Ontario Drug Benefit Formulary/Comparative Drug Index
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1 Ministry of Health and Long-Term Care Ontario Drug Benefit Formulary/Comparative Drug Index Edition 43 Summary of Changes June 2018 Effective June 29, 2018 Drug Programs Policy and Strategy Branch Ontario Public Drug Programs Ministry of Health and Long-Term Care Visit Formulary Downloads: Edition 43
2 Table of Contents New Multi-Source Products... 3 New Off-Formulary Interchangeable (OFI) Products... 6 New and Revised Reason For Use Codes... 7 Changes to Reason For Use Content... 8 Product Status Changes... 9 Product Brand and Manufacturer Name Changes Drug Benefit Price (DBP) Changes Discontinued Products Delisted Products
3 New Multi-Source Products DIN/PIN Brand Name Strength Dosage Form Mfr DBP Apo-Aripiprazole 2mg Tab APX Apo-Aripiprazole 5mg Tab APX Apo-Aripiprazole 10mg Tab APX Apo-Aripiprazole 15mg Tab APX Apo-Aripiprazole 20mg Tab APX Apo-Aripiprazole 30mg Tab APX (Interchangeable with Abilify) Therapeutic Note Notes: For the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. DIN/PIN Brand Name Strength Dosage Form Mfr DBP Mint-Eplerenone 25mg Tab MIN Mint-Eplerenone 50mg Tab MIN (Interchangeable with Inspra) Reason For Use Code and Clinical Criteria Code 458 For persons suffering from New York Heart Association (NYHA) class II chronic heart failure with left ventricular systolic dysfunction (with ejection fraction less than or equal to 35 percent), as a complement to standard therapy. Note: Patients must be on optimal therapy with an angiotensin-converting-enzyme (ACE) inhibitor, an angiotensin-receptor blocker (ARB), or both and a beta-blocker (unless contraindicated) at the recommended dose or maximal tolerated dose. LU Authorization Period: Indefinite 3
4 New Multi-Source Products (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr DBP PMS-Tenofovir 300mg Tab PMS (Interchangeable with Viread) Reason For Use Code and Clinical Criteria Code 517 Confirmed chronic Hepatitis B infection in persons with HBV DNA greater than or equal to 1000 IU/mL AND ALT levels greater than ULN OR Evidence of fibrosis OR Documented evidence of cirrhosis LU Authorization Period: 1 year Code 518 For patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine. LU Authorization Period: 1 year Code 519 Patient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL. LU Authorization Period: 1 year Code 520 Patients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation. LU Authorization Period: 1 year 4
5 New Multi-Source Products (Continued) Code 521 Patients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment. LU Authorization Period: 1 year Code 522 For the treatment of HIV/AIDS, the prescriber must be approved for the Facilitated Access to HIV/AIDS Drug Products mechanism. LU Authorization Period: 1 year 5
6 New Off-Formulary Interchangeable (OFI) Products DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Diclofenac Topical Solution 1.5% W/W Top Sol STE /mL Jamp-Diclofenac 1.5% W/W Top Sol JPC /mL (Interchangeable with Pennsaid) DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Jamp-Rizatriptan ODT 5mg Orally Disintegrating Tab JPC Jamp-Rizatriptan ODT 10mg Orally Disintegrating Tab JPC (Interchangeable with Maxalt RPD) 6
7 New and Revised Reason For Use Codes DIN/PIN Brand Name Strength Dosage Form Mfr Urso 250mg Tab BFI Ursodiol Tablets USP 250mg Tab GLP PMS-Ursodiol C 250mg Tab PMS New Reason For Use Code and Clinical Criteria Code 534 For the treatment of primary sclerosing cholangitis. LU Authorization Period: Indefinite Existing Reason For Use Code Code 273 No changes to the criteria of this code. DIN/PIN Brand Name Strength Dosage Form Mfr Cipro 10g/100mL Oral Susp BAY Removed Reason For Use Codes Current LU codes 332, 333, 334, 336, 350, 353 and 977 are removed. New Reason For Use Code and Clinical Criteria Code 533 For patients who are unable to swallow or tolerate solid oral dosage forms. LU Authorization Period: 1 Year 7
