                                 CODE OF VIRGINIA

PRESCRIPTION DRUG PRICE TRANSPARENCY (§ 54.1-3442.02)

A. As used in this section:
			&#8220;Biosimilar&#8221; means a drug that is produced or distributed
pursuant to a biologics license application approved under 42 U.S.C. &#xA7;
262(k)(3).
			&#8220;Brand-name drug&#8221; means a prescription drug approved under 21
U.S.C. &#xA7; 355(b) or 42 U.S.C. &#xA7; 262.
			&#8220;Generic drug&#8221; means a prescription drug approved under 21 U.S.C.
&#xA7; 355(j) or 42 U.S.C. 262(k).
			&#8220;New prescription drug&#8221; means a drug or biological product
receiving initial approval under an original new drug application pursuant to 21
U.S.C. &#xA7; 355(b) or under a biologics license application under 42 U.S.C.
&#xA7; 262.
			&#8220;Nonprofit data services organization&#8221; has the same meaning as
set forth in &#xA7; 32.1-23.4.
			&#8220;Pharmacy benefits manager&#8221; has the same meaning as set forth in
&#xA7; 38.2-3407.15:4.
			&#8220;Wholesale acquisition cost&#8221; has the same meaning as set forth in
42 U.S.C. &#xA7; 1395w-3a(c)(6)(B).

B. Every manufacturer shall report annually by April 1 to the nonprofit
organization with which the Department of Health has entered into a contract or
agreement pursuant to § 32.1-23.4, for each (i) brand-name drug and biologic
other than a biosimilar with a wholesale acquisition cost of $100 or more for a
30-day supply or a single course of treatment and any increase of 15 percent or
more in the wholesale acquisition cost of such brand-name drug or biologic over
the preceding calendar year; (ii) biosimilar with an initial wholesale
acquisition cost that is not at least 15 percent less than the wholesale
acquisition cost of the referenced brand biologic at the time the biosimilar is
launched; and (iii) generic drug with a price increase that results in an
increase in the wholesale acquisition cost of such generic drug that is equal to
200 percent or more during the preceding 12-month period, when the wholesale
acquisition cost of such generic drug is equal to or greater than $100, annually
adjusted by the Consumer Price Index for All Urban Consumers, for a 30-day
supply, with such increase defined as the difference between the wholesale
acquisition cost of the generic drug after such increase and the average
wholesale acquisition cost of such generic drug during the previous 12 months,
the following information:

   1. The name of the prescription drug;

   2. Whether the drug is a brand name or generic;

   3. The effective date of the change in wholesale acquisition cost;

   4. Aggregate, company-level research and development costs for the most recent
   year for which final audit data is available;

   5. The name of each of the manufacturer&#8217;s new prescription drugs
   approved by the U.S. Food and Drug Administration within the previous three
   calendar years;

   6. The name of each of the manufacturer&#8217;s prescription drugs that,
   within the previous three calendar years, became subject to generic
   competition and for which there is a therapeutically equivalent generic
   version; and

   7. A concise statement regarding the factor or factors that caused the
   increase in wholesale acquisition cost.

C. A manufacturer&#8217;s obligations pursuant to this section shall be fully
satisfied by the submission to the nonprofit data services organization with
which the Department of Health has entered into a contract pursuant to &#xA7;
32.1-23.4 of information and data that a manufacturer includes in the
manufacturer&#8217;s annual consolidation report on Securities and Exchange
Commission Form 10-K or any other public disclosure.

HISTORY: 2021, Sp. Sess. I, c. 304.