Final date close for submissions to controversial drug post-marketing review
Tuesday, 6 June is the last day on which pharmacists can make a submission to a Government review that has called into question the way ezetimibe is prescribed and dispensed to patients with dyslipidemia who are inadequately controlled on, or unable to tolerate, statin therapy.
A draft Department of Health Post-market Review of ezetimibe claims that at least 18% of scripts written for the 300,000 Australians receiving the cholesterol lowering agent are outside the PBS restriction: requirement for titration of statins to maximum tolerated doses before initiating ezetimibe; or for use in patient with high CVD risk who experience an adverse event during treatment with a statin necessitating a reduction in the dose or withdrawal of the statin.
The review authors stated that, in fact, the proportion of off-label scripts may be as high as 53 per cent.
The authors concluded that they could not confirm that the further 35% of ezetimibe scripts were within the listing, and thus proposed a price reduction for a proportion of ezetimibe use between 18 and 53 per cent.
MSD, the manufacturer of ezetimibe, believes the calculation is flawed as it only looked back on two years of data to see if a patient had been previously treated with a statin. “If the group had done a more comprehensive review of patient history and looked back over the previous decade they would have found less than 10% of patients out of restriction,” the company stated in a release.
MSD said that, “If the PBAC were to act on this recommendation, it would undermine the committee’s integrity and put the Minister of Health in the difficult position of making a decision that could impact up to 300,000 Australians which is not evidenced based.”
PBAC will review the final Review recommendations in July and if the Committee recommends a major price cut, it will set in motion a process that will involve the Federal Health Minister and could even lead to the delisting of ezetimibe in Australia.
Submissions must be lodged by 5pm Tuesday, 6 June 2017. They can be lodged here
Click here to access the review home page