Nova Scotia Formulary Updates New Exception Status Benefits be listed

MAY 2014 • VOLUME 14-02
PHYSICIANS’ EDITION
Nova Scotia Formulary
Updates
New Exception Status Benefits
• Xtandi® (enzalutamide)
• Effient® (prasugrel
hydrochloride)
• Fycompa® (perampanel)
• Latuda® (lurasidone)
Criteria Updates
• Eliquis® (apixaban)
• Humira® (adalimumab)
• Votrient® (pazopanib)
New Products
Nova Scotia Formulary Updates
New Exception Status Benefits
The following product has been reviewed by the pCODR Expert Review
Committee (pERC) and will be listed as an exception status benefit, with the
following criteria effective May 20, 2014.
PRODUCT
STRENGTH
Xtandi®
40mg Cap
(enzalutamide)
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
02407329
DNP
E
ASL
New Diabetic Products
Pharmacare Reminders
Smaller Quantities
Nova Scotia Pharmacare Programs
Contact Information
Included with this
Bulletin
Proton Pump Inhibitor (PPI) Form
Criteria •
For the treatment of patients with metastatic castrationresistant prostate cancer who have previously received
docetaxel therapy with the following criteria:
o
As a single agent treatment option for metastatic
CRPC patients with ECOG PS 0-2, no risk for
seizures and progression after previous
treatment with docetaxel.
o
Enzalutamide would be an alternative to
abiraterone for patients in the post-docetaxel
setting and not a sequential therapy.
PAGE 2 OF 7
PHYSICIANS’ EDITION
VOLUME 14-02
New Exception Status Benefits Continued…
The following products have been reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed as
exception status benefits, with the following criteria effective May 20, 2014.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Effient®
(prasugrel
hydrochloride)
10mg Tab
02349124
DNP
E
LIL
Criteria •
•
In combination with ASA for patients with:
o
ST-elevated myocardial infarction (STEMI) undergoing primary percutaneous
coronary intervention (PCI) who have not received antiplatelet therapy prior to
arrival in the catheterization lab.
o
Treatment must be initiated in hospital.
o
Approval period 12 months (up to 3 months for patients with bare metal stents).
Notes:
1. Criteria Code 30 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.
2. As per the product monograph, prasugrel is contraindicated in patients with a
known history of transient ischemic attack or stroke; those with active
pathological bleeding such as gastrointestinal bleeding or intracranial
hemorrhage; and those with severe hepatic impairment (Child-Pugh Class C).
3. As per the product monograph, prasugrel is not recommended in patients ≥ 75
years of age because of the increase risk of fatal and intracranial bleeding; or
those with body weight < 60k kg because of increased risk of major bleeding due
to an increase in exposure to the active metabolite of prasugrel.
PAGE 3 OF 7
PHYSICIANS’ EDITION
VOLUME 14-02
New Exception Status Benefits Continued…
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Fycompa®
(perampanel)
2mg Tab
02404516
DNP
E
EIS
4mg Tab
02404524
DNP
E
EIS
6mg Tab
02404532
DNP
E
EIS
8mg Tab
02404540
DNP
E
EIS
10mg Tab
02404559
DNP
E
EIS
12mg Tab
02404567
DNP
E
EIS
Criteria •
Decision Highlights •
As an adjunctive therapy in the management of partial-onset seizures, in adult patients
with epilepsy who are not satisfactorily controlled with conventional therapy who meet all
of the following criteria:
o
Are under the care of a physician experienced in the treatment of epilepsy;
o
Are currently receiving two or more antiepileptic drugs; and
o
In whom all other antiepileptic drugs are ineffective or not appropriate.
Perampanel is cost neutral when used in adult patients with partial-onset seizures
compared to other adjunct therapies, such as lacosamide. The Committee noted,
however, that the combination of perampanel and lacosamide has not been studied and
this combination would be more costly than other combinations of antiepileptic drugs.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Latuda®
(lurasidone)
40mg Tab
02387751
DNP
E
SNV
80mg Tab
02387778
DNP
E
SNV
120mg Tab
02387786
DNP
E
SNV
Criteria •
For the treatment of schizophrenia or schizoaffective disorder in patients who have a
contraindication to quetiapine and risperidone, or have failed a trial of quetiapine and
risperidone due to intolerance or lack of response.
PAGE 4 OF 7
PHYSICIANS’ EDITION
VOLUME 14-02
Criteria Update: Eliquis®
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 May 20, 2014.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Eliquis®
(apixaban)
2.5mg Tab
02377233
DNP
E
BRI
Criteria •
•
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]
• Notes:
1. The total duration of therapy includes the period during which doses are
administered post-operatively in an acute care (hospital) setting, and the
approval period is for the balance of the total duration after discharge.
2. The first dose is typically administered 12 to 24 hours after surgery, assuming
adequate hemostasis has been achieved.
3. The ADVANCE clinical trial program did not evaluate the efficacy or safety of
sequential use of molecular weight heparin followed by apixaban for the
prophylaxis of VTE. Due to the current lack of evidence for sequential use,
coverage is not intended for this practice.
4. Clinical judgment is warranted to assess the increased risk for VTE and/or
adverse effects in patients with a history of previous VTE, myocardial infarction,
transient ischemic attack or ischemic stroke; a history of intraocular or
intracerebral bleeding; a history of gastrointestinal disease with gastrointestinal
bleeding; moderate or severe renal insufficiency (estimated creatinine clearance
<30 mL/min); severe liver disease; concurrent use of other anticoagulants; or age
greater than 75 years.
