The devastating societal effects of the national opioid crisis are as far reaching as they are complex and require multimodal and highly coordinated interventions involving policy makers, public health, law enforcement, the medical community, payers, and community stakeholders.
In the face of this crisis, policy makers and health care providers have responded vigorously with numerous recommendations and proposed reforms to reduce the risk of harm. While we applaud the recognition of the problem and the effort to solve it, it is imperative that recommendations, and particularly mandates, are evidence-based and are not so costly that they jeopardize alternative, proven strategies.
Abuse-Deterrent Opioids
One approach that is gaining energy both at state and national levels would be to require payers to cover abuse-deterrent opioids. Abuse-deterrent formulations are developed with the goal of meaningfully deterring certain types of abuse or making abuse more difficult or less rewarding. The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving.
From a clinical perspective, newer abuse-deterrent products are not novel chemical entities. Rather, they are existing opioids that have proven efficacy with patented abuse-deterrent properties added to them. Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing to snort and dissolving to inject.
Complicating matters, however, is the fact that many of the original chemical entities have already lost patent protection, which has led to the entry of significantly less expensive generic (but non-abuse-deterrent) drugs. Consequently, many prescribers face a dilemma. On one hand, they might prescribe the more affordable, nonabuse-deterrent version of a drug but potentially expose a small fraction of their patients to greater risk of abusing the drug by injecting or snorting it. On the other hand, if they prescribe a newer abuse-deterrent version of the drug it is likely to cost so much as to make it inaccessible to many patients. Indeed, some patient advocates have (rightfully) noted that legitimate pain patients are being asked to pay for the abuse predilection of a small minority of patients looking to get high.
Take, for example, Arymo ER, which was developed by taking the generically available chemical morphine sulfate extended release and reformulating it with abuse-deterrent properties. As such, it is only available as a brand-name product, at a multiple-fold increase in the cost over the original generic. Because this product has no better effectiveness for pain relief and only adds the abuse-deterrent properties at a greatly increased cost, coverage of abuse-deterrent products by insurers has been mixed.
The Food and Drug Administration (FDA) has significant interest in abuse-deterrent opioids identified as part of its comprehensive opioid action plan. More specifically, there is considerable debate among lawmakers regarding whether insurers should be mandated to provide coverage for these products. Consistent with a desire to promote abuse-deterrent products, there is also discussion regarding a FDA requirement that all opioid products be transitioned to abuse-deterrent products. Indeed, the FDA has held several public meetings to address abuse-deterrent products and at a recent meeting suggested that in the future all major opioids (including generic products) will be required to have abuse-deterrent formulations. Payers were challenged to provide coverage for these products to encourage development of abuse-deterrent opioids.
Payers generally have robust infrastructure and algorithms in place that enable a systematic approach to evaluate the clinical value and cost-effectiveness of drugs. Underpinning these drug evaluation processes is an industry-wide value movement across a number of medical care models, which at their core, are rooted in evidence and guidelines. We believe that abuse-deterrent opioid products should be scrutinized using the same clinically rigorous lens that we apply to all drugs.
The evidence of abuse-deterrent products' efficacy continues to be limited to niche areas of "abuser likeability" and potential for abuse, which has a somewhat narrower weighting when evaluating all of the elements contributing to the crisis. It is important to note that abuse-deterrent products only address unintended use of opioids by injecting or snorting these products. Abuse of opioids through other unintended uses—such as illegal acquisition of prescription opioids, taking opioids at higher than intended doses or frequency, use for getting high—is not prevented by abuse-deterrent formulations. Likewise, these products can still be diverted for illegal use, and they are no less addictive than nonabuse-deterrent products. Indeed, the FDA refers to these drugs as "abuse deterrent" not "abuse proof." With this in mind, the FDA requires that any drug approved as having abuse-deterrent properties be further evaluated by its manufacturer after it is marketed. The manufacturer is required to conduct studies to evaluate the impact of the product on abuse in the community. If necessary, the FDA may approve updated product labeling that describes the drug's abuse-deterrent features after approval.
