Md. Code Regs. 14.01.04.04

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

Section 14.01.04.04 - Request for Information for Cost Review

A. Request for Information.

(1) The Board shall post notice of the prescription drug product or products selected for cost review through the process outlined in Regulation .03I of this chapter on the Board's website.

(2) To the extent there is no publicly available information to conduct an aspect of the statutory cost review, the Board may request information to conduct a cost review study under Health-General Article, §21-2C-09(a)(2), Annotated Code of Maryland, and this regulation.

(3) The Board may request information by sending an email or postal mail to the manufacturer, PBMs, health insurance carriers, wholesale distributors, HMOs, and MCOs.

(4) The Board shall post notice of the request for information on its website.

(5) An entity that has not received a request for information from the Board may submit relevant information in accordance with this regulation.

(6) Within 30 days of the date the request for information is posted to the website or transmitted to the entity, an entity may submit the information requested by the Board, and any other relevant information, in accordance with §C of this regulation.

(7) An entity may request one 30-day extension of time to submit information under §A(6) of this regulation.

(8) An entity shall submit the request for a 30-day extension to the Board in writing on or before the expiration of the initial submission period.

B. For each prescription drug product under review, the Board may request the following information from:

(1) Manufacturer:

(a) Documents and research explaining the relationship between the pricing of the prescription drug product and the cost of development, the relationship between the pricing of the prescription drug product and the therapeutic benefit, and information that is otherwise pertinent to the manufacturer's pricing decision such as:

(i) Life cycle management;

(ii) Net average price in the State; and

(iii) The estimated value or cost-effectiveness of the prescription drug product;

(b) The total amount of the price concessions, discounts, and rebates provided to each payor type operating in the State;

(c) The total amount of the price concessions, discounts, and rebates the manufacturer is expected to provide to each payor type;

(d) The net price received by manufacturers for the drug product in the State accounting for all price concessions, discounts, and rebates;

(e) The units of the prescription drug product sold in the State;

(f) The units of the prescription drug product sold nationally;

(g) The total dollar amount of sales of the prescription drug product into the State;

(h) The total dollar amount of sales of the prescription drug product nationally;

(i) The invoice price per unit for the prescription drug product charged to purchasers in the United Kingdom, Germany, France, and Canada, reported in U.S. dollars;

(j) Prices charged to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers;

(k) The average profit margin of the prescription drug product over the prior 5-year period and the projected profit margin anticipated for the current year for the prescription drug product;

(l) Maryland and national gross and net manufacturer revenues for the prescription drug product under review for the most recent tax year;

(m) Information concerning all authorized generics as defined by 42 CFR § 447.502 for the prescription drug product;

(n) Information concerning all other ANDAs, BLAs, and NDAs that pertain to the same active moiety and the same manufacturer;

(o) The manufacturer's research and development costs, as indicated on the manufacturer's federal tax filing or information filed with the Federal Securities and Exchange Commission for the most recent tax year;

(p) The portion of direct-to-consumer marketing costs eligible for favorable federal tax treatment in the most recent tax year that are specific to the prescription drug product under review; and

(q) Any additional factors or information the manufacturer proposes that the Board consider.

(2) Health Insurance Carrier, HMO, and MCO:

(a) The total amount of the price concessions, discounts, and rebates the manufacturer provides to each health plan operating in the State, expressed as a percent of the WAC;

(b) The average price concession, discount, and rebate provided in the State for therapeutic alternatives;

(c) Placement in each formulary offered or administered in the State and the number of covered lives for each formulary;

(d) Benefit design around the prescription drug product, including copayment and coinsurance amounts in the State;

(e) The net cost incurred by the insurance carrier for the prescription drug product in the State; and

(f) Any additional factors or information the health insurance carrier, HMO, or MCO proposes that the Board consider.

(3) Pharmacy Benefits Managers:

(a) The therapeutic alternatives for the prescription drug product(s) under review identified by each formulary administered by the PBM;

(b) The total amount of the price concessions, discounts, and rebates the manufacturer provides to each PBM operating in the State, expressed as a percent of the WAC;

(c) The average price concession, discount, and rebate provided in the State for therapeutic alternatives;

(d) Placement in each formulary offered or administered in the State and the number of covered lives for each formulary;

(e) Benefit design around the prescription drug product, including copayment and coinsurance amounts;

(f) Maryland and national gross and net PBM revenues for the prescription drug product under review for the most recent tax year; and

(g) Any additional factors or information the PBM proposes that the Board consider.

(4) Wholesale Distributors:

(a) Prices charged to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers;

(b) The total amount of price concessions and discounts provided by the wholesale distributor to purchasers in the State, including but not limited to pharmacies, pharmacy chains, pharmacy wholesalers, and other direct purchasers;

(c) Units of the prescription drug product sold in the State; and

(d) Any additional factors or information the wholesale distributor proposes that the Board consider.

C. Submission of Information.

(1) An entity may submit the information requested in §A of this regulation by:

(a) Completing the data form developed by the Board; and

(b) Providing supporting documentation.

(2) A person submitting information, including data and records, for the Board's consideration shall comply with the procedures for designating confidential, trade-secret, and proprietary information set forth in COMAR 14.01.01.04.

(3) Information may be submitted to the Board:

(a) In paper form using a tracked common carrier, courier, or postal service; or

(b) Electronically using secure file transfer.

Md. Code Regs. 14.01.04.04

Regulation .04 adopted effective 50:25 Md. R. 1089, eff. 12/25/2023