If You Must Do Step Therapy, Do It Right

By Jennifer Graff, PharmD, Vice President of Policy Research, NPC

Finding consensus among health care stakeholders is never easy and that is certainly true when it comes to the use of care management tools. But if we look for areas of agreement, we can find them, especially if we focus on what makes sense clinically and for the patient. That is the focus of new research I published with my colleagues Robert Dubois and Taruja Karmarkar in the Journal of Managed Care & Specialty Pharmacy which examines the care management tool, step therapy.

Step therapy protocols require patients to try a first-line (and often less-expensive) medication before their health insurance plans will cover an alternative drug. The use of step therapy is common, especially for specialty medications used to treat rheumatoid arthritis, rare diseases, and other serious health conditions. But the policies and patient impact can vary between medications and health plans.

Unfortunately, these “steps” can potentially require significant administrative resources from physicians who must determine the optimal treatment based not on the individual patient’s clinical needs, but the health plan’s unique requirements. This can cause confusion and delay patient access to needed medications. But step therapy done right can promote clinically recommended and safe care while also ensuring affordable access.

The problem is there are no common standards for those protocols. So NPC convened a group of 16 stakeholders and experts—representing the patient, physician, payer, pharmacy, health policy and ethics communities—to determine what should define appropriate step therapy and to see whether a diverse of stakeholders could agree on what these standards should include.

Although, not surprisingly, there was no agreement on whether step therapy is an appropriate tool, stakeholders did agree on 21 criteria regarding how step therapy should be developed, implemented, communicated, safeguarded and evaluated. For example:

• Clinical evidence should be considered before costs. Step therapy protocols should be based on all clinical evidence, patient perspectives, clinical practice guidelines and be reviewed by an objective, unbiased, evidence-based group of experts.
• Patients should face no more steps than are clinically reasonable. Implementation practices, such as lengthy trials of treatments or interruptions in patient care, are not appropriate.
• Transparency and communication are critical. Step therapy requirements should be transparent, publicly available, and clearly communicated to patients, pharmacists, and physicians.
• Patient safeguards are needed. There should always be a clear, understandable and electronic process to request an exception to a policy or appeal a coverage denial.
• Evaluate the results. Step therapy has been shown to reduce inappropriate care but unfortunately also appropriate care. Plans should monitor whether there are overly burdensome processes or unintended consequences on other health care use, costs, or patient outcomes.

If health insurance plans implement step therapy, they should follow the criteria and best practices agreed upon by our diverse stakeholder panel. Step therapy policies — those that exist now and those in development — can and should adhere to common standards that account for patient needs and concerns, not just costs.

Even a diverse group can agree on criteria needed to promote clinically appropriate care, mitigate patient and provider burden, ensure access to appropriate, affordable care and optimize patient outcomes. That is a goal we can likely all agree and act on.