Market access strategy is the integrated set of choices that ensure a drug, biologic, or medical device is available and can be efficiently and sustainably utilized by those who need it. Effective execution requires a symphony of activities across diverse functions within a biopharma organization and often extends into collaboration with external stakeholders. Here we present a way of organizing this strategy into four core pillars, each of which is crucial for success, with a special emphasis on one often underrated element: value marketing and messaging.

Pillar 1: Understanding the Link Between Regulatory Approval and Reimbursement Status

Navigating the interplay between regulatory approval and commercial and access strategy is the first major pillar of success. This work involves understanding how the approval pathway, indications studied and sought, and regulatory dialog both can impact probability of access and can vary across regions. For example, securing orphan drug designation or breakthrough therapy status can expedite regulatory approval and, in the case of orphan drug designation, can protect from long-term impacts of price controls. Additionally, certain indications (e.g., obesity) may fall in or out of scope for coverage by entities like Medicare, thus potentially requiring a dual-brand strategy. Lastly, manufacturers ought to be aware that documents between them and regulatory agencies may come into scope for review by payers, as appears to have been the case in the Aduhelm™ NCD. A comprehensive understanding of these dynamics is foundational to developing an informed market access strategy, setting the stage for subsequent pillars.

(Often-Overlooked) Pillar 2: Value Marketing and Messaging

The communication of value is a critical aspect of market access, yet it often doesn’t receive the attention it deserves. A well-articulated value story, grounded in robust evidence, serves as an anchor for all market access activities. It’s not only about generating compelling health economic and real-world evidence but also about understanding how one technically conveys this evidence effectively to payers, providers, and patients. Specifically, the most commonly overlooked question in establishing a Value Evidence Generation Plan (VEGP) is how one will get approval for claims through a company’s medical-legal-regulatory (MLR) review process. Without a visceral understanding of the MLR process, global Access Leads and Health Economics Leads can fall into a trap of executing studies that are not ultimately used in value marketing.

We will do a separate post on how to use value marketing to organize and construct your VEGP. In the meantime, effective execution of this pillar involves creating a Value Story or Value Proposition, message testing, literature review, study design, and study execution. In the absence of a clear value narrative, even the most promising products may struggle to achieve optimal market access. Investing in value marketing and messaging from an early stage can significantly enhance the market positioning and success of a product.

Pillar 3: Pricing & Competitive Strategy

Pricing research usually underpins the third pillar of market access strategy, and this research often entails a combination of secondary research on substitutes and primary research with current payers (e.g., ad boards, mock HTAs). Part and parcel with pricing research is competitive intelligence, as the prices of other drugs, biologics, and devices can anchor payer-customers’ expectations and can be used against your field teams in coverage negotiations. Likewise, a realistic understanding of the potential impact of rebate walls and one-of-one contracts on your brand’s access strategy requires nuanced attention to potential competitors’ positioning and messaging.

A price is a signal wrapped up in an incentive.

Alex Tabarrok, George Mason University

Understanding the pricing landscape, including how pricing impacts reimbursement and access, is crucial. A well-informed competitive strategy not only addresses pricing but also anticipates potential market shifts, enabling companies to adapt their market access strategies proactively. This pillar underscores the importance of staying ahead in a competitive market, ensuring that the product remains viable and attractive to both payers and patients.

Pillar 4: Distribution and Pull Through

Efficient distribution and pull-through strategies ensure that once a product is in the market, it reaches the intended patients and creates the desired impact. This pillar encompasses channel strategy, specialty pharmacy engagement, patient assistance programs (PAPs), advocacy, and communication strategies. Channel strategy determines the most effective and cost-efficient route to get the product to patients, while specialty pharmacies often play a crucial role in distributing specialized medications. (Importantly, an early point of view on channel strategy is an input into gross-to-net [GTN] assumptions for price and sales forecast models.) PAPs, advocacy, and effective communication strategies ensure that barriers to access are minimized, and that patients, providers, and payers are well-informed about the product’s value proposition. Through strategic pull-through initiatives, companies can overcome market access barriers, drive product uptake, and ensure sustained success in the market.

Conclusion

Creating an effective market access strategy is a multifaceted endeavor that requires a well-orchestrated approach across several pillars. Among these, value marketing and messaging is often underestimated but holds significant potential in steering a product towards market success. By investing in a robust value narrative, pharma companies can ensure they are well-positioned to navigate the complex market access landscape and achieve optimal reimbursement and uptake for their products.

We welcome your thoughts and questions. If you have any reflections on these pillars or others, we invite you to get in touch with us. Your insights and the ensuing discussions enrich the collective understanding and strategies necessary for success in the biopharma market access domain.