A pharmaceutical company focused on the discovery, development, and commercialization of new treatments for orphan drug diseases with significant unmet needs recently asked us to provide strategic Market Access insights into the current European landscape.

The Challenge

As we’ve highlighted in previous Solem articles, this client understood the importance of the process of due diligence. The client came searching for early insights. They wanted to better understand payer evidence needs on a more informal basis as they were about to enter phase III and had a European market approval targeted for mid-2025.

The objective was to lower the barriers associated with the submission and negotiation of pricing and reimbursement after EMA approval. As well as to aid in guiding their market access strategy.

Solution

We undertook early HTA/Thought Leader Advice to gather information from payors and physicians across Europe about the early clinical and PReMA perceptions of their lead product.

Thanks to our extensive network of payers and country experts, we were able to provide our client with the right insights and answers to their questions.

17 countries were included in the project’s scope, with Tier 01 countries receiving most of the attention (G-5 plus Switzerland and Netherlands). We were able to draw conclusions from desk research, internal stakeholder discussions, and anonymous 1:1 interviews with more than 20 payers and physicians.

We posed questions to the participant during the interview process, including:

• How much impact would be perceived in pricing and reimbursement discussions if no head-to-head comparisons are provided in the clinical data?
• Assuming similar efficacy, how would the new route of administration be valued? What would be needed to justify an equal / premium price compared to other on demand treatments?
• Are there any shortcuts or byways which could be an opportunity for their product (e. g. early access programs, “fast track” procedures)?
• Would reference pricing be applied? External or internal? From which countries / which products?
• What kind of data is mandatory for a P&R dossier, rsp. for P&R negotiations?

Results

After a busy six months of research, we delivered a report with country-specific results and recommendations, as well as a general perspective from payers and physicians across Europe.

The Global Value Dossier (GVD), its significance prior to initial encounters with HTA authorities, and how far behind our client was in preparing this document were some of the primary findings.

The GVD is a critical document that has been dubbed the “heart” of the payer communication strategy for pharmaceutical products. It also serves as a foundation for the subsequent development of country-specific health economic models.

Another critical component was the generation of comparable data to support premium pricing (indirect comparisons, RWE or others).

We used the results of these interviews to deliver and validate a Market Access Milestone Timeline project.

Based on the data, we were able to provide our client with the appropriate strategic advice and recommendations to maximise their chances of obtaining EU pricing and reimbursement.

Ensure you gain abetter understanding of your position before going to market. Gain insights that could potentially put you in a stronger negotiating position for reimbursement. Mitigate potential challenges and hurdles along the way. We’d love to talk to you about how we can help and support you.

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