High Cost of IPF Therapies Tied to ‘Substantial Economic Burden’

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Interstitial lung diseases (ILDs), particularly idiopathic pulmonary fibrosis (IPF), are associated with a substantial economic burden to healthcare systems due to the high cost of their treatments, a German study reported.

Medication costs for IPF patients, recruited between November 2016 and April 2017 and followed for one year, rose from €1,442 (around $1,690) to €11,000 (around $12,888), with the anti-fibrotic therapies Esbriet (pirfenidone) and Ofev (nintedanib) accounting for nearly 85% of total ILD medication costs.

Additional disorders, or comorbidities, and disease duration were factors driving this cost increase, supporting the need for approaches that might ease their toll on health systems, its researchers wrote.

The study “Cost drivers in the pharmacological treatment of interstitial lung disease” was published in the journal Respiratory Research.

IPF belongs to a family of ILDs broadly characterized by scarring, or fibrosis, of lung tissue, which diminishes lung function over time.

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Current ILD therapies mainly focus on symptom relief and disease stabilization by controlling inflammation and halting lung scarring. Since ILDs are typically chronic and progressive disorders, patients rely on medications and use healthcare services frequently, which can result in a significant economic burden.

A group of researchers in Germany assessed medication costs and factors associated with those costs in ILD patients by analyzing data from the observational Health Care in ILD Outpatient Visitors (HILDA) study.

The study, which enrolled 271 patients, collected information on their treatments before enrollment (baseline value), and at follow-up intervals at six months and 12 months after being enrolled.

Each medicine was classified either as ILD-related — which including immunosuppressants, steroids, Genentech’s Esbriet, and Boehringer Ingelheim’s Ofev — or in an “other” category.

Of these 271 people, 72 had IPF, 32 had progressive fibrosing ILDs, and 45 had sarcoidosis — a disease marked by an over-active immune system, leading to the formation of small clumps of inflammatory cells. The remaining 122 patients had various other forms of ILD.

Most were men who had never smoked. Disease onset and duration differed among these patient groups.  People with sarcoidosis had the longest disease duration, a mean of 8.1 years, while those with IPF had the shortest duration, a mean of 2.4 years; sarcoidosis patients were the youngest group, with a mean age of 52, while IPF patients were the oldest, with a mean of 71.3;  and sarcoidosis patients had the fewest comorbidities, a mean of 2.4 other disorders, while IPF patients had the most, a mean of 3.8 comorbidities.

Patients with progressive fibrosing ILDs were similar to those with sarcoidosis in these measures.

Steroids were the treatment of choice for the majority of non-IPF patients (52.5% at baseline), followed by immunosuppressants (33.1% at baseline). A smaller group, 19.5% of patients, were on a combination of steroids and immunosuppressant medication.

At the study’s start through six months of follow-up, one in every five IPF patients (20.8%) were being treated with either Esbriet of Ofev. By the study’s end, all were being treated with one of these two medications. A small group switched from steroids to either Esbriet or Ofev within six months of diagnosis.

The adjusted mean medication costs at the study’s start ranged from €216 for sarcoidosis to €1,442 for IPF.

IPF medication costs increased to €11,000 at the study’s end. Costs for other ILDs also increased, but less than that of IPF patients.

Over the study’s year, the mean cost of ILD-specific medications ranged from €487 for other ILDs to €9,142 for IPF.

“Our results showed that IPF patients had the highest medication costs of all ILD groups within the study period, which rose sharply after baseline,” the researchers wrote.

“The reason beyond this observation is the high cost of the two approved anti-fibrotic medications for IPF, pirfenidone [Esbriet] and nintedanib [Ofev],” they added. “Indeed 12 months after baseline, when all IPF patients had received either pirfenidone or nintedanib, corresponding expenditures explained almost 85% of total medication costs.”

Esbriet was first approved for use across the European Union in 2011, and Ofev in 2015.

Among other factors weighing on costs, older age was linked with a 10% increase for those with IPF, a 4% increase for those with progressive fibrosis ILDs, and a 3% increase in those with other ILDs.

Notably, smoking increased costs for IPF patients by 247%.

Better lung function, as shown in higher predicted forced vital capacity (FVC), associated with lower costs in IPF (9% lower) and sarcoidosis (1% lower).

Across all ILD types, a higher comorbidity burden at the study’s start was associated with a significant increase in medication costs, from a 23% in sarcoidosis patients to a 89% increase in those with other ILDs.

This was maintained through the year of follow-up, with a higher burden of comorbidities linked to a 52% cost escalation with progressive fibrosing ILDs, a 60% rise with sarcoidosis, and 24% in the other ILDs category.

“Comorbidity burden was a cost-driving factor in all subtypes either at baseline or throughout the study period,” the researchers wrote, likely because “a sensitive pharmaceutical management of comorbidities is required in treatment of ILD.”

Longer disease duration associated with lower costs with both progressive fibrosing ILDs (8% lower) and sarcoidosis (6% lower). For IPF patients, however, longer disease duration increased costs by 11%.

Male sex was linked to higher costs for progressive fibrosis ILDs and sarcoidosis.

“The results of our study suggest that the pharmacological management of ILD, in particular that of IPF, imposes a substantial economic burden on the healthcare system in Germany,” the researchers concluded.

“The steep rise in medication costs suggests that there was a rollout” of Esbriet and Ofev “until all eligible IPF patients were on these medications by the second half of the study, as shown in our results.”

Approaches are needed that might “reduce comorbidity burden and lung function decline” to “essentially reduce the burden of all ILD on both caregivers and the healthcare system.”

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