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The drugs advisory body for England and Wales has recommended a “refund” scheme in which the manufacturer of bortezomib (Velcade) would reimburse the NHS for the cost of the drug in patients who do not respond to treatment.
The refund scheme, proposed by the National Institute for Health and Clinical Excellence (NICE), could signal a way for the NHS to cope with funding the rapidly growing range of new and expensive drugs. It was suggested by the company making bortezomib, Janssen-Cilag, as part of its appeal against NICE's previous recommendation that the drug was not cost effective.
NICE's independent advisory committee agreed and recommended in draft guidance published this week that all suitable patients with progressive multiple myeloma should be offered bortezomib. Patients who show a full or partial response should continue treatment, with the costs of treatment being met by the NHS. Patients showing a minimal or no response after four cycles should stop treatment, and the manufacturer will refund the costs of the drug to the NHS.
Andrew Dillon, chief executive of NICE, said, “We are aware of the challenge that the NHS faces in ensuring that patients can access expensive but potentially effective treatments for life threatening conditions such as cancer.” Bortezomib costs about Â£9000 (€13000; $18000) for a course of three cycles of treatment per patient, with eight cycles costing about Â£25000.
“If the drug's manufacturer accepts the proposals we are consulting on, it will mean that when the drug works well the NHS pays, but when it doesn't the manufacturer should bear the cost. All patients suitable for treatment will get the chance to see if the drug works well for them,” said Mr Dillon.
The draft guidance recommends bortezomib as an option for people with progressive multiple myeloma who have received at least one previous treatment and who have had, or are unsuitable for, bone marrow transplantation. The response to bortezomib must be measured using serum M protein (a protein produced in vast excess in multiple myeloma) after a maximum of four cycles of treatment.
NHS funded treatment can be continued only in patients showing a 50% or more reduction in serum M protein, which indicates a complete or partial response. The manufacturer will refund the full cost of bortezomib in patients who show less than a 50% reduction, the draft guidance suggests.
The manufacturer had proposed that treatment should be continued in patients showing at least a 25% reduction in serum M protein, but the NICE committee considered that there was insufficient evidence on outcomes in people whose disease showed only minimal response. It therefore recommended a 50% reduction for the NHS to continue funding treatment.
Judith Behrens, consultant haematologist at St Helier Hospital, Carshalton, and secretary of the UK Myeloma Forum considered the NICE proposal reasonable and that it fitted with how multiple myeloma is currently managed. She said that the forum would be writing to NICE to support the refund scheme. “We think this is a neat way round the problem of bortezomib costing so much. It is effectively a way of reducing the price to the NHS.” She noted that it would bring the cost per quality adjusted life year (QALY) to within the nominal NICE guideline of Â£30000.
Dr Behrens said, “We think this is a groundbreaking way of solving the problem of expensive drugs. It means that clinicians can use what we see as an excellent and useful drug in this group of patients.” She thought it likely that health services in other countries would watch the scheme with interest.
The draft guidance is available on the NICE website for public consultation until 22 June. The final decision on whether to put the refund scheme into practice will then be made with the manufacturer and the Department of Health. NICE expects to issue final guidance, pending any appeals, to the NHS in October 2007.
The draft guidance is at http://guidance.nice.org.uk/page.aspx?o=282557, where comments can be posted as part of the consultation.