BILL NUMBER: S1795

SPONSOR: FERNANDEZ
 
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 ensure affordable access to epinephrine.

 
SUMMARY OF PROVISIONS:

Section 1 of the bill adds a new subdivision 6 to education law § 6816-a
to authorize a pharmacist to substitute an alternate generic epinephrine
auto-injector containing the same active ingredients, dosage, form and
strength as the brand name product prescribed, provided: (1) the pres-
criber 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 avail-
              

ability 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 prop-
er usage and operating features of the alternate epinephrine auto-injec-
tor.

Section 2 is the effective date.

 
JUSTIFICATION:

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; and (3) the patient consents.

The extraordinary price increases of EpiPens by Mylan Pharmaceutical,
that made national headlines, have made access to life saving epineph-
rine unaffordable for many families. Since acquiring the drug in 2007,
Mylan has increased the price of Epipens 600% bringing the cost to over
$600. In 2016, Mylan announced they will authorize a generic version of
the EpiPen for $300, which is still more than triple the price of EpiPen
when they acquired it.

These rate increases hurt all consumers. For those who need this life-
saving medication the cost can be prohibitive, even with insurance
coverage, depending on the deductible. Some may have to pay the entire
cost out-of-pocket, while others will have larger co-pays.  Families
often need multiple epinephrine auto-injectors available at home,
school, or daycare. Insurance may not cover multiple packages.  More-
over, since they expire annually this becomes a yearly expense.
Epinephrine auto-injectors are a necessity forcing families to make
difficult decisions to cover these costs. Finally, all consumers are
impacted by increased insurance premiums and taxpayer dollars spent on
epinephrine auto-injectors by EMTs and the State Medicaid program.

Less expensive epinephrine auto-injector alternatives are available.
For example, Impax Laboratories makes an alternate epinephrine auto-in-
jector Adrenaclick - which can be purchased for as little as $140 with a
free coupon found on GoodRx. While both products contain epinephrine and
are auto-injectors, the injectors differ - Adrenaclick has two
caps,while EpiPen has one. Due to this difference in technology, they
are considered two different drugs and a pharmacist cannot substitute
one for the other. CVS has also recently announced they will offer an
alternate epinephrine auto-injector for a fraction of the price of
EpiPen.

Since there is technically no generic version of the EpiPen, a pharma-
cist cannot substitute Adrenaclick if the prescription specifies EpiPen.
A pharmacist may only dispense a less expensive generic version of the
Epipen if the prescription is written for an epinephrine auto-injector.

Mylan has spent billions of dollars marketing EpiPen. It has almost
become synonymous with epinephrine auto-injector. As a result, most
prescribers issue prescriptions specifying EpiPens. Many prescribers are
not aware that they should or could write epinephrine auto-injector
instead. Many families aren't aware to ask for this either.

This legislation will allow a pharmacist to dispense a less costly
alternative epinephrine auto-injector under an EpiPen prescription with
the consent of the purchaser. In addition, families can request a phar-
macist dispense the less expensive alternative without obtaining a new
prescription. New York would be joining more than a dozen states that
allow for this substitution. We cannot let a technicality come between
New Yorkers and affordable access to this life saving medication.

 
PRIOR LEGISLATIVE HISTORY:;,

2023-2024: S4447 / A6988

2021-2022: S6393 / A3981

2019-2020: S3539 2017-2018: S2489

2015-2016: S8189

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
This act shall take effect immediately.