Sometimes we get what we pay for. Other times we pay too much.
That's the message of a study published today in the Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative.
In 2019, the US Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta-2 adrenergic agonist fluticasone–salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic's effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela's effectiveness in controlling symptoms of COPD to that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.
The result: "The generic looks to be as safe and effective as the brand name. I don't see a clinical reason why one would ever need to get the brand name over the generic version," said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women's Hospital in Boston.
Same Types of Patients, Different Inhalers, Same Outcomes
Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.
The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.
For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio [HR], 0.97; 95% CI, 0.90 - 1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86 - 1.15.
"To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version," Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.
Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.
"I don't want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics," Feldman said.
"There are very few generic options for patients with COPD," said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Bhatt noted, with few generic options.
"The results are quite compelling," said Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.
Bhatt noted that the FDA's 2019 approval — given that the agency requires bioequivalence studies between branded and generic products — was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.
"There are so many similarities between asthma, COPD, and some obstructive lung diseases," Bhatt noted.
In his experience, the only time someone with COPD continues using the branded inhaler — now that a potentially cheaper generic is available — is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.
"Patients are generally ok with being on a generic for inhalers, just because of the high cost," Bhatt said.
The study was primarily supported by the National Heart, Lung, and Blood Institute. Feldman reports funding from Arnold Ventures, the Commonwealth Fund, and the US Food and Drug Administration, and consulting relationships with Alosa Health and Aetion. Bhatt reports no relevant financial relationships.
Ann Intern Med. Published online August 7, 2023. Abstract
Marcus A. Banks, MA, is a journalist based in New York City who covers health news with a focus on new cancer research. His work appears in Medscape, Cancer Today, The Scientist, Gastroenterology & Endoscopy News, Slate, TCTMD, and Spectrum.
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Cite this: Generic Inhalers for COPD Support HoldTheir Own - Medscape - Aug 07, 2023.