Empowering clients in navigating complex healthcare systems in Europe
Strategic market positioning, reimbursement and pricing potential.
Why 90% of startup products fail to reach the market
In the biotech and pharmaceutical industry, reaching the market means obtaining a wide patient access to a developed drug. Authorities within countries have to secure national and regional reimbursement of the therapy under an insurance or reimbursement scheme, in order to secure the adequate provision of medicines to all patients.
In some cases, products may be available without reimbursement on the private market, but this does not ensure wide access to the patient population.
Here are most common stumbling blocks to a successful drug reimbursement strategy, that can be avoided with a timely market access assessment:
01
Competitors are already on the market
Market landscaping is the necessary early step in a drug product development. It will define the extent of your product differentiation, or failure to differentiate, among other success factors.
02
The unmet medical need is low
Unmet medical need refers to a condition that is not adequately addressed by existing therapies. For a given indication the overall medical need might be low, but there could be a subpopulation with a high unmet need, requiring new treatment options.
03
The price anchor exists
Competitors that already are on the market might indicate the payers' willingness to pay for a novel product that provides improvement over the current standard of care (SoC).
04
The evidence gap is high
A clinical trial needs to be planned according to both, regulatory marketing authorisation and reimbursement requirements. What is the evidence necessary for a positive reimbursement decision? You might need a contingency plan for the mitigation of the evidence gap.
05
Delay in reaching the market
Timelines for patient access can exceed 1-2 years post marketing autorisation in some European markets. This will affect returns and bring additional competitive risks.
06
No KOL support
Timely engagement with KOLs is crucial when developing and launching a new medicine on the market. KOLs influence the opinions of healthcare practitioners, health authorities, patient advocacy groups, and other stakeholders towards the prescription and use of a new treatment.
After about ten years of R&D, three
milestones must be reached to bring new therapies to patients
01 European marketing authorisation
Marketing authorisation is granted when a regulatory MA agency (EMA, Swissmedic, MHRA, AIFA, Halmed, etc.) has positively evaluated quality, safety and clinical efficacy of a new pharmaceutical product.
02 National reimbursement
EU member states need to make evidence-based decisions on national healthcare expenditures, including if a new drug will be added on the list of reimbursed drugs. Reimbursement decisions are generally informed by the unmet health need, added clinical benefit, cost effectiveness and budget impact. Decision criteria vary by country, leading to a significant disparity in patient access across the EU.
03 Post-reimbursement access
Once reimbursed the medicine must reach patients and must be used well. This requires distribution through pharmacies, hospitals and other available channels, integration into the healthcare infrastructure and care pathways and ensuring that physicians and health providers can prescribe new treatment.
The typical lifecycle of an early stage biotech company
The transformative impact of a successful drug, often life-changing or even life-saving, fuels optimism in the biotechnology industry for both leaders and investors. Building value in this field is a step-by-step process, where achieving success in biotech involves overcoming regulatory hurdles and the uncertainties of trial results. Early developers often focus on regulatory MA requirements, forgetting about the patient access, as the next major hurdle that needs a simultaneous early planning and strategy.
PRECLINICAL: Animal data demonstrate efficacy and safety of a drug, which will hopefully translate to humans
Key market access questions for leaders and investors:
- Are you in the right disease area?
- What is the optimal regulatory pathway for drug development (trial design, endpoints, target patients)?
- What are the most relevant comparators?
CLINICAL: Human data demonstrate safety and efficacy of a drug, with each successful phase increasing company's value
Key market access questions for leaders and investors:
- What is the likelihood of the drug reimbursement?
- What is the value proposition of the drug?
- What is the strategy for price and reimbursement negotiation?
- Is the commercial case still valid for the drug?
- What competitors are on the horizon?
COMMERCIALISATION: Negotiating with health authorities and insurance companies so that patients can get access to the drug
Key market access questions for leaders and investors:
- What is the time lag to patient access?
- Do we have enough key opinion leaders' support ?
- What is the expected patient uptake?
- How is the competitive landscape evolving?
We are market access consulting helping firms position their product within the right disease, for the right patients, at the right time, on the right market and at the right price.
The right treatment
No company wants to start off their drug development in a wrong indication and waste millions of investment money.
This strategic process enables companies to select the most promising indications based on various criteria, such as the potential for clinical validation, commercial potential, and stakeholder interest. Choosing which indications to prioritize requires evaluating a wide range of scientific, clinical, and commercial factors to strategically pinpoint the most valuable and defensible routes to market.
The right patients
Key is identifying patient subpopulations with the highest unmet need, that are most likely to benefit from the treatment.
This assessment includes epidemiological characteristics, disease severity, genetic or biomarker profiles, and clinical considerations. The goal is to define meaningful patient subpopulations that are relevant for decision-making in clinical practice. Additionally, the assessment involves considering the generalizability of findings in subgroups to the broader patient population and addressing potential heterogeneity within the target population.
The right time
A quick time to market plays a significant role in overcoming barriers that can hinder market entry, can give businesses a competitive edge and increase return on investment. Understanding the market trends, unmet needs, and the competitive landscape is vital for identifying the right time to enter the market. To reduce market access delays, and increase speed to reimbursement for innovative products, we bring to you the awareness of the market dynamics and conscious trade-offs in pursuit of sustainable, profitable market access.
The right market
International Reference Pricing (IRP) is a pricing mechanism used by governments to establish or adjust the price of a drug in one country in relation to the price of the same drug in other countries. This approach is also known as external reference pricing and is widely used across developed nations. IRP is used to inform negotiations with the pharmaceutical industry or as a cap on market prices. It is a common element of price regulation in the vast majority of EU and EFTA countries, with the exception of Sweden and the UK. IRP can have significant implications for pharmaceutical companies, as it influences the pricing of drugs in different markets. Therefore, the sequence in which drugs are launched in various countries and the decision of whether to launch in specific markets can be influenced by IRP considerations. Understanding and strategically approaching IRP is essential for pharmaceutical companies to navigate the complexities of international pricing and market access.
The right price
Drug launches in Europe often miss price expectations due to various factors:
- The implementation of price controls and regulation for cost containment
- External reference pricing systems incentivize pharmaceutical companies to adopt international pricing strategies, leading to delays or avoidance of launching new drugs in countries with potentially lower prices
- Inadequate understanding of market needs
- Poor product differentiation
- Complex regulatory framework that varies across countries
The interplay of these factors helps shape drug pricing in Europe, balancing considerations of innovation and profitability, affordability, and healthcare sustainability.
