Tony Hagen is senior managing editor for The Center for Biosimilars®.
An Avalere analysis suggests costs are more moderate and lower under a no–step therapy scenario for patients with Crohn disease.
Step therapy policies, which require patents to fail on a preferred therapy before switching to an agent doctors may consider more appropriate, could end up costing payers more money and shouldering patients with high, up-front out-of-pocket (OOP) costs, according to an Avalere Health analysis of patients receiving treatment for Crohn disease, paid for by Bristol Myers Squibb. Avalere is a health care consulting firm.
Avalere said that under a hypothetical step therapy scenario, a patient with Crohn disease and a negative outcome would max out payer deductible and copay requirements as soon as 5 months into a plan year, whereas a patient with no step therapy requirement would not hit the maximum OOP (MOOP) until the end of the 12 month period.
“A patient hitting a plan’s MOOP may be viewed as a positive event due to the capping of any additional costs. However, when the MOOP is hit early in the plan year, patients are responsible for high OOP costs clustered within the first few months of the year as opposed to having costs spread throughout the year,” Avalere wrote.
The resulting clustered payment load can create affordability challenges for patients that may affect adherence to therapy and the pace of disease progression, Avalere said.
Different Scenarios, Different Results
In each scenario, the hypothetical patients incurred $4065 in total OOP costs, but in the case of the patient not on step therapy, monthly costs averaged $339. In the non–step therapy scenario, steady disease management using the doctor’s first choice of therapies is assumed. In the step therapy example, the patient switches to the doctor’s choice of therapy in July of the plan year after a negative outcome, Avalere said.
The Avalere analysis indicated that payer costs were 37% higher in the case of the patient on step therapy with a negative outcome: $186,000 vs $136,000.
Often controversial, step therapy policies are also referred to as “fail-first” policies. The Association for Accessible Medicines, which represents many large biosimilar and generic drug manufacturers and developers, has called upon the FDA to establish guidance that patients who are stable on biologic reference medicines are candidates for transition to corresponding biosimilars. Payer policies may require patients to fail on a reference product before switching to a biosimilar, which the AAM contends is illogical because biosimilars are identical in efficacy and safety to reference products, so a switch after failure is not likely to produce a positive outcome.
The Avalere analysis mentions the Safe Step Act, which would require group health plans to provide an exceptions process to step therapy requirements. “Stakeholders should continue to monitor the experience patients have with step therapy policies to better understand the effect on patients, insurers, and market dynamics,” Avalere said. The analysis also states that more than half of states have moved to enact step therapy protections for patients.
“Step therapy requires patients to try a preferred drug before gaining access to the drug prescribed by their provider. In some instances, step therapy may provide patients with an effective generic or low-cost treatment option and can therefore be associated with lower patient OOP and insurer costs. In other instances, step therapy may require patients to try a preferred brand option due to considerations related to contracts and rebate negotiations. In those instances, step therapy could serve as an obstacle to getting the product that a provider has deemed most appropriate for their patient and may be associated with delayed treatment, poor patient adherence, or a negative clinical outcome that may cause increased overall costs,” Avalere wrote.