New Exception Status Benefits

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1 JULY 2012 Nova Scotia Formulary Updates New Exception Status Benefits Criteria Update: Xarelto Criteria Update: Sutent New Diabetic Products PRP Non-Insured Products Pharmacare Reimbursement Changes to Generic Drug Pricing New Products Added to Reimbursement List PRP Standardization of Package Sizes Pharmacare Reimbursement Price (PRP) Transition Fees Included with this Bulletin Prescriber List Reimbursement List 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 July 3, PRODUCT STRENGTH DIN PRESCRIBER Visanne (dienogest) Criteria Decision Highlights 2mg Tab DNP E(SF) BAY 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.

2 PAGE 2 OF 8 New Exception Status Benefits continued 120mg/1.7mL Sol DNP E(SFC) AGA PRODUCT STRENGTH DIN/PIN PRESCRIBER Xgeva (denosumab) Criteria Decision Highlights 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, mg Tab DNP E(SFC) GSK PRODUCT STRENGTH DIN/PIN PRESCRIBER Votrient (pazopanib) Criteria Decision Highlights 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.

3 PAGE 3 OF 8 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, mg Tab DNP E(SF) BAY PRODUCT STRENGTH DIN/PIN PRESCRIBER Xarelto (rivaroxaban) Criteria Decision Highlights Criteria Update: Sutent 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 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, PRODUCT STRENGTH DIN/PIN PRESCRIBER Sutent (sunitinib) Criteria 12.5mg Cap 25mg Cap 50mg Cap Decision Highlights DNP DNP DNP E(SFC) E(SFC) PFI PFI PFI E(SFC) 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 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).

4 PAGE 4 OF 8 New Diabetic Products - PRP The following products are new listings to the Nova Scotia Formulary, effective July 3, The benefit status and PRP within the Nova Scotia Pharmacare Programs is indicated. PRODUCT DIN/PIN PRP PRESCRIBER Contour NEXT Blood Glucose Test Strips (50 s) Contour NEXT Blood Glucose Test Strips (100 s) Non-Insured Products DNP SFD BDD DNP SFD BDD The following product was reviewed by the Canadian Drug Expert Committee (CDEC), and was not recommended to be listed as an insured benefit under the Nova Scotia Pharmacare Programs. PRODUCT STRENGTH DIN PRESCRIBER Ozurdex (dexamethasone) 0.7mg Intravitreal Implant N/A Not Insured ALL 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.

5 PAGE 5 OF 8 Pharmacare Reimbursement Changes to Generic Drug Pricing The province has developed a plan to get fair drug prices for Nova Scotians and to slow the rapid growth of spending on drugs through Pharmacare. As a result the price of generic drugs changed under the Pharmacare Programs on July 1, The third phase of the change is July 1, 2012, and generic prices are being reduced to 35% of the cost of the equivalent brand drug. Some generic drugs have exceptions to the Maximum Reimbursable Price (MRP) formula, and their MRP is also included in the Reimbursement List. Included with this bulletin is the Reimbursement List with the pricing for the Pharmacare Programs. It contains the MRP and Pharmacare Reimbursement Price (PRP) for applicable drugs. A copy of the Reimbursement List is also available online at For the products on the Reimbursement List, unless otherwise indicated, the MRP is effective August 1, Manufacturers will begin selling their products at the new lower price effective July 1, As a result of the changes, the following products will no longer be eligible benefits as of August 1, 2012: DIN PRODUCT DIN PRODUCT Amoxicillin 250mg chew tab ratio-meloxicam 7.5mg tab Apo-Ciproflox 0.3% oph sol ratio-meloxicam 15mg tab pms-bromocriptine 2.5mg tab ratio-mirtazapine 30mg tab pms-bromocriptine 5mg cap Nabumetone 500mg tab Clonidine 0.025mg tab ratio-pantoprazole 20mg DR tab Clonidine 0.1mg tab ratio-pantoprazole 40mg DR tab Nu-Clonidine 0.1mg tab Jamp-Pioglitazone 30mg Tab Clonidine 0.2mg tab Jamp-Pioglitazone 45mg Tab Nu-Clonidine 0.2mg tab ratio-quetiapine 25mg tab Dihydroergotamine 1mg/mL inj ratio-quetiapine 100mg tab RAN-Fentanyl 25mcg/hr patch ratio-quetiapine 200mg tab RAN-Fentanyl 50mcg/hr patch ratio-quetiapine 300mg tab RAN-Fentanyl 75mcg/hr patch ratio-ramipril 1.25mg cap RAN-Fentanyl 100mcg/hr patch ratio-ramipril 2.5mg cap ratio-gabapentin 300mg cap ratio-ramipril 5mg cap

