criteria Code 14]
For the prophylaxis of venous thromboembolism following total hip replacement
surgery for up to 35 days, as an alternative to low molecular weight heparins
[Criteria Code 35]
The Canadian Drug Expert Committee (CDEC) noted the following factors:
- Similar costs of enoxaparin and rivaroxaban
- Evolving clinical practice
- The Health Canada recommended duration of treatment of 35 days for
rivarobaxan after elective total hip replacement surgery
Criteria Update: Sutent®
The following product was reviewed by the Cancer Systemic Therapy Policy Committee (CSTPC) and will
be listed with the following new criteria, effective July 3, 2012.
BENEFIT
MFR
STATUS
Sutent®
12.5mg Cap
02280795
DNP
E(SFC)
PFI
(sunitinib)
25mg Cap
02280809
DNP
E(SFC)
PFI
50mg Cap
02280817
DNP
E(SFC)
PFI
Criteria  As a single agent first line treatment in patients with documented evidence of
histologically confirmed advanced or metastatic clear cell renal cell carcinoma
(RCC) who have an ECOG performance status of 0 or 1. In any one patient all of
the following conditions must be met:
- Sunitinib may be a first line option
- Sunitinib may not be used after another tyrosine kinase inhibitor
(i.e., sorafenib or pazopanib) as sequential therapy
- In the event of severe toxicity, a switch to another tyrosine kinase inhibitor
(i.e., sorafenib or pazopanib) may be allowed
 As a single agent for the treatment of advanced gastrointestinal stromal tumor
(GIST) patients after failure of imatinib due to intolerance or resistance
 Coverage approved for 9 months with reassessment
Decision Highlights  Sunitinib malate is a small molecule that inhibits multiple receptor tyrosine kinases,
some of which are implicated in tumour growth, pathologic angiogenesis, and
metastatic progression of cancer.
 Sutent is indicated for the treatment of metastatic renal cell carcinoma (MRCC) of
clear cell histology. Approval of MRCC is based on statistically significant
progression free survival in patients with good performance status (ECOG 0-1).
PRODUCT
STRENGTH
DIN/PIN
PRESCRIBER
PAGE 4 OF 5
VOLUME 12-06
The following products are new listings to the Nova Scotia Formulary, effective July 3, 2012. The benefit
PRODUCT
Contour® NEXT Blood Glucose
Test Strips (50’s)
Contour® NEXT Blood Glucose
DIN/PIN
PRESCRIBER
BENEFIT
STATUS
MFR
97799460
DNP
SFD
BDD
97799459
DNP
SFD
BDD
The following product was reviewed by the Canadian Drug Expert Committee (CDEC), and was not
recommended to be listed as an insured benefit under the Nova Scotia Pharmacare Programs.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
Not Insured
MFR
Ozurdex®
0.7mg Intravitreal 02363445
N/A
ALL
Implant
(dexamethasone)
Decision Highlights  Ozurdex® is available as a biodegradable polymer matrix implant containing
700mcg of dexamethasone for intravitreal injection
 Dexamethasone intravitreal implant has a Health Canada indication for the
treatment of macular edema following central retinal vein occlusion
 The product monograph includes a warning that no more than two consecutive
injections should be used, and an interval of approximately six months should be
allowed between the two injections
 The proportion of patients achieving a greater than or equal to 15-letter
improvement in best corrected visual acuity which was assessed using the Early
Treatment of Diabetic Retinopathy Study visual acuity chart was statistically higher
for dexamethasone 700 mcg than for sham-treated patients at days 30 and 60, but
not thereafter (days 90 and 180)
 The proportion of patients experiencing a loss of greater than or equal to 15 letters,
or meeting the criteria for legal blindness at day 180, was not statistically
significantly different between dexamethasone 700 mcg and sham: 14% versus
20%, and 23% versus 29%, respectively.
PAGE 5 OF 5
VOLUME 12-06
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
D
N
P
S
F
AGA
ALL
BAY
BDD
- Pharmacist
C
D
E
- Seniors’ Pharmacare
- Community Services Pharmacare
- Family Pharmacare
- Drug Assistance for Cancer Patients
- Diabetes Assistance Program
- Exception status applies
GSK
PFI
- Amgen Canada Inc.
- Allergan Inc.
- Bayer Inc.
- Bayer HealthCare, Diabetes
Care Division
- Pfizer Canada Inc.
AUGUST 2012 • VOLUME 12-07
Updates
New Product
New Ostomy Products
The following product will be listed as an exception status benefit, with the
following criteria, effective August 1, 2012.
PRODUCT
Appendix I – Lantus® Information
Lantus®
(insulin
glargine)
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
100u/mL vial
02245689
DNP
E (SF)
SAV
100u/mL
02251930
DNP
E (SF)
SAV
cartridge
100u/mL 3mL
02294338
DNP
E (SF)
SAV
Solostar
prefilled
disposable pen
Criteria  For the treatment of patients who have been diagnosed
with type 1 or type 2 diabetes requiring insulin and are
currently taking NPH and/or premix insulin daily at optimal
dosing for at least three months AND
 Have experienced unexplained nocturnal hypoglycemia at
least once a month despite optimal management OR
 Have documented severe or continuing systemic or local
allergic reaction to existing insulin
For more Lantus® information, please refer to Appendix I.
PAGE 2 OF 6
VOLUME 12-07
New Product
The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and was
recommended to be listed as an open benefit in the Nova Scotia Formulary, effective August 1, 2012.
PRODUCT
STRENGTH
DIN
PRESCRIBER
Asmanex®
(mometasone furoate)
BENEFIT
STATUS
SF
MFR
200mcg/act
02243595
DNP
FRS
Twisthaler
400mcg/act
02243596
DNP
SF
FRS
Twisthaler
Decision Highlights  Mometasone furoate is an inhaled corticosteroid with anti-inflammatory properties.
 Mometasone furoate has a Health Canada indication for the prophylactic
management of steroid-responsive bronchial asthma in patients 12 years of age
and older.
 Based on the systematic review, mometasone demonstrated similar or greater
efficacy compared with other available inhaled corticosteroids based on
improvements in lung function tests and symptom scores and reductions in rescue
medication use.
The following products were reviewed by the Canadian Drug Expert Committee (CDEC) and were not
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
Not Insured
MFR
Gelnique®
100mg/g Gel
02366150
N/A
WTS
(oxybutynin chloride)
Decision Highlights  Oxybutynin chloride is an antispasmodic, anticholinergic agent.
 Oxybutynin chloride gel has a Health Canada indication for the treatment of
overactive bladder with symptoms of urge urinary incontinence, urgency, and
frequency.
 The Committee considered the comparative clinical benefit of oxybutynin chloride
gel to be uncertain because of the absence of any randomized controlled trials
(RCTs) that directly compare it with other pharmacological treatments for
overactive bladder.
