By Pat Anson, Editor

Over the last decade great strides have been made in the treatment of rheumatoid arthritis (RA), but the cost of treating the disease with new biologic drugs has become a “significant financial burden” for many patients.

According to a new study published in Arthritis & Rheumatology, RA patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic disease modifying drug (DMARD) in 2013. Costs varied widely depending on the drug – from $269 a month for the biologic infliximab to $2,993 a month for anakinra.

Costs remained high because the vast majority of Part D plans required RA patients to pay about a third of the cost of DMARD drugs, rather than a fixed dollar co-pay amount. In addition, catastrophic coverage under Part D didn’t kick in until out-of-pocket costs reached $4,450, after which patients paid 5% of the cost of DMARD drugs.

The financial burden is too much for many patients. According to a previous study, 1 in 6 adults with RA 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 lead author Jinoos Yazdany, MD, with the Division of Rheumatology at the University of California, San Francisco (UCSF).

"Rather than determining which drug is best for the patient, we find ourselves making treatment decisions based on whether patients can afford drugs.”  

Rheumatoid arthritis is a chronic and incurable autoimmune disease that causes pain and stiffness in joints. Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. In recent years there has been significant improvement in RA treatment, with disease control now possible for many patients who receive DMARD therapy.

Treatment with DMARDs is now a standard component of care with costs for some of 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 an increase in the number of patients with RA – which is expected to grow from 1.3 million Americans to 1.68 million by 2020.

The UCSF study analyzed Medicare Part D coverage of 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).

Although nearly all Part D plans covered at least 1 biologic DMARD, access was tightly controlled, with 95% of plans requiring prior authorization.

Researchers said implementation of the Affordable Care Act (Obamacare) will not significantly lessen the cost of biologic drugs.

"Many patients are strapped with a substantial financial burden," said Yazdany. “Clinicians caring for individuals with RA should be aware of this and be prepared to discuss long-term affordability as well as relative efficacy of biologic DMARDs with their patients to help them make informed decisions about treatment. Currently, cost discussions occur in only one-third of RA office visits where changes are made to RA drug treatment.”

One alternative is the use of non-biologic DMARDs, such as methotrexate, which were once the standard treatment for RA. Both Medicare Advantage plans and PDP plans cover nearly all non-biologic DMARDs, with most charging fixed dollar co-pays that averaged $4 to $34 a month.

Researchers in Belgium recently found that a combination of older generic drugs (methotrexate, sulfasalazine and leflunomide) treated RA in its early stages just as effectively as biologics, but with less medication, fewer side effects, and at a significantly lower cost.

A similar study published in the New England Journal of Medicine found that RA patients who took three oral generic drugs (methotrexate, sulfasalazine and hydroxychloroquine) saw just as much improvement in their symptoms as those who used methotrexate and Enbrel, an injectable biologic sold by Amgen.

The average annual cost of the three drug therapy was about $1,000, compared to about $25,000 per year for Enbrel.