6 PAGE 6 OF 8 Changes to Generic Drug Pricing Continued DIN PRODUCT DIN PRODUCT ratio-ramipril 10mg cap Sandoz Sotalol 160mg tab ratio-ramipril 15mg cap ratio-temazepam 15mg cap ratio-ranitidine 300mg tab ratio-temazepam 30mg cap ratio-sertraline 25mg cap MYLAN-Trazodone 50mg tab ratio-sertraline 50mg cap MYLAN-Trazodone 100mg tab ratio-sertraline 100mg cap ratio-valproic 250mg cap ratio-simvastatin 10mg tab Taro-Warfarin 6mg tab ratio-simvastatin 20mg tab Warfarin 7.5mg tab ratio-simvastatin 40mg tab ratio-simvastatin 80mg tab New Products Added to Reimbursement List PRP The following products now have a PRP, effective August 1, The PRP within the Nova Scotia Pharmacare Program is indicated. PRODUCT lansoprazole 15mg cap DIN PRP (EFFECTIVE AUGUST 1, 2012) PRESCRIBER Apo-Lansoprazole 15mg DR cap DNP E APX Lansoprazole 15mg DR cap DNP E SAS MYLAN-Lansoprazole 15mg DR cap DNP E MYL Novo-Lansoprazole 15mg DR cap DNP E TEV Prevacid 15mg cap DNP E ABB pantoprazole 20mg EC tab Apo-Pantoprazole 20mg DR tab DNP E APX Pantoloc 20mg DR tab DNP E NYC RAN-Pantoprazole 20mg DR tab DNP E RAN Sandoz Pantoprazole 20mg DR tab DNP E SDZ Teva-Pantoprazole 20mg DR tab DNP E TEV

7 PAGE 7 OF 8 Standardization of Package Sizes In order to ensure claims are paid correctly, pharmacists are reminded that the Pharmacare Programs have developed guidelines for the standardization of package sizes. Please use the following guidelines when calculating quantities for each claim and ensure your cost per unit is correct in your system. FORM QUANTITY FORM QUANTITY Aeosols Per dose Nasal sprays Per dose Capsules Per capsule Nebules Per ml Creams Per gram Ointments Per gram Enemas Per ml Oral contraceptives As 21 or 28 Gels Per gram Ostomy supplies Per item (e.g. 20 pouches) Inhalers Per dose Patches Per patch Insulin Per ml Powders Per gram Kits Per kit Powder injectables Per vial Lancets Per lancet Suppositories Per suppository Liquid injectables Per ml Tablets Per tablet Liquids (excluding methadone) Liquid methadone Per ml Testing strips Per testing strip Per mg FORM Package/Kits of more than one drug (e.g., HP-Pac, Monistat 3 Dual-Pack, Didrocal ) Packages of blood glucose testing strips with built-in meter (e.g., Sidekick Blood Glucose Testing System) QUANTITY Per package Per test strip The majority of calls received regarding billing involve the following products: Humira - Claims should be billed by ml, and not by syringes (i.e., one syringe is 0.8mL). Simponi - Claims should be billed per ml, and not by syringe (i.e., one syringe is 0.5mL). Miacalcin and generics Claims should be billed per dose not by package or bottle (i.e., one box is 28 doses). Didrocal kit and generics Claims should be billed per kit and not number of tablets (i.e., one box is one kit).

8 PAGE 8 OF 8 Pharmacare Reimbursement Price (PRP) PRP is the special maximum price assigned to: certain groups of drugs that are similar in therapeutic effect; specific services for which coverage is established; certain unit dose and special delivery formats that are also available in less expensive bulk formats; and certain supplies that are used for the same function. The PRP is the maximum amount the Pharmacare Program reimburses providers for one unit of a drug (tablet, capsule, ml, etc.) supply or service. In the case of methadone, one unit is a milligram. According to the current Tariff Agreement between the Department of Health and Wellness and the Pharmacy Association of Nova Scotia, when a PRP applies, pharmacies are reimbursed the PRP plus a 6% mark up (to a maximum of $250), plus the dispensing fee and the transition fee. Providers may charge the beneficiary the portion of their Actual Acquisition Cost (AAC) that exceeds the PRP, but are not permitted to charge the beneficiary any excess mark-up, transition fee or dispensing fee beyond what is set out in the Tariff Agreement. Any extra cost is not counted toward the beneficiary s annual maximum copayment or annual maximum deductible. A complete list of current MRP and PRP and can be found on the Reimbursement List on the Pharmacare website at Transition Fees for the period of April 1, 2012 to March 31, 2013 According to Section 6 of the Tariff Agreement, the provider is entitled to bill a transition fee up to $0.75 per prescription. Transition fees are to be submitted with the dispensing fee. There will be no retroactive payment of transition fees.