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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, & Rhode Island all passed biosimilar bills this year. The following states have passed legislation regarding biosimilar substitution in previous years: California, Colorado, Delaware, Florida, Georgia, Indiana, Illinois, Louisiana, Massachusetts, New Jersey, North Carolina, North Dakota, Tennessee, Texas, Utah, Virginia, Washington and 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.
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.