Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Nova Scotia Formulary Updates
Document related concepts
Transcript
FEBRUARY 2012 • VOLUME 12-01 PHYSICIANS’ EDITION Nova Scotia Formulary Updates New Products New Diabetic Products – PRP Nova Scotia Formulary Updates 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 PHYSICIANS’ EDITION 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 (potassium chloride) 1500mg (20mgEq) SR Tab 80013007 DNP SFC JPC ODAN K-20 (potassium chloride) 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 PHYSICIANS’ EDITION VOLUME 12-01 New Diabetic Products 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/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 New Exception Status Benefits 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 PHYSICIANS’ EDITION VOLUME 12-01 New Exception Status Benefits continued… PRODUCT DIN PRESCRIBER Novo-Methylphenidate ER-C 18mg Tab 02315068 D BENEFIT STATUS E (F) Novo-Methylphenidate ER-C 27mg Tab 02315076 D E (F) TEV Novo-Methylphenidate ER-C 36mg Tab 02315084 D E (F) TEV Novo-Methylphenidate ER-C 54mg tab 02315092 D E (F) TEV Criteria Decision Highlights 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 PHYSICIANS’ EDITION VOLUME 12-01 New Exception Status Benefits continued… 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 PHYSICIANS’ EDITION VOLUME 12-01 New Exception Status Benefits continued… 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 PHYSICIANS’ EDITION 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. Non-Insured Products 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION Nova Scotia Formulary Updates OxyContin®/OxyNEO® Communication Palliative Home Care Drug Coverage Program Exception Status Drugs New Products Non-Insured Products Changes to the Nova Scotia Formulary on the Pharmacare Website Included with this Bulletin Palliative Home Care Medication Authorization Form Nova Scotia Formulary Updates 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION 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 Non-Insured Products 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 PHYSICIANS’ EDITION VOLUME 12-02 Legend PRESCRIBER CODES BENEFIT STATUS MANUFACTURER CODES D N P S F ABB ALL NVR - Physician / Dentist - Nurse Practitioner - Pharmacist C E - Seniors’ Pharmacare - Community Services Pharmacare - Under 65-Long Term Care Pharmacare - Family Pharmacare - Drug Assistance for Cancer Patients - Exception status applies PFR PMS - Abbott Laboratories Inc. - Allergan Inc. - Novartis Pharmaceuticals 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 NOVA SCOTIA PROVINCIAL PHARMACARE PROGRAMS 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) 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. 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: _______________________________ 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 APRIL 2012 • VOLUME 12-03 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary 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 PHYSICIANS’ EDITION 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) Non-verbal, non-ambulatory Adapted from: Reisberg, B. Functional Assessment Staging (FAST). Psychopharmacology Bulletin 1988;24(4):653-9 PAGE 3 OF 4 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION VOLUME 12-03 Understanding Generic Drugs 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. 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 Pradax® 110mg bid Pradax® 150mg 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 ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ 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 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 PHYSICIANS’ EDITION Nova Scotia Formulary Updates New Exception Status Benefits Criteria Updates: Xeloda®, Gleevec® Non-Insured Products Legend Included with this Bulletin Request for Coverage of Dabigatran (Pradax®) Form Pradax® Information Sheet Nova Scotia Formulary Updates New Exception Status Benefits 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 PHYSICIANS’ EDITION VOLUME 12-05 New Exception Status Benefits continued… 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION 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 Non-Insured Products The following products were reviewed by the Canadian Drug Expert Committee (CDEC), and were not recommended to be listed as insured benefits under the Nova Scotia Pharmacare Programs. 