Why You Need Market Access and How to Get Started

Why Do We Need Market Access?

The Healthcare Value Challenge

Market access is about understanding how much a product is worth in the marketplace. Determining product value is especially challenging in healthcare because this industry has completely separate stakeholders who determine a product’s value:

• Payers who pay for the value
• Physicians who prescribe the value
• Patients who benefit from the value

The difficulty with this separation of stakeholders, each defining their own healthcare value, is compounded by key macroeconomic and population health trends:

• Providing the highest quality healthcare to balance population health outcomes vs. individual care
• How to pay and administer healthcare despite the states’ limited budgets and the rapidly growing demand for new technology
• Ensuring equality of care provides universal healthcare coverage

Market access in healthcare must not only address the traditional four P’s of strategy: Product, Placement, Promotion and Pricing, but also include Procurement and Policy. A healthcare market access strategy must also reckon with the variety of diverse requirements across countries.

Achieving Product Success

Traditionally, healthcare companies have defined “launch” as achieving regulatory approval. However, there are countless examples of products obtaining regulatory approval, but never succeeding in terms of clinical adoption or revenue growth. Market access is vital to revenue growth.

For regulatory approval, the risk assessment criteria are whether the product is effective on patients and safe to use on patients. No comparator is needed. Post-regulatory approval, however, requires a comparative exercise. Regulators determine acceptability while payers determine value.

For payers and Health Technology Assessment (HTA) organizations, the incremental cost-effectiveness ratio (ICER) is used to determine in which quadrant a medical technology falls.

Traditionally, companies have defined ‘launch’ as achieving regulatory approval. However, there are countless examples of products obtaining regulatory approval, but NEVER succeed in terms of clinical adoption or revenue growth. Access = revenue growth.

The purpose of Regulatory Approval and Reimbursement is different. Regulators determine acceptability while Reimbursement determines value. For Manufacturers, the ‘risk’ being shared is certainty (timing) of revenue. For Payers, it is uncertainty of improved health outcomes versus costs. 

To successfully bring a product to market after regulatory approval, sponsors must engage with key stakeholders to obtain reimbursement, including:

• Supranational (such as EU Commission or Medicines and Healthcare Products Regulatory Agency in UK)
• National HTA organizations
• Regional HTA organizations & regional payers
• Procurement & finance “payers”: Hospital-Based HTA organizations

Market access is fundamental to reducing the uncertainty and risks tied to the limited evidence at hand when launching new technologies. At the same time, it enables negotiations between payers and manufacturers so they can establish a mutually agreeable pricing structure. This is often accomplished through Value Based Agreements, which effectively alleviate concerns about patients’ outcomes and prevent undue strain on healthcare system budgets.

How Do I Get Started?

No matter what type of product you’re launching, you need to tackle your market access challenges by setting short-, mid-, and long-term goals for product development, launch, and commercialization.

Short-Term Goals: Key Questions

• What is the current market landscape, including potential direct and indirect competitors in the country in scope?
• Which are the epidemiology figures within the country in scope?
• What are the access and potential pricing and reimbursement scenarios?
• What are the key product levers, those differentiation factors that build the value proposition? What are the potential gaps?
• What is the potential market size?
• What are the commercial models/options and the related trade-offs?

Mid-Term Goals: Key Questions

• What are the regional dynamics that could impact the product appraisal in key countries?
• Which stakeholders at the regional level should be involved, how and when?
• What are the potential market opportunities and barriers in other countries?
• What are the additional clinical development steps?
• What is the patient perspective and impact on decision-making processes in disease management?
• Who the are potential partners, if a partnership is needed, and which type of partnership agreement would apply?

Long-Term Goals: Key Questions

• What are the steps and requirements for the dossier submission to the central and local regulatory agencies?
• What are the best global and local market access plans, launch sequences, pricing strategies and price corridors to pursue in the prioritized countries?
• What are the Health Economics and Outcomes Research (HEOR) and PRO strategies, economic models, and RWE plans needed for negotiations with payers and other key stakeholders?
• How can digital solutions and patient engagement be integrated?
• What is the company organizational model to be implemented, including detailed full-time equivalents based on the commercial model?

Answering these questions will help you to develop your market access strategy and detailed plans for execution.

Market Access Success

Market access is a critical function of your journey to market and, ultimately, your commercial success. Through your market access strategy, you will prove the value of your product, achieve optimal pricing and reimbursement, and successfully deliver your product to the patients who will benefit.

Whether you need to understand which asset best aligns with your long-term strategy, which new market or therapeutic area to explore, or how to expand into another sector, Alira Health is ready to help you lead the way. We deliver in-depth, customized market access strategies and solutions—all designed to maximize your product’s value across its full lifecycle.