(Received from the Ministry January 24, 2018)
We are pleased to provide you with the Summary of Changes – January 2018 to Edition No. 43 of the Ontario Drug Benefit (ODB) Formulary / Comparative Drug Index (Formulary), which becomes effective January 31, 2018. The Edition No. 43 document will be posted on the Ministry’s website http://www.health.gov.on.ca/en/pro/programs/drugs/edition_43.aspx by January 31, 2018.
The information in this Summary of Changes – January 2018 is based on the decisions made by the Executive Officer, taking into consideration recommendations from the Ministry’s expert advisory committee, the Committee to Evaluate Drugs (CED).
– 1 existing single source drug with Limited Use criteria change (1 DIN)
– 4 multiple source drugs (6 DINs)
– 1 new Off-Formulary Interchangeable (OFI) generic drug (1 DIN)
– 1 drug (1 DIN) has an additional dosage format funded and one drug (1 DIN) has its funding criteria modified in the Exceptional Access Program (EAP)
– 4 drugs (8 DINs) transitioned from the Exceptional Access Program (EAP) to the Formulary
– 1 change in Limited Use (LU) criteria
Single Source Drug
Prolia (denosumab) 60mg/mL Inj Sol-Pref Syr (AMG)
Limited Use (LU) Criteria
Revised LU criteria content for LU Codes 428 and 429 (for female patients)
New LU Codes 515 and 516 (for male patients)
Please see the Summary of Changes (SOC) document for details of the LU criteria
New Multiple Source Drug Products
ACT Buprenorphine/Naloxone 2mg/0.5mg, 8mg/2mg SL Tab ACV
CCP-Letrozole 2.5mg Tab CCP
Mylan-Propafenone 150mg, 300mg Tab MYL
Sandoz Moxifloxacin 400mg Tab SDZ
Exceptional Access Program (EAP) Products
Cimzia (certolizumab pegol) 200mg/mL Inj Sol – Pref Pen (UCB) – Effective Date: January 31, 2018
New prefilled pen dosage format added to existing funded prefilled syringe format. No changes to funding criteria or Drug Benefit Price (DBP).
Imbruvica (ibrutinib) 140mg Cap (JAN) – Effective Date: December 28, 2017
The relapsed and refractory Mantle Cell Lymphoma (MCL) indication is now funded for eligible patients according to clinical criteria. The existing clinical criteria for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) have been revised to include first line treatment in previously untreated patients.
The reimbursement criteria for the above product will be included on the list of Frequently Requested Drugs, which can be found on the Ministry’s website:
Transition from the Exceptional Access Program (EAP) to the Formulary
From the EAP’s Palliative Care Facilitated Access (PCFA) mechanism to the Formulary as Limited Use (LU) drugs
Morphine Sulfate 2mg/mL, 10mg/mL Inj Sol SDZ
Phenobarbital Sodium Injection USP 120mg/mL Inj Sol SDZ
LU Code 481
For the management of patients receiving palliative care*.
LU Authorization Period: 1 year
NOTE: *The patient must have a progressive life-limiting illness and require this medication for palliative purposes.
From the EAP to the Formulary as General Benefit (GB) drugs
Phenobarb 15mg, 30mg, 60mg, 100mg Tab PEN
Phenobarb Elixir 5mg/mL Oral Elixir PEN
Revised Limited Use (LU) Criteria
Applies to various strengths of Aptiom (eslicarbazepine acetate), Fycompa (perampanel) and Vimpat (lacosamide). Please see the SOC document for details.
Revised LU Code 430
As adjunctive therapy in the treatment of patients with partial onset seizures who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND
Patients are under the care of a physician experienced in the treatment of epilepsy.
Note: Less costly anticonvulsant therapies may include the following:
Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc.
LU Authorization Period: Indefinite
The Ministry has posted a new file with the listing changes for download and review (Edition No. 43, Summary of Changes – January 2018). It is accessible from the Ministry’s website: http://www.health.gov.on.ca/en/pro/programs/drugs/edition_43.aspx.
In addition, the Formulary, Summaries of Changes and Bulletins, including a searchable electronic version of the Formulary (e-Formulary), are also accessible from the ministry’s website: https://www.formulary.health.gov.on.ca/formulary/ – The e-Formulary will be updated on the effective date – January 31, 2018.
We appreciate your continued cooperation in making these benefit adjustments.