Formulary changes cause problems for asthmatic kids

October 21, 2019

Researchers find lower lung function after inhaler change.

A novel study found that asthmatic children forced to switch inhaler types to accommodate insurance formulary changes may experience a loss of lung function.

The study was presented at the CHEST Annual Meeting 2019 in New Orleans, October 19 to 23, and published in the journal CHEST.

Inhaled corticosteroid (ICS) therapy, a cornerstone of daily asthma management, is delivered by several types of inhalers that require different usage techniques. Insurance formulary coverage often dictates inhaler selection and can change abruptly, requiring children to switch inhaler types with little notice, wrote the article’s author, Scott Bickel, MD, with the University of Louisville School of Medicine.

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Bickel and colleagues found that, when a major Medicaid regional provider switched from beclomethasone dipropionate (BDP) delivered via a metered dose inhaler (MDI) to an ICS delivered by a dry powder inhaler on its formulary, pediatric asthma patients had a loss of lung function compared to those who did not switch. “Anecdotally, this change caused considerable confusion among both providers and families,” Bickel wrote in the abstract.

"Changes in insurance formulary coverage are a major reason why patients who are otherwise stable are switched to a different asthma medication," said Bickel in a press release from CHEST 2019. "Our findings suggest that when considering formulary changes, insurance organizations should take into account the unique needs of pediatric patients with asthma, ensuring all children have access to the inhaler device that is most appropriate for their individualized care."

Bickel and other researchers retrospectively reviewed charts of children aged 6 to 18 years with asthma served by the impacted Medicaid plan from a large, university-based general pediatric clinic who had spirometry performed both before and after the formulary change.

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Sixty-eight patients were identified on inhaled controller therapy with 98.5% being supported by MDIs prior to the formulary change and 60% afterward.

The investigators found that, of the 24 patients switched to a dry powder inhaler, the average FEV1, a measure of maximum air expelled in one second, was 99% predicted prior to the change and 89% predicted after being transitioned to the dry powder inhaler.

A statistically significant decline was also seen in FEF25-75%, a measure of small airway function measured by spirometry, where the average was 89% predicted prior to the change and 77% afterwards. Of those who remained on a metered dose inhaler, no statistically significant changes in lung function were observed (FEV1 101% pre-formulary change and 98.9% post).

“Our data suggests abrupt insurance formulary changes leading to use of a different inhaler device has a detrimental impact on pediatric asthma control,” Bickel wrote in the abstract. “This is likely secondary to patient and family confusion on proper device use owing to a lack of adequate timely educational intervention as well as the inability for some younger children to use DPIs.”

"This study demonstrates that formulary-dictated changes in inhaled corticosteroids decreases control of asthma and raises the following question: Are changes in formulary driven only by financial concerns appropriate in patients with asthma?” said Victor Test, MD, co-chair of the CHEST Scientific Program Committee and Professor of Texas Tech University Health Sciences Center, in the press release.

“We suggest insurance formulary changes, when required, be clearly communicated well in advance to providers, pharmacists and families and that they take into account the unique needs of the pediatric population,” Bickel wrote.

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