PracticalDermatology

The Safe Step Act of 2023 places limits on the use of step therapy to improve access for our patients. Many states already have such legislation in place, but if this Bill is passed by the House and Senate and signed into law, it will bring similar patient protections to the national level.

This legislation was recently included as an amendment to the Pharmacy Benefit Reform Act and approved by the Senate’s Health, Education, Labor, and Pensions Committee. Now, it will head to the Senate for a full vote. It was also introduced in the House and has been referred to the House Committee on Education and Labor.

Many dermatologists deal with step-therapy hassles and frustrations every day. We must jump through hoops to get our patients the life-saving medication they need via burdensome prior authorization processes, many of which call for step- or fail-first therapy. These administrative hassles are contributing to the high rates of burnout in our specialty. These policies also cause real physical and mental pain for our patients, delaying our ability to provide relief for often debilitating conditions.

The National Psoriasis Foundation (NPF) noted that more than 99% of step therapy protocols are more stringent than the treatment guidelines for psoriasis.1 Resulting delays in care can lead to more skin areas affected by plaques, missed workdays, social isolation, and prolonged systemic inflammation. A 2020 NPF survey found that 70% of people with psoriatic disease who take a biologic agent have been subject to step therapy.2

What’s in the Safe Step Act?

The Safe Step Act does not ban the use of step therapy. Instead, it places parameters and reasonable timelines around the practice.

The Safe Step Act details five exceptions to step protocols including granting an exemption if:

• a patient already tried and failed on the required drug
• delayed treatment will cause irreversible consequences
• the required drug will cause harm to the patient
• the required drug will prevent a patient from working or participating in activities of daily living
• the patient is stable on their current medication

As it stands, step-therapy strategies often do not take a patient’s medical or medication history into account.

The Safe Step Act also creates a Response Timeframe for Exemption Requests. It requires a group health plan to respond to an exemption request within 72 hours in all circumstances, and 24 hours if the patient’s life is at risk. This commonsense legislation is supported by more than 200 patient and provider organizations including the NPF and The National Alopecia Areata Foundation (NAAF).

There’s lots we can do to help get this act passed, starting in the Senate. Take to social media and thank bill sponsors for their support with #SafeStepAct #steptherapyreform and #steptherapy hashtags. Senate sponsors include Lisa Murkowski (@lisamurkowski), Maggie Hassan (@SenatorHassan), Dr. Robert Marshall (@RogerMarshallMD), and Jacky Rosen (@SenJackyRosen). The House sponsors include Brad Wenstrup (@RepBradWenstrup), Dr. Raul Ruiz (@repraulruizmd), Lori Chavez DeRemer (@LChavezDeRemer), Lucy McBath, (@RepLucyMcBath), Mariannette Miller-Meeks (@RepMMM), and Earl Blumenauer (@RepBlumenauer).

Treatment decisions belong with patients and their physicians who understand their conditions best. Let’s help get this done for our patients who deserve better.

1. National Psoriasis Foundation. Patient Advocates and Health Care Provider Groups Applaud Filing of the ‘Safe Step Act’ in U.S. House and Senate. https://www.psoriasis.org/applaud-filing-of-the-safe-step-act-in-u.s.-house-and-senate/ Accessed July 6, 2023.

2. National Psoriasis Foundation. U.S. House and Senate Reintroduce the Safe Step Act. https://www.psoriasis.org/us-house-and-senate-reintroduce-the-safe-step-act/. Accessed July 6, 2023