Ministers to rule on NICE timing
pharmafile | October 22, 2003 | News story | |
Ministers are to have the final say on when NICE reviews new drugs, and could delay appraisals on the advice of the industry and the Department of Health's Technologies Advisory Group.
The pharmaceutical industry has objected to NICE's timing of appraisals since it was founded three years ago, arguing that some drugs need longer to accumulate data to prove their clinical and cost-effectiveness.
Controversy surrounding Novartis' groundbreaking cancer drug Glivec earlier this year appeared to back this argument, with NICE reversing an early decision not to recommend the drug after new evidence was submitted.
It remains unclear whether or not the new rules would have avoided the row over beta-interferon and glatiramer, which eventually resulted in the creation of a 'risk-sharing' agreement between the Government and manufacturers after NICE twice refused to recommend the drugs.
ABPI spokesman Richard Ley said the new measures appeared to address industry concerns but declined to make any further comment until details of the plans were released.
The new arrangement is part of a wider reform of how the timing and topics for NICE appraisal are chosen, which will see NHS professional bodies, front line healthcare workers and the industry joining the existing TAG. The number of patient representatives in the group will now double to four.
The criteria for topic selection, in particular whether it should be a guideline or a mandatory technology appraisal, will be clarified, while discussion with stakeholders will be simplified by combining separate NICE and DoH consultations.
Announcing the plans, Health Minister Lord Hunt also unveiled a new facility to allow anyone to suggest topics via NICE's website, which would complement the Institute's new Citizens' Council in allowing ordinary people to influence its work.
"NICE is already making a major impact on standards of healthcare in this country, by ensuring speedy and equitable access to treatments which work. These changes will strengthen the process and make it easier for everyone to be involved", he said.
"It is clearly important for an effective NICE appraisal process that there is greater involvement by patients and stakeholders and also that there is a better understanding of how decisions are made.
"We will publish full details of these changes shortly. In the meantime, the new web-based system will go live initially on a pilot basis with effect from the middle of December this year".
