Ontario Drug Benefit Formulary/Comparative Drug Index
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1 Ontario Drug Benefit Formulary/Comparative Drug Index Edition 42 Summary of Changes - September 2014 Effective September 25, 2014 Ministry of Health and Long-Term Care
2 Table of Contents New Single Source Products... 3 New Multi-Source Products... 4 New Off-Formulary Interchangeable (OFI) Products... 8 New Nutrition Product... 9 Change to Reason For Use Content Addition of New Reason For Use Code Drug Benefit Price (DBP) Changes OFI Product Price Change Nutrition Product Name Change Discontinued Products Delisted Products
3 New Single Source Products DIN/PIN PRODUCT NAME GENERIC NAME MFR DBP Emend Tri-Pack 125mg & 80mg Cap APREPITANT MEK Reason For Use Code and Clinical Criteria Code 452 In combination with a 5HT3 receptor antagonist and dexamethasone for highly emetogenic chemotherapy (HEC) regimens: Cisplatin-based chemotherapy where a single daily dose is greater than or equal to 70 mg per meter squared Cisplatin and cyclophosphamide combinations where the single daily dose is greater than or equal to 50mg per meter squared Cisplatin (any dose) given for 3 to 5 consecutive days Non-cisplatin based highly emetogenic chemotherapy (such as those containing anthracycline greater than or equal to 60mg per meter squared plus cyclophosphamide) Dosage: Recommend aprepitant 125mg orally on Day 1 of HEC followed by 80mg orally on Days 2 to 3 post-chemotherapy for each cycle. LU Authorization Period: 1 year. Code 453 For patients receiving moderately emetogenic chemotherapy (MEC) regimens AND who have had inadequate symptom control using a 5HT3 antagonist and dexamethasone in a previous cycle. Dosage: Recommend aprepitant 125mg orally on Day 1 of MEC followed by 80mg orally on Days 2 to 3 post-chemotherapy for each cycle. LU Authorization Period: 1 year. 3
4 New Multi-Source Products DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Abbott-Rabeprazole 20mg Tab ABB (Interchangeable with Pariet) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Act Dutasteride 0.5mg Cap ACV Apo-Dutasteride 0.5mg Cap APX PMS-Dutasteride 0.5mg Cap PMS Sandoz Dutasteride Capsule 0.5mg Cap SDZ Teva-Dutasteride 0.5mg Cap TEV (Interchangeable with Avodart) Reason For Use Code and Clinical Criteria Code 384 For use in combination with an alpha blocker for the treatment of men with symptomatic* Benign Prostatic Hyperplasia. LU Authorization Period: Indefinite. Code 385 For monotherapy, as a second line agent in patients with symptomatic* Benign Prostatic Hyperplasia following treatment failure or intolerance to an alpha blocker. * Symptomatic is defined as having moderate (about half the time) to severe (almost always) symptoms related to the prostate in at least 4 of the following domains: 1. feeling of incomplete emptying of the bladder after voiding 2. needing to urinate again less than 2 hours after previous void 3. stopping and starting urine several times while voiding 4. difficulty postponing urination 5. weak urinary stream 6. pushing or straining to begin voiding 7. the need to get up to void at least 3 times in the night. LU Authorization Period: Indefinite. 4
5 New Multi-Source Products (Cont d...) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Auro-Galantamine ER 8mg ER Cap AUR Auro-Galantamine ER 16mg ER Cap AUR Auro-Galantamine ER 24mg ER Cap AUR (Interchangeable with Reminyl ER) Reason For Use Code and Clinical Criteria Code 347 Initial Trial: For patients with mild to moderate Alzheimer's Disease (Mini-Mental State Exam [MMSE] 10-26). Patients will be reimbursed for a period of up to 3 months after which continued treatment must be reassessed. Network note: Maximum duration 3 months. LU Authorization Period: 1 year. Code 348 Continuation: Further reimbursement will be made available to those patients whose disease has not progressed/deteriorated while on this drug. Patients must continue to have a MMSE score of LU Authorization Period: 1 year. 5
![2465 (Interchangeable with Reminyl ER) Reason For Use Code and Clinical Criteria Code 347 Initial Trial: For patients with mild to moderate Alzheimer's Disease (Mini-Mental State Exam [MMSE] 10-26).](/docs-images/43/18906275/images/page_5.jpg "Patients will be reimbursed for a period of up to 3 months after which continued treatment must be reassessed. Network note: Maximum duration 3 months. LU Authorization Period: 1 year.")
