33-32-109. (Effective January 1, 2026) Biologic prescriptions for minors.
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33-32-109 . (Effective January 1, 2026) Biologic prescriptions for minors.
(1)Biologic therapies may be prescribed by a treating provider for individuals under 18 years of age as provided in this section. The biologic therapies must meet the following requirements:
(a)the biologic therapies must be approved by the U.S. food and drug administration for use on adults but need not be approved for use on persons under 18 years of age; and
(b)the biologic therapies must be medically necessary, covered benefits and supported by medical literature in at least two peer-reviewed journals demonstrating that the off-label use is both safe and effective for use on persons in the following comparable phases of life age ranges:
(i)infancy, between birth and 2 years of age;
(ii)childhood, from 2 to 12 years of age; and
(iii)adolescence, from 12 to 18 years of age.
(2)Upon receipt of the request for prior authorization and medical records supporting the request and the literature described in section (1)(b), an entity covered under the provisions of this chapter performing a utilization review must approve or deny a request for prior authorization for biologic therapies under subsection
(1)in the timeframe set forth in this chapter.
(3)For the purposes of this section, the term "biologic therapies" means a treatment that uses substances made from living organisms to treat disease. These substances may be made in a laboratory or occur naturally in the body.