Understanding payer perceptions of subjective endpoints

Analysis of the perception of subjective endpoints and caregiver perspective for communicating value for treatments in psychiatric indications

Scope:

EU4 + UK and Sweden

Therapy Area:

Psychiatry

Client:

Medium sized pharmaceutical company

The Challenge

Traditionally, HTA guidance focuses on patient-relevant and objective outcomes, and there is often no specific guidance regarding subjective endpoints (such as behavioural/cognitive endpoints) or the consideration of caregiver burden

As such, payers may perceive these endpoints to be of limited value in the HTA assessment of new medicines for psychiatric and developmental diseases where the scope for the collection of objective outcomes is limited

Despite the high caregiver burden in these disease areas, caregiver perspective is not perceived to be of high value and there are currently limited effective ways of capturing this

Project objectives

Understand payer perceptions of subjective (cognitive/behavioural) endpoints in indications with limited scope for the collection of objective endpoints, and to understand the key drivers of payer value in these disease areas

Understand payer perceptions of reducing caregiver burden and improving caregiver quality of life in the communication of value of a new product for these indications

Determine requirements for increasing payer understanding of clinically relevant value and aligning payer and physician views on what is required to demonstrate value in these disease areas with a high unmet need

Approach

A desk research programme to i) understand key symptoms and burden of disease; ii) review HTA guidance on formal requirements for clinically relevant outcomes; and iii) perform analogue analysis on products assessed with inclusion of subjective endpoints

Primary research was completed with 28 payers and six KOLs across six markets to assess guidance and perception of subjective endpoints and caregiver perspective, and to understand the key unmet needs and key drivers of value in these psychiatric indications

Research findings were analysed, and outputs were further explored in a stakeholder roundtable to reach a consensus on key points

VALUE DELIVERED

The client was provided with a comprehensive overview of the disease landscape, key unmet needs and the key drivers of payer and physician value for each indication: Schizophrenia, Alzheimer’s Disease, Autism Spectrum Disorder and Post-Traumatic Stress Disorder. Detailed analysis was performed on the perception and acceptance of behavioural/cognitive endpoints, patient quality of life, caregiver burden and quality of life, healthcare resource use and societal implications in HTA processes across markets

Strategic recommendations were generated on how the client can support the use of subjective endpoints and include the caregiver perspective across the entire clinical development programme; including recommendations on endpoint selection and validation, the positioning of endpoints in the clinical trial, and the inclusion of metrics of caregiver burden. The client was advised on the endorsement of endpoints outside of the pivotal trial to support the wider, holistic value narrative

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