NICE and the role of scientific advice in shaping access strategy
- July 19, 2016
Seeking advice from a health technology assessment (HTA) body, whether alone or in combination with a regulatory body, can help companies to focus on the payer perspective at an early stage of clinical development, and shape the therapy development and access strategy based on the feedback. By ensuring that the clinical trials include the types of outcomes that both the regulators and payers will need, companies may face smaller hurdles around the time of submission for approval, pricing and reimbursement.
The National Institute for Health and Care Excellence (NICE) provides scientific advice to companies developing and launching new therapeutics. This takes four forms – standard scientific advice, light scientific advice for small to medium enterprises (SMEs), HTA-EMA scientific advice and NICE-MHRA scientific advice.
These processes start with an initial discussion on the proposal, followed by the submission of a briefing book. This document, which should be no longer than 50 pages, includes information on the drug and disease background, and the drug’s current status, plans and value story:
- Drug name, indication, regulatory status, current treatment options and unmet need
- Drug properties, use, target population, data available, including patient safety and risks, costs and summary of patient engagement (where applicable)
- Product value – benefits to patients, healthcare system and sustainability agenda
- Planned clinical studies
- Planned economic evaluation
- Challenges associated with adoption
Advice can be sought any time from the completion of the first-in-human trials (with the exception of certain med-tech products) until the beginning of a NICE technology appraisal or 12 months before anticipated marketing authorisation. It is most commonly sought during the setup of pivotal clinical trials.
Standard scientific advice
Standard scientific advice is the most detailed form of NICE’s scientific advice, and provides pharma and medtech companies with support and advice on producing the data needed for HTA submissions.
The process, which takes 18 weeks for smaller projects and 20 weeks for larger projects, starts with the receipt of the briefing book. It includes a face-to-face meeting at the NICE office, and a final advice report. There is an option to submit clarification questions, which will extend the timeline of the project.
Light scientific advice
This is a shortened and more concise process designed for SMEs, and takes 12 weeks. It results in an advice letter, with optional additional time for clarification.
HTA-EMA scientific advice
HTA-EMA scientific advice is designed for companies looking to get regulatory advice from the European Medicines Agency (EMA) in parallel with advice from European HTA bodies.
The process to gain HTA-EMA scientific advice takes up to 17 weeks from submission of data to receipt of advice. Companies can shorten the time to 11 weeks if they opt not to go for pre-validation; however, this additional step does allow companies to make changes and resubmit based on initial teleconference feedback. Once the briefing book has been submitted, the next step is a face-to-face meeting at the EMA to discuss the briefing book, after which NICE will provide a summary of the advice.
NICE-MHRA scientific advice
NICE-MHRA scientific advice is aimed at companies seeking joint regulatory advice from the Medicines & Healthcare products Regulatory Agency (MHRA) and NICE advice for a UK launch. Parallel advice with the MHRA takes 20 weeks from submission of the briefing book. After submission on the briefing book, the company will get clarification questions in writing. After responding to these, a face-to-face meeting with the MHRA and NICE takes place, which results in an advice report from both NICE and the MHRA. There is an option to send in clarification questions after receiving the report, which will add seven weeks onto the timeline.
The process of seeking scientific advice can seem a daunting one, particularly for small companies and those that are new to the HTA payer environment.
To find out how Valid Insight can help you prepare for the process and develop the briefing book, contact us at firstname.lastname@example.org.