NICE Pauses Plans To Charge Manufacturers For Medical Device Appraisals

The U.K.’s National Institute of Health and Care Excellence’s (NICE) plan to recoup the appraisal cost of drugs, devices, and diagnostics by charging industry has been temporarily suspended. Andrew Dillon, chief executive of NICE, said that implementation of the plan will wait until after the British government completes its life sciences strategy associated with Britain’s decision to leave the E.U.

Before a company may market a product through the U.K.’s National Healthcare Service (NHS), it must first receive an appraisal from NICE, which determines the product’s clinical efficacy and cost-effectiveness compared to other products available to NHS patients. The U.K.’s Department of Health currently funds these appraisals, a funding strategy that limits the number of appraisals the agency can complete each year.

In a 2015 triennial review of NICE, the Cabinet Office recommended that agency consider funding appraisals by charging fees to drug, device, and diagnostic manufacturers. NICE announced plans for the fees — which could charge upwards of $350,000 for each appraisal — and the agency’s decision was met with considerable controversy, according to Regulatory Affairs Professionals Society (RAPS).

Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry (ABPI), stated that the fee plan would create “further inequalities” in access and would be cost-prohibitive to companies launching medicines for rare diseases, reported the Sunday Times.

Dillon retorted that the fees are negligible when weighed against the cost of bringing a product to market and the potential revenue of a product marketed in the U.K., and it is only fair that industry agrees to share risk involved in introducing a new drug or device. Charging companies for the cost of a safety and value assessment “may not be welcome, but it is fair” and will give NICE greater flexibility to meet changing demand.

Now, that plan is on hold as the U.K. government grapples with Brexit and the business of extracting the country and its industry from the E.U., a plan that parliament intends to have finished by February. The ABPI recently gave evidence to the Exiting the EU committee encouraging that the U.K. continue close alignment and cooperation with the European Medicines Agency (EMA), currently housed in London.

 “We have been working to create a new funding model for technology evaluation to meet the government’s challenge to drive efficiency and deliver better value,” stated Dillon recently. “We’ve agreed with the Department of Health to wait for the Government’s life sciences strategy to be completed before we move forward with our plans.”

Dillon added that NICE will continue testing the proposal and comparing the funding strategy to other “suggestions and challenges” introduced by industry stakeholders.

In October, NICE proposed a plan that would “fast track” funding for certain medical technologies and open up funding for highly specialized treatments indicated for rare disease. The NHS and NICE collaborated on a list of 12 proposals geared toward making the appraisal process “more agile and flexible,” according to Dillon.

NICE also recently announced plans to work with the FDA’s Payer Communication Task Force (PCTF) in a program designed to help sponsors of medical devices gather necessary clinical evidence to prove clinical efficacy, as well as value of their products. Early engagement with developers will not only help ensure regulatory approval, but also reimbursement from payers.