Manufacturer to offer money back if treatment fails
A refund scheme that could allow bortezomib (Velcade) to be funded by the NHS to treat multiple myeloma has been proposed by the drug's manufacturer Janssen-Cilag.
The manufacturer has offered to reimburse the NHS if a patient fails
to respond adequately to the drug.
The National Institute for Health and Clinical Excellence has evaluated
the benefits of the scheme and published draft
guidance for consultation as part of its appraisal of bortezomib.
This is the first time that NICE has made recommendations about such
a scheme, however, a similar approach was taken by the pharmaceutical
industry when it agreed a risk-sharing scheme with the Department of
Health to fund beta
interferon and glatiramer acetate for multiple sclerosis (PJ, 9 February 2002, p163).
The draft guidance details the circumstances in which bortezomib can
be prescribed for patients in England and Wales with progressive multiple
myeloma who have received at least one prior therapy and have undergone,
or are unsuitable for, bone marrow transplantation.
Response to the drug must be assessed by measuring serum M-protein after
a maximum of four cycles of treatment and treatment continued only in
patients who show a reduction in serum M-protein of 50 per cent or more,
indicating a complete or partial response.
Patients showing a minimal or no response (less than 50 per cent reduction
in M-protein) will be taken off the drug and the costs refunded in full
by the manufacturer.
NICE’s recommendations are adapted from a scheme proposed by Janssen-Cilag
as part of its appeal against initial draft guidance, which advised that
bortezomib should not be made widely available on the NHS. The manufacturer’s “Velcade
response scheme” defines responders as those who reach a minimal
response or better (measured as at least a 25 per cent reduction in serum
M-protein). NICE says that insufficient clinical evidence was provided
to persuade it of the cost-effectiveness of continuing treatment beyond
four cycles in these patients.
Andrew Dillon, NICE chief executive, said: “If the drug’s
manufacturer accepts the proposals we are consulting on today, 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.”
The draft guidance, which is out for consultation until 22 June 2007,
is available on the NICE
website
The final decision on whether to put the refund scheme into practice
will lie with the manufacturer and the Department of Health.
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The
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