Global Insight Perspective | |
Significance | In a spectacular U-turn, the National Institute for Health and Clinical Excellence (NICE) has changed its mind on multiple myeloma drug Velcade after Johnson & Johnson unit Janssen-Cilag appealed and put forward a novel suggestion for a refund scheme. |
Implications | Under new draft guidance issued by NICE, the NHS in England and Wales will fund Velcade as long as patients show partial or complete response to treatment. Those who do not benefit will be taken off the drug, with the cost refunded by Janssen-Cilag. |
Outlook | The money-back guarantee scheme could set a precedent for many more proposals between manufacturers and NICE. Drug manufacturers such as Janssen-Cilag receive payment for patients that benefit, while the NHS frees up financial resources for other expensive treatments. |
Money-Back Guarantee Scheme
The National Institute for Health and Clinical Excellence (NICE) has recommended the use and funding of Velcade (bortezomib) on the National Health Service (NHS) in England and Wales for multiple myeloma, or bone marrow cancer, as along as patients show partial or full response. Under NICE’s draft guidance, those with minimal or no response would no longer be prescribed the drug and the cost would be refunded by the manufacturer Janssen-Cilag, a unit of U.S. drug-maker Johnson & Johnson (J&J).
Velcade monotherapy has been recommended as an alternative to treat progressive multiple myeloma in patients who have previously been treated with at least one therapy and who have undergone, or are not suited for, bone marrow transplantation under two specific instances (for more details see NICE’s website: www.nice.org.uk/page.aspx?o=433063).
All suitable patients will be offered the treatment, according to the consultation document published by NICE, based on an analysis of a refund scheme proposed by the drug manufacturer itself. The consultation document was generated after Janssen-Cilag’s appeal against the Institute’s initial draft guidance was upheld. As a result, NICE’s Appraisals Committee was asked to analyse the money-back deal.
The final guidance is expected in October, after the manufacturer and the Department of Health (DoH) decide whether to put the scheme into practice. These proposals are also subject to a three-week consultation. Until that date, funding of the drug will be continued to be ascertained by local health authorities on a case-by-case basis, the Institute said.
Subject to the proposals being accepted by the manufacturer, Andrew Dillon, the watchdog’s chief executive, said that the NHS would fork out when the drug ”works well, but when it doesn’t the manufacturer should bear the cost”. The chief executive also reiterated the dilemmas faced by the NHS in making sure that patients gain access to costly treatments with therapeutic potential for life-threatening diseases such as cancer.
Outlook and Implications
NICE’s spectacular change of mind comes after its initial guidance on Velcade published last year caused a major outrage. In October 2006, the watchdog’s Final Appraisal Determination (FAD) recommended against Velcade’s use as it was deemed too expensive to be cost-effective, given the proportion of patients that respond to it. Besides the manufacturer’s complaints, the turnaround came after cancer charities Myeloma UK, Cancerbackup and Leukemia CARE argued that the Institute’s initial decision was purely based on cost rather than clinical effectiveness.
The refund scheme is the first of its kind, and was put forward by Janssen Cilag because it thought NICE would refuse all patients the drug. However, the company strongly disagrees over what specific level of improvement would be needed in patients taking Velcade to trigger a payment from the NHS. J&J’s unit suggested that the NHS should only fork out when a particular serum protein showed a better than 25% reduction after four cycles of treatment, at a cost of approximately £12,000 (US$23,840). NICE has supported the idea, but suggests that the NHS should only pay when the response rate is better than 50%.
Janssen-Cilag’s proposal is significant in that it was suggested by the manufacturer itself rather than by NICE. The potential deal on Velcade, which costs about £25,000, could set a trend for other deals which would enable the NHS to get better value on drug expenditure and consequently improve its ability to fund new treatments. Dillon has even said that recent talks with other manufacturers have given signs that they are ”thinking along the same lines”.
Related Articles
- United Kingdom: 27 July 2006: NICE Recommends Against Making Velcade Available on U.K. NHS
- United Kingdom: 13 September 2006: Velcade, Nebilet Fail to Make SMC Grade
- United Kingdom: 23 October 2006: NICE Confirms Rejection of Velcade for Multiple Myeloma