The evidence provided shows that the price that the NHS is being asked to pay for olaparib is too high for the benefit it may provide to patients, so the preliminary guidance does not recommend it.
This draft guidance is now open for public consultation: NICE has not yet published final guidance to the NHS.
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: "Olaparib slows the progression of the disease for patients with some forms of ovarian cancer but the evidence that it can extend life is uncertain. Because patients are already living longer than two years with conventional treatment, we weren't able to apply the flexibility we can sometimes use when we appraise cancer drugs."
He continued: "The cost to the NHS of using this new drug isn't consistent with the benefits that patients for whom it works will gain and so we were disappointed not to be able to recommend it in this draft guidance."
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 may have an increased risk of ovarian cancer. For many people, their cancer will return within 2 years of finishing treatment, requiring further drug therapy.
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary guidance. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
About the draft guidance
1. The draft guidance, 'Olaparib for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer following response to second-line or subsequent platinum-based chemotherapy', will be available at from 1 June 2015, athttp://www.nice.org.uk/guidance/indevelopment/gid-tag481.
2. The draft recommendations are:
a) Olaparib is not recommended, within its marketing authorisation, as maintenance treatment for adults with relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer who have BRCA1 or BRCA2 mutations and whose disease has responded to second-line or subsequent platinum-based chemotherapy.
b) People whose treatment with olaparib was started within the NHS before this guidance was published should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
3. Olaparib (Lynparza; AstraZeneca) is a poly-ADP-ribose polymerase (PARP) enzyme inhibitor that selectively kills tumour cells with an impaired homologous recombination DNA repair pathway while sparing normal cells.
4. The Committee concluded that the most plausible ICER (incremental cost effectiveness ratio) for olaparib compared with routine surveillance was likely to be considerably above the range normally considered to be a cost-effective use of NHS resources (that is, £20,000 to £30,000 per QALY [quality adjusted life year] gained). It noted that, in the analysis that excluded the costs of testing for a BRCA mutation, the base-case probabilistic ICER estimated by the company for olaparib compared with routine surveillance was £49,146 per QALY gained. However, the Committee considered that this was likely to be an underestimate of the true ICER because it did not incorporate the cost of tumour testing to identify patients with the non-inherited mutation, and it probably overestimated the overall survival gain associated with olaparib.
5. The list price of olaparib is £3950 per pack, with each pack containing 448 capsules of 50 mg each (equivalent to 28 days' treatment of 16 capsules per day at continuous full dose of treatment); price excludes VAT, 'British national formulary' [BNF] edition 69). The company has agreed a patient access scheme with the Department of Health. If olaparib had been recommended, this scheme would involve the NHS paying for a patient's treatment with olaparib up to a certain time, with the company providing olaparib free-of-charge beyond that point and for as long as each individual patient continues to have olaparib. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.
6. The Committee concluded that the end-of-life criteria did not apply to olaparib.
7. NHS Scotland has not issued guidance on olaparib for this indication.
8. Although a significant percentage of people have disease that responds to initial chemotherapy, between 55% and 75% of people whose tumours respond to initial therapy relapse within 2 years of completing treatment.
9. NICE has published a clinical guideline on the detection, diagnosis and initial management of epithelial ovarian cancer: www.nice.org.uk/guidance/CG122 , and quality standard on ovarian cancer which defines clinical best practice within this topic area: www.nice.org.uk/guidance/qs18.
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