Clinical and Payer Engagement
Understanding and aligning to the needs of clinicians and payers is key to the success of any market access strategy. In evolving healthcare systems the role and relationship between clinicians and payers is intertwined and constantly shifting. A successful clinical and payer stakeholder engagement strategy is based on knowing with whom, when and how to engage.
Tips for engagement
Stakeholder mapping: early identification of the key stakeholders and an ongoing understanding of relationships, the level of influence individuals exert, as well as how and who they influence, should be used to inform the engagement approach.
Engagement approach: typically clinician and payer engagement is carried out in advisory boards, in one-to-one discussion, or via research interviews. The method of engagement should be considered as it may be critical to the desired outcome:
- use an advisory board to present and discuss clinical data
- use a Delphi panel to gain clinical consensus
- use mixed clinical/payer advisory boards at a local level to assist in successful navigation of funding pathways
Governance: strict rules apply in Europe and the USA regarding engagement with: healthcare professionals, prescribers, and funding decision makers, in particular during the pre-launch phase. It is therefore essential that any engagement is carried out after careful consideration of any restrictions that apply in individual countries.
Clinical stakeholder engagement
Early engagement with clinical stakeholders can provide invaluable insights into how they perceive unmet need and the benefits that new treatments could and should aim to deliver. An in-depth understanding of patient pathways, treatment guidelines and local clinical practice, as well as their interpretation of the available data, will ultimately ensure that any new treatment is optimally positioned and that further data generation is tailored to support use in the relevant populations.
In the natural course of drug development, clinical thought leaders are often identified during the trial programme. Advocacy from these experts is critical not only due to their clinical influence, but because they are often called upon to advise national and regional payers and can therefore directly influence reimbursement decisions. Ensuring reimbursement submissions are aligned with the expectations of clinical experts is critical, and vice versa; clinical experts often need to be aware that new treatments may need to be positioned where the cost to the healthcare system will be acceptable.
Wider clinical advocacy beyond key opinion leaders is vital in order to ensure access to treatments for all patients. Often reimbursement decisions are not made at a national level, and clinical support is vital in order to ensure that local funding is secured. Funding routes at this level can be complex and less transparent, thus the pharmaceutical industry has a role to play in educating and supporting clinicians in navigating the system.
The nature of the disease area and the anticipated value proposition will often drive stakeholder engagement strategy, which may involve a wide range of clinicians and other healthcare professionals including consultants, doctors working in primary care, nurses, hospital pharmacists and community pharmacists.
As with clinical experts, early engagement with healthcare payers (i.e. national and local funding decision makers, policy makers and budget-holders) is becoming an integral part of market access planning. Health technology assessment (HTA) agencies are increasingly being consulted at very early stages to ensure their requirements are reflected in clinical trial design, and that the necessary data is collected to support their assessment of cost-effectiveness.
Healthcare payers come in a wide number of guises:
- Hospital pharmacists
- Commissioners of primary care services
- Commissioners of secondary care services
- Medicines management leads
- Hospital business managers
- National reimbursement and health technology assessment agencies
Understanding the funding route for a specific product in individual countries and identifying the relevant payer(s) and the appropriate time to engage with them are crucial. There are two key stages to consider: early engagement to understand requirements in terms of the data, clinical and cost-effectiveness analyses, and timely engagement at the point of reimbursement where the data are presented in the appropriate manner.