← Katalog Appraisal
TAPublishedCancer / Ovarian cancer· 2024-09-17
TA1007
Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
14 item
Rekomendasi numbered
1.1
Rucaparib is recommended, within its marketing authorisation, as an option for the maintenance treatment of relapsed platinum-sensitive high-grade epithelial, ovarian, fallopian tube or primary peritoneal cancer that has completely or partially responded to platinum-based chemotherapy in adults. Rucaparib is only recommended if the company provides it according to the commercial arrangement .
1.2
If people with the condition and their healthcare professional consider rucaparib to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. Why these recommendations were made This evaluation reviews the evidence for rucaparib for the maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer from NICE technology appraisal guidance 611. It also reviews data from a clinical trial and people having treatment in the NHS in England collected as part of the managed access agreement. Standard maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer includes niraparib and olaparib. There are no direct comparisons of rucaparib with niraparib or olaparib. But the results of an indirect comparison suggest that rucaparib is likely to work as well as niraparib in terms of how long people live and how much time they have until the cancer progresses. The company considers the results of an indirect comparison with olaparib to be confidential, so they cannot be reported here. The company considers niraparib to be the main comparator for rucaparib. Using NICE's cost-comparison methods , rucaparib only needs to provide similar or greater health benefits at similar or lower costs to 1 relevant comparator to be recommended as a treatment option. A cost comparison suggests that rucaparib has similar or lower costs and similar overall health benefits to niraparib. So, rucaparib is recommended. For all the evidence, see the committee papers . To see what NICE did for niraparib, see the committee discussion section in NICE's technology appraisal guidance on niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer .
2.1
Rucaparib (Rubraca, Pharm&) is indicated 'as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy'.
2.2
The dosage schedule is available in the summary of product characteristics for rucaparib .
2.3
The list price of rucaparib is £3,562 per 60‑tablet pack of 300‑mg, 250‑mg or 200‑mg tablets (excluding VAT, BNF online, accessed August 2024).
2.4
The company has a commercial arrangement . This makes rucaparib available to the NHS with a discount. The size of the discount is commercial in confidence.
3.1
Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication. Because rucaparib has been recommended through the cost-comparison process , NHS England and integrated care boards have agreed to provide funding to implement this guidance 30 days after publication.
3.2
Chapter 2 of Appraisal and funding of cancer drugs from July 2016 (including the new Cancer Drugs Fund) – A new deal for patients, taxpayers and industry states that for those drugs with a draft recommendation for routine commissioning, interim funding will be available (from the overall Cancer Drugs Fund budget) from the point of marketing authorisation, or from release of positive draft guidance, whichever is later. Interim funding will end 90 days after positive final guidance is published (or 30 days in the case of drugs with an Early Access to Medicines Scheme designation or cost-comparison evaluation), at which point funding will switch to routine commissioning budgets. The NHS England Cancer Drugs Fund list provides up-to-date information on all cancer treatments recommended by NICE since 2016. This includes whether they have received a marketing authorisation and been launched in the UK.
3.3
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.
3.4
When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer and the healthcare professional responsible for their care thinks that rucaparib is the right treatment, it should be available for use, in line with NICE's recommendations.
1.1
Rucaparib is recommended, within its marketing authorisation, as an option for the maintenance treatment of relapsed platinum-sensitive high-grade epithelial, ovarian, fallopian tube or primary peritoneal cancer that has completely or partially responded to platinum-based chemotherapy in adults. Rucaparib is only recommended if the company provides it according to the commercial arrangement .
1.2
If people with the condition and their healthcare professional consider rucaparib to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. Why these recommendations were made This evaluation reviews the evidence for rucaparib for the maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer from NICE technology appraisal guidance 611. It also reviews data from a clinical trial and people having treatment in the NHS in England collected as part of the managed access agreement. Standard maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer includes niraparib and olaparib. There are no direct comparisons of rucaparib with niraparib or olaparib. But the results of an indirect comparison suggest that rucaparib is likely to work as well as niraparib in terms of how long people live and how much time they have until the cancer progresses. The company considers the results of an indirect comparison with olaparib to be confidential, so they cannot be reported here. The company considers niraparib to be the main comparator for rucaparib. Using NICE's cost-comparison methods , rucaparib only needs to provide similar or greater health benefits at similar or lower costs to 1 relevant comparator to be recommended as a treatment option. A cost comparison suggests that rucaparib has similar or lower costs and similar overall health benefits to niraparib. So, rucaparib is recommended. For all the evidence, see the committee papers . To see what NICE did for niraparib, see the committee discussion section in NICE's technology appraisal guidance on niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer .
1.1
Rucaparib is recommended, within its marketing authorisation, as an option for the maintenance treatment of relapsed platinum-sensitive high-grade epithelial, ovarian, fallopian tube or primary peritoneal cancer that has completely or partially responded to platinum-based chemotherapy in adults. Rucaparib is only recommended if the company provides it according to the commercial arrangement .
1.2
If people with the condition and their healthcare professional consider rucaparib to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account. Why these recommendations were made This evaluation reviews the evidence for rucaparib for the maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer from NICE technology appraisal guidance 611. It also reviews data from a clinical trial and people having treatment in the NHS in England collected as part of the managed access agreement. Standard maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer includes niraparib and olaparib. There are no direct comparisons of rucaparib with niraparib or olaparib. But the results of an indirect comparison suggest that rucaparib is likely to work as well as niraparib in terms of how long people live and how much time they have until the cancer progresses. The company considers the results of an indirect comparison with olaparib to be confidential, so they cannot be reported here. The company considers niraparib to be the main comparator for rucaparib. Using NICE's cost-comparison methods , rucaparib only needs to provide similar or greater health benefits at similar or lower costs to 1 relevant comparator to be recommended as a treatment option. A cost comparison suggests that rucaparib has similar or lower costs and similar overall health benefits to niraparib. So, rucaparib is recommended. For all the evidence, see the committee papers . To see what NICE did for niraparib, see the committee discussion section in NICE's technology appraisal guidance on niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer .