OBJECTIVES:

The start of the EU-HTA in 2025 requires a framework guiding HTA bodies and manufacturers reliably and efficiently through the process. The necessary guidelines are currently developed by the EUnetHTA 21. Herein, the scoping process is of particular importance as it defines the scientific questions to be addressed in the assessment. Stakeholders (e.g., manufacturers, associations, service providers) are supposed to be involved in the guideline development by means of a public consultation. It is unclear if and how the hereby identified criticism is addressed by the EUnetHTA 21.

METHODS:

Using the scoping guideline (ID D4.2) it is investigated which obstacles exist from the stakeholders’ point of view with respect to the planned scoping process and whether they were addressed by the EUnetHTA 21 in the final guideline. For this purpose, the published comments are consolidated in a first step. Secondly, the draft deliverable is compared with the final guideline. Finally, the modifications in the guideline are compared with the main issues commented on by stakeholders.

RESULTS:

Public consultation of the scoping guideline took place in May 2022. The final version was published on September 12, 2022. A total of 27 parties have commented, addressing in particular following concerns as critical:

1. No participation of the manufacturers in the scoping process
2. Non-transparent procedure to determine (one or many) PICOs
3. Lack of binding and realistic timelines

Adaptations in the final guideline were of linguistic nature only. Concerns identified by stakeholders were not addressed. The refusal for implementation was not explained.

CONCLUSIONS:

The stakeholder’s influence on the scoping guideline has been extremely limited, neglecting valuable input from the industry. It remains to be seen whether the identified concerns will be addressed in future guidelines. Starting with the first EU-HTA assessments in 2025, a pragmatic solution is needed.