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Nonmedical Switching Led to Gaps in COPD Care, Study Says


After Medicare Part D plans stopped covering a chronic obstructive pulmonary disease (COPD) therapy, patients had gaps in care and increased out-of-pocket costs, according to a recent study.

Nonmedical switches of inhaled respiratory medications for Medicare patients with chronic obstructive pulmonary disease (COPD) and asthma resulted in gaps in care and potential increases in exacerbations, according to a study published in Pulmonary Therapy.

In 2017, Medicare Part D payers removed coverage for budesonide and formoterol (BUD/FORM), a combination therapy consisting of an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA). When the payers stopped BUD/FORM coverage, patients were forced to switch to another ICS/LABA therapy, switch to another controller, or stop controller therapy.

Switches for nonmedical reasons dictated by payers is often done to reduce insurance costs. However, evidence has shown that forced switches can lead to reduced treatment adherence, poor disease control, errors in inhalation technique, reduced quality of life, increased use of health care resources, and greater chances of treatment failure.

Between January 2016 and December 2017, investigators set out to evaluate the extent to which coverage cessation of BUD/FORM and subsequent nonmedical switches disrupted care for patients with asthma and COPD. The retrospective pharmacy benefit prescription claims analysis incorporated data from the IQVIA Longitudinal Access and Adjudication Data.

Information on 42,553 patients with asthma, COPD, or both who were aged 12 or older and were receiving BUD/FORM in 2016 were included in the analysis. A majority of the patients were women (64%), aged 65 or older (61%), and had a Medicare Part D subsidy status of low income subsidy (65%).

Overall, 28% of the patients had asthma, 42% had COPD, 18% had COPD and asthma, and 12% had an unknown diagnosis. Patients with an unknown diagnosis were assigned a diagnosis based on whether they were receiving asthma or COPD medications.

After the formulary change, 30,016 (71%) patients switched to another controller therapy, 20,628 (69%) switched to another ICS/LABA therapy that was covered by Medicare, 7081 (23%) pivoted to a monotherapy option, and 2307 (8%) switched to a controller that did not have an ICS. Additionally, 7% of patients remained on BUD/FORM and 23% didn’t switch to any controller.

Overall, patients experienced an average gap in care of 114 days after the change, while 25% had a gap of 30 days or longer, and 50% had a gap of 6 months or longer.

Of the patients who experienced any gap in care, 47% filled a prescription for an acute medication, indicating that they may have had an exacerbation. Eighteen percent of patients with a care gap of 1 to 30 days and 71% of patients who had a gap in care of 6 months or longer also showed evidence of possible exacerbation.

The investigators said that a potential increase in exacerbations may be a result of inhaler misuse, which could have manifested from a lack of instruction from health care providers, who may not be proficient in teaching patients how to use their devices or may not have received information that the switches were going to occur in advance.

“The fact that more than 50% of patients may not have been aware of the formulary change and went to the pharmacy to obtain a BUD/FORM prescription may also indicate that many were likely never trained on and/or observed for correct inhaler technique with their new controller,” noted the investigators.

Additionally, patients experienced an average 6% increase in out-of-pocket (OOP) costs across all therapeutic areas. All respiratory controllers, acute medications, and rescue medicines were linked with 12% average increases in OOP costs. For the patients who switched to another ICS/LABA, OOP costs rose by an average of 26%.

The investigators said that their results could only be generalized within the Medicare Part D space and that total costs as a result of the nonmedical switch could not be estimated because data on hospitalizations and emergency department visits were unknown.

“Because of these impacts on disease control and economic costs to the patient, it is important to ensure that switching a patient’s inhaler includes consideration of the individual patient’s clinical status, medical needs, and ability to use the device correctly,” wrote the investigators.


Gilbert I, Mahmood AA, Devane K, Tan L. Association of nonmedical switches in inhaled respiratory medications with disruptions in care: A retrospective prescription claims database analysis. Pulm Ther. Published online March 12, 2021. doi: 10.1007/s41030-021-00147-8

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