6 New Multi-Source Products (Cont d...) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Septa-Losartan 25mg Tab SET Septa-Losartan 50mg Tab SET Septa-Losartan 100mg Tab SET (Interchangeable with Cozaar) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Telmisartan Tablets 40mg Tab ACH Telmisartan Tablets 80mg Tab ACH (Interchangeable with Micardis) DIN/PIN BRAND NAME STRENGTH DOSAGE MFR DBP FORM Telmisartan and 80mg & 12.5mg Tab ACH Hydrochlorothiazide Tablets Telmisartan and 80mg & 25mg Tab ACH Hydrochlorothiazide Tablets (Interchangeable with Micardis Plus) 6
7 New Multi-Source Products (Cont d...) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Zoledronic Acid Injection 5mg/100mL Inj Sol-100mL Pk DRR (Interchangeable with Aclasta) Reason For Use Code and Clinical Criteria Code 319 For the treatment of Paget's disease. LU Authorization Period: Indefinite. Code 436 For the treatment of osteoporosis in postmenopausal women who would otherwise be eligible for funding for oral bisphosphonates, but for whom bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia), AND have at least two of the following:. Age greater than 75 years old. A prior fragility fracture. A bone mineral density (BMD) T-score less than or equal to -2.5 NOTE: Patients receiving Aclasta should not be receiving concomitant bisphosphonate therapy. The recommended dose of Aclasta (zoledronic acid) is a single IV injection of 5mg, once yearly. LU Authorization Period: Indefinite. 7
8 New Off-Formulary Interchangeable (OFI) Products DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Mint-Hydrochlorothiazide 12.5mg Tab MIN (Interchangeable with PMS-Hydrochlorothiazide) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST PMS-Olanzapine ODT 20mg Rapid Dissolve Tab PMS (Interchangeable with Zyprexa Zydis) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Ran-Memantine 10mg Tab RAN (Interchangeable with Ebixa) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Teva-Modafinil 100mg Tab TEV (Interchangeable with Alertec) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Zoledronic Acid for 4mg/5mL Inj Sol-5mL Pk DRR Injection Concentrate (Interchangeable with Zometa Concentrate) 8
9 New Nutrition Product DIN/PIN PRODUCT NAME STRENGTH DOSAGE FORM MFR COST/PKG AMOUNT MOH PAYS AMOUNT PATIENT PAYS KetoCal 4:1 (Unflavoured) 1.5kcal/mL Liq-237mL Tetra Pk NUT
10 Change to Reason For Use Content DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR Xarelto 15mg Tab BAH Xarelto 20mg Tab BAH Updated Reason For Use Code 444 For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) for up to six (6) months. LU Authorization Period: 6 months. Notes: The recommended dose of rivaroxaban for patients initiating DVT or PE treatment is 15mg twice daily for 3 weeks, followed by 20mg once daily. ODB Program coverage for rivaroxaban is an alternative to heparin/warfarin for up to 6 months. When used for greater than 6 months, rivaroxaban is more costly than heparin/warfarin. As such, patients with an intended duration of therapy greater than 6 months should be considered for initiation on heparin/warfarin. Since renal impairment can increase bleeding risk, it is important to monitor renal function regularly. Other factors that increase bleeding risks should also be assessed and monitored (see product monograph). 10
