Medicare Coverage Gap for Therapy Increases Costs for Patients with Rheumatoid Arthritis

Released: 11/7/2012 9:00 AM EST
Embargo expired: 11/10/2012 4:30 PM EST
Source Newsroom: American College of Rheumatology (ACR)
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Newswise — WASHINGTON – According to research presented this week at the American College of Rheumatology Annual Meeting in Washington, D.C., Medicare patients with rheumatoid arthritis may face higher drug costs and barriers to newer medications.

Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, limitation of motion and loss of function of multiple joints. Though joints are the principal areas affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men.

Medicare Part D is a federal health insurance plan that provides prescription drug benefits to older and disabled Americans, and the program has expanded to include many of the latest therapies to treat RA. However, the program requires participants to pay full costs for medications when a certain dollar amount has been reached, known as a coverage gap. Biologic disease-modifying anti-rheumatic drugs (also called DMARDs) are effective but expensive medications proven to slow RA disease progression and symptoms. Yearly costs for biologic medications can range from $12,000 to $48,000 or more with traditional health insurance.

To understand the potential impact of paying full price for medication during the coverage gap, researchers from the University of California, San Francisco, compared the out-of-pocket expenses for RA drugs. The expenses were calculated for two groups: patients responsible for the medication’s cost during the coverage gap and patients who were eligible to receive the same therapy at a significantly reduced cost.

“We found that many patients face high costs during the coverage gap for biologic drugs. Those that don’t face high costs because they are eligible for low-income subsidies are actually much more likely to be on a biologic through their Part D benefit,” says Jinoos Yazdany, MD, MPH, co-investigator of the study and assistant professor in residence and at the University of California, San Francisco.

The researchers found that patients eligible for low-income subsidies that cover the cost of medications during the coverage gap were significantly more likely to receive biologic drugs for RA through Part D than those without subsidies. This suggests that the coverage gap may prevent patients who face substantial cost-sharing from accessing biologics through Part D.

Researchers reviewed insurance claims from a random sample of patients who received government health insurance and participated in the prescription drug program, Medicare D. The study included 5,808 individuals at least 65 years-old, with at least two medical visits for RA, were continuously enrolled in the government prescription plan and had at least one prescription for RA during the year.

The researchers then compared patients who had no, partial or full coverage during the gap to those who were fully eligible for the low-income subsidy program. For each participant, the research team calculated the average yearly costs of non-biologic and biologic DMARDs.

The researchers studied data from 2009, and among the 5,808 participants with prescription coverage that included DMARDs, 679 (12 percent) were classified as biologic DMARD users, 5,129 (88 percent) as non-biologic DMARD users and 1,414 (24 percent) received a low-income subsidy. Additionally, 44 percent of biologic DMARD users received a low-income subsidy compared to 22 percent of non-biologic users under Part D.

For the low-income subsidy group, yearly out-of-pocket costs for biologic and non-biologics were low as expected ($26; $11, respectively) and varied little over the year (ranging from $2 to $13).The group that was not eligible for the government program had annual out-of-pocket costs for biologics and non-biologics of $3,009 and $85, respectively.

The study suggests that many elderly patients with RA who face substantial costs for their biologic drugs may have trouble accessing them through Part D.

Funding for this study was provided by the National Institute of Health, The National Institute of Arthritis and Musculoskeletal and Skin Diseases, University of California, San Francisco Resource Allocation Program and University of California, San Francisco Rosalind Russell Center for Arthritis.

The American College of Rheumatology is an international professional medical society that represents more than 9,000 rheumatologists and rheumatology health professionals around the world. Its mission is to advance rheumatology. The ACR/ARHP Annual Meeting is the premier meeting in rheumatology. For more information about the meeting, visit www.acrannualmeeting.org or join the conversation on Twitter by using the official hashtag: #ACR2012.

Learn more about living well with rheumatic disease as well as rheumatologists and the role they play in health care. Also, discover the ACR’s Simple Tasks campaign, which highlights the severity of rheumatic diseases and the importance of early and appropriate referral to a rheumatologist.

Editor’s Notes: Chris Tonner, MPH, will present this research during the ACR Annual Meeting at the Walter E. Washington Convention Center at 3:15 PM on Wednesday, November 13 in Room 202 B. Dr. Yazdany will be available for media questions and briefing at 1:30 PM on Monday, November 12 in the on-site press conference room, Room 203 A–B.

Presentation Number: 2464

Cost-Sharing and Utilization of Biologic and Non-Biologic Dmards Among U.S. Medicare Beneficiaries with Rheumatoid Arthritis

Chris Tonner (University of California San Francisco, San Francisco, Calif.)
Jinoos Yazdany (University of California San Francisco, San Francisco, Calif.)
Gabriela Schmajuk (University of California San Francisco, San Francisco, Calif.)

Background/Purpose: While Medicare's Part D prescription drug benefit expanded access to drugs for many patients, it also includes a controversial provision called the "coverage gap" during which beneficiaries are fully responsible for drug costs. As an initial step in understanding the potential impact of cost-sharing for beneficiaries with rheumatoid arthritis (RA), we compared drug utilization and out-of-pocket (OOP) costs for biologic and non-biologic disease-modifying anti-rheumatic drugs (DMARDs) for two groups of patients: those with a coverage gap and those who were not subject to cost-sharing because they were fully eligible for the low-income subsidy program.

Methods:Data derive from Medicare fee-for-service claims files for 2009 for a 5% random sample of beneficiaries linked to the Medicare Part D prescription drug event file. We included 5,808 individuals age ≥ 65 years with ≥ 2 face-to-face encounters for RA who were continuously enrolled in a Part D drug plan and had at least one prescription DMARD event. We compared patients who had no, partial or full coverage during the gap phase to those who were fully eligible for the low-income subsidy program, which is intended to reduce OOP costs for those with low socioeconomic status. We calculated mean annual RA drug OOP costs per patient for the deductible, initial, gap, and catastrophic phases of Part D coverage in two mutually exclusive groups: 1) those using biologic DMARDs (with or without non-biologic DMARDs) and 2) those using only non-biologic DMARDs.

Results:Among the 5,808 RA beneficiaries with Part D drug events for DMARDs in 2009, 679 (12%) were classified as biologic DMARD users, 5,129 (88%) as non-biologic DMARD users and 1,414 (24%) received a low-income subsidy. 44% of biologic DMARD users received a low-income subsidy compared to 22% of non-biologic users. For the low-income subsidy group, OOP annual costs for biologic and non-biologics were low as expected ($26, $11, respectively) and varied little over the benefit phases (range $2-13; see Figure). The non-subsidized group's annual OOP costs for biologics and non-biologics were $3,009 and $85, respectively; larger variations in OOP cost existed for biologics ($21 to $1,805) compared to non-biologics ($21 to $75) across the benefit phases (Figure) with the highest costs incurred during the gap phase.

Conclusion:We found that a significantly larger proportion of biologic DMARD users were enrolled in the low-income subsidy program compared to non-biologic DMARD users. Whether the low rates of biologic DMARD use among Medicare beneficiaries who are not eligible for financial subsidies is a consequence of substantial cost-sharing warrants further investigation.

Disclosure: J. Yazdany, None; C. Tonner, None; G. Schmajuk, None; A. N. Trivedi, None; G. Lin, None


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