The Fallacy of Traditional Fail-First Policies Applied to Abuse-Deterrent Opioids

Mar 24, 2016

Abuse-deterrent opioids (ADOs) serve a vital role in mitigating certain types of opioid abuse by making manipulation of the tablet or capsule more difficult by employing various types of barriers. This is especially critical for extended-release (ER) opioids that are commonly used to treat severe chronic pain as a single dose may be three to eight times more potent than its immediate-released (IR) counterpart. Yet, lack of patient access to the currently available ADOs is becoming one of the biggest challenges in the opioid abuse space. People in pain are forced by their commercial insurance companies to “fail” on a non-ADO before they can be treated with an ADO (“fail-first”).  In 2014, Massachusetts was the first state in the U.S. to pass a law that essentially eliminates this fail-first prior authorization policy on ADOs for its citizens covered by commercial insurance plans, leading the way for states across the country to take up similar bills.  However, much work is left to be done, especially with Medicaid programs where these laws typically do not apply.

The manipulation of ER opioids by crushing, chewing, grinding, or melting may cause an escalated effect of the medication as it is released in a significantly shorter span of time than what is intended. Opioid abuse typically starts from manipulating the tablet or capsule and administering it orally, then progresses to the abuser snorting or injecting the opioid. Evidence shows that this type of manipulation and abuse of oral ER opioids may be a critical step prior to moving on to heroin abuse. In fact, the Food and Drug Administration (FDA) has made the development of and access to ADOs one of the cornerstones of their action-plan to better address the opioid epidemic sweeping the country. In a perfect world all opioids would be reformulated to be abuse-deterrent. Mandating that a chronic pain patient “fail” non ADOs before accessing an ADO fuels the very epidemic that we as a society are trying to curb.  

Traditional fail-first policies have always been controversial. The very idea of forcing healthcare providers to start a patient on a therapy they do not consider to be the optimum therapy and documenting “failure” has always rankled the patient advocacy community. Quite often providers know the older medicine is not right for the patient but must force their patients to endure weeks of sub-optimal therapy. By applying this same measure to ADOs, the payers are forcing the providers to document failure of a non-ADO, in the traditional sense of sub-optimal therapy, before they can prescribe the ADO that is engineered to reduce abuse, misuse, and diversion. There is a clinical disconnect here.

This was undoubtedly a consideration by Massachusetts law makers when they passed the 2014 bill, which contains the following provision:

Any……….. insurance issued…….which is considered creditable coverage …, shall provide coverage for abuse deterrent opioid drug products listed on the formulary…… on a basis not less favorable than non-abuse deterrent opioid drug products that are covered….. An increase in patient cost sharing shall not be allowed to achieve compliance with this section. (AN ACT TO INCREASE OPPORTUNITIES FOR LONG-TERM SUBSTANCE ABUSE RECOVERY (see Senate, No. S2142). Approved by the Governor, August 6, 2014)

Additionally, the Medicaid population should not be ignored while efforts are being made to curtail opioid abuse. States should provide safer opioids for this vulnerable population by eliminating fail-first policies that restrict the availability of ADOs. The cost difference caused by the changing policy can be offset by working with manufacturers on additional rebates and by considering the savings associated with reducing abuse, misuse, and diversion of opioids within this population.

While progress has been made to establish legislation that prohibits the implementation of fail-first policies for ADOs, it is imperative that this become a priority to address not only for private insurance plans and but for Medicaid programs as well. Abuse-deterrent opioids are important tools in the fight against opioid abuse. But the fallacy of applying traditional fail-first policies creates a barrier to access that is clinically unsound and an additional hurdle in addressing the risk of abuse, misuse, and diversion of opioids.


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