NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) issued a draft guidance on Friday that did not recommend olaparib (AstraZeneca's Lynparza) as a treatment for hormone-relapsed metastatic prostate cancer that harbors BRCA1 or BRCA2 mutations.
The draft guidance noted that there is no direct comparison of olaparib to the current standard of care, docetaxel, cabazitaxel, or radium-223. NICE said an indirect comparison suggests that olaparib increases how long people live compared with cabazitaxel, but it was uncertain. NICE based its indirect comparison on data from the Phase III PROfound trial comparing olaparib to investigators' choice of enzalutamide or abiraterone in prostate cancer, and the Phase III CARD trial evaluating cabazitaxel and prednisone with enzalutamide or abiraterone in prostate cancer.
NICE concluded that olaparib may benefit patients over cabazitaxel, but the differences between the two trials, including the trial population and the treatments people had after disease progression, make this comparison data uncertain.
The regulator also said that AstraZeneca limited the patient population in its submission to those who had been previously treated with docetaxel, a narrower group than olaparib's marketing authorization by the European Medicines Agency.
AstraZeneca limited its submission to those who have received docetaxel because it was advised that about 75 percent of people in the NHS have gotten docetaxel, NICE said. However, the committee disagreed that the number of NHS patients receiving docetaxel was that high and noted that limiting olaparib to only this group would exclude patients who may benefit from the drug.
NICE also found that the cost-effectiveness estimates for olaparib were uncertain due to limitations in the clinical evidence and economic model. The group found its estimates were higher than what it considers an acceptable use of the UK's National Health Service (NHS) resources. The price of olaprib is about £2,317.50 ($3,200) for a pack of 56 tablets, but AstraZeneca offered the drug to NHS at a confidential discount.
Olaparib was approved by the EMA in November for previously treated patients with prostate cancer harboring BRCA1/2 mutations. It was also approved by the US Food and Drug Administration for a broader prostate cancer patient population, including those with homologous recombination repair deficiency, in May.