HTA early dialogue and EMA HTA parallel consultation
The key challenge for pharma and biotech companies is ensuring fast patient access with limited market access restrictions at a price level that fully realizes the value of the product. Early engagement with payers, health technology assessment (HTA) bodies, and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful market access.
The process of gaining HTA scientific advice can seem a daunting one, particularly for small companies and those that are new to the HTA payer environment. We have significant expertise in conducting early scientific advice with HTA bodies and undertaking EMA Parallel Consultations, to help you adapt your clinical trials to maximize your product’s value.
Potential routes to gain payer insight into your clinical development program include:
- Parallel consultation with both regulators and HTA bodies, such as EUnetHTA’s early dialogue program
Country-specific scientific advice processes (e.g. NICE’s scientific advice, G-BA’s early benefit assessments)
Payer advisory boards to understand payer evidence needs on a more informal basis. Whilst they are less structured, the insights can be equally as valuable, depending on the commercial challenges facing your product. We have an extensive network of payers and country experts that can help you address your burning questions
By ensuring that their clinical trials include the types of outcomes that both the regulators and payers will need, our clients may face reduced hurdles around the time of submission for approval, pricing and reimbursement.
EMA Parallel Consultation
The Parallel Consultation procedure provides consolidated feedback from European regulators (EMA) and a group of national health technology assessment bodies on the data needed to get both regulatory approval and reimbursement.
Previously known as the EMA-HTA Parallel Scientific Advice procedure, in 2017 this has been replaced with the EMA Parallel Consultation initiative. This pathway provides a single gateway for parallel consultations with EMA, EUnetHTA and HTA bodies on evidence generation plans.
Payer engagement is essential to optimise your products pricing and reimbursement strategy
HTA scientific advice
Payer scientific advice can be sought from a number of countries, including the UK (NICE), Germany (G-BA), France (HAS), Italy (AIFA), Sweden (TLV). Country scientific advice can provide detail, targeted guidance on critical pricing and market access topics, to help your development plan. It can also be more cost effective if on a limited budget
Payer scientific advice can be sought at a pan European or individual country level
This was an excellent initiative for our company to undertake, the process helped the entire company understand the importance of generating evidence for payers. Remap supported us through the entire process providing invaluable insights and guidance that resulted in us receiving relevant payer feedback on our clinical development program.
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