The objective of market access is ensuring that the right patients get the right treatments at the right time. A robust commercialization and market access strategy ensures that pharmaceutical products reach patients and are covered by diverse healthcare systems, whether through public or private payers in the U.S. or single-payer systems in the European Union.

Global Market Access

Market access strategies vary by country and payer model. In the EU, obtaining European Medicines Agency (EMA) approval does not guarantee that a drug can be prescribed until it is included in each country’s reimbursement catalog. Similarly, in the U.S., despite FDA approval, there are no guarantees that insurers will cover the cost.

It's essential to initiate the market access process early in the product lifecycle, ideally during Phase II or III clinical trials. This ensures that a product meets regulatory requirements and gains payer approval within a defined timeframe, accelerating patient access to treatment.

Key Strategies for Market Access

Many pharmaceutical manufacturers, particularly smaller biotech companies, may struggle to execute a successful market access strategy due to limited resources. Increasingly, companies outsource this function to experienced professionals who can manage and steer comprehensive campaigns.

In the EU, post-EMA approval challenges include negotiating pricing and reimbursement with each country’s distinct payer system. In the U.S., overcoming payer barriers involves deep market contacts, expertise in negotiating reimbursement terms and addressing potential barriers to access.

Effective strategies include preparing payer negotiation tactics based on value messaging, market conditions, and competitive insights. A proactive, collaborative approach can address potential barriers. Thorough market access analysis helps uncover reimbursement gaps and coverage limitations, guiding pricing strategies to secure coverage and reimbursement.

Drug Formulary Design

Securing favorable positioning on drug formularies and national guidelines is a critical indicator of market access success. This involves understanding the intricacies of formulary design or guideline management, including navigating the policies and procedures that dictate how drugs are selected for inclusion.

Pharmaceutical companies must not only demonstrate a drug’s efficacy through rigorous clinical trials but also provide robust evidence of its real-world clinical performance, substantiate the drug’s cost-effectiveness and highlight its value proposition to the patient, payer and healthcare provider.

Value-Based Contracting

Manufacturers must be prepared for value-based contracting, including alternative payment models such as risk share and pay-for-performance. These contracts tie payment terms to clinical outcomes and effectiveness, aligning incentives across the healthcare system. The prevalence of value-based contracting is increasing as payers and providers seek to optimize healthcare expenditures while improving patient care.

Financial Support Solutions

Financial support solutions help patients access programs designed to make medicines more affordable, enhance medication access and increase medication adherence.

For patients who do not qualify for insurance patient assistance programs (PAPs) provide free or low-cost medications to low-income individuals. In the U.S., co-pay assistance programs help reduce out-of-pocket expenses that insured patients must pay, helping patients manage financial burdens.

Reimbursement Nuances

Reimbursement of medicines differs by geography, often being distinguished by whether a payer requires a health technology assessment (HTA). In the U.S., each insurer performs internal assessments to decide on payment for new products. In Europe, Australia and Canada, HTAs are required and national HTA bodies are increasingly collaborating on their assessments, as evidenced by the Joint Clinical Assessment (JCA) regulations set to begin in January 2025. This will centralize the assessment of clinical features of new medicines at the European level, with individual member states handling pricing and reimbursement negotiations.

Future Outlook for Commercial Launches

The market access landscape is complex and ever-changing, with payers continually reassessing their business models, priorities and strategies. To help navigate this uncertainty, AscellaHealth provides industry expertise to support successful market access and reimbursement strategies to the drug commercialization process. This guidance enables pharmaceutical manufacturers to seamlessly adapt to regulatory changes and confidently implement a streamlined approach to commercialization. As a trusted industry partner providing single-source, specialty pharmaceutical solutions, AscellaHealth proudly sponsors National Gene Therapy and Specialty Pharmacy Awareness Month, highlighting the importance of advocating for patient-centric care and collaboration to enhance the quality of life for patients with complex, chronic conditions.

For more information, contact businessdevelopment@ascellahealth.com