Biosimilar medicines

AN ACT Relating to reducing prescription drug costs by 1
eliminating barriers impeding access to biosimilar medicines; 2
amending RCW 48.43.420, 41.05.410, 69.41.120, and 69.41.125; and 3
creating a new section. 4
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:5
NEW SECTION. Sec. 1. The legislature finds that increasing 6
access to biosimilar medicines has the potential to significantly 7
reduce prescription drug costs. Biosimilar medicines are approved 8
according to the same food and drug administration standards of 9
pharmaceutical quality, safety, and efficacy as their reference 10
medicines. Therefore, it is the intent of the legislature to 11
eliminate barriers impeding access to biosimilar medicines and the 12
savings they can provide.13
Sec. 2. RCW 48.43.420 and 2019 c 171 s 3 are each amended to 14
read as follows: 15
For health plans delivered, issued for delivery, or renewed on or 16
after January 1, 2021: 17
(1) When coverage of a prescription drug for the treatment of any 18
medical condition is subject to prescription drug utilization 19
management, the patient and prescribing practitioner must have access 20
S-0988.1
SENATE BILL 5594
State of Washington 69th Legislature 2025 Regular Session
By Senators Harris, Cleveland, Hasegawa, and Shewmake
Read first time 01/30/25. Referred to Committee on Health & Long-
Term Care.
p. 1 SB 5594
to a clear, readily accessible, and convenient process to request an 1
exception through which the prescription drug utilization management 2
can be overridden in favor of coverage of a prescription drug 3
prescribed by a treating health care provider. A health carrier or 4
prescription drug utilization management entity may use its existing 5
medical exceptions process to satisfy this requirement. The process 6
must be easily accessible on the health carrier and prescription drug 7
utilization management entity's website. Approval criteria must be 8
clearly posted on the health carrier and prescription drug 9
utilization management entity's website. This information must be in 10
plain language and understandable to providers and patients.11
(2) Health carriers must disclose all rules and criteria related 12
to the prescription drug utilization management process to all 13
participating providers, including the specific information and 14
documentation that must be submitted by a health care provider or 15
patient to be considered a complete exception request.16
(3) An exception request must be granted if the health carrier or 17
prescription drug utilization management entity determines that the 18
evidence submitted by the provider or patient is sufficient to 19
establish that: 20
(a) The required prescription drug is contraindicated or will 21
likely cause a clinically predictable adverse reaction by the 22
patient; 23
(b) The required prescription drug is expected to be ineffective 24
based on the known clinical characteristics of the patient and the 25
known characteristics of the prescription drug regimen;26
(c) The patient has tried the required prescription drug or 27
another prescription drug in the same pharmacologic class or a drug 28
with the same mechanism of action while under his or her current or a 29
previous health plan, and such prescription drug was discontinued due 30
to lack of efficacy or effectiveness, diminished effect, or an 31
adverse event; 32
(d) The patient is currently experiencing a positive therapeutic 33
outcome on a prescription drug recommended by the patient's provider 34
for the medical condition under consideration while on his or her 35
current or immediately preceding health plan, and changing to the 36
required prescription drug may cause clinically predictable adverse 37
reactions, or physical or mental harm to, the patient; or38
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(e) The required prescription drug is not in the best interest of 1
the patient, based on documentation of medical appropriateness, 2
because the patient's use of the prescription drug is expected to:3
(i) Create a barrier to the patient's adherence to or compliance 4
with the patient's plan of care; 5
(ii) Negatively impact a comorbid condition of the patient;6
(iii) Cause a clinically predictable negative drug 7
interaction; or 8
(iv) Decrease the patient's ability to achieve or maintain 9
reasonable functional ability in performing daily activities.10
(4) Upon the granting of an exception, the health carrier or 11
prescription drug utilization management entity shall authorize 12
coverage for the prescription drug prescribed by the patient's 13
treating health care provider. 14
(5)(a) For nonurgent exception requests, the health carrier or 15
prescription drug utilization management entity must:16
(i) Within three business days notify the treating health care 17
provider that additional information, as disclosed under subsection 18
(2) of this section, is required in order to approve or deny the 19
exception request, if the information provided is not sufficient to 20
approve or deny the request; and 21
(ii) Within three business days of receipt of sufficient 22
information from the treating health care provider as disclosed under 23
subsection (2) of this section, approve a request if the information 24
provided meets at least one of the conditions referenced in 25
subsection (3) of this section or if deemed medically appropriate, or 26
deny a request if the requested service does not meet at least one of 27
the conditions referenced in subsection (3) of this section.28
(b) For urgent exception requests, the health carrier or 29
prescription drug utilization management entity must:30
(i) Within one business day notify the treating health care 31
provider that additional information, as disclosed under subsection 32
(2) of this section, is required in order to approve or deny the 33
exception request, if the information provided is not sufficient to 34
approve or deny the request; and 35
(ii) Within one business day of receipt of sufficient information 36
from the treating health care provider as disclosed under subsection 37
(2) of this section, approve a request if the information provided 38
meets at least one of the conditions referenced in subsection (3) of 39
this section or if deemed medically appropriate, or deny a request if 40
