Business Analysis: Drug firms in fury over U-turn on Alzheimer's treatments

Ban on four drugs in the NHS sets off another conflict iwth Government regulator

The pharmaceuticals industry is up in arms over a government regulator's recommendation that four Alzheimer's drugs should no longer be made available on the National Health Service. Nice, the National Institute of Clinical Excellence, says the products do not show sufficient benefits to justify the £80m annual bill.

The pharmaceuticals industry is up in arms over a government regulator's recommendation that four Alzheimer's drugs should no longer be made available on the National Health Service. Nice, the National Institute of Clinical Excellence, says the products do not show sufficient benefits to justify the £80m annual bill.

The drugs involved include Aricept, made by the global pharmaceutical giant Pfizer, and Reminyl, developed by UK-listed Shire Pharmaceuticals. The manufacturers said they would challenge Nice's conclusions, setting the scene for another showdown with the agency, which had previously been patching up relations with the pharmaceutical industry.

Nice was created in 1999 to put an end to so-called "postcode prescribing" by setting national guidelines on which of the drugs should be available on the NHS. It has a mandate to limit the use of expensive drugs with little clinical benefit and to encourage the uptake of new drugs which offer a genuine breakthrough in treatment. The industry thinks it concentrates too much on the former and too little on the latter. Pfizer said Nice's ruling will lead to "chequebook prescribing", where those who can afford the drugs privately will buy them.

Nice's preliminary ruling is that three similar drugs, Aricept, Reminyl and Novartis's Exelon, are not cost-effective treatments for mild Alzheimer's, although they appeared to have some effect in slowing the degenerative condition. No more patients will be put on the drugs, if the recommendation is upheld after a last bout of consultation this month, although 52,000 present users can continue to be given prescriptions. A fourth, recently licensed drug for severe Alzheimer's - Ebixa, from the Dutch firm Lundbeck - should not be on the NHS, Nice says.

In 2001, Nice had cleared the three mild Alzheimer's drugs, but an NHS-funded study last year found that Aricept, the most commonly prescribed, does not delay the point when a patient needs to be taken into care.

The industry, doctors and patient groups acted with fury that Nice is changing its mind. Richard Barker, director general of the Association of the British Pharmaceuticals Industry, said Nice's new proposals were "heartless and damaging" to patients and the industry. "The draft recommendations send a discouraging message to pharmaceutical companies that are putting major research work into discovering new, innovative medicines to help people with Alzheimer's and other forms of dementia," he said.

"How can companies justify investing huge sums in research and development - it costs on average about £550m to develop a new medicine - if such decisions can be made to withhold medicines from patients despite their benefits?"

Pfizer and its drug development partner Eisai condemned Nice for "sending dementia treatment back 10 years". Shire expressed its "considerable concern", since drugs in this class represent the standard of care in more than 70 countries worldwide. The Royal College of Psychiatrists said the drugs can slow the progression of Alzheimer's by up to nine months and there are no other treatments available. Neil Hunt, chief executive of the Alzheimer's Society, said he was "stunned".

Nice rarely retreats on its assessment groups' recommendations, and the ruling contained significant condemnation of the science behind the drugs' claims for improved quality of life. "The quality of the reporting and methodology of the included published was generally mixed. The assessment group suspected selection bias, measurement bias and attrition bias in a number of the reviewed studies."

Andrew Dillon, chief executive of Nice, said the assumption four years ago when Nice ruled the drugs cost-effective had been that Alzheimer's sufferers would be able to live independently for longer, but this had been thrown into doubt. And he slapped down the ABPI's suggestion that research on new Alzheimer's treatments is less likely because Nice's ruling dramatically reduces potential sales in the UK.

"Rather the opposite," he said. "When we do a full clinical guide like this, we often identify holes in the evidence, get new research questions on the agenda and stimulate manufacturers to do more research themselves, in many cases."

The drug companies involved said they would work to change Nice's mind and could even begin a formal appeal if they fail. They say the "health economic" model used by Nice to assess the cost-benefit of drugs is too rigid or inappropriate.

The industry condemned the introduction of Nice in 1999 as a "fourth hurdle" to overcome before a drug can be successfully launched in the UK, after it had cleared regulations of effectiveness, safety and consistency. Almost immediately, a row developed over Relenza, a flu drug which was deemed not cost-effective, prompting Sir Richard Skyes, chairman of Glaxo Wellcome, to threaten to move research out of Britain.

Nice's processes and appeals procedures were made more transparent after lobbying, but the industry continues to complain that Nice's positive rulings are not effectively applied in the NHS and new drugs take longer to gain wide use in the UK than in most other countries.

Alzheimer's represents a multibillion-pound global market for the drug industry, with many companies searching for cures or for treatments that can slow mental decline and be given at earlier stages of the disease.