SB 5594 — Concerning biosimilar medicines.

ENGROSSEDS-0988.1 SUBSTITUTE SENATE BILL 5594 State of Washington 69th Legislature 2025 Regular Session By Senate Health & Long-Term Care (originally sponsored by Senators Harris, Cleveland, Hasegawa, and Shewmake)Shewmake READRead FIRSTfirst TIMEtime 02/19/25.01/30/25.

ANReferred ACT Relating to reducingCommittee prescriptionon drugHealth costs& byLong- eliminatingTerm barriersCare. impeding access to biosimilar medicines and interchangeable biological products;

andAN amendingACT RCWRelating 48.43.420,to 41.05.410,reducing 69.41.120,prescription anddrug 69.41.125.costs by eliminating barriers impeding access to biosimilar medicines;

amending RCW 48.43.420, 41.05.410, 69.41.120, and 69.41.125;

and creating a new section.

NEW SECTION.

The legislature finds that increasing access to biosimilar medicines has the potential to significantly reduce prescription drug costs.

Biosimilar medicines are approved according to the same food and drug administration standards of pharmaceutical quality, safety, and efficacy as their reference medicines.

Therefore, it is the intent of the legislature to eliminate barriers impeding access to biosimilar medicines and the savings they can provide.

Sec.

2.

(1) When coverage of a prescription drug for the treatment of any medical condition is subject to prescription drug utilization management, the patient and prescribing practitioner must have access top. a clear, readily accessible, and convenient process to request an exception through which the prescription drug utilization management can be overridden in favor of coverage of a prescription drug prescribed by a treating health care provider.

1 SB 5594 to a clear, readily accessible, and convenient process to request an exception through which the prescription drug utilization management can be overridden in favor of coverage of a prescription drug prescribed by a treating health care provider.

Approval criteria must be clearly posted on the health carrier and prescription drug p.utilization management entity's website.

1 ESSB 5594 utilization management entity's website.

or (e)p. The required prescription drug is not in the best interest of the patient, based on documentation of medical appropriateness, because the patient's use of the prescription drug is expected to:

2 SB 5594 (e) The required prescription drug is not in the best interest of the patient, based on documentation of medical appropriateness, because the patient's use of the prescription drug is expected to:

p.(4) Upon the granting of an exception, the health carrier or prescription drug utilization management entity shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.

2 ESSB 5594 (4) Upon the granting of an exception, the health carrier or prescription drug utilization management entity shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.

and (ii) Within one business day of receipt of sufficient information from the treating health care provider as disclosed under subsection (2) of this section, approve a request if the information provided meets at least one of the conditions referenced in subsection (3) of this section or if deemed medically appropriate, or deny a request if thep. requested service does not meet at least one of the conditions referenced in subsection (3) of this section.

3 SB 5594 the requested service does not meet at least one of the conditions referenced in subsection (3) of this section.

(d) For purposes of this subsection, exception requests are considered urgent when an enrollee is experiencing a health condition that may seriously jeopardize the enrollee's life, health, or ability p.to regain maximum function, or when an enrollee is undergoing a current course of treatment using a nonformulary drug.

3 ESSB 5594 to regain maximum function, or when an enrollee is undergoing a current course of treatment using a nonformulary drug.

(a) A health carrier or prescription drug utilization management entity from requiring a patient to try an AB-rated generic equivalent or((or a biological product that isis)), an interchangeable biological productp. prior to providing coverage for the equivalent branded prescription drug;

(b)4 BeginningSB January5594 1,product, 2026, a health carrier or prescription drug utilization management entity from requiring a patient to try a biosimilar prioras todefined providingunder coverage42 forU.S.C. the equivalent branded prescription drug;

(c) A health carrier or prescription drug utilization management entity from denying an exception for a drug that has been removed p.

4 ESSB 5594 from the market due to safety concerns from the federal food and drug administration;

or (((c))) (d) A health care provider from prescribing a prescription drug that is determined to be medically appropriate.

2.262 (i)(2), prior to providing coverage for the equivalent branded prescription drug;

(b) A health carrier or prescription drug utilization management entity from denying an exception for a drug that has been removed from the market due to safety concerns from the federal food and drug administration;

or (c) A health care provider from prescribing a prescription drug that is determined to be medically appropriate.

Sec.

3.

(e)p. The qualified health plan must meet additional participation requirements to reduce barriers to maintaining and improving health and align to state agency value-based purchasing.

5 SB 5594 (e) The qualified health plan must meet additional participation requirements to reduce barriers to maintaining and improving health and align to state agency value-based purchasing.

p.care coordination and chronic disease management;

5 ESSB 5594 care coordination and chronic disease management;

(3)(a) At the request of the authority for monitoring, enforcement, or program and quality improvement activities, a qualified health plan offered under this section must provide cost and quality of care information and data to the authority, and may not enter into an agreement with a provider or third party that would restrictp. the qualified health plan from providing this information or data.

6 SB 5594 restrict the qualified health plan from providing this information or data.

p.(4) Nothing in this section prohibits a health carrier offering qualified health plans under this section from offering other health plans in the individual market.