Cancelled meetings and assessment delays: HTA bodies are revising priorities in response to COVID-19

By Nicola Allen, Associate Director

Email: [email protected]

The priorities of health technology assessment (HTA) bodies are evolving as health care systems around the world are seeking to manage the strain of the Covid-19 pandemic and the biopharmaceutical industry are rising to the challenge to find an effective treatment. Initially, agencies moved in-person meetings to teleconferences to comply with social distancing measures. As the situation progresses, several national European HTA agencies have announced changes to activities as expertise are needed for more pertinent tasks in response to tackling the COVID-19 pandemic.

Italy is the most affected country in Europe and the Italian Medicines Agency (AIFA) has issued various measures to refocus efforts, such as dedicating meetings if the Scientific Technical Commission to exclusively discussing topics related to the COVID-19 emergency and postponing requirements for doctors and pharmacists to update the web-based AIFA register for up to 90 days.

In Germany, the G-BA has authorised a series of temporary special regulations, including an amendment to allow a written voting procedure to enable activities to continue to in the absence of face-to-face meetings.

In France, the Haute Autorité de santé (HAS) has released an updated agenda, to prioritise assessments for drugs intended to manage the COVID-19 epidemic and treatments for oncology, paediatrics and diseases with a high unmet need.

In Sweden, the TLV has issued a press release to confirm that while operations are continuing as usual with online meetings, a continuity plan has been developed to prioritise activities if necessary.

In the UK, the Scottish Medicines Consortium (SMC) have cancelled SMC and New Drugs Committee meetings scheduled from March 31^st to May 26^th. In the meanwhile, a core team will continue working on current assessments and urgent activities. In England, NICE have announced they will be providing free fast track scientific advice for companies developing novel diagnostics or therapeutics for COVID-19. In England, NICE are currently prioritising activities related to therapeutically critical topics (e.g. oncology appraisals) and diagnosis and treatment of COVID-19. Timelines for other activities are being revised. , NICE have also announced they will be providing free fast track scientific advice for companies developing novel diagnostics or therapeutics for COVID-19.

The European Network for HTA (EUnetHTA) has also published an updated response to the Coronavirus pandemic that outlines expectations for delays to assessments and a likely reduction or suspension in requests for EUnetHTA early dialogues.

P4A are continuing to track the ongoing impact of the COVID-19 pandemic while continuing to support biopharmaceutical industry to minimise disruption to activities for launching innovative new treatments. Contact us at [email protected] for more information