The guidance recommends paclitaxel and pegylated liposomal doxorubicin hydrochloride (PLDH) for treating ovarian cancer that has returned after previous chemotherapy treatment. Paclitaxel can be used on its own, or in combination with platinum. PLDH can be used alone or alongside platinum – this use is currently outside of its licence but Ministers agreed that NICE could consider it.
An estimated 3,000 women may be eligible for these recommended treatments. The cost of a course of treatment over one year with paclitaxel alone is just over £3,600, and the cost for PLDH is around £8,500.
The guidance does not recommend gemcitabine, trabectedin or topotecan for treating the first recurrence of platinum-sensitive ovarian cancer – this is where the disease responds to first-line platinum-based therapy but returns after six months or more. Topotecan is also not recommended for treating cancer that has returned within six months of platinum treatment, or for cancer which did not respond to platinum treatment at all.
Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “The independent committee agreed that paclitaxel plus platinum was the most cost-effective option for women with ovarian cancer that has returned, but that PLDH plus platinum could also be considered. The committee found that the evidence on the further three drugs indicated didn’t provide as much benefit for the cost to the NHS as other options available, so we could not recommend those drugs. NICE makes difficult decisions to ensure that people using the NHS get access to the most cost-effective treatments, and to help the NHS to share its resources fairly.”
People currently receiving NHS treatment with gemcitabine in combination with carboplatin, trabectedin in combination with PLDH, or topotecan that is not recommended for them in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
Notes to Editors
About the guidance
- The guidance, ‘Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (including reviews of technology appraisal guidance 91 and 222)’ is available from the NICE website from Weds 27 April 2016 at www.nice.org.uk/ta389.
- The five drugs considered in this appraisal are: paclitaxel (various companies), pegylated liposomal doxorubicin hydrochloride (Caelyx, Jansen-Cilag; PLDH), gemcitabine (various manufacturers), topotecan (various manufacturers), trabectedin (Yondelis, PharmaMar).
- The recommendations are:
a) Paclitaxel in combination with platinum or as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer.
b) Pegylated liposomal doxorubicin hydrochloride (PLDH) as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer.
c) PLDH in combination with platinum is recommended as an option for treating recurrent ovarian cancer*.
(*At the time of publication (April 2016), PLDH (Caelyx) in combination with platinum did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council’s Good practice in prescribing medicines – guidance for doctors for further information.
The use of PLDH (Caelyx) in combination with platinum is outside the terms of the marketing authorisation for Caelyx. Consequently the statutory funding requirement does not apply to this recommendation. NICE received a remit to appraise this combination under Regulation 5 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013).
d) The following are not recommended within their marketing authorisations for treating the first recurrence of platinum-sensitive ovarian cancer:
• gemcitabine in combination with carboplatin
• trabectedin in combination with PLDH
The Appraisal Committee was unable to make recommendations on the use of these technologies for treating platinum-sensitive ovarian cancer beyond the first recurrence.
e) Topotecan is not recommended within its marketing authorisation for treating recurrent platinum-resistant or platinum-refractory ovarian cancer.
f) People whose treatment with gemcitabine in combination with carboplatin, trabectedin in combination with PLDH, or topotecan 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.
- At list price, the cost of a dose of paclitaxel 175 mg/m2 (based on an average body surface area of 1.7 m2) is £601 per 3 weekly cycle (excluding administration costs). The cost of a course of treatment with paclitaxel alone is £3606 (based on 6 cycles).
The cost per dose of PLDH 50 mg/m2 (based on an average body surface area of 1.7 m2) on day 1 of every 28 day cycle is £1,425. The cost of a course of treatment with PLDH alone is £8,550 (based on 6cycles).
For both drugs, the figures exclude administration costs, and costs may vary in different settings because of negotiated procurement discounts.
- Ovarian cancer is a common gynaecological cancer. The most common type of ovarian cancer arises from epithelial cells (the outside layer of cells) on the surface of the ovary, and can often spread from the ovary to any surface within the abdominal cavity including the fallopian tubes and peritoneal cavity.
- There are an estimated 3110 women with recurrent ovarian cancer (ovarian cancer that has returned after previous chemotherapy treatment) who could benefit from the treatments recommended in this guidance.
- Ovarian cancer predominantly occurs in older women, with over 53% of cases being diagnosed in women aged over 65 years. In 2013, 7284 new cases of ovarian cancer were diagnosed in the UK (Cancer Research UK).
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