2023 Laws of Puerto Rico › TITLE TWENTY-SIX - Insurance (§§ 101 — 10377) › Subtitle 3 - Puerto Rico Health Insurance Code (§§ 9001 — 10377) › Chapter 102 - Prescription Drug Management (§§ 9041 — 9052) › § 9045 - Requirements for the development, maintenance, and management of prescription drug formularies and other pharmaceutical benefit management procedures

(a) Each health insurance organization or issuer that provides benefits for prescription drugs and manages such benefit through the use of a formulary or other procedure shall establish one or more Pharmacy and Therapeutics Committees, as considered appropriate by the health insurance organization or issuer, to develop, maintain, and manage such formulary and related procedures as provided in this section. The Pharmacy and Therapeutics Committee shall not participate in the benefit determination process established by the health insurance organization or issuer for the dispensation of prescription drugs.
The health insurance organization or issuer shall ensure that any Pharmacy and Therapeutics Committee establishes policies and disclosure requirements that address potential conflict of interests that the members of the committees may have with developers or manufacturers of prescription drugs. No member of the Pharmacy and Therapeutics Committee may have any relationship or interest, financial or otherwise, with developers or manufacturers of prescription drugs.
(b) The health insurance organization or issuer shall ensure that any Pharmacy and Therapeutics Committee establishes a process in writing to evaluate medical and scientific evidence concerning the safety and effectiveness of prescription drugs, including available comparative information on clinically similar prescription drugs, when deciding what prescription drugs to include on a formulary or bioequivalent and when developing other management processes. The health insurance organization or issuer shall also ensure that the Pharmacy and Therapeutics Committee uses a process for analysis and possible inclusion in the formulary of prescription drugs for off-label use, the effectiveness of which has been proven by medical and scientific evidence to treat other health conditions.
Every Pharmacy and Therapeutics Committee shall maintain documentation of the process required under this subsection and make any records and documents related to the process available, upon request, to the health insurance organization or issuer.
(c) The health insurance organization or issuer shall ensure that every Pharmacy and Therapeutics Committee adopts and follows a written process to enable it to consider the need for and implement appropriate updates and changes to the formulary in a timely manner based on:
(1) Newly available scientific and medical evidence or other information concerning prescription drugs currently listed on the formulary or subject to any other management process, and scientific and medical evidence on newly approved prescription drugs and other prescription drugs not currently listed on the formulary or subject to any other management process, to determine whether a change to the formulary or management process should be made;
(2) if applicable, information received from the health insurance organization or issuer with respect to medical exception requests to enable the Pharmacy and Therapeutics Committee to evaluate whether the prescription drugs currently listed on the formulary or subject to any other management process are meeting the healthcare service needs of covered persons or enrollees, and
(3) information related to the safety and effectiveness of a prescription drug currently listed on the formulary or subject to any other management process, related to clinically similar or bioequivalent prescription drugs not currently listed on the formulary or subject to any other management process, information arising from the health insurance organization or issuer's quality assurance activities, or claims data that was received since the date of the Pharmacy and Therapeutics Committee's most recent review of the prescription drug.
(4) the health insurance organization or issuer shall require the Pharmacy and Therapeutics Committee to evaluate prescription drugs newly approved by the Food and Drug Administration (FDA) within a term that shall not exceed ninety (90) days counted as of the FDA's date of approval. Within a term that shall not exceed ninety (90) days, counted as of the release in the market of the new prescription drug, the Pharmacy and Therapeutics Committee shall issue its determination as to whether or not such prescription drug shall be listed in the formulary.
(d) Subject to this chapter, a health insurance organization or issuer may contract with another person to perform the functions of the Pharmacy and Therapeutic Committee as described in this section. Such health insurance organization or issuer shall answer to the Commissioner for the Pharmacy and Therapeutics Committee's actions, noncompliance with, and violations of this chapter.
History —Aug. 29, 2011, No. 194, § 4.050, eff. 180 days after Aug. 29, 2011.