Section 182-530-3100. How the medicaid agency determines when a drug requires authorization.

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

(a) The clinical team uses a drug evaluation matrix to evaluate and score the benefit/risk assessment and cost comparisons of drugs to similar existing drugs based on quality evidence contained in compendia of drug information and peer-reviewed medical literature.

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

(c) Information reviewed in the drug evaluation matrix includes, but is not limited to, the following:

(i) The drug, device, or drug-related supply's benefit/risk ratio;

(ii) Potential for clinical misuse;

(iii) Potential for client misuse/abuse;

(iv) Narrow therapeutic indication;

(v) Safety concerns;

(vi) Availability of less costly therapeutic alternatives; and

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

(d) Based on the clinical team's evaluation and the drug evaluation matrix score, 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) Drugs in therapeutic classes on the Washington preferred drug list are not subject to determination of authorization requirements through the drug evaluation matrix. Authorization requirements are determined by their preferred status according to WAC 182-530-4100.

(3) 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.

(4) 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.

[Statutory Authority: RCW 41.05.021 and 41.05.160. WSR 16-01-046, § 182-530-3100, filed 12/9/15, effective 1/9/16. WSR 11-14-075, recodified as § 182-530-3100, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. WSR 07-20-049, § 388-530-3100, filed 9/26/07, effective 11/1/07.]

RCW 41.05.021 and 41.05.160. WSR 16-01-046, § 182-530-3100, filed 12/9/15, effective 1/9/16. WSR 11-14-075, recodified as § 182-530-3100, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. WSR 07-20-049, § 388-530-3100, filed 9/26/07, effective 11/1/07.

Rules

182-530-4100,182-530-3200,