Drugs, Prescription

Plain English Breakdown

The bill summary and text do not provide detailed information on how biosimilar drugs will be implemented or what specific cost-saving measures TennCare will take, leaving these aspects open to interpretation.

Act to Allow Biosimilar Drugs in Tennessee

This act allows Tennessee's TennCare program and health plans to consider biosimilar drugs as cost-saving measures and requires consideration of these drugs when making recommendations for the state’s preferred drug list.

What This Bill Does

• Allows the bureau of TennCare to implement cost-saving measures that include using biosimilars.
• Requires health carriers, health benefit plans, or utilization review organizations to consider requiring patients to try a biosimilar product before covering the equivalent branded prescription drug.
• Adds that the TennCare pharmacy advisory committee must consider biosimilars when recommending drugs for the state's preferred drug list.

Who It Names or Affects

• Tennessee residents covered by TennCare or other health plans in Tennessee.
• Healthcare providers and pharmacies in Tennessee.
• The bureau of TennCare, health carriers, health benefit plans, and utilization review organizations.

Terms To Know

biosimilar

A biological product that is similar to an already approved medicine (called a reference medicine) and meets the same standards for quality, safety, and effectiveness as set by federal law.

TennCare

The state's Medicaid program providing health insurance coverage to low-income individuals and families in Tennessee.

Limits and Unknowns

• This act only applies within the limits of federal laws and TennCare waiver provisions.
• It does not specify how biosimilar drugs will be implemented or what specific cost-saving measures will be taken by TennCare.

Official Summary Text

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 co
mbination 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 p
rotocol" 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 re
v
iew 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 t
h
e 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. T
h
is 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 bil
l
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
"
b
iosimilar"
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"
.

Current Bill Text

HOUSE BILL 1198
By Kumar

SENATE BILL 436
By Reeves

SB0436
001713
- 1 -

AN ACT to amend Tennessee Code Annotated, Title 4;
Title 53; Title 56; Title 68 and Title 71, relative to
biosimilar medicine.

WHEREAS, the legislature finds that increasing access to biosimilar medicines has the
potential to significantly reduce prescription drug costs; and
WHEREAS, biosimilar medicines are approved according to the same federal food and
drug administration (FDA) standards of pharmaceutical quality, safety, and efficacy as the FDA's
reference medicines; and
WHEREAS, it is the intent of the legislature to eliminate barriers impeding access to
biosimilar medicines and the savings biosimilar medicines can provide; now, therefore,
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Section 4-3-1013(e), is amended by adding
the language "or biosimilars" at the end of the subsection.
SECTION 2. Tennessee Code Annotated, Section 56-7-3502(f)(1), is amended by
deleting the subdivision and substituting:
(1) A health carrier, health benefit plan, or utilization review organization from
requiring a patient to try an AB-rated generic equivalent product, interchangeable
biological product, or biosimilar product prior to providing coverage for the equivalent
branded prescription drug;
SECTION 3. Tennessee Code Annotated, Section 71-5-198(c), is amended by adding
the language "or biosimilars" at the end of the subsection.
SECTION 4. Tennessee Code Annotated, Section 71-5-2404(a), is amended by
deleting the language "including, but not limited to, efficacy, the use of generic drugs and

- 2 - 001713

therapeutic equivalent drugs, and cost information related to each drug" and substituting
"including efficacy; the use of generic drugs, biosimilars, and therapeutic equivalent drugs; and
cost information related to each drug".
SECTION 5. This act takes effect upon becoming a law, the public welfare requiring it.