As an update to INFOBulletin 230302, the Ontario government is continuing the biosimilar policy regarding the funding of biologics through the Ontario Drug Benefit (ODB) program. The Ministry of Health (the “ministry”) is providing important information for physicians about the application of the biosimilar policy to Prolia® (denosumab) and Xgeva® (denosumab).
Biosimilar policy update for denosumab
Biosimilar versions of Prolia® and Xgeva® were listed on the Formulary as Limited Use benefits on August 30, 2024 and became subject to a “New Start Rule”. In accordance with this New Start Rule, ODB program recipients who are treatment naïve to denosumab will only receive coverage for the biosimilar versions, provided that they meet the applicable Limited Use criteria for the products.
ODB program recipients who are already using Prolia® or Xgeva® are subject to a “Transition Rule”. In accordance with this Transition Rule, treatment-experienced recipients will have 9 months to transition to a biosimilar version, subject to certain exceptions. This 9-month transition period begins on November 29, 2024 and ends on August 29, 2025. At the end of this transition period, Prolia® and Xgeva® will not be funded under the ODB program, subject to certain exceptions.
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