Steep Costs
It's been estimated that by mandating coverage of abuse-deterrent products, the incremental increase in costs in the opioid category would be five to 15 fold—particularly alarming considering that the overwhelming majority of opioid users are not at risk for injection, snorting, or illicit delivery. At UPMC Health Plan, where we practice, the opioid costs across all lines of business for 2016 were approximately $40 million. Applying a 10-fold mid-point factor would increase opioid costs to a staggering $400 million annually. Data released by the Department of Veterans Affairs (VA) showed that in fiscal 2016, its opioid costs were nearly $100 million treating 1.2 million unique patients with at least one opioid prescription. Of this, only 1.9 percent of the opioids dispensed were for an abuse-deterrent product. However, that 1.9 percent represented $37 million or 37 percent of the overall VA opioid spending. Applying a similar 10-fold increase for the VA would result in approximately $1 billion yearly for these products and could represent as much as 20 percent of the VA pharmacy budget.
Widespread adoption of these products through coverage mandates would also produce a frenzied effort by those prone to abuse drugs to overcome the abuse-deterrent properties of the drug. Of greater concern is that mandatory coverage of abuse-deterrent products will potentially result in greater use of illegal opioids such as heroin. There is no convincing evidence that abuse-deterrent opioids will discourage those who intend to use prescription opioids for injection or snorting and result in overall lower rates of illegal use of opioids.
What is more, any form of coverage mandate would eliminate the existing competitive market environment—in essence handing pharmaceutical manufacturers a free market without any incentive to negotiate discounts with payers. This pricing burden would not only be felt by payers and employers but also policyholders in the form of higher copayments, posing a potentially significant burden on members who legitimately require these agents.
Is There A Better, More Cost-Effective Approach?
The question is whether the premium spent (hundreds of millions of dollars for individual payers and billions nationwide) on these agents, to protect a relatively small slice of the "at risk" population, could be better used for broader improvements in other areas. For example, might these monies be better spent building out community frameworks that address the crisis more comprehensively, focused educational efforts, fusion centers that aid coordination activities, screening, guideline-based care, appropriate disposal, naloxone awareness, and wider access to high-quality substance abuse treatment?
That is exactly what we're doing at the University of Pittsburgh Medical Center (UPMC), leveraging our payer/provider construct in collaboration with public health officials, the University of Pittsburgh, and law enforcement. Together, we've created a framework for improved care across the continuum. The framework involves a multipronged educational effort both at the Schools of Health Sciences at the University of Pittsburgh and the community at large. Additional focus areas include provider education regarding opioid prescribing, adoption of opioid prescribing guidelines, and increased awareness of opioid use with provider benchmarking. Moreover, there are efforts to incorporate enhanced analytics to enable a population-based approach to illuminate areas of opportunity. Finally, UPMC is increasing awareness on naloxone use as well as raising the bar on substance abuse treatment access and quality.
Likewise, the VA health care system has implemented a comprehensive "Opioid Safety Initiative," which uses provider-level ongoing feedback for high-risk opioid prescribing, academic detailing to improve use of opioids, a robust naloxone distribution program for at-risk veterans, and residential treatment programs for substance abuse. Investments in these initiatives have resulted in significant decreases in high-risk opioid prescribing within the VA.
It is tempting to see abuse-deterrent opioids as a powerful and singular solution that might go a long way toward addressing our nation's opioid crisis. In that case, mandating coverage would seem to be a no-brainer. But, it is not so simple. Policy makers must evaluate both the benefits and overall cost of any potential decision, before acting. Payers have been doing just that for years, relying on their own robust infrastructure and mature, systematic processes to appropriately evaluate value. The resulting formulary decisions and clinical algorithms are rooted in scientific evidence and expert consensus. Our hope is that policy makers and regulators will work collaboratively with the payer and provider communities to enable stakeholder value consensus thus enabling alignment regarding coverage.
from Health Affairs BlogHealth Affairs Blog http://ift.tt/2qn8sLV
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