The Fundamentals of Commercialization Strategy

Evidence: How do you define the value of your product? What evidence do you have to support your value story?

Manufacturers should start by developing a Health Economics & Outcomes Research (HEOR) strategy early in the product development cycle. By gathering input from various stakeholders early in the development process, manufacturers can design their clinical trials strategically and prepare for discussions on both clinical and pharmacoeconomic evidence at launch.

As a result, manufacturers who take this approach are more likely to be prepared with the optimal product evidence package for both regulatory submissions and market access or reimbursement coverage decisions.

Regulatory authorities are focused on evaluating the product's clinical trial evidence - focusing on the product's safety and efficacy. Health Technology Assessment authorities, reimbursement bodies and commercial payers, who make decisions on market access and reimbursement, are evaluating a product from a health economic point of view - looking at burden of illness, cost effectiveness, quality of life and other measures. Because these measures can vary significantly by local market, it is important to seek strategic guidance from local experts who understand the specific criteria different decision makers use to determine product reimbursement and/or formulary placement.

Once a product has been approved and the manufacturer has secured market access and demonstrated sufficient evidence for reimbursement, commercialization efforts shouldn't stop. Successful product positioning requires evidence generation throughout the product life cycle. Simply put, real-world evidence matters throughout every phase of commercialization.

It's also important throughout the product life cycle, starting long before launch for manufacturers to collaborate with patients, physicians and advocacy groups. These groups will have different value drivers, and it is important to keep these in mind when building the product value proposition for every constituency. Post-launch work must include the collection of real-world evidence that demonstrates how a product's key value messages support the health outcomes data. It is also important to demonstrate the product's evidence through tools such as dossiers, scientific posters and publications, economic models, strategic bulletins and treatment guidelines. These tools will help the brand reach important stakeholders for continual improvements in market acceptance and defend the product's position as new products come to market.

The most important thing for pharma manufacturers to keep in mind is that payers want data - from pre-launch to far beyond launch. It is this continual proving of product value through evidence that will pave the way for market access and reimbursement.

Access: Can patients get the product and pay for it? Can providers get reimbursed for specialty products?

Access is at the heart of any successful commercialization effort. A product's access strategy has many components, from distribution model decisions to payer formulary considerations and the patient support services that are critical to helping patients start and remain on therapy. When designing a patient access strategy, manufacturers can use existing data and predictive analysis, as well as stakeholder input, to design their patient support programs and then adapt those programs to changes in the coverage landscape (when necessary). They can identify patients eligible for expanded coverage by analyzing patient assistance data, and they should consider benchmarking competitors so that the support offering will be best in class. For co-pay programs in particular, it will be important for manufacturers to assess risk and estimate costs associated with support programs during program design.

Adherence: Are you designing programs centered on the patient?

Patient adherence may be one of the most difficult areas to impact throughout the product life cycle, as there are multiple dimensions to patient adherence. External factors such as the disease itself, other available therapies and socio-economics will play a major role in whether a patient stays on therapy, as will internal factors such as emotional state, belief systems and knowledge. Side effect management is also key. And these factors alone do not take into account influencers, from family and caregivers to advocacy groups, or the fact that non-adherence may not even be intentional.

Developing a successful and patient-focused adherence program to support a product's commercialization includes some essential steps. The first step is focusing on the patient's treatment journey. With regard to a product's channel or distribution strategy, there are two common options to consider. Will open distribution be used to maximize access to patients? Or, if the product that will support a disease state with a small patient population, will a limited distribution model be more appropriate? A limited distribution model gives the manufacturer greater control over inventory management, product data and the overall patient experience, including reimbursement support and adherence services.

As for the development of the adherence program itself, manufacturers must establish program goals based on an assessment of key barriers and influencing factors, then align services to targeted therapeutic value messages. Also important to consider is how technology could streamline the program and how to meet users where they are in terms of technology consumption. For example, will providers use online portals for prescribing or prior authorization? Will patients and/or caregivers take advantage of hotlines, Web chat or texting? Mapping the patient experience throughout the treatment journey can provide important insights that will help manufacturers answer these and other important questions and enable the manufacturer to develop a flexible approach to care coordination services, with patient screening, tailored interactions and intervention strategies.

The product's journey to commercial success.

A successful commercialization strategy starts in the early stages of product development, with strategic clinical trail design so that the right evidence will be available to support not only market approval, but also acceptance by all key stakeholders: regulatory authorities, physicians, patients, HTA bodies and payers. To maximize access, manufacturers must continually provide stakeholders with credible scientific evidence of the product's clinical and health economic value. At the same time, manufacturers must design their distribution channel strategies and support services to meet the needs of their specific patient populations. Finally, those manufacturers who address adherence from a patient-centric perspective, and design a program with the right data collection instruments, will conquer a critical step in the equation of commercialization success: the ability to demonstrate positive health outcomes by keeping a patient on therapy.