NICE is once again saying no to AstraZeneca’s new ovarian cancer drug – but is opening up a second consultation on its decision.
The Institute is minded, in preliminary draft guidance, to reject Lynparza (olaparib) for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer.
The drug is for cancers in people who have tested positive for the BRCA1 or BRCA2 mutations, and whose disease has responded to platinum-based chemotherapy.
NICE’s appraisal committee is now asking AZ to provide a “robust estimate” of the drug’s cost-effectiveness for the subgroup of patients with relapsed disease who have had three or more courses of platinum-based chemotherapy.
The information requested includes cost of somatic testing, taking into account the committee’s concerns about its previous models.
But NICE is clear that for people who’ve had fewer than three previous courses of platinum-based chemotherapy, the evidence provided shows that the price that the NHS is being asked to pay for the drug is “too high” for the benefit it may provide to these particular patients, so the preliminary guidance does not recommend for these patients.
NICE said that the drug costs £3,950 per pack, which gives a supply for 28 days, but AZ has agreed a patient access scheme with the Department of Health.
Had the drug been recommended, this scheme would involve the NHS paying for a patient’s treatment with AZ’s treatment up to a certain time, with the company providing it free-of-charge beyond that point, and for as long as each individual patient continues to have Lynparza.
NICE also said that the drug would have a QALY of more than £50,000 – it does not usually recommended medicines with a QALY of more than £30,000.
This draft guidance is now open for public consultation: NICE has not yet published final guidance to the NHS.
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.
AZ’s drug works as a PARP inhibitor (poly ADP-ribose polymerase) that work by blocking the repair of DNA in tumour cells.
Last year, Lynparza is the first drug in the class to be approved for marketing, beating rivals such as Merck & Co/Tesaro’s niraparib and AbbVie’s veliparib which are in phase III testing in ovarian and breast cancer, respectively.
The drug is not currently available via England’s £340m a year Cancer Drugs Fund, as AZ said it would not even bother submitting it for approval under the silo budget, after a number of treatments were de-listed from its funding stream earlier this year.