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