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Regulatory News | 31 March 2016 | By Michael Mezher
The European Medicines Agency (EMA) says its pilot project for delivering scientific advice to sponsors in parallel with health technology assessment (HTA) bodies has been successful in helping to design efficient clinical development plans and speeding access to new drugs.
Due to the success of the pilot, which concluded on Wednesday, EMA says it will continue to offer parallel scientific advice as part of its routine activities.
"Our parallel scientific advice fosters a different, more rational approach to the development of medicines, by bringing together requirements of regulators and HTA bodies in a single development programme," said EMA Executive Director Guido Rasi.
In Europe, many countries require a HTA body to assess new drugs to determine whether or not they are cost effective before the drugs can be reimbursed by their national health systems.
HTA bodies and regulators often require different types of data when reviewing a drug. Regulators typically want to see that a drug is safe and effective, while HTA bodies may want to see how well the drug fares against its competitors, and at what cost.
However, this discrepancy has often led to delays between when a drug is approved for marketing and when it is approved for reimbursement.
The goal of EMA's parallel scientific advice pilot was to address those delays by bringing HTA bodies to the table while a sponsor is developing its clinical development plan. That way, sponsors could design their clinical programs to meet both sets of requirements in a more efficient manner.
Alongside its announcement, EMA released a new report detailing the results of the pilot and issued a consolidated best practice guide for sponsors to follow when seeking parallel scientific advice.
Significantly, EMA says its analysis of a sampling of roughly half (31) of its 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. On top of that, the agency says it has another 14 advice procedures in various stages of completion that were initiated before the pilot's close.
Demand for the procedure also increased dramatically over time, with nearly half of the finished procedures completed in 2015.
According to EMA, up to five HTA bodies from various countries participated in each parallel advice procedure, with a median of three bodies participating. Additionally, the UK's National Institute for Health and Care Excellence (NICE), Germany's Federal Joint Committee (G-BA) and the Italian Medicines Agency (AIFA) were the most active HTA participants in the pilot.
Additionally, EMA says that patient representatives participated in 40% of the finished procedures, with the amount of procedures with patient representatives shooting up in 2015 after the agency began routinely inviting them to join in.
EMA also says that a number of sponsors expressed concern about the non-binding nature of scientific advice given by the agency. In order to settle those concerns, the agency says it will hold itself to providing an explanation "in the rare case of diverging from its position in scientific advice." Similarly, the agency says it expects sponsors to justify their position in cases where they do not follow the advice they have been given.
The agency also detailed a number of takeaways from the pilot on areas that can be improved, including establishing a "clear relationship between advice and final appraisal, optimizing patient contributions, sustainable funding supporting capacity building/meeting demand [and] broader [HTA] engagement."
EMA, Report, Best Practice Guide
Tags: HTA advice, EMA pilot project, scientific advice