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Supplements Use of Opioid Analgesics in Managed Care Practice: Challenges, Controversies, REMS, and Optimizing P

The Economics of Opioids: Abuse, REMS, and Treatment Benefits

Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP
Since the 1990s, there has been a 10-fold increase in the use of opioid analgesics, which has placed a significant financial burden on the healthcare system. Extra costs include time lost from work, multiple emergency department (ED) and ambulatory clinic visits, frequent office visits, doctorshopping, prescriptions, and rehabilitation facilities. In an attempt to ensure the safe use of extendedrelease (ER) and long-acting (LA) opioids, including methadone, the FDA has enacted a classwide Risk Evaluation and Mitigation Strategy (REMS) program mandating prescriber and patient education to encourage proper patient screening and appropriate monitoring. The REMS components require a time and financial commitment for both healthcare providers and payers. Although physicians have said they are willing to comply with REMS mandates, many have said they would be reluctant to prescribe opioids covered under REMS. The FDA does not have adequate data on the effectiveness of the current opioid REMS, so evidence is lacking to confirm its utility in diminishing opioid abuse. Payers could play an important role by reimbursing healthcare providers for the time spent issuing opioid risk tools, implementing patient and caregiver education risk stratification, providing naloxone reversal prescriptions with appropriate education, and monitoring overall. Furthermore, payment for abuse-deterrent formulations might also help to mitigate risk, but at a significant cost to society.

Am J Manag Care. 2015;21:S188-S194
Economic Burden of Opioid Misuse and Abuse

The use of opioids for chronic non-cancer pain (CNCP) has increased in the last 2 decades; in turn, so has the misuse and abuse of these medications, which has resulted in increased healthcare costs. In an attempt to ensure the safe use of opioids, the FDA has implemented a classwide Risk Evaluation and Mitagation Strategy (REMS) program requiring prescriber and patient education.1 Educating prescribers and patients on the proper use of opioids, monitoring patients at high risk for abuse, and encouraging the use of abuse-deterrent formulations (ADFs) could potentially reduce healthcare costs associated with opioid misuse.1-3

Economic Impact on Prescribers, Payers, and Patients

Opioid misuse is the use of opioid medication in a manner other than that intended by the prescriber, either by ingesting higher doses, or by ingesting doses more or less frequently.

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5, opioid use disorder includes the following4:

  • recurrent use that results in failure to fulfill major role/obligation at work, home, or school
  • recurrent use in physically hazardous situations
  • important social, occupational, or recreational activities are given up or reduced because of use
  • continued use despite persistent or recurrent social or interpersonal problems that are caused or exacerbated effects of the substance
For the purpose of this article, the term abuse will be used to refer to both the misuse and abuse of prescription opioid therapies. The opioids most commonly abused are oxycodone, hydromorphone, and hydrocodone. Although the true cost of opioid abuse is considered difficult to assess because many instances of abuse go unreported, studies have estimated the cost to society at more than $53 billion in the United States annually.5

According to the CDC, there has been a 10-fold increase in the use of opioid analgesics during the last 20 years.6 Increased opioid use has resulted in increased healthcare costs, with patients who abuse opioids having direct healthcare costs 8 times those of nonabusers.2 Costs include time lost from work, multiple emergency department (ED) and ambulatory clinic visits, frequent office visits, doctor-shopping, prescription costs, and rehabilitation facilities.7-9

A 2007 review of administrative claims data from privately insured patients who abused opioids, along with their caregivers (individuals sharing the same plan as an opioid abuse patient), indicated that the abuse accounted for $25 billion in direct healthcare costs—44.9% of total US societal costs related to opioid abuse. Patients were identified as the source of 92% of excess medical and drug costs, with caregivers contributing the remainder.8

A 2008 Drug Abuse Warning Network report stated that approximately 1 million ED visits were attributable to nonmedical use of prescription or over-the-counter (OTC) drugs, comparable to the number of visits resulting from illicit drug use (eg, heroin, cocaine). Of the prescription and OTC drugs reported, opioids were the most common, with 306,000 ED visits. By comparison, heroin accounted for 201,000 ED visits; cocaine, 482,000. The top 3 drugs responsible for unintentional drug overdose deaths were opioids, cocaine, and heroin, with opioid deaths totaling more than those of cocaine and heroin combined.6 It should also be noted that the majority of opioid deaths involve concomitant use of benzodiazepines, alcohol, and/or sedative hypnotics. Moreover, although methadone accounts for less than 5% of all prescribed opioids, it accounts for about 30% of all opioid deaths.10

A recent study by Zedler et al identified risk factors for increased morbidity (ie, life-threatening opioid-related respiratory/central nervous system depression) and mortality associated with opioid abuse. The strongest risk factors were the opioid dose that the patient was taking in a 24-hour period, hospitalization due to toxicity or overdose within the previous 6 months, and a history of opioid dependence. Other significant risk factors included use of ER or LA opioids, liver disease, and a morphineequivalent daily dose of 20 mg or more.11

ED visits are financially taxing: a 2010 study showed the mean cost for patients not admitted to the hospital following an ED visit to be $4121, and the mean cost for those admitted to be $29,669.12

Of course, the increased use of healthcare services because of opioid abuse places a significant economic burden on managed care organizations and payers. One study reports that Medicaid patients and their caregivers account for one-third of excess medical and drug costs due to opioid abuse, with privately insured and uninsured patients and their caregivers each contributing smaller portions to the total cost.8

