Association of Formulary Exclusions and Restrictions for Opioid Alternatives With Opioid Prescribing Among Medicare Beneficiaries

Rao, Tanvi; Kiptanui, Zippora; Dowell, Paul; Triebwasser, Corey; Alexander, G. Caleb; Harris, Ilene

doi:10.1001/jamanetworkopen.2020.0274

Cited by 5 publications

(3 citation statements)

References 19 publications

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“…This inconclusive finding is aligned with international evidence on the effectiveness of opioid medication review interventions. In addition to the factors mentioned above, other qualitative and contextual mediating factors may also play an important explanatory role, such as individual commitment, leadership, interpersonal skills, political priority, financial incentives, etc ( Gomes et al, 2014 ; Chang et al, 2016 ; Chang et al, 2018 ; Winstanley et al, 2018 ; Brighthaupt et al, 2019 ; Ranapurwala et al, 2019 ; Bhimji et al, 2020 ; Rao et al, 2020 ). Even so, multifaceted interventions designed with a strategic continuity over time and pursuing a sustained improvement of prescribing may prove more suitable to enable long-term prescription changes than isolated, one-component, one-off efforts ( Majumdar and Soumerai, 2003 ; Huiskes et al, 2017 ).…”

Section: Discussionmentioning

confidence: 99%

Impact of Three Safety Interventions Targeting Off-Label Use of Immediate-Release Fentanyl on Prescription Trends: Interrupted Time Series Analysis

et al. 2022

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Background: The Spanish health authorities are concerned by the off-label use of immediate-release formulations of fentanyl (IRF) in noncancer pain and cancer pain in patients with no chronic pain therapy.Aim: To evaluate the impact of different interventions to improve appropriateness of IRF prescription on off-label prescription.Patients and methods: We used interrupted time series (ITS) to estimate immediate and trend changes of IRF prescription for noncancer pain (NCP) and breakthrough cancer pain (BCP) in patients with and without chronic cancer pain therapy associated with two medication reviews (I1 and I2) and the issue of a safety warning letter (I3) with data from a Spanish region with 5 million inhabitants, from 2015 to 2018.Results: The use of IRF for NCP in the region Valencia was reduced from about 1,800 prescriptions per week to around 1,400. The first medication review was followed by an immediate level change of −192.66 prescriptions per week (p < 0.001) and a downward trend change of −6.75 prescriptions/week (p < 0.001), resulting in a post-intervention trend of −1.99 (p < 0.001). I2 was associated with a trend change of -23.07 (p < 0.001) prescriptions/week. After I3, the trend changed markedly to 27.23 additional prescriptions/week, for a final post-intervention trend of 2.17 (p < 0.001). Controlled-ITS provided comparable results. For potentially inappropriate BCP use, the second medication review was followed by a downward, immediate level change of −10.10 prescriptions/week (p = 0.011) and a trend change of 2.31 additional prescriptions/week (p < 0.001) and the issue of the safety warning (I3) was followed by a downward trend change of −2.09 prescriptions/week (p = 0.007).Conclusion: Despite IRF prescription for NCP decreased, the interventions showed modest and temporary effect on off-label prescription. Our results call for a review of the design and implementