The first national investigation of Medicare coverage of biologic disease-modifying drugs (DMARDs) found that in starting a single biologic DMARD, patients face more than $2,700 in co-payments each year before receiving relief from catastrophic coverage.

During the initial phase of coverage, most people are expected to pay a striking 29.6% of total biologic drugs costs (just under one-third) out-of-pocket, creating an enormous financial burden for patients with chronic, rheumatic diseases such as rheumatoid arthritis. 

Rheumatoid arthritis  is a chronic autoimmune disease affecting 1.3 million Americans. Medical evidence shows that until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. Over the last decade there has been significant improvement in treatment, with disease control now possible for many RA patients who receive early, aggressive DMARD therapy, according to results in Arthritis&Rheumatology. 

Treatment with DMARDs is now a standard component of guideline-based care with costs for some the newer drugs topping $20,000 annually. A recent report by GBI Research estimates that the U.S. market for RA treatment will increase from $6.4 billion in 2013 to $9.3 billion by 2020, driven in part by the increase in RA prevalence, forecasted to reach 1.68 million by 2020. 

A study team analyzed the drug lists (formularies) of 2,737 Medicare Part D plans in 50 states and Washington, DC using the January 2013 Centers for Medicare and Medicaid Services Prescription Drug Plan Formulary and Pharmacy Network Files. Researchers included DMARDS based on the 2012 ACR RA guidelines and the National Committee for Quality Assurance's DMARD quality measure. Nine biologic medications (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) and nine non-biologic DMARDs (azathioprine, cuprimine, cyclophosphamide, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, minocycline, and sulfasalazine were analyzed. 

Nationwide, although nearly all Part D plans covered at least 1 biologic DMARD, access was tightly controlled, with 95% of plans requiring prior authorization. Between 81% and 100% of plans required a coinsurance averaging 30% of the drug cost rather than a fixed copayment amount.

Regardless of the biologic DMARD, the study found that patients face high initial co-payments, then fall into the coverage gap or "donut hole" by February or March. During the donut hole, patients' cost-sharing increases to 45% of drug costs (for 2015) until they reach catastrophic coverage. Patients generally reach catastrophic coverage between January and July. After that taxpayers, insurers and pharmaceutical companies will pick up 95% of the cost of the biologic DMARD. 

A previous study of 1,100 adults with RA found that 1 in 6 decreased their medication because of cost. "While specialty DMARDs have improved the lives of those with chronic diseases like RA, many patients face a growing and unacceptable financial burden for access to treatment," said Dr. Jinoos Yazdany with the Division of Rheumatology at the University of California, San Francisco and lead author of the present study. "Rather than determining which drug is best for the patient, we find ourselves making treatment decisions based on whether patients can afford drugs."   

Citation: "Coverage For High Cost Specialty Drugs for Rheumatoid Arthritis in Medicare Part D." Jinoos Yazdany, R. Adams Dudley, Randi Chen, Grace A. Lin and Chien-Wen Tseng. Arthritis & Rheumatology; Published Online: April 21, 2015 (DOI: 10.1002/art.39079).