Md. Code Regs. 14.01.04.03

Current through Register Vol. 51, No. 24, December 2, 2024

Section 14.01.04.03 - Selecting Drugs for Cost Review

A. Board staff may provide the Board with a dashboard containing the prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter.

B. To the extent practicable, Board staff may provide the following information for each prescription drug product in the dashboard:

(1) FDA Approval:

(a) The date the FDA first approved the prescription drug product;

(b) If applicable, the date the last patent expired or will expire;

(c) Whether the prescription drug product was approved through an FDA accelerated approval pathway; and

(d) Whether the prescription drug product is designated by the Secretary of the FDA, under 21 U.S.C. § 360bb, as a drug for a rare disease or condition;

(2) Therapeutic Class:

(a) The class of the prescription drug product as identified in a recognized classification system;

(b) Whether the prescription drug product is the only prescription drug product in its class;

(c) Any therapeutic equivalent prescription drug product identified by examination of the FDA Orange Book, FDA Purple Book, or other therapeutic equivalence databases; and

(d) The availability and number of therapeutic equivalents for sale in the State;

(3) Utilization, Spending and Price Data:

(a) The patient count for the prescription drug product in the most recent available calendar year;

(b) The total gross spending for the prescription drug product in the most recent available calendar year;

(c) The total gross spending per patient for the prescription drug product in the most recent available calendar year;

(d) The WAC on January 1 of the current calendar year, on January 1 of the previous calendar year, and at launch of the product;

(e) The percent increase in WAC of the prescription drug product over the most recent available calendar year;

(f) The percent increase in WAC of the prescription drug product over the most recent available 5-year period;

(g) The dollar increase in WAC over the most recent available calendar year;

(h) The dollar increase in WAC over the most recent available 5-year period;

(i) The dollar increase in WAC per year or course of treatment over the most recent available calendar year;

(j) The percent increase in overall total gross spending for the prescription drug product in the most recent available calendar year;

(k) The estimated percentage of manufacturer national net sales to gross sales of a prescription drug product for the most recently reported year;

(l) The average payor cost per patient for the prescription drug product in the most recent available calendar year; and

(m) The average cost share for the prescription drug product;

(4) Patient Out-of-Pocket:

(a) The total patient out-of-pocket cost for the prescription drug product in the most recent available calendar year;

(b) The average total out-of-pocket costs in the most recent available calendar year;

(c) Patient total out-of-pocket costs ranked at the 50th percentile in the most recent available calendar year; and

(d) Patient total out-of-pocket costs ranked at the 90th percentile in the most recent available calendar year;

(5) Whether the prescription drug product is currently in active shortage status; and

(6) Whether the prescription drug product is currently subject to or has been subject to the Medicare Drug Price Negotiation Program, under the Inflation Reduction Act (IRA) (Public Law 117-169).

C. Selecting Drugs for Referral to Stakeholder Council.

(1) The Board may select one or more prescription drug products identified in Regulation .02 of this chapter as eligible for cost review to refer to the Stakeholder Council.

(2) Prior to a Board meeting, a Board member may request that a prescription drug product or products be placed on the Board's meeting agenda for consideration for referral to the Stakeholder Council by submitting the proprietary drug name or nonproprietary name, as applicable, and NDC to the Board Chair in writing.

(3) The Board Chair may include the prescription drug product name and dose on the Board's agenda.

(4) The public may provide oral and written comments concerning the drugs proposed for referral to the Stakeholder Council and identified on the meeting agenda in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2).

(5) Notwithstanding the pre-meeting identification of drugs for consideration, the Board may consider any drug identified in Regulation .02 of this chapter for referral to the Stakeholder Council.

(6) At an open meeting, the Board may:

(a) Consider the prescription drug products identified on the Board's agenda and any eligible drug proposed for consideration by a Board member at the meeting; and

(b) Select one or more prescription drug products by NDC to refer to the Stakeholder Council to receive input from the Stakeholder Council on the selection of prescription drug products for cost review.