 There are no RCTs comparing the incidence of anticholinergic adverse effects
(such as cognitive and neurological) between oxybutynin chloride gel and other
oxybutynin products, particularly in the elderly.
PAGE 3 OF 6
VOLUME 12-07
Non-Insured Products Continued…
BENEFIT
MFR
STATUS
Benlysta®
120mg/5mL vial
02370050
N/A
Not Insured GSK
(belimumab)
400mg/20mL vial 02370069
N/A
Not Insured GSK
Decision Highlights  Belimumab is a fully human monoclonal antibody, classified as an
immunosuppressant.
 Belimumab has a Health Canada indication for reducing disease activity in adult
patients with active, autoantibody-positive systemic lupus erythematosus (SLE)
when used in combination with standard therapy.
 Trials provided no evidence that belimumab alters the risk of organ damage,
improves quality of life, or allows for a reduction in prednisone dose.
 In two randomized controlled trials (C1056 and C1057), the proportion of
responders was statistically significantly higher for belimumab groups than for
placebo at 52 weeks, but not at 76 weeks in the trial that extended beyond one
year.
PRODUCT
STRENGTH
DIN
PRESCRIBER
HIV Program at the QEII Health Sciences Centre (VG site).
PRODUCT
STRENGTH
DIN
Complera®
(emtricitabine/rilpivirine/
tenofovir)
200mg/25mg/300mg 02374129
Tab
PRESCRIBER
N/A
BENEFIT
STATUS
Not Insured
MFR
GIL
New Ostomy Products
The following products are new listings to the Nova Scotia Formulary, effective August 1, 2012.
PRODUCT
DIN/PIN
PRODUCT
NUMBER
PRESCRIBER
BENEFIT
STATUS
MFR
Esteem + Closed Pouch
95098119
416700
DNP
SFC
CON
95098118
416701
DNP
SFC
CON
95098117
416702
DNP
SFC
CON
95098116
416703
DNP
SFC
CON
95098115
416704
DNP
SFC
CON
95098114
416705
DNP
SFC
CON
95098113
416706
DNP
SFC
CON
95098112
416707
DNP
SFC
CON
PAGE 4 OF 6
VOLUME 12-07
New Ostomy Products Continued…
PRODUCT
DIN/PIN
PRODUCT
NUMBER
PRESCRIBER
BENEFIT
STATUS
MFR
95098111
416708
DNP
SFC
CON
95098110
416709
DNP
SFC
CON
95098109
416710
DNP
SFC
CON
95098108
416711
DNP
SFC
CON
95098107
416712
DNP
SFC
CON
95098106
416713
DNP
SFC
CON
95098105
416714
DNP
SFC
CON
95098104
416715
DNP
SFC
CON
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
95098103
416719
DNP
SFC
CON
95098102
416725
DNP
SFC
CON
95098101
416729
DNP
SFC
CON
95098100
416733
DNP
SFC
CON
95098099
416737
DNP
SFC
CON
95098098
416739
DNP
SFC
CON
95098097
416741
DNP
SFC
CON
95098096
416743
DNP
SFC
CON
95098095
416745
DNP
SFC
CON
95098094
416747
DNP
SFC
CON
95098093
416749
DNP
SFC
CON
95098092
416751
DNP
SFC
CON
95098091
416718
DNP
SFC
CON
95098090
416721
DNP
SFC
CON
95098089
416724
DNP
SFC
CON
95098088
416728
DNP
SFC
CON
95098087
416732
DNP
SFC
CON
95098086
416736
DNP
SFC
CON
95098082
416742
DNP
SFC
CON
Esteem + Drainable
Pouch
95098084
416738
DNP
SFC
CON
PAGE 5 OF 6
VOLUME 12-07
PRODUCT
DIN/PIN
PRODUCT
NUMBER
PRESCRIBER
BENEFIT
STATUS
MFR
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Esteem + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Drainable
Pouch
Natura + Closed Pouch
95098083
416740
DNP
SFC
CON
95098081
416744
DNP
SFC
CON
95098080
416746
DNP
SFC
CON
95098079
416748
DNP
SFC
CON
95098078
416750
DNP
SFC
CON
95098077
416415
DNP
SFC
CON
95098076
416416
DNP
SFC
CON
95098075
416417
DNP
SFC
CON
95098074
416420
DNP
SFC
CON
95098073
416423
DNP
SFC
CON
95098072
416418
DNP
SFC
CON
95098071
416421
DNP
SFC
CON
95098070
416424
DNP
SFC
CON
95098069
416472
DNP
SFC
CON
95098068
416419
DNP
SFC
CON
95098067
416422
DNP
SFC
CON
95098066
416400
DNP
SFC
CON
95098065
416401
DNP
SFC
CON
95098064
416402
DNP
SFC
CON
95098063
416403
DNP
SFC
CON
95098062
416404
DNP
SFC
CON
95098061
416405
DNP
SFC
CON
95098060
416406
DNP
SFC
CON
95098059
416407
DNP
SFC
CON
95098058
416408
DNP
SFC
CON
95098057
416409
DNP
SFC
CON
95098056
416410
DNP
SFC
CON
PAGE 6 OF 6
VOLUME 12-07
PRODUCT
DIN/PIN
PRODUCT
NUMBER
PRESCRIBER
BENEFIT
STATUS
MFR
95098055
416411
DNP
SFC
CON
95098054
416412
DNP
SFC
CON
95098053
416413
DNP
SFC
CON
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
P - Pharmacist
- Family Pharmacare
CON
FRS
GIL
GSK
SAV
WTS
- ConvaTec Canada Ltd.
- Merck Canada Ltd.
- Gilead Sciences Inc.
- Sanofi-Aventis Canada
Inc.
- Watson Pharma Company
The Canadian Agency for Drugs and Technologies and Health (CADTH) has developed handouts for both
patients and health professionals, which help to answer common questions about generic drugs. You can
access these handouts through the following links:
http://www.cadth.ca/resources/generics
Generic Drugs: Your Questions Answered:
http://www.cadth.ca/en/resources/generics/your-questions-answered
Similarities and Differences Between Brand Name and Generic Drugs:
http://www.cadth.ca/en/resources/generics/similarities
What are Bioavailability and Bioequivalence?:
http://www.cadth.ca/media/pdf/Generic_prof_supplement_en.pdf
Appendix I
Lantus® Information
Insulin glargine (Lantus®) is a recombinant human insulin analog that provides longacting controlled release of insulin over 24 hours without a pronounced peak. Insulin
glargine is indicated for once-daily administration in the treatment of patients with type 1
and type 2 diabetes requiring basal insulin.
Insulin glargine was reviewed by the National Common Drug Review (CDR) in 2009.
