The European Medicines Agency (EMA) has published draft best-practice guidance for industry on parallel scientific advice with health technology assessment (HTA) agencies, aimed at facilitating early dialogue between regulators, HTA bodies and drug developers.
Some new medicines authorised by the European Commission based on EMA scientific opinions fail to be reimbursed and/or used as expected because they fail to match the requirements of HTA bodies, says the Agency. The aim of early dialogue is to reach agreement on a development plan that generates data which both EMA and HTA bodies can use to determine a medicine’s risk-benefit balance and its value, respectively, and allow the product’s developer to receive simultaneous feedback from them at an early stage.
The draft guidance, which is now out for public consultation until July 14, sets out the different phases of the process for EMA-HTA parallel scientific advice and highlights the ideal timelines for action by all parties involved.
The draft is a key outcome of last November’s EMA-HTA workshop on parallel scientific advice, which was the first of its kind to try to “bridge the two worlds” of regulators and HTA bodies, noted EMA executive director Guido Rasi. “A strong interaction between regulators and HTAs is critical to enable innovation to reach patients, and ultimately for the benefit of public health,” he said.
Tomas Salmonson, chair of the EMA’s Committee for Medicinal products for Human Use (CHMP), said the new guidance “can be a major tool for medicines development, which will help new medicines with a positive benefit-risk balance and expected added value to reach patients in a faster and more transparent way. This simultaneous feedback will ultimately lead to better advice for companies, to help them meet the requirements of all stakeholders and consequently increase predictability.”
Commenting on the move, analysts at HIS point out that early dialogue is likely to involve discussions on relevant clinical trial data required for drug approval, and this may enable companies to design clinical development programmes able to meet requirements of regulators and HTA agencies.
“This opportunity would certainly be appealing for pharmaceutical companies that may be equipped with the opportunity to streamline the process and reduce clinical trial costs. In addition, early dialogue may also help to reduce risks of regulatory application rejections as information required by the evaluating authorities is discussed beforehand,” the firm adds.
- A pilot project for parallel scientific advice, established by EMA with HTA agencies in 2010, is still running.
EMA is also associated with the Shaping European Early Dialogues for health technologies (SEED) consortium, which is financed by the European Commission to explore a number of scenarios for conducting early dialogues. The consortium is led by France’s Haute Autorite de Sante (HAS) and consists of 14 national and regional HTA bodies.