The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year.
News of the new fees stirred controversy in London’s Sunday Times, and a NICE spokesman emailed Focus on Monday with NICE Chief Executive Sir Andrew Dillon’s response to that story on the fees for technology appraisal and guidance:
“Charging pharmaceutical companies for the cost of considering their drugs for use in the NHS [National Health Service] may not be welcome but it is fair. Companies take risks in developing their products, but the NHS has to make millions of pounds available to put them into practice, frequently when relatively little is known about their use in 'real world' settings. The risks therefore need to be shared.”
An article last month in PharmExec discussed the proposed fee structure (discussions on what NICE could charge have been circulating since March 2016), and it looks like NICE could charge more than other Health Technology Assessment (HTA) agencies in Australia and Canada.
EMA and HTAs
Since 2008, the European Medicines Agency (EMA) has been working with HTA agencies, including NICE, as the regional and national groups provide recommendations on which medicines and other health technologies can be financed or reimbursed by the health system (the European Commission and EUnetHTA Joint Action 3 have a forum on 21 October 2016 on: "European Cooperation on HTA: what's next?" in Brussels).
EMA launched the parallel scientific advice procedure with HTA bodies with a pilot project in 2010 and has seen an increasing number of requests from pharmaceutical companies who wish to obtain simultaneous feedback from the regulator and HTAs (for more information, see EMA's Parallel scientific advice from regulators and HTA bodies.)
EMA also recently said it would continue this pilot for delivering advice to pharma sponsors alongside HTAs.
An analysis of a sample of about half (31) of the parallel scientific advice procedures from the pilot resulted in a "high level of alignment between the requirements of regulators and HTA bodies." According to the agency, in roughly 70% of those procedures a single clinical trial was sufficient to provide evidence for both groups.
Between July 2010 and December 2015, EMA says it completed 63 parallel scientific advice procedures.
New NICE Fees and Reaction
The additional fees would come as a UK Government report from 2015 concluded that, “The core functions that NICE carries out are necessary and that dropping any or all of these functions would have a negative impact on the health and care system and on the quality of care received by service users.”
The fee for a single technology appraisal could cost about £150,000 while a complex multi-technology appraisal could run fees near £300,000, whereas Australia’s Pharmaceutical Benefits Advisory Committee and the Canadian Agency for Drugs and Technologies for Health charge less than £100,000.
“The charges NICE proposes to make won't delay access to new drugs,” Dillon added in a statement. “The amounts are a vanishingly small proportion of the cost of bringing a new drug to market. More importantly, they are tiny compared to revenue generated by companies from their UK businesses.”
The Association of the British Pharmaceutical Industry (ABPI)’s Dr. Paul Catchpole, Value & Access director, however, said in a statement on Sunday: "NICE is facing significant budgetary pressures whilst the demands being placed on its work programmes are increasing, but we believe that there are considerable efficiency savings that could be me made to its current appraisal processes which would either eliminate the need to charge for services or reduce the amount that has to be charged.”
NICE processes “need to evolve so they are fit to properly appraise the new medicines being produced by the pharmaceutical industry, and this should happen before they consider charging,” Catchpole added.