Preserving Patient-Centric Oncology Care Amid Step Therapy Changes

NCODA Perspective:

The Inflation Reduction Act of 2022 (IRA) is designed to enhance Medicare by expanding benefits, lowering drug costs, and aiming to improve the program’s long-term sustainability. Provisions within the IRA allow Medicare to negotiate prices with drug manufacturers for certain Medicare Part B and Part D medications to help lower prescription drug costs and reduce federal spending. As part of Medicare price negotiations, one oncology drug was included in the initial round, with four more oncology medications set to be added in 2025.

While the intent of the IRA is to improve affordability and access for patients while reducing healthcare costs, NCODA recognizes the importance of monitoring for unintended consequences that could affect the oncology community and impact patient care. Recently, it was reported that two PBMs were implementing step therapy edits, prioritizing a drug selected for Medicare price negotiations, potentially as part of broader payer-driven pricing strategies. Although this represents an isolated case, it raises significant concerns about the potential for such practices to set a precedent as the latest method to limit the care of patients based on insurance preferences.

In the absence of new clinical data, these actions risk limiting physician autonomy, restricting patient access to optimal therapies, and creating barriers to high-quality oncology care through step-edits which have been well documented¹^–⁶to negatively impact patient care. It is critical to monitor these developments closely to ensure that measures intended to improve affordability do not inadvertently disrupt the continuity of care, compromise patient outcomes, or place additional burdens on oncology practices.

NCODA’s position is clear:

Clinicians must retain the ability to choose the best therapy for their patients.
Some clinicians, based on available data, believe that certain therapies demonstrate distinct benefits over others in terms of efficacy and safety for specific patient populations. The ability to prescribe treatments should remain guided by clinical evidence and tailored to individual patient needs, rather than being influenced by cost-driven policies such as step edit restrictions. When external pressures from payers or pharmacy benefit managers (PBMs) mandate a switch to alternative therapies, patient outcomes and trust in the healthcare system may be compromised.

Step therapy policies could cause unnecessary delays in care.
Oncology patients often face aggressive disease progressions, making speed to therapy crucial in ensuring the most effective treatment. Step therapy requirements force patients to fail on an insurer-preferred treatment before gaining access to potentially superior options, delaying optimal care. Such delays are particularly egregious in cancer care, where time-sensitive decisions can mean the difference between effective disease control and significant disease progression.

Increased administrative burden on oncology practice.
Oncology practices are already operating with lean resources, navigating complex therapies, reimbursement challenges, and delivering compassionate care. Additional administrative requirements, such as appealing step therapy decisions or obtaining prior authorizations, further strain these teams diverting valuable time and energy away from patient care. These burdens can create consequences that ripple across the healthcare system, exacerbating inefficiencies and frustration.

Restrictive Payers’ Policies to Circumvent the IRA
The IRA was designed to improve patient access and affordability. However, some payers have implemented restrictive policies, exploiting therapies selected under the drug negotiation program to justify step therapy requirements and other coverage restrictions. These actions prioritize cost savings over patient health, creating inequities in access to treatment and undermining the intent of the legislation. For oncology patients, such policies can delay or limit access to optimal therapies, ultimately compromising outcomes.

The implementation of step therapy protocols for oncology treatments sets a concerning precedent. If adopted as a standard operating procedure or normalized as a way of working, this approach could have widespread, long-lasting implications for the treatment landscape of oncology patients. We cannot accept new frameworks that prioritize preserving margins for insurers and increasing administrative burdens for clinicians over driving optimal patient care. Policies and practices must focus on enhancing the continuity of care and improving outcomes for patients, not on perpetuating financial and operational inefficiencies.

NCODA’s Call to Action
We urge payers, policymakers, and manufacturers to recognize the potential harm of these practices and to prioritize patient well-being above cost-saving measures. Policies must be patient-centric and ensure that clinical data drives decision-making in oncology care. NCODA will continue to advocate for:

Supporting clinicians in making treatment decisions based on evidence and patient needs by providing educational resources and policy support.

Addressing administrative inefficiencies that detract from care delivery.

Holding stakeholders accountable for aligning their actions with the spirit and intent of the IRA to foster innovation and equitable access.

NCODA remains committed to empowering oncology teams and advocating for the best possible outcomes for every patient. Together, we must ensure that financial considerations do not override the critical importance of timely, personalized cancer care.

References

Preserving Patient-Centric Oncology Care Amid Step Therapy Changes

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