NICE consults on a new treatment for skin cancer
NICE has issued new draft guidance which recommends against the use of ipilimumab (Yervoy, Bristol-Myers Squibb) for advanced malignant melanoma in people who have received prior chemotherapy.
The draft guidance has been issued for consultation; it has not been issued to the NHS. Until final guidance is issued, 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.
Commenting on the draft recommendations Sir Andrew Dillon, Chief Executive of NICE said: "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay.
"In the case of ipilimumab, the data submitted by the manufacturer primarily came from a trial called the MDX010 20 trial. This did not compare ipilimumab with the drugs currently used to treat people with advanced or metastatic melanoma, but the results did show the drug could potentially be very effective for a small percentage of patients. However, the follow up from the trial was too short to determine how long this effect would last. Clinical specialists also told the independent appraisal committee that only around 30% of people treated with ipilimumab would have improved survival, with only 10% potentially experiencing long-term benefits.
"Unfortunately, no patient characteristics or biomarkers have yet been identified to help identify this small group of people most likely to gain long-term benefit from receiving ipilimumab.
"The drug is also isassociated with a number of adverse reactions including diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain which can significantly affect a patient's quality of life.
"The Committee considered all these factors and concluded that, on the basis of the evidence provided so far, ipilimumab could not be considered a cost effective use of NHS resources.
"However, 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. The manufacturer can also consider whether it wishes to reduce the acquisition cost to the NHS of the drug by proposing a patient access scheme Ipilimumab currently costs around £80k per patient whether the treatment is effective for them or not."
Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
Notes to Editors
About the guidance
1. The draft guidance will be available at http://guidance.nice.org.uk/TA/WaveCRS2/48 from 14 October until 4 November 2011.
2. Ipilimumab costs an average of around £20k per dose and each patient will receive four doses.
3. Patients with advanced or metastatic malignant melanoma are usually treated with carboplatin-based chemotherapy or dacarbazine, or given best support care.
4. The Committee concluded that the most plausible ICER (the cost per year of improved health) would fall between £54,000 to £70,000 per QALY gained, but noted that because of the lack of data available on the long-term benefits of treatment, further analyses are unlikely to confirm the true ICER estimate, which could be significantly higher.
5. Ipilimumab met the criteria for being a life-extending, end-of-life treatment. However, the Committee considered that the magnitude of additional weight that would need to be assigned to the original QALY benefits for people with advanced melanoma would be too great for ipilimumab to be considered a cost-effective use of NHS resources.
6. There are approximately 400 to 500 people with advanced melanoma whose disease has progressed on second-line treatment each year in the UK
7. The Scottish Medicines Consortium has not appraised this drug for any indication.
8. The committee also considered whether the drug met the criteria to be considered under the recent clarification to the technology appraisal methods guide on how discounting is applied. This involves assessing the way in which health benefits are valued and calculated over a very long period of time.
The Committee heard from the clinical specialists that malignant melanoma which cannot be removed by surgery and has progressed despite previous therapy is not considered to be curable. Therefore, as ipilimumab is not a curative treatment and it is unlikely to have sustained benefits of 30 years duration, the Committee concluded that there was no case for differential discounting to be applied.
9. 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
10. 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 sectorhealth technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHSclinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.11. 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 servicesQuality 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 patients12. 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.
This page was last updated: 13 October 2011