The National Institute for Health and Clinical Excellence has opened a one-month consultation period to enable the public to comment on proposals for including patient access and flexible pricing schemes in a product’s appraisal for use on the National Health Service.

The health cost watchdog had planned to make available updated guides to its single and multiple technology appraisal processes this month following an original consultation last December, but new requirements laid out within the 2009 Pharmaceutical Price Regulation Scheme on such pricing schemes has triggered a delay in their publication to allow the Institute to take into account the public’s views on the matter.

“We feel it is important that our stakeholders are able to comment on this, and are therefore consulting for one month,” NICE explained in a statement, adding that the consultation period will run until 5pm on July 20.

The Association of the British Pharmaceutical Industry and the Department of Health published their agreement on a new Pharmaceutical Price Regulation Scheme in January 2009, which allows manufacturers to submit proposals for patient access schemes or flexible pricing arrangements either as part of an ongoing or concluded NICE decision.

As it stands, the Institute, which can only consider flexible pricing and patient access schemes following Ministerial approval and confirmation by the Department of Health, looks at the impact of the patient access or flexible pricing scheme on the clinical and cost effectiveness of the technology under review, and this is then reviewed by an independent Expert Review Group before being considered by an appraisal committee.

Risk-sharing schemes are essentially designed to facilitate patient access to novel therapies on the NHS while ensuring that they remain a cost-effective use of resources. Their popularity is on the rise as drugmakers are increasingly turning to new ways of getting their drugs into the public domain at a time when purse strings are being tightened and experts are warning of “dark times ahead” for the NHS as it juggles budget squeezes with growing demand.

Obvious benefits
The attraction of such schemes is clear, as most are based on the deferral or refunding of payment for therapies considered to be ineffective in certain patients, so that the NHS only picks up the tab in cases where the treatment has shown a beneficial impact.

For example, under Celgene’s recently accepted patient access scheme the NHS will cover the cost of the blood cancer therapy Revlimid for up to 26 cycles of treatment, lasting about two years, after which the drugmaker will cover the cost of any further therapy, therefore minimising the financial burden on the health service.

By Selina McKee/Claire Bowie