NY State Senate Bill 2025-S3485A

Senate Bill S3485A

2025-2026 Legislative Session

Relates to prescription drug formulary coverage for interchangeable biologics and biosimilars

download bill text pdf

Current Bill Status - In Senate Committee Insurance Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jun 04, 2025	print number 3485a
Jun 04, 2025	amend and recommit to insurance
Jan 27, 2025	referred to insurance

Bill Amendments

Original

A (Active)

2025-S3485 - Details

See Assembly Version of this Bill:: A3973
Current Committee:: Senate Insurance
Law Section:: Insurance Law
Laws Affected:: Amd §§4903, 3242 & 4329, Ins L
Versions Introduced in 2023-2024 Legislative Session:: S7768, A9055

2025-S3485 - Summary

Relates to prescription drug formulary coverage for interchangeable biologics and biosimilars.

2025-S3485 - Sponsor Memo

                                 
BILL NUMBER: S3485

SPONSOR: HINCHEY
 
TITLE OF BILL:

An act to amend the insurance law, in relation to prescription drug
formulary coverage for interchangeable biologics and biosimilars

 
PURPOSE:

To reduce prescription drug costs in New York by allowing biosimilar
Medicines to be substituted for the original biologics.

 
SUMMARY OF PROVISIONS:

Section one amends section 4903 of the Insurance law to add both inter-
changeable biologics and biosimilars to New York's step therapy proto-
col, allowing utilization review agents to require an insured to try an
interchangeable biologic or biosimilar medication before covering the
name brand

Section two amends section 3242 of the Insurance law to allow insurance

companies to move a reference drug to a tier with a larger deductible,
copayment, or coinsurance if a biosimilar version of that drug exists
and is added to the formulary at the same time.

Section three amends section 4329 of the Insurance law to allow non-pro-
fit insurance companies to move a reference drug to a tier with a larger
deductible, copayment, or coinsurance if a biosimiiar version of that
drug exists and is added to the formulary at the same time.

Section four redesignates a subsection from (c) to (d).

Section five redesignates a subsection from (c) to (d).

Section six establishes the the effective date.

 
JUSTIFICATION:

Biological medications or 'biologics' are on the cutting edge of medical
technology and are used to treat complicated conditions and diseases
including cancer, rheumatoid arthritis, diabetes, and multiple sclero-
sis. These drugs are often life-changing and lifesaving, but they are
also delicate and complicated to produce.  Biologics are made using
living organisms that produce the proteins required to make the medica-
tion. This process makes these medications incredibly cost prohibitive
for companies develop and test, resulting in high costs to patients and
insurance companies.

However, alternative versions of biologics called 'biosimilars' have
been developed. Biosimilars are FDA-approved drugs that are similar to
an existing biologic medication (for reference drug)and produce the same
outcome. Biosimilars are produced by manufactures did not develop the
original biologic. Because these manufacturers did not have to finance
the extensive costs associated with biologic development, they can sell
the medication at a lower cost. In addition, biosimilar undergo an
abbreviated FDA approval process because the reference biologic has
demonstrated the medication's effectiveness. This shorter proceeding

further reduces a development costs for biosimilar manufacturers and
contributes to lower biosimilar prices.

This bill would amend New York State's insurance law to allow insurance
providers to require their insureds to try a biosimilar medication
instead of the reference drug and place a biosimilar in a less expensive
tier of prescription medication. This would generate cost savings for
both the patient and the insurance company as biosimilars can vary in
price from the reference product from as low as 5% to in most cases 85%
less expensive, making access to medication more affordable for patients
and relieving the costs that insurance plans are incurring as well as
subscribers who continue to see higher costs in premiums due to alleged
high prescription drug costs. By encouraging lower cost products to be
offered at the lowest cost for patients, we are encouraging lower costs
for the patients and those employers and plant paying for the products.

 
LEGISLATIVE HISTORY:

2023-2024: A.9055/S.7768

 
FISCAL IMPLICATIONS:

To be determined.

 
EFFECTIVE DATE:
This act shall take effect immediately.

2025-S3485 - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   3485
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                             January 27, 2025
                                ___________
 
 Introduced  by  Sen. HINCHEY -- read twice and ordered printed, and when
   printed to be committed to the Committee on Insurance
 
