(1) As used in this subchapter:(1) “Costs associated with the manufacture of the individualized investigational treatment” means the actual out-of-pocket costs incurred in providing the individualized investigational treatment to the patient in his or her specific case;(2) “Eligible facility” means an institution that is operating under a Federalwide Assurance for the Protection of Human Subjects under 42 U.S.C. § 289(a) and 45 C.F.R. Part 46, as existing on January 1, 2025, and is subject to the laws, regulations, policies, and guidelines relating to Federalwide Assurance for the Protection of Human Subjects, including renewals or updates;(3) “Eligible patient” means a person who meets the requirements of eligibility under § 20-15-2503;(4) “Individualized investigational treatment” means a drug, biological product, or device that is unique to and produced exclusively for use for an individual patient, based on his or her own genetic profile, including without limitation an individualized gene therapy antisense oligonucleotide and individualized neoantigen vaccines;(5) “Life-threatening” means a disease or condition:(A) Where the likelihood of death is high unless the course of the disease or condition is interrupted; and(B) With a potentially fatal outcome, where the endpoint of clinical trial analysis is survival;(6) “Physician” means an individual licensed to practice medicine in the State of Arkansas under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq.; and(7) “Severely debilitating” means a disease or condition that causes major irreversible morbidity.
(1) “Costs associated with the manufacture of the individualized investigational treatment” means the actual out-of-pocket costs incurred in providing the individualized investigational treatment to the patient in his or her specific case;
(2) “Eligible facility” means an institution that is operating under a Federalwide Assurance for the Protection of Human Subjects under 42 U.S.C. § 289(a) and 45 C.F.R. Part 46, as existing on January 1, 2025, and is subject to the laws, regulations, policies, and guidelines relating to Federalwide Assurance for the Protection of Human Subjects, including renewals or updates;
(3) “Eligible patient” means a person who meets the requirements of eligibility under § 20-15-2503;
(4) “Individualized investigational treatment” means a drug, biological product, or device that is unique to and produced exclusively for use for an individual patient, based on his or her own genetic profile, including without limitation an individualized gene therapy antisense oligonucleotide and individualized neoantigen vaccines;
(5) “Life-threatening” means a disease or condition:(A) Where the likelihood of death is high unless the course of the disease or condition is interrupted; and(B) With a potentially fatal outcome, where the endpoint of clinical trial analysis is survival;
(A) Where the likelihood of death is high unless the course of the disease or condition is interrupted; and
(B) With a potentially fatal outcome, where the endpoint of clinical trial analysis is survival;
(6) “Physician” means an individual licensed to practice medicine in the State of Arkansas under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq.; and
(7) “Severely debilitating” means a disease or condition that causes major irreversible morbidity.