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Issue Background

Step Therapy/Specialty Tier

SPPAN Position

SPPAN supports policies that limit the ability of third party payers to mandate step therapy protocols for the treatment of chronic pain. Protocols that consider treatments’ efficacy, safety, and cost (in that order) may be implemented, but no person with pain should be required to try an inordinate number of ineffective treatments. Clinicians should be able to easily override protocols if they can document reasons for doing so. Third party payers should be encouraged to conduct research into the true costs of step therapy protocols, considering utilization of other medical services as well as their impact on quality of life.


Step therapy policies, also known as “fail first” policies, are commonly used by insurance companies and other pharmacy benefit managers as a way of controlling the costs and risks associated with prescription drugs.  In essence, these policies require the safest and least expensive drug in any class to be prescribed to a patient first, even if a patient’s physician, using their medical judgment, believes that another therapy is in the patient’s best interest.  If the initial medication is ineffective for the patient, treatment is then able to progress to other more costly or risky therapies.  This process is also known as a “step protocol” and is a type of prior authorization requirement.

A troubling and dangerous trend is health plans’ frequent denial of providers’ requests for proven and effective pain treatments.  Rather, many plans using step therapy policies require a person with pain to try an alternative treatment (including non-prescription medications, non-pharmacologic interventions, or medications used off-label) before approving the physician-recommended prescription medication, even when that medication indicated for the patient’s condition. 

Fail first policies are not currently subject to any restrictions or time limits; consequently, patients with serious and degenerative medical conditions are often forced to undergo an indefinite, painful, and often dangerous, process of trial and error before finally receiving the treatment originally recommended by their physician.  In some cases, the process can cause patients’ medical conditions to deteriorate, increasing the need for more expensive and invasive medical treatment in the future.  What’s more, patients’ untreated pain increases incidents of depression, non-compliance, and self-medication.  Further, the step therapy process can increase the direct cost of health care due to increased hospital admissions, excessive use of emergency rooms, and even loss of employment.  Indirect costs include lost wages and productivity of both people living with pain and their caregivers.

Health plans’ frequent denial of clinicians’ requests for proven and effective pain treatments is troubling and dangerous. Policies should limit these protocols and allow clinicians to override them if they can document good reasons for doing so.