A leading orphan and rare disease product manufacturer was approaching a key inflection point in the evolution of its industry-leading intravenously (IV) administered product and faced a near-term need to launch a subcutaneous (SC) formulation to meet an identified unmet patient need and respond to its first competitor product launching across multiple indications and therapy areas.
This subcutaneous formulation represented the manufacturer’s first IV to SC product transition, and the manufacturer required a complete distribution and dispensing strategy designed to meet the particular needs of patients and clinicians for seamless navigation of transitions across sites of care, insurance benefit designs, and route of administration. The strategy also needed to meet identified needs to support patient training, education, and support for appropriate use of the device that would deliver the SC injection formulation. The strategy and implementation needed to be accelerated to meet a hard launch window within twelve months.
Blue Fin Solution
Blue Fin Group leveraged its extensive understanding of the manufacturer, its IV product, patients, and disease areas, and the requirements to engineer a seamless transition from IV to SC for rare disease patients in coordination with the manufacturer’s industry-leading patient services and case management platform.
We aligned the client’s project team to a common understanding of the critical success factors for their SC product based on a detailed understanding of their product, market access requirements, and patient self-administration dynamics and needs.
We collaboratively designed a distribution and dispensing channel strategy built upon an aligned view of critical channel objectives, speciality pharmacy dispensing requirements, and unique considerations for the manufacturer’s first foray into an IV to SC transition platform.
We built a business rationale with supporting detail and a detailed multi-generational implementation plan to support the client’s internal alignment, commercial launch sequence, communication planning and buy-in from senior leadership, and subsequent transition to commercial implementation of the solution.
Benefit to Client
Blue Fin Group’s solution resulted in:
- A complete distribution and dispensing strategy to support the continuity of care, benefit design migration, site of administration transition, self administration training and a best-in-industry patient experience for the product
- A robust rationale to support rapid internal alignment across key commercial stakeholders
- A detailed commercial implementation plan to support incorporation of the strategy prior to the manufacturer’s hard launch readiness date
As a result of this engagement, our client had a clear path to navigate its first IV to SC product transition and the organizational confidence that its distribution and dispensing strategy would align to its commercial strategic plan for the product franchise, maintaining its longstanding commitment to improving the experience patients in its disease areas of focus and proactively meeting its first competitive challenges. Blue Fin Group’s significant over delivery against the original project scope enabled our client to accelerate its commercial plan and accelerate its go-to-market strategy.
Across a range of orphan and rare disease therapy areas, manufacturers with successful IV-administered products will face a need to transition identified patients to an SC product formulation. Manufacturers in this situation must take a focused, requirements-driven approach to maintaining the continuity of appropriate patient care, training, and support through a seamless transition across sites of care, insurance benefits, and route of administration. Blue Fin Group has the experience and industry knowledge to construct an optimal distribution and dispensing strategy and implementation plan to meet these needs in the interest of patients and our clients continued commercial success.