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