Ongoing reviews of the evidence support the CDR report.





No studies have found statistically or clinically significant differences in
Hemoglobin A1C between insulin glargine and NPH insulin in patients with
either type 1 or type 2 diabetes.
No studies have found significant differences between insulin glargine and
NPH insulin in the incidence of severe symptomatic hypoglycemia.
Studies vary in findings for incidence of overall and nocturnal
hypoglycemia. Some evidence shows that significantly fewer patients with
type 2 diabetes using insulin glargine experienced nocturnal
hypoglycemia. However, many of these studies have design flaws,
including lack of randomization.
No studies have found significant differences in quality of life associated
with different insulins in patients with type 2 diabetes; for patients with type
1 diabetes results are inconsistent.
Insulin glargine is significantly more expensive than NPH insulin.
NPH insulin should be the first choice for patients with type 1 or type 2 diabetes
requiring basal insulin. Although the evidence is limited and inconsistent, insulin
analogues may offer some advantage over other types of insulin for some people in
specific circumstances, such as in patients experiencing significant nocturnal
hypoglycemia while using NPH insulin. For this reason, the Nova Scotia Pharmacare
Program has decided to add Lantus® to the Nova Scotia Formulary under special
authorization with specific criteria required for coverage. The criteria are:
-
-
-
For the treatment of patients who have been diagnosed with type 1 or type 2
diabetes requiring insulin and are currently taking NPH and/or premix insulin
daily at optimal dosing for at least three months
AND
Have experienced unexplained nocturnal hypoglycemia at least once a month
despite optimal management.
OR
Have documented severe or continuing systemic or local allergic reaction
to existing insulin. NOVA SCOTIA PROVINCIAL PHARMACARE PROGRAMS
Request for Coverage of Dabigatran (Pradax®)
PATIENT INFORMATION
PATIENT SURNAME
PATIENT GIVEN NAME
HEALTH CARD NUMBER
DATE OF BIRTH
PATIENT ADDRESS
DOSE REQUESTED
DIAGNOSIS
 CHADS2 score: ___________________
(range 0-6)
Serum creatinine [SCr]: ___________________ mg/dL
Date: ___________________
Date: ___________________
Recommended dosing based on renal function:
CrCI < 30mL/min: Pradax® use is contraindicated
CrCI 30-49mL/min: Pradax® 110mg bid
CrCI ≥ 50mL/min: Pradax® 150mg bid
MEDICATION HISTORY
Agents tried:
 Warfarin
_________________________________________________________
 Other ______________________________
_________________________________________________________
* Inadequate anticoagulation is defined as INR testing results that are outside the desired INR range for at least 35% of the tests during the
monitoring period.
 Other ____________________________________________________________________________________________________________
CPSNS #
PHYSICIAN SIGNATURE
DATE
Fax: (902) 468-9402
05/2012
PRADAX® (dabigatran) INFORMATION
INDICATION:
On October 26, 2010, Health Canada approved dabigatran for the prevention of stroke and
systemic embolism in patients with atrial fibrillation (AF). Dabigatran etexilate (Pradax®) is the
first of a new class of oral anticoagulants to reach the market. It is a direct thrombin inhibitor.
With a more targeted mechanism of anticoagulation, dabigatran offers several potential clinical
advantages over warfarin therapy, including obviating the need for routine monitoring; a faster
onset and offset of action; no required dietary restrictions for patients; and few drug interactions.
Anticoagulation agents are associated with a risk of bleeding complications. Bleeding in patients
treated with warfarin can be managed with the administration of vitamin K but for the new
anticoagulants there is no established specific antidote for reversal of the anticoagulation effect.
CDEC RECOMMENDATION:
On June 22, 2011, CADTH released the CDEC recommendation on dabigatran for the
prevention of stroke and systemic embolism in patients with non-valvular AF. The Canadian
Drug Expert Committee (CDEC) recommends that dabigatran be listed for the prevention of
stroke and systemic embolism in patients with atrial fibrillation meeting one of the following
criteria:
-
-
Patients in whom warfarin is indicated but who fail to achieve adequate international
normalized ratio (INR) control, despite monitored warfarin treatment, such as with:
regular INR testing, dosage adjustment according to a validated nomogram, and
patient education. Patients who fail to achieve adequate INR control should be
referred to an anticoagulation management service, if available. Or
Patients who have a history of a serious hypersensitivity reaction to warfarin.
PRECAUTIONS:
Bleeding is typically the main safety issue of concern with all anticoagulants, including
dabigatran. In RE-LY, the major randomized controlled trial (RCT) comparing dabigatran with
warfarin, the risk of severe bleeding was reduced with the lower 110mg dose of dabigatran
compared with adjusted-dose warfarin, but there was no such reduction with the higher,
150mg dose. However, there was evidence that in elderly patients there was no reduction in
severe bleeding risk at either dose versus warfarin, and in the post-marketing period there
was some evidence from case reports that elderly patients and/or those with severe renal
impairment are at risk for serious bleeding events.
MONITORING:
Kidney function should be assessed in all patients prior to beginning dabigatran therapy.
Patients with severe kidney impairment (i.e. CrCL<30 mL/min) should not take dabigatran.
While on treatment, kidney function should be assessed in clinical situations where a decline
in kidney function is suspected. Such situations include low blood volume, dehydration and
when certain medications are taken at the same time.
In elderly patients (> 75 years) or in patients with moderate kidney impairment, kidney
function should be assessed at least once a year.
®
NOTE: The Exception Status Drug Request Form for Pradax is available on the Nova Scotia
Pharmacare website at: www.gov.ns.ca/health/Pharmacare/info_pro/exception_status_drugs.asp
Request for Coverage of Dabigatran (Pradax®) or Rivaroxaban (Xarelto®)
PATIENT INFORMATION
PATIENT SURNAME
PATIENT GIVEN NAME
HEALTH CARD NUMBER
DATE OF BIRTH
PATIENT ADDRESS
DOSE REQUESTED
 Xarelto® 15mg once daily
 Xarelto® 20mg once daily
Diagnosis:
 CHADS2 score: ___________________
(range 0-6)
Serum creatinine [SCr]: ___________________ µmol/L
Date: ___________________
Date: ___________________
Selected notes regarding dosing in AF (Refer to monograph for complete dosing information):
CrCI < 30mL/min:
- Pradax® use is contraindicated
- Xarelto® use is contraindicated
CrCI 30-49mL/min:
- Pradax® 110mg bid
- Xarelto® 15 mg once daily
CrCI ≥ 50mL/min:
- Xarelto® 20 mg once daily
Age > 80 years:
- Xarelto® 20 mg or 15 mg once daily as appropriate
MEDICATION HISTORY
Agents tried:
 Warfarin
_________________________________________________________
 Other ______________________________
_________________________________________________________
* Please provide the percentage of INR testing results that are outside the desired INR range.