8 Changes to Reason For Use Content DIN/PIN Brand Name Strength Dosage Form Mfr Keppra 250mg Tab UCB Act Levetiracetam 250mg Tab ACV Apo-Levetiracetam 250mg Tab APX Auro-Levetiracetam 250mg Tab AUR Jamp-Levetiracetam 250mg Tab JPC Nat-Levetiracetam 250mg Tab NAT Levetiracetam 250mg Tab PMS Sandoz Levetiracetam 250mg Tab SDZ Keppra 500mg Tab UCB Act Levetiracetam 500mg Tab ACV Apo-Levetiracetam 500mg Tab APX Auro-Levetiracetam 500mg Tab AUR Jamp-Levetiracetam 500mg Tab JPC Nat-Levetiracetam 500mg Tab NAT Levetiracetam 500mg Tab PMS Sandoz Levetiracetam 500mg Tab SDZ Keppra 750mg Tab UCB Act Levetiracetam 750mg Tab ACV Apo-Levetiracetam 750mg Tab APX Auro-Levetiracetam 750mg Tab AUR Jamp-Levetiracetam 750mg Tab JPC Nat-Levetiracetam 750mg Tab NAT Levetiracetam 750mg Tab PMS Sandoz Levetiracetam 750mg Tab SDZ Revised Reason For Use Content Code 473 As adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory. LU Authorization Period: Indefinite 8
9 Product Status Changes Transition from the Exceptional Access Program to Limited Use Benefits DIN/PIN Brand Name Strength Dosage Form Mfr DBP Ciprodex 0.3% w/v & 0.1% Otic Susp-7.5mL Pk (with NOV w/v preservative) Reason For Use Code and Clinical Criteria Code 509 The treatment of otitis externa in patients: With known perforated tympanic membrane or ventilation tubes; OR Requiring chronic therapy (i.e., more than 14 days); OR Who have been receiving more than 7 days of topical aminoglycoside therapy without improvement, where there is concern of a resistant pathogen; OR With documented pre-existing hearing impairment. LU Authorization Period: 1 year 9
10 Product Status Changes (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr DBP Campral 333mg DR Tab MYL Reason For Use Code and Clinical Criteria Code 531 For the treatment of alcohol use disorder in patients who: Meet clinical criteria for alcohol use disorder; and Express a commitment to abstain from alcohol; and Have been abstinent from alcohol for at least 3 days prior to starting acamprosate; and Have confirmed participation in counselling and treatment for alcohol use disorder* * An individualized treatment plan will have one or more of the following components: Counselling and follow-up with the patient s family physician, addiction physician, or psychiatrist; self-help groups such as Alcoholics Anonymous; and outpatient, day, or inpatient psychosocial rehabilitation programs. LU Authorization Period: 1 year 10
11 Product Status Changes (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Revia 50mg Tab TEV * Apo-Naltrexone 50mg Tab APX * Naltrexone Hydrochloride 50mg Tab STN Tablets USP * Products currently listed as Off-Formulary Interchangeable (OFI) Reason For Use Code and Clinical Criteria Code 532 For the treatment of alcohol use disorder in patients who: Meet clinical criteria for alcohol use disorder; and Express a commitment to reduce or abstain from alcohol; and Have confirmed participation in counselling and treatment for alcohol use disorder* * An individualized treatment plan will have one or more of the following components: Counselling and follow-up with the patient s family physician, addiction physician, or psychiatrist; self-help groups such as Alcoholics Anonymous; and outpatient, day, or inpatient psychosocial rehabilitation programs. LU Authorization Period: 1 year 11
