Code of Maryland Regulations
Title 14 - INDEPENDENT AGENCIES
Subtitle 01 - PRESCRIPTION DRUG AFFORDABILITY BOARD
Chapter 14.01.04 - Cost Review Study Process
Section 14.01.04.04 - Request for Information for Cost Review
Universal Citation: MD Code Reg 14.01.04.04
Current through Register Vol. 51, No. 19, September 20, 2024
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.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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