Over the last couple of weeks, the UK's National Institute for Clinical Effectiveness (NICE) has made some positive and interesting decisions.
Celgene announced that:
Image by Aldor via Flickr
What was interesting about the decision was that a deal was clearly reached after the initial rejection last August, when the agency baulked at the £4,400/month price tag. Revlimid is an oral therapy normally taken for 26 treatment cycles of 28 days per cycle, giving a two year regimen.
Under the terms of the pricing arrangement with the company, the NHS will pay for treatment with Revlimid for the first two years in patients who have received at least one prior therapy, but should treatment be required after this time then Celgene will cover any costs for patients who continue to benefit, thereby reducing the financial burden on the health service.
This approach is very similar to that taken with Genentech last year.
NICE also reversed an earlier decision not to fund targeted therapy for renal cell cancer when it announced that Pfizer's Sutent is considered cost-effective as a first-line treatment, after taking into account the added value society puts on treatments that extend life at the end of life, in addition to Pfizer's proposal to provide the first cycle of the drug free to the NHS. The average daily cost of sunitinib is £74.74, with an average six-week cycle costing £3,139 per patient.
Those patients who fail Sutent first line therapy, however, will have no other options since NICE rejected Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth) as first-line treatments, as well as Sutent and Nexavar as second-line treatments. In the light of the EMEA's forthcoming review of Novartis's Afinitor (everolimus), it will be interesting to see how they handle that product since the trials were performed in patients who had failed either Sutent or Nexavar.
Rather than limiting the choice of drugs, my own view is that it might make more sense to approve several, since there is little difference between them in efficacy, and find a way to encourage discounting between the companies to encourage uptake. Competitive tenders are another approach which encourage price negotiation in a free market economy. Paying full price for a limited selection of products makes little sense from afar.
It's interesting how different cultures and systems manage limited resources and budgets. In the US, for example, the costs are borne by the Insurers, Companies, Governments and patients. While there is a greater choice, this being the free market, patients increasingly make choices on their prescription co-pay costs.
The more socialised health care systems in Europe rely on the Nationalised health service budgets to be managed by the Government based on national insurance contributions to the kitty. In the system, resources and hence choices, are much more limited but few patients are required to take out a second mortgage to extend the life of a family member by a few months.
In other areas of the world such as China, India and Africa, the UN and WHO have a greater role to play in access to medicines especially for the indigent or the patient pays if they are ineligible for manufacturer patient assistance programs.
Caveat emptor. There is no perfect system; each country can only offer patients the best it can within the constraints and limited resources it has.