 Other ____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
CPSNS #
PHYSICIAN SIGNATURE
DATE
Fax: (902) 468-9402
09/2012
SEPTEMBER 2012 • VOLUME 12-08
Updates
Criteria Updates: Pegasys RBV®,
Pegetron® and Pegetron® Redipen
Injection
Criteria Update: Afinitor®
effective September 1, 2012.
New Diabetic Product
PRODUCT
Included with this
Bulletin
Xarelto®
15mg Tab 02378604
DNP
BAY
(rivaroxaban) 20mg Tab 02378612
DNP
BAY
Criteria  Inclusion Criteria:
At-risk1 patients with non-valvular atrial fibrillation (AF)
who require rivaroxaban for the prevention of stroke and
systemic embolism AND in whom:
- Anticoagulation is inadequate2 following a
reasonable trial3 on warfarin; OR
- Anticoagulation with warfarin is contraindicated
or not possible due to inability to regularly
monitor via International Normalized Ratio (INR)
testing (i.e. no access to INR testing services at
a laboratory, clinic, pharmacy, and at home)
(Pradax®) or Rivaroxaban
(Xarelto®) Form
STRENGTH

DIN
PRESCRIBER
BENEFIT
STATUS
E (SF)
E (SF)
Legend
MFR
Exclusion Criteria:
Patients with impaired renal function4 (creatinine clearance
or estimated glomerular filtration rate < 30 mL/min) OR ≥
75 years of age and without documented stable renal
function5 OR hemodynamically significant rheumatic
valvular heart disease6, especially mitral stenosis; OR
prosthetic heart valves
PAGE 2 OF 5
VOLUME 12-08
New Exception Status Benefits cont’d…
1) At-risk patients with non-valvular atrial fibrillation are defined as those with
Criteria
2)
3)
4)
5)
6)
a CHADS2 score of ≥ 1. Although the ROCKET-AF trial included patients
with higher CHADS2 scores (≥ 2), other landmark studies with the other
newer oral anticoagulants demonstrated a therapeutic benefit in patients
with a CHADS2 score of 1. Prescribers may consider an antiplatelet
regimen or oral anticoagulation for patients with a CHADS2 score of 1.
Inadequate anticoagulation is defined as INR testing results that are
outside the desired INR range for at least 35% of the tests during the
monitoring period (i.e. adequate anticoagulation is defined as INR test
results that are within the desired INR range for at least 65% of the tests
during the monitoring period).
A reasonable trial on warfarin is defined as at least two months of therapy.
Since renal impairment can increase bleeding risk, renal function should
be regularly monitored. Other factors that increase bleeding risk should
also be assessed and monitored (see Xarelto® (rivaroxaban) Product
Monograph).
Documented stable renal function is defined as creatinine clearance or
estimated glomerular filtration rate of 30-49 mL/min for 15mg once daily
dosing or ≥ 50 mL/min for 20mg once daily dosing that is maintained for at
least 3 months.
There is currently no data to support that rivaroxaban provides adequate
anticoagulation in patients with rheumatic valvular disease or those with
prosthetic heart valves, so rivaroxaban is not recommended in these
populations.
* Please Note: Patients starting rivaroxaban should have ready access to appropriate
medical services to manage a major bleeding event.
Decision Highlights  Rivaroxaban is an anticoagulant that directly inhibits Factor Xa.
 Rivaroxaban has a new Health Canada indication for prevention of stroke and
systemic embolism in patients with non-valvular atrial fibrillation.
 In the ROCKET-AF study, the proportion of patients in the per-protocol population
who experienced a primary outcome event was numerically lower for rivaroxaban
(2.7%) than for warfarin (3.4%), and rivaroxaban was determined to be non-inferior
to warfarin.
PRODUCT
STRENGTH
DIN
PRESCRIBER
Incivek®
(telaprevir)
375mg Tab
02371553
DNP
Criteria 
BENEFIT
STATUS
E (SF)
MFR
VTX
For the treatment of chronic hepatitis C genotype 1 infection in combination with
peginterferon α (PegIFNα/ribavirin (RBV)), if the following criteria are met:
- Detectable levels of hepatitis C virus (HCV) RNA prior to treatment
- Fibrosis stage of F2, F3, or F4 as determined by a biopsy or fibroscan
where available or for patients who are assessed to have significant
disease in the professional experience of a hepatologist or a prescriber
with a specialty in hepatitis
- Patient not co-infected with HIV
- One course treatment only (12 weeks duration)
PAGE 3 OF 5
VOLUME 12-08
New Exception Status Benefits cont’d…


Telaprevir is a protease inhibitor used as a treatment for hepatitis C genotype 1 in
combination with PegIFNα/RBV.
In five RCTs, a statistically significantly higher percentage of telaprevir-treated
patients achieved a sustained virologic response (SVR) compared with placebo.
The Committee concluded that the balance of benefits and harms suggests that
patients with higher fibrosis scores should be a priority for treatment.
PRODUCT
STRENGTH
DIN
PRESCRIBER
Victrelis®
(boceprevir)
200mg Cap
02370816
DNP
BENEFIT
STATUS
E (SF)
MFR
FRS
DNP
E (SF)
FRS
02371448
200mg Cap /
200mg Cap /
80mcg Inj
FRS
200mg Cap /
DNP
E (SF)
02371456
200mg Cap /
100mcg Inj
200mg Cap /
FRS
E (SF)
DNP
02371464
200mg Cap /
120mcg Inj
200mg Cap /
E (SF)
FRS
DNP
02371472
200mg Cap /
150mcg Inj
Criteria  For the treatment of chronic hepatitis C genotype 1 infection in combination with
peginterferon α (PegIFNα/ribavirin (RBV)), if the following criteria are met:
- Detectable levels of hepatitis C virus (HCV) RNA prior to treatment
- Fibrosis stage of F2, F3, or F4 as determined by a biopsy or fibroscan
where available or for patients who are assessed to have significant
disease in the professional experience of a hepatologist or a prescriber
with a specialty in hepatitis
- Patient not co-infected with HIV
- One course of treatment only (up to 44 weeks duration)
Decision Highlights  Boceprevir is a protease inhibitor used as a treatment for hepatitis C genotype 1.
 Boceprevir is the first direct-acting antiviral agent approved by Health Canada for
the treatment of chronic hepatitis C genotype 1 infection, in combination with
PegIFNα/RBV in adult patients (18 years and older) with compensated liver
disease, including cirrhosis, who are previously untreated or who have failed
previous therapy.
