Rates of opioid use disorder (OUD) have risen sharply over the past decade,1–3 and the number of overdose deaths involving opioids has quadrupled since 1999. In total, 91 Americans currently die every day from an opioid overdose.4 One driver of the increase in OUD and overdose deaths has been increased sales of prescription opioids, aimed at improving pain management.5 Despite recent evidence of decreases in opioid prescribing, rates remain 3-fold higher than they were in 1999.6 An important challenge in combating the epidemic has been connecting individuals with OUD to evidence-based treatment. Although about 1.9 million individuals met diagnostic criteria for an OUD,7 only 1 million received medication-assisted treatment for their OUD in 2014.8
Three medications have been approved by the Food and Drug Administration (FDA) for treating OUD—methadone, naltrexone, and buprenorphine. Although all 3 have showed efficacy, each has different side-effect profiles, safety factors, adherence limitations that influence effectiveness, and diversion risks that are important for prescribers to consider when individualizing care to best meet a given patient’s needs.9,10 These 3 drugs also differ in terms of who can prescribe or dispense them, and how burdensome it is to receive the treatment. Methadone can only be dispensed through licensed and highly regulated outpatient specialty opioid treatment programs, and, at least initially, patients must come to the clinic nearly daily to receive their methadone dose. Adhering to daily observed dosing in a specialized methadone treatment program can be challenging for patients, interfere with employment and other responsibilities, and stigmatizing to some.9 As a result, there was an effort to search for alternative OUD treatment medications that could be prescribed in office-based settings.11 Buprenorphine can be prescribed in office-based settings, but only by physicians who receive a waiver from the Drug Enforcement Agency after they complete a mandatory 8-hour training; any licensed physician can prescribe naltrexone in an office-based or other setting. Among the office-based OUD medications, experts recommend buprenorphine/naloxone preparations over other buprenorphine formulations for most patients due to a lower risk of diversion; patients who are pregnant or have co-occurring conditions for which naloxone is contraindicated are an exception.9,10 Among naltrexone formulations, the long-acting injection is preferred due to high rates of nonadherence when using the oral preparation.9,10 Buprenorphine implants also have low diversion risk, and like naltrexone, can improve adherence among some patients.12
A number of short-acting and long-acting opioid pain medications, which can lead to OUD, are available, many with generic formulations. Beginning in 2014, several abuse-deterrent formulations of these medications were introduced. These products are designed to have lower potential for abuse and diversion (eg, oxycodone/naltrexone extended release has pellets of oxycodone that are surrounded by naltrexone; if the pellet is crushed, the naltrexone would be released to block the opioid receptors in the brain and attenuate the effects of the oxycodone).
Despite the fact that OUD medication-assisted treatment is efficacious,13 these medications have been slow to diffuse into practice.13 Insurance coverage limits may be one important barrier to broader use of OUD medications. Previous research has documented that many state Medicaid programs and large private health plans place restrictions on coverage of OUD medications.14,15 Likewise, while changes in provider guidelines and education, dosing regulations and other policies have been associated with reductions in opioid prescribing for pain,6 insurance coverage restrictions such as prior authorization (PA) (ie, enrollee must obtain plan approval before coverage is granted) or step therapy (ST) (ie, enrollees must document previous trial of a lower-cost medication before receiving coverage for a higher-cost medication) could also be tools used by insurers to limit access to opioids.
In this study, we compared coverage for OUD medications and opioids commonly prescribed for pain management in plans for individuals and families offered on the 2017 Marketplace exchanges. Our goal was to examine how benefit design might serve to influence use of these 2 categories of medications.
We identified a sample of 100 plans offered on the 2017 Health Insurance Marketplaces, randomly selecting a silver plan from a rural county and a silver plan from an urban county in each state, where possible. We utilized the most recent Rural-Urban Continuum Codes information from the US Department of Agriculture to identify rural and urban counties. The counties randomly selected for Arizona each offered the same silver plan, so 1 plan is included for Arizona. Only 1 plan is included for the District of Columbia (DC), as DC is comprised of only 1 county. Delaware, New Jersey, and Rhode Island include only urban counties; we randomly selected a silver plan from each of 2 urban counties in those states. We focused on silver plans because they account for the highest proportion of exchange plan enrollees (70%).16 Our sample includes 54 urban plans and 46 rural plans. We weighted each plan according to the total population in each stratum; thus, each plan from an urban county is weighted by the total urban population in the state and each plan from a rural county is weighted by the total rural population in the state. We present weighted percentages of plan coverage requirements. These weighted estimates describe coverage for the plans available to everyone in the United States through the Marketplaces.
