As Step Therapy Becomes More Popular, Opinions Vary on Its Usefulness

by Angela Maas

Step therapy has long been a go-to utilization management strategy for payers, as it is often applied to specialty drugs. But as more and more costly medications come onto the market, the practice has become nearly ubiquitous, prompting some pushback from various stakeholders.

"Step therapy can be a very good method of ensuring that patients always get the treatment that is clinically best for them," states Lisa Kennedy, Ph.D., chief economist and managing principal at Innopiphany LLC. "In theory it should ensure that they consistently receive the safest, most effective and best tolerated treatment."

Larry Kocot, the national leader of KPMG’s Center for Healthcare Regulatory Insight, tells AIS Health that "when used effectively, step therapy can help prevent the use of more costly, unnecessary medications, thereby helping to control overall prescription costs and ensuring that patients receive the most economical and effective treatment for them."

A study by consulting group Visante Inc. that was commissioned by the Pharmaceutical Care Management Association (PCMA) and released in January 2019 found that step therapy can result in savings of more than 10% for targeted categories. PCMA is a PBM advocacy group.

However, notes Kocot, there is "some evidence that although step therapy often results in reduced prescription drug spending, outpatient services spending can increase."

Step therapy, "like other prior-authorization requirements, complicates prescriber decision making and reduces prescriber and office efficiency," says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. Kocot adds that while the clinical evidence used to establish step-therapy protocols "may be applicable to most patients, it is possible that certain individuals may not have typical responses or protocols."

"The problem arises when step therapy is applied for cost reasons in the absence of clinical rationale and even worse when there is a financial rebate for drugs on a formulary, requiring patients to step through treatments not because of clinical reasons but because a payer or PBM receives a financial rebate for this (e.g., in commercial plans)," Kennedy says.

In addition, she says, "if a patient is subject to stepping through treatments, and this delays getting the correct treatment on time, this can have a monumental impact on outcomes and is a perfect example of where misapplied, step therapy can result in sicker patients who suffer more and are placed at greater risk of death."

From RADAR on Specialty Pharmacy