NICE publishes draft guidance on suite of ovarian cancer drugs
September 26, 2013
Tasked with recommending only the most cost-effective treatments to the NHS, the National Institute for Health and Care Excellence (NICE) is currently considering if five ovarian cancer treatments work well enough to be funded by the NHS.
In draft guidance published for consultation, NICE recommends two of the drugs - paclitaxel and pegylated liposomal doxorubicin hydrochloride (PLDH) - for the treatment of ovarian cancer that has returned after previous treatment with chemotherapy. Three other drugs (gemcitabine, topetecan and trabectedin) have not been recommended as treatments for ovarian cancer that has returned for the first time six months or more after platinum-based chemotherapy (platinum-sensitive disease). Topetecan is also not recommended for treating cancer that has returned less than 6 months after treatment with a platinum-based regimen or did not respond to platinum at all (platinum-resistant or refractory recurrent ovarian cancer). The independent Appraisal Committee concluded they provide little benefit to patients compared with other options that can be used at these stages. This was based on evidence from the assessment group, manufacturers' submissions, health professionals and patient organisations.
Sir Andrew Dillon, NICE Chief Executive, said: "NICE's role is to ensure that the NHS gives people access to the most cost-effective treatments that will make the greatest difference to their lives. These difficult decisions help the NHS to allocate its limited 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 This draft guidance recommends paclitaxel and pegylated liposomal doxorubicin hydrochloride for the treatment of ovarian cancer that has returned after previous treatment with chemotherapy. But the committee found the other treatments were not cost-effective."
Ovarian cancer is the fifth most common cancer in women. More than 7,000 women were diagnosed with the disease in 2010 and, for up to three-quarters of those women, their cancer will return within two years of finishing treatment.
Consultees, including the manufacturer, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website and submit any further evidence on the drugs' effectiveness until Friday 18 October 2013. All comments received during this consultation will be considered by the committee and a second draft of the guidance will then be published. NICE is expected to publish its final guidance next year and until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
The draft guidance (called an Appraisal Consultation Document or ACD) for topotecan, pegylated liposomal doxorubicin hydrochloride (PLDH), paclitaxel, trabectedin and gemcitabine for recurrent ovarian cancer will be available from the NICE website from Friday 27 September 2013.
Ovarian cancer is a common gynaecological cancer which represents a group of different tumours that arise from diverse types of tissue contained within the ovary. 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. Fallopian tube cancer and primary peritoneal cancer are histologically equivalent diseases to epithelial ovarian cancer. Symptoms of ovarian cancer tend to be non-specific and include persistent pelvic and abdominal pain, abdominal bloating, urinary frequency or urgency, loss of appetite, and abnormal or postmenopausal bleeding. Most women are diagnosed with advanced stage disease.
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 and there were approximately 4300 deaths from ovarian cancer in the UK. The overall 5-year survival rate for ovarian cancer is approximately 43%.
About the treatments being appraised
Paclitaxel is one of the most commonly used treatments for ovarian cancer and has been recommended by NICE since 2003. It is a cytotoxic anticancer drug that belongs to the taxane group of drugs, which prevent the formation of mitotic spindles, thus interfering with the process of cell division and resulting in cell death. Paclitaxel has a UK marketing authorisation 'for the treatment of metastatic carcinoma of the ovary after failure of standard, platinum containing therapy'.
Pegylated liposomal doxorubicin hydrochloride (Caelyx, Jansen-Cilag; PLDH) is an anthracycline - a group of cytotoxic antibiotics that inhibit DNA synthesis. They also interact with cell membranes, altering their function and generating cytotoxic chemicals. PLDH has a UK marketing authorisation for the treatment of advanced ovarian cancer in women for whom a first-line platinum-based chemotherapy regimen has failed.
Gemcitabine (various manufacturers) is a chemotherapeutic agent that inhibits DNA synthesis. It is a nucleoside analogue with antitumour activity against a number of solid tumours. Gemcitabine, plus carboplatin, has a UK marketing authorisation for the treatment of 'patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy'.
Topotecan (various manufacturers) is a naturally derived chemotherapeutic agent that prevents DNA replication in cancer cells. It has a UK marketing authorisation for the treatment of women with 'metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy'.
Trabectedin (Yondelis, PharmaMar) is an anticancer agent that binds to the minor groove of the DNA and as a result bends the helix to the major groove, which disrupts the cell cycle. It has a UK marketing authorisation, in combination with PLDH, for the treatment of women 'with relapsed platinum-sensitive ovarian cancer'.
For a summary of the Appraisal Committee's key conclusions, please see the Appraisal Consultation Document.
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