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the requested service does not meet at least one of the conditions 1
referenced in subsection (3) of this section. 2
(c) If a response by a health carrier or prescription drug 3
utilization management entity is not received within the time frames 4
established under this section, the exception request is deemed 5
granted. 6
(d) For purposes of this subsection, exception requests are 7
considered urgent when an enrollee is experiencing a health condition 8
that may seriously jeopardize the enrollee's life, health, or ability 9
to regain maximum function, or when an enrollee is undergoing a 10
current course of treatment using a nonformulary drug.11
(6) Health carriers must cover an emergency supply fill if a 12
treating health care provider determines an emergency fill is 13
necessary to keep the patient stable while the exception request is 14
being processed. This exception shall not be used to solely justify 15
any further exemption. 16
(7) When responding to a prescription drug utilization management 17
exception request, a health carrier or prescription drug utilization 18
management entity shall clearly state in their response if the 19
exception request was approved or denied. The health carrier must use 20
clinical review criteria as referenced in RCW 48.43.410 for the basis 21
of any denial. Any denial must be based upon and include the specific 22
clinical review criteria relied upon for the denial and include 23
information regarding how to appeal denial of the exception request. 24
If the exception request from a treating health care provider is 25
denied for administrative reasons, or for not including all the 26
necessary information, the health carrier or prescription drug 27
utilization management entity must inform the provider what 28
additional information is needed and the deadline for its submission.29
(8) The health carrier or prescription drug utilization 30
management entity must permit a stabilized patient to remain on a 31
drug during an exception request process. 32
(9) A health carrier must provide sixty days' notice to providers 33
and patients for any new policies or procedures applicable to 34
prescription drug utilization management protocols. New health 35
carrier policies or procedures may not be applied retroactively.36
(10) This section does not prevent: 37
(a) A health carrier or prescription drug utilization management 38
entity from requiring a patient to try an AB-rated generic equivalent 39
((or a biological product that is )), an interchangeable biological 40
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product, or a biosimilar as defined under 42 U.S.C. Sec. 262 (i)(2), 1
prior to providing coverage for the equivalent branded prescription 2
drug; 3
(b) A health carrier or prescription drug utilization management 4
entity from denying an exception for a drug that has been removed 5
from the market due to safety concerns from the federal food and drug 6
administration; or 7
(c) A health care provider from prescribing a prescription drug 8
that is determined to be medically appropriate. 9
Sec. 3. RCW 41.05.410 and 2021 c 246 s 6 are each amended to 10
read as follows: 11
(1) The authority, in consultation with the health benefit 12
exchange, must contract with one or more health carriers to offer 13
qualified health plans on the Washington health benefit exchange for 14
plan years beginning in 2021. A health carrier contracting with the 15
authority under this section must offer at least one bronze, one 16
silver, and one gold qualified health plan in a single county or in 17
multiple counties. The goal of the procurement conducted under this 18
section is to have a choice of qualified health plans under this 19
section offered in every county in the state. The authority may not 20
execute a contract with an apparently successful bidder under this 21
section until after the insurance commissioner has given final 22
approval of the health carrier's rates and forms pertaining to the 23
health plan to be offered under this section and certification of the 24
health plan under RCW 43.71.065. 25
(2) A qualified health plan offered under this section must meet 26
the following criteria: 27
(a) The qualified health plan must be a standardized health plan 28
established under RCW 43.71.095; 29
(b) The qualified health plan must meet all requirements for 30
qualified health plan certification under RCW 43.71.065 including, 31
but not limited to, requirements relating to rate review and network 32
adequacy; 33
(c) The qualified health plan must incorporate recommendations of 34
the Robert Bree collaborative and the health technology assessment 35
program; 36
(d) The qualified health plan may use an integrated delivery 37
system or a managed care model that includes care coordination or 38
care management to enrollees as appropriate; 39
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(e) The qualified health plan must meet additional participation 1
requirements to reduce barriers to maintaining and improving health 2
and align to state agency value-based purchasing. These requirements 3
may include, but are not limited to, standards for population health 4
management; high-value, proven care; health equity; primary care; 5
care coordination and chronic disease management; wellness and 6
prevention; prevention of wasteful and harmful care; and patient 7
engagement; 8
(f) To reduce administrative burden and increase transparency, 9
the qualified health plan's utilization review processes must:10
(i) Be focused on care that has high variation, high cost, or low 11
evidence of clinical effectiveness; and 12
(ii) Meet national accreditation standards; 13
(g) The total amount the qualified health plan reimburses 14
providers and facilities for all covered benefits in the statewide 15
aggregate, excluding pharmacy benefits, may not exceed one hundred 16
sixty percent of the total amount medicare would have reimbursed 17
providers and facilities for the same or similar services in the 18
statewide aggregate; 19
(h) For services provided by rural hospitals certified by the 20
centers for medicare and medicaid services as critical access 21
hospitals or sole community hospitals, the rates may not be less than 22
