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Politics & Policy

The problem with single-payer healthcare systems with fixed budgets like the U.K.'s National Health Service is that they are zero-sum games: to pay for one new drug that comes on the market, something else has to give. The stresses on the system are beginning to show, as patients and companies are starting to fight back in court and in the media against NHS and NICE.

The National Institute for Health and Clinical Excellence, which has become the arbiter of coverage by the nationalized scheme, originally was set up as an independent organization responsible for providing national guidance. But many stakeholders affected by NICE's recommendations no longer believe the agency is independent. Rather, they see it as an agent of government tasked with deciding when the NHS should say "no" to treatments that patients want.

This drop in confidence is based partly on the perception that much of the agency's guidance is negative, flies in the face of medical evidence and clinical practice elsewhere, and often is based solely on grounds of cost, not efficacy.

Most recently, after initially recommending against coverage of Velcade bortezomib for multiple myeloma, NICE recommended the drug be made available on NHS, but only if the manufacturer refunds the cost of treating patients who don't achieve a complete or partial response after four cycles(see BioCentury, June 18 & Sept. 10).

The problem is that in the real world, patients who achieve only a minor response after four cycles are typically treated for the full eight cycles, and many go on to become responders.

Under the new recommendation, these patients will be taken off the drug, and Janssen-Cilag Ltd., a subsidiary of Johnson & Johnson (JNJ, New Brunswick, N.J.), will have to refund the cost of their treatment.

As a result of these types of decisions, patient groups and the media are increasingly portraying NICE as an agent of government whose sole purpose is to restrict NHS spending.

Patient groups are arguing that their input is being ignored, while pharma executives are calling for greater transparency in NICE's deliberations and more industry input at key committee meetings. Both groups are beginning to fight back in the courts.

A recent court ruling concerning coverage of Alzheimer's disease drugs suggests patient groups and companies aren't likely to succeed in suits against NICE itself, but suing local healthcare providers and applying political pressure may hold more sway.

Thus, while the agency has been commended by the World Health Organization and the rest of the world is looking at NICE as a possible model, it is likely the institute's decisions will lead to more court battles where those with

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