The Department of Health is mulling over the establishment of a new subgroup within the National Institute for Health and Clinical Excellence that will advise on the workability of patient access schemes within the National Health Service, PharmaTimes UK News has learned.

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.

For example, earlier this year, NICE overturned its earlier rejection of Celgene’s cancer drug Revlimid for patients with multiple myeloma, after the drugmaker proposed a new pricing scheme under which the NHS pays for treatment with the drug for the first two years, after which point Celgene will cover any costs, thereby ensuring that the therapy falls within the cost-effectiveness threshold.

But as stated in the Pharmaceutical Price Regulation Scheme, PAS must be agreed in principle first by the DH before they can be incorporated by NICE into its appraisal guidance.

“To enable it to take an informed view on the practicality of implementing of a proposed scheme, the Department needs to be able to validate them with NHS stakeholders,” a DH spokesman told PharmaTimes, explaining the rationale behind the proposed new NICE unit, and he confirmed that the Department is "currently discussing with NICE and other stakeholders how these arrangements might operate".

Pricing and appraisals
If the proposals for an advisory committee within NICE get the go ahead, there will likely be some concern over the potential danger of cross-over between the appraisals and pricing processes, which the PPRS stresses should be kept separate.

But David Fisher, Commercial Director of the Association of the British Pharmaceutical Industry, says he has been assured that such fears are unfounded. “We have discussed with the Department of Health our concern that any role which NICE has in the validation of patient access schemes should be completely separate from its appraisal work”, he told PharmaTimes.

He says the Association has “received reassurances” from the DH that NICE will not play a role in deciding whether proposed schemes are acceptable, “rather it will have an advisory role and the Department will retain overall responsibility for the validation of the schemes”.

The DH spokesman was also keen to stress that should the Institute gain the additional role of advising on the workability of PAS, there will be a “clear distinction” between this activity and its independent technology appraisals.