Development of evidence generation strategies and (abbreviated) value dossiers for two COVID-19 treatments (m-f-n)

Development of evidence generation strategies and (abbreviated) value dossiers for two COVID-19 treatments

Project description:

The service is requested as part of Boehringer Ingelheim's efforts to develop therapeutic options to treat or prevent COVID-19 infections and related complications (target indications). The project has the ultimate purpose to provide equitable access to two of Boehringer Ingelheim's COVID-19 treatments under emergency conditions and to guide their most appropriate use. More specifically, it will inform the development of evidence generation strategies and (abbreviated) value dossiers for two COVID-19 treatments, in light of public and government scrutiny, potential supply shortages requiring benefit stratification, non-standard Health Technology Assessment (HTA) pathways, and frequently sub-optimal pandemic response plans on national/regional and local levels.

Task description:

The service will entail the following tasks:

• Independent interpretation and consolidation of HTA reports, market research, existing internal analyses and publicly available data on the evidence requirements of payers, HTA agencies and pandemic response teams to develop evidence generation strategies and (abbreviated) value dossiers for two COVID-19 treatments in the target indications, including:
• Evaluation and assessment of payer insights on evidence needs in relevant treatment and (emergency) care pathways for the two COVID-19 treatments in their target indications based on extensive external expertise in Health Economics & Outcomes Research (HEOR)
• Conduct and roll-out of literature reviews on the health economic value of key competitor products in our target indications
• Evaluation and assessment of value and cost/benefit of utilizing the above compounds in different treatment settings / patient populations in order to inform public health priorities of governments, Non-governmental organizations (NGOs) and pandemic response teams on national, regional or local levels
• Developing and communication of patient-reported outcomes (PRO) strategies and relevant indirect treatment comparisons for the two compounds in question in their target indications to demonstrate product value to payers and HTA agencies based on extensive external methodological knowledge and expertise in HEOR
• Evaluation and design of required value demonstration studies to quantify and demonstrate the health-economic benefit of the two compounds in question in their target indication relative to previously identified payer value-drivers
• Development and delivery of key elements of the value story and (abbreviated) dossier to demonstrate and communicate the value of the two compounds to payers, HTA agencies and pandemic response teams on national, regional and local levels and to provide results for integrating them into pandemic response plans based on the above consolidated data and extensive existing external HEOR knowledge in terms of Excel sheets and presentations.
• All results will be delivered to the HEOR lead for the two products for review and approval

Consult

•  the HEOR lead on designing, developing and implementing a global long-term value demonstration strategy for two COVID-19 treatments in question
• the HEOR lead in the development of a health economic model for the two compounds in question
• the Epidemiology lead on the development of Real-World-Evidence (RWE) strategies, which take the needs of payers, HTA agencies and pandemic response teams into account
• based on approved results of the above analyses and extensive external HEOR knowledge

In light of the market conditions, we expect significant synergies by pooling the tasks above across two of our compounds.

The performance of the contractor has the goal to develop and deliver key-elements of BI's evidence generation strategies and (abbreviated) value dossiers for two COVID-19 treatments, to obtain and maintain patient access and to facilitate their integration into existing pandemic response plans.

Possible timelines to be kept:

Compound 1 may already receive emergency use authorization as early as in November 2021.

Compound 2 may already receive emergency use authorizations in December 2021.

Key elements of the value story will be shared with regions and affiliates on a rolling basis, as and when they are available.