NICE draft guidance does not recommend bevacizumab for recurrent advanced ovarian cancer

NICE draft guidance does not recommend bevacizumab for recurrent advanced ovarian cancer

The National Institute for Health and Clinical Excellence (NICE) has published draft guidance today (1 February) on the use of bevacizumab (Avastin, Roche) for treating advanced ovarian cancer that has returned six months or more after initial treatment with platinum-based chemotherapy (platinum-sensitive disease).

The draft guidance for this indication - which focuses on treating the first recurrence of the disease and also includes fallopian tube and primary peritoneal cancer - does not recommend the use of the drug (when used with the chemotherapy agents, gemcitabine and carboplatin), as a cost-effective treatment for the NHS. However, it does say that people currently receiving this treatment combination should be able to continue until they and their clinician consider it appropriate to stop.

This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS.

Ovarian cancer is the fifth most common cancer in women in the UK[i] with 7,011 new cases of the disease diagnosed in 2010[ii]. Recurrent advanced ovarian cancer refers to when the tumour has spread from its original site (the lining of the ovary) to other parts of the body and has returned following initial treatment. Bevacizumab is designed to target cancer cells and stop them from growing.

Sir Andrew Dillon, NICE Chief Executive, said: "With any treatment that our independent advisory committees appraise, we must develop recommendations based on the clinical and cost effectiveness evidence provided, weighing up how well a treatment works compared with currently available treatments and taking into consideration any possible side-effects. The NHS has finite resources so it is imperative that treatments are only recommended if they represent good value for money for the NHS for the amount of benefit they offer patients.

"In this instance, the Appraisal Committee concluded that, although bevacizumab may help to delay the spread of a patient's cancer for a limited time, the evidence did not show that bevacizumab justifies its very high cost and could not be recommended."

Sir Andrew Dillon continued: "We understand there are limited treatment options available to women with recurrent advanced ovarian cancer and it is always disappointing when we are not able to recommend a treatment. However, it is important to remember that there are other treatments already available in the NHS for treating this condition."

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation until 22 February. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.


Notes to Editors

About the guidance

1. The draft guidance on the use of bevacizumab for recurrent advanced ovarian cancer (including fallopian tube and primary peritoneal cancer) will be available from Friday 1 February 2012.

2. The evidence submitted to the independent Appraisal Committee by the manufacturer highlighted that the median progression-free survival benefit (the time point in the trial at which the 50% of people's cancers began to progress once again) of bevacizumab (with gemcitabine and carboplatin) was four months more than gemcitabine and carboplatin alone.

3. The committee heard from both clinical and patient experts that progression-free survival is important to patients and their families, giving them time to deal with the physical, emotional and psychological effects of ovarian cancer and its treatment. However, the committee noted that some clinical trial data relating to around one in three trial participants (30%) had been censored and concluded that it was unclear what impact the censoring had on the results for progression-free survival.

4. The Appraisal Committee concluded that there was insufficient evidence of clinical benefit in terms of overall survival for bevacizumab plus gemcitabine and carboplatin.

5. The committee considered cost-effectiveness data submitted by the manufacturer but concluded that the manufacturer's estimate of the Incremental Cost-Effectiveness Ratio (ICER) of £149,050 per QALY gained was likely to be optimistic, and that the most plausible ICER could be much higher than this. With this in mind, the Appraisal Committee noted that the cost effectiveness estimates for bevacizumab in combination with gemcitabine and carboplatin were outside the range normally considered as a cost-effective use of NHS resources. It therefore concluded that bevacizumab in combination with gemcitabine and carboplatin would not be a cost-effective use of NHS resources for treating recurrent advanced ovarian cancer compared with gemcitabine and carboplatin alone.

6. Bevacizumab is available in 100 mg and 400 mg vials at net prices of £242.66 and £924.40 respectively (excluding VAT; 'British national formulary' [BNF] edition 63). The manufacturer estimated the cost of a course of treatment with bevacizumab (excluding VAT and assuming vials are not shared between patients) to be £25,208 for a patient weighing 60.5 kg at a dosage of 15 mg/kg every 3 weeks for an average treatment length of around 7.5 months (10.8 cycles). Costs may vary in different settings because of negotiated procurement discounts.

7. There has been no patient access scheme agreed between the manufacturer and the Department of Health for this particular appraisal.

8. End of life considerations were considered by the Appraisals Committee but bevacizumab did not meet the population criterion. The Committee decided it was not necessary to make a decision about the life-expectancy or extension-to-life criteria.

9. The manufacturer estimates that around 2,100 patients in the UK should be eligible for this treatment option, if it were to be recommended.

10. The Scottish Medicines Consortium has not yet published their advice on bevacizumab for this indication. Its advice is due to be published in March 2013.

11. In 2005, NICE published guidance recommending the following as options for second-line (or subsequent) treatment for advanced ovarian cancer:

  • paclitaxel in combination with a platinum compound in platinum-sensitive or partially platinum sensitive disease

  • pegylated liposomal doxorubicin hydrochloride in partially platinum-resistant disease

  • single agent paclitaxel or pegylated liposomal doxorubicin hydrochloride in platinum-resistant or platinum refractory disease or for those with an allergy to platinum-based compounds

  • topotecan only where the other recommended options are considered inappropriate.

Paclitaxel in combination with a platinum-based therapy is currently seen as one of the most effective treatments for ovarian cancer and is one of the more widely-used treatment options in clinical practice.

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS

  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services

  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.