Fierce Biotech

In the realm of oncology, the advent of clinical pathways has gained substantial traction in the past two decades as the increasing cost and complexity of cancer care demanded structured, multidisciplinary, and cost-effective approaches. Pathways have become a critical strategy for both physicians and payers to streamline treatment decision-making, standardize evidence-based care, improve patient outcomes by minimizing unnecessary variation, and reduce cost by guiding care to the most cost-effective treatments. These pathways, often referred to as care pathways or clinical guidelines, are structured, evidence-based recommendations primarily based on efficacy, tolerability, and cost.

According to The Dedham Group’s research, approximately 70% of U.S. oncologists are exposed to one or more clinical pathways, representing more than 100% growth over the past five years. This surge in adoption can be attributed to the launch of pathway programs developed by national payers such as United Healthcare and Cigna, and the commercialization of home-grown pathways created by renowned cancer centers like Dana-Farber Cancer Institute and Moffitt Cancer Center. One of the pivotal catalysts for such growth was also the launch of CMMI’s Oncology Care Model (OCM) in 2016, which prompted providers and payers to look towards pathways to meet the requirement of following evidence-based guidelines as well as better manage costs while ensuring optimal patient outcomes. Without doubt, the influence of oncology pathways is anticipated to continue to expand as more players enter the landscape, including community practice collaboratives such as OneOncology and Quality Cancer Care Alliance which are actively developing their own pathways to standardize care across their member practices.

What Are the Key Implications for Biopharmaceutical Companies?

Payer access: Clinical pathway programs implemented by payers, such as Elevance Health’s Carelon (formerly AIM Specialty Health) and Evolent Health’s New Century Health, often reward healthcare providers (HCPs) for following these pathways by streamlining prior authorization processes for on-pathway options and/or providing financial bonuses linked to pathway adherence. These incentives are most effective at provider organizations where prior authorizations represent a significant administrative burden and/or a sizable patient volume are exposed to these pathways. While it’s important to note that pathways do not dictate whether a product will be covered and reimbursed by payers, they can create obstacles for HCPs seeking access to products that are not included on these pathways.

Opting for an off-pathway product often involves navigating a more cumbersome authorization process, sometimes requiring HCPs to undergo a peer-to-peer review to justify the rationale for deviating from on-pathway options. To optimize product access, biopharmaceutical companies should strategically consider not only engaging with payers on formulary and coverage policy but also supporting favorable placement of their products on these pathways. By aligning their products with established clinical pathways, biopharma companies can enhance accessibility and navigate the complexities associated with payer-driven treatment decision-making processes.

Provider treatment decision-making: Clinical pathways are exerting a growing influence on the HCP’s decision-making processes and operational workflows. Pathways implemented by providers, such as Elsevier’s ClinicalPath (formerly Via Oncology) and McKesson’s Value Pathways Powered by NCCN, are often integrated into electronic medical record (EMR) systems, allowing pathway recommendations to be presented at the point of care. Technological advancements have facilitated tracking and reporting of pathways adherence, even at the physician level. Additionally, some provider organizations have implemented strategies to encourage pathway utilization, including mechanisms such as peer benchmarking (comparing physician adherence across the department or organization), requiring internal committee approval for prescribing off-pathway products, and linking pathway utilization or adherence rates to a portion of a HCP’s compensation.

Non-inclusion in these provider-centric pathways can limit the HCP’s awareness and perception of a pharmaceutical product and increase their administrative burden for choosing the product, consequently affecting its utilization. Thus, it is increasingly imperative for biopharmaceutical companies to strategically engage with these pathways to expedite product review and secure favorable recommendations. The influence of pathways, however, is not uniform across provider organizations, varying based on local philosophies and implementation. Recognizing this, biopharma companies should also cultivate a nuanced understanding of local dynamics to tailor and optimize their customer engagement strategies effectively.

Evidence generation: The integration of therapies into established pathways requires robust evidence of their efficacy, safety, comparative effectiveness, and cost. To secure favorable pathways placement, pharmaceutical companies often need to illustrate how their drugs complement or improve existing treatments outlined in these pathways, providing better outcomes, reducing toxicity, or offering a more cost-effective alternative.

As early as clinical trial design stage, clinical pathways could be considered to inform valued endpoints and determine appropriate comparators for demonstrating the effectiveness and superiority of the pipeline drug. Post-approval, biopharma companies could strategically facilitate real-world data (RWD) generation, demonstrating how their products perform in targeted patient populations and various healthcare settings to support or maintain favorable pathways inclusion, especially in highly competitive diseases. Besides proving clinical strength, it is also critical to holistically illustrate the product’s economic value and cost-effectiveness through the patient journey, including the costs of the drug itself but also its associated services such as adverse events management, hospitalization, ER visits, and supportive care.

What Are the Challenges & Opportunities?

Internal fluency and strategic focus: Navigating the complex landscape of clinical pathways involves a sophisticated interplay among various stakeholders across payers, providers, and third-party developers, marked by both national influence and nuanced local variability. To effectively engage with pathways, biopharmaceutical companies must acquire an in-depth understanding of their intricacies. This encompasses a thorough examination of how their products are positioned relative to competitors, and how they may impact HCP treatment decision making and product utilization. Given the expansive reach associated with these pathways, strategic prioritization of internal resources and engagement efforts also becomes imperative. Proficiency in integrating landscape knowledge with localized nuances is critical for biopharma companies seeking to navigate this complex and multifaceted terrain with strategic acumen.

Adapting to pathway changes: On top of its inherent complexity, the landscape of clinical pathways is also quickly evolving, with the entry of new players, the establishment of new partnerships, and shifting treatment recommendations spurred by new approvals and data releases. Biopharmaceutical companies frequently face the challenges of swiftly adapting to dynamic changes to clinical pathways. The emergence of new pathways or the inclusion of new participants often demands a recalibration of internal resource allocation and engagement priorities. Modifications or updates in pathways recommendations necessitate adjustments in customer engagement approaches, data submission strategies, and evidence generation frameworks to align with the latest pathways. Maintaining close vigilance on the evolving pathways landscape is paramount, as it enables companies to proactively respond and strategically maneuver amidst the ever-changing dynamics.

Matrix team collaboration and alignment: Successful engagement with clinical pathways typically requires a close collaboration across diverse functions, including but not limited to commercial, medical, brand marketing, and health economics and outcomes research (HEOR) teams. Depending on the existing team infrastructure, it can be challenging for biopharmaceutical companies to identify the appropriate internal stakeholders, define clear roles and responsibilities, and establish an effective communication flow for pathways engagement. Striking a balance between these elements is instrumental in ensuring a cohesive and coordinated approach, allowing biopharma companies to navigate the intricacies of clinical pathways with strategic precision.

Looking ahead, the future of clinical pathways is poised for further advancement, as integration with artificial intelligence, machine learning, and genomic profiling holds promise in refining these pathways, enabling more precise and personalized treatment strategies. Furthermore, the influence of pathways is expanding beyond oncology, extending into other therapeutic areas such as immunology and cardiology, meaning that pathways have become yet another barrier to access for a wider swath of products. As clinical pathways continue to evolve, biopharmaceutical companies face the imperative of staying abreast of these changes, adapting to new strategies, and adopting a unified and data-driven approach to successfully navigate this complex landscape and mitigate access barriers for their products.