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 April 2018 Effective April 30, 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 Single Source Products... 3 New Multi-Source Products... 5 New Off-Formulary Interchangeable (OFI) Products Product Status Changes Product Brand and Manufacturer Name Changes Drug Benefit Price (DBP) Changes Discontinued Products Delisted Products
3 New Single Source Products DIN/PIN Brand Name Strength Dosage Form Generic Name Mfr DBP Repatha 120mg/mL Inj Sol-Pref Cart EVOLOCUMAB AMG Repatha 140mg/mL Inj Sol-Pref Inj EVOLOCUMAB AMG Reason For Use Code and Clinical Criteria Code 527 For the treatment of Heterozygous Familial Hypercholesterolemia (HeFH) in patients 18 years of age or older who meet the following criteria: AND OR Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; Unable to reach Low Density Lipoprotein Cholesterol (LDL-C) target (i.e., LDL-C less than 2.0 mmol/l for secondary prevention) or at least a 50% reduction in LDL-C from untreated baseline despite: A. Confirmed adherence to high dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for at least a total of 3 months; B. Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high dose statin defined as: i. Inability to tolerate at least 2 statins with at least one started at the lowest starting daily dose; AND ii. For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) greater than 5 times the upper limit of normal) resolution rather than discontinuation of statin altogether; AND iii. For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (creatine kinase (CK) greater than 5 times the upper limit of normal) changes are reversible upon statin discontinuation but reproducible by re-challenge of statins where clinically appropriate; AND iv. One of the following: 3
4 New Single Source Products (Continued) I. Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out; OR II. Patient developed confirmed and documented rhabdomyolysis; OR III. Patient is statin contraindicated i.e. active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal Treatment with Repatha should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of Repatha). 3. Patient continues to have a significant reduction in LDL-C (with continuation of Repatha) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (e.g., every 6 months). Patients prescribed Repatha 140mg every two weeks are limited to 26 prefilled syringes (PFS) per year. Patients prescribed Repatha 420mg every month must use the automated mini doser (AMD) and are limited to 12 AMD per year. LU Authorization Period: 1 year 4
5 New Multi-Source Products Teva-Budesonide 0.125mg/mL Inh Susp TEV (Interchangeable with Pulmicort Nebuamp) Reason For Use Code and Clinical Criteria For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler. Code 260 Children aged 6 years or less. LU Authorization Period: Indefinite Code 261 Patients who have a tracheostomy. LU Authorization Period: Indefinite Code 262 Patients with cystic fibrosis in whom nebulizer therapy is indicated. LU Authorization Period: Indefinite Code 263 Patients with severe mental or physical disabilities. LU Authorization Period: Indefinite Code 264 Patients who have previously used nebulizer therapy within the last 12 month period. LU Authorization Period: Indefinite 5
6 New Multi-Source Products (Continued) Act Dextroamphetamine SR 10mg SR Cap ACV Act Dextroamphetamine SR 15mg SR Cap ACV (Interchangeable with Dexedrine Spansules) Therapeutic Note Stimulant medication should only be used when diagnostic criteria for narcolepsy or attention deficit disorder have been met and when stimulant medication has been demonstrated to produce clinical benefits. The use of conventional-release medication should almost always precede the use of extended-release preparations. Notes: Patients greater than 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR, and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: inability of a school to dose the child at lunch; the school lunch hour does not coincide with the dosing schedule; poor compliance with noon or afternoon doses; the patient is unable to swallow tablets. Societal barriers include: the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives 6
7 New Multi-Source Products (Continued) Mint-Acitretin 10mg Cap MIN Mint-Acitretin 25mg Cap MIN (Interchangeable with Soriatane) Therapeutic Note This drug should be used with extreme caution in females of childbearing potential due to its teratogenicity. Effective contraception must be practised for at least 2 years following discontinuation Apo-Perindopril 2mg Tab APX Auro-Perindopril 2mg Tab AUR PMS-Perindopril 2mg Tab PMS Sandoz Perindopril Erbumine 2mg Tab SDZ Teva-Perindopril 2mg Tab TEV (Interchangeable with Coversyl) Apo-Perindopril 4mg Tab APX Auro-Perindopril 4mg Tab AUR PMS-Perindopril 4mg Tab PMS Sandoz Perindopril Erbumine 4mg Tab SDZ Teva-Perindopril 4mg Tab TEV (Interchangeable with Coversyl) 7
