California Code of Regulations › Title 22 - Social Security › Division 3 - Health Care Services › Subdivision 1 - California Medical Assistance Program › Chapter 3 - Health Care Services › Article 4 - Scope and Duration of Benefits › Section 51313.6 - Drug Evaluation Criteria

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The Director shall use the following
					 criteria when evaluating drugs to add to and to delete from the Medi-Cal List
					 of Contract Drugs. The Director may restrict usage of any drug or therapeutic
					 category of drugs on the Medi-Cal List of Contract Drugs.
The Director's decision shall be made upon consideration
						of all of the five criteria specified below in items (1) through (5), without
						regard to the order in which the criteria are presented. The examples recited
						under each criterion shall not be exhaustive of those factors which may be
						considered.
(1) Cost. For the purpose
					 of this section, cost means the potential fiscal impact of the proposed change
					 on the Medi-Cal drug program or the Medi-Cal program. Evaluation of cost may
					 involve a single drug or comparison between two or more drugs, and may take
					 into account, but is not limited to, differences of unit cost, differences of
					 cost of total treatment, or cost of alternative methods of treatment.
(2) Efficacy. For the purposes of this
					 section, efficacy means the speed, duration, and extent to which a drug will
					 alleviate, control or cure a medical condition. Evaluation of efficacy may
					 involve a single drug or comparisons between two or more drugs, and may take
					 into account such factors as efficacy of alternative methods of
					 treatment.
(3) Essential Need. For
					 the purpose of this section, essential need means that the availability of a
					 drug through the Medi-Cal List of Contract Drugs is necessary to protect life
					 or to prevent significant disability. Evaluation of essential need may involve
					 a single drug or comparisons between two or more drugs, and may take into
					 account such facts as the availability of alternative methods of treatment, the
					 incidence, severity and prognosis of the medical conditions for which a drug is
					 indicated; whether a drug is a lifesaving agent or palliative in effect; or
					 whether a drug may provide treatment for a medical condition not adequately
					 treated by any marketed drug.
(4)
					 Misuse Potential. For the purpose of this section, misuse potential means the
					 opportunity for unjustified, inappropriate, irresponsible, or improper use of a
					 drug. Evaluation of unjustified, inappropriate, or irresponsible use may
					 involve a single drug or comparisons between two or more drugs, and may take
					 into account such factors as utilization of a drug where there is insufficient
					 medical necessity for its use; continued utilization of a drug despite loss of
					 effectiveness; utilization of a drug where more efficacious or more safe drugs
					 are available; utilization of a drug where the drug is a mixture and less than
					 the total number of active ingredients may suffice; or utilization of a drug
					 where a less costly but equally safe and efficacious drug may be used.
					 Evaluation of improper use may involve a single drug or comparisons between two
					 or more drugs, and may take into account such factors as utilization of a drug
					 in a manner that deviates from approved medical, legal, or social
					 standards.
(5) Safety. For the
					 purpose of this section, safety means relative freedom from side effects and is
					 determined by reviewing the contraindications, precautions, warnings, adverse
					 effects, and drug interactions associated with the use of a drug. Evaluation of
					 safety may involve a single drug or comparisons between two or more drugs, and
					 may take into account such factors as safety of alternative methods of
					 treatment, or the relationship of safety of a drug to the severity of prognosis
					 of the medical conditions for which the drug is indicated.