The draft guidance gives provisional recommendations on whether the drugs paclitaxel, pegylated liposomal doxorubicin hydrochloride (PLDH), topotecan, trabectedin and gemcitabine should be offered as treatment options for ovarian cancer that has returned after prior chemotherapy treatment.
The draft guidance recommends paclitaxel and pegylated liposomal doxorubicin hydrochloride (PLDH) for treating recurrent ovarian cancer. Paclitaxel can be used as monotherapy, or in combination with platinum. PLDH can be used as monotherapy, and is also an option in combination with platinum – an indication which is currently outside of its marketing authorisation but which NICE was asked to consider.
The draft guidance proposes not recommending the three further drugs – gemcitabine, topotecan and trabectedin – for treating the first recurrence of platinum-sensitive ovarian cancer (where the disease responds to first-line platinum-based therapy but returns over 6 months after this treatment). Topotecan is also provisionally not recommended for treating cancer that has returned within 6 months of treatment with a platinum-based regimen or cancer which did not respond to platinum treatment at all (platinum-resistant or refractory recurrent ovarian cancer). 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with carboplatin, trabectedin in combination with PLDH, or topotecan that is not recommended for them in this draft guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
This draft guidance is now open for public consultation: NICE has not yet published final guidance to the NHS.
Meindert Boysen, NICE Programme Director – Appraisals, said: “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. This draft guidance recommends paclitaxel and pegylated liposomal doxorubicin hydrochloride for the treatment of ovarian cancer that has returned after previous treatment with platinum chemotherapy. However the independent committee found that the evidence on the further three drugs indicated that they didn’t provide enough extra health benefit for the cost to the NHS. NICE welcomes comments on this draft guidance a part of the public consultation.”
Consultees, including the manufacturer, healthcare professionals and members of the public are able to comment on the draft recommendations until 15 December 2015 via the NICE website. Comments received during this consultation will be fully considered by the Committee before the next draft guidance is issued. Until final guidance next is published, 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 draft guidance
- The draft guidance, ‘Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer (including reviews of technology appraisal guidance 91 and 222)’ will be available from the NICE website from Tuesday 24 November 2015.
- 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 draft 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 (November 2015), 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 currently receiving treatment initiated within the NHS with gemcitabine in combination with carboplatin, trabectedin in combination with PLDH, or topotecan that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
4. This is the second consultation on draft guidance, following an appeal that was held on 24 April 2015. Further information is available at https://www.nice.org.uk/guidance/indevelopment/gid-tag325/document
5. 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. Ovarian cancer predominantly occurs in older women, with over 80% of cases being diagnosed in women over 50 years. In 2010, around 7000 new cases of ovarian cancer were diagnosed.
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