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 PHYSICIANS’ EDITION 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 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 ACT BOE EIS GIL HLR NVR - Actelion Pharmaceuticals Canada Ltd. - Boehringer Ingelheim (Canada) Ltd. - Eisai Limited - Gilead Sciences Inc. - Hoffmann-LaRoche Limited - Novartis Pharmaceuticals Canada Inc. JULY 2012 • VOLUME 12-06 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary Updates New Exception Status Benefits New Exception Status Benefits Criteria Update: Xarelto® Criteria Update: Sutent® New Diabetic Products Non-Insured Products 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 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 PHYSICIANS’ EDITION VOLUME 12-06 New Exception Status Benefits continued… PRODUCT STRENGTH DIN/PIN PRESCRIBER Xgeva® (denosumab) 120mg/1.7mL Sol 02368153 DNP Criteria Decision Highlights 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 Decision Highlights 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 PHYSICIANS’ EDITION 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 Decision Highlights 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 PHYSICIANS’ EDITION VOLUME 12-06 New Diabetic Products The following products are new listings to the Nova Scotia Formulary, effective July 3, 2012. The benefit status within the Nova Scotia Pharmacare Programs is indicated. PRODUCT Contour® NEXT Blood Glucose Test Strips (50’s) Contour® NEXT Blood Glucose Test Strips (100’s) DIN/PIN PRESCRIBER BENEFIT STATUS MFR 97799460 DNP SFD BDD 97799459 DNP SFD BDD Non-Insured Products 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 PHYSICIANS’ EDITION VOLUME 12-06 Legend PRESCRIBER CODES BENEFIT STATUS MANUFACTURER CODES D N P S F AGA ALL BAY BDD - Physician / Dentist - Nurse Practitioner - Pharmacist C D E - Seniors’ Pharmacare - Community Services Pharmacare - Under 65-Long Term Care 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 - GlaxoSmithKline Inc. - Pfizer Canada Inc. AUGUST 2012 • VOLUME 12-07 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary Updates New Exception Status Benefits New Exception Status Benefits New Product Non-Insured Products New Ostomy Products The following product will be listed as an exception status benefit, with the following criteria, effective August 1, 2012. Understanding Generic Drugs 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 PHYSICIANS’ EDITION 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. Non-Insured Products The following products were reviewed by the Canadian Drug Expert Committee (CDEC) and were not recommended to be listed as insured benefits under the Nova Scotia Pharmacare Programs. 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 PHYSICIANS’ EDITION 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 The following product was not recommended to be listed as a benefit, however, will be funded through the 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 Esteem + Closed Pouch 95098118 416701 DNP SFC CON Esteem + Closed Pouch 95098117 416702 DNP SFC CON Esteem + Closed Pouch 95098116 416703 DNP SFC CON Esteem + Closed Pouch 95098115 416704 DNP SFC CON Esteem + Closed Pouch 95098114 416705 DNP SFC CON Esteem + Closed Pouch 95098113 416706 DNP SFC CON Esteem + Closed Pouch 95098112 416707 DNP SFC CON PAGE 4 OF 6 PHYSICIANS’ EDITION VOLUME 12-07 New Ostomy Products Continued… PRODUCT DIN/PIN PRODUCT NUMBER PRESCRIBER BENEFIT STATUS MFR Esteem + Closed Pouch 95098111 416708 DNP SFC CON Esteem + Closed Pouch 95098110 416709 DNP SFC CON Esteem + Closed Pouch 95098109 416710 DNP SFC CON Esteem + Closed Pouch 95098108 416711 DNP SFC CON Esteem + Closed Pouch 95098107 416712 DNP SFC CON Esteem + Closed Pouch 95098106 416713 DNP SFC CON Esteem + Closed Pouch 95098105 416714 DNP SFC CON Esteem + Closed Pouch 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 Esteem + Closed 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 Esteem + Closed Pouch 95098090 416721 DNP SFC CON Esteem + Closed Pouch 95098089 416724 DNP SFC CON Esteem + Closed Pouch 95098088 416728 DNP SFC CON Esteem + Closed Pouch 95098087 416732 DNP SFC CON Esteem + Closed Pouch 95098086 416736 DNP SFC CON Esteem + Closed Pouch 95098082 416742 DNP SFC CON Esteem + Drainable Pouch 95098084 416738 DNP SFC CON PAGE 5 OF 6 PHYSICIANS’ EDITION VOLUME 12-07 New Ostomy Products Continued… 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 Natura + Closed Pouch 95098065 416401 DNP SFC CON Natura + Closed Pouch 95098064 416402 DNP SFC CON Natura + Closed Pouch 95098063 416403 DNP SFC CON Natura + Closed Pouch 95098062 416404 DNP SFC CON Natura + Closed Pouch 95098061 416405 DNP SFC CON Natura + Closed Pouch 95098060 416406 DNP SFC CON Natura + Closed Pouch 95098059 416407 DNP SFC CON Natura + Closed Pouch 95098058 416408 DNP SFC CON Natura + Closed Pouch 95098057 416409 DNP SFC CON Natura + Closed Pouch 95098056 416410 DNP SFC CON PAGE 6 OF 6 PHYSICIANS’ EDITION VOLUME 12-07 New Ostomy Products Continued… PRODUCT DIN/PIN PRODUCT NUMBER PRESCRIBER BENEFIT STATUS MFR Natura + Closed Pouch 95098055 416411 DNP SFC CON Natura + Closed Pouch 95098054 416412 DNP SFC CON Natura + Closed Pouch 95098053 416413 DNP SFC CON Legend PRESCRIBER CODES BENEFIT STATUS MANUFACTURER CODES D - Physician / Dentist N - Nurse Practitioner P - Pharmacist 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 CON FRS GIL GSK SAV WTS - ConvaTec Canada Ltd. - Merck Canada Ltd. - Gilead Sciences Inc. - GlaxoSmithKline Inc. - Sanofi-Aventis Canada Inc. - Watson Pharma Company Understanding Generic Drugs 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 Pradax® 110mg bid Pradax® 150mg 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]: ___________________ mg/dL Date: ___________________ Creatinine clearance [CrCl]: ___________________ mL/min 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: Dose, length of therapy, and outcome: (i.e. inadequate anticoagulation*, etc.) 