NEW YORK – The National Institute for Health and Care Excellence on Tuesday said it did not find AstraZeneca/Merck's Lynparza (olaparib) to be a cost-effective treatment for metastatic, hormone-relapsed prostate cancer patients with BRCA1/2 mutations.
As such, the institute said it does not recommend the National Health Service provide the PARP inhibitor to patients in England with this type of cancer at its current price.
AstraZeneca submitted data from PROfound and other trials. Data from PROfound, which showed that Lynparza improved median radiographic progression-free survival against Pfizer/Astellas' Xtandi (enzalutamide) or Janssen's Zytiga (abiraterone), led the US Food and Drug Administration to approve the PARP inhibitor for metastatic castration-resistant prostate cancer patients with mutations in a handful of genes involved in homologous recombination repair deficiency. Updated overall survival data showed that BRCA1/2- and ATM-mutated patients lived longer on Lynparza than with the comparator drugs.
The European Commission and regulators in the UK reasoned that most of the benefit seen in the study was being driven by those with BRCA1/2 mutations and limited the drug only to patients with mutations in these two genes.
In its appraisal, NICE recognized that Lynparza does seem to extend the time patients have before their cancer worsens and helps them live longer overall compared to retreatment with Xtandi and Zytiga, but it noted that these weren't the proper comparators because it didn't reflect standard practice. The trial included patients who had received prior treatment with Xtandi and Zytiga, and some of those patients were randomized to these drugs again in the comparator arm. However, most advanced prostate cancer patients in the NHS who receive anti-androgen agents wouldn't receive retreatment with these drugs again, because such therapy is considered ineffective. Moreover, the sponsor didn't provide any direct evidence showing that Lynparza is better than available treatments in patients who have and have not had prior taxanes.
Although indirect evidence exists in this regard showing Lynparza extends lives, NICE said it did not find the treatment to be cost-effective even after taking this into account. "At the price currently offered, the treatment could not be considered a cost-effective use of NHS resources," it said.
The list price for Lynparza is £2,317.50 ($2,668.81) per pack of 56 tablets, though the sponsor is providing it to the NHS at an undisclosed discount for other indications. The discount would have applied had NICE recommended Lynparza for advanced, previously treated BRCA1/2-mutated prostate cancer patients, the institute said.
"It is the company's responsibility to let relevant NHS organizations know details of the discount," NICE wrote in the draft final decision.
NICE said it may reconsider the cost-effectiveness of the drug under a revised price. AstraZeneca has a month to appeal NICE's draft recommendations, but if it doesn’t, then the present decision will be published as final.