From Approval to Access: 4 Steps to Rethinking Market Access Strategy in Specialty Pharma

Market access—ensuring that medications reach the patients who need them, through regulatory approval, reimbursement, and equitable pricing—is a crucial component of any drug’s journey. And as a growing number of small to mid-sized pharma and biotech companies choose to take their assets through commercialization, rather than license them out in later phases, market access strategy is becoming an increasingly important area of focus.

The good news is that developing and executing a successful access strategy doesn’t have to happen in a vacuum. Specialty pharmacies bring visibility into the real-world dynamics between payers, providers, and patients, and can help manufacturers shape strategies that align directly with patient populations who will benefit.¹

Four Successful Strategies for Improving Market Access

There are many components to consider when developing a market access strategy, and several steps manufacturers can take to both increase market share and ensure therapies reach the patients who need them. Key considerations include:

1. Secure placement on payer formularies:² One of the most critical, and often most challenging, components of market access is gaining placement on payer formularies. Manufacturers need to make a compelling case for both the clinical and economic value of their therapy. Understanding what payers prioritize, from comparative data to budget impact, can help shape that case.
2. Deploy a sales team to reach providers:³ A strong sales team helps guide providers in prescribing with confidence. This is especially important with specialty medications, where providers may be less familiar with certain rare or complex conditions, or have limited experience with newer biosimilars. Partnering with disease advocacy organizations and specialty pharmacy sales teams can also help raise awareness among both clinicians and patient communities.
3. Establish a trusted pharmacy network: Manufacturers are often eager to establish pharmacy relationships early. While that’s critical, those connections only become effective once payer coverage is in place. Distribution networks should be built with careful timing, after formulary placement and reimbursement pathways are confirmed, to ensure access plans can be executed smoothly.
4. Consider the patient experience: Long before launch, manufacturers should map out the treatment journey from the patient’s point of view. What education will patients need? What financial support programs will be available? How will delays in prior authorization be handled? For example, bridge programs that provide a short-term supply of the drug at no cost can ensure therapy begins without delay, especially critical for patients managing chronic or complex conditions.⁴

Seeing the Bigger Picture

A common challenge in market access planning is the tendency to focus narrowly on one product, its trial data, its value proposition, its launch timeline. But payers are looking at broader questions: how a therapy fits into the treatment landscape, what the cost of care looks like across patient populations, and how the product optimizes adherence and outcomes.

Manufacturers who take this wider view, who understand how their product compares to others in terms of support services, copay assistance,⁵ and downstream value, are often better positioned to secure and maintain favorable access. When multiple therapies offer similar clinical results, what tips the scale may be factors such as patient education services, copay support, or a more streamlined prior authorization process.

By anticipating how access decisions are made and tailoring strategies accordingly, manufacturers can better align with the needs of payers and providers alike.

The Patient is at the Center

Much of access strategy focuses on coverage and prescribing but ensuring that patients can start and stay on therapy is just as important. Specialty medications often require navigation of complex benefit designs, distribution models, and treatment regimens, all of which can create barriers to timely initiation and long-term adherence.

Manufacturers who proactively address these hurdles can improve both patient outcomes and market performance. Identifying common friction points, like delays in benefit verification or lack of clarity around financial support, and building services to address them can have a measurable impact. That might include bridge programs, intuitive copay portals, or tailored onboarding support.

Even small operational elements such as refill reminders, pharmacist outreach, and adverse effect guidance can influence whether a patient stays on therapy.⁶ These touchpoints are often underestimated in their value but are essential to long-term success.

At its core, market access is about more than pricing and placement. It’s about ensuring therapies are safe, effective, and truly accessible to the people who need them.

Especially when it comes to specialty medications, that requires manufacturers to think beyond the launch, to understand how payers make decisions, how providers prescribe, and how patients experience treatment in the real world. Because of their collaborative relationships with all these stakeholders, specialty pharmacies can make strong partners when it comes to developing a market access strategy.

Access isn’t achieved in isolation. It’s built through collaboration, foresight, and a willingness to design with all stakeholders, especially patients, in mind.

About the Author

George Kridner, President and CEO of Acelpa Health.

Compliance and Disclosure notes

1. Any collaboration between manufacturers and specialty pharmacies must be structured to comply with applicable fraud and abuse laws, with pharmacy activities focused on operational execution and patient support—not influencing prescribing decisions or payer coverage determinations.

2. Access discussions with payors should be grounded in transparent, evidence-based information and should not involve incentives or arrangements that could improperly influence coverage or utilization decisions.

3. All sales, education, and advocacy-related activities should remain non-promotional in nature, be independently controlled by the respective organizations, and comply with federal and state fraud and abuse laws, including restrictions on remuneration and inducements.

4. Any bridge or free-drug programs should be structured to comply with federal and state beneficiary inducement laws, include clear eligibility criteria, exclude federally reimbursed patients where required, and be time-limited and independent of future prescribing or coverage decisions.

5. Copay assistance and patient support programs must be designed in accordance with applicable laws, including restrictions related to federal healthcare program beneficiaries, and should operate independently of prescribing or utilization decisions.

6. Patient support services should be clinically appropriate, offered consistently, and designed to improve safety and understanding of therapy rather than to encourage continued use absent medical necessity.

Legal Disclaimer:

The content provided in this article is based on industry experience and is for informational purposes only. It is not intended to serve as legal, regulatory, or reimbursement advice. While we make every effort to provide accurate and up-to-date information, the details shared here should not be considered a substitute for professional consultation or advice. By accessing this content, you agree to hold harmless the author, publisher, and any associated parties from any claims, liabilities, or damages arising from the use or interpretation of this content.