The ACR’s Advocacy at State Legislature Level in 2016 Focuses on Biosimilars, Step Therapy

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A majority of state legislatures have concluded their work for 2016. The ACR’s state advocacy efforts continued to focus on policy benefiting rheumatologists and patients alike. The two dominant issues this year were biosimilar substitution and step therapy.

Biosimilar Substitution

Biosimilar substitution remains the most prevalent issue throughout the states. The ACR continues to monitor all of these bills and to comment and take action on behalf of the rheumatology community.

The major biosimilars policy issue at the state level is centered on prescriber substitution. Meaning, if a lower-cost biosimilar that the FDA has deemed “interchangeable” is available, the pharmacist can dispense the lower-cost option. The ACR’s position on substitution is that the prescriber must be notified if a substitution takes place prior to or within 24 hours. Since 2012, some states have not required the prescriber to be notified of this type of substitution, creating potential patient safety issues. The ACR succeeded in working with partners, such as the Arthritis Foundation and others, and coalitions so that state substitution laws resemble the ACR’s policy.

In 2016, all biosimilar substitution legislation that was signed into law had prescriber notification of no longer than five business days.

Arizona, Idaho, Kentucky, Missouri, Oregon and Rhode Island all passed biosimilar bills this year. The following states and territories passed legislation regarding biosimilar substitution in previous years:

• California
• Colorado
• Delaware
• Florida
• Georgia
• Illinois
• Indiana
• Louisiana
• Massachusetts
• New Jersey
• North Carolina
• North Dakota
• Tennessee
• Texas
• Utah
• Virginia
• Washington
• Puerto Rico

The FDA has not approved any interchangeable biosimilars for use.

Step Edits/Step Therapy Reform

Continued success for insurance reform has been seen throughout 2016. Legislatures were receptive to patient/consumer issues that arise from step therapy. The ACR does not support step therapy and believes that rheumatologists should direct their patients’ care, not insurance formularies. The reform measures that the ACR supported across the country would allow a physician to override an insurer’s step therapy protocol or reduce the time the patient has to participate in that step.

The ACR was effective in partnering with patient groups and others in support of these reforms and supported lobby days in state capitols across the country.

Illinois, Indiana, New York and West Virginia passed step therapy reform this year, with multiple bills still showing promise in other states.

Looking Forward

Insurance reform is still a major focus for patient and provider groups across the country. Payers of all kinds continue to put more pressure on providers by increasing the cost share for patients and through burdensome administrative requirements. This forces the providers’ offices to focus on navigating paperwork, allowing less time for increased access for patients.