06 August 2015
NICE asks company for more information on olaparib for ovarian, fallopian tube and peritoneal cancer
NICE has today (Thursday 6 August) opened a second consultation on preliminary draft guidance on the drug olaparib (Lynparza) for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer.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.
The independent Appraisal Committee which developed the draft guidance is asking the company to provide a robust estimate of the cost effectiveness of olaparib for the subgroup of patients with relapsed disease who have had 3 or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 includes cost of somatic testing[1] taking into account the Committee’s concerns about its previous models, and full details of the data supporting.
For people who’ve had fewer than 3 previous courses of platinum-based chemotherapy, 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 these particular patients, so the preliminary guidance does not recommend it in this situation.
This draft guidance is now open for public consultation: NICE has not yet published final guidance to the NHS.
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: “Olaparib slows the progression of the disease for patients with some forms of ovarian cancer but the evidence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. Life expectancy for patients who’ve had 3 or more courses of platinum-based chemotherapy could be less than 2 years so the end-of-life criteria, which allows more flexibility in our guidance could apply in this situation. Our Advisory Committee has therefore asked the company to provide a robust estimate of the cost effectiveness of olaparib for these patients, along with further information on supporting data.
He continued: “However for patients who’ve had fewer than 3 courses of platinum-based chemotherapy, we weren’t able to apply the flexibility we can sometimes use when we appraise cancer drugs as they are already living longer than two years with this conventional treatment. For this group of patients, 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 circumstance 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 have an increased risk of ovarian cancer.
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the new 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.
Ends
For more information call Dr Tonya Gillis the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.
Notes to Editors
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 6 August 2015, at http://www.nice.org.uk/guidance/indevelopment/gid-tag481.
2. The draft recommendations are:
a) The Committee is minded not to recommend olaparib 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 platinum-based chemotherapy, only if they have had 3 or more courses of platinum-based chemotherapy. However, the Committee requests from the company a robust estimate of the cost effectiveness of olaparib for this subgroup of patients, including the cost of somatic testing and taking into account the Committee’s concerns about its previous models. This should be accompanied by the model, full details of the data supporting it and access to the full patient data set.
b) Olaparib is not recommended as maintenance treatment for adults with relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer who have BRCA1 or BRCA2 mutations, if they have had fewer than 3 previous lines of platinum-based chemotherapy.
c) 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). The company’s further analysis, submitted in response to consultation, that incorporated the costs of tumour testing in line with the Committee’s preference (and corrections to 2 minor errors in the model identified by the Evidence Review Group) produced a probabilistic ICER of £51,600 for olaparib compared with routine surveillance, for the whole population in whom olaparib is indicated. However, the Committee considered that this was likely to be an underestimate of the true ICER because it overestimated the overall survival gain associated with olaparib.
No ICER was estimated for the subgroup of patients who’ve had 3 or more courses of platinum-based chemotherapy and the Committee has now requested that the company provides a robust estimate of the cost effectiveness of olaparib for this subgroup of patients, along with further information.
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 could apply to olaparib for patients who’ve had 3 or more courses of platinum-based chemotherapy, but that it did not apply for patients who’ve had fewer than 3 courses of platinum-based chemotherapy.
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.
[1] Somatic testing involves testing the tumour, not the blood. It can pick up tumours that are linked to inherited gene mutations, and tumours which develop from gene mutations that are not inherited.
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