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 February 2019 Effective February 28, 2019 Drug Programs Policy and Strategy Branch Drugs and Devices Division Ministry of Health and Long-Term Care Visit Formulary Downloads: Edition 43
2 Table of Contents New Single Source Product... 3 New Multi-Source Products... 8 New Off-Formulary Interchangeable (OFI) Products Removal of Therapeutic Note Manufacturer Name Change Drug Benefit Price (DBP) Changes Discontinued Products Delisted Products
3 New Single Source Product DIN/PIN Brand Name Strength Dosage Form Generic Name Mfr DBP GLECAPREVIR & Maviret 100mg & 40mg Tab PIBRENTASVIR ABV Reason For Use Code and Clinical Criteria Code 550 For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other physician experienced in treating a patient with chronic hepatitis C); (ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, or 6; (iii) Two Laboratory confirmed quantitative HCV RNA values taken at least 6 months apart as demonstration of chronicity of infection. One level must be within the last 6 months while the first level may be at the time of the initial diagnosis. Exclusion criteria: Patients with genotype 1 who have relapsed but are treatment experienced on both NS3/4A protease inhibitor and an NS5A inhibitor For use in combination with other hepatitis C antiviral agents Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C) Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program. (Continued on next page) 3
4 Treatment regimens for Maviret: I. Treatment-naive, non-cirrhotic genotype 1, 2, 3, 4, 5, or 6. Approved duration: 8 weeks II. Notes: Treatment-experienced, non-cirrhotic genotype 1, 2, 4, 5, or 6 who have failed peginterferon/ribavirin and/or sofosbuvir ONLY. Approved duration: 8 weeks (1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. (2) NS3/4A Pls include simeprevir, boceprevir, and telepravir. (3) NS5A inhibitors include daclatasvir and ledipasvir. Code 551 For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other physician experienced in treating a patient with chronic hepatitis C); (ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, or 6; (iii) Two Laboratory confirmed quantitative HCV RNA values taken at least 6 months apart as demonstration of chronicity of infection. One level must be within the last 6 months while the first level may be at the time of the initial diagnosis. (Continued on next page) 4
5 New Single Source Product (Continued) Exclusion criteria: Patients with genotype 1 who have relapsed but are treatment experienced on both NS3/4A protease inhibitor and an NS5A inhibitor For use in combination with other hepatitis C antiviral agents Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C) Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program. Treatment regimens for Maviret: I. Treatment-naive genotype 1, 2, 3, 4, 5, or 6 with compensated cirrhosis. Approved duration: 12 weeks II. III. Notes: Treatment-experienced, cirrhotic genotype 1, 2, 4, 5, or 6 who have failed peginterferon/ribavirin and/or sofosbuvir ONLY. Approved duration: 12 weeks Treatment-experienced genotype 1 non-cirrhotic or compensated cirrhosis who have failed an NS3/4A protease inhibitor (2) but are NS5A inhibitor naive. Approved duration: 12 weeks (1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. (2) NS3/4A Pls include simeprevir, boceprevir, and telepravir. (3) NS5A inhibitors include daclatasvir and ledipasvir. 5
6 Code 552 For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other physician experienced in treating a patient with chronic hepatitis C); (ii) Laboratory confirmed hepatitis C genotype 1 or 3; (iii) Two Laboratory confirmed quantitative HCV RNA values taken at least 6 months apart as demonstration of chronicity of infection. One level must be within the last 6 months while the first level may be at the time of the initial diagnosis. Exclusion criteria: Patients with genotype 1 who have relapsed but are treatment experienced on both NS3/4A protease inhibitor and an NS5A inhibitor For use in combination with other hepatitis C antiviral agents Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C) Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program. Treatment regimens for Maviret: I. Treatment-experienced genotype 1 non-cirrhotic or compensated cirrhosis who have failed an NS5A inhibitor (3) but is NS3/4A protease inhibitor naive. Approved duration: 16 weeks II. Treatment-experienced genotype 3 non-cirrhotic or compensated cirrhosis who have failed peginterferon/ribavirin and/or sofosbuvir ONLY. Approved duration: 16 weeks (Continued on next page) 6
7 Notes: (1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. (2) NS3/4A Pls include simeprevir, boceprevir, and telepravir. (3) NS5A inhibitors include daclatasvir and ledipasvir. 7
