Five cancer drugs, including the revolutionary breast-cancer treatment Herceptin, will be the first to be assessed under the new scheme, announced by ministers yesterday, and could be recommended for NHS use by June, up to a year ahead of present plans.
Ministers accepted yesterday a proposal from the National Institute for Health and Clinical Excellence (Nice), the Government's medicines watchdog, to speed up its work by cutting down the amount of evidence it reviews.
The first five drugs, all for cancer treatment, will be followed by a further eight cancer drugs and one cholesterol-lowering drug to be assessed in the New Year.
Jane Kennedy, a Health minister said: "This new guidance will benefit many thousands of patients ... and provide greater certainty about the provision of important new treatments."
The move is in response to growing protests about patients being denied urgently needed treatments because of the lengthy approval process.
Under the new system, drugs will be assessed in six months rather than the current 14 months and the process may begin before the drug is licensed so it can be approved for NHS use as little as eight weeks after obtaining a licence.
Andrew Dillon, chief executive of Nice, denied yesterday that shortening the process would reduce its robustness. Instead of requesting an independent academic review, Nice will in future rely on data submitted by the manufacturer which would be submitted to "rigorous" scrutiny.
"It will have all the principal characteristics of the current scheme but in a shortened timeline," he said.
The issue of the long wait for Nice assessments came to a head this summer after new evidence suggested Herceptin could halve the chances of breast cancer returning in one-third of women with the disease in its early stages. Nice had not planned to issue its verdict on the drug until 2007. Herceptin, which costs £20,000 for a year's treatment, is expected to be licensed next Spring.
NHS doctors are free to prescribe drugs that have not been licensed or approved by Nice but, in practice, primary care trusts are reluctant to pay for them. Patricia Hewitt, the Health Secretary, ordered PCTs last week not to withhold Herceptin from women on grounds of cost.
Ms Kennedy said yesterday that where a woman and her doctor wanted the drug, the PCT "must consider it". She said no new funds would be allocated to PCTs to pay for the new drugs.
Health economists at the University of East Anglia said that in a typical PCT with 23 patients eligible for Herceptin, the treatment would cost £460,000, necessitating cuts elsewhere.
Joanne Rule, chief executive of CancerBacup said: "These proposals represent a bold reform package for the future but they don't solve the problem of the backlog of new cancer treatments currently held up at Nice. It is crucial that the Government make it clear that doctors can prescribe licensed cancer drugs now."
The Tory shadow Health Secretary, Andrew Lansley, said: "Inequalities exist in the provision of approved drugs because of the lack of PCT resources. Unless financial problems are resolved the benefits of life-saving drugs will be limited."
- More about:
- Department Of Health And Social Issues