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Progress on Bills to Address Step Therapy

May 26, 2017

Thanks to MS Activists, the importance of an exception and appeal process to insurers’ step therapy protocols have continued to be debated in state legislatures across the country this year.  Step-therapy protocols — also known as “fail first” — are a tool insurers often use to evaluate prescribed treatments and control costs. This month, Iowa Governor Terry Branstad and Texas Governor Greg Abbott signed step therapy bills into law.

MS activist Sheldon Metz of Texas shares, “I was diagnosed with multiple sclerosis in 2012, and thanks to step-therapy requirements by my health insurance company, I still have not been able to take the medication my doctor believes will best control my symptoms and disease progression. 

Immediately following my diagnosis, my neurologist prescribed an oral MS disease-modifying drug that had been recently approved by the Food and Drug Administration. Unfortunately, my health insurance company refused to authorize my doctor’s first choice for treatment and required me to try and fail on an older, injectable drug before they would cover the oral therapy. We appealed the step therapy requirement but were not successful. The first injectable drug I tried came with the side effect of severe flu-like symptoms. For 10 weeks, I had fever, chills and nausea — every symptom associated with the flu. 

Eventually it was so bad that I could no longer go to work, and both my doctor and I knew that I had to switch medications. Unfortunately, I had not been on an injectable medication long enough to switch to my neurologist’s first choice for me, so I started another injectable medication. I am still taking that injectable drug. It has prevented a major relapse in my MS, but it has not effectively managed my disease progression.”

Many people with MS — like Sheldon — and their healthcare providers report the negative effects that step therapy has on their health and lives. Delaying access to the right treatment means prolonging ineffective treatment which may result in increased disease activity, loss of function and irreversible progression of disability. 

Substantial evidence from clinical research has demonstrated that early and ongoing treatment with a disease-modifying therapy is the best available strategy for limiting new disease activity and progression of disability in MS. Most of the medications are approved for relapsing forms of MS and have been shown to have greatest benefit early in the disease when the inflammatory process tends to be most active.

Each person with MS must work with his/her healthcare provider to choose a treatment that will best meet current needs, and then discuss changing to another option if the goals of treatment are not being met. Change from one disease-modifying therapy to another should only occur for medically appropriate reasons as determined by a treating clinician and patient.

The Society’s leadership on these bills is in response to the Make Medications Accessible Recommendation: Step therapy should make sense, and not result in detrimental delays accessing appropriate medications. The Society will to continue to seek opportunities to improve step therapy protocols in state regulation, and is pleased to learn of the introduction of H.R. 2077, the Restoring the Patient’s Voice Act, in the U.S. House of Representatives which addresses step therapy in federally regulated insurance plans. 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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