RCW 70.405.040 — Affordability reviews.

1. (1) The board may choose to conduct an affordability review of up to 24 prescription drugs per year identified pursuant to RCW 70.405.030. When deciding whether to conduct a review, the board shall consider:

   1. (a) The class of the prescription drug and whether any therapeutically equivalent prescription drugs are available for sale;
   2. (b) Input from relevant advisory groups established pursuant to RCW 70.405.020; and
   3. (c) The average patient's out-of-pocket cost for the drug.
2. (2) For prescription drugs chosen for an affordability review, the board must determine whether the prescription drug has led or will lead to excess costs to patients. The board may examine publicly available information as well as collect confidential and proprietary information from the prescription drug manufacturer and other relevant sources.
3. (3) A manufacturer must submit all requested information to the board within 30 days of the request.
4. (4) The authority may assess a fine of up to $100,000 against a manufacturer for each failure to comply with an information request from the board. The process for the assessment of a fine under this subsection shall be established by the authority in rule and is subject to review under the administrative procedure act, chapter 34.05 RCW. The rules adopted under this subsection may not go into effect until at least 90 days after the next regular legislative session.

5. (5) When conducting a review, the board shall consider:

   1. (a) The relevant factors contributing to the price paid for the prescription drug, including the wholesale acquisition cost, discounts, rebates, or other price concessions;
   2. (b) The average patient copay or other cost sharing for the drug;
   3. (c) The effect of the price on consumers' access to the drug in the state;
   4. (d) Orphan drug status;
   5. (e) The dollar value and accessibility of patient assistance programs offered by the manufacturer for the drug;
   6. (f) The price and availability of therapeutic alternatives;

   7. (g) Input from:

      1. (i) Patients affected by the condition or disease treated by the drug; and
      2. (ii) Individuals with medical or scientific expertise related to the condition or disease treated by the drug;
   8. (h) Any other information the drug manufacturer or other relevant entity chooses to provide;
   9. (i) The impact of pharmacy benefit manager policies on the price consumers pay for the drug; and
   10. (j) Any other relevant factors as determined by the board.

6. (6) In performing an affordability review of a drug the board may consider the following factors:

   1. (a) Life-cycle management;
   2. (b) The average cost of the drug in the state;
   3. (c) Market competition and context;
   4. (d) Projected revenue;
   5. (e) Off-label usage of the drug; and
   6. (f) Any additional factors identified by the board.
7. (7) All information collected by the board pursuant to this section is confidential and not subject to public disclosure under chapter 42.56 RCW.
8. (8) The board shall publicize which prescription drugs are subject to an affordability review before the review begins.

[ 2022 c 153 s 4.]