They may not like it, but Europe's top regulators are having to accommodate the growing influence of the continent's health technology assessment (HTA) bodies.
Eric Abadie, chairman of Europe's top scientific regulatory body, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP), initially appeared to reject the idea that the committee should become involved with HTA bodies.
Speaking at the Drug Information Association's 22nd annual EuroMeeting in Monaco on March 8, Abadie argued that CHMP was governed by regulations that explicitly say that marketing authorizations should be based on quality, safety and efficacy, to the exclusion of economic and other considerations. "We will not move from that," he declared.
However, he then conceded that a 2008 High-Level Pharmaceutical Forum meeting between the industry, member states and the EU Commission had set a political mandate for regulators to discuss European Public Assessment Reports with HTA bodies.
EPARs contain a discussion of the scientific and medical evidence on which a product approval is based, but are not at the moment particularly helpful for HTAs looking for comparative effectiveness evidence, Abadie noted. HTAs are unhappy with clinical trial results that use surrogate biomarkers and composite endpoints, for example, since both make product-to-product comparisons difficult.
So in February 2010, European regulators including CHMP members met for the first time with a group of HTAs, the European Network for Health Technology Assessment (EUnetHTA) Joint Action, with the ultimate aim of improving EPARs and the Summary of Product Characteristics ('The Pink Sheet DAILY', Feb 19, 2010).
Health care payers are a broad and diverse group, and it is not always clear who the right people are to talk to, Abadie warned. But EUnetHTA includes among its members the UK's National Institute for health and Clinical Excellence, Germany's IQWiG and France's Haute Autorite de Sante, and similar bodies from other EU countries. As such, a series of workshops will be held over the coming months with the network.
Abadie clearly remains uncomfortable with the idea of regulators' establishing close ties with HTAs, however. He warned that any dialog may eventually focus on the incremental benefits of new products, which he described as a "hot potato." If a product is not reimbursed because it only gives a small benefit over marketed therapies, this could lead to a major change in the way pharmaceuticals are developed, he opined.
Industry is sensitive to the issue of incremental benefits. Earlier at the DIA meeting, Eddie Gray, GlaxoSmithKline's president of Pharmaceuticals Europe, argued that patients might value highly a new anticancer agent whose main advantage over other therapies is that it can be administered at home, but this might be considered by HTAs to be an incremental benefit not worth funding. If incremental benefits are rejected, there would likely be fewer medicines under development than at present, the industry believes.
Public advisory committee meetings? Not quite
The DIA EuroMeeting also heard there were tentative plans to increase the openness of scientific advisory group meetings, the nearest equivalent European regulators have to U.S. FDA advisory committees. SAGs consist of independent scientific and medical experts in different therapeutic areas, who invite company representatives, regulatory assessors and other professionals to discuss specific questions set by the CHMP.
The plans don't include moves to open up the SAG meetings to the public, however, as is the case for FDA advisory committee gatherings. EMA representatives have in the past suggested that this is largely because of confidential company and product information aired in these meetings.
Instead, Xavia Luria, head of safety and efficacy at the EMA, said that it was being proposed that patient representatives should be allowed to attend meetings of the seven SAGs. For now, that appears to be as far as this drive towards more openness will go, although, notes Luria, "the outcome [of the meetings] is reflected in the EPARs."
Scientific advice strengthened
Luria also revealed plans to make the CHMP's various working parties, which draw up guidelines on regulatory topics and provide scientific advice to companies, more flexible.
It is being proposed that the only permanent working parties will be the biological, quality, and safety working parties, while the efficacy working party will be divided up into temporary therapeutic subgroups, which will only be set up when needed. Each working party will have fewer members than now, and encouraged to use teleconferences and other flexible media to meet more often than quarterly, as they have usually done in the past. A full report on the proposals will be issued in the next few months.
- John Davis (j.davis @elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY – March 12, 2010
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