Launching a New Drug: An Overview of Common Mistakes

Jackie DeAngelis discusses some of the common mistakes that hinder access attainment when launching a new drug.

Jackie DeAngelis

The majority of marketing budgets are spent driving prescriptions with providers and consumers. The success of those efforts is limited, however, without an effective market access launch. Access attainment-gaining formulary coverage, reimbursement, and/or placement on system protocol-is the backbone to prescription fulfillment, and should be a major component of any launch strategy.

Attaining access requires defining a new therapy’s value to access decision makers. Namely, how does a new therapy meet an unmet need in a well-defined patient population, with both clinical and economic justification? Access must then be communicated effectively to providers in order to support utilization.

Mistake No. 1: Launching with a weak payer value message

The impact of a weak payer value message should not be understated and can be demonstrated by the payer value proposition (PVP) equation:

• PVP with a strong payer value message:
  Payer Value Proposition = Payer Value Message + Pricing/Contracting

• PVP with a weak or no payer value message:
  Payer Value Proposition = Pricing/Contracting

Launch with the second equation, and pricing discussions are not supported by product value-making for a tough negotiation. A good example is the crowded diabetes space. Contracting is a given for most products in the category, but those with a solid value message in place are able to minimize the amount of their rebate offering.

Payer values messages are weak when clinical messaging to HCPs is repurposed for the payer audience. Payers have a responsibility to drive results across populations not just the individual and to consider budget impact, requiring both clinical and economic information to make decisions. In general, when covering a new therapy, payers ask hard questions to determine access:

•      What is my organization’s exposure in this therapeutic area?

•      How is this new product different and improved compared with other available treatments?

•      How will providing access to this new therapy help my organization manage our population effectively?

An effective payer value message should strive to answer these questions.

Mistake No. 2: Failing to make a data-driven economic argument for access

To optimize access attainment, a manufacturer is best served by defining the subpopulation in which its product provides the most value-and backing it up with both clinical and economic evidence. This targeted differentiation will become even more important in a healthcare landscape that is increasingly offering more biomarker-specific treatments. This economic narrative starts well before launch.

•      Providing evidence to payers before launch primes the market, encouraging payers to begin thinking about the size of the population affected, where outcomes remain subpar, and what is driving costs in the category. For example, a manufacturer with a new heart failure therapy expected to reduce hospitalizations will want to show prior to launch current hospitalization rates and average associated costs to establish the value of a treatment that reduces hospitalizations.

•      Having relevant outcomes end points as part of the clinical trial program strengthens the utility of the data available to payers at launch. Keeping with the heart failure example, showing reduced hospitalizations allows payers to readily model the potential cost savings of providing access to the new therapy.

•      Finally, having a real-world evidence plan in place post-launch helps confirm the clinical trial results and refine any budget impact modeling in the real-world setting

Credible data provide support for the mission-critical task of a payer to define value over a population, including providing medical cost offsets.

Mistake No. 3: Overlooking the pull-through challenge

With access attained, market access–related efforts should continue. Pulling through positive access is important to both the manufacturer and payer. In a preferred setting, a payer is looking to realize cost savings by shifting market share toward a preferred product. The payer supports this shift through formulary design and utilization management; the manufacturer supports it through HCP communications that feature access. Even in a nonpreferred setting, access communications around coverage and co-pay assistance support appropriate prescribing.

Because access also looks different by office, local messaging is more effective than national messaging. A sales team can be undermined by being supplied with national coverage data for a product, when what HCPs want is relevant coverage data for their patient population. A good example is erectile dysfunction medications, where coverage at the plan level does not guarantee access unless the self-funded employer has purchased the rider to cover ED therapies. Because of these factors, access communications are complex, but certainly worthwhile in realizing the access attained.

Opportunities to support a market access launch

A strong payer value message optimizes the access gained at launch, which in turn supports appropriate prescribing. Providing evidence relevant to payers-beyond that used with HCPs-gives payers the economic justification they need to provide access to a new therapy. Pulling through that access with prescribers is equally as important to support prescribing.

Jackie DeAngelis is SVP and managing director at Precision for Value.