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.
Specifically, the draft recommendations say that olaparib should be available for people only if they have had 3 or more courses of platinum-based chemotherapy and the drug cost of olaparib for people who remain on treatment after 15 months is met by the company.
The independent Appraisal Committee which developed the draft guidance had previously asked the makers of olaparib to provide more information on the cost effectiveness of the drug. Specifically requested was information on the subgroup of patients with relapsed disease who have had 3 or more courses of platinum-based chemotherapy. The company provided this further information for the committee’s consideration. The analysis supplied by the company included both a patient access scheme in which the company meets the cost of the drug for people who remain on treatment after 15 months and a proposed reduction to the list price, which allowed the draft guidance to move from potentially not recommending the drug to instead saying that olaparib should be available for this particular group of people.
Meindert Boysen, NICE Programme Director – Appraisals, said: “We’re pleased to recommend olaparib for maintenance treatment of relapsed platinum-sensitive ovarian cancer in specific patients in this final draft guidance. 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 This further detail on the cost effectiveness of the drug for these patients means that this final draft guidance now recommends olaparib in specific circumstances, only if the company meets the cost of olaparib for people who remain on treatment after 15 months.”
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 of ovarian cancer, 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.
The final draft guidance is now with consultees, who have the opportunity to appeal against it. NICE has not yet published final guidance to the NHS. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.
Notes to Editors
About the final draft guidance
1. The final 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 11 December 2015, at http://www.nice.org.uk/guidance/indevelopment/gid-tag481 . Embargoed copies of the draft guidance are available from the NICE press office on request.
2. The draft recommendations are:
a) Olaparib is recommended within its marketing authorisation as an option for treating adults with relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer who have BRCA1 or BRCA2 mutations and whose disease has responded to platinum-based chemotherapy only if:
• they have had 3 or more courses of platinum-based chemotherapy and
• the drug cost of olaparib for people who remain on treatment after 15 months will be met by the company.
b) People whose treatment with olaparib is not recommended in this NICE guidance, but 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. For the subgroup of patients with relapsed BRCA mutation-positive, platinum-sensitive ovarian cancer who have received 3 or more previous lines of platinum-based chemotherapy, the Committee accepted that the most plausible ICERs were £46,600 to £46,800 per QALY gained.
5. The Committee concluded that there was sufficient evidence to suggest that olaparib met the end-of-life criteria for the subgroup of patients with relapsed BRCA mutation-positive, platinum-sensitive ovarian cancer who have received 3 or more previous lines of platinum-based chemotherapy.
6. 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). It is anticipated that the list price will be reduced before the final guidance is published. 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.
7. In second draft guidance that was open for public consultation in August 2015, the independent Appraisal Committee asked the company to provide a robust estimate of the cost effectiveness of olaparib for the subgroup of patients with relapsed disease who have had 3 or more courses of platinum-based chemotherapy. The information requested included an updated cost-effectiveness analysis taking into account the Committee’s concerns about its previous models, and full details of the data supporting it.
8. Olaparib is not recommended for use within NHS Scotland for this indication (https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1047_15_olaparib_Lynparza/olaparib_Lynparza).
9. 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.
10. 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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