Ribociclib funding decision
Thank you for your request dated 28 July 2023 under the Official Information Act 1982 (OIA) for information relating to ribociclib. You requested:
An application for ribociclib to be funded for HR-positive HER2-negative breast cancer was made in 2019. A decision has not yet been made. When does Pharmac expect to make this decision, and please advise what has caused the delay in this decision being made.
Given ribociclib improves the recurrence rate of breast cancer, what financial analyses have been carried out comparing the cost of this medication vs the cost of treating recurrent breast cancer?
Ribociclib has been considered for first- and second-line treatment of locally advanced/metastatic, human epidermal growth factor receptor 2-negative (HER2-), hormone receptor-positive (HR+) breast cancer. In 2019 it was ranked on the Options for Investment list following clinical advice and an economic assessment, including a cost utility analysis and budget impact analysis.
Advice was received from the Cancer Treatments Advisory Committee (CTAC) in October 2019 [PDF, 588 KB] that ribociclib and palbociclib (both are in a class of medicine called CDK4/6 inhibitors) had comparable benefit due to a ‘class effect’ amongst CDK4/6 inhibitors in the treatment of HR-positive HER2-negative locally advanced breast cancer. It was recommended that Pharmac fund one of these medicines for the treatment of HER2-, HR+ breast cancer, either as a first or second-line treatment, with high priority.
A competitive commercial process was then carried out with suppliers of CDK4/6 inhibitors. Following this, a decision was made to fund palbociclib in 2020, and ribociclib was ranked on the ‘Cost Neutral’ list(external link). This means that ribociclib could be funded if Pharmac can negotiate a deal that saves money (or at least does not cost extra). However, as part of the funding arrangement, the supplier of palbociclib was guaranteed a 3-year period of market exclusivity. This means that even if a company offered to sell ribociclib at a price which saved money, the proposal for ribociclib could not be progressed in the same market (i.e. New Zealand) until the market exclusivity period ended on 30 June 2023.
We have recently sought advice from CTAC on how to manage CDK4/6 inhibitors after the market exclusivity period ends. This included consideration of updated evidence supporting the health benefit from ribociclib for people with HER2-, HR+ breast cancer. The advice received will guide Pharmac’s next steps; records from this meeting will be published when finalised. Next steps may include further economic evaluation and re-ranking on the Pharmac Options for Investment list(external link) based on the Pharmac’s Factors for Consideration, depending on the advice received.
Unfortunately, we’re unable to give a definitive timeframe for if, or when, funding decisions will be made. The relative priority of funding choices can change over time depending on the relative health benefits, amount of funding available, success of negotiations with suppliers, new clinical data, and the variety of other funding applications.
We trust that this information answers your queries. Please note, you have the right to make a complaint to the Ombudsman about our response to your OIA, under section 28(3) of the OIA. Details of how to make a complaint(external link) are on the Ombudsman’s website.
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