We accessed plan and formulary information available on healthcare.gov for states with a federally facilitated exchange, the state exchange website for state-based exchanges, and insurance company websites to determine formulary coverage for OUD medications and selected opioid pain medications. The OUD medications included buprenorphine/naloxone combination, buprenorphine, methadone, and naltrexone. The opioid pain medications included hydrocodone/acetaminophen, hydromorphone, oxycodone, oxycodone/acetaminophen, fentanyl, and morphine sulfate extended release, plus 5 abuse-deterrent formulations. We examined both brands and generics (where available), as well as different types of formulations such as implantable and injectable formulations. The long-acting injectable buprenorphine formulation was not included, as it was FDA approved on December 1, 2017, too late for inclusion in 2017 Marketplace formularies. We reviewed each plan formulary and recorded whether the plan covered each medication as well as whether the plan required PA or ST for all formulations/administrations of the drug. For key types of medications, we conducted t tests using the weighted means to determine the statistical significance of coverage differences and of PA requirement differences. We looked separately at coverage of medications preferred by experts as maintenance treatment for OUD9,10 that can be prescribed in office-based settings (buprenorphine/naloxone, buprenorphine implants, and injectable naltrexone), and at coverage of abuse-deterrent formulations of opioid pain medications.
Although most plans cover at least 1 formulation of each of the 4 OUD medications, 13.9% of plans do not cover any forms of buprenorphine/naloxone (data not shown). In total, 43% of plans that cover generic buprenorphine/naloxone require PA before coverage can be obtained (Table 1). ST is rarely required for OUD medications (between 0% and 4.5% of plans require ST for coverage of each drug studied). With regard to newer injectable or implantable formulations that may facilitate adherence for some patients with OUD, only 10.6% of plans cover implantable buprenorphine and 26.1% cover long-acting injectable naltrexone. Plans were significantly less likely to cover long-acting injectable naltrexone compared with the oral version (26.1% vs. 100%; P<0.0001), despite the fact that the injectable version is recommended by experts for OUD maintenance treatment, not the oral version.9,10 Similarly, plans were significantly less likely to cover buprenorphine implants relative to oral forms of buprenorphine/naloxone (10.6% vs. 86.1%; P<0.0001).
All plans (100%) cover at least 1 form of the short-acting opioid pain medications we examined (Table 2). For each of the short-acting opioid medications, only 0%–2.8% of plans required PA or ST, with the exception of brand oxycodone (13.3% of plans required PA and 13.3% required ST), generic oxycodone (8.4% of plans required ST), and fentanyl (4.5% of plans required PA and 33.7% required ST). Although 63.6% of plans that covered any of the OUD medications preferred as maintenance therapy for most patients (ie, any buprenorphine/naloxone, buprenorphine implants, or long-acting, injectable naltrexone) required PA for coverage, only 19.4% of the plans that covered any short-acting pain medication required PA for these drugs (P<0.0001). Four of the 5 abuse-deterrent formulations of opioid pain medications that we studied (all but morphine sulfate/naltrexone extended release, which was covered by 69.9% of plans) are covered by only a minority of plans (0%–42.6%). Plans were less likely to cover any abuse-deterrent opioid pain medications than any short-acting opioid pain medications (73.4% vs. 100%; P<0.0001). Plans were more likely to require PA for abuse-deterrent versus short-acting opioid pain medications (40.4% vs. 19.4%; P=0.002).
Among a sample of 100 plans offered on Health Insurance Marketplaces, plans were less likely to cover the buprenorphine and naltrexone formulations that can be prescribed in office-based settings and are preferred medications for maintenance OUD treatment (buprenorphine/naloxone, buprenorphine implants, and long-acting injectable naltrexone) than they are the short-acting opioid pain medications that can lead to an OUD. Plans that did cover these OUD medications were more likely to require PA for their coverage compared with short-acting opioids. Plans were also less likely to cover any abuse-deterrent formulations of opioid pain medications than short-acting opioids. PA requirements were common even for the relatively lower-cost generic buprenorphine/naloxone formulations, with over 40% of plans that covered the drug requiring PA. Not covering an OUD medication or requiring PA for coverage may reflect efforts to dissuade plan enrollment among high-cost individuals, including individuals with OUD, as has been documented for other medication classes.17
The high rates of PA for buprenorphine products relative to other OUD medications seem unlikely to reflect buprenorphine’s Drug Enforcement Agency Schedule III listing (and thus concern about abuse potential). Methadone and opioids used to treat pain are Schedule II drugs (and thereby have a greater abuse potential than buprenorphine), yet were less likely to have PA or other formulary restrictions.
In the midst of an opioid epidemic, it is hard to justify the exclusion of OUD medications like buprenorphine/naloxone, buprenorphine implants, or injectable naltrexone, particularly generic forms, from a plan formulary or high rates of PA requirements that may create barriers to using these medications. Providing access to these OUD medications is particularly important given the Mental Health Parity and Addiction Equity Act requirements that formulary design, including PA and ST requirements, for mental health and substance use disorder drugs be comparable to formulary requirements for other medications.