12 Product Status Changes (Continued) Transition from the Exceptional Access Program to General Benefits DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Strattera 10mg Cap LIL * Apo-Atomoxetine 10mg Cap APX * PMS-Atomoxetine 10mg Cap PMS * Sandoz Atomoxetine 10mg Cap SDZ * Teva-Atomoxetine 10mg Cap TEV * Products currently listed as Off-Formulary Interchangeable (OFI) DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Strattera 18mg Cap LIL * Apo-Atomoxetine 18mg Cap APX * PMS-Atomoxetine 18mg Cap PMS * Sandoz Atomoxetine 18mg Cap SDZ * Teva-Atomoxetine 18mg Cap TEV * Products currently listed as Off-Formulary Interchangeable (OFI) DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Strattera 25mg Cap LIL * Apo-Atomoxetine 25mg Cap APX * PMS-Atomoxetine 25mg Cap PMS * Sandoz Atomoxetine 25mg Cap SDZ * Teva-Atomoxetine 25mg Cap TEV * Products currently listed as Off-Formulary Interchangeable (OFI) 12
13 Product Status Changes (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Strattera 40mg Cap LIL * Apo-Atomoxetine 40mg Cap APX * PMS-Atomoxetine 40mg Cap PMS * Sandoz Atomoxetine 40mg Cap SDZ * Teva-Atomoxetine 40mg Cap TEV * Products currently listed as Off-Formulary Interchangeable (OFI) DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Strattera 60mg Cap LIL * Apo-Atomoxetine 60mg Cap APX * PMS-Atomoxetine 60mg Cap PMS * Sandoz Atomoxetine 60mg Cap SDZ * Teva-Atomoxetine 60mg Cap TEV * Products currently listed as Off-Formulary Interchangeable (OFI) DIN/PIN Brand Name Strength Dosage Form Mfr DBP * Apo-Fluoxetine 20mg/5mL Oral Sol APX * Odan-Fluoxetine 20mg/5mL Oral Sol ODN (Interchangeable with Prozac) * Products currently listed as Off-Formulary Interchangeable (OFI) 13
14 Product Status Changes (Continued) Transition from Limited Use to General Benefits DIN/PIN Brand Name Strength Dosage Form Mfr Cipro 250mg Tab BAY Apo-Ciproflox 250mg Tab APX Auro-Ciprofloxacin 250mg Tab AUR Co Ciprofloxacin 250mg Tab COB Jamp-Ciprofloxacin 250mg Tab JPC Mar-Ciprofloxacin 250mg Tab MAR Mint-Ciproflox 250mg Tab MIN Mylan-Ciprofloxacin 250mg Tab MYL Novo-Ciprofloxacin 250mg Tab NOP PMS-Ciprofloxacin 250mg Tab PMS Ran-Ciproflox 250mg Tab RAN Ratio-Ciprofloxacin 250mg Tab RPH Sandoz Ciprofloxacin 250mg Tab SDZ Septa-Ciprofloxacin 250mg Tab SET Van-Ciprofloxacin 250mg Tab VAN Cipro 500mg Tab BAY Apo-Ciproflox 500mg Tab APX Auro-Ciprofloxacin 500mg Tab AUR Co Ciprofloxacin 500mg Tab COB Jamp-Ciprofloxacin 500mg Tab JPC Mar-Ciprofloxacin 500mg Tab MAR Mint-Ciproflox 500mg Tab MIN Mylan-Ciprofloxacin 500mg Tab MYL PMS-Ciprofloxacin 500mg Tab PMS Ran-Ciproflox 500mg Tab RAN Ratio-Ciprofloxacin 500mg Tab RPH Sandoz Ciprofloxacin 500mg Tab SDZ Septa-Ciprofloxacin 500mg Tab SET Van-Ciprofloxacin 500mg Tab VAN 14
15 Product Status Changes (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr Cipro 750mg Tab BAY Apo-Ciproflox 750mg Tab APX Auro-Ciprofloxacin 750mg Tab AUR Co Ciprofloxacin 750mg Tab COB Jamp-Ciprofloxacin 750mg Tab JPC Mar-Ciprofloxacin 750mg Tab MAR Mint-Ciproflox 750mg Tab MIN PMS-Ciprofloxacin 750mg Tab PMS Ran-Ciproflox 750mg Tab RAN Ratio-Ciprofloxacin 750mg Tab RPH Sandoz Ciprofloxacin 750mg Tab SDZ Septa-Ciprofloxacin 750mg Tab SET Van-Ciprofloxacin 750mg Tab VAN Removed Reason For Use Codes Current LU codes 332, 333, 334, 336, 350, 353 and 977 are removed. DIN/PIN Brand Name Strength Dosage Form Mfr Apo-Levofloxacin 250mg Tab APX Co Levofloxacin 250mg Tab COB Novo-Levofloxacin 250mg Tab NOP PMS-Levofloxacin 250mg Tab PMS Sandoz Levofloxacin 250mg Tab SDZ Apo-Levofloxacin 500mg Tab APX Co Levofloxacin 500mg Tab COB Novo-Levofloxacin 500mg Tab NOP PMS-Levofloxacin 500mg Tab PMS Sandoz Levofloxacin 500mg Tab SDZ (Interchangeable with Levaquin) Removed Reason For Use Codes Current LU codes 337, 338, 339 and 977 are removed. 15
16 Product Status Changes (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr Avelox 400mg Tab BAY Apo-Moxifloxacin 400mg Tab APX Auro-Moxifloxacin 400mg Tab AUR Jamp-Moxifloxacin 400mg Tab JPC Jamp-Moxifloxacin Tablets 400mg Tab JPC Mar-Moxifloxacin 400mg Tab MAR Med-Moxifloxacin 400mg Tab GMP Sandoz Moxifloxacin 400mg Tab SDZ Teva-Moxifloxacin 400mg Tab TEV Removed Reason For Use Codes Current LU codes 337, 338, 339 and 977 are removed. DIN/PIN Brand Name Strength Dosage Form Mfr Valtrex 500mg Tab GSK Apo-Valacyclovir 500mg Tab APX Auro-Valacyclovir 500mg Tab AUR Co Valacyclovir 500mg Tab COB Jamp-Valacyclovir 500mg Tab JPC Mar-Valacyclovir 500mg Tab MAR Mylan-Valacyclovir 500mg Tab MYL PMS-Valacyclovir 500mg Tab PMS Sandoz Valacyclovir 500mg Tab SDZ Teva-Valacyclovir 500mg Tab TEV Valacyclovir 500mg Tab SAI Removed Reason For Use Code Current LU code 159 is removed. 16
