BILL NUMBER: S7009

SPONSOR: LANZA
 
TITLE OF BILL:  An act to amend the insurance law, in relation to the
use of abuse-deterrent technology for opioids as a mechanism for reduc-
ing abuse and diversion of opioid drugs

 
PURPOSE OR GENERAL IDEA OF BILL:

To help prevent the abuse and diversion of opioid analgesic drugs by
ensuring that abuse-deterrent drugs approved by the FDA are accessible
to patients and that that insurance coverage does not disadvantage
access for patients to drugs approved by the FDA as abuse-deterrent.

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1 adds a new section 3216-a to the insurance law to ensure
patient access to abuse-deterrent opioid analgesic drugs by requiring
that a minimum of one opioid abuse-deterrent opioid analgesic drug per
opioid analgesic active ingredient is covered by insurance plans and to
ensure that a patient is not required to take a non-abuse deterrent
              

opioid before an abuse-deterrent opioid version.

Section 2 is the effective date of the bill.

 
JUSTIFICATION:

While pain management is an important and integral part of the health
care system, abuse and diversion of opioids has necessitated the imple-
mentation of various anti-abuse policies. These policies need to be
approached comprehensively by government, law enforcement, health care
providers and manufacturers and an important component is to ensure that
opioids incorporating abuse-deterrent technologies are dispensed whenev-
er possible.

The U.S. Food and Drug Administration (FDA) has recognized that the
development and implementation of abuse-deterrent technologies is an
important "step towards the goal of creating safer opioid analgesics."
In recently published FDA guidance on abuse-deterrent technologies for
opioids, the FDA provided that they "consider the development of these
products a high public health-priority."

To combat opioid misuse and abuse, the FDA is encouraging manufacturers
to develop abuse-deterrent formulations that when taken as prescribed
still provide appropriate pain relief, but are-formulated to make it
more difficult to alter the drug product for purposes of misuse or
abuse, such as making the product harder to crush or liquefy in order to
snort or inject. The FDA has provided guidance as to the steps that a
manufacturer can take to demonstrate that an opioid drug product is
formulated with abuse-deterrent technologies and after rigorous testing
has shown that the abuse-deterrent formulation is expected to deter or
reduce abuse of the drug product. It is only after achieving successful
results on these tests that the FDA will allow for a drug product's
label to include claims based on demonstration of meaningful abuse-det-
errent properties.

This proposal recognizes that to further the goal of encouraging the use
of abuse-deterrent technologies as part of a broader plan to reduce
opioid addiction and abuse, it is imperative that insurance coverage is
applied equitably and does not provide a disincentive to the use of
abuse-deterrent opioids.

This will help advance safe patient care by ensuring that abuse-deter-
rent versions of available opioid analgesic drug products are covered,
including those containing nonopioid drug substances to form a single
drug product.

While New York State has been at the forefront of fighting prescription
drug abuse, it is critical that the State continue to strengthen its
laws and protect against abuse while enhancing the integrity of its
health care system. Enacting this proposal will be consistent with these
goals and with the priorities set out by the FDA.

 
PRIOR LEGISLATIVE HISTORY:

New bill.

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
This act shall take effect on the 120th day, and shall apply to all
policies and contracts issued, renewed, modified, altered or amended on
or after such date.