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Step Therapy

What is Step Therapy?

Step therapy is a coverage restriction placed on drug coverage by private health plans and Medicare private drug plans. Before your plan will cover some (generally more expensive) drugs, you must try other (generally less expensive) drugs that treat your condition to see if they will be effective for you[i].

A growing number of insurers and government health programs (e.g., Medicare and Medicaid) are trying to contain prescription drug costs by restricting patient access to expensive medicines.

In some cases, patients will have to go through step therapy: the patients will be required to try (and fail on) a listed drug before getting access to the non-listed medicine that their doctors believe will be the best treatment for them. Sometimes the patients and their doctors may even know, from prior experience, that the listed drug won’t be effective – and even so they may have to repeat the unsuccessful effort to treat with that medicine.

Non-medical switching is another cost-saving practice closely related to step therapy. Non-medical switching happens when an insurer forces a patient to switch from a current medication to a different drug for reasons wholly unrelated to the patient’s health, typically because the preferred drug is cheaper.

How does it affect those with Bleeding Disorders? 

Fortunately, step therapy and non-medical switching are not now common in the context of bleeding disorders treatment. But the increased use of formularies and preferred drug lists in the context of other health conditions sets the stage for insurers and government payers to follow suit with respect to bleeding disorders. HFA strongly maintains that non-medical switching and step therapy are inappropriate tools in the context of hemophilia care.

  • Clotting factor products are biological products and are not therapeutically equivalent or interchangeable. No generic clotting factors exist, and there is no one-size-fits-all approach that works in hemophilia care.
  • Instead, prescribing clotting factor is a complex exercise that has to be left to hemophilia specialists in consultation with their patients. In hemophilia care a strong doctor-patient relationship is especially important and has to be respected.
  • Allowing immediate patient access to the most appropriate clotting factor product will result in better treatment outcomes (more effective bleeding control, less long-term joint damage, less pain, reduced absences from school and/or work) and lower treatment costs.
  • By contrast, switching patients from a one product to another for non-medical reasons can undermine patient adherence to therapy and worsen outcomes. This would actually raise payer costs (via additional doctors’ visits, hospitalization, extra required factor usage, permanent injury, or even death).
  • Step therapy policies, too, are unacceptable in hemophilia care because the consequences of a treatment “failure” are so serious. The risks of a major bleed, or of cumulative damage from repeated bleeds, are too high to expose hemophilia patients to potentially ineffective treatments, or to delay their access to the therapies prescribed by their doctors.

For all these reasons, step therapy and non-medical switching have no place in hemophilia treatment.

Read Our Issue Brief on Step Therapy

[i] https://www.medicareinteractive.org/glossary

Assisting and Advocating for the Bleeding Disorders Community