Ontario Drug Benefit Formulary/Comparative Drug Index
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1 Ontario Drug Benefit Formulary/Comparative Drug Index Edition 42 Summary of Changes - November 2014 Effective November 27, 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... 9 Drug Benefit Price (DBP) Changes Product Formulation Change Product Manufacturer Name Changes Discontinued Products Delisted Products
3 New Single Source Products DIN/PIN PRODUCT NAME, STRENGTH & DOSAGE FORM GENERIC NAME MFR DBP Jetrea 2.5mg/mL Inj Sol-0.2mL Vial Pk (Preservative-Free) OCRIPLASMIN ALC Reason For Use Code and Clinical Criteria Code 455 For the treatment of symptomatic vitreomacular adhesion (VMA) that has been confirmed through optical coherence tomography. Patients should not have any of the following: large diameter macular holes (greater than 400 micrometres), high myopia (greater than 8 dioptre spherical correction or axial length greater than 28 millimetres), aphakia, history of retinal detachment, lens zonule instability, recent ocular surgery or intraocular injection (including laser therapy), proliferative diabetic retinopathy, ischemic retinopathies, retinal vein occlusions, exudative age-related macular degeneration, or vitreous hemorrhage. Ocriplasmin should be administered by a qualified ophthalmologist experienced in intravitreal injections and should be limited to a single injection per eye (i.e., retreatments are not covered). LU Authorization period: 1 year DIN/PIN GENERIC NAME MFR DBP PRODUCT NAME, STRENGTH & DOSAGE FORM Komboglyze 2.5mg & 500mg Tab SAXAGLIPTIN & METFORMIN AZC Komboglyze 2.5mg & 850mg Tab SAXAGLIPTIN & METFORMIN AZC Komboglyze 2.5mg & 1000mg Tab SAXAGLIPTIN & METFORMIN AZC Therapeutic Note: Treatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; or Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. 3
4 New Multi-Source Products PMS-Azithromycin 100mg/5mL O/L-15mL Pk PMS (Interchangeable with Zithromax DIN ) PMS-Azithromycin 200mg/5mL O/L-15mL Pk PMS (Interchangeable with Zithromax DIN ) PMS-Azithromycin 200mg/5mL O/L-22.5mL Pk PMS (Interchangeable with Zithromax PIN ) 4
5 New Multi-Source Products (Cont d...) Mint-Dutasteride 0.5mg Cap MIN (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. 5
6 New Multi-Source Products (Cont d...) Apo-Escitalopram 10mg Tab APX Co Escitalopram 10mg Tab COB Jamp-Escitalopram 10mg Tab JPC Mar-Escitalopram 10mg Tab MAR Mylan-Escitalopram 10mg Tab MYL PMS-Escitalopram 10mg Tab PMS Ran-Escitalopram 10mg Tab RAN Sandoz Escitalopram 10mg Tab SDZ Teva-Escitalopram 10mg Tab TEV (Interchangeable with Cipralex) Apo-Escitalopram 20mg Tab APX Co Escitalopram 20mg Tab COB Jamp-Escitalopram 20mg Tab JPC Mar-Escitalopram 20mg Tab MAR Mylan-Escitalopram 20mg Tab MYL PMS-Escitalopram 20mg Tab PMS Ran-Escitalopram 20mg Tab RAN Sandoz Escitalopram 20mg Tab SDZ Teva-Escitalopram 20mg Tab TEV (Interchangeable with Cipralex) 6
7 New Multi-Source Products (Cont d...) Ach-Ezetimibe 10mg Tab ACH Act Ezetimibe 10mg Tab ACV Apo-Ezetimibe 10mg Tab APX Jamp-Ezetimibe 10mg Tab JPC Mar-Ezetimibe 10mg Tab MAR Mint-Ezetimibe 10mg Tab MIN PMS-Ezetimibe 10mg Tab PMS Ran-Ezetimibe 10mg Tab RAN Sandoz Ezetimibe 10mg Tab SDZ Teva-Ezetimibe 10mg Tab TEV (Interchangeable with Ezetrol DIN ) Reason For Use Code and Clinical Criteria Code 380 For use in combination with a HMG-CoA reductase inhibitor ('statin') in patients with hypercholesterolemia who have not reached target LDL levels despite the use of maximally tolerated doses. LU Authorization Period: Indefinite. Code 381 For use as monotherapy in the management of hypercholesterolemia in patients who are intolerant to HMG-CoA reductase inhibitors or where HMG-CoA reductase inhibitors are contraindicated. LU Authorization Period: Indefinite. 7