 AN ACT to amend the insurance law,  in  relation  to  prescription  drug
   formulary coverage for interchangeable biologics and biosimilars
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Paragraph 4 of subsection (c-1)  of  section  4903  of  the
 insurance  law,  as added by chapter 512 of the laws of 2016, is amended
 to read as follows:
   (4) The insured is stable on a prescription drug or drugs selected  by
 their health care professional for the medical condition under consider-
 ation,  provided  that this shall not prevent a utilization review agent
 from [requiring an insured to try an AB-rated generic  equivalent  prior
 to providing coverage for the equivalent brand name prescription drug or
 drugs; or]:
   (I)  REQUIRING  AN INSURED TO TRY AN AB-RATED GENERIC EQUIVALENT OR AN
 INTERCHANGEABLE BIOLOGICAL PRODUCT PRIOR TO PROVIDING COVERAGE  FOR  THE
 EQUIVALENT BRAND NAME PRESCRIPTION DRUG OR DRUGS, OR
   (II)  REQUIRING  AN  INSURED  TO  TRY  A BIOSIMILAR PRIOR TO PROVIDING
 COVERAGE FOR THE BRAND  NAME  PRESCRIPTION  REFERENCE  PRODUCT  DRUG  OR
 DRUGS.
   § 2. Subparagraph (A) of paragraph 3 of subsection (c) of section 3242
 of  the  insurance  law,  as added by chapter 99 of the laws of 2022, is
 amended to read as follows:
   (A) An insurer with a formulary that includes two  or  more  tiers  of
 benefits  providing for different deductibles, copayments or coinsurance
 applicable to prescription drugs in each tier may  move  a  prescription
 drug  to a tier with a larger deductible, copayment or coinsurance if an
 AB-rated generic equivalent [or], AN interchangeable biological product,
 OR BIOSIMILAR for such prescription drug is added to  the  formulary  at
 the  same  time; PROVIDED THE CHANGE IS NOT APPLICABLE TO AN INSURED WHO
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD03429-02-5

 S. 3485                             2
 
 IS ALREADY RECEIVING SUCH PRESCRIPTION DRUG OR HAS BEEN  DIAGNOSED  WITH
 OR  PRESENTED WITH A CONDITION ON OR PRIOR TO THE START OF THE PLAN YEAR
 THAT IS TREATED BY SUCH PRESCRIPTION DRUG OR IS A PRESCRIPTION DRUG THAT
 IS OR WOULD BE PART OF THE INSURED'S TREATMENT PLAN FOR SUCH CONDITION.
   §  3.    Subparagraph  (A) of paragraph 3 of subsection (c) of section
 4329 of the insurance law, as added by chapter 99 of the laws  of  2022,
 is amended to read as follows:
   (A)  A corporation with a formulary that includes two or more tiers of
 benefits providing for different deductibles, copayments or  coinsurance
 applicable  to  prescription  drugs in each tier may move a prescription
 drug to a tier with a larger deductible, copayment or coinsurance if  an
 AB-rated generic equivalent [or], AN interchangeable biological product,
 OR  BIOSIMILAR  for  such prescription drug is added to the formulary at
 the same time; PROVIDED THE CHANGE IS NOT APPLICABLE TO AN  INSURED  WHO
 IS  ALREADY  RECEIVING SUCH PRESCRIPTION DRUG OR HAS BEEN DIAGNOSED WITH
 OR PRESENTED WITH A CONDITION ON OR PRIOR TO THE START OF THE PLAN  YEAR
 THAT IS TREATED BY SUCH PRESCRIPTION DRUG OR IS A PRESCRIPTION DRUG THAT
 IS  OR  WOULD BE PART OF THE INSURED'S TREATMENT REGIMEN FOR SUCH CONDI-
 TION.
   § 4. Subsection (c) of section 3242 of  the  insurance  law, as  added
 by chapter 99 of the laws of 2022, is redesignated subsection (d).
   §  5. Subsection (c) of section 4329 of the insurance law, as added by
 chapter 99 of the laws  of  2022, is redesignated subsection (d).
   § 6. This act shall take effect immediately.

2025-S3485A (ACTIVE) - Details

See Assembly Version of this Bill:: A3973
Current Committee:: Senate Insurance
Law Section:: Insurance Law
Laws Affected:: Amd §§4903, 3242 & 4329, Ins L
Versions Introduced in 2023-2024 Legislative Session:: S7768, A9055

2025-S3485A (ACTIVE) - Summary

Relates to prescription drug formulary coverage for interchangeable biologics and biosimilars.

2025-S3485A (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S3485A

SPONSOR: HINCHEY
 
TITLE OF BILL:

An act to amend the insurance law, in relation to prescription drug
formulary coverage for interchangeable biologics and biosimilars

 
PURPOSE:

To reduce prescription drug costs in New York by allowing biosimilar
medicines to be substituted for the original biologics.

 
SUMMARY OF PROVISIONS:

Section one amends section 4903 of the Insurance law to add both inter-
changeable biologics and biosimilars to New York's step therapy proto-
col, allowing utilization review agents to require an insured to try an
interchangeable biologic or biosimilar medication before covering the
name brand drug. Section two amends section 3242 of the Insurance law to
allow insurance companies to move a reference drug to a tier with a
larger deductible, copayment, or coinsurance if a biosimilar version of

that drug exists and is added to the formulary at the same time. Section
three amends section 4329 of the Insurance law to allow non-pro- fit
insurance companies to move a reference drug to a tier with a larger
deductible, copayment, or coinsurance if a biosimilar version of that
drug exists and is added to the formulary at the same time. Section four
redesignates a subsection from (c) to

(d). Section five redesignates a subsection (c) to (d). Section six
establishes the effective date.

