Step therapy, which requires those seeking prescription medication to try less expensive drugs before more expensive options are approved, is sometimes imposed by health insurers as a cost-control strategy. This requirement, also known as a “fail first” protocol, is commonly imposed in cases when lower-cost generic drugs are available (relative to name brand prescriptions) or when clinical guidelines recommend a specific sequence of medications. In Missouri, patients may currently seek to override step therapy requirements if they have already tried a prescription ordered by the insurer and demonstrated its lack of efficacy or a negative side effect. SB 959 expands the criteria that would allow a patient to seek a step therapy override for drug disbursement in cases where the suggested prescription is likely to cause harm or is not in the best medical interest of the patient, as determined by their medical provider.
- The majority of private health insurers and the Medicare Part D program use step therapy protocols to save costs on prescription drugs for conditions such as hypertension, chronic pain, and depression. As of 2022, 26 states (including AR, IA, IL, NE, and OK) permit override exceptions in cases where there is evidence to suggest that the required drug will be ineffective or harmful.
- Step therapy protocols have been shown to provide cost savings to insurers on drugs such as anti-inflammatories and antidepressants without affecting patient health outcomes. In certain cases, step therapies may result in more hospital admissions, which can be costly to the patient.
- Step therapy protocols for some conditions, such as bipolar disorder, or other drugs, such as antipsychotics, may cause patients to discontinue treatment due to adverse side effects or barriers to access to their preferred medication.
- Federal legislation is also being considered for step therapy overrides, and several states have protected classes of drugs from step therapy protocols.
- While cost savings have been documented for several classes of drugs, there is not a large body of research analyzing health outcomes following implementation of step therapy protocols.
- Requirements for evidence-based recommendations for step therapy protocols are not widespread, so the effects of such requirements on cost and health outcomes are not known.
This Note has been updated. See the previous version (published April 2021) here.