 In three double-blind, RCTs comparing placebo with boceprevir, both in
combination with PegIFNα/ribavirin, a statistically significantly higher percentage of
boceprevir-treated patients achieved a sustained virologic response; the benefit of
boceprevir was observed both in treatment-naive patients, and patients who had
either not had an adequate response or had relapsed after previous
PegIFNα/ribavirin therapy.
Victrelis Triple®
(boceprevir/ribavirin
peginterferon alfa-2b)
PAGE 4 OF 5
VOLUME 12-08
Criteria Updates: Pegasys® RBV, Pegetron® and Pegetron® Redipen
Injection/Capsule
Effective September 1, 2012, the criteria for Pegasys® RBV Injection/Tablet, Pegetron® and Pegetron®
Redipen Injection/Capsule will change to the following:
PRODUCT
STRENGTH
DIN
PRESCRIBER
Pegasys RBV®
(peginterferon alfa-2a
and ribavirin)
BENEFIT
STATUS
E
MFR
180mcg/mL Inj /
02253410
DNP
HLR
200mg Tab
180mcg/0.5mL Inj / 02253429
DNP
E
HLR
200mg Tab
180mcg/0.5mL Inj / 00999450
DNP
E
HLR
200mg Tab
Criteria  For the treatment of hepatitis C in patients who are treatment naive, upon the written
request of a hepatologist or prescriber with a specialty in hepatitis
 A 24 week period will initially be approved at which time a further request will be
required documenting the patient’s response. If a positive response occurs,
coverage can be continued for an additional 24 weeks (48 weeks total)
 As combination therapy with new protease inhibitors (i.e., boceprevir or telaprevir);
futility rules being enforced. Patients should stop all therapy (both protease inhibitor
and PegIFNα/RBV) if hepatitis C virus levels are:
- with boceprevir, ≥ 100 IU/mL at 12 weeks or detectable at 24 weeks
- with telaprevir, ≥ 1,000 IU/mL at 4 weeks or 12 weeks, or detectable at 24
weeks
PRODUCT
STRENGTH
DIN
PRESCRIBER
Pegetron® Redipen
(peginterferon alfa-2b
and ribavirin)
80mcg/0.5mL Inj /
200mg Cap
100mcg/0.5mL Inj /
200mg Cap
120mcg/0.5mL Inj /
200 mg Cap
150mcg/0.5mL Inj /
200mg Cap
50mcg/mL Inj /
200mg Cap
80mcg/mL Inj /
200mg Cap
100mcg/mL Inj /
200mg Cap
120mcg/mL Inj /
200 mg Cap
150mcg/mL Inj /
200mg Cap
02254581
DNP
BENEFIT
STATUS
E
02254603
DNP
E
FRS
02254638
DNP
E
FRS
02254646
DNP
E
FRS
02246026
DNP
E
FRS
02246027
DNP
E
FRS
02246028
DNP
E
FRS
02246029
DNP
E
FRS
02246030
DNP
E
FRS
Pegetron®
(peginterferon alfa-2b
and ribavirin)
MFR
FRS
PAGE 5 OF 5
VOLUME 12-08
Criteria Updates cont’d…
Criteria 


For the treatment of hepatitis C in patients who are treatment naive, upon the
written request of a hepatologist or prescriber with a specialty in hepatitis
A 24 week period will initially be approved at which time a further request will be
required documenting the patient’s response. If a positive response occurs,
coverage can be continued for an additional 24 weeks (48 weeks total)
As combination therapy with new protease inhibitors (i.e., boceprevir or telaprevir);
futility rules being enforced. Patients should stop all therapy (both protease
inhibitor and PegIFNα/RBV) if hepatitis C virus levels are:
- with boceprevir, ≥ 100 IU/mL at 12 weeks or detectable at 24 weeks
- with telaprevir, ≥ 1,000 IU/mL at 4 weeks or 12 weeks, or detectable at 24
weeks
Criteria Update: Afinitor®
The following coverage criteria has been updated effective September 1, 2012.
PRODUCT
Afinitor®
(everolimus)
BENEFIT
MFR
STATUS
2.5mg Tab
02369257
DNP
E (SFC)
NVR
5mg Tab
02339501
DNP
E (SFC)
NVR
10mg Tab
02339528
DNP
E (SFC)
NVR
Criteria  As a single agent for metastatic renal cell carcinoma (RCC) patients with
documented clear cell histology who have a Karnofsky performance status 70% or
higher after progression or intolerance to the VEGF multi-targeted tyrosine kinase
inhibitors (TKIs), (e.g., sunitinib, pazopanib and/or sorafenib)
STRENGTH
DIN
PRESCRIBER
New Diabetic Product
The following product is a new listing to the Nova Scotia Formulary, effective September 1, 2012. The
PRODUCT
DIN/PIN
PRODUCT
NUMBER
PRESCRIBER
Ulticare Pen Needles
32g x 4mm
97799440
00543
DNP
BENEFIT
STATUS
SFC
MFR
DRX
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
P - Pharmacist
- Under-65 Long Term Pharmacare
- Family Pharmacare
BAY
DRX
FRS
HLR
NVR
VTX
- Bayer Inc.
- Domrex Pharma Inc.
- Merck Canada Ltd.
- Hoffmann-LaRoche Ltd.
- Novartis Pharmaceuticals Canada Ltd.
- Vartex Pharmaceuticals (Canada) Inc.
SEPTEMBER 2012 • VOLUME 12-09
Included with this
Bulletin
(Pradax®) or Rivaroxaban
(Xarelto®) Form
Dabigatran (Pradax®) or Rivaroxaban (Xarelto®) Form
Please be advised that there was an error in the Request for Coverage of
Dabigatran (Pradax®) or Rivaroxaban (Xarelto®) form for atrial fibrillation
which was provided with a recent Pharmacare Bulletin. Specifically the dose of
Xarelto® was indicated to be twice daily, instead of once daily. The corrected
form is attached for your use and is posted on the Pharmacare website,
www.nspharmacare.ca.
We apologize for any inconvenience.
NOVEMBER 2012 • VOLUME 12-10
Updates
New Exception Status Benefit
 Levemir
New Exception Status Benefit
Coverage of Antiviral Therapies for
Influenza-Like Illness (ILI)
The following product will be listed as an exception status benefit with the
following criteria, effective November 1, 2012.
