What actions can be undertaken by the manufacturer, in order to fully leverage the benefits of the new AIFA algorithm?
Considering the increasingly challenging market access environment in ITA given budgetary pressures, and to fully address the above-mentioned challenges that come with the introduction of the new AIFA algorithm, the manufacturer should consider these key actions during the submission process and CTS evaluation:
- PREPA E FOR ASSESSMENT SUBJECTIVITY THROUGH ONGOING PAYER COLLABORATTION AND COMMUNICATION
- Manufacturers should develop their clinical value dossier for submission in ITA based on the CTS perspective on preferred clinical evidence dimensions
- To accomplish this, manufacturers should take advantage of AIFA’s Early Scientific Advice service in order to align around expectations for their product
- Manufacturers should promote more frequent and productive communication with AIFA to ensure alignment on key milestones and achieve common goals from the earliest stages of the process
- ANTICIPATE HIGHER QUALITY CLINICAL EVIDENCE REQUIREMENTS AND SEEK BUY-IN FOR NOVEL ENDPOINTS
- Manufacturers should focus on designing trials to yield what AIFA considers ‘high quality evidence’, seeking to reflect AIFA’s expectations through early communication with the authority
- Manufacturer should initiate payer education initiatives (i.e. conferences, symposia, sponsored events) in order to gain buy-in from the CTS with regard to lesser known endpoints for evaluation (i.e., those beyond the traditional OS, PFS in oncology)
- DEVELOP FINANCIAL BASED CONTRACTS TO SUPPORT ‘INNOVATIVE’ PRODUCT ACCESS
- While ‘payback mechanisms’ involving outcomes-based agreements are expected to decline as a result of the new policy, manufacturers should develop a stronger focus on purely financial based solutions (i.e. price / volume, patient and cycle cap) given the historical focus on such arrangements in an effort to secure access throughout the country’s many regions