What are the best practices and pitfalls of working with health technology assessment agencies?

A landscape assessment covering HTA and Pricing/reimbursement is often the first step to take when strategizing global market access. This should come very early during the development of a new product, as there are often only one or few opportunities to reflect the needs of authorities in your evidence development plans. With the development of adaptive clinical trials in BioPharma, this is a critical step to take as early as the time of first-in-human.

Know the HTA Landscape: Research HTA Agencies: Understand the specific processes, methodologies, and criteria used by various HTA agencies (e.g., NICE, CADTH, ICER). Stay Informed: Keep up with changes in policies, frameworks, and evaluations to tailor your approach accordingly.

Market Access Startegy should start from the product ideation phase. The device should be designed keeping in mind the end user needs and gaps in the current market. An early engagement with the regulatory authorities and HTA agencies can also help in aligning the development process with market access requirement.

Initial Discussions: Start conversations during the early stages of product development to align on expectations and data needs. Regular Updates: Maintain continuous dialogue throughout the assessment process to provide updates and address questions.

Open Communication: Ensure all communications are clear, honest, and consistent to foster trust. Document Everything: Keep a detailed record of discussions, decisions, and submitted data to maintain accountability.

Identify Potential Hurdles: Anticipate common challenges such as data gaps, regulatory hurdles, or market access barriers. Develop Contingency Plans: Have strategies in place to address these challenges proactively, such as gathering additional data or modifying approaches.

KOL reviews and engagements are important as healthcare professionals, patient groups and decision makers need to advocate for the device. Education and training programs needs to be part of this startegy.

Collaborate with Key Players: Engage healthcare providers, patient advocacy groups, and payers to gather diverse perspectives and insights. Integrate Feedback: Use stakeholder feedback to refine your submission and demonstrate the product's relevance to the market.

Track Evolving Guidelines: Stay updated on changes in HTA methodologies, evidence requirements, and market conditions. Be Flexible: Adjust your strategies and submissions in response to new information or shifts in the healthcare landscape.

Local Context: Consider regional healthcare priorities, reimbursement landscapes, and patient demographics to ensure alignment with local needs. Build Relationships: Establish strong relationships with HTA personnel, fostering collaboration and enhancing your understanding of their priorities. Educational Outreach: Provide educational materials or training to HTA assessors, highlighting your product's unique benefits and clinical significance.