(1) The medicaid agency's pharmacists or medical consultants periodically evaluate covered drugs, covered indications, or new dosages approved by the Food and Drug Administration (FDA) to determine the drug authorization requirement.

(a) The clinical team evaluates and grades available information for each drug or drug class based on quality evidence contained in compendia of drug information and peer-reviewed medical literature. The information evaluated includes, but is not limited to:

(i) Evidence for efficacy and safety;

(ii) Cost comparisons of drugs with similar existing drugs;

(iii) Potential for clinical misuse;

(iv) Potential for client misuse or abuse;

(v) Drugs with a narrow therapeutic index;

(vi) Other safety concerns; or

(vii) Product cost and outcome data demonstrating the cost effectiveness of the drug, device, or drug-related supply.

(b) In performing this evaluation the clinical team may consult with other agency clinical staff, financial experts, and program managers. The agency clinical team may also consult with an evidence-based practice center (EPC), evidence-based drug reviews, other purchasers, the drug use review (DUR) board, and medical experts in this evaluation.

(c) Based on the clinical team's evaluation, the agency may determine that the drug, device, or drug-related supply:

(i) Requires authorization;

(ii) Requires authorization to exceed agency-established limitations; or

(iii) Does not require authorization.

(2) The agency periodically reviews existing drugs, devices, or drug-related supplies and reassigns authorization requirements as necessary according to the same provisions as outlined above for new drugs, devices, or pharmaceutical supplies.

(3) For any drug, device, or drug-related supply with limitations or requiring authorization, the agency may elect to apply automated authorization criteria according to WAC 182-530-3200.