NY State Senate Bill 2025-S3485

Senate Bill S3485

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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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 27, 2025	referred to insurance

2025-S3485 (ACTIVE) - Details

Current Committee:: Senate Insurance
Law Section:: Insurance Law
Laws Affected:: Amd §§4903, 3242 & 4329, Ins L
Versions Introduced in 2023-2024 Legislative Session:: S7768

2025-S3485 (ACTIVE) - Summary

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

2025-S3485 (ACTIVE) - 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 (ACTIVE) - 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.

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