2ESSB 5594
In CommitteeSenate
Biosimilar medicines
Concerning biosimilar medicines. (REVISED FOR ENGROSSED: Concerning biosimilar medicines and interchangeable biological products.)
This status may be delayed. See Action History below for the latest updates.
How does a bill become law?
- Introduced: The bill is filed and assigned a number.
- Committee: A subject-matter committee holds hearings, takes public testimony, and decides whether to advance the bill.
- Floor Vote: The full chamber (House or Senate) debates and votes on the bill.
- Opposite Chamber: The bill repeats the committee and floor vote process in the other chamber.
- Governor: The Governor reviews the bill and decides whether to sign or veto it.
- Signed: The bill has been signed into law.
AI Analysis
This bill aims to lower prescription drug costs in Washington by making it easier for patients to access biosimilar medicines—lower-cost versions of biologic drugs—by removing barriers in insurance coverage rules, pharmacist substitution rules, and state health plan requirements. It strengthens patients’ rights to request exceptions to drug coverage rules and clarifies when pharmacists can or must substitute biosimilars for more expensive biological drugs.
- Health insurers must create a clear, fast, and accessible process for patients and providers to request exceptions to drug coverage rules—especially to use a biosimilar or other drug if the required drug is unsafe or ineffective for the patient.
- Insurers must approve or deny exception requests within 3 business days for nonurgent cases and 1 business day for urgent cases; if no response is received, the request is automatically approved.
- Pharmacists may substitute a biosimilar or interchangeable biological product for a prescribed biological drug—unless the prescriber says ‘do not substitute’—and must choose the lower-cost option for the patient.
- When a biosimilar is substituted, the pharmacist must tell the patient the name of the drug dispensed and ensure it is cheaper than the prescribed drug (including any pharmacist fees).
- State-qualified health plans on the Washington Health Benefit Exchange must include policies to increase use of biosimilars and generic drugs, and must meet standards for transparency, equity, and value-based care.
Who is affected
- Patients and their families — Patients who need biosimilar or biological medications may face fewer barriers to accessing lower-cost alternatives, and have clearer rights to request exceptions if a required drug is not appropriate for them.
- Health insurance companies (health carriers) — Health plans and insurers must follow new rules for processing exception requests, disclose utilization management rules clearly, and cover emergency drug supplies when needed.
- Pharmacists — Pharmacists gain clearer authority to substitute biosimilars or interchangeable biological products for prescribed biological drugs—unless the prescriber says not to—and must ensure the substituted product is lower-cost for the patient.
- State government agencies — State agencies (like the Health Benefit Exchange and Insurance Commissioner) must ensure qualified health plans meet new standards promoting biosimilar use and transparency in pharmacy benefits.
- Health care providers and prescribers — Prescribers (doctors, nurse practitioners, etc.) must communicate clearly whether substitution is allowed, but are protected from liability for pharmacists’ substitution decisions—as long as they follow the new rules.
Pro/Con Analysis
Stronger case for benefits
Potential Benefits (5)
Creates a legally enforceable, time-bound exception process with automatic approval if delayed—this significantly reduces administrative barriers for patients needing biosimilars or alternative drugs, especially those with complex or failing regimens, directly improving access and reducing out-of-pocket costs.
HealthcarePeopleRef: Sec. 2(3)(a)-(e), Sec. 2(5)(a)(ii), (b)(ii), (c)Mandates pharmacist substitution of lower-cost biosimilars unless ‘do not substitute’ is specified—and requires the substituted product to cost less to the patient—this directly lowers out-of-pocket drug costs for patients using biologics (e.g., for autoimmune or cancer conditions), where biosimilars can be 15–30% cheaper.
HealthcarePeopleRef: Sec. 4(3)(a), Sec. 4(4), Sec. 5Requires clear, plain-language disclosure of exception rules to providers and patients, and mandates denial reasons tied to clinical criteria—this empowers patients and providers to navigate coverage rules more effectively, reducing arbitrary denials and improving trust in the system.
HealthcarePeopleRef: Sec. 2(2), Sec. 2(7), Sec. 2(10)(c)Requires state Exchange plans to promote biosimilar use and allows step therapy *toward* biosimilars—this creates a structural incentive for plans to include lower-cost biosimilars in formularies, potentially lowering overall premiums over time.
HealthcarePeopleRef: Sec. 3(j), Sec. 2(10)(a)Clarifies that ‘cost’ includes pharmacist fees and mandates substitution only when the biosimilar is cheaper to the patient—this prevents hidden cost-shifting and ensures patients benefit from price differences, not just list prices.
HealthcarePeopleRef: Sec. 4(3)(b), Sec. 5
Potential Concerns (5)
Mandates strict 1- or 3-day turnaround for exception requests and automatic approval if delayed, plus emergency fill coverage—this improves access to needed drugs but increases administrative burden and operational risk for insurers, potentially leading to narrower formularies or higher premiums over time as plans seek to offset compliance costs.
HealthcarePeopleRef: Sec. 2(5)(a)(ii), (b)(ii), (c), (d); Sec. 2(6)Expands exception approval criteria to include functional ability and adherence barriers, and requires plans to allow patients to remain on a drug during the exception process—this strengthens patient autonomy and clinical discretion, but may increase utilization of higher-cost drugs if plans cannot enforce step therapy effectively.
HealthcarePeopleRef: Sec. 2(3)(e)(iv), Sec. 2(8)Requires pharmacists to select the lower-cost biosimilar (including pharmacist fees) and disclose the substituted product to patients—this directly reduces out-of-pocket costs for patients who use biosimilars, but may increase liability exposure for pharmacists if cost comparisons are miscalculated or miscommunicated.
HealthcarePeopleRef: Sec. 4(3)(a), Sec. 4(4)Requires qualified health plans on the Exchange to increase biosimilar/generic utilization and allows step therapy *toward* biosimilars—but does not prohibit step therapy *away* from biosimilars, and allows plans to require prior use of generics or interchangeable products first, limiting immediate biosimilar access for some patients.
HealthcarePeopleRef: Sec. 3(j), Sec. 2(10)(a)Requires 60-day notice before applying new utilization management policies—but this may delay implementation of cost-saving changes and could be exploited by plans to phase in restrictive policies gradually, reducing predictability for patients and providers.
HealthcareLean peopleRef: Sec. 2(9)
Who Is Most Affected
Patients with chronic conditions requiring biologics (e.g., rheumatoid arthritis, Crohn’s disease, cancer) stand to gain significantly: faster access to biosimilars, automatic approval if insurers delay, and guaranteed lower out-of-pocket costs when substitutions occur. However, those on stable regimens may face unexpected switches if prescribers do not explicitly opt out.
Health insurers face new administrative obligations (3/1-day review deadlines, emergency fills, disclosure requirements), which may increase operational costs and reduce flexibility in formulary design—though increased biosimilar use may lower drug spending over time. Smaller insurers may struggle more with compliance than large carriers.
Pharmacists gain clearer authority to substitute biosimilars and are protected from liability—but must verify cost differences and document substitutions carefully. This increases their role in cost-containment but adds documentation burden and potential liability if cost comparisons are inaccurate.
State agencies (Health Benefit Exchange, Insurance Commissioner) gain enforcement authority over Exchange plans’ biosimilar utilization policies, but must monitor compliance and potentially litigate noncompliance—adding regulatory workload without new funding.
Prescribers gain protection from liability for pharmacist substitutions but must now explicitly indicate ‘do not substitute’ (e.g., by initialing a box) to prevent unwanted switches—shifting some clinical control to pharmacists and increasing documentation burden.