New research suggests that the latest trend in opioids may not be so helpful.
Abuse-deterrent Formulations (ADFs) have gained popularity as a part of the solution to end the ongoing opioid crisis. Massachusetts, Maine, Maryland, Florida, and West Virginia have passed legislation mandating coverage for ADFs, and more than 20 other states are considering similar bills. But a review of 10 ADFs shows that the health gains from ADFs are uncertain and the costs are high. So are they worth it?
That’s the question the Institute for Clinical and Economic Review (ICER), an independent, non-profit research organization, attempted to answer in their recent report on the effectiveness and value of ADFs. ICER looked at the available data on 10 different ADFs to determine the value of ADFs on health and to perform a cost-benefit analysis. ICER evaluated:
Of the 10, nine are extended release while only one, RoxyBond, is instant release.
Purdue’s reformulation of Oxycontin was released in 2010 and was the first ADF and now holds 90% of the ADF market, according to ICER. ADFs are generally made more difficult to crush, which inhibits chewing, injecting, or snorting the medication. However, ADFs do not inhibit swallowing the pills, which is the most common method of abuse.
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The current research on the efficacy of ADFs in reducing abuse is uncertain and limited. Pre-market studies showed that recreational drug users said that both crushed and intact ADFs are less useful to them than non-ADF forms, and that they were less likely to take the ADF version again. However, no threshold exists for measuring abuse potential, and according to ICER this means that the clinical significance of these findings are unclear. In post-market studies, it was found that after OxyContin was reformulated, drug users were less likely abuse the drug. But, other studies showed an increase in the abuse of other opioids, indicating that abusers simply shifted to another drug. Currently, there is limited data available on ADFs other than OxyContin-in fact, there is no real-world evidence for any ADF other Purdue’s drug.
The evidence led ICER to determine that OxyContin TR provided “moderate certainty” of a net health benefit for patients prescribed an opioid. Reports on other ADFs were “promising but inconclusive,” and overall the evidence was “insufficient to determine a net health benefit of ADFs.”
Up next: What the data mean
Based on the limited evidence available, ICER then created a hypothetical model using 100,000 non-cancer patients who were prescribed opioids to determine a cost-benefit model. They used an average price of $11.60 per day for ADFs and $5.82 per day for non-ADFs. This model showed that per 100,000 population over five years, ADFs would prevent 2,300 new cases of abuse, but cost the health-care system $533 million. Even when factoring in societal costs like criminal justice or productivity loss, the costs remained $393 million higher. In order to attain cost-neutrality relative to non-ADFs, ADFs would need to operate at 35% effectiveness, preventing 35% of abuse cases. But even at 100% effectiveness, ADFs would still cost an additional $113 million over five years. Alternately, the price of ADFs would need to be lowered by 41% to $6.86 to achieve cost-neutrality.
On July 20, 2017, the New England Comparative Effectiveness Public Advisory Council (New England CEPAC)-an ICER board made up of 12 physicians and various health specialists who make recommendations to improve the quality and value of health care-met to discuss the findings. When asked, “For a patient being considered for a prescription of an immediate release opioid, is the evidence adequate to demonstrate a reduced risk of abuse for patients using RoxyBond versus non-ADF immediate release opioids?” two voted yes and 10 voted no. When asked about adequate evidence to demonstrate a reduced risk of abuse in patients using OxyContin TR versus non-ADF formulations, nine voted yes and three voted no. The council voted one to 11 against the question regarding enough evidence to show a reduced risk using other non-OxyContin TR ADFs, and voted two to 10 against evidence demonstrating a net health benefit with OxyContin TR versus non-ADF extended-release opioids.
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When asked about ADF-substitution policies based on health benefits alone, 10 voted in favor of determining a way to target high-risk individuals with ADFs as compared to mandating all current non-ADFs be replaced with ADFs. When also considering cost, all 12 voted in favor of the targeting option.
The New England CEPAC made several recommendations to policy makers, payers, manufacturers, and physicians, including: reducing barriers to out-of-pocket payments for ADFs, the need for the development and study of instant-release ADF’s, requiring medical schools to teach the role of ADFs in clinical practice, and the need for health-care practitioners to share information on ADFs and non-ADFs with patients.
Based on their research and the New England CEPAC’s voting, ICER concluded that “ADF opioids have the potential to reduce the incidence of abuse in opioid-prescribed chronic pain patients relative to non-ADF opioids, but at higher costs to the health care system. Even when important societal costs are included, ADF opioids are still expected to increase overall costs.”