WEP Clinical’s Market Access team can help you maximize the potential for your product in the European market. We work closely with each of our clients to understand their unique product and develop the best strategy for driving access. Find out more in the boxes below about how we can help your company, whatever your needs and prior experience in Europe.
Commercialization
Companies wishing to commercialise their product in Europe will firstly need to file for European Marketing Approval via the EMA (European Marketing Authorisation), which can take between 12-18 months to complete.
During this period, the WEP Clinical Market Access team will work with your company to set out the strategy to secure access and reimbursement across each of the top 5 EU countries.
EAP/PA-NPP (unlicensed)
Companies providing unlicensed supply under an early access type arrangement in Europe will likely have developed a legacy of clinical experience and patient advocacy. We work, at the outset, to understand this experience and build this into the commercialization strategy.
EMA Marketing Authorisation
During this period we will work to drive advocacy through our network of KOLs in each of the EU countries. We will engage stakeholders at all levels to ensure the clinical value benefit of the treatment to patients in the specific therapy area is understood.
Market Access
Once the Licence submission is completed, the WEP Clinical Market Access team will work with your company to set out the strategy to secure access and reimbursement across each of the top 5 EU countries.
Launch Acceleration
WEP Clinical works closely with our clients to develop Launch acceleration strategies of Advanced notification, pre licence access schemes & innovative Access agreements negotiated per country aligned to their commercial ambitions.
New Market Analysis
For companies looking to fully understand the opportunity to pursue a Marketing Authorisation within the EU5 for their FDA-approved product, WEP Clinical can help to uncover and resolve some of the uncertainty and pitfalls of securing access and reimbursement across the various healthcare systems in Europe.
Our team works round the clock to understand all these different variables in order to provide our clients with an informed evidence-based framework for portfolio investment decisions.
Healthcare Systems
The WEP Clinical Market Access team understands the dynamics of payer driven healthcare decisions. Our team works round the clock to understand all these different variables in order to provide our clients with an informed evidence-based framework for portfolio investment decisions.
Clinical Evidence
Evaluation of the strength of clinical trial data, meta-analysis, Systematic Literature reviews, combined with research of both Physicians and Payers creates a deeper understanding of the clinical value within the treatment pathway and ultimately patient outcomes.
Economic Value
Demonstrating cost effectiveness and the overall impact on Healthcare budgets are both primarily determined by the price achieved in each market. This is affected, in turn, by how price evaluation is considered both in terms of reference pricing, freedom of pricing regimes and negotiation strategies to secure target prices linked to current market conditions.
Pricing
Evaluation of the competitive marketplace, comparators, patient population and the demonstration of clinical value and willingness to pay are all determinant factors in establishing the optimal price and market access potential.
RESEARCH PROGRAM
For companies with promising new treatments in late stage clinical trials for rare or orphan diseases, WEP Clinical can help you understand the value of your asset with respect to securing marketing authorisation from EMA and having the capability to then pursue access and reimbursement across the leading EU5 European markets.
Asset Profiling
Asset profiling is a deep dive approach to the evaluation of a product comprising such factors as:
Therapy area and unmet need; Burden of the disease; Competitor landscape (including comparators); Price potential; Clinical value benefit
Clinical Evaluation
Using our expertise, the WEP Clinical Market Access team will consider the various access arrangements and analyse previous Health Technology Assessments to determine analogues of similar product profiles and precedents of previous decisions. Most importantly will perform evaluation of clinical trial data and identify data gap analysis.
Stakeholder Engagement
We undertake stakeholder mapping exercises to identify decision makers & KOLs in each market. Through our networks, we engage with Physicians & Payers to gain their insights on clinical value benefit and possible cost effectiveness challenges. In addition we use research methodologies to validate the results of our combined research.
Strategic Recommendations
Ultimately, our team will provide invaluable insights into the potential challenges of adopting an EU5 market strategy, whilst at the same time highlighting the potential growth opportunities in each market.
The outcome of this approach to asset profiling provides our clients with an evidential based answer to their question.