On November 27, 2018 the BC Ministry of Health changed coverage of glatiramer products, GLATECT™ and COPAXONE®, which demonstrates a shift from previous public drug plan approaches for funding of subsequent entry products (biosimilars) for chronic diseases.
Background
GLATECT™ is the first subsequent entry glatiramer-based treatment available for reimbursement for RRMS in Canada – i.e. a follow on product to Copaxone®. It is classifed as a non-biological complex drug (NBCD) – a new type of drug with parallels to biologics. NBCDs are defined as a medicinal product of non-biological origin with an active substance that is not a homo-molecular structure, but consists of different closely related and mostly nanoparticulate structures. Both subsequent entry NBCDs and biosimilars require proof of therapeutic equivalence between originator and follow-on product, in addition to data considering potential discrepancies in safety and tolerability.
GLATECT™’s reimbursement pathway has paralleled that of other biosimilars, being reviewed through CADTH and negotiated through the pCPA process. As of November 2018, seven provincial drug plans have added GLATECT™ to their drug formularies with similar approaches to how other biosimilars have been implemented.
It is important to note that the manufacturer of GLATECT™ conducted a 15-month extension phase which evaluated the efficacy, safety and tolerability of switching from COPAXONE® 20 mg/mL to GLATECT™ 20 mg/mL in patients previously treated with COPAXONE® 20 mg/mL and evaluated the long-term (2 years total) treatment effects of GLATECT™ 20 mg/mL.
BC Pharmacare’s New Coverage for Glatiramer Acetate
Limited Coverage Drugs – Glatiramer Acetate
PharmaCare is changing coverage of glatiramer products.
- Multiple sclerosis patients currently using Copaxone® brand glatiramer must transition to GLATECT™ (in consultation with their prescriber) to maintain PharmacCare coverage.
- As of November 27, 2018, all Special Authority (SA) requests and renewals for glatiramer acetate for multiple sclerosis patients will be approved for GLATECT™ brand only.
- Patients with existing SA approval for glatiramer will have coverage for both brands during the transition period beginning November 27, 2018 until May 28, 2019 when Copaxone® coverage for MS patient ends.
- To maintain patients’ coverage, prescribers must write a new prescription for their Copaxone® patients, indicating the transition to GLATECT™ . The patient’s existing glatiramer SA remains in effect until the next renewal date.
- For patients who are medically unable to transition, you can submit a new SA request for exceptional coverage of Copaxone® , which will be reviewed by Special Authority on a case-by-case basis. This request must be submitted before May 28, 2019 to ensure continued coverage.
Signals Decoded:
BC’s approach to Glatect marks the first time a Canadian public payer has implemented transitioning (often referred to as non-medical switching) for a biosimilar/NBCD used to treat a chronic disease. While BC’s approach was not entirely unexpected, most stakeholders were anticipating the initial implementation would be for biosimilars used for treatment of rheumatoid diseases, where there has been more local market experience and some stakeholder support.
The Ontario Rheumatology Association’s Position paper released in June 2018 supports transitioning patients to biosimilars for rheumatic diseases based on certain principles and also makes 3 recommendations for implementation. While BC has implemented in a different therapeutic area, they appear to have given consideration to at least 2 of these recommendations, including allowing more than 6 months of time to make the transition as well as consideration of exceptional cases for patients who are medically unable to transition. The third recommendation is to re-invest the cost savings into care for patients (rheumatology patients in the case of the ORA). It is not yet clear if BC will be considering this approach for patients with multiple sclerosis.
BC’s approach, along with the tiered listings for biologics in Manitoba, remain consistent with the Biologics Policy Directions document released by the pCPA in September. Whether these approaches will be implemented by other public drug plans over the coming months is not yet known and experience from BC and Manitoba will likely prove important in those decisions.
