NEW YORK – The UK's National Institute for Health and Care Excellence on Thursday recommended that the National Health Service provide Merck and AstraZeneca's PARP inhibitor Lynparza (olaparib) to patients in England with HER2-negative, high-risk, early-stage breast cancers harboring germline BRCA1 or BRCA2 mutations as well as patients with advanced prostate cancers harboring mutations in these genes.
The recommendations, which follow confidential commercial discount agreements with AstraZeneca, reverse NICE's earlier draft decisions in which NICE said it did not consider Lynparza cost-effective for these indications.
For the breast cancer indication, NICE issued a draft guidance recommending Lynparza alone or with endocrine therapy as adjuvant treatment for patients who have received surgery and chemotherapy. The recommendation is based on the results of the Phase III OlympiA trial, in which Lynparza improved patients' invasive disease-free survival versus placebo.
For the metastatic prostate cancer indication, NICE issued a draft guidance recommending the PARP inhibitor for patients whose cancers relapsed after hormone therapy and progressed after treatment with a newer hormone therapy such as Janssen's Zytiga (abiraterone) or Pfizer/Astellas Oncology's Xtandi (enzalutamide). To make this recommendation, NICE considered results from the Phase III PROfound trial and the Phase III CARD trial.
NICE considered the therapy's cost effectiveness in its recommendation. Lynparza's list price is £2,317.50 ($2,881.38) for a 56-pack of 150 mg tablets, though AstraZeneca has agreed to provide Lynparza to the NHS at an undisclosed discounted rate.
"We are delighted that the NHS England and the company have been able to reach agreement on this groundbreaking deal enabling NICE to recommend olaparib for routine NHS use and good value for money for taxpayers," Helen Knight, the director of medicines evaluation at NICE, said in a statement. "Olaparib represents an important development in the treatment of early breast and advanced prostate cancer, and today's announcement addresses a significant need by giving people with these types of cancer access to an effective, targeted treatment."
NICE plans to publish a final guidance on Lynparza in these breast and prostate cancer patient populations in May.
Lynparza is already approved as an adjuvant treatment for high-risk early-stage breast cancer patients harboring BRCA1/2 mutations in the US and Europe. The US Food and Drug Administration approved the PARP inhibitor for metastatic castration-resistant prostate cancer harboring homologous recombination repair (HRR) gene deficiencies including BRCA1/2 mutations. European regulators approved the drug for a narrower population with BRCA1/2 mutations only.