one hundred one percent of allowable costs as defined by the United 23
States centers for medicare and medicaid services for purposes of 24
medicare cost reporting; 25
(i) Reimbursement for primary care services, as defined by the 26
authority, provided by a physician with a primary specialty 27
designation of family medicine, general internal medicine, or 28
pediatric medicine, may not be less than one hundred thirty-five 29
percent of the amount that would have been reimbursed under the 30
medicare program for the same or similar services; and31
(j) The qualified health plan must comply with any requirements 32
established by the authority to address amounts expended on pharmacy 33
benefits including, but not limited to, increasing generic and 34
biosimilar utilization and use of evidence-based formularies.35
(3)(a) At the request of the authority for monitoring, 36
enforcement, or program and quality improvement activities, a 37
qualified health plan offered under this section must provide cost 38
and quality of care information and data to the authority, and may 39
not enter into an agreement with a provider or third party that would 40
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restrict the qualified health plan from providing this information or 1
data. 2
(b) Pursuant to RCW 42.56.650, any cost or quality information or 3
data submitted to the authority is exempt from public disclosure.4
(4) Nothing in this section prohibits a health carrier offering 5
qualified health plans under this section from offering other health 6
plans in the individual market. 7
Sec. 4. RCW 69.41.120 and 2015 c 242 s 2 are each amended to 8
read as follows: 9
(1) ((Every drug prescription shall contain an instruction on 10
whether or not a therapeutically equivalent generic drug or 11
interchangeable biological product may be substituted in its place, 12
unless substitution is permitted under a prior-consent authorization.13
If a written prescription is involved, the prescription must be 14
legible and the form shall have two signature lines at opposite ends 15
on the bottom of the form. Under the line at the right side shall be 16
clearly printed the words "DISPENSE AS WRITTEN." Under the line at 17
the left side shall be clearly printed the words "SUBSTITUTION 18
PERMITTED." The practitioner shall communicate the instructions to 19
the pharmacist by signing the appropriate line. No prescription shall 20
be valid without the signature of the practitioner on one of these 21
lines. In the case of a prescription issued by a practitioner in 22
another state that uses a one-line prescription form or variation 23
thereof, the pharmacist may substitute a therapeutically equivalent 24
generic drug or interchangeable biological product unless otherwise 25
instructed by the practitioner through the use of the words "dispense 26
as written," words of similar meaning, or some other indication.27
(2) If an oral prescription is involved, the practitioner or the 28
practitioner's agent shall instruct the pharmacist as to whether or 29
not a therapeutically equivalent generic drug or interchangeable 30
biological product may be substituted in its place. The pharmacist 31
shall note the instructions on the file copy of the prescription.32
(3))) A pharmacist filling a prescription order for a drug 33
product prescribed by its trade or brand name may select a biosimilar 34
as defined under 42 U.S.C. Sec. 262 (i)(2), or interchangeable 35
biological product.36
(2) In no case shall a selection be made under this section if 37
the practitioner personally indicates, either orally or in the 38
practitioner's own handwriting, "do not substitute," "dispense as 39
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written," or words of similar meaning. Nothing in this subsection 1
prohibits a practitioner from checking a box on a prescription marked 2
"do not substitute" if the practitioner personally initials the box 3
or checkmark. 4
(3)(a) Selection under this section is within the discretion of 5
the pharmacist, except as provided in subsection (2) of this section. 6
The person who selects the drug product to be dispensed under this 7
section assumes the same responsibility for selecting the dispensed 8
drug product as would be incurred in filling a prescription for a 9
drug product prescribed by generic name. There shall be no liability 10
on the practitioner for an act or omission by a pharmacist in 11
selecting, preparing, or dispensing a drug product under this 12
section. In no case shall the pharmacist select a drug product under 13
this section unless the drug product selected costs the patient less 14
than the prescribed drug product.15
(b) For the purposes of this subsection, "cost" includes any 16
professional fee that may be charged by the pharmacist.17
(4) When a substitution is made under this section, the intent of 18
the substitution should be to provide a product with a lower out-of-19
pocket cost to the patient. The drug product dispensed must be 20
communicated to the patient with the name of the dispensed drug 21
product indicated on the prescription label.22
(5) The pharmacist shall note the manufacturer of the drug 23
dispensed on the file copy of a written or oral prescription.24
(((4))) (6) The pharmacist shall retain the file copy of a 25
written or oral prescription for the same period of time specified in 26
RCW 18.64.245 for retention of prescription records.27
Sec. 5. RCW 69.41.125 and 2015 c 242 s 3 are each amended to 28
read as follows: 29
Unless the prescribed biological product is requested by the 30
patient or the patient's representative, ((if "substitution 31
permitted" is marked on the prescription as provided in RCW 32
69.41.120)) or the prescriber has indicated "do not substitute," or 33
words of similar meaning , the pharmacist must substitute ((an)) a 34
biosimilar as defined under 42 U.S.C. Sec. 262 (i)(2) or 35
interchangeable biological product that he or she has in stock for 36
the biological product prescribed if the wholesale price for the 37
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biosimilar or interchangeable biological product to the pharmacist is 1
less than the wholesale price for the biological product prescribed.2
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