A UMass Medical School pharmacy expert says the delay in the results of a trial on proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors is frustrating for prescribers waiting to give the drugs to patients with uncontrolled cholesterol levels, according to an article in Specialty Pharmacy Continuum.
“We’ve obviously waited a long time for these drugs and their potential promise. We are still continuing to see a slow uptake in their use in the U.S., with providers and payors both wanting better data, and this is just going to mean that takes a little bit longer,” Mark Tesell, PharmD, BCPS, a clinical consultant pharmacist in UMass Medical School’s Clinical Pharmacy Services unit, said in the June 23 article.
Specialty Pharmacy Continuum reported that results on Amgen’s evolocumab (Repatha) from the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial, which were expected in late 2016, will not be released until 2017. The results of another trial, ODYSSEY Outcomes, on Sanofi/Regeneron’s PCSK9 inhibitor alirocumab (Praluent), are not expected until December 2017, according to the article.
The delayed release of evolocumab results will give Amgen less time to advance in the market before the outcomes data for alirocumab is known, Tesell said in the article.
“The provider community is likely to go with the agent that has the data first. Will a three- to six-month head start make a big difference five to 10 years from now? I don’t know, but in the short term it might,” Tesell told Specialty Pharmacy Continuum.
Tesell told Specialty Pharmacy Continuum he doesn’t expect an overnight change in use of the expensive new drugs, even if the results are positive.
“It won’t be like the news comes out on Monday, and on Tuesday we have a 200 percent increase in use. Usage probably will go up fairly quickly in patients who are candidates if there are good outcomes data, but because these drugs are injectables, expensive and fairly new, they will still be a tough sell for some providers and patients,” Tesell said in the article.
Clinical Pharmacy Services provides results-oriented solutions to containing pharmacy costs and improving patient outcomes. As part of UMass Medical School, it offers direct access to clinical resources and the latest research, data and trends.