8 New Multi-Source Products DIN/PIN Brand Name Strength Dosage Form Mfr DBP Mint-Hydrochlorothiazide 25mg Tab MIN (Interchangeable with HydroDIURIL) DIN/PIN Brand Name Strength Dosage Form Mfr DBP Sandoz Morphine SR 100mg SR Tab SDZ (Interchangeable with MS Contin) Therapeutic Note Narcotic analgesics can produce dependence and may be abused. Physical dependence, psychological dependence and tolerance may develop. Prescribers are cautioned about ordering these drugs for patients with a history of either emotional disturbances or drug abuse, including alcohol. DIN/PIN Brand Name Strength Dosage Form Mfr DBP Jamp-Tenofovir 300mg Tab JPC (Interchangeable with Viread) 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 8
9 New Multi-Source Products (Continued) 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 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 9
10 New Off-Formulary Interchangeable (OFI) Products DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Inj Sol-1mL Pk Baclofen Injection 0.05mg/mL (Preservative-Free) TEL (Interchangeable with Lioresal Intrathecal) DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Inj Sol-20mL Pk Baclofen Injection 0.5mg/mL (Preservative-Free) TEL (Interchangeable with Lioresal Intrathecal) DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Inj Sol-5mL Pk Baclofen Injection 2mg/mL (Preservative-Free) TEL (Interchangeable with Lioresal Intrathecal) DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Sandoz Morphine SR 200mg SR Tab SDZ * Sandoz Morphine SR 200mg SR Tab SDZ (Interchangeable with MS Contin) * Palliative Care Facilitated Access PIN 10
11 Removal of Therapeutic Note The following Therapeutic Note is removed from the Therapeutic Classification 40:28 DIURETICS. Therapeutic Note The Canadian Hypertension Society Consensus Conference recommends lower doses of diuretics for treatment of hypertension, particularly in the elderly, to avoid dose-related adverse effects. Hydrochlorothiazide, 25 to 50mg daily, or other diuretics in equivalent amounts are recommended. 11
12 Manufacturer Name Change DIN/PIN Brand Name Strength Dosage Form Current Mfr New Mfr Buscopan 20mg/mL Inj Sol BOE SAC 12
13 Drug Benefit Price (DBP) Changes DIN/PIN Brand Name Strength Dosage Form Mfr DBP/ Unit Price * Purg-Odan PMS-Oxycodone 3.5g & 12g & 10mg 5mg Pd for Sol-12g Sachet Tab ODN PMS ** PMS-Oxycodone 5mg Tab PMS * PMS-Oxycodone 10mg Tab PMS ** PMS-Oxycodone 10mg Tab PMS * PMS-Oxycodone 20mg Tab PMS ** PMS-Oxycodone 20mg Tab PMS Teva-Morphine SR 100mg SR Tab TEV * Off-Formulary Interchangeable (OFI) Product ** Palliative Care Facilitated Access Product 13
14 Discontinued Products (Some products will remain on Formulary for six months to facilitate depletion of supply) DIN/PIN Brand Name Strength Dosage Form Mfr Bactroban 2% Cr GSK Bactroban 2% Oint GSK Mar-Losartan 25mg Tab MAR Mar-Losartan 50mg Tab MAR Mar-Losartan 100mg Tab MAR * Mylan-Fentanyl Matrix Patch 12mcg/hr Trans Patch MYL Mylan-Fentanyl Matrix Patch 25mcg/hr Trans Patch MYL Mylan-Fentanyl Matrix Patch 50mcg/hr Trans Patch MYL * Mylan-Fentanyl Matrix Patch 75mcg/hr Trans Patch MYL * Mylan-Fentanyl Matrix Patch 100mcg/hr Trans Patch MYL PMS-Potassium Chloride 1.33mEq/mL O/L PMS Teva-Ondansetron 4mg Tab TEV Teva-Ondansetron 8mg Tab TEV * Off-Formulary Interchangeable (OFI) Product 14
15 Delisted Products DIN/PIN Brand Name Pedialyte Regular Strength n/a Dosage Form O/L Mfr ABB Pedialyte Flavored n/a O/L ABB * Cardura-1 1mg Tab AZC * Cardura-2 2mg Tab AZC * Cardura-4 4mg Tab AZC Mylan-Cyclobenzaprine 10mg Tab MYL Mylan-Meloxicam 7.5mg Tab MYL Mylan-Meloxicam 15mg Tab MYL * Frisium 10mg Tab OVA ** PMS-Repaglinide 0.5mg Tab 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 Zoledronic Acid Injection 5mg/100mL Inj Sol-100mL Pk (Preservative-Free) * Remain on Formulary as Not-a-Benefit (NAB) to serve as a reference product in interchangeable group ** Off-Formulary Interchangeable (OFI) Product TEV 15
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See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Epclusa) Reference Number: CP.CPA.286 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
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Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
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Address: City: State: ZIP code: Inferferon Product Requested (Include Strength):
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
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Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
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Pharmacy Coverage Guidelines are subject to change as new information becomes available.
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