NICE rejects AZ's Lynparza tablets in ovarian cancer maintenance

AstraZeneca has said it will continue pricing negotiations with the NHS and NICE after the cost-effectiveness body said the tablet formulation of Lynparza (olaparib) is too expensive for regular funding on the health service as a maintenance therapy for some ovarian cancer patients.

In a first draft decision NICE said Lynparza was not cost effective as a maintenance therapy for relapsed, platinum sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, that is in response to platinum-based chemotherapy in adults regardless of BRCA status.

In a decision that applies to England, NICE’s independent appraisal committee said that clinical trials show the drug extends the time until cancer progresses compared with routine surveillance, and the benefit appears to be greater in a group of patients with the BRCA mutations.

Part of the issue is that NICE has ruled Lynparza does not qualify as an end-of-life therapy – even though AZ said “real-world” data showed life expectancy in this patient population is less than 24 months.

NICE gives extra cost-effectiveness leniency for drugs meeting its end-of-life criteria, allowing a threshold of up to £50,000 per Quality Adjusted Life Year, instead of the standard £30,000 limit.

This guidance relates to the tablet formulation of Lynparza – in a capsule form the drug is recommended by NICE as an option for women with relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer who have BRCA1/2 mutations, after three or more rounds of platinum-based chemo.

In a statement, AstraZeneca said it will “continue to engage with NICE, NHS England and the Cancer Drugs Fund” to secure funding for the drug in this indication.

Eisai and Jazz cancer drugs get NICE green light

Meanwhile, NICE has recommended two new cancer drugs for liver cancer and blood cancer, from Eisai and Jazz Pharmaceuticals in final draft guidance.

The cost-effectiveness body recommended Eisai’s Lenvima (lenvatinib) for patients with untreated advanced unresectable hepatocellular carcinoma.

Patients must have Child-Pugh grade A liver impairment, and active and capable of light work based on a standard scale to qualify.

An oral tyrosine kinase inhibitor, Eisai hopes to offer liver cancer patients an alternative to Bayer’s Nexavar (sorafenib), which is standard of care in this indication.

Lenvima was approved on the basis of a study showing it matched Nexavar against an endpoint of overall survival, and showed improvements in secondary measures of progression free survival, time to progression and objective response rate.

Gary Hendler, chairman and CEO of Eisai EMEA, said: “Lenvatinib is the first new treatment option to be made available in this first-line systemic treatment setting of hepatocellular carcinoma (HCC) in over a decade which we anticipate could become the new standard of care for patients.”

Eisai is jointly developing and marketing Lenvima with Merck & Co., both as monotherapy and as a potential combination with the US pharma’s cancer immunotherapy, Keytruda (pembrolizumab).

In a separate final draft guidance decision, NICE also recommended Jazz Pharmaceuticals’  Vyxeos (daunorubicin and cytarabine) for acute myeloid leukaemia (AML) with or AML with myelodysplasia-related changes (AML-MRC).