Adoption of newer antifibrotic medications for IPF low in US in everyday practice: Study

Adoption of pirfenidone and nintedanib for the treatment of idiopathic pulmonary fibrosis has been low in the U.S., according to an analysis published in the Annals of the American Thoracic Society.

“After approval, there was much anticipation regarding the availability of two effective medical therapies for patients with idiopathic pulmonary fibrosis. However, there were also several concerns, largely surrounding potential adverse events and the reported price of the medications,” Timothy M. Dempsey, with the department of pulmonary and critical care medicine and the Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery at the Mayo Clinic in Rochester, Minnesota, and colleagues wrote. “Even now, several years after their introduction in the U.S., the important questions of how widely these medications are used in everyday clinical practice, how long patients remain on the medications and how much patients can expect to pay out of pocket for the drugs remain largely unanswered.”

The researchers conducted a retrospective cohort analysis that evaluated 10,996 patients with IPF who were privately insured or Medicare Advantage beneficiaries. Patients were categorized by nontreatment (n = 8,095; mean age, 73.9 years), those who filled a prescription for pirfenidone (Esbriet, Genentech; = 1,448; mean age, 71.9 years) or those who filled a prescription for nintedanib (Ofev, Boehringer Ingelheim; n = 1,453; mean age, 72.1 years) from October 2014 to July 2019.

The primary outcome was adoption of pirfenidone or nintedanib during the study period. Secondary outcomes included medication persistence and costs of each prescription drug.

Both pirfenidone and nintedanib were approved by the FDA in 2014. Following approval, only 26.4% of patients with IPF in this study initiated treatment; the adoption of pirfenidone or nintedanib was comparable at 13.2%, according to the results.

Patients who received treatment with either medication tended to be younger (72 years vs. 73.9 years) and have fewer comorbidities (3.9 comorbidities vs. 4.9 comorbidities) compared with patients who did not receive either medication (P < .0001 for both). In addition, men were more likely than women to receive treatment with either medication (30% vs. 21.9%; P < .0001), according to the results.

During the study period, 42.8% of patients discontinued pirfenidone or nintedanib.

According to the researchers, out-of-pocket costs were high for patients who received pirfenidone (mean cost per month, $394.49) and nintedanib (mean cost per month, $397.51). Patients with commercial insurance paid less out of pocket for pirfenidone ($123.53 vs. $434.11) and nintedanib ($172.90 vs. $434.22) compared with Medicare Advantage beneficiaries. Both medications cost more than $106,000 per year, according to the results.

“High out-of-pocket costs represent one potential obstacle to the adoption of the medications,” the researchers wrote. “Further real-world cohort analyses, including cost-effectiveness studies, are needed to help answer the lingering questions surrounding the use of pirfenidone and nintedanib in everyday clinical practice.”