biosimilars: Bipartisan Bill Seeking to Curb Step Therapy Introduced in Senate

Patient advocacy groups are pleased that a bipartisan group of senators introduced a bill this week that seeks to limit the use of step therapy.

The Safe Step Act of 2019 (S. 2546) was introduced by Senators Lisa Murkowski, R-Alaska; Bill Cassidy, R-Louisiana; and Doug Jones, D-Alabama. The bill would amend the Employee Retirement Income Security Act to require group health plans to provide an exception process for step therapy so that patients can access treatment without delays. Step therapy requires patients to try other medications first—often less expensive ones or ones preferred on a formulary—before taking a therapy that may be a physician’s first choice.

Some studies have tied treatment delays to worse outcomes, such as one published recently that says step therapy in rheumatoid or psoriatic arthritis can hurt treatment outcomes.

The bill lays out an appeals process, requires health plans to respond to step therapy appeals within 24-72 hours, and sets circumstances in which an appeal request should be granted.

“With the Senate introduction of the Safe Step Act, we are one step closer to removing a treatment barrier that hurts patients,” said Angus Worthing, MD, FACR, FACP, a practicing rheumatologist and chair of the American College of Rheumatology’s (ACR) Government Affairs Committee. “We applaud Congressional leaders for recognizing that forcing patients to ‘fail first’ through harmful step therapy practices puts them at unnecessary risk, prolongs pain and discomfort, worsens patient outcomes, and undermines the clinical judgment of medical professionals across the country.”

The ACR said the bill follows similar reforms passed in 25 states, saying that Congressional action is needed to address the use of step therapy in employer-provided plans, which are regulated by federal law.

"This robust legislation has the potential to benefit over 150 million Americans by enabling patient access to treatments prescribed by their healthcare provider, regardless of whether or not the treatment is on their insurance providers preferred formulary," said Randy Beranek, chief executive officer and president of the National Psoriasis Foundation.

The patient groups have all conducted surveys of their members asking about the impact of step therapy.

According to a 2019 national patient survey conducted by the ACR, almost half (46.49%) of people taking rheumatic disease medications reported that their insurance company asked them to use step therapy. A 2016 survey by the Arthritis Foundation found that most respondents experienced negative health effects from treatment delays caused by step therapy.

Additional cosponsors of S. 2546 are Senators Maggie Hassan, D-New Hampshire; Cindy Hyde-Smith, R-Mississippi; Jacky Rosen, D-Nevada; Kevin Cramer, R-North Dakota; and Angus King, I-Maine.

A version of the Safe Step Act was introduced in the House of Representatives in April by Representatives Raul Ruiz, MD, D-California, and Brad Wenstrup, DPM, R-Ohio.

By:  Allison Inserro
Source: Biosimilars