Strategizing High-Wire, Multi-Indication Launches

Left to right: Jeremy Dann and Reena Patel

For a given product, a market access strategy must start with clear expectations for the therapeutic area(s) and the utilization controls and financial barriers that will be deployed by payers. Then, depending on whether the product is covered under the pharmacy or medical benefit, an understanding of the types of pharmacies and sites of administration that are capable of solving for these access challenges on behalf of patients must be developed.

These points through which patients will access their therapies will have their own internal economics driven by their contracted payer reimbursement and drug procurement capabilities. The ability of a clinic or pharmacy to administer or dispense a drug often depends on whether they can access beneficial contract pricing or prime vendor discounts only available to them through specific distribution intermediaries.

Lastly, the physical flow of product, along with the patient and provider support services strategy, will determine the breadth and depth of data available to inform and direct the sales and reimbursement-focused field teams to support uptake and solve for payer challenges. Understanding and designing a market access strategy around this cascading impact of payers on site of care and dispense, distribution, and support services is critical to ensuring the benefits of new treatments can be accessed by patients.

When multiple indications are in the picture, the ideal market access strategies for each may negatively impact one another, or be so different as to merit special focus on key elements.

Mapping out the strategy

The needs of an indication-specific market can be assessed using the proprietary “5Ps Framework,” which calls for the market access team to understand the attributes of patients, providers, payers, products, and the anticipated physical flow of a drug through the channel. The needs and expectations within these categories can be drastically different between indications, especially when they span therapeutic areas.

Multiple indication strategy scenarios

A product may require a healthcare provider to administer a loading dose prior to transitioning to self-administration for one indication but not the other, which will require a broader channel configuration capable of supporting the economics and procurement capabilities of in-office drug administration. Patient age or population size may vary between indications, implying expansive services to support onboarding and ongoing adherence for younger, older, or physically or mentally limited patients that may not be applicable for all indications. Prescribing specialties may vary by indication between those that are adept at buy and bill versus those that refer patients to alternate sites of care, implying a need to support physical access across a diverse site of care mix and to support patients who may need to receive treatment at a site other than that which is providing their ongoing care.

One indication may be crowded with competitors that have already set expectations for broad, open access, while expectations for the second indication are more aligned to a rare or orphan disease therapy. Still, in some cases, such as multiple indications within oncology, there is little material difference across the 5Ps that would impact market access strategies. Manufacturers must conduct the 5Ps analysis to understand where the key differences between these dimensions sit and deploy flexible strategies to ensure their product attains the full value proposition it represents across indications.

Prioritizing when multiple indication strategies might not mesh

Special consideration must be given to cases in which indications have markedly different patient population sizes, along with the fact that pricing pressures will exert a downward force within larger indications where payer may face greater exposure on a per-member, per-month basis. Larger patient populations may be enticing for manufacturers looking to establish an early foothold in a broader indication, thus driving revenues, but the likely lower price point required to gain access and share can ultimately be too low to support dispensing economics and required support services in the rare or orphan disease space.

The inability to deploy indication-specific pricing, and hence truly distinct market access strategies for multi-indication drugs, means that manufacturers will need to set priorities and perhaps make difficult choices around which sites of administration and dispensing to support when commercializing such products.

Looking even wider at the big picture

Manufacturers launching concurrent or sequential indications for a given product must develop a multi-generational market access strategy(ies) that threads the needle in the context of material differences across the 5Ps between indications. Moving between routes of administration, and hence introduction of a new benefit type, may constrain the manufacturer’s ability to deploy product discounts or to utilize specific types of distribution intermediaries due to their impact on average sales price (ASP)-based reimbursement.

For similar reimbursement reasons, certain classes of trade and sites of care that rely on product discounts to support their business model may need to be de-emphasized in order to best support reimbursement economics in others. Specialty pharmacy networks may need to be expanded or support programs updated to address the needs of additional, new patient populations under later indications with different needs. Extending product access to health system specialty pharmacies may be advisable to the extent KOLs and the prescribing base generally may practice in affiliated sites of care. Each indication may also require different levels of support for patients and/or providers, and significantly different levels of financial and/or operational investment.

Manufacturers in this situation must understand where their product has an inherent tension between the attributes of the 5Ps across indications. This requires knowing how decisions made with respect to one indication can negatively impact others, and in turn, which indication to prioritize, or at a minimum, which sites of care and/or dispense represent the greatest opportunity. A coherent, multi-generational market access strategy that reflects the realities of the multiple, indication-differentiated markets into which a product will launch represents the best chance for the manufacturer to achieve their organizational goals for these significant investments.

About the Authors

Jeremy Dann is a senior principal, and Reena Patel is a partner, both at Blue Fin Group, IntegriChain’s consulting business.