5. Apixaban has not been studied in clinical trials in patients undergoing hip fracture
surgery, and is not recommended in these patients.
Decision Highlights •
Apixaban (2.5mg twice daily) compared with enoxaparin (40mg daily) following total knee
or hip replacement surgeries was associated with a statistically significant lower incidence
of the primary composite end point (deep vein thrombosis, pulmonary embolism, and
death from any cause).
PAGE 5 OF 7
PHYSICIANS’ EDITION
VOLUME 14-02
Criteria Update: Humira®
The following product was reviewed by the Canadian Drug Expert Committee (CDEC) and will be listed with the
following new criteria May 20, 2014.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Humira®
(adalimumab)
50mg/mL
02258595
DNP
E
ABV
Criteria •
For the treatment of polyarticular juvenile idiopathic arthritis (pJIA)with the following
criteria:
o
For patients aged 4-17 years with moderately or severe pJIA who have had an
inadequate response to one or more disease-modifying anti-rheumatic drugs
(DMARDs); and
•
Treatment must be initiated by a rheumatologist who is familiar with the use of DMARDs
and/or biologic DMARDs in children.
Decision Highlights •
Adalimumab, with or without methotrexate, has been shown to be superior to placebo for
reducing the proportion of polyarticular juvenile idiopathic arthritis (pJIA) patients with
experiencing a disease flare. Adalimumab with methotrexate in pJIA patients has also
been shown to be superior to placebo with methotrexate for achieving an American
College of Rheumatology (ACR) pediatric (Pedi) 30 and ACR Pedi 70 response.
Criteria Update: Votrient®
The following product was reviewed by the pCODR Expert Review Committee (pERC) and will be listed with the
following new criteria effective May 20, 2014.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Votrient®
(pazopanib)
200mg Tab
02352303
D
E
GSK
Criteria •
As a single agent first-line treatment option for patients with documented evidence of
histologically confirmed advanced or metastatic clear cell renal cell carcinoma (RCC) who
have an ECOG PS of 0 or 1. In any one patient, all the following conditions must be met:
o
Pazopanib may be a first line option.
o
Pazopanib may not be used after another VEGF tyrosine kinase inhibitor as
sequential therapy.
o
In the event of significant toxicity, a switch to another VEGF tyrosine kinase
inhibitor may be allowed.
PAGE 6 OF 7
PHYSICIANS’ EDITION
VOLUME 14-02
New Products
The following products are new listings to the Nova Scotia Formulary, effective May 20, 2014. The benefit status
within the Nova Scotia Pharmacare Programs is indicated.
PRODUCT
STRENGTH
DIN
PRESCRIBER
BENEFIT
STATUS
MFR
Epuris®
(isotretinoin)
10mg Tab
02396971
DNP
F
CIP
20mg Tab
02396998
DNP
F
CIP
30mg Tab
02397005
DNP
F
CIP
40mg Tab
02397013
DNP
F
CIP
25mg Tab
02388839
DNP
E
FRS
50mg Tab
02388847
DNP
E
FRS
Januvia®
(sitagliptin)
New Diabetic Products
The following products are a new listing to the Nova Scotia Formulary, effective June 9, 2014. The benefit status
and reimbursement price within the Nova Scotia Pharmacare Programs is indicated.
PRODUCT
DIN/PIN
MRP
PRESCRIBER
BENEFIT
STATUS
MFR
BD Ultra-Fine II Syringes, 0.5cc, 31g
97799385
0.3555
DNP
SFD
BTD
BD Ultra-Fine II Syringes, 1cc, 31g
97799384
0.3555
DNP
SFD
BTD
Legend
PRESCRIBER CODES
BENEFIT STATUS
D - Physician / Dentist
S
- Seniors’ Pharmacare
ABV
- AbbVie Corporation
N - Nurse Practitioner
F
- Community Services Pharmacare
ASL
- Astellas Pharma Canada Inc.
P - Pharmacist
C
D
E
MANUFACTURER CODES
BRI
- Family Pharmacare
- Drug Assistance for Cancer Patients
BTD
- Diabetes Assistance Program
CIP
- Exception status applies
EIS
- Bristol-Myers Squibb Canada Inc.
- Becton Dickinson Canada Inc.
- Cipher Pharmaceuticals Inc.
- Eisai Limited
FRS
- Merck Canada Ltd.
GSK
- GlaxoSmithKline Inc.
LIL
- Eli Lilly Canada Inc.
SNV
- Sunovion Pharmaceuticals Inc.
PAGE 7 OF 7
PHYSICIANS’ EDITION
VOLUME 14-02
Pharmacare Reminders
Smaller Quantities
In order to minimize calls from pharmacies relating to smaller quantities, please refer to the statement below which
was included in the Pharmacare News Pharmacists’ Edition:
“The Pharmacare Programs will not pay multiple dispensing fees where the pharmacist dispenses a
quantity less than the quantity prescribed. Therefore, more than one dispensing fee cannot be charged on a
prescription when the original quantity is reduced and refills are generated, (even at the beneficiary’s
request) unless the prescriber is contacted and the reduced quantity plus refills are authorized”.
Nova Scotia Pharmacare Programs Contact Information
To ensure accurate and prompt responses, please select the following automated options when phoning Nova Scotia
Pharmacare Programs.
496-7001 or 1-800-305-5026
Option 1: Seniors Pharmacare Inquires
Option 2: Nova Scotia Family Pharmacare Inquires
Option 3: Claim Inquires/ Information regarding other Pharmacare Programs/
General Inquires
Option 4: Physicians/ Criteria/ Specific Exception Status Drug (ESD) Inquires
Option 5: Audit