Affordability and Sustainability improvements by using new pricing, Cost-Effectiveness and ReimbursemenT models to Appraise iNnovative health technologies

Project Information

ASCERTAIN

Grant agreement ID: 101094938

DOI

10.3030/101094938

EC signature date 24 November 2022

Start date 1 December 2022

End date 30 November 2026

Funded under

• Health

Total cost

€ 4 966 716,00

EU contribution

€ 4 966 716,00

Coordinated by

ERASMUS UNIVERSITEIT ROTTERDAM
Netherlands

Periodic Reporting for period 2 - ASCERTAIN (Affordability and Sustainability improvements by using new pricing, Cost-Effectiveness and ReimbursemenT models to Appraise iNnovative health technologies)

Reporting period: 2024-06-01 to 2025-11-30

Summary of the context and overall objectives of the project

The affordability of newly approved innovative health technologies (IHTs) is a significant challenge for many European health systems. So far, discussions have mostly focused on traditional issues like cost-effectiveness, quality of care and patient involvement, with limited success. ASCERTAIN addresses this by developing a Policy Support Tool. The tool covers new pricing models, a comprehensive health technology assessment (HTA) framework including cost-effectiveness and budget impact calculations, and new reimbursement and payment schemes. The ASCERTAIN framework is based on a review and analysis of existing pricing, thresholds, reimbursement models, and HTA frameworks, helping to define necessary elements for developing new models. New pricing models aim to balance improving patient access and encouraging entrepreneurship. Additionally, dynamic HTA models that consider the entire life cycle of health technologies include clinical cost-effectiveness, and budget impact aspects, allowing for updates when there are changes in indications or new comparators. The results from these models inform new reimbursement models and payment schemes. Recognising that affordability varies across EU member states, new methods to define thresholds were developed. Finally, the Policy Support Tool will be publicly available, enabling stakeholders to configure scenarios, execute models, and interpret results in a transparent and user-friendly manner.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Objective 1: Develop the ASCERTAIN Framework
The ASCERTAIN Framework v3.0 builds on previous work by developing cross-interactions between models. I.e how model outputs can be used as inputs for other models, and how input parameters are applied to multiple models.

Objective 2: Develop New Pricing Models for IHTs
A working version of the pricing model was implemented in R for integration into the ASCERTAIN Policy Support tool. The model was presented to stakeholders in informal review sessions, allowing further refinement. Technical testing included verification, face validity and error checks.

Objective 3: Develop Open-Access and Dynamic Cost-Effectiveness Models
A core cost-effectiveness and budget impact model were developed and tested, with a general coding structure that is used for all three use cases and adjusted according to individual requirements. All prototype models were developed in R for integration into the ASCERTAIN Policy Support tool.

Objective 4: Improve Cost-Effectiveness Threshold Methods
A preliminary flexible cost-effectiveness model was created, providing the technical framework needed to translate preference weights into threshold adjustments. Groundwork for dynamic and cyclic reimbursement models was established through the development of a stakeholder survey on contracting needs and the creation and testing of prototype structures for various types of managed entry agreements (MEAs). The first version of the models were also technically tested.

Objective 5: Create ASCERTAIN Policy Support Tool
A cloud-based prototype was implemented and deployed for internal testing. The tool enables stakeholders to configure scenarios, execute models, and interpret results. The current version supports the execution of individual models, with input parameters configurable via a web interface. Model outputs are returned in tabular and graphical formats.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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. For uptake, the consortium has pursued 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 developed a pricing model 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: ASCERTAIN included the patient voice in the development of its models and framework and created and disseminated related educational materials (webinars, videos, animations, Q&As, interviews, infographic). The potential impact involves better-informed patients who can support decision-making on pricing, HTA and reimbursement.

Affordable IHTs for Health Authorities, Insurers, and Providers: Balancing the short and long-term affordability of IHTs is essential. ASCERTAIN develops 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.

ASCERTAIN kick-off meeting

ASCERTAIN Oslo Consortium Meeting

ASCERTAIN stakeholder roundtable

ASCERTAIN HTA event

ASCERTAIN behind the scenes