In recent years, managed care organizations (MCO) have increased the use of “fail first” policies, commonly called “step therapy,” as a way to control pharmacy benefit costs. The idea is to encourage (or mandate) the use of less expensive drugs (often generics) in treating a certain disease state – rather than the drug the provider prescribed. When a patient must fail first on a drug before being allowed to take the medication originally prescribed, the patient, physician and public health suffers. This can be especially frustrating in treating chronic diseases, to our patients, and to the treating provider. We have seen step therapy move beyond generic vs. branded products; to requiring over-the-counter failures before approval of a prescription; and even to recommendations that just don’t seem to make sense at all. Examples of such recommendations include failure on a drug or biologic that is in no way equivalent to the prescribed product, (e.g. omalizamab failure before the use of mepolizumab or single entity inhaled corticosteroid failure before combination therapy in treating severe asthma.)
Recently the Advocacy Council joined a coalition that includes several physician and patient organizations, in supporting both Federal and state legislation designed to address step therapy issues. We are pleased to report that Ohio has enacted legislation that promises to restrict the ability of insurers to impose unreasonable step therapy requirements on patients in that state. The legislation, recently signed by the governor, will require insurers to base step therapy on clinical guidelines developed by independent experts. It will provide for transparent exceptions and an appeals process for prescribing physicians that will allow for exceptions when medically appropriate for the patient.
The coalition is also advancing step therapy legislation in several other states. Currently, bills are pending in Florida, Georgia, Maine, Massachusetts, New Mexico, Oregon, Rhode Island, Utah and Vermont. We will keep you posted on the efforts in those states. Meanwhile, if you practice in any of those states and would like to help the coalition efforts, please contact the Advocacy Council at AdvocacyCouncil@ACAAI.org