EXCITE International was formed in part to address the discontinuous nature of regulatory and coverage decision-making and to address these through single harmonized studies that meet the needs and expectations of both. While the EI process does not expect pre-market approval of health technologies that might be effective, by including the perspectives of Payers in protocol design, it hopes to mitigate the risk of rejection downstream recognizing that the final coverage decisions rests with individual Payers alone.
Given the pivotal nature of the Payer perspective, the Payers’ Advisory Committee (PAC) provides a generic framework for addressing the interests of Payers specifically as these relate to protocol development. In addition, the PAC will provide Payers an opportunity to share any perspectives between each other regarding implementation or adoption once the results of EI clinical evaluations are available. The PAC cannot and will not provide any advice or undertake steps to influence adoption decision making by any of its members’ host organizations, respecting the independent policy and legislative realities of all jurisdictions represented.