Tensions grow over cancer treatments as NICE blocks drugs

The new generation of cancer medicines raises delicate and potentially explosive issues for the labour government’s medicines advisory body National Institute for Curbing Expenditure (NICE).

In the past decade, the NICE has recommended an overwhelming majority of the 251 drugs it has reviewed. More recently, however, Nice has rejected half a dozen cancer therapies and forced the manufacturers of others to develop more imaginative, and cheaper, alternatives.

Already the agency has encountered difficulty obtaining some of the information it needs to make its assessments. Now, two manufacturers – Roche and Merck Serono – have raised the stakes.

They are explicitly refusing to co-operate with requests for cost-effectiveness data on their medicines Avastin, for lung and breast cancer, and Erbitux, for late-stage colorectal cancer, respectively.

“Roche did not consider it a good use of either public sector or indeed Roche’s own resources to produce a full submission … for a year-long appraisal which would have resulted anyway in negative guidance,” Roche said.

Professor Michael Rawlins, chairman of Nice, has a different explanation: “They’re saying that they felt they could not substantiate the high prices they expected to command in relation to the benefits of the product.”

Nice’s role is to assess both clinical and cost-effectiveness, based on the principle that it is unjust to expect the National Health Service to buy expensive medicines that offer little benefit.

The agency does not scrutinise all medicines, nor does it or the NHS refuse treatments simply because they are expensive – developing effective but costly treatments for rare conditions has fostered an entire sub-sector of companies.

But cancer affects a vast and growing patient pool. While a few new medicines, some linked to diagnostic “markers” such as Herceptin for breast cancer, are providing breakthrough treatments, many others have so far shown far less impressive results, extending life by a few months at best in some patients. Yet prices remain high.

The Association of the British Pharmaceutical Industry, the trade body, stresses the costs of developing cancer medicines and the fact that many fail and never come to market.

The body says medicine prices overall in the UK are below those of a number of other European countries and represent a small and declining proportion of total health spending – below 10 per cent of the NHS budget.

There is debate over the need for Nice both to accelerate its review of new drugs and to review its criteria, as well as for similar levels of scrutiny to apply to other parts of the NHS.

Denise Richard, head of the UK oncology business unit for Merck Serono of Germany, which has failed to win Nice approval for Erbitux for late-stage colo-rectal cancer at £2,700 ($5,330) a month, argues that Nice needs to review its criteria, speed up its reviews and change its procedures.

She says that few cancer specialists are involved in Nice technical reviews because of possible conflicts of interest; that companies cannot update Nice during long appeals, despite fast-changing data on drug efficacy; and that the thresholds for cost-effectiveness should be raised for patients with late-stage cancer, since they rarely lived more than a few extra months.

Pharmaceutical companies are reluctant to cut prices. While the UK represents only 3-4 per cent of the global market for medicines, it punches above its weight, in part because Nice’s assessments are closely followed internationally. Price reductions in the UK would likely trigger copycat actions by purchasers elsewhere and encourage “parallel trade”, by which medicines sold in countries at lower prices are exported by arbitrageurs to higher priced ones.

The result has been a series of hidden discounts, such as on Velcade for multiple myeloma – the nominal list price stays the same, but the company will reimburse the cost to those patients in whom it proves ineffective.

Ultimately, the best hope for better value might be that, as drugs are used for earlier stage treatment in many more patients for a wider range of cancers, falling prices will be compensated by rising volumes. But for now, the industry remains cautious.

From:
http://www.ft.com/cms/s/0/fc9fa62a-42e4-11dd-81d0-0000779fd2ac.html

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