8 New Multi-Source Products (Continued) Apo-Perindopril 8mg Tab APX Auro-Perindopril 8mg Tab AUR PMS-Perindopril 8mg Tab PMS Sandoz Perindopril Erbumine 8mg Tab SDZ Teva-Perindopril 8mg Tab TEV (Interchangeable with Coversyl) DIN/PIN Brand Name Strength Dosage Mfr DBP Form Sandoz Perindopril Erbumine/ 2mg & 0.625mg Tab SDZ Indapamide LD (Interchangeable with Coversyl Plus LD) DIN/PIN Brand Name Strength Dosage Form Sandoz Perindopril Erbumine/ Indapamide Mfr DBP 4mg & 1.25mg Tab SDZ Teva-Perindopril/Indapamide 4mg & 1.25mg Tab TEV (Interchangeable with Coversyl Plus) DIN/PIN Brand Name Strength Dosage Form Sandoz Perindopril Erbumine/ Indapamide HD Mfr DBP 8mg & 2.5mg Tab SDZ Teva-Perindopril/Indapamide 8mg & 2.5mg Tab TEV (Interchangeable with Coversyl Plus HD) 8
9 New Multi-Source Products (Continued) Auro-Risedronate 150mg Tab AUR (Interchangeable with Actonel) Pharma-Simvastatin 10mg Tab PMS (Interchangeable with Zocor) 9
10 New Off-Formulary Interchangeable (OFI) Products DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Apo-Fluoxetine 20mg/5mL Oral Sol with Preservative APX (Interchangeable with Prozac) DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Reddy-Progesterone 100mg Cap DRR (Interchangeable with Prometrium) DIN/PIN Brand Name Strength Dosage Form Mfr Unit Price Mar-Rizatriptan ODT 5mg Orally Disintegrating Tab MAR Mar-Rizatriptan ODT 10mg Orally Disintegrating Tab MAR (Interchangeable with Maxalt RPD) 10
11 Product Status Changes Transition from the Exceptional Access Program to General Benefits Vancomycin Hydrochloride for 500mg/Vial Inj-500mg Vial FKC Injection, USP Pk (Interchangeable with Vancocin) Vancomycin Hydrochloride for 1g/Vial Inj-Vial Pk FKC Injection, USP (Interchangeable with Vancocin) Limited Use Criteria Changed and Facilitated Access HIV/AIDS Restriction Removed DIN/PIN Brand Name Strength Dosage Form Mfr Diflucan P.O.S. 10mg/mL O/L PFI Removed Reason For Use Codes Current LU codes 274, 275, 276 and 277 are removed. New Reason For Use Code and Clinical Criteria Code 528 For patients who are unable to swallow or tolerate solid oral dosage forms. LU Authorization Period: 12 months 11
12 Product Status Changes (Continued) Transition Limited Use to General Benefit and Facilitated Access HIV/AIDS Restriction Removed DIN/PIN Brand Name Strength Dosage Form Mfr Apo-Fluconazole 50mg Tab APX Co Fluconazole 50mg Tab COB Mylan-Fluconazole 50mg Tab MYL PMS-Fluconazole 50mg Tab PMS Teva-Fluconazole 50mg Tab TEV (Interchangeable with Diflucan) DIN/PIN Brand Name Strength Dosage Form Mfr Apo-Fluconazole 100mg Tab APX Co Fluconazole 100mg Tab COB Mylan-Fluconazole 100mg Tab MYL PMS-Fluconazole 100mg Tab PMS Teva-Fluconazole 100mg Tab TEV (Interchangeable with Diflucan) Removed Reason For Use Codes Current LU codes 202, 203, 204 and 205 are removed. 12
13 Product Brand and Manufacturer Name Changes DIN/PIN Current Brand Name Current Mfr New Brand Name New Mfr Strength Dosage Form Teva- TEV PMS- PMS 2mg & SL Tab Buprenorphine/ Buprenorphine- 0.5mg Naloxone Naloxone Teva- TEV PMS- PMS 8mg & SL Tab Buprenorphine/ Buprenorphine- 2mg Naloxone Naloxone 13
14 Drug Benefit Price (DBP) Changes To view the DBP changes by DIN/PIN, the ministry has posted an Excel file with the details of the listing changes for download and review (Edition 43: Summary of Changes Drug Benefit Price Changes April 30, 2018). It is accessible from the ministry s website: 14
15 Discontinued Products (Some products will remain on Formulary for six months to facilitate depletion of supply) DIN/PIN Brand Name Strength Dosage Form Mfr * Galexos 150mg Cap JAN Mylan-Azithromycin 250mg Tab MYL Mylan-Clopidogrel 75mg Tab MYL Mylan-Donepezil 10mg Tab MYL Mylan-Propafenone 150mg Tab MYL Mylan-Propafenone 300mg Tab MYL Mylan-Sertraline 50mg Cap MYL * Exceptional Access Program (EAP) Product 15
16 Delisted Products DIN/PIN Brand Name Strength Dosage Form Mfr Mylan-Acebutolol (Type S) 200mg Tab MYL * Mylan-Alprazolam 1mg Tab MYL * Mylan-Gabapentin 600mg Tab MYL * Mylan-Gabapentin 800mg Tab MYL * Off-Formulary Interchangeable (OFI) Product 16
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UPDATE F Ontario Drug Benefit Formulary/Comparative Drug Index No. 41 Effective 30 January, 2009 SUMMARY OF CHANGES
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Pharmacy Coverage Guidelines are subject to change as new information becomes available.
Ezetimibe-simvastatin 10-80 mg oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy
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If yes, continue to #2. If no, do not approve. DENIAL TEXT: See the initial denial text at the end of the guideline.
Generic Brand HICL GCN Exception/Other LOMITAPIDE JUXTAPID 39883 This drug requires a written request for prior authorization. All requests for Juxtapid (lomitapide) require review by a pharmacist prior
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It is the policy of health plans affiliated with PA Health & Wellness that Vytorin is medically necessary when the following criteria are met:
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Clinical Policy: (Kynamro) Reference Number: CP.PHAR.284 Effective Date: 10.16 Last Review Date: 02.19 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy
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Primary Prevention Patients aged 85yrs and over
Rotherham Guideline for the management of Non-Familial Hypercholesterolaemia Type 1 Diabetes Offer lifestyle advice Over 40yrs of age? Diabetic for more than 10 years? Established nephropathy? Other CVD