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HEOR & Market Access
Patient Engagement & Advocacy

Patient Group Training on Marketing Authorization and HTA

Building the knowledge and confidence patients need to participate meaningfully in regulatory and market access decisions.

Situation

A pharmaceutical company developing a new therapy for a rare neuromuscular disease recognized that patient organizations wanted to play a more active role in upcoming access discussions, but often lacked the knowledge and confidence to engage in marketing authorization and HTA processes. To support meaningful involvement, there was a need for a training approach that translated complex regulatory and market access topics into clear, relevant, and practical guidance for patient representatives.

Objective

To design and deliver a comprehensive yet accessible HTA training program for European patient organization representatives, enabling them to better understand marketing authorization and market access processes and prepare for meaningful involvement in upcoming country-specific HTA discussions, in full compliance with applicable requirements.

Our Solution

1
Definition of project objectives: Clearly defining project goals and general training content with our client, while keeping potential patient requirements in mind and considering compliance aspects.
2
Assessment of patient organizations’ needs: Inviting European, national, and regional patient organizations targeting the product’s indication, verifying their interest in the training, background knowledge and desired topics.
3
Development of a tailored training program: Training structure and outline developed by admedicum expert team in the field of patient involvement in HTA, contents along the timeline of pharmaceutical marketing authorization and HTA processes, structured into pan-European content and country-specific information.
4
Execution of country-specific training: Content delivered in local language by trainers experienced in patient engagement and with prior involvement with local HTA processes and / or health care systems.
5
Evaluation and availability for follow-up questions: Gathering feedback throughout the training to check understanding of contents, availability for questions after training incl. follow-up calls with patient organizations.

Outcomes and Impact

1
Strong participant appreciation and enjoyment of the interactive training and learning opportunity.
2
Boost to patient organizations’ motivation to become actively involved in market access and sharing of HTA results with members.

“It was a great pleasure to meet you! Thanks again for the beautiful presentation. It was really useful! :) We will try to apply and explore the opportunities mentioned.”

Training participant
Patient organization representative

“Thanks for the good and interactive training today. This helps us as an association in our empowerment and influence. Thank you also for sending the presentation. If there are any issues, I will be happy to contact you.”

Training participant
Patient organization representative

Conclusion

admedicum translated complex regulatory and HTA concepts into a practical, patient-friendly training experience that empowered patient organizations to engage more confidently and effectively. By combining subject-matter expertise with strong patient engagement know-how, admedicum helped build the capabilities needed for more meaningful patient involvement in future marketing authorization and market access processes.

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