NEW YORK (Reuters Health) – Patients who switch to a generic version of a drug are less likely to switch back if the generic looks just like the branded version, according to new findings.
“Across two different databases, we consistently saw that patients who were switched to the authorized version had lower switchback rates,” Dr. Rishi J. Desai of Brigham and Women’s Hospital and Harvard Medical School in Boston told Reuters Health by phone.
From 12% to 65% of patients who change from a branded to a generic drug will change back, Dr. Desai and his colleagues write in The BMJ, online April 3. Some experience a “nocebo effect,” or negative outcomes, after making the switch to generics, they add.
“There is a widespread negative perception of generics, that they are not as good,” Dr. Desai said.
But there is little evidence that generic drugs are any less effective than branded drugs, and multiple postmarketing studies suggest that they are equivalent, he added. “Most of them show that the outcomes do not differ, which makes perfect sense because it’s the same active ingredient, and it’s bioequivalent.”
Dr. Desai and his colleagues hypothesized that patients would be less likely to switch back to a branded drug if they were changed to an authorized generic, which looks the same as the branded version, than if they were switched to a generic that looks different and may contain different excipients. Because they are identical to the branded drug, authorized generics do not have to undergo Food and Drug Administration review. Non-authorized generics aren’t tested in clinical trials, but they undergo bioequivalence testing.
The researchers reviewed Medicare and commercial insurer data on 94,909 patients who were switched to the authorized generic version of one of eight drugs, and 116,017 who switched to a non-authorized generic. The drugs included alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended-release tablets, quinapril tablets and sertraline tablets.
Switchback rates varied among the drugs, from 3.8 per 100 person-years for alendronate to 17.8 per 100 for amlodipine-benazepril. The overall average rate of switchback was 8.2 per 100 person-years for all drugs. Switchback rates were significantly lower for the patients who switched to an authorized generic (pooled hazard ratio, 0.72).
“Use of branded drug products when generic drug products are available increases patient expenses by an estimated $1.2 bn . . . and overall healthcare system costs by an estimated $7.7 bn annually in the US,” they write. “The higher costs of branded drug products can result in lower adherence which, in turn, can lead to worse clinical outcomes.”
Patients are often automatically switched to the generic version of a drug when it becomes available, Dr. Desai noted. “If you prepared the patient for this upcoming change, it might make them more willing to stick to their treatment, even if it looks slightly different,” he said.
Another possibility for improving adherence would be to keep appearance uniform across generic versions of the same drug, he added, noting that this approach is controversial because it would raise intellectual property concerns.
The study was funded by the U.S. Food and Drug Administration.
SOURCE: https://bit.ly/2JG0Duz
BMJ 2018.
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