The National Institute for Clinical Excellence (NICE) has recommended in a draft guidance against Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of advanced malignant melanoma in patients who have already been treated with chemotherapy. NICE decides whether a drug, medical device or treatment should be covered by the National Health Service (NHS), the country's universal health care service.
If NICE turns something down, it does not mean it is banned, it means the patient will have to pay for it privately if the country's regulatory agency, MHRA (Medicines and Healthcare products Regulatory Agency), approves it.
The draft guidance is not a final decision, NICE stressed. It has not been issued to the NHS, but rather for consultation. Until a final decision is made, local NHS trusts will have to decide for themselves whether they will fund Yervoy treatment.
As soon as NICE issues its final guidance, local recommendations around the country are replaced (by the final guidance).
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."
NICE says that its Committee will fully consider comments made during the current consultation. Subsequently, another draft will be issued.
Ipilimumab is given in four doses, at £20k per dose. Individuals with metastatic or advanced malignant melanoma are generally given carboplatin-based chemotherapy or dacarbazine, or given support care.
Written by Christian Nordqvist