To the extent permitted by federal law and the TennCare waiver, present law authorizes the bureau of TennCare ("bureau") to implement, either independently or in combination with a preferred drug list (PDL), cost-saving measures for pharmaceutical services. This bill adds that the bureau may implement cost-saving measures that include biosimilars. STEP THERAPY PROTOCOLS Present law provides that a "step therapy protocol" is a protocol, policy, or program that establishes a specific sequence in which prescription drugs for a specified medical condition are covered by a health carrier or health benefit plan. A health carrier, health benefit plan, or utilization review organization is authorized to require a patient to try an AB-rated generic equivalent or interchangeable biological product prior to providing coverage for the equivalent branded prescription drug. This bill adds that such organizations may require the patient to try a biosimilar product. UNINSUREDS Present law authorizes the TennCare prescription program to provide a prescription benefit to individuals lacking prescription drug insurance coverage who meet criteria established by the bureau and the general assembly in its annual appropriation bill. To the extent permitted by federal law and the TennCare waiver, the bureau may implement cost-saving measures for pharmaceutical services including, for example, by mandating the use of generic drugs. This bill adds that the bureau is authorized to mandate the use of biosimilars. TENNCARE PHARMACY ADVISORY COMMITTEE Present law requires the TennCare pharmacy advisory committee to submit to the bureau both specific and general recommendations for drugs to be included on any state PDL adopted by the bureau. In making its recommendations, the committee must consider factors including efficacy, the use of generic drugs and therapeutic equivalent drugs, and cost information related to each drug. This bill adds that the committee must consider biosimilars in making its recommendations. ON MARCH 31, 2025, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 1198, AS AMENDED. AMENDMENT #1 defines, for purposes of the bill, a "biosimilar" as a biological product that is licensed under federal law that regulates biological products and that is not listed as "discontinued" in the federal food and drug administration's database of licensed biological products, also known as the "Purple Book".

Statutes affected:
Introduced: 4-3-1013(e), 4-3-1013, 56-7-3502(f)(1), 56-7-3502, 71-5-198(c), 71-5-198, 71-5-2404(a), 71-5-2404