NICE is considering whether or not the drugs gemcitabine, paclitaxel, pegylated liposomal doxorubicin hydrochloride (PLDH), topetecan and trabectedin should be recommended as treatment options for ovarian cancer that has returned after previous treatment with chemotherapy (recurrent disease).

Sir Andrew Dillon, NICE Chief Executive, said: “Ovarian cancer is one of the most common cancers in women and for the majority of these people, their cancer will return within 2 years of finishing treatment.

“These women, just like all other patients within the NHS, deserve access to treatments that will make the greatest difference to their lives and that the NHS can afford.”

In final draft guidance, NICE says that paclitaxel and PLDH are cost-effective and should continue to be recommended for routine NHS use.

The draft guidance also recommends the treatment PLDH in combination with platinum chemotherapy, a use for which it is not currently licenced. Shown to be 1 of the 2 most effective treatment options for recurrent ovarian cancer, special agreement from the Department of Health was obtained to allow the Institute’s Appraisal Committee to develop this recommendation.

However, the drugs gemcitabine, topetecan and trabectedin were shown to provide less benefit to patients than other options when the disease recurs for the first time at least 6 months after first-line platinum-based chemotherapy. NICE does not recommend them at this stage of the disease.

The Appraisal Committee did not make any recommendations on using these drugs for treating ovarian cancer at later stages because there was no evidence on which to base an estimate of clinical and cost effectiveness.

For people with ovarian cancer that has not responded to platinum-based chemotherapy or that has recurred within 6 months of such treatment, the committee concluded that both PLDH and paclitaxel could be recommended for use, but that topotecan was not cost-effective.

Sir Andrew added: “These recommendations have been developed according to the best available evidence from the manufacturers, an independent assessment group, health professionals and patient organisations.

”The manufacturers and other organisations who are registered stakeholders for this appraisal can appeal against any of these recommendations, but only if they believe NICE has either acted unfairly or exceeded its powers. Otherwise, this draft guidance will proceed to publication next year.”

Until final guidance is published NHS bodies should make decisions locally on the funding of specific treatments.

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the guidance

The draft NICE recommendations say:

• Paclitaxel in combination with platinum or as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer.
• Pegylated liposomal doxorubicin hydrochloride (PLDH) as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer.
• PLDH in combination with platinum is recommended as an option for treating recurrent ovarian cancer.
• 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; topotecan.

The Appraisal Committee was unable to make recommendations on the use of these technologies for treating platinum-sensitive ovarian cancer beyond the first recurrence.

• Topotecan is not recommended within its marketing authorisation for treating recurrent platinum resistant or platinum-refractory ovarian cancer.
• 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.

PLDH in combination with platinum is not currently licenced to treat recurrent ovarian cancer. The Department of Health agreed that the NICE Appraisal Committee could make this recommendation because it is a commonly used treatment, despite lack of licence. This recommendation is made under the same regulations as applied to NICE Clinical guidelines and therefore the requirement for funding does not apply.

For 4 of the 5 drugs this is a routine review of past guidance, which is in line with the Institute’s normal process. For the other, gemcitabine, this is a first-time appraisal.

About ovarian cancer

• Ovarian cancer is the 5th most common cancer among women in the UK.
• In 2011, 6,356 women in England and Wales were diagnosed with the disease.
• Ovarian cancer is more common in older women. Three out of 4 cases are diagnosed in people aged 55 and over.
• About one-third (35%) of adults diagnosed with ovarian cancer in 2010-11 in England and Wales are predicted to survive for at least 10 years.

These statistics have been taken from Cancer Research UK. For more cancer statistics, visit their website:  http://www.cancerresearchuk.org/cancer-info/cancerstats/types/ovary/.