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MPs Call for rethink over NICE drug assessments

January 10, 2008 By: Dr Search- Principal Consultant at the Search Clinic Category: Uncategorized

The cost effectiveness of new medicines should be judged by National Institute for Curbing Expenditure (NICE) in terms of the wider social benefits that their availability on the National Health Service would bring, according to MPs.

In a report published on Thursday, the Commons health committee also says the threshold at which the life enhancing impact of expensive drugs is deemed to outweigh their cost must be subject to independent scrutiny.

The report recommends a sharp increase in the workload of the NICE to evaluate medicines as they are launched, and to weed out older treatments that are no longer cost-effective.

The committee calls for a change in the law so that Nice can assess not only medical costs and benefits but also the broader social impact of new medicines. It proposes that an independent body should review the balance of cost versus effectiveness.

Paul Hooper, head of the UK subsidiary of Eisai, the Japanese pharmaceutical company that last year challenged Nice’s rejection of its Alzheimer’s drug, said he “welcomed” the demand that wider social benefits be considered – a reference to the burden imposed on family members and social workers by caring for someone with Alzheimer’s.

However, the Association of the British Pharmaceutical Industry, the main trade body, warned that “patients will see little benefit” from the recommendations, and that assessments at the time of drug launches could further obstruct the use of innovative medicines.

Thursday’s report – the second on Nice by the committee since it was set up in 1999 to advise the government on whether the NHS should pay for new medicines – steers clear of radical calls for reforms to pharmaceutical prices at a time when the government is considering an overhaul of the pricing mechanisms.

“Nice plays a vital role in determining NHS policy and it will become more important and demanding as time goes on, especially with reducing budget increases,” said Kevin Barron, chairman of the committee.

He called for an end to political interference from government ministers in Nice’s work, highlighting the pressure to approve Herceptin for early breast cancer treatment and a decision by the Department of Health to authorise new multiple sclerosis drugs despite opposition from the institute.

The report’s demands could require substantial extra funding for Nice and stretch the ability to recruit specialist health economists to carry out the expanded work. However, Doug Naysmith, a member of the committee, said: “This [advice] should not result in a vast increase of new medicines, and possibly the reverse.”

Prof Sir Michael Rawlins, chairman of Nice, said he broadly supported many of the recommendations in the report, but warned of the risk of “unintended consequences” and cautioned that “the details would have to be looked at very carefully”.

The MPs advised caution in the shift towards “risk-sharing” schemes, including one endorsed by Nice last year by which Janssen-Cilag would rebate the cost to the NHS of its multiple myeloma drug Velcade if patients showed no significant improvement. The committee said such schemes had shown no clear benefits.

http://www.ft.com/cms/s/0/be469c0e-bf08-11dc-8c61-0000779fd2ac.html?nclick_check=1

Health Direct has publicised several recent controversial Nice decisions:

Dec 2007- Nice backs down under heavy public pressure on its previous advice that Lucentis should only be used by the NHS to treat wet age-related macular degeneration, which causes blindness, once it affects a patient’s second eye. It can now be used in the first eye to suffer. Consultation closes next week on its revised guidance that Novartis, the manufacturer, should pay if more than 14 injections are required.

Sept 2007- Nice stands by its ruling that the NHS should not use three drugs for early stage Alzheimer’s disease, after winning most aspects of a judicial review challenging this brought by Eisai, manufacturer of one of the drugs, with support from others – Pfizer and Shire – as well as from the Alzheimer’s Society. Nice supports treatment with the drugs, once moderate Alzheimer’s is diagnosed.

June 2007- Nice recommends approval of Velcade for multiple myeloma – but only on condition that Janssen-Cilag, the manufacturer, agrees to a “risk-sharing agreement” to rebate the cost to the NHS for patients who fail to show a significant improvement.

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