The U.K.'s National Institute for Health and Clinical Excellence heads into its annual conference with a review that may add fuel to objections by some stakeholders that its decisions have led to apparent rationing of oncology treatments.

A draft guidance, issued May 5, turns down three products for use in chronic myeloid leukemia (CML)- Bristol-Myers Squibb Co.'s Sprycel (dasatinib), and Novartis AS' high-dose imatinib (Glivec) and nilotinib (Tasigna) -in patients whose disease is resistant to standard-dose imatinib.

The appraisal shouldn't be confused with another examining the role of dasatinib and nilotinib in patients with imatinib-intolerant CML. That review is more advanced than the current appraisal, with a draft guidance released in the first quarter of 2010 Also see "UK's NICE Says No To Two CML Drugs; Invites Cost-Sharing Schemes" - Pink Sheet, 15 February, 2010.).

However, in July 2010, NICE indicated that it would not issue a final appraisal determination for imatinib-intolerant CML patients until the final appraisal determination for imatinib-resistant CML was completed. The outcome of the former is expected to depend on the conclusions of the latter.

Little Good Clinical Data

After reviewing the clinical data submitted by the companies regarding the imatinib-resistant indication, NICE's appraisal committee concluded "it is clear that dasatinib, high-dose imatinib and nilotinib provide clinical benefit for people with imatinib-resistant CML," yet there was very little good clinical data to back this conclusion and the magnitude of the benefit was uncertain.

The appraisal committee also noted that incremental cost-effective ratios (ICERs) of more than £43,800 per quality-adjusted life year were associated with the drugs. All of the estimated ICERs were higher than those normally considered acceptable for the National Health Service. The committee therefore rejected use of the medicines in patients with imatinib-resistant CML in the draft appraisal.

First Conference In Two Years

The current draft guidance comes just days before this year's NICE annual conference starts, on May 10. It is one of the leading conferences worldwide for debating health technology assessment, but NICE this year will also be debating its own future, with plans afoot to downgrade its role in assessing whether new medicines are a cost-effective use of NHS resources Also see "NICE Likely To Lose Cost-Watchdog Status By 2013" - Pink Sheet, 1 November, 2010.).

This will in fact be the first NICE conference to be held in two years; no meeting was held in 2010 because it would have clashed with the U.K.'s general election.

As the most recent appraisal to be released by NICE, the CML appraisal will likely be used by attendees as an example of the way the institute's decisions have led to an apparent rationing of the use of anticancer therapies Also see "NICE Continues Tough Approach On Cancer Drugs, Rejects Tarceva, Javlor and Yondelis" - Pink Sheet, 11 March, 2011.).

There will also be questions raised about why the UK Cancer Fund had to be set up to provide funding specifically for medicines rejected by NICE Also see "U.K. Provides £50 Million Extra For Cancer Drugs" - Pink Sheet, 1 October, 2010.).

On the other hand, NICE could very well point to the successes it has had in encouraging companies to reduce the cost of therapeutics for the NHS through approaches such as patient access schemes.

The cost of dasatinib treatment is estimated in the current CML appraisal at £30,477 ($50,000) per year, assuming a treatment regimen of 100 mg once daily and an acquisition cost of £83.50 per 100 mg tablet.

High-dose imatinib and nilotinib are no less expensive. The annual cost of imatinib therapy is estimated at £41,960 per year, assuming a treatment regimen of 400 mg twice daily and an acquisition cost of £57.48 per 400 mg tablet (the price of imatinib was increased by 7.5% in December 2010). And the annual cost of nilotinib therapy is £31,711 per year, assuming a treatment regimen of 400 mg twice daily and an acquisition cost of £21.72 per 200 mg tablet.

The figures do not take into account any patient access programs.

NICE Guidelines Affect Prescribing

Although NICE appraisals and guidelines have attracted widespread criticism, they can also have a marked effect on medical practice as well as on prescribing. A paper published online May 3 by the British Medical Journal shows that the prescribing of antibiotics before dental procedures fell dramatically after NICE guidance concluded that the practice did not prevent infective endocarditis.

There is little evidence to support the effectiveness of antibiotic prophylaxis, Dr Martin Thornhill and colleagues said in their paper. After the NICE guidance was introduced in March 2008, the prescribing of antibiotics before dental procedures dropped by 78.6%, but there was no marked increase in the number of cases of infective endocarditis, or infective endocarditis-related deaths, in hospitals in England.

- John Davis (j.davis@elsevier.com )

NICE Rejects Leukemia Drugs On Eve Of Conference That Likely Will Debate Cancer Policies, NICE's Future

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