In the third and final part of this three-part series, Charles River Association (CRA) examines options for manufacturers to shape the future opportunity and landscape for combinations.
Strategic Considerations for Oncology Combinations
With combination therapy, healthcare systems are faced with the challenge of how to value incremental clinical improvements in oncology and how to fund regimens that may be exponentially more costly than monotherapy (see Article 1)1 . From the manufacturer perspective, payer value recognition, price determination, and management of access through contracting represent fundamental hurdles impacting pricing and market access (P&MA) for combinations (See Figure 1). As discussed in Article 2,2 manufacturers can navigate the current environment by evaluating pricing flexibility throughout clinical development, leveraging combination ownership strategies, and optimizing evidence generation and pricing strategy.
However, as combinations become more commonplace in therapeutic areas beyond oncology, manufacturers must consider their role in shaping broader P&MA considerations and policies to achieve an accurate reflection of value for a more sustainable commercial landscape that supports innovation.
Shaping the Combination Therapy Pricing and Access Landscape
Considering the fundamental P&MA hurdles, manufacturers have several options to shape the future landscape. These must be evaluated against the underlying commercial and portfolio strategy.
“Creative approaches are needed to support access to combinations in a way that does not disadvantage existing indications or uses for the combination components.”
Payer Value Recognition
For a true and accurate assessment of value, new assessment frameworks are needed that lay out metrics and methodologies for evaluating combination therapy.
Manufacturers can put forward proposals for these new frameworks and work together with decisionmakers to shape the health technology assessment (HTA) landscape across markets. With this approach, manufacturers must be prepared for the potential risk of a less favorable value assessment for an individual combination component.
There is also a requirement for the value assessment framework to be linked to price determination processes in order for value to be recognized in practice.
Price Determination
Manufacturers can broadly advocate for new combination-specific price determination processes that support sustainable pricing opportunities for all components, from enabling individual monotherapy components to be priced independently to facilitating multi-party negotiations where combination components are owned by different manufacturers.
With these approaches, a new pathway for the pricing of combination components, independent from
their use as monotherapy or in other indications, could be introduced.
Manufacturers have begun to participate in pilots with major payer bodies to explore the utility of these approaches.
Contracting
Manufacturers are already communicating the unique clinical benefits of combinations and the need to improve patient access to these therapies. However, the availability and implementation of combination-specific innovative contracting options have thus far been limited.
Creative approaches are needed to support access to combinations in a way that does not disadvantage existing indications or uses for the combination components.
If manufacturers can advocate for innovative access arrangements for combinations, this can help to optimize both price and access across indications.
Several examples of successful strategies are outlined in Figure 2.
Future Focus
Ultimately, manufacturers, payers and policymakers can unite in a common goal to ensure patients have access to the best possible therapies. Policies need to evolve to support access to combination therapies that offer patient-relevant benefit—even if incrementa—within the constraints of national healthcare systems.
As payers grapple with these challenges, manufacturers will need to remain agile and prepare to engage proactively in ongoing policy discussions to shape the future combination landscape. The key to success will be in identifying and advocating for initiatives that simultaneously support current and future portfolios and business objectives, while also offering a mutual benefit for patients and healthcare systems.
