Pre-launch Commercialization Strategy for Small Pharma/Biotech
Client:
A small biotech manufacturer, with more than 10 years of success in developing injectable pharmaceutical products for the acute care market, was preparing to launch its first product in the oncology space — a new delivery technology for an existing, well-established generic oncology product. The company needed a comprehensive, cohesive reimbursement, pricing, and payer strategy for this product.
Challenge:
The client used a generic base compound and combined it with a new delivery technology to create a product that produced fewer and less severe side effects than competing products. Although the product improved clinical efficacy and safety for many patients receiving this type of therapy, the manufacturer still faced several issues prior to product launch.With FDA approval approximately 12 months away, the manufacturer had no brand recognition or company name recognition among stakeholders in the oncology space, and the product was launching into an established market where generic and branded competition already existed.
Xcenda’s Action:
We partnered with the manufacturer to develop an evidence-based, value-driven reimbursement, pricing, and payer strategy and tactical tools to support a branded product in a generic market environment. Our team worked with the manufacturer to create a tactical implementation plan that would optimize patient access. We initialized the project with a comprehensive market assessment, which discovered that a large segment of the market was unaware of the total cost and burden associated with the product’s competition. Based on these findings, our managed markets experts developed value messaging for the product centered on its overall clinical and economic impact, including the significant value provided by its improved safety and tolerability compared to competing products. Even though the acquisition cost of the product itself was higher, these efforts demonstrated that the product reduced the overall cost of care and improved patients’ quality of life compared to “less expensive” competitors.
Our economic modeling team then put these value messages into action by creating a cost-effectiveness model, a value dossier, and publications designed to raise awareness among stakeholders. From a reimbursement and patient access perspective, the company provided strategic counsel that included:
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Payer segmentation and recommendations
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Coding assessment
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Analysis of total cost of care for the Centers for Medicare & Medicaid Services (CMS)
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CMS economic impact analysis
Tactical elements followed to generate value-specific product awareness, including provider and payer mailings as well as advisory boards and reimbursement education for the manufacturer’s account managers and provider customers.
Results:
The manufacturer realized measurable results in the 12 months leading up to the product’s FDA approval and the 6 months following it.
Value Messaging and Evidence that Supported Pricing –
The manufacturer was able to demonstrate the costs associated with the toxicity burden of its competitors and compare this to the product’s documented clinical and pharmacoeconomic value.
Successful Coverage through CMS and Commercial Payers –
The product launched with favorable reimbursement, including a unique C-code and a J-code that allows a separate and more beneficial pricing scenario than the pricing of similar, generic products.
Improved Patient Access to a Clinically Superior Product –
Based on the favorable reimbursement and coverage decisions supported by the value messaging, appropriate patients were able to receive this innovative product in a timely manner, with fewer barriers to access.