 
JUSTIFICATION:

Biological medications or 'biologics' are on the cutting edge of medical
technology and are used to treat complicated conditions and diseases,
including cancer, rheumatoid arthritis, diabetes, and multiple sclero-
sis. These drugs are often life-changing and lifesaving, but they are
also delicate and complicated to produce.  Biologics are made using
living organisms that produce the proteins required to make the medica-
tion. This process makes these medications incredibly cost-prohibitive
for companies to develop and test, resulting in high costs to patients
and insurance companies. However, alternative versions of biologics
called 'biosimilars' have been developed. Biosimilars are FDA-approved
drugs that are similar to an existing biologic medication (or reference
drug) and produce the same outcome. Biosimilars are produced by manufac-
turers who did not develop the original biologic. Because these manufac-
turers did not have to finance the extensive costs associated with
biologic development, they can sell the medication at a lower cost. In
addition, biosimilars under- go an abbreviated FDA approval process
because the reference biologic has demonstrated the medication's effec-
tiveness. This shorter proceeding further reduces development costs for
biosimilar manufacturers and contributes to lower biosimilar prices.
This bill would amend New York State's insurance law to allow insurance
providers to require their insureds to try a biosimilar medication
instead of the reference drug and place a biosimilar in a less expensive
tier of prescription medication. This would generate cost savings for
both the patient and the insurance company as biosimilars can vary in
price from the reference product from as low as 5% to in most cases 85%
less expensive, making access to medication more affordable for patients
and relieving the costs that insurance plans are incurring as well as
subscribers who continue to see higher costs in premiums due to alleged
high prescription drug costs. By encouraging lower cost products to be
offered at the lowest cost for patients, we are encouraging lower costs
for the patients and those employers and plans paying for the products.

 
LEGISLATIVE HISTORY:

2023-2024: A.9055/5.7768

 
FISCAL IMPLICATIONS:

To be determined.

 
EFFECTIVE DATE:
This act shall take effect immediately.

2025-S3485A (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  3485--A
 
                        2025-2026 Regular Sessions
 
                             I N  S E N A T E
 
                             January 27, 2025
                                ___________
 
 Introduced  by  Sen. HINCHEY -- read twice and ordered printed, and when
   printed to be committed to the Committee  on  Insurance  --  committee
   discharged, bill amended, ordered reprinted as amended and recommitted
   to said committee
 
 AN  ACT  to  amend  the  insurance law, in relation to prescription drug
   formulary coverage for interchangeable biologics and biosimilars
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  Paragraph  4  of  subsection (c-1) of section 4903 of the
 insurance law, as added by chapter 512 of the laws of 2016,  is  amended
 to read as follows:
   (4)  The insured is stable on a prescription drug or drugs selected by
 their health care professional for the medical condition under consider-
 ation, provided that this shall not prevent a utilization  review  agent
 from  [requiring  an insured to try an AB-rated generic equivalent prior
 to providing coverage for the equivalent brand name prescription drug or
 drugs; or]:
   (I) REQUIRING AN INSURED TO TRY AN AB-RATED GENERIC EQUIVALENT  OR  AN
 INTERCHANGEABLE  BIOLOGICAL  PRODUCT PRIOR TO PROVIDING COVERAGE FOR THE
 EQUIVALENT BRAND NAME PRESCRIPTION DRUG OR DRUGS, OR
   (II) REQUIRING AN INSURED TO  TRY  A  BIOSIMILAR  PRIOR  TO  PROVIDING
 COVERAGE  FOR  THE  BRAND  NAME  PRESCRIPTION  REFERENCE PRODUCT DRUG OR
 DRUGS.
   § 2. Subparagraph (A) of paragraph 3 of subsection (c) of section 3242
 of the insurance law, as added by chapter 99 of the  laws  of  2022,  is
 amended to read as follows:
   (A)  An  insurer  with  a formulary that includes two or more tiers of
 benefits providing for different deductibles, copayments or  coinsurance
 applicable  to  prescription  drugs in each tier may move a prescription
 drug to a tier with a larger deductible, copayment or coinsurance if  an
 AB-rated generic equivalent [or], AN interchangeable biological product,
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD03429-04-5

 S. 3485--A                          2
 
 OR  BIOSIMILAR for such prescription drug is added to  the  formulary at
 the same time.
   §  3.    Subparagraph  (A) of paragraph 3 of subsection (c) of section
 4329 of the insurance law, as added by chapter 99 of the laws  of  2022,
 is amended to read as follows:
   (A)  A corporation with a formulary that includes two or more tiers of
 benefits providing for different deductibles, copayments or  coinsurance
 applicable  to  prescription  drugs in each tier may move a prescription
 drug to a tier with a larger deductible, copayment or coinsurance if  an
 AB-rated generic equivalent [or], AN interchangeable biological product,
 OR  BIOSIMILAR  for  such prescription drug is added to the formulary at
 the same time.
   § 4. Subsection (c) of section 3242 of  the  insurance  law, as  added
 by chapter 99 of the laws of 2022, is relettered subsection (d).
   §  5. Subsection (c) of section 4329 of the insurance law, as added by
 chapter 99 of the laws  of  2022, is relettered subsection (d).
   § 6. This act shall take effect immediately.

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