BULLETIN 25-EX-6: STEP THERAPY PROHIBITED FOR STAGE-FOUR METASTATIC CANCER

BULLETIN 25-EX-6

TO: ALL HEALTH PLANS IN THE STATE OF GEORGIA

FROM: JOHN F. KING INSURANCE AND SAFETY FIRE COMMISSIONER

DATE: DECEMBER 31, 2025

RE: STEP THERAPY PROHIBITED FOR STAGE-FOUR METASTATIC CANCER

This Bulletin is intended for all health benefit plans1 issued for delivery in Georgia, including any plans established under Article 1 of Chapter 18 of Title 45 (Georgia state employee plans) and plans under Article 7 of Chapter 4 of Title 49 (Georgia Medicaid managed care plans).

O.C.G.A § 33-24-59.20 prohibits any health benefit plan from utilizing step therapy (also known as a “fail first” protocol) for the treatment of stage four advanced, metastatic cancer.2

While plans may ensure that the use of a drug is consistent with best practices for the treatment of stage four advanced, metastatic cancer and is supported by peer reviewed medical literature, a health benefit plan which directly or indirectly covers the treatment of stage four advanced, metastatic cancer may not limit or exclude coverage for an FDA approved drug and may not require that a patient fails to successfully respond to a different drug or prove a history of failure of such drug or drugs prior to authorizing treatment or covering such drug. A health benefit plan shall not require a patient with stage four, advanced metastatic cancer to try another prescription drug or demonstrate past failure with another prescription drug either explicitly through the terms of its coverage criteria or indirectly through the use of prior authorization before having coverage approved for a prescription drug approved for this condition or where use of the drug for the condition is supported by best practices and peer reviewed medical literature.

1 “Health benefit plan” means any hospital, health, or medical expense insurance policy, hospital or medical service contract, employee welfare benefit plan, contract or agreement with a health maintenance organization, subscriber contract or agreement, preferred provider organization, accident and sickness insurance benefit plan, or other insurance contract under any other name. The term shall include any health insurance plan established under Article 1 of Chapter 18 of Title 45 and under Article 7 of Chapter 4 of Title 49, the “Georgia Medical Assistance Act of 1977.” O.C.G.A. § 33-24-59.20(a)(1). 2 “Stage four advanced, metastatic cancer” means cancer that has spread from the primary or original site of the cancer to nearby tissues, lymph nodes, or other areas or parts of the body. O.C.G.A. § 33-24-59.20(a)(2). This Bulletin is intended to remind health plans of their obligation to comply with O.C.G.A. § 33- 24-59.20 and the Department of Insurance will take regulatory action as necessary to enforce compliance with such obligation.

_____________________________________________ JOHN F. KING INSURANCE AND SAFETY FIRE COMMISSIONER STATE OF GEORGIA