HB 1725
In CommitteeHouse
Biosimilar medicines
Increasing access to biosimilar medicines.
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 insurance and pharmacy barriers. It strengthens patient and provider rights to request exceptions to drug coverage rules, clarifies pharmacists’ authority to substitute biosimilars, and requires state health plans to promote biosimilar use.
- Requires health insurers to create a clear, fast, and accessible process for patients and providers to request exceptions to drug coverage rules—especially to cover a biosimilar or other prescribed drug when standard rules would block it.
- Sets strict time limits: insurers must decide nonurgent exception requests within 3 business days and urgent requests within 1 business day; if no decision is made on time, the request is automatically approved.
- Allows pharmacists to substitute a biosimilar or interchangeable biological product for a brand-name biologic if the brand was prescribed by name, as long as the substitution results in lower out-of-pocket cost to the patient and the prescriber did not explicitly prohibit substitution.
- Requires pharmacists to inform patients about any substitution, including the name of the substituted product, and to keep records of the manufacturer of the dispensed drug.
- Mandates that state-contracted health plans on the Washington Health Benefit Exchange must promote use of biosimilars and other high-value drugs through their formularies and pharmacy practices.
- Prohibits insurers from using prior authorization rules to block access to biosimilars when they are medically appropriate and would reduce costs.
Who is affected
- Patients with chronic or complex conditions requiring biologic or biosimilar medications (e.g., rheumatoid arthritis, cancer, psoriasis) — Patients who need biosimilar or biological medications may gain easier access to lower-cost alternatives and have more control over treatment decisions through streamlined exception processes.
- Health insurance carriers and pharmacy benefit managers — Health plans and insurers must revise their prior authorization and exception processes to be faster, more transparent, and more likely to approve exceptions based on medical need, especially for biosimilars.
- Pharmacists — Pharmacists gain clearer authority to substitute biosimilars for brand-name biologics when appropriate, and must ensure patients are informed about substitutions and cost differences.
- State health agencies and Washington Health Benefit Exchange — State agencies managing public health plans (e.g., Washington Health Benefit Exchange) must ensure plans they contract with promote use of high-value, evidence-based drugs—including biosimilars.
- Prescribing health care providers — Health care providers (doctors, nurse practitioners) must navigate updated exception request processes and may see faster responses when advocating for biosimilars or other needed medications on behalf of patients.
Pro/Con Analysis
Stronger case for benefits
Potential Benefits (5)
Requires automatic approval of exception requests when health plans miss deadlines and explicitly allows coverage of a drug that supports patient functional ability—directly benefiting patients with chronic conditions (e.g., rheumatoid arthritis, MS) who need timely access to biosimilars or alternative drugs without arbitrary delays.
HealthcarePeopleRef: Sec. 2(3)(e)(iv), Sec. 2(5)(d)Requires health plans to permit stabilized patients to remain on their current drug during exception review—protecting continuity of care for patients with complex or unstable conditions who might otherwise be forced to switch mid-treatment, risking relapse or hospitalization.
HealthcarePeopleRef: Sec. 2(8)Empowers pharmacists to substitute biosimilars only when the patient’s out-of-pocket cost is lower—ensuring direct, immediate savings at the pharmacy counter for patients, especially those on high-cost biologics (e.g., Humira, Enbrel), without requiring prior authorization delays.
HealthcarePeopleRef: Sec. 4(3), Sec. 4(4)Requires state-contracted health plans on the Washington Health Benefit Exchange to promote biosimilar use and mandates transparent exception processes—potentially lowering premiums and out-of-pocket costs for low- and middle-income enrollees who rely on Exchange coverage and are most vulnerable to drug cost spikes.
HealthcarePeopleRef: Sec. 3(j), Sec. 2(1)Shortens exception review timelines to 3 days (nonurgent) and 1 day (urgent), significantly reducing treatment delays for patients needing urgent biosimilar access—especially beneficial for patients with aggressive conditions (e.g., cancer, autoimmune flares) where timely treatment affects outcomes.
HealthcarePeopleRef: Sec. 2(5)(a)(ii), Sec. 2(5)(b)(ii)
Potential Concerns (5)
Mandates strict 3-day (nonurgent) and 1-day (urgent) turnaround for exception decisions, which may strain health plan operational capacity—especially for smaller insurers or those with limited prior authorization infrastructure—potentially increasing administrative costs that could be passed to employers or subscribers through higher premiums or reduced plan options.
HealthcareRef: Sec. 2(5)(a)(ii), Sec. 2(5)(b)(ii)Requires 60-day advance notice for changes to utilization management protocols, which may delay health plans’ ability to rapidly update formularies or respond to new clinical evidence or market changes—potentially reducing agility in managing drug costs or adapting to new biosimilars or generics.
HealthcareRef: Sec. 2(9)Automatic approval of exception requests after missed deadlines may lead to inappropriate or non-evidence-based coverage approvals if health plans lack adequate internal controls or oversight—potentially increasing utilization of high-cost drugs when lower-cost alternatives exist, offsetting savings from biosimilar promotion.
HealthcareRef: Sec. 2(5)(c)The automatic approval provision may create moral hazard—providers or patients may delay submitting complete requests knowing they’ll be approved by default—increasing administrative burden and potentially undermining the rigor of medical necessity reviews.
HealthcareRef: Sec. 2(5)(e)Mandates detailed public posting of exception criteria and provider communication of documentation requirements, which may increase transparency but also expose health plans to legal or regulatory scrutiny if criteria are vague or inconsistently applied—potentially increasing legal risk and compliance costs for insurers.
HealthcareRef: Sec. 2(1), Sec. 2(2)
Who Is Most Affected
Patients with chronic conditions requiring biologics (e.g., RA, psoriasis, IBD, cancer) stand to gain significantly: faster access to lower-cost biosimilars, automatic coverage if insurers miss deadlines, and pharmacist-led substitution at lower out-of-pocket cost. This directly reduces financial burden and improves treatment adherence.
Health insurers and PBMs face new operational requirements—faster exception processing, automatic approvals, and stricter transparency rules—which may increase administrative costs and reduce leverage in negotiating drug prices. However, long-term savings from increased biosimilar use could offset some costs if formulary management improves.
Pharmacists gain clearer authority to substitute biosimilars when it reduces patient cost, and must inform patients of substitutions—empowering them as cost-conscious gatekeepers. However, they also bear responsibility for ensuring substitutions are appropriate and documented, increasing liability exposure if errors occur.
State agencies (e.g., Washington Health Benefit Exchange, DOH) gain stronger tools to enforce value-based drug use in public plans, potentially reducing state drug expenditures. However, they also inherit monitoring and enforcement responsibilities for compliance with exception timelines and substitution rules.
Providers benefit from faster exception decisions and streamlined advocacy for biosimilars, but must adapt to new documentation and timing requirements. The automatic approval rule reduces administrative friction when advocating for patients, but may increase workload if insurers delay responses to trigger automatic approvals.