Despite consistent arguments that current health technology assessment (HTA) methodologies fail to account for the full value advanced therapy medicinal products (ATMPs) bring to patients and society, there is limited research aimed at understanding the value attributes of these innovative products. 

As part of a multi workstream research project aiming to understand the full benefits of advanced therapies from a multistakeholder perspective and to inform the development of a value assessment framework for advanced therapies, a comprehensive literature review was conducted to identify all published evidence on the value attributes for advanced therapies. The review aimed to address three key research questions:

• What are the value attributes of ATMPs? 
• Do value attributes differ by disease area? 
• Do value attributes differ by type of advanced therapy?

This research did not utilise a specific definition for ‘value’ or ‘value attribute’ as this will be defined in subsequent research, but the aim was to identify all value attributes without any limitation. That is, all value attributes including those that relate to clinical, economic, and societal benefits. As such, the search terms were purposefully broad to ensure that all value attributes were included in the findings. Common databases including MedLine and Embase were searched. 

Fifty-six unique studies were included in the comprehensive review. Twenty-one (37%) were qualitative research studies, 8 (14%) of these were literature reviews, 14 (25%) were perspectives, commentaries or viewpoints, 5 (9%) were reviews of health technology appraisals, 6 (10%) were reports, and 2 (3%) were presented at conferences or provide feedback from conference discussions.

What are the value attributes of ATMPs? 

A summary of the identified value attributes categorised into direct treatment-specific, economic and societal, is given below. 

Category	Value Attribute
Direct treatment-specific	Safety/toxicity Efficacy (including durability and chance of failure) Cure/potential for cure Treatment burden (includes type of administration, frequency and monitoring) Value of hope Impact on future treatment choice i.e., real option valueImpact on daily activities Quality of life (of patient and carer) Uncertainty (around efficacy (including durability and changing of a trusted treatment) and side effects) Mortality Disease severity (burden of illness including mental health burden; lifetime burden of illness, impact on comorbid conditions) Scientific spillovers Unmet need (including rarity) Quality-adjusted life year Age of onset Value of knowing  Innovation (including mechanism of action) Availability of alternative treatment options
Economic	Costs/financial burden (including on insurance) Family and caregiver spillovers Insurance value  Improvements to process of care/impact on care infrastructure  Productivity (patient and carer; includes losses in tax revenue)
Societal	Ethics and equity Altruism

Do value attributes differ by disease area or therapy type?

There is no indication that the value attributes of ATMPs differ by disease area or by type of ATMP. Indeed, the research suggests otherwise. However, there are indications that some of the attributes may be context dependent including insurance value and the value of knowing (relevant only when ATMPs are combined with a diagnostic). Further, attributes such as altruism may only be relevant where individuals are considering participating in clinical trials, as per the findings of this study. Additionally, some of the value attributes may be indistinguishable from others (e.g., value of hope and ‘cure’ from clinical benefits) while others may not be important in decision making (e.g., improvements to process of care). Finally, several of the value attributes are prone to uncertainty and it is important to ensure that a final list of value attributes is mutually exclusive. These outstanding questions will be explored further in subsequent research to inform the development of a value assessment framework for advanced therapies.

Subsequent research will not only confirm the final list of attributes but will also seek to define a definition for value attributes with respect to ATMPs. Finally, quantification of the final value attributes of ATMPs will be conducted. 

The interested reader can find the link to the full paper here: Value attributes of advanced therapy medicinal products: a comprehensive literature review