For our October Virtual Monthly Meetup, we had the opportunity to host the Everylife Foundation for Rare Diseases to share about the topic of step therapy. In case you missed it, they have so graciously written a blog post as a recap.
Step Therapy: A Primer
What is step therapy?
Step therapy is a process where insurers limit coverage for a drug until the patient tries one or more alternative, often less expensive, medications. This is known as a “fail first” process because patients must “fail” on the cheaper medication before they can obtain the drug their provider initially prescribed. While it can cut costs for insurers, step therapy requirements interrupt care, divert resources from patients, and complicate [DS1] medical decision-making.
Why is step therapy a HUGE problem?
Step therapy increases time demands for patients and providers alike, burdening health systems and worsening health outcomes. In each step, providers prescribe a new medication, liaise with insurance companies, and complete paperwork, taking time away from medical decision-making. Step therapy requirements also delay access to proper and timely care. These delays are especially burdensome for patients with rapidly progressive conditions or limited life expectancies and who have waited months or years to receive a diagnosis. Some patients are unable to complete the many required steps set out by their insurance, in effect “falling down the staircase”.
Startling facts about step therapy:
· Patients can be required to try medications they have already tried under prior insurances.
· Patients can be required to try medications that are not FDA-approved for their condition (i.e. “off-label” use).
So, what can be done to help patients?
Elected officials, clinicians, and patients are working together to support legislation that will limit step therapy’s reach for those who need it most. In some states, for example, passed legislation has created processes to appeal step therapy denials and exemption guidelines so patients can avoid step therapy in cases of medical need. Some regulations would also require guidelines for step therapy to follow evidence from peer-reviewed journals to ensure clinical merit. Additionally, the federal SAFE Step Act, if passed, would ensure that group health plans offer exceptions to step therapy in specified cases, including when delaying effective treatment would lead to irreversible consequences.
An example of state advocacy
During RDLA’s 2022 Massachusetts State Advocacy Day, attendees advocated for state-level rare disease policies that would improve step therapy practices, increase access to genetic counselors, and lower patient out-of-pocket expenses. A few months later, H 4929 unanimously passed, increasing transparency and timeliness for step therapy practices for Massachusetts residents. This is just one example of patient voices leading legislative action.
So, what can YOU do to advocate?
Encourage your state and federal representatives to support step therapy reform. You can learn about how to engage in state advocacy by accessing the Rare Disease Legislative Advocate’s State Advocacy Hub, linked here. You can also learn more about the federal SAFE Step Act here.
[DS1]This section is good, but focuses a little too much on step therapy. It is a great example to cite and should for sure stay included, but I would use more broader prior auth language as well since it goes beyond step therapy
S