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A05029 Summary:

BILL NOA05029
 
SAME ASSAME AS S01795
 
SPONSORJacobson
 
COSPNSR
 
MLTSPNSR
 
Amd §6816-a, Ed L
 
Relates to the substitution of brand name epinephrine auto-injectors with alternate epinephrine auto-injectors in certain cases.
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A05029 Actions:

BILL NOA05029
 
02/11/2025referred to higher education
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A05029 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A5029
 
SPONSOR: Jacobson
  TITLE OF BILL: An act to amend the education law, in relation to the substitution of brand name epinephrine auto-injectors with alternate epinephrine auto- injectors for dispensation by pharmacists   PURPOSE OR GENERAL IDEA OF BILL: This legislation will help to ensure affordable access to epinephrine   SUMMARY OF PROVISIONS: Section 1 adds a new subdivision 6 to Education Law § 6816-a to author- ize a pharmacist to substitute an alternate generic epinephrine auto-in- jector containing the same active ingredients, dosage, form and strength as the brand name product prescribed, provided: 1 The prescriber does not indicate that the prescription must be dispensed as written; 2. The alternate epinephrine auto-injector available would cost less; 3. The pharmacist has advised the purchaser of the availability of an alternate epinephrine auto-injector and obtained consent to dispense the alternate; and 4. The pharmacist has counseled the patient or person authorized to act on the patient's behalf on the proper usage and operating features of the alternate epinephrine auto-injector. Section 2 sets forth the effective date which is immediately.   JUSTIFICATION: Epinephrine auto-injectors save lives. After ingesting or being other- wise exposed to a life-threatening allergen (e.g. nuts, shellfish, latex), a person who suffers from catastrophic allergies will immediate- ly experience anaphylaxis and can die within minutes unless they are injected with epinephrine. There are many auto-injectors that deliver epinephrine on the market, but EpiPen is practically synonymous with the device and Mylan Pharmaceutical has come to dominate the market. In 2007, Mylan acquired EpiPen and spent billions of dollars marketing it while also increasing the price 600%, bringing the cost to over $600. Yet, epinephrine auto-injectors only cost around $30 to produce. Less expensive epinephrine auto-injector alternatives are available. For example, Impax Laboratorie's Adrenaclick can be purchased for as little as $140 and CVS has also announced plans for an alternate epinephrine auto-injector that will sell for a fraction of the price of an EpiPen. There are other companies and pharmacies which charge about $110 for a two pack and this not include possible available coupons. However, since there is technically no generic version of the EpiPen, a pharmacist is only permitted to dispense a less expensive version if the prescription is written for an epinephrine auto-injector rather than for EpiPen. Today, many of those who suffer from catastrophic allergies are still paying as much as $600 to fill an EpiPen prescription. (A single prescription usually includes two injectors in case the first injection proves insufficient and a second injection is required to save a sufferer's life.) Families of children with catastrophic allergies are also required to keep a set of two epinephrine auto-injectors with their school nurse or daycare center, potentially doubling the cost to $1,200, Epinephrine auto-injectors are the only treatment to reverse the effects of a catastrophic allergic reaction, making them a life-or-death neces- sity. And since epinephrine auto-injectors expire and must be replaced annually, EpiPens are a recurring financial burden to the allergy sufferer and their family. Even with insurance coverage, theocost can be prohibitive. On a broader level, all consumers are impacted by increased insurance premiums and taxpayer dollars spent on EpiPens by EMTs and the State Medicaid program. As a result of Mylan's marketing efforts, most prescribers issue prescriptions specifying EpiPens unaware that they should or could write epinephrine auto-injector instead. Many families don't realize it either. While New York generic substitution law permits pharmacists to dispense a lower cost generic drug for a brand name prescription drug unless the prescriber writes "dispense as written," questions have arisen about whether the current law covers epinephrine auto-injectors, which are a combination drug and a device for administering the drug, or whether an alternate brand name injector may be substituted where the prescribed injector is not available. This bill would authorize a pharmacist to substitute an alternate epinephrine auto-injector containing the same active ingredients, where: (1) the prescriber does not indicate that the prescription must be dispensed as written; (2) the alternate epinephrine auto-injector avail- able would cost less; (3) the pharmacist has advised the purchaser of the availability of an alternate epinephrine auto-injector and obtained consent to dispense the alternate; and (4) The pharmacist has counseled the patient or person authorized to act on the patient's behalf on the proper usage and operating features of the alternate epinephrine auto- injector. 2 In passing this legislation, New York would be joining more than a dozen states that allow for this substitution. We cannot let a technicality come betwe en New Yorkers and affordable access to this life saving medication.   PRIOR LEGISLATIVE HISTORY: 2023-2024: A6988 - Referred to Assembly Higher Education Committee S4447 - Passed Senate   FISCAL IMPLICATIONS FOR STATE AND LOCAL GOVERNMENTS: None   EFFECTIVE DATE: This act shall take effect immediately.
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A05029 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          5029
 
                               2025-2026 Regular Sessions
 
                   IN ASSEMBLY
 
                                    February 11, 2025
                                       ___________
 
        Introduced by M. of A. JACOBSON -- read once and referred to the Commit-
          tee on Higher Education
 
        AN  ACT  to  amend the education law, in relation to the substitution of
          brand name epinephrine auto-injectors with alternate epinephrine auto-
          injectors for dispensation by pharmacists

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1. Section 6816-a of the education law is amended by adding a
     2  new subdivision 6 to read as follows:
     3    6. (a) Notwithstanding subdivision two of this section  or  any  other
     4  section  of  law  to  the contrary, when a patient is prescribed a brand
     5  name epinephrine auto-injector, a pharmacist may substitute an alternate
     6  epinephrine auto-injector containing the same active ingredients, dosage
     7  form and strength as the  brand  name  product  prescribed,  ordered  or
     8  demanded,  regardless of whether the alternate epinephrine auto-injector
     9  is included in the latest list of interchangeable drug products for  the
    10  prescribed epinephrine auto-injector device, provided that:
    11    (i)  the  prescriber  does not indicate that the prescription therefor
    12  shall be dispensed as written pursuant to paragraph (a)  of  subdivision
    13  six of section sixty-eight hundred ten of this article;
    14    (ii) the alternate epinephrine auto-injector available would reflect a
    15  lower unit cost to the purchaser;
    16    (iii)  the pharmacist has advised the purchaser of the availability of
    17  an alternate epinephrine auto-injector and obtained consent to  dispense
    18  the alternate epinephrine auto-injector; and
    19    (iv)  the pharmacist has counseled the patient or person authorized to
    20  act on the patient's behalf on the proper usage and  operating  features
    21  of the alternate epinephrine auto-injector.
    22    (b) For purposes of this subdivision "epinephrine auto-injector" shall
    23  have the same meaning as provided in paragraph (b) of subdivision one of
    24  section three thousand-c of the public health law.
    25    § 2. This act shall take effect immediately.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD03148-01-5
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