How do you monitor and manage the risks and uncertainties of patient access schemes?

2 Establish trust and collaboration

A PAS is not a one-off transaction, but a long-term partnership that requires trust and collaboration between the pharmaceutical company and the payer. You need to build and maintain a good relationship with your counterpart, based on transparency, honesty, and mutual respect. You also need to involve other key stakeholders, such as prescribers, patients, regulators, and health technology assessment (HTA) bodies, to ensure their buy-in and support. By fostering a culture of trust and collaboration, you can reduce the potential conflicts and disputes that may arise during the PAS.

3 Anticipate and mitigate risks

A PAS is subject to various risks and uncertainties that may affect its performance and viability. For example, you may face operational issues, such as delays, errors, or fraud, in the data collection and payment processes. You may also encounter ethical dilemmas, such as how to handle patient confidentiality, consent, or discontinuation. Moreover, you may have to deal with external factors, such as changes in the market environment, the regulatory framework, or the clinical evidence. To manage these risks, you need to conduct a thorough risk assessment, identify the possible scenarios and consequences, and develop contingency plans and mitigation strategies.

4 Adapt and learn

A PAS is not a static agreement, but a dynamic and flexible one that needs to adapt to the changing needs and circumstances of the parties involved. You need to monitor and review your PAS regularly, using the data and feedback you collect, to assess its effectiveness and efficiency. You also need to learn from your experience and best practices, to identify the strengths and weaknesses of your PAS, and to make the necessary adjustments and improvements. By being adaptive and learning-oriented, you can optimize your PAS and ensure its long-term value and sustainability.

5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?