Criteria Update – Infliximab
BENEFIT
STATUS
E (SF)
Criteria Update – Capecitabine
PRODUCT
Duration of Helicobacter pylori
Eradication Treatment
Levemir®
100u/mL
02271842
DNP
NNO
(insulin
Penfill
detemir)
Criteria - for the treatment of patients who have been diagnosed
with Type 1 or Type 2 diabetes requiring insulin and have
previously taken NPH and/or premix insulin daily at
optimal dosing
AND
- have experienced unexplained nocturnal
hypoglycemia at least once a month despite
optimal management
OR
- have documented severe or continuing systemic
or local allergic reaction to existing insulin(s)
STRENGTH
DIN
PRESCRIBER
MFR
Coverage of Antiviral Therapies for Influenza-Like Illness
(ILI)
Please be reminded that coverage for antiviral therapies for influenza (oseltamivir,
zanamivir) is available to Pharmacare recipients who are long-term care residents,
according to established coverage criteria and provincial guidelines for use. The
provincial 2012–2013 Guide to Influenza Control for Long-Term Care Facilities
and Adult Residential Centers is available at: http://novascotia.ca/hpp/cdpc/infofor-professionals.asp.
PAGE 2 OF 3
VOLUME 12-10
Criteria Update – Infliximab
Please note that effective November 1, 2012, the criteria for infliximab (Remicade®) will be updated to
include the treatment of ankylosing spondylitis, with the following criteria:
-
-
for the treatment of patients with moderate to severe ankylosing spondylitis (e.g., Bath AS Disease
Activity Index (BASDAI) score ≥ 4 on 10 point scale) who:
·
have axial symptoms** and who have failed to respond to the sequential use of at least 2
NSAIDs at the optimum dose for a minimum period of 3 months observation, or in whom
NSAIDs are contraindicated OR
·
have peripheral symptoms and who have failed to respond to, or have contraindications to, the
sequential use of at least 2 NSAIDs at the optimum dose for a minimum period of 3 months
observation and have had an inadequate response to an optimal dose or maximal tolerated
dose of a DMARD
must be prescribed by a rheumatologist or prescriber with a specialty in rheumatology
requests for renewal must include information showing the beneficial effects of the treatment,
specifically:
·
a decrease of at least 2 points on the BASDAI scale, compared with the pre-treatment score;
OR
·
patient and expert opinion of an adequate clinical response as indicated by a significant
functional improvement (measured by outcomes such as HAQ or "ability to return to work")
** Patients with recurrent uveitis (2 or more episodes within 12 months) as a complication of axial
disease, do not require a trial of 2 NSAIDs.
Initial Coverage Duration and Maximum Dosage approved:
Infliximab – initial coverage period 6 months, maximum dose 5mg/kg at 0, 2, and 6 weeks then every
6-8 weeks thereafter and not in combination with other anti-TNF agents
Criteria Update – Capecitabine in Colon and Rectal Cancer
Please note that effective November 1, 2012, the criteria for capecitabine (Xeloda®) in colon and rectal
cancer will change to the following:
Neo-Adjuvant and Adjuvant – Colon and Rectal Cancer
- neo-adjuvant treatment of stage II or stage III rectal cancer as a single agent prior to radiotherapy
and/or concurrent with radiotherapy
- adjuvant treatment of stage II or stage III rectal cancer as a single agent and/or concurrent with
radiotherapy
- adjuvant treatment of stage III colon cancer as a single agent
- adjuvant treatment of stage III colon or rectal cancer as part of the XELOX (CAPOX) regimen as an
alternative to infusional 5-FU in the FOLFOX regimen
Metastatic Colorectal Cancer
- first line single agent as an alternative to combination chemotherapy
- alternative to the infusional 5-FU in the FOLFOX regimen as part of the XELOX (CAPOX) regimen
PAGE 3 OF 3
VOLUME 12-10
Duration of Helicobacter pylori Eradication Treatment
Please be reminded that H.pylori eradication treatment regimens insured in the Nova Scotia Pharmacare
Programs are limited to one week of therapy. For example, coverage of the Hp-Pac is limited to one
package (1 week therapy) per person, per year. In the event of treatment failure, an alternative antibiotic
therapy should be selected. Exceptional cases can be reviewed by the Pharmacare office upon request.
The Nova Scotia Formulary is available on the Nova Scotia Pharmacare website (www.nspharmacare.ca) in
PDF and is updated on a monthly basis. Criteria for exception status drugs are available in the Formulary
as well as in a seperate document that is available on the website. Please avoid using any previous
publications, including any printed versions of the Formulary or the “Blue Book” as these are now
significantly out of date.
REQUEST FOR COVERAGE OF OSTEOPOROSIS THERAPY
PATIENT
PATIENT'S SURNAME
INFORMATION
PATIENT'S GIVEN NAME
HEALTH CARD NUMBER
DATE OF BIRTH
PATIENT'S ADDRESS
DRUG
REQUESTED
Alendronate ____mg (10mg, 70mg)
Risedronate ____mg (5mg, 35mg)
Alendronate/Cholecalciferal 70mg/5600IU
Calcitonin Nasal Spray – for fracture pain x 3 months only
The following choices must be explained:
Raloxifene 60 mg
Etidronate 200mg
Etidronate/Calcium Kit 400mg/500mg
Denosumab 60mg/mL
Zoledronic acid 5mg/100mL
Calcitonin Nasal Spray - long term
Explanation:
DIAGNOSTIC
INFORMATION
Please indicate the clinical indication for oral bisphosphonate therapy. At least one of the following
criteria must be fulfilled for coverage to be provided.
Previous/Current Fragility* Fracture (As per the 2010 Osteoporosis Canada (OC) Clinical Practice
Guidelines, fractures of the skull, hands, feet and ankles are not considered fragility fractures)
On or will be on therapy with oral prednisone for ≥ 3 months. Once prednisone is stopped assess
further need‡ for antiresorptive therapy
High 10 year fracture risk (>20%) as indicated by the radiologist on a BMD report
Exceptional circumstances predicting high 10 year fracture risk. Provide details below:
* Defined as a fracture that occurs as a result of minimal trauma such as a fall from standing height or less (at no greater than
walking speed) or no identifiable trauma. The most common fragility fractures occur in the wrist, spine and hip.
‡
The 2010 Canadian OC guidelines recommend that antiresorptive therapy be continued for at least the duration of the CS
therapy. The “at least” recognizes that fracture risk does not return to pretreatment levels immediately upon discontinuation of the
CS. Antiresorptive therapy may be continued up to 18 months after stopping corticosteroids.
