Prescribers Face Growing Web of Restrictions on PAH Therapies

As treatment options for people with pulmonary arterial hypertension (PAH) expand, the path to insurance coverage for new therapies is becoming more complicated, according to a new report published in the Journal of Managed Care & Specialty Pharmacy.

A team of investigators used the Tufts Medical Center Specialty Drug Evidence and Coverage database to analyze how 17 major insurance plans treated PAH drugs, and to note changes in coverage provisions over time. The 17 health plans represented 70% of the commercially insured population in the United States, about 188 million people.

The analysis was based on 13 PAH drugs, including phosphodiesterase-5 inhibitors (PDE5is), endothelin receptor antagonists (ERAs), soluble guanylate cyclase (sGC) stimulators, and prostacyclin pathway agents (PPAs). It was based on rules in place between August 2017 and August 2022, and thus the analysis did not include sotatercept (Winrevair), Merck’s latest PAH therapy, which was just approved in March of this year.

In broad terms, the report found payers instituted more coverage restrictions as time went on. In 2017, 38% of policies had at least one restriction on PAH prescriptions. By 2022, 73% of policies included at least one restriction. In particular, the investigators found step therapy protocols increased significantly over time, from 29% of plans including step therapy requirements, to 46%. Such requirements mandate that patients try particular drugs in a certain order, only moving to another “step” if the previous therapy fails.

Corresponding author James Chambers, PhD, MPharm, MSc, told Managed Healthcare Executive, that although there was a trend toward more step therapy requirements, it was not universal.

“It was surprising to observe the wide variation in step therapy protocols,” he said. “Four payers included step therapy protocols in all coverage policies for PAH drugs, while three payers did not have any such requirements.”

Chambers, an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, said the variance means that patients with PAH will experience unequal access to therapies, depending on which health plan they have.

The investigators also found that 10 plans required at least one drug to be prescribed by a specialist (cardiologist or pulmonologist), while seven plans had no specialist prescribing requirements.

Chambers said payers generally do not publicly disclose their reasons for imposing restrictions, but the report notes that generics were the most common step required, and the proportion of plans with step requirements in a given class increased as generics became available in that class.

“I think it is fair to say that plans often use step therapy to control costs and that the increased use of step therapy may reflect pharmaceutical budgets becoming increasingly stretched,” he said.

Chambers added that step therapy can also be a tool when payers negotiate coverage for drug companies; with payers offering preferential coverage for products with the largest rebates.

Another key finding from the study, though, is that policies and coverage are changing rapidly. The report found that between 40% and 75% of PAH coverage policies underwent revision each year of the analysis. They said that was consistent with previous research showing payers frequently review and revise their policies. Chambers and colleagues wrote that there appeared to be a lull in revisions in 2020, which they said may have been related to shifting priorities associated with the COVID-19 pandemic.

For providers, Chambers said the shifting policies amount to an added layer of complication.

“Instead of basing treatment decisions solely on a patient’s clinical presentation, prescribers must also consider the patient’s insurance coverage,” he said. “These restrictions often result in more paperwork (including appeals) and additional time spent navigating the plan’s coverage requirements.”

Though such complications might be frustrating, Chambers said they are likely to increase over time.

“Our research has found that plans’ use of step therapy (and other utilization management tools) is on the rise, and I would expect to see that trend continue,” he said.