11 Addition of New Reason For Use Code DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR Granisetron 1mg Tab AAP Ondansetron 4mg/5mL O/L AAP Zofran 4mg/5mL O/L GSK Apo-Ondansetron 4mg Tab APX Co Ondansetron 4mg Tab COB Jamp-Ondansetron 4mg Tab JPC Mar-Ondansetron 4mg Tab MAR Mint-Ondansetron 4mg Tab MIN Mylan-Ondansetron 4mg Tab MYL Ondansetron-Odan 4mg Tab ODN PMS-Ondansetron 4mg Tab PMS Phl-Ondansetron 4mg Tab PHE Ran-Ondansetron 4mg Tab RAN Ratio-Ondansetron 4mg Tab RPH Sandoz Ondansetron 4mg Tab SDZ Septa-Ondansetron 4mg Tab SET Teva-Ondansetron 4mg Tab TEV Zofran 4mg Tab GSK Zym-Ondansetron 4mg Tab ZYN Ondissolve ODF (Film) 4mg Film TAK Zofran ODT (Tablet) 4mg Tab GSK New Reason For Use Code and Clinical Criteria in addition to the existing codes Code 454 For the treatment of emesis in cancer patients receiving moderately emetogenic chemotherapy (MEC) regimens. LU Authorization Period: 1 year. 11
12 Addition of New Reason For Use Code (Cont d ) DIN/PIN BRAND NAME STRENGTH DOSAGE MFR FORM Apo-Ondansetron 8mg Tab APX Co Ondansetron 8mg Tab COB Jamp-Ondansetron 8mg Tab JPC Mar-Ondansetron 8mg Tab MAR Mint-Ondansetron 8mg Tab MIN Mylan-Ondansetron 8mg Tab MYL Ondansetron-Odan 8mg Tab ODN PMS-Ondansetron 8mg Tab PMS Phl-Ondansetron 8mg Tab PHE Ran-Ondansetron 8mg Tab RAN Ratio-Ondansetron 8mg Tab RPH Sandoz Ondansetron 8mg Tab SDZ Septa-Ondansetron 8mg Tab SET Teva-Ondansetron 8mg Tab TEV Zofran 8mg Tab GSK Zym-Ondansetron 8mg Tab ZYN Ondissolve ODF (Film) 8mg Film TAK Zofran ODT (Tablet) 8mg Tab GSK New Reason For Use Code and Clinical Criteria in addition to the existing codes Code 454 For the treatment of emesis in cancer patients receiving moderately emetogenic chemotherapy (MEC) regimens. LU Authorization Period: 1 year. 12
13 Drug Benefit Price (DBP) Changes DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR DBP Haloperidol LA 100mg/mL Oily Inj Sol-5mL Pk SDZ Humalog Mix25 Kwikpen 25% & 75% Inj Susp-5x3mL Pk LIL
14 OFI Product Price Change DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Apo-Adefovir 10mg Tab APX
15 Nutrition Product Name Change PIN/PIN CURRENT PRODUCT NAME NEW PRODUCT NAME KetoCal 4:1 KetoCal 4:1 (Vanilla Flavoured) STRENGTH DOSAGE FORM MFR 1.5kcal/mL Liq-237mL Tetra Pk NUT 15
16 Discontinued Products (Some products will remain on Formulary for six months to facilitate depletion of supply) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR Drisdol 8288IU/mL O/L SAV Ratio-IPRA SAL UDV 500mcg/2.5mg/2.5mL Inh Sol-2.5mL Pk RPH Tamofen 10mg Tab SAV Tamofen 20mg Tab SAV Trental 400mg SR Tab SAV 16
17 Delisted Products DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR Cytosar 100mg Inj Pd-Vial Pk PFI Apo-Haloperidol 1mg Tab APX Apo-Haloperidol 10mg Tab APX Cafergot 1mg & 100mg Tab NOV * Monopril 10mg Tab BQU * Monopril 20mg Tab BQU Naprosyn 25mg/mL O/L HLR Simvastatin-Odan 5mg Tab ODN Simvastatin-Odan 10mg Tab ODN Simvastatin-Odan 20mg Tab ODN Simvastatin-Odan 40mg Tab ODN Simvastatin-Odan 80mg Tab ODN * Remain in the Formulary as reference product. 17
18 ISSN (PDF) September 2014 Queen s Printer for Ontario, 2014.
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