— With substantially higher costs for abuse-deterrent formulations, and uncertainty regarding their impact on abuse, diversion, and switching to other opioids, ICER economic analysis highlights difficulty in assessing societal impact and value of shifting patients to abuse-deterrent opioids —

Boston, Mass., June 28, 2017 – The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of 10 abuse-deterrent formulations (ADFs) of opioids. The report finds that current evidence is limited to judge the potential of ADFs to effectively reduce abuse on a widespread basis, and that their use generates significant costs, even after accounting for possible reductions in abuse.

“Addressing the opioid crisis is a top public health priority,” said Steven D. Pearson, MD, MSc, ICER’s President.  “Opioid formulations that contain abuse-deterrent properties have great potential as part of multi-pronged efforts to contain opioid abuse.  However, there are major unknowns, such as the extent to which reductions in abuse from ADFs may be counteracted by increased use of heroin and other illicit opioids.  Given the high costs of ADFs, policymakers face difficult decisions in prioritizing their use alongside other systemwide efforts to combat the opioid crisis.”

ADF opioids are specially formulated opioid pain medications intended to make the drugs more difficult to manipulate for abuse. ADFs may be formulated to deter chewing, intranasal, or intravenous routes of abuse; however, swallowing pills whole is the most common form of abuse and is not deterred by ADFs.

In 2015, the FDA issued recommendations encouraging manufacturers to produce ADF opioids, and in 2016-2017, the FDA approved five new ADFs.

In addition to reviewing evidence on the impact of ADF opioids on abuse, ICER’s review provides a cost-benefit analysis of using extended-release (ER) ADF opioids versus non-ADF opioids for chronic pain. Among other findings noted below, ICER’s analyses found that approximately $500 million in additional costs would be generated for every 100,000 individuals treated with ADFs instead of older formulations, even after accounting for savings from reduced levels of abuse.

This Evidence Report will be the subject of an upcoming public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on July 20th in Concord, NH.

A draft version of this report was previously open for a four-week public comment period.  The updated Evidence Report reflects changes made based on comments received from patient groups, clinicians, the manufacturers of the drugs, and other stakeholders.

ICER’s report considers 10 drugs, all of which are extended release opioids, with the exception of RoxyBond®, which is an immediate release opioid. The drugs included in the review are:

  • Hysingla,® ER (Hydrocodone, Purdue Pharma)
  • VantrelaTM (Hydrocodone, Teva Pharmaceutical Industries)
  • Arymo® ER (Morphine, Egalet)
  • Embeda® (Morphine + naltrexone, Pfizer)
  • Morphabond® (Morphine extended release, Inspirion Delivery Technologies)
  • OxyContin® TR (Oxycodone, Purdue Pharma)
  • Xtampza® ER (Oxycodone, Collegium Pharmaceutical, Inc.)
  • Targiniq® (Oxycodone + naloxone extended release, Purdue Pharma)
  • Troxyca® ER (Oxycodone + naltrexone, Pfizer)
  • RoxyBond® (Oxycodone, Inspirion Delivery Technologies)
Key Report Findings

 

ICER’s report reviewed the available clinical trial data on abuse potential, as well as real-world evidence on abuse and diversion (the illegal transfer of opioids to a non-prescribed abuser). For patients prescribed an opioid, analyses found moderate certainty of a comparable or better net health benefit for individuals newly prescribed OxyContin, the only ADF with real-world evidence on its effects on abuse and diversion. Evidence for all other ADFs was promising but inconclusive, based on a lack of real-world evidence as well as possible safety concerns.

On a population-wide basis, however, evidence was insufficient to determine a net health benefit of ADF opioids, given uncertainties regarding the balance between reductions in abuse and transition to abuse of heroin and other opioids.

Cost-benefit analyses in ICER’s report found that use of ADFs instead of non-ADF opioids would result in an additional $533 million of net health system spending per 100,000 patients over a five-year period. Calculations suggest that in order to be cost-neutral, average prices of ADFs would need to be discounted by approximately 41%, or ADFs would need to maintain current levels of abuse reduction and lower rates of diversion by 35%.

In addition to cohort analyses, the report also included a state-level policy assessment.  Results indicate that, in the state of Massachusetts, converting all non-ADF prescriptions to an ADF counterpart would increase statewide costs by $475 million annually.

The Evidence Report, as well as the accompanying voting questions, public comments received, and ICER’s written response to comments, are available on the ICER website.

The Evidence Report will be the subject of the July 20th public meeting of the New England CEPAC, during which the independent council will vote on key questions raised in the report, and a policy roundtable of experts will discuss recommendations to apply the evidence to policy and practice.  During the meeting, pre-registered stakeholders will provide brief oral comments on the report and its findings.  Requests to make an oral comment were accepted during the public comment period on the Draft Evidence Report and are now closed.

Registration for the in-person meeting is open here.  Registration for a live webcast of the meeting is open here.