Several patient advocacy groups have been quite active in supporting and lobbying for enactment of limitations on mandates of step therapy from health insurers. More than 20 states have enacted legislation in this area, and the advocacy groups have targeted an additional 10 jurisdictions for heightened legislative activity related to step therapy.1

A step therapy mandate from a health insurance company is a policy adopted by the insurer that requires a patient to try a medication or a series of less expensive medications dictated by the firm and have them fail to address the patient’s health situation before the underwriter will cover the medication originally selected and prescribed by the physician.2,3 Advocates sometimes refer to this as a fail-first policy.3

Legislation enacted in Missouri, for instance, acknowledged some of the issues with this approach, stating that “requiring a patient to follow a step therapy protocol may have adverse and even dangerous consequences for the patient who either may not realize a benefit from taking the prescription drug required by the step therapy protocol or may suffer harm from taking an inappropriate drug that is so required.”The bill also emphasized that “it is imperative that step therapy protocols in the state preserve the health care provider’s right to make treatment decisions in the best interest of the patient.”4

The legislature in Missouri went as far as outlining mutually exclusive circumstances under which “an exception request shall be expeditiously granted”:
  1. The patient has previously tried the step therapy–required drug or a drug in the same pharmacologic class or with the same mechanism of action, and the drug caused an adverse event or was ineffective.
  2. The patient is stable on a prescription drug for the medical condition under consideration.
  3. The required prescription drug is contraindicated or will likely cause an adverse reaction in or mental or physical harm to the patient.
  4. The required prescription drug is expected to be ineffective based on the known characteristics of the regimen and the known clinical characteristics of the patient.
  5. The required prescription drug is not in the best interest of the patient based on medical necessity.

The legislature went on to specify what it meant by including the word expeditiously in the context of processing a request for an exception: “The insurer, health plan, or utilization review organization shall respond to a step therapy override exception request or an appeal related to such request within 72 hours of receipt. If exigent circumstances exist…insurer, health plan, or utilization review organization shall respond within 24 hours of receipt. If an insurer, health plan, or utilization review organization does not respond within the time allotted under this subdivision, the step therapy override exception request or appeal related to such request shall be deemed granted.”4

As the legislature was refining the wording of the proposal, the body declared “it a matter of public interest that patients have a fair, transparent, and independent process for requesting an exception to a step therapy protocol if the patient’s health care provider deems such exception appropriate.”

Importantly, although these legislative proposals— and the Missouri enactment is a prime example—do impose limitations on insurers’ use of step therapy mandates, such programmatic mandates are not totally prohibited. Moreover, a provision of possible interest to pharmacists is that the program administrators “are permitted to require a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug.”

Extensive research is not necessary to uncover the influence of certain disease state– or health-focused foundations behind these legislative initiatives. They can marshal patients and their supporters to be forceful advocates with legislators, counterbalancing the legislative efforts of the health insurance industry. 
 
Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy.


REFERENCES
  1. Step therapy legislation by State. National Psoriasis Foundation website.  steptherapy.com/step-therapy-legislation-by-state/. Accessed June 10, 2019.
  2. Step therapy bill makes huge progress in Missouri legislature with help of young advocates. Arthritis Foundation website. blog.arthritis.org/advocacy/step-therapy-arthritis-missouri. Updated June 2016. Accessed June 10, 2019.
  3. Missouri patients ring in new year with “step therapy” law. Patients Rising website. patientsrising.org/step-therapy-in-missouri. Published December 27, 2016. Accessed June 10, 2019.
  4. H.B. 2029, Missouri Legislature (2016). house.mo.gov/BillContent.aspx?bill=HB2029&year=2016&code=R. Accessed June 10, 2019.