The National Institute for Health and Clinical Excellence has launched a one-month consultation period to review patient access and flexible pricing schemes as part of a product’s appraisal for use on the National Health Service.

The health watchdog had originally planned to publish updated guides to its single and multiple technology appraisal processes this month following an original consultation last December, but additional requirements laid out within the 2009 Pharmaceutical Price Regulation Scheme triggered the delay. “We feel it is important that our stakeholders are able to comment on this, and are therefore consulting for one month,” the Institute says in a statement issued today. The consultation period will run until 5pm on 20 July.

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, allowing manufacturers to submit proposals for patient access schemes or flexible pricing arrangements either as part of an ongoing or concluded NICE decision.

The move comes as patient access schemes (also known as risk-sharing schemes) seem to be gaining in popularity, as drugmakers increasingly look to new ways of getting their drugs past the cost effectiveness watchdog and onto the NHS treatment menu before sufficient outcomes data can be collected.

The crux of such schemes is to facilitate patient access to novel therapies while ensuring that their cost falls below the threshold set by NICE, by deferring or refunding 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.

To have your say go to: