• Introduction
• WP 1: Project management and administration
• WP 2: Disease understanding and outcome definition
• WP 3: Data access and sources
• WP 4: Data platform
• WP 5: Data analytics
• WP 6: HTA regulator-payer integration
• WP 7: Dissemination and communication
• WP 8: Legal, ethics and governance

Work Package 6: HTA regulator-payer integration

The main aim of WP6 is to identify and address evidence gaps which can delay decision-making by regulatory agencies, health technology assessment (HTA) bodies and payers, which ultimately compromises timely patient access to innovative treatments for prostate cancer. WP6 will build upon previously gained experience in other EU-funded projects and international initiatives and will provide advice and support to work packages 2, 3, 4 and 5 to ensure that the HTA-, patient-, regulator-, and payer-relevant perspectives are reflected.

Objectives

1. Develop an ‘evidence framework’ for centralised regulatory approval and national/regional HTA across EU member states to support the decision-making processes for market access of innovative treatments for prostate cancer.
2. Develop a ‘clinical value framework’ to assess the magnitude of clinical benefit/added therapeutic value offered by a new medicine in relation to the available therapies for prostate cancer, integrating the feedback from WP2 and other relevant partners in the scope of their respective responsibilities.
3. Ensure uptake of PIONEER’s findings by key stakeholders; therefore, facilitating adoption of new policies and increasing policy change regarding the treatment of prostate cancer all aimed at sustainable long-term implementation of PIONEER’s outcomes.

To achieve its objectives WP6 will develop a new model for multi-stakeholder dialogue by creating an Expert Committee Policy Stakeholder Feedback Forum (ECPSFF) involving the consortium members, external experts at the EU and Member State level (ensuring broad representation of the diverse models of healthcare systems in the EU), patients and clinicians, regulators, HTA bodies and payers, as well as stakeholders involved in evidence generation. The input and advice of the ECPSFF will be essential to ensure the generalisability and applicability of PIONEER’s outcomes to the relevant health agencies within EU member states.

WP6 Partners

European Alliance for Personalised Medicine, Swedish Institute for Health Economics, Janssen Pharmaceutical, Bayer and Sanofi.