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NICE changes stance on AZ’s Lynparza after concessions

NHS patients in England and Wales to get ovarian cancer drug

AstraZeneca headquarters

AstraZeneca will be able to supple its ovarian cancer therapy Lynparza to the NHS in England and Wales after agreeing to cut the price of the drug.

The National Institute for Health and Care Excellence (NICE) turned down Lynparza (olaparib) as a maintenance treatment for BRCA-positive ovarian, fallopian tube and peritoneal cancer in August, but opened a second consultation on the decision.

Now, AZ has agreed to reduced the list price of the poly ADP-ribose polymerase (PARP) inhibitor, which works by blocking DNA repair in cancer cells, to £3,550 per 28 day pack. Meanwhile, AZ said that it would provide the NHS with Lynparza free of charge for patients who remain on therapy for over 15 months, "until further data become available to give greater clarity on the long term costs and benefits of olaparib for this small group of patients".

Consequently, NICE has backed use of  Lynparza in final draft guidance, but only in patients who have received three or more course of chemotherapy, and NICE has set the condition that AZ will have to provide the drug free of charge if treatment extends beyond 15 months. NICE's earlier guidance indicated the price of Lynparza was £3,950 per 28-day pack.

NICE programme director for appraisals, Meindert Boysen, said: "The independent appraisal committee asked the company which makes olaparib to provide further information on this subgroup of patients." 

"This further detail on the cost effectiveness of the drug for these patients means that this final draft guidance now recommends olaparib in specific circumstances."

Ovarian cancer is the fifth most common cancer in women. Epithelial ovarian cancer, which affects the surface layers of the ovary, is the most common type, and is similar to fallopian tube and peritoneal cancer.  People who have BRCA 1 or 2 gene mutations have an increased risk of ovarian cancer.

After winning partial access to Lynparza, AZ said in a statement that "the UK needs to reform the medicines value assessment framework; increase investment in the latest medicines, and ensure that NICE and the NHS have an increased focus on measuring patient outcomes, so that UK patients have access to innovative and much-needed cancer treatments and that the standard of patient care improves".

UK bioscience played a significant role in the development of Lynparza, according to the BioIndustry Association (BIA).  The drug has been held up as evidence that the UK's health technology assessment (HTA) framework makes it hard for innovative products - even if they are developed within the UK - to reach patients.

Article by
Phil Taylor

11th December 2015

From: Regulatory



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