A review of claims for 611,801 privately insured patients in a single Midwestern state reported that chronic opioid users accounted for more healthcare services than other patients. Patients with chronic opioid use filed 5% of medical claims and received 45% of all opioids prescribed in the state. Although it is not known whether these factors are directly attributable to opioid use, this population also had more physician office visits, ED visits, non−pain-related physical disorders, and psychiatric comorbidities.13 In addition to the acute services made necessary by opioid misuse, admissions to publicly funded treatment facilities have increased healthcare costs, growing from 98,909 in 2007 to 186,986 in 2011, for an increase of 89%.5

One study that looked at the monetary impact of opioid abuse reported that both privately and publicly insured patients who abused opioids had significantly higher mean annual healthcare costs than nonabusers. The study cites excess costs per patient at $20,546 for privately insured and $15,183 for publicly insured patients.14

Another costly aspect of opioid use is drug diversion, broadly defined as distribution from a legitimate legal source, such as a licensed medical professional, into the black market for purposes other than originally intended.15 While the common perception of drug diversion involves illegal channels, one widespread variety is “doctor shopping,” where patients obtain prescriptions from multiple healthcare providers who are unaware of the patient’s preexisting opioid prescriptions or other healthcare providers.16 It is estimated that drug diversion costs payers $72.5 billion each year, with two-thirds of that cost coming from Medicare and Medicaid.9,17

A nationwide sample of all opioids sold during 2008 showed that 1 out of every 143 patients obtained opioids from more than 1 prescriber, with 31% seeing 1 prescriber, 14% seeing 2 prescribers, 3% seeing 5 to 9 prescribers, 0.35% seeing 10 to 19, and 0.04% seeing 20 or more.16 Doctor shopping is often associated with covert behavior, and it is often assumed that patients will pay cash for multiple prescriptions to avoid detection. However, many patients will still utilize insurance to pay for their multiple prescriptions. For example, in the aforementioned study, patients who were identified as doctor shoppers and who used insurance had prescriptions written by an average of 8 different healthcare providers.16 Another study obtained a 20% random sample of prescription data from 2010 of the 37 million Medicare Part D beneficiaries. Of the 1,808,355 beneficiaries who filled at least 1 opioid prescription, 23.1% filled prescriptions from 2 different healthcare providers, 9.5% from 3 healthcare providers, and 7.9% from 4 or more providers. There were 1,208,100 beneficiaries who filled more than 1 prescription, which resulted in even higher numbers of beneficiaries demonstrating doctor-shopping behavior, with 34.6% of beneficiaries obtaining prescriptions from 2 healthcare providers, 14.2% from 3, and 11.9% from 4 or more.18

Obtaining opioids from multiple prescribers has been associated with increased annual hospital admissions, with one report stating patients who received opioids from 4 or more healthcare providers had twice the annual rate of admissions.18 These doctor shoppers generate unnecessary prescriptions and healthcare costs that burden the payer and result in higher premiums paid by all those in the insurance plan.

The Drug Enforcement Administration estimated the economic burden of opioid misuse at $53 billion in 2011.5 Specifically, employed persons who misuse opioids account for 64.5% of medically related absenteeism and 90.1% of disability costs. Comparatively, caregivers of those with opioid issues are responsible for 35.5% of absenteeism and 9.9% of disability costs. Monetarily, opioid abuse is responsible for $25.6 billion annually in lost work productivity.8 It can be assumed, although the reports do not specify it, that there are direct healthcare costs (ie, office visits, prescription costs) related to absenteeism and disability.

The Economic Impact of Implementing REMS to Prevent Opioid Misuse

Educating both physicians and patients on the safe use of opioids is a presumed way of reducing risks associated with abuse.2 The FDA Amendments Act of 2007 (FDAAA; PL 110-85) established the FDA’s role in ensuring that the benefits of certain therapeutics outweigh their risks through the REMS program.19 Between 2007 and August 2014, over 200 REMS programs were approved by the FDA and 144 were released, leaving 68 approved REMS programs and 6 single, shared-system REMS programs. In a single, shared system REMS, multiple drugs follow the same program.20 The ER/LA Opioid REMS initiative is the largest shared REMS to date.19 The goal of this program is to “reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting” opioids. The FDA released the REMS elements in April 2011. They require all manufacturers of ER and LA opioids, including methadone, to provide prescriber education through accredited continuing education, as well as information prescribers can use to educate patients on the risks and benefits of opioids. Although methadone is rightfully included, it is technically neither an ER or LA opioid but rather an opioid with a long and variable half-life. According to the FDA blueprint, the expected result of healthcare education in a REMS is an understanding of1:

  • Patient assessment for treatment with opioid therapy, including when to refer to a pain management specialist
  • Initiating therapy, modifying doses, and discontinuing use
  • Ongoing management of opioid therapy
  • How to educate patients regarding safe use
  • General and product-specific drug information
It is imperative that healthcare providers have an understanding of, and are comfortable with, prescribing opioids and undertaking the associated risk assessment that comes along with responsible prescribing. Despite the abundance of available education on the subject, many physicians remain uncomfortable prescribing opioids for non−cancer-related pain, especially in patients who have a history of substance abuse. It could be theorized that the educational goals of the REMS program could give providers greater confidence in identifying appropriate patients for opioid therapy and initiating at the correct therapeutic dose. In addition, schools of medicine, pharmacy, and nursing education must help clinicians by laying a solid foundation for understanding the proper use and potential abuse of opioids.

 
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