The new rules of cancer care: Responding to increasing CMS influence on the oncology landscape
The Inflation Reduction Act and Enhancing Oncology Model are increasing pressure on manufacturers to reduce costs and drive value-based care. In this extract from the new report, “Reducing the cancer care gap: Building connections to improve advancement in cancer prevention, diagnosis, and treatment,” policy and market access experts at Avalere (part of Fishawack Health) explore the increasing influence of the Centers for Medicare & Medicaid Services on oncology product commercialization in the United States and share their advice for succeeding in this high-pressure environment.
During the past year, the Centers for Medicare & Medicaid Services (CMS) has sharpened its focus on oncology, introducing new policies designed to improve access to transformative therapies and drive better care for cancer patients. However, in developing these policies, the CMS is, in turn, introducing significant market disruption and increasing pricing pressure for manufacturers. How the biopharmaceutical industry responds to these changes today will have significant implications for the oncology products and portfolios of the future.
The most substantial legislative development impacting the pricing efforts of the CMS is the Inflation Reduction Act, signed into law in August 2022 by President Joe Biden to make innovative medicines more affordable, drive equity, and improve outcomes. The act includes a Medicare Part D redesign that caps out-of-pocket costs and shifts liability across stakeholders, including manufacturers, government, and Part D plans.
Under the act, manufacturers will be penalized if the price of Part B and Part D products rises faster than inflation. The federal Health and Human Services secretary has also been given the power to negotiate price changes with manufacturers on behalf of Medicare. This negotiation process will accelerate the commercial life cycle—with small molecule drugs eligible for negotiation seven years after approval and biologics eligible for negotiation 11 years after approval, at which point revenue may decline pending negotiations.
The Enhancing Oncology Model (EOM) is another initiative anticipated to disrupt the oncology landscape. The EOM is scheduled to begin in July 2023 as the successor to the Oncology Care Model. It is a five-year voluntary payment model spanning seven cancer types: breast cancer, small intestine/colorectal cancer, lung cancer, prostate cancer, lymphoma, multiple myeloma, and chronic leukemia. The model is designed to maintain or improve quality and reduce costs with participating providers taking on financial and performance accountability, measured in six-month episodes of care.
Both the inflation act and EOM are increasing pressure on biopharmaceutical manufacturers to drive down costs while increasing focus on improving care for patients. To succeed in this landscape will require manufacturers to rethink their approach to and execution of commercial strategy.
How are these policy changes impacting manufacturers developing oncology products?
Shalini Parekh: Under the act, and specifically with the redesign of Medicare Part D, the prescription benefit for Medicare beneficiaries, biopharmaceutical companies will likely experience pressure on product market share and rebating due to the potential for narrower formularies, increased utilization management by plans, and increased net plan liability.
Drugs selected for negotiation will be subject to a maximum fair price (MFP), including those on the market and additional indications under development. This will impact how products are sequenced, requiring manufacturers to think differently about the evidence generation and value story. To do this, they will need to review the clinical trial design and strategy to ensure the best evidence is generated to increase the MFP, along with developing a deeper understanding of the competitive dynamics of the drugs within the class selected for negotiation because the CMS will apply this lens to price negotiation.
Amy Schroeder: The eye is on clinical competition, which is reflected in the price. This adds a layer to pipeline development for manufacturers to design clinical trials to focus more on comparing their pipeline products to standards of care. This shift will simplify the methods for comparisons that the CMS, clinical guidelines, and other entities have to make.
Maddi Davidson: Manufacturers need to ensure that their commercialization strategy accounts for incentives of the EOM and tells a clear value story to mitigate the potential impact on utilization. EOM participants aim to achieve performance-based payments by managing the patient’s total cost of care and must reduce total spending by 3-4% to be eligible for performance-based payments. Drug spending accounts for 50% or more of episode costs, so providers will likely focus on ways to manage drug cost in the episode. If two products are clinically equivalent, the EOM framework incentivizes the use of the lower-cost option, so manufacturers need to tell a clear value story to overcome this hurdle because the provider will first and foremost choose the best drug for the patient.
Additionally, Part D provisions of the act will impact the EOM beginning in 2025, and it is not clear how the Center for Medicare and Medicaid Innovation will address this overlap. In 2025, Medicare liability for Part D drugs will change from 80% to 20%. Because the EOM only counts payments made by Medicare toward the total cost of care calculation, this may incentivize the use of Part D drugs.
How can manufacturers overcome these challenges and better navigate CMS negotiation?
Maddi Davidson: The EOM and the inflation act were not designed together, but they are not happening in isolation. Manufacturers need to align their value story with providers’ approaches, broadening the focus past the EOM and inflation act to consider the business of oncology. Oncology practices have to continue delivering high-quality care while navigating complex payment models. Manufacturers should consider what sort of data can they generate to show practices how their product plays in the broader practice economic picture and accounts not only for the inflation act and the EOM but also net cost recovery.
Amy Schroeder: It requires taking an entirely different perspective to understand the total cost of care, paying attention to much more than the product to consider how not only the provider makes pharmacologic treatment choices with the patient but the care others provide across the patient journey, such as surgery or radiotherapy. It calls for everyone to come together and understand the bigger picture.
Laura Housman: Manufacturers who approach the evidence-generation strategy early in the product life cycle, generating clearer and more specific data that align with the future market, will be more successful in achieving the highest reimbursement possible for the largest number of users.
By becoming more candid with internal decision-making and making challenging decisions based on the evidence and the markets, companies will be better equipped to develop a compelling value story. This includes considering the comparator and how your evidence stacks up against them because that is how the CMS will assess the clinical value associated with that drug or drug class.
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Download the ebook for the full Q&A with further expert insights on navigating CMS involvement in oncology drug development, along with more articles on:
- Integrating patient-centricity in multiple myeloma
- Responding to CMS influence on the oncology landscape
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- CAR-T: Marketing the promise, delivering beyond the need
- Phase 2 Trials: A pivotal moment for launch success