D. In selecting one or more prescription drug products to refer to the Stakeholder Council, the Board may consider:

(1) The prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter;

(2) The information provided under §B this regulation;

(3) The average cost share of the prescription drug product, the average patient total out-of-pocket cost, and the average total payor cost; and

(4) Any written or oral public comment.

E. The Board shall post notice of the prescription drug products referred to the Stakeholder Council on its website.

F. The public may provide written comments concerning the list of prescription drug products referred to the Stakeholder Council by:

(1) Complying with the procedures in COMAR 14.01.01.05B(3); and

(2) Submitting the written comments to the Board within 30 calendar days of the date the list is posted on the Board's website.

G. Stakeholder Council Input.

(1) To the extent practicable, the Board may provide the Stakeholder Council with:

(a) The information set forth in §B of this regulation;

(b) Whether the prescription drug product was reported by an individual member of the public; and

(c) Whether the prescription drug product was added by the Board for consideration under Regulation .02 of this chapter.

(2) To the extent practicable, the Stakeholder Council shall:

(a) Review the information provided for each referred prescription drug product; and

(b) Discuss the referred prescription drug products at an open meeting.

(3) Board staff may present the Stakeholder Council input discussed at the open meeting to the Board.

H. Therapeutic Alternatives.

(1) Board staff may develop a list of therapeutic alternatives for each prescription drug product referred to the Stakeholder Council.

(2) Board staff shall post a list of therapeutic alternatives developed by staff on the Board's website for comment.

(3) The public may provide written comments concerning the list of therapeutic alternatives by:

(a) Complying with the procedures in COMAR 14.01.01.05B(3); and

(b) Submitting the written comments to the Board within 30 calendar days of the date the list is posted on the Board's website.

(4) Board staff may modify the list of therapeutic alternatives for consideration by the Board.

(5) The Board shall determine the therapeutic alternatives for each prescription drug product selected for a cost review study.

I. Board Selection of Drugs for Cost Review.

(1) At an open meeting, the Board may select one or more prescription drug products for a cost review study.

(2) The public may provide oral and written comments concerning the selection of a prescription drug product for cost review in accordance with the procedures and timelines in COMAR 14.01.01.05A and B(2).

(3) In selecting a prescription drug product for cost review, the Board shall consider:

(a) The prescription drug products referred to the Stakeholder Council from the prescription drug products identified under the statutory metrics and regulatory criteria in Regulation .02 of this chapter and the information provided under §B of this regulation;

(b) The average cost share of the prescription drug product, the average patient total out-of-pocket cost, the average total payor cost, and publicly available data on direct-to-consumer advertising spending for the prescription drug product;

(c) Input from the Stakeholder Council provided under §G of this regulation; and

(d) Input from the public provided under COMAR 14.01.01.05.

(4) During an open meeting, the Board may select one or more prescription drug products for cost review under Regulation .05 of this chapter and provide notice of the selection on its website within 3 work days of the meeting.

(5) The prescription drug product shall be identified by:

(a) NDC;

(b) ANDA, NDA, or BLA, as applicable; and

(c) Active moiety or active ingredient.

(6) If the Board selects a prescription drug product for cost review, the Board may identify and approve all NDCs marketed under the same ANDA, NDA, or BLA to be included in the cost review.

(7) If the Board selects a prescription drug product for cost review that is an unapproved generic within the meaning of Health-General Article, §21-2C-01(f), Annotated Code of Maryland, the Board may identify and approve all NDCs with the same active moiety and manufacturer to be included in the cost review study.

(8) If the Board selects a prescription drug product for cost review, the Board shall approve the therapeutic alternatives to be used in conducting the cost review study.

Md. Code Regs. 14.01.04.03

Regulation .03 adopted effective 50:25 Md. R. 1089, eff. 12/25/2023