By Taruja Karmarkar, Patrick Stone and Jennifer Graff
Taruja Karmarkar, PhD, is the 2018-20 National Pharmaceutical Council (NPC)/Duke-Margolis Health Policy Fellow. Jennifer Graff, PharmD, is NPC Vice President of Comparative Effectiveness Research. Patrick Stone is Vice President, Advocacy and Government Relations, at the National Psoriasis Foundation.
The COVID-19 pandemic has exacerbated Americans’ challenges in accessing much-needed and effective care. One such hurdle, step therapy, requires patients to try a clinically recognized, lower cost first-line therapy before reimbursement for an alternative therapy prescribed by the physician and can delay access to care. Pre-pandemic, experts expressed concern around step therapy’s focus on financial impacts rather than efficacy.
During a public health crisis, it has been more important than ever that unnecessary barriers to high-value care are minimized. While federal and state governments have waived or relaxed prior authorization and step therapy requirements during the initial pandemic response, insurers and others, such as AHIP (American’s Health Insurance Plans), have indicated care management, including step therapy, is ready to resume.
There are three ways that we can lessen the barriers for patients as we look toward a post-pandemic world and prepare for the future of patient-centered formularies and access to medicines: regularly review the evidence, be flexible and be transparent.
How Was Step Therapy Used Pre-Pandemic?
Step therapy is common for many patients as employer-sponsored health plans walk a tightrope to keep premiums affordable for patients and employers, while managing patient care. Its impact is growing since the Centers for Medicare and Medicaid Services (CMS) began allowing greater use of step therapy for Medicare Advantage programs in 2019.
The processes and impact of step therapy protocols can vary for different patients. Some patients can access an effective physician-prescribed treatment in just one step; however, other patients must try three, four or even five treatments before their health plan provides reimbursement for the treatment that works for them. For example, a patient with psoriasis may find that his health plan requires him to try a first-line treatment which may not be recommended by clinical guidelines, followed by a biologic that is less efficacious but provides a higher rebate. His psoriasis may be exacerbated while trying the first two therapies but is then treated to a greater degree by a newer, more efficacious biologic prescribed by his physician. Step therapy can be especially problematic for patients with conditions like rheumatoid arthritis, which can vary in severity and may not be so forgiving to such a treatment delay. For these reasons, several physician groups and patient advocacy organizations have expressed concern with greater use of step therapy.
Any short-term drug cost savings realized by step therapy, may be outweighed by long-term increases in hospitalizations or treating worsening conditions. Moreover, step therapy can be burdensome for both patients and doctors, taking time away from patient care, potentially increasing therapy abandonment, and sometimes resulting in worse clinical outcomes.
Recommendations for Patient-Centered Step Therapy
State and federal policies have been proposed to ensure patient protections in step therapy, such as outlining protocol exceptions. While patient and provider groups support these proposals as good first steps, more can be done to ensure easier access.
Research highlights that while stakeholders may disagree on when step therapy is appropriate, they agree on the components that should guide step therapy protocol implementation.
- Regularly review the evidence: When making coverage decisions, health plans should adhere to best practices, including regularly reviewing new evidence. Documenting the underlying evidence from randomized clinical trials, real-world evidence and patient experience, ensures all data and patient information are considered when plans make decisions.
- Be flexible: Criteria allowing exceptions for step therapy and clear appeals processes are critical to avoiding a “one-size-fits-all” approach to care that may leave patients with unique circumstances behind. Timely response by health plans to exception and appeals requests from patients and providers are needed to prevent unnecessary delays in care. Peer-to-peer (i.e. dermatologist to dermatologist) evaluation of provider exception requests also can facilitate clinically complex decisions. Finally, flexibility is needed when objective clinical metrics, such as lab tests or physical symptoms may not be sufficient. Provider judgment and patient experience should also be considered.
- Transparency is key: Health plans should be transparent about their decisions and processes. Sharing the evidence that led to the coverage decisions and outlining how to navigate the medication formulary empowers patients, providers and purchasers with important information. Information should be easily accessible in print or electronically, so patients know the requirements for reimbursement, their options for appeals and who to reach out to for assistance along the way.
Patient-Focused Shift in Step Therapy Post-Pandemic
Access to more patient information and the use of big data analytics capabilities has fueled the shift towards personalized medicine. While the therapies themselves are tailored to specific patient needs, many policies that determine access often provide “one-size-fits-all” coverage. This paradox is evident when a health condition presents differently across patients and the benefit derived from one therapy may not be similar for all patients. In these scenarios, a flexible and nuanced approach to step therapy considers the specific needs of patients as they navigate the health care system.
In this unprecedented time, we have seen where the challenges exist in our health care system. Private and government payers should reconsider a “return to normal” post-pandemic—the step therapy barriers that existed for patients before COVID-19 will not go away once the virus is minimized. If step therapy programs are to become patient-centered, they will, at a minimum, need a codified process to review up-to-date evidence, communicate decisions and processes transparently and support flexibility. It is important to consider these recommendations as we all work together to ensure our health care system remains focused on the needs of patients.