COMMENTS:
PHYSICIAN’S NAME & ADDRESS:
CPSNS #: _____________
_________________________________
PHYSICIAN'S SIGNATURE
______________
DATE
12/2012
Please Return Form To: Nova Scotia Pharmacare Department, P.O. Box 500, Halifax, NS B3J 2S1
FAX: (902) 468-9402
MAY 2012 • VOLUME 12-04
Updates
Criteria Update: Olanzapine
Criteria Update: Olanzapine
Criteria Update: Terbinafine
Criteria Update: Revlimid®
New Products
Please note that effective immediately, the exception status criteria for olanzapine
ODT will change to be consistent with the olanzapine tablet criteria:
Product
Strength
Olanzapine
ODT
(Zyprexa®
Zydis® and
generic
brands)
Criteria
5mg
10mg
15mg
20mg



Decision
Highlights

DIN
Prescriber
DNP
DNP
DNP
DNP
Benefit
Status
E (SF)
E (SF)
E (SF)
E (SF)
MFR
For the treatment of schizophrenia and related psychotic
disorders upon the written request of a psychiatrist, either
first line or upon failure of other antipsychotic agents
For the acute treatment of manic or mixed episodes in
bipolar I disorder in patients with intolerance or a history of
failure to one other atypical antipsychotic
For maintenance therapy in patients with bipolar disease
who are currently stabilized on olanzapine
Olanzapine ODT is similar in price to the regular
olanzapine tablets
PAGE 2 OF 5
VOLUME 12-05
Criteria Update: Terbinafine
The following product was reviewed by the Atlantic Expert Advisory Committee (AEAC) and will be listed
with the following new criteria, effective May 4, 2012.
Product
Strength
Terbinafine
(Lamisil® and generic
brands)
Criteria
250mg Tab


DIN
Prescriber
DNP
Benefit
Status
E (SF)
MFR
For the treatment of severe onychomycosis caused by dermatophyte fungi
(Suggested treatment periods: 6 weeks for fingernails and 12 weeks for toenails.
Longer periods of time will be considered on a case by case basis)
For the treatment of dermatophyte infection unresponsive to other treatments or
unlikely to respond to other treatments due to the site or severity of the infection
Criteria Update: Revlimid®
The following products were reviewed by the Cancer Systemic Therapy Policy Committee (CSTPC) and will
be listed with the following new criteria, effective May 4, 2012.
Product
Revlimid®
(lenalidomide)
Criteria
Benefit
MFR
Status
5mg Cap
02304899
DNP
E (SFC)
CEL
CEL
10mg Cap
02304902
DNP
E (SFC)
CEL
15mg Cap
02317699
DNP
E (SFC)
CEL
25mg Cap
02317710
DNP
E (SFC)
 In combination with dexamethasone in adult patients with progressive multiple
myeloma (MM) after at least one previous treatment, not resistant to
dexamethasone, documented measurable disease and an ECOG performance
status of 0-2
 As a single agent in adult myelodysplastic syndrome (MDS) patients with
transfusion dependent anemia due to low or intermediate-1 risk MDS associated
with a deletion 5q cytogenetic abnormality with or without additional cytogenic
abnormalities
Strength
DIN
Prescriber
PAGE 3 OF 5
VOLUME 12-05
Effective May 4, 2012, the following strength of Risperdal Consta® will be added as an exception status
benefit with the following already existing criteria:
Product
Strength
DIN
Prescriber
Risperdal Consta®
(risperidone)
Criteria
12.5mg/Vial Inj
02298465
DNP
Decision Highlights




Benefit
Status
E (SF)
MFR
JAN
For patients having problems with compliance on an oral antipsychotic or
For patients who are currently receiving conventional depot antipsychotic and are
experiencing significant side effects (EPS or TD) or lack of efficacy
Other strengths of Risperdal Consta® are currently listed on the provincial
formulary as exception status.
The 12.5mg strength has a similar (slightly less) price per mg. Utilization is
expected to be low with few clinical indications for use.
The following product was reviewed by the Canadian Systemic Therapy Policy Committee (CSTPC) and will
be listed with the following criteria, effective May 4, 2012.
Product
Strength
DIN
Prescriber
Zytiga®
(abiraterone acetate)
Criteria
250mg Tab
02371065
DNP

Benefit
Status
E (SFC)
MFR
JAN
In combination with prednisone for metastatic castration resistant prostate cancer
patients with histologically confirmed prostate cancer, ECOG performance status
of 0-2 and progression after previous treatment with docetaxel
New Products
The following products are new listings to the Nova Scotia Formulary, effective May 4, 2012. The benefit
PRODUCT
STRENGTH
DIN
PRESCRIBER
MINT-Citalopram
10mg Tab
02370077
DNP
BENEFIT
STATUS
SFC
MINT-Atenol
25mg Tab
02368013
DNP
SF
MFR
MNT
MNT
PAGE 4 OF 5
VOLUME 12-05
The following products are new listings to the Nova Scotia Formulary, effective May 4, 2012, benefit status
and PRP within the Nova Scotia Pharmacare Programs are indicated.
PRODUCT
Rapid Response® Blood
Glucose Test Strips (50’s)
MyGlucoHealth® Glucose
DIN/PIN
PRP
PRESCRIBER
BENEFIT
STATUS
MFR
97799451
0.7100
DNP
SFC
BTX
97799458
0.6730
DNP
SFC
EHS
The following products were reviewed by the Canadian Drug Expert Committee (CDEC), and were not
Product
Strength
DIN
Prescriber
Brilinta®
(ticagrelor)
Decision Highlights
90mg Tab
02368544
N/A


Product
Onsolis®
(fentanyl citrate buccal
soluble film)
Decision Highlights
Benefit
Status
Not Insured
MFR
AZE
Ticagrelor is a selective and reversibly bound antagonist of the adenosine
diphosphate P2Y12 receptor.
The pre-specified subgroup analysis (by region), in one large randomized
controlled trial of patients with acute coronary syndromes, did not provide evidence
of the superiority of ticagrelor compared with clopidogrel in North American patient
population to support a higher price for ticagrelor.
Benefit
MFR
Status
200mcg Film
02350661
N/A
Not Insured MVL
400mcg Film
02350688
N/A
Not Insured MVL
600mcg Film
02350696
N/A
Not Insured MVL
800mcg Film
02350718
N/A
Not Insured MVL
1200mcg Film
02350726
N/A
Not Insured MVL
 Fentanyl citrate buccal soluble film has a Health Canada indication for the
management of breakthrough pain in cancer patients aged 18 years and older who
are already receiving and are tolerant to 60mg per day morphine equivalents for a
week or longer.
 There are no randomized controlled trials directly comparing fentanyl citrate buccal
soluble film with other less costly opioids for the management of breakthrough
cancer pain.
 The cost of fentanyl citrate buccal soluble film greatly exceeds that of other
available oral opioids.
Strength
DIN
Prescriber
PAGE 5 OF 5
VOLUME 12-05
Non-Insured Products Continued...
HIV Program at the QEII Health Sciences Centre.
Product
Strength
DIN
Prescriber
Edurant®
(rilpivirine hydrochloride)
25mg Tab
02370603
N/A
Benefit
Status
Not Insured
MFR
JAN
Legend
PRESCRIBER CODES
BENEFIT STATUS
MANUFACTURER CODES
P - Pharmacist
- Family Pharmacare
AZE
BTX
CEL
EHS
JAN
MNT
MVL
.
