A deep understanding of access drivers and barriers is crucial to biopharma market access success. In this bizi blog post, we explore three major market shaping trends impacting pharmaceutical US market access and their implications on access competency development.
Trend #1: Consolidation within the US healthcare ecosystem is creating a new breed of sophisticated customers with increased purchasing power and centralized evidence-based decision-making. Healthcare reform and declining reimbursement coupled with historical tensions between key players within the US pharmaceutical supply chain have resulted in massive consolidation among the US delivery sector and more recently led to a more integrated and concentrated payer landscape (e.g., DOJ preliminary approval of CVS and Aetna merger, Cigna’s acquisition of Express Script).
Fewer, larger health systems and payers not only result in increased purchasing power by these large customer groups but also shift treatment decisions away from individual physicians to enterprise administrators through formulary control and clinical pathway development emphasizing product value.
This structural shift requires manufacturers to re-assess not only their “Key Accounts” but also their Key Account Management (KAM) capabilities. Historically, it’s been all about selling to doctors via features and benefits detailing. However, value-based selling to C level non-clinician administrators requires markedly different skills and backgrounds.
Key Account Management is about creating value for the customers and the company. As such, a deep understanding of both the customers’ goals and needs and how one’s own company makes money is key to success. This demands Key Account Managers who are strategically minded, number savvy, capable of establishing common ground creating win-win solutions for the customers and the company, and able to articulate value messages (clinical and economic) to address specific stakeholder’s specific needs.
Successful key account relationships are not built overnight. As such, companies should consider structuring the KAM role as a career role to provide stability between the customers and the company rather than as a stepping stone to greener pastures.
Trend #2: US payers increasingly use tools to manage risks associated with products’ uncertain clinical outcomes limiting patient access driving down pricing. Tools such as requiring prior authorization and/or companion diagnostics, step therapy, developing clinical pathways, reforming payment models (e.g., pay per episode rather than buy-and-bill) and entering into risk sharing agreements with manufacturers are on the rise in the US especially for high per patient cost specialty products including orphan drugs (e.g., starting Jan 1, 2019, Medicare Advantage health plans can apply step therapy to Part B physician administered medications.).
In addition, consolidation in the payer sector is breaking down the pharmacy and medical benefit management silos subjecting products traditionally covered under the “medical benefit” to increased “value” scrutiny.
To address payer uncertainty and demonstrate “better value for money”, biopharma firms need to evolve its business model to support an end-to-end evidence-based approach to product development and commercialization. This requires “Access Leaders” capable of connecting technical access domains to the rest of the business effectively integrating access considerations into clinical, medical, regulatory and commercial. In particular, Access Leaders need to work cross-functionally to align evidence strategy and execution with payer requirements and apply relevant clinical and health economic data to support pricing and reimbursement negotiations.
In the shift to value, biopharma firms will also be increasingly assessed on their ability to create value for the healthcare ecosystem overall. Patient services “beyond the pill” solutions are no longer optional. According to a recent survey of 200 patient services executives across the US and Europe, patient disease education and medication delivery and support are driving above-average business impact. However, the study also revealed to sustain success companies must establish a clear ownership for patient services rather than spread it across organization silos diffusing accountability. What’s more, companies need to figure out how to measure the impact of patient services on patient outcomes, the main goal for investing in patient-centric capabilities.
Trend #3: Increasing pressure on pharmaceutical pricing transparency highlights the importance of policy and health economics capabilities. 22 States across the U.S. have introduced bills focused on ensuring greater pharmaceutical price transparency around maximum allowable price, net price disclosure and list price increases. This legislative trend requires manufacturers to closely monitor relevant policy trends, identify key policy stakeholders at state and federal levels, and invest in “policy” and “health economics” capabilities to both positively influence policy positioning addressing access barriers and to justify drug prices in a more transparent environment.
bizi specializes in systematic and other literature reviews and meta-analysis to help inform market access, HEOR, clinical development and safety risk benefit assessment. We also provide consulting staff augmentation services for market access and HEOR functions.