BILL NUMBER: S4447

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 epine-
phane 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 available 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 epinephrine
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-injector
- 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 consid-
ered 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:

2021-2022 S6393 A3981

2019-2020 S3539

2017-2018 S2489

2015-2016 S8189

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
This act shall take effect immediately.