- AstraZeneca Canada Inc.
- BTNX Inc.
- Celgene
- Entra Health Systems
- Janssen-Ortho Inc.
- Mint Pharmaceuticals Inc.
- Meda Valeant Pharma
Canada
DECEMBER 2012 • VOLUME 12-11
Updates
Update of Criteria and New ESD
Form for Osteoporosis Therapies
Update of Criteria and New ESD Form for Osteoporosis
Therapies
- Brilinta®
- Saphris®
- Resotran®
Included with this
Bulletin:
Osteoporosis Form
Included in this bulletin is an updated form which can be used to request coverage
of therapies for the treatment of osteoporosis. The form includes all therapies
available on the formulary for this condition.
The form and the criteria for coverage for oral bisphosphates has been adjusted to
reflect current treatment and diagnostic methods. Coverage for oral
bisphosphonates includes:
1. Current/Previous Fragility Fracture
2. On or Will be on Oral Prednisone for ≥3 months
3. High Ten Year Fracture Risk (>20%) as indicated by the radiologist on a
bone mineral density (BMD) report
Note: Fracture risk tables are no longer provided on the form. Instead radiologists
use the CAROC risk assessment tool to determine the 10 year fracture risk which
considers BMD results as well as other patient factors. The radiologist typically
indicates fracture risk on the returned BMD report.
As a reminder, alendronate (10mg, 70mg), risedronate (5mg, 35mg), and
alendronate/colecalciferal 70mg/5600IU (Fosavance®) are provided as first line
therapies when a patient meets these criteria. Other therapies listed on the
request form are insured when these agents are not tolerated or are
contraindicated as per their specific criteria. Full coverage criteria for each agent
have been previously published and are detailed in the Nova Scotia Formulary
and in the Criteria for Exception Status Drugs documents available on the
Pharmacare website http://www.gov.ns.ca/health/pharmacare.
PAGE 2 OF 3
VOLUME 12-11
The following products were reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed as
exception status benefits, with the following criteria, effective December 1, 2012.
PRODUCT
STRENGTH
DIN
PRESCRIBER
Brilinta®
(ticagrelor)
90mg Tab
02368544
DNP
Criteria -
BENEFIT
STATUS
E (SF)
MFR
AZE
To be taken in combination with ASA 75 mg -150mg daily1 for patients with acute
coronary syndrome (i.e. ST elevation myocardial infarction (STEMI), non-ST
elevation myocardial infarction (NSTEMI), or unstable angina (UA), as follows:
STEMI2,3
 STEMI patients undergoing primary percutaneous coronary intervention (PCI)
NSTEMI or UA2,3
 Presence of high risk features irrespective of intent to perform
revascularization:
- High GRACE risk score (>140)
- High TIMI risk score (5-7)
- Second ACS within 12 months
- Complex or extensive coronary artery disease e.g. diffuse three vessel
disease
- Definite documented cerebrovascular or peripheral vascular disease
- Previous CABG
OR
 Undergoing PCI + high risk angiographic anatomy4
-
Coverage duration 12 months
NOTE: Criteria Code 30 (written on the prescription) may be used for the initial 30 day
coverage period, however a written request submitted to the Pharmacare office is
required to allow coverage for the remaining duration of treatment.
1
2
3
4
Co-administration of ticagrelor with high maintenance dose ASA (>150 mg daily) is not
recommended.
In the PLATO study more patients on ticagrelor experienced non CABG related major
bleeding than patients on clopidogrel, however, there was no difference between the rate
of overall major bleeding, between patients treated with ticagrelor and those treated with
clopidogrel. As with all other antiplatelet treatments the benefit/risk ratio of antithrombotic
effect vs. bleeding complications should be evaluated.
Ticagrelor is contraindicated in patients with active pathological bleeding, in those with a
history of intracranial hemorrhage and moderate to severe hepatic impairment.
High risk angiographic anatomy is defined as any of the following: left main stenting, high
risk bifurcation stenting (i.e., two-stent techniques), long stents ≥ 38 mm or overlapping
stents, small stents ≤ 2.5 mm in patients with diabetes.
PAGE 3 OF 3
VOLUME 12-11
BENEFIT
MFR
STATUS
Saphris®
5mg SL Tab
02374803
DNP
E (SF)
FRS
(asenapine)
10mg SL Tab
02374811
DNP
E (SF)
FRS
Criteria For the acute treatment of manic or mixed episodes associated with bipolar I disorder
as either:
 Monotherapy, after a trial of lithium or divalproex sodium has failed, and trials
of less expensive atypical antipsychotic agents have failed due to intolerance
or lack of response
 Co-therapy with lithium or divalproex sodium, after trials of less expensive
atypical antipsychotic agents have failed due to intolerance or lack of
response
Decision Highlights  Asenapine is an atypical antipsychotic agent available as a sublingual tablet.
 Health Canada approved asenapine for the acute treatment of manic or mixed
episodes associated with bipolar I disorder and for the treatment of schizophrenia.
 It was recommended that asenapine not be insured for the treatment of
schizophrenia. Asenapine failed to consistently demonstrate superiority in the five
placebo-controlled trials; and in one of the three trials comparing olanzapine with
asenapine, olanzapine was superior to asenapine based on the primary outcome
and a number of secondary outcomes.
PRODUCT
STRENGTH
DIN
PRESCRIBER
The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and was not
recommended to be listed as an insured benefit under the Nova Scotia Pharmacare Programs.
PRODUCT
Resotran®
(prucalopride)
Decision Highlights
BENEFIT
MFR
STATUS
1mg Tab
02377012
N/A
Not Insured JAN
2mg Tab
02377020
N/A
Not Insured JAN
 Prucalopride has a Health Canada indication for the treatment of chronic idiopathic
constipation in adult female patients in whom laxatives failed to provide adequate
relief.
 Given the uncertain clinical effectiveness in patients who had previously failed
laxative therapy, the Canadian Drug Expert Committee noted that there was
uncertainty regarding the cost-effectiveness of prucalopride.
 At the recommended daily doses, the cost of prucalopride ranges from $2.15 (1mg
for adults > 65 years) to $3.30 (2mg daily for adults ≤ 65 years). Most oral
laxatives cost < $1 a day.
STRENGTH
DIN
PRESCRIBER
Legend
PRESCRIBER CODES
P - Pharmacist
BENEFIT STATUS
- Under-65 Long Term Pharmacare
- Family Pharmacare
MANUFACTURER CODES
AZE
- AstraZeneca Canada Inc.
FRS
- Merck Canada Ltd.
JAN
- Janssen-Ortho Inc.

Nova Scotia Formulary Updates

Transcription

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