Sutent to be first to benefit from NICE reform

pharmafile | January 20, 2009 | News story | Sales and Marketing NICE, par 

Sutent and other rival treatments for renal cell carcinoma look set to be the first drugs to benefit from reforms to NICE.

From January, the cost effectiveness body will use a new 'end of life' QALY to assess drugs which treat people with terminal conditions, such as cancer, and the new approach should see far more treatments being approved.

Pfizer's Sutent, and its rivals Bayer's Nexavar, Wyeth's Torisel and Roche's Avastin were all rejected in a preliminary review by NICE last year, but will be the first drugs to receive a final decision under the new system.

Many patients eligible for the drugs have until now been denied them, but NICE looks set to say yes soon.

NICE's appraisal committee met on 14 January to review the drugs again, and are set to announce their decision in March.

Until now, NICE routinely rejected drugs which had a QALY above the £30,000 mark, and cancer drug Sutent, which has a QALY of 71,000, fell well outside this upper limit.

The Institute's calculations found Avastin had a QALY of £171,000 suggesting that NICE would have to more than double its current threshold in order to recommend any of these drugs.

The highest QALY rating for any NICE approved drug was for Novartis' leukaemia drug Glivec. It was approved by NICE in 2002 with a cost-per-QALY of £48,000, but this must be exceeded if more new cancer drugs are to be approved.

NICE has carefully avoided giving its appraisal committees explicit QALY thresholds for the new 'end of life' assessment, but it seems clear that more high cost drugs will be approved.

In cases where NICE still rejects a drug, manufacturers can now suggest a 'patient access scheme' – similar to the 'risk sharing' concept pioneered by Janssen-Cilag's Velcade.

NICE is determined that the end of life QALY should not appear to simply be a lowering of its high standards, and has issued detailed guidance to its appraisal committees on how it should be assessed.

The guidance makes it clear that manufacturers' cost assessment data and methodology must still be of a good standard to gain approval, for instance.

Another precaution is the introduction of a system where NICE collects its own data on how well end of life drugs extend lives and improve quality of life.

NICE's chairman Prof Sir Michael Rawlins has indicated that appraisal committees need their own data to satisfy themselves that the drugs are delivering the benefits claimed by manufacturers.

"We want our appraisal committees to be confident in the benefits and the longevity being claimed," Prof Rawlins said in November.

More patient access schemes

Even with the new end of life QALY, it is anticipated that some drugs will still fail to gain NICE approval.

The government and the pharmaceutical industry have now agreed that negotiations on pricing deals should now routinely take place in this scenario.

This approach has been enshrined in the new PPRS deal which says there should be "more systematic use of patient access schemes" by pharmaceutical companies when a drug has been rejected by NICE as not sufficiently cost or clinically effective.

A key concession the ABPI won in the negotiations is that drug prices could rise if more evidence subsequently emerged of a drug's effectiveness. This means that pharma companies are now more reassured that lowering prices of high-value drugs need not be permanent, and will be a way to overcome negative NICE decisions.

Related Stories:

NICE makes end-of-life drugs more available

Tuesday, January 06, 2009

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