Limits the substitution of abuse-deterrent analgesic opioid drug products for analgesic opioids lacking such technology

11 Co-sponsors

• Fredrick J. Akshar II
• George Amedore
• Phil Boyle
• Thomas Croci
• Martin J. Golden
• William J. Larkin Jr.
• George Latimer
• Jack M. Martins
• Terrence P. Murphy
• Thomas F. O'Mara
• Robert Ortt

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 reducing abuse and diversion of opioid drugs

Purpose

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 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 before an abuse-deterrent 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 implementation 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 whenever 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-deterrent 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.

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.

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.