8 New Multi-Source Products (Cont d...) Mylan-Ezetimibe 10mg Tab MYL (Interchangeable with Ezetrol PIN *) *New Ezetrol PIN created to serve as reference brand product for Mylan-Ezetimibe, which is interchangeable with Ezetrol for RFU Code 381 only. Reason For Use Code and Clinical Criteria Code 381 For use as monotherapy in the management of hypercholesterolemia in patients who are intolerant to HMG-CoA reductase inhibitors or where HMG-CoA reductase inhibitors are contraindicated. LU Authorization Period: Indefinite Mint-Gliclazide MR 30mg SR Tab MIN (Interchangeable with Diamicron MR) Ecl-Metformin 500mg Tab ECL (Interchangeable with Glucophage) 8
9 New Off-Formulary Interchangeable (OFI) Products DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Methotrexate Injection USP 25mg/mL Inj Sol-2mL Single Dose Vial Pk MYL (Preservative-Free) (Interchangeable with Methotrexate Injection USP DIN ) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Mint-Olopatadine 0.1% Oph Sol-5mL Pk MIN (Interchangeable with Patanol) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR UNIT COST Tigecycline 50mg/Vial Pd for Inj-5mLVial Pk (Preservative-Free) APX (Interchangeable with Tygacil) 9
10 Drug Benefit Price (DBP) Changes DIN/PIN BRAND NAME STRENGTH DOSAGE FORM * Cubicin 500mg/10mL Pd for Inj - 10mL Vial Pk MFR DBP SUO Tri-Cyclen Lo 3 Phase Tab-21 Pk JAN Tri-Cyclen Lo 3 Phase Tab-28 Pk JAN Tylenol with Codeine No mg & 15mg & 15mg Tab JAN Tylenol with Codeine No mg & 15mg & 30mg Tab JAN Tylenol with Codeine No mg & 60mg Tab JAN *Exceptional Access Program product 10
11 Product Formulation Change OLD FORMULATION NEW FORMULATION MFR DuoTrav 0.5% & 0.004% Oph Sol-2.5mL Pk DuoTrav PQ 0.5% & 0.004% Oph Sol-2.5mL Pk ( *) (PIN ) DuoTrav 0.5% & 0.004% Oph Sol-5mL Pk DuoTrav PQ 0.5% & 0.004% Oph Sol-5mL Pk ( *) (PIN ) *Delisted in this November 2014 Formulary Update. ALC ALC Reason For Use Code Clinical Criteria Code 310 As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with ophthalmic beta-blocking agents. LU Authorization Period: Indefinite. Code 393 For use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective. LU Authorization Period: Indefinite. 11
12 Product Manufacturer Name Changes DIN/PIN BRAND NAME STRENGTH DOSAGE FORM CURRENT MFR NEW MFR Loestrin 1.5/ mg&1.5mg Tab-21 Pk PAL WAR Loestrin 1.5/ mg&1.5mg Tab-28 Pk PAL WAR Minestrin 1/ mg & 1mg Tab-21 Pk PAL WAR Minestrin 1/ mg & 1mg Tab-28 Pk PAL WAR Onglyza 2.5mg Tab BQU AZC Onglyza 5mg Tab BQU AZC 12
13 Discontinued Products (Some products will remain on the Formulary for six months to facilitate depletion of supply) DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR Alendronate-FC 70mg Tab MEL Apo-Sulin 150mg Tab APX Apo-Sulin 200mg Tab APX Gabapentin 100mg Cap MEL Gabapentin 300mg Cap MEL Gabapentin 400mg Cap MEL Levaquin 250mg Tab JAN PMS-Deferoxamine 500mg/Vial Inj Pd-500mg Vial Pk PMS PMS-Deferoxamine 2g/Vial Inj Pd-2g Vial Pk PMS Quetiapine 25mg Tab MEL Quetiapine 100mg Tab MEL Quetiapine 200mg Tab MEL Quetiapine 300mg Tab MEL 13
14 Delisted Products DIN/PIN BRAND NAME STRENGTH DOSAGE FORM MFR Apo-Nitrazepam 5mg Tab APX Apo-Nitrazepam 10mg Tab APX Apo-Nizatidine 150mg Cap APX Apo-Nizatidine 300mg Cap APX DuoTrav 0.5% & 0.004% Oph Sol-2.5mL Pk ALC DuoTrav 0.5% & 0.004% Oph Sol-5mL Pk ALC Glucerna 1.0 Cal 1kcal/mL Liq-1000mL Pk ABB Hycort 100mg/60mL Enema-60mL Pk VAL Jevity 1 Cal 1.06kcal/mL Liq-1000mL Pk ABB Mylan-Gemfibrozil 300mg Cap MYL Niacin-ICN 100mg Tab VAL Optimental Liq-237mL Pk ABB Polycose Pd-350g Pk ABB PMS-Azithromycin 100mg/5mL O/L-15mL Pk PMS PMS-Azithromycin 200mg/5mL O/L-15mL Pk PMS PMS-Azithromycin 200mg/5mL O/L-22.5mL Pk PMS Ratio-Diltiazem CD 120mg LA Cap RPH Ratio-Diltiazem CD 180mg LA Cap RPH Ratio-Diltiazem CD 240mg LA Cap RPH Ratio-Diltiazem CD 300mg LA Cap RPH 14
15 ISSN (PDF) November 2014 Queen s Printer for Ontario, 2014.
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