What Is Step Therapy and How Does It Work?

Step therapy is a common practice within healthcare insurance, influencing how patients access prescription medications. It functions as a process where individuals are often required to try specific, typically lower-cost, treatments before their insurance will cover alternative, more expensive options. This approach is widely used by health plans to manage prescription drug costs and promote what they consider to be appropriate care.

Understanding Step Therapy

Step therapy is often referred to as a “fail first” policy. It requires patients to initially use a preferred, often generic or less expensive, medication. If this initial medication proves ineffective or causes adverse reactions, the patient may then be approved to “step up” to a more advanced or higher-cost alternative.

The process involves a tiered system for medications. First-step drugs are generic or lower-cost brand-name drugs. If a patient’s prescription requires step therapy, the pharmacy or insurer reviews the patient’s medication history to determine if they have attempted the first-step treatment. Only after the initial medication fails or causes side effects, can the patient progress to a second-step or more expensive drug. This practice is commonly applied to medications for chronic conditions such as arthritis, asthma, high blood pressure, cancer, diabetes, and neurological or autoimmune conditions.

The Rationale Behind Step Therapy

Insurance companies and healthcare systems implement step therapy protocols for several reasons, primarily centered on cost management and promoting specific treatment pathways. Step therapy helps control healthcare expenditures by encouraging the use of less expensive, yet often equally effective, medications first. This approach contributes to formulary management, where insurers categorize drugs to guide prescribing decisions and obtain better prices from manufacturers.

The protocols also aim to ensure patient safety and treatment effectiveness. They encourage the use of drugs with established safety profiles and proven efficacy as first-line treatments, potentially reducing the risk of adverse effects associated with newer or more potent medications. By starting with widely accepted and well-understood treatments, step therapy aligns with evidence-based care principles.

Patient Experience and Options

Patients often learn about step therapy when their prescription is denied at the pharmacy or when their doctor informs them of the requirement. This can be a frustrating experience, as it may delay access to the specific medication a doctor initially prescribed. Navigating this process requires close communication between the patient and their prescribing physician.

If a prescribed medication is subject to step therapy, patients have options, including an appeal process. The first step involves gathering crucial medical documentation and justification from the doctor, explaining why the preferred drug is not suitable or why the initially prescribed drug is medically necessary. An internal appeal is then submitted directly to the insurance company, detailing the medical reasons for an exception to the step therapy protocol. Insurers must respond to standard exception requests within 72 hours, and expedited requests, for urgent medical situations, within 24 hours.

Should the internal appeal be denied, an independent external review process may be available. This involves an independent third party, often medical experts, evaluating the insurer’s decision. External reviews are decided within 45 days for standard requests and within 72 hours for expedited ones. Patients may qualify for an exception to step therapy requirements in specific situations, such as a documented adverse reaction to the preferred drug, a medical contraindication, or if the preferred drug is expected to be ineffective.