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. If warfarin has not been tried, please indicate the reason why: Warfarin contraindicated _____________________________________________________________________________________________ Other ____________________________________________________________________________________________________________ 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 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 NOVA SCOTIA PROVINCIAL PHARMACARE PROGRAMS 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 Pradax® 110mg bid Pradax® 150mg bid Xarelto® 15mg once daily Xarelto® 20mg once daily 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: ___________________ 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: - Pradax® 150mg bid - Xarelto® 20 mg once daily Age > 80 years: - Pradax® 110mg bid - Xarelto® 20 mg or 15 mg once daily as appropriate 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 ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ 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 09/2012 SEPTEMBER 2012 • VOLUME 12-08 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary Updates New Exception Status Benefits New Exception Status Benefits Criteria Updates: Pegasys RBV®, Pegetron® and Pegetron® Redipen Injection Criteria Update: Afinitor® 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 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) Request for Coverage of Dabigatran (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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION VOLUME 12-08 New Exception Status Benefits cont’d… Decision Highlights 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION 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 benefit status within the Nova Scotia Pharmacare Programs is indicated. 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 D - Physician / Dentist N - Nurse Practitioner P - Pharmacist S - Seniors’ Pharmacare F - Community Services Pharmacare - Under-65 Long Term Pharmacare - Family Pharmacare C - Drug Assistance for Cancer Patients D - Diabetes Assistance Program E - Exception status applies 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 PHYSICIANS’ EDITION Included with this Bulletin Request for Coverage of Dabigatran (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 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary 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) Nova Scotia Formulary 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION 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. Nova Scotia Formulary 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 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary Updates Criteria Update: Olanzapine Criteria Update: Olanzapine Criteria Update: Terbinafine Criteria Update: Revlimid® New Exception Status Benefits New Products New Diabetic Products Non-Insured 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 PHYSICIANS’ EDITION 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 PHYSICIANS’ EDITION VOLUME 12-05 New Exception Status Benefits 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 status within the Nova Scotia Pharmacare Programs is indicated. 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 PHYSICIANS’ EDITION VOLUME 12-05 New Diabetic Products 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 Test Strips (50’s) DIN/PIN PRP PRESCRIBER BENEFIT STATUS MFR 97799451 0.7100 DNP SFC BTX 97799458 0.6730 DNP SFC EHS Non-Insured Products The following products were reviewed by the Canadian Drug Expert Committee (CDEC), and were not recommended to be listed as insured benefits under the Nova Scotia Pharmacare Programs. 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 PHYSICIANS’ EDITION 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 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 D - Physician / Dentist N - Nurse Practitioner P - Pharmacist 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 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 PHYSICIANS’ EDITION Nova Scotia Formulary Updates Nova Scotia Formulary Updates Update of Criteria and New ESD Form for Osteoporosis Therapies Update of Criteria and New ESD Form for Osteoporosis Therapies New Exception Status Benefits - Brilinta® - Saphris® Non-Insured Products - 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 PHYSICIANS’ EDITION VOLUME 12-11 New Exception Status Benefits 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 PHYSICIANS’ EDITION VOLUME 12-11 New Exception Status Benefits continued… 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 Non-Insured Products 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 D - Physician / Dentist N - Nurse Practitioner P - Pharmacist BENEFIT STATUS S - Seniors’ Pharmacare F - Community Services Pharmacare - Under-65 Long Term Pharmacare - Family Pharmacare E - Exception status applies MANUFACTURER CODES AZE - AstraZeneca Canada Inc. FRS - Merck Canada Ltd. JAN - Janssen-Ortho Inc.
