Periodic Reporting for period 1 - ASCERTAIN (Affordability and Sustainability improvements by using new pricing, Cost-Effectiveness and ReimbursemenT models to Appraise iNnovative health technologies)
Periodo di rendicontazione: 2022-12-01 al 2024-05-31
The affordability of newly approved innovative health technologies (IHTs) is a significant challenge for many European health systems. Discussions have mostly focused on traditional issues like cost-effectiveness, quality of care, and patient involvement, but with limited success. ASCERTAIN aims to address this by developing a policy support tool. The tool will cover new pricing models for IHTs, a comprehensive health technology assessment (HTA) framework including cost-effectiveness and budget impact calculations, and new reimbursement and payment schemes. The ASCERTAIN framework will be based on a review and analysis of existing pricing, thresholds, reimbursement models, and HTA frameworks. This will help define the necessary elements for developing new models. New pricing models for IHTs will be created, reviewed, and quality-checked. These models will aim to balance improving patient access and encouraging entrepreneurship. Additionally, dynamic HTA models that consider the entire life cycle of health technologies will be developed, reviewed, and quality-checked. These new models will include clinical, cost-effectiveness, and budget impact aspects and will allow for updates when there are changes in indications or new comparators. The results from these models will inform new reimbursement models and payment schemes. Recognizing that affordability varies across EU member states, new methods to define thresholds will be developed, reviewed, and quality-checked. Finally, the developed policy support tool will be publicly available and used by various stakeholders.
During the first 18 months the consortium has done several preparatory work for the development of the ASCERTAIN framework, consisting of the following activities and achievements:
Objective 1: Develop the ASCERTAIN Framework
Completion of five scoping reviews on pricing, HTA frameworks, and reimbursement; identification of key findings and knowledge gaps; summaries included in version 2.0 of the ASCERTAIN (ACCESS2MEDS) Framework
Objective 2: Develop New Pricing Models for IHTs
Completion of two literature reviews on EU and EEA pricing models and fair pricing definitions, engagement with stakeholders, and gap identification in stakeholder views on fair pricing and the pricing of in-vitro diagnostic medical devices
Objective 3: Develop Open-Access and Dynamic Cost-Effectiveness Models
Completion of two scoping reviews on single-arm trials and open-access global models; selection of the medical device for use case 3 and development of a framework for cost-effective models; identification of clinical trials and development of economic models for use case 1 (NSCLC), use case 2 (CAR-T cell therapy), and use case 3 (Next Genome Sequencing- NGS); expert elicitation and real-world data used to estimate outcomes for use case 1
Objective 4: Improve Cost-Effectiveness Threshold Methods
Completion of two scoping reviews on cost-effectiveness thresholds and managed entry agreements
Objective 5: Create ASCERTAIN Policy Support Tool
To Integrate results from Objectives 1-4 into a publicly accessible tool, a first step required the definition of a requirement analysis process.
Objective 1: Develop the ASCERTAIN Framework
Completion of five scoping reviews on pricing, HTA frameworks, and reimbursement; identification of key findings and knowledge gaps; summaries included in version 2.0 of the ASCERTAIN (ACCESS2MEDS) Framework
Objective 2: Develop New Pricing Models for IHTs
Completion of two literature reviews on EU and EEA pricing models and fair pricing definitions, engagement with stakeholders, and gap identification in stakeholder views on fair pricing and the pricing of in-vitro diagnostic medical devices
Objective 3: Develop Open-Access and Dynamic Cost-Effectiveness Models
Completion of two scoping reviews on single-arm trials and open-access global models; selection of the medical device for use case 3 and development of a framework for cost-effective models; identification of clinical trials and development of economic models for use case 1 (NSCLC), use case 2 (CAR-T cell therapy), and use case 3 (Next Genome Sequencing- NGS); expert elicitation and real-world data used to estimate outcomes for use case 1
Objective 4: Improve Cost-Effectiveness Threshold Methods
Completion of two scoping reviews on cost-effectiveness thresholds and managed entry agreements
Objective 5: Create ASCERTAIN Policy Support Tool
To Integrate results from Objectives 1-4 into a publicly accessible tool, a first step required the definition of a requirement analysis process.
Adoption of New Payment Models by Health Authorities and Insurers: ASCERTAIN is developing payment and reimbursement models that consider both the financial impact and the uncertainties associated with high-priced health technologies. The potential impact includes enhanced stakeholder engagement, with the establishment of an Advisory Board and a wider stakeholder circle, including payers. Future steps involve continued engagement with payers and authorities through interviews, surveys, and workshops to validate models and promote their adoption.
Improved Market Conditions for Health Industries: ASCERTAIN aims to develop transparent pricing models to clarify expected prices and address information asymmetry between developers and payers. The potential impact of these efforts includes improved collaboration between industry and payers to ensure a joint interest in enhancing patient access. Transparent pricing models will help developers understand payer expectations and improve market entry.
Faster Access to IHTs for Patients and Providers: Ensuring faster access to IHTs is a critical challenge. ASCERTAIN is laying the groundwork for patient input through educational activities, such as the organization of a webinar on pricing basics and a patient symposium session on fair pricing. The potential impact involves better-informed patients who can support future decisions about pricing.
Affordable IHTs for Health Authorities, Insurers, and Providers: Balancing the short and long-term affordability of IHTs is essential. ASCERTAIN is developing models that consider broader societal outcomes and dynamic reimbursement schemes. The potential impact is an efficient value chain, with smoother marketing processes facilitated by stakeholder engagement and new models for pricing and reimbursement.
Improved Market Conditions for Health Industries: ASCERTAIN aims to develop transparent pricing models to clarify expected prices and address information asymmetry between developers and payers. The potential impact of these efforts includes improved collaboration between industry and payers to ensure a joint interest in enhancing patient access. Transparent pricing models will help developers understand payer expectations and improve market entry.
Faster Access to IHTs for Patients and Providers: Ensuring faster access to IHTs is a critical challenge. ASCERTAIN is laying the groundwork for patient input through educational activities, such as the organization of a webinar on pricing basics and a patient symposium session on fair pricing. The potential impact involves better-informed patients who can support future decisions about pricing.
Affordable IHTs for Health Authorities, Insurers, and Providers: Balancing the short and long-term affordability of IHTs is essential. ASCERTAIN is developing models that consider broader societal outcomes and dynamic reimbursement schemes. The potential impact is an efficient value chain, with smoother marketing processes facilitated by stakeholder engagement and new models for pricing and reimbursement.