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NICE issues latest draft guidance on bevacizumab for recurrent advanced ovarian cancer

The cancer treatment bevacizumab (Avastin, Roche) is not recommended as an NHS treatment for a type of recurrent, advanced ovarian cancer*, according to the latest draft guidance published by the National Institute for Health and Care Excellence (NICE).

This draft guidance, which has been produced following a public consultation on earlier initial recommendations, concludes that bevacizumab (when used with the chemotherapy drugs, gemcitabine and carboplatin) does not represent good value for money for the NHS.

Sir Andrew Dillon, NICE Chief Executive, said: "Although the independent Appraisal Committee acknowledged that bevacizumab may help to delay a person's cancer from spreading for a few months, it noted that clinical trial data was unavailable for around one in three trial participants, possibly due to discontinuation of treatment, side-effects or because they had been lost to follow-up, making it difficult to know what effect this had on progression-free survival rates. The committee also couldn't be sure the drug would help people live longer.

"The current evidence of benefit for patients does not support the cost of the treatment, which the manufacturer estimates to be just over £25,000 for one course for an average patient."

The draft guidance goes on to recommend that people currently receiving this treatment combination should be able to continue until they and their clinician consider it appropriate to stop.

The Institute is developing recommendations on the use of this drug to treat the first recurrence of advanced ovarian cancer if it has returned six months or more after initial treatment and if the person has previously received platinum-based chemotherapy (platinum-sensitive disease). The draft guidance is also relevant to women with fallopian tube and primary peritoneal cancer.

Consultees now have an opportunity to appeal against the draft recommendations if they believe there are reasonable grounds to do so. If no appeals are lodged, publication of the final guidance is expected in May 2013. Until then, 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.

Ends

Notes to Editors

* Recurrent advanced ovarian cancer refers to when a person's cancer has spread outside the ovaries and has returned following initial treatment.

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 19 April 2013.

2. Bevacizumab (Avastin) is licensed for the "first recurrence of platinum-sensitive advanced ovarian cancer (including fallopian tube and primary peritoneal cancer) who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents".

3. 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.

4. 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 the data from around 30% of patients had been censored and it was unclear what effect censoring might have had on progression-free survival rates. It was unclear whether these data had been censored because of patients stopping treatment because of adverse events or patients being lost to follow-up.

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

6. 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.

7. 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.

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

9. 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.

10. Ovarian cancer is the fifth most common cancer in women in the UK with 7,011 new cases of the disease diagnosed in 2010[i]. The manufacturer estimates that around 2,100 patients in the UK should be eligible for

bevacizumab (in combination with gemcitabine and carboplatin) for recurrent advanced ovarian cancer, if it were to be recommended.

11. The Scottish Medicines Consortium does not recommend bevacizumab, in combination with carboplatin and gemcitabine, for the treatment of adults with first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

12. 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

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website and follow us on Twitter: @NICEComms.

This page was last updated: 19 April 2013

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.