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Britain
’s National Institute of Health and Clinical Excellence (NICE) said
Millennium Pharmaceuticals’ cancer drug Velcade (bortezomib) should not be
paid for on the National Health Service. NICE said the value of the medicine is
unclear, and is recommending in draft guidance that Velcade should only be used
in clinical trials. Velcade is a treatment for multiple myeloma.
The FDA plans to develop
regulatory guidelines for adaptive clinical trials. While advocates of
adaptive trials believe that they can save time and money, such trials are also
statistically complex and pose major logistical challenges. In addition to its
planned draft guidelines, FDA has put together an internal team to work with its
drug-review divisions on the adaptive designs and is gathering examples of ones
it has already reviewed.
Planned changes to the Medicare
payment system seek to pay hospitals more accurately for the cost of care.
According to federal officials, biases and distortions in the current payment
system have created financial incentives for hospitals to treat certain patients
and to avoid other, “less profitable” ones. The proposed changes raise
concerns because, under the new system, reimbursements to hospitals for some
procedures could be cut by as much as 30 percent.
Democratic lawmakers have
introduced a proposal that would have the federal government negotiate drug
prices on behalf of the 43 million elderly and disabled Americans who are
eligible for Medicare. Democrats contend that the federal government
would be able to negotiate better drug prices for Medicare recipients than
private insurers. They envision the savings would be used to close a gap in
coverage that will affect an estimated 6.9 million people this year.
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