PA requirements could pose barriers to use of OUD medications depending on the administrative burden and the approval rate associated with PA requests.18–20 A number of large commercial group insurers have dropped PA requirements for generic buprenorphine over the past 2 years21,22; nevertheless, we found that this practice remains common among plans offered on the Marketplaces. On the basis of these findings, regulators tasked with enforcement of Mental Health Parity and Addiction Equity Act may wish to focus attention on formulary coverage of OUD medications.
Some have called for a mandate that plans cover all abuse-deterrent opioid pain medications or for the FDA to require all opioid products to have abuse-deterrent properties. Given that there are currently no abuse-deterrent generics, others have noted that this would weaken price competition in the market for opioid pain medications and could result in higher spending on these drugs.23 As a subset of opioid medication users will develop a substance use disorder, formulary listing for abuse-deterrent products seems prudent, although PA or ST requirements could be appropriate for these higher-cost brand formulations to ensure that they are used only by individuals for whom other formulations are more likely to result in opioid misuse.
As the death toll from the opioid epidemic continues to mount, it is critical to identify all available strategies to reduce the likelihood that individuals develop opioid addiction and to ensure access to OUD treatment for those with an addiction. Formulary design constitutes an important lever not only for controlling costs, but also for ensuring that consumers have access to medications in a manner that protects the public’s health. This investigation of exchange plans’ medication benefit design indicates that some plans may want to reconsider formulary design decisions regarding both opioids for pain treatment and OUD medications, which are vastly underused.
1. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration (SAMHSA). Key substance use and mental health indicators in the United States: Results from the 2015 National Survey on Drug Use and Health. HHS Publication No. SMA 16-4984, NSDUH Series H-51. 2016.
2. Han B, Compton WM, Jones CM, et al. Nonmedical prescription opioid use and use disorders among adults aged 18 through 64 years in the United States, 2003-2013. JAMA. 2015;314:1468–1478.
3. Saha TD, Kerridge BT, Goldstein RB, et al. Nonmedical prescription opioid use and DSM-5 nonmedical prescription opioid use disorder in the United States. J Clin Psychiatry. 2016;77:772–780.
4. Rudd RA, Seth P, David F, et al. Increases in drug and opioid-involved overdose deaths—United States, 2010–2015. MMWR Morb Mortal Wkly Rep. 2016;65:1445–1452.
5. King NB, Fraser V, Boikos C, et al. Determinants of increased opioid-related mortality in the United States and Canada, 1990–2013: a systematic review. Am J Public Health. 2014;104:e32–e42.
6. Guy GP Jr, Zhang K, Bohm MK, et al. Vital signs: changes in opioid prescribing in the United States, 2006–2015. MMWR Morb Mortal Wkly Rep. 2017;66:697–704.
7. Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-50). 2015.
9. Connery HS. Medication-assisted treatment of opioid use disorder: review of the evidence and future directions. Harv Rev Psychiatry. 2015;23:63–75.
11. Schuckit MA. Treatment of opioid-use disorders. N Engl J Med. 2016;375:357–368.
12. Rosenthal RN, Goradia VV. Advances in the delivery of buprenorphine for opioid dependence. Drug Des Devel Ther. 2017;11:2493–2505.
13. US Department of Health and Human Services. Facing addiction in America: the Surgeon General’s report on alcohol, drugs, and health. 2016.
14. Reif S, Horgan CM, Hodgkin D, et al. Access to addiction pharmacotherapy in private health plans. J Subst Abuse Treat. 2016;66:23–29.
15. Grogan CM, Andrews C, Abraham A, et al. Survey highlights differences in Medicaid coverage for substance use treatment and opioid use disorder medications
. Health Aff (Millwood). 2016;35:2289–2296.
17. Jacobs DB, Sommers BD. Using drugs to discriminate—adverse selection in the insurance marketplace. N Engl J Med. 2015;372:399–402.
18. Lu CY, Adams AS, Ross-Degnan D, et al. Association between prior authorization for medications
and health service use by Medicaid patients with bipolar disorder. Psychiatr Serv. 2011;62:186–193.
19. Adams AS, Zhang F, LeCates RF, et al. Prior authorization for antidepressants in Medicaid: effects among disabled dual enrollees. Arch Intern Med. 2009;169:750–756.
20. Soumerai SB, Zhang F, Ross-Degnan D, et al. Use of atypical antipsychotic drugs for schizophrenia in Maine Medicaid following a policy change. Health Aff (Millwood). 2008;27:w185–w195.