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NICE responds to Janssen-Cilagís Velcade NHS reimbursement scheme

NICE has said the possible refund scheme with Velcade could potentially happen with other drugs in the future but that it may not be suitable for some drugs

The National Institute for Clinical Excellence (NICE) has said the possible refund scheme with Velcade (bortezomib) could potentially happen with other drugs in the future but that it may not be suitable for some drugs.

"There are some things that make this drug particularly suitable for the scheme; the patient responds quite quickly, so it is easy to see in a short time if they are responding," explained Lucy Betterton, associate director of external communications at NICE.

The NHS has been struggling to cope with expensive new treatments, especially for cancer, and it has been suggested that this scheme could prove a solution to the problem.

"Any further schemes with other drugs and drug manufacturers would in all probability be initiated by the manufacturer, and in some incidences drugs will potentially not be suitable," stated Betterton.

GlaxoSmithKline (GSK) is also reported to be considering a similar scheme for its next generation of cancer drugs, according to a report in The Times.  GSK has already introduced similar schemes in two European countries.

Janssen-Cilag, Velcade's manufacturer, approached NICE with its refund scheme and proposed it would refund the NHS, if patients showed no improvement.

"NICE reviewed the scheme and came to the conclusion it would be clinically and cost-effective subject to change - the manufacturer should refund if there is no response or a minimal response," concluded Betterton.

M-protein measurements will test Velcade efficacy
The response to Velcade will be measured using serum M-protein after a maximum of four cycles of treatment, and treatment will only be continued only in people who have a reduction in serum M-protein of 50 per cent or more, or what is termed a "complete or partial response".

If the patient shows a full or partial response, the NHS will foot the bill for the treatment, which costs GBP 25,000.

The final decision now rests with Janssen-Cilag and the Department of Health. The consultation process will end on 22 June and the committee will meet on 4 July. NICE hopes to have guidance out in October 2007. If there are appeals, there will be a second draft.

Richard Ley, head of media relations at the ABPI, did not believe it was a huge issue as only a small amount of the NHS' budget was spent on cancer drugs in the first place; he questioned why the NHS could not spend more on cancer treatments.

"NICE originally said Velcade was not cost-effective under its rules, but we don't think NICE's health technology assessment system incorporates enough information to assess a drug's true value," continued Ley.

"It is hardly surprising that certain companies are looking at schemes like this in the current environment," concluded Ley.

Velcade was initially rejected by NICE in 2006, who said it should not be made widely available on the NHS. However, the government body changed its mind after Janssen-Cilag appealed and suggested the refund scheme.

Analyst comment
Andrew Jones, pharmaceutical analyst from Ernst & Young, said: "The agreement offers the prospect of a win-win situation for patients, the NHS and industry: patients get access to a new medicine; the NHS ensures efficiency of expenditure and the manufacturer secures an opportunity to get a return on its investment."

"The news should come as a welcome development to the biopharmaceutical industry which is being hit hard by pricing and reimbursement pressure across Europe. NICE's endorsement of the scheme signals willingness for flexibility, and if agreed and successfully implemented, the scheme could help guide future change to the UK system and support market access for other new therapeutics," continued Jones.

"Risk-sharing schemes offer a mechanism for the NHS to secure value-for-money from the drugs it purchases and achieve greater efficiency of expenditure. Unfortunately, such schemes do little to address the issue of affordability - the NHS will still have to find the budget to meet the cost of new and effective drugs. With budgets under pressure across Europe, the issue of affordability raises the question of how the healthcare systems such as the NHS, will be able to support the introduction of new and important drugs into the future without compromising in other areas," concluded Jones.

7th June 2007

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