Cystic Fibrosis Medicine Applications To Be Considered By PHARMAC And Medsafe In Parallel
PHARMAC met this week with Vertex, a supplier of cystic fibrosis medicines, and with Medsafe, the safety and quality regulator for medicines. The meeting was an opportunity to discuss Vertex’s modulator therapy and the process for this type of treatment to be made available in New Zealand.
“We’re aware of the keen interest in this new treatment for people with cystic fibrosis, so we were pleased to be able to meet to discuss next steps with a group of interested stakeholders,” says PHARMAC’s director of operations Lisa Williams. “The meeting was valuable and productive, with Vertex confirming that they are actively working on applications to both Medsafe and PHARMAC.
“We’ve invited the supplier, Vertex, to concurrently apply to Medsafe for marketing approval and to PHARMAC for funding of their modulator therapy. Medsafe and PHARMAC would consider the applications in parallel.
“Patient advocacy groups have been asking the supplier to submit an application to PHARMAC for a while now. Parallel assessment will allow our funding assessment process to start sooner than it normally would.
“We look forward to receiving detailed information in order to undertake a thorough and robust assessment of the funding application. We will continue to actively engage and work closely with Vertex, Medsafe and the cystic fibrosis community.
“We understand and appreciate that cystic fibrosis has a significant and distressing impact on those who have it and their whānau. We remain committed to funding medicines that are proven to make a difference for people,” concludes Ms Williams.
We currently assess funding applications, in parallel with Medsafe assessment, for rare disorders and cancer medicines; however our robust process for considering applications remains the same, namely:
- Our expert advisory committees consider all the evidence and make their recommendations to PHARMAC.
- PHARMAC then undertakes an economic assessment then compares the medicine with, and ranks it against, all other medicine funding options using our decision-making framework - the Factors for Consideration.
- Medsafe marketing approval is generally required before a medicine can be progressed to funding.
- PHARMAC must have budget available before we can fund a new medicine.