17 Product Brand and Manufacturer Name Changes DIN/PIN Current Brand Name Current Mfr New Brand Name New Mfr Strength Dosage Form * Duragesic Mat JNO Duragesic JAN 25mcg/hr Trans Patch * Duragesic Mat JNO Duragesic JAN 50mcg/hr Trans Patch ** Duragesic Mat JNO Duragesic JAN 75mcg/hr Trans Patch ** Duragesic Mat JNO Duragesic JAN 100mcg/hr Trans Patch * Not-a-Benefit (NAB) to serve as a reference product in interchangeable group ** Off-Formulary Interchangeable (OFI) Product 17
18 Drug Benefit Price (DBP) Changes DIN/PIN Brand Name Strength Dosage Form Mfr DBP/ Unit Price * Apo-Metformin ER 500mg ER Tab APX ** Cayston 75mg/Vial Pd Inh Sol- Vial Pk GIL Genvoya 150mg & 150mg & Tab GIL mg & 10mg Lasix 10mg/mL O/L SAV ** Kineret 150mg/mL Inj Pref Syr- 0.67mL Pk SWE * Off-Formulary Interchangeable (OFI) Product ** Exceptional Access Program (EAP) Product 18
19 Discontinued Products (Some products will remain on Formulary for six months to facilitate depletion of supply) DIN/PIN Brand Name Strength Dosage Form Mfr 12.5mg & 75mg & * Holkira Pak 50mg & 250mg 4 Tab Combi Pk ABV ** Mirapex 0.5mg Tab BOE Mirapex 1mg Tab BOE Mirapex 1.5mg Tab BOE Mirapex 1mg Tab BOE Mirapex 1.5mg Tab BOE ReQuip 0.25mg Tab GSK ReQuip 1mg Tab GSK ReQuip 2mg Tab GSK ReQuip 5mg Tab GSK SereVent Diskhaler Diskhaler-60 Disk Disks 50mcg/Blister Pk GSK Zantac 150mg Tab GSK Zantac 300mg Tab GSK Mylan-Donepezil 5mg Tab MYL Mylan-Duloxetine 30mg DR Cap MYL Mylan-Duloxetine 60mg DR Cap MYL Mylan-Losartan HCTZ 50mg & 12.5mg Tab MYL Mylan-Losartan HCTZ 100mg & 12.5mg Tab MYL Mylan-Losartan HCTZ 100mg & 25mg Tab MYL * Exceptional Access Program (EAP) Product ** Off-Formulary Interchangeable (OFI) Product 19
20 Discontinued Products (Continued) DIN/PIN Brand Name Strength Dosage Form Mfr Mylan-Omeprazole 20mg DR Cap MYL Mylan-Rosuvastatin 40mg Tab MYL ** Mylan-Zopiclone 5mg Tab MYL ** Myl-Sildenafil 50mg Tab MYL Lopresor 50mg Tab NOV Lopresor 100mg Tab NOV Lotensin 20mg Tab NOV Benztropine 2mg Tab PMS PMS-Latanoprost 0.005% Oph Sol-2.5mL Pk PMS PMS-Metronidazole 500mg Cap PMS Intron A 15mu/mL 18mu MD Pen Kit SCH Intron A 25mu/mL 30mu MD Pen Kit SCH Intron A 50mu/mL 60mu MD Pen Kit SCH Cyclocort 0.1% Oint STI Cyclocort 0.1% Lot STI Emo-Cort 2.5% Cr STI * Exceptional Access Program (EAP) Product ** Off-Formulary Interchangeable (OFI) Product 20
21 Delisted Products DIN/PIN Brand Name Strength Dosage Form Mfr * Depakene 250mg Cap ABB * Hytrin 1mg Tab ABB * Hytrin 2mg Tab ABB * Hytrin 5mg Tab ABB * Hytrin 10mg Tab ABB Mylan-Acebutolol (Type S) 400mg Tab MYL Mylan-Azathioprine 50mg Tab MYL Mylan-Entacapone 200mg Tab MYL ** Mylan-Atomoxetine 18mg Cap MYL ** Mylan-Atomoxetine 25mg Cap MYL ** Mylan-Atomoxetine 40mg Cap MYL ** Mylan-Atomoxetine 60mg Cap MYL * Remain on Formulary as Not-a-Benefit (NAB) to serve as a reference product in interchangeable group ** Off-Formulary Interchangeable (OFI) Product 21
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UPDATE AX Ontario Drug Benefit Formulary/Comparative Drug Index No. 41 Effective August 29, 2013 SUMMARY OF CHANGES
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UPDATE B Ontario Drug Benefit Formulary/Comparative Drug Index No. 41 Effective October 01, 2008 SUMMARY OF CHANGES
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Manager, PEI Drug Programs Date : December 7, 2009 Tel / Tél : (902) Fax / Téléc : (902)
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