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Supplements Combating the Opioid Epidemic
Introduction to the Opioid Epidemic: The Economic Burden on the Healthcare System and Impact on Quality of Life
Nicholas E. Hagemeier, PharmD, PhD
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Courtney Kominek, PharmD, BCPS, CPE
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The Role of Managed Care Professionals and Pharmacists in Combating Opioid Abuse
Kirk Moberg, MD, PhD
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The Role of Managed Care Professionals and Pharmacists in Combating Opioid Abuse

Kirk Moberg, MD, PhD
Clinical practice guidelines and recommendations should be followed when considering opioid use for chronic pain management. The American Society of Interventional Pain Physicians issued guideline recommendations for the use of opioids in the management of noncancer pain in 2017. Key areas/phases of focus are included in Table 4.10

Practitioners should also be aware of the current CDC guidelines for prescribing opioids for chronic pain, produced in 2016, which include 12 distinct recommendations grouped under 3 headings/categories, as seen in Table 5.11 Overall, the CDC guidelines were designed to facilitate communication between clinicians and patients about the risks and benefits of opioids for chronic pain, increase effectiveness and safety of pain therapy, and reduce risk of opioid use disorder, overdose, and fatalities. These guidelines will continue to be revisited and revised in the future to further improve patient outcomes in pain management.11

The American College of Physicians (ACP) also addressed this issue in a 2017 guideline document for the management of lower back pain. Among their recommendations were the following12:
  • Recommendation 1: Because most patients with acute or subacute lower back pain see improvement in their pain over time regardless of type of treatment, clinicians and patients should initially choose nonpharmacologic options for therapy. These may include superficial heat, massage, acupuncture, or spinal manipulation. If pharmacologic therapy is desired, nonsteroidal anti-inflammatory drugs (NSAIDs) or skeletal muscle relaxants should be chosen for therapy.
  • Recommendation 2: For those with chronic lower back pain, initial therapy should also be based on nonpharmacologic options, including exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation.
  • Recommendation 3: For those with lower back pain not responding to nonpharmacologic therapy, first-line treatment with NSAIDs should be considered, with tramadol or duloxetine as second-line options. Opioids should only be considered in patients who have failed treatment with the recommended first- and second-line options, and only if the benefits of opioid use outweigh the potential risks for each individual patient.
According to the ACP, opioids should be considered the last treatment option for patients with chronic lower back pain who have not responded to other recommended therapy options because of the significant potential harm they can cause. Studies that have addressed opioids for use in chronic lower back pain have not addressed the risk for addiction, abuse, and overdose. Data from observational studies have demonstrated a dose-dependent relationship between the use of opioids and potentially serious AEs.12,13 Clinicians should select therapies for chronic lower back pain that deliver the fewest harms and also lower costs overall because there are no distinct comparative advantages for most treatments.12

The Value and Limits of Abuse-Deterrent Opioid Formulations in Therapy

The development of abuse-deterrent formulations (ADFs) has been an important advance in the armamentarium to fight opioid misuse and abuse and to reduce diversion of these therapies. ADFs are designed to prevent extraction of the active drug in formulations, prevent administration through alternative routes and/or make abuse of a manipulated agent less appealing. ADFs can still lead to abuse via the intended route of administration by increasing dosage or frequency of administration. The science of ADFs and regulatory landscape   surrounding them continues to evolve, as do their usage in clinical practice.14 ADF technologies present both advantages and limitations for use in clinical practice, as seen in Table 6.14

Although considered effective alternatives, ADFs have not proven to be a panacea for opioid abuse, misuse, and diversion. A study by Cassidy et al assessed patterns of abuse of opioids and other drugs after the introduction of the reformulation of oxycodone hydrochloride controlled-release tablets (ADF). This study used a sentinel sample of 232,874 adults assessed for substance abuse treatment at 437 facilities to evaluate for quarterly prevalence of past 30-day abuse and changes in abuse pre- and post-introduction of the ADF agent. Results demonstrated that increased abuse prevalence occurred for all prescribed opioid classes (pre-post relative risk = 1.08) and for extended-release (ER) opioids (relative risk = 1.11). In fact, there was a nearly 3-fold increase in the abuse of ER oxymorphone and a 2-fold increase for buprenorphine in the time period after the introduction of ADFs, and the increases were prominent among patients who reported abuse by preferential administration routes, including oral, nasal (snorting), and injectable administration. The investigators concluded that additional follow-up studies will be needed to monitor changing opioid abuse patterns and their impact on public health as newer ADFs and other formulations are developed and introduced as therapy options.15 Other studies have also identified trends of patient switching from ADFs to more easily abused opioids, further emphasizing the need to monitor abuse patterns, as noted in the Cassidy analysis.16-18

The economics and potential cost increases or savings with ADFs continue to be elucidated. For example, data from Kirson et al have suggested that the ADF reformulation of oxycodone hydrochloride is associated with an estimated $340 million in annual medical cost savings along with $605 million in indirect cost savings, providing a total annual societal cost savings estimated at $1.0 billion in the United States. Such savings associated with reduction in opioid abuse could continue to grow with the development and introduction of more ADFs.14,19 However, these potential cost benefits must be considered in conjunction with the often-higher cost of these opioid formulations. It has been estimated that the average additional costs for ADF opioids would range from approximately $600 to $2800 per month, depending on the individual drug.20,21 And in contrast to the Kirson study, a study by Keast et al found that greater Medicaid expenditures were discovered in 2013 and 2014 for patients who were prescribed ADFs versus standard opioid agents. ADF costs were estimated at $24,979 versus $15,043 (per patient) for the traditional opioids.21,22 The economic impact of ADFs can be better elucidated by considering overall healthcare costs associated with opioid abuse along with the cost impact on patients shifting to other opioid formulations. Careful selection of patients in need of ADF products is important in maximizing the cost-benefit ratio of ADF products.21

Prior Authorization and Opioid Management

Prior authorization (PA) remains an important aspect of prescribing and medication management. PA is administered to ensure that benefits for prescribed drugs are administered as designed. With PA, patients receive the most appropriate agents while waste, error, and unnecessary drug usage and cost are diminished.23 The PA process requires the prescribing clinician to receive pre-approval for prescribing a certain pharmaceutical for that agent to qualify for coverage under terms laid out in the pharmacy benefit plan.23,24 If a drug requires a PA, it will not be approved for payment until conditions for approval and use are met and the PA is actually entered into the ordering system. The procedures for PA and requirements for coverage are based on both the actual clinical need and therapeutic justification for use of that drug. The PA process allows a prescriber to justify the therapeutic rationale and need for a specific drug for an individual patient.23,25

PA is considered a tool to both promote appropriate drug use and prevent misuse/abuse. In some cases, including prescribing of opioid drugs, PA may be used to limit coverage in certain situations to patients where safety and appropriate use has been documented, especially if there is not enough clinical evidence to support the use of a medication for an off-label indication (eg, an opioid approved for breakthrough cancer pain but not for chronic low back pain). Step therapy is also an approach used as part of PA, requiring the use of clinically recognized first-line drugs before approval of a more complex and costly agent where safety, effectiveness, and value have not been established for a specific medical condition.23

PA has been used to potentially lower the rates of opioid misuse and abuse. A study by Cochran et al compared rates of opioid abuse and overdose in Pennsylvania Medicaid enrollees in plans that varied in their use of PA, namely requiring PA for 17 to 74 opioids (high PA); requiring a PA for 1 opioid (low PA); or those requiring no PA policies for opioid drugs. Assessments were made between the presence of PA policies and opioid abuse and overdose, measured in Medicaid claims data. Overall, there were 297,384 enrollees included, comprising 382,828 opioid treatment episodes. Enrollees in high and low PA plans were found to have lower rates of abuse compared with plans that had no PA policies. Individuals in high PA plans were found to be 11% less likely to develop opioid abuse than patients in plans with no PA, and enrollment in a low PA plan was associated with a 7% lower rate of abuse development in comparison enrollment in a no-PA plan. Adjusted rates of abuse were 2.49% for high PA, 2.58% for low PA, and 2.76% for no PA per average person-days. Those in low-PA plans had lower adjusted overdose rates than those in no-PA plans, and those patients in high-PA plans were also less likely to overdose versus those enrolled in no-PA plans, although this association did not reach statistical significance (adjusted rate ratio of 0.21, 0.17, and 0.23 for high, low, and no PA, respectively). Overall, the investigators concluded that Medicaid plans using PA policies appeared to have lower rates of opioid abuse and overdose following opioid therapy initiation.26

However, PA also has created troublesome and disruptive barriers affecting both prescribers and patients. A previous survey of 2400 physicians by the American Medical Association (AMA) found that two-thirds of physicians reported waiting times of several days to receive a PA for prescribed drugs, with 10% of those reporting waits of more than a week.27 More recent data from 2017 demonstrated that 33% of physicians waited 1 to 2 business days for PA, with 20% reporting delays of 3 to 5 business days.28 In addition, 75% of physicians recently surveyed described PA burdens as high or extremely high and nearly one-third reported having staff in place who exclusively work on PA. Nearly 90% reported that PA sometimes, often, or always delays access to healthcare.29

 
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