Therapy Disruption by Medicare Coverage Could Harm Asthma Control

A regulatory disruption in prescription therapy refills for patients with pulmonological disease may have harmed their disease control status and resulted in costly, debilitating exacerbations and even hospitalizations.

In a retrospective pharmacy analysis involving 44,832 patients aged 12 years or older whose inhaler therapy costs were covered by the Medicare Part D program in 2016 and 2017, investigators observed that switches in controller therapies and regimens—as well as acute medications and rescue inhalers—notably impacted patient symptoms.

The study results are to be presented at the 2018 CHEST Annual Meeting in San Antonio, TX, this week.

Through their Medicare Part D coverage, the observed patient population had received fixed-dose combination budesonide/formoterol (BUD/FORM; Symbicort) as their inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) medication in 2016. Each patient was observed through 2017, in order to assess their ICS/LABA switches, changes in controller medication, and use of oral corticosteroids (OCS), antibiotics, and rescue inhalers.

Because of the program’s policies, plan administrators are required to offer patients plans with at least a standard minimum benefit that reflects in the plan’s deductible, co-pay, and formulary offered. According to the investigators, led by Katie Devane, PhD, about half (49%) of the retrospective study’s patients had made an attempt to fill a BUD/FORM prescription at a pharmacy following the formulary block of the combination therapy on January 1, 2017.

In phase 3 SYGMA Trial data released earlier this year, BUD/FORM reported superiority in as-need anti-inflammatory relief in patients with mild asthma versus 2 standard-of-care therapies.

Of the population to request the therapy, another near-half (46%) were approved for more than 1 refill of BUD/FORM; 52% had their refill request rejected.

Of the patients rejected from a refill, 37% switched onto another ICS/LABA fixed-dose combination, 27% stopped their controller therapy, 10% switched to monotherapy, 10% switched to triple therapy, and 16% received other controller therapy combinations.

Investigators concluded that, among the patients to not switch to an alternative controller medication, more than one-third (37%) eventually filled a prescription for acute medication. In fact, a third of all 44,832 patients did not fill any controller medication following the 2017 formulary block, with another 12% switching to just a monotherapy and 17% having no inhaled medication fills at all.

In a statement accompanying the study, Devane expressed concern for the disparity in controller medication usage.

“This Medicare Part D formulary switch was associated with a disruption in the management of patients’ respiratory conditions,” Devane said. “Approximately 45% of the patients did not receive an ICS/LABA after the formulary block, which may have impacted patients’ symptoms and disease control, and potentially lead to an increased rate of costly exacerbations and hospitalizations.”

The study, “Disruption in Care After a Forced Formulary Switch in Inhaled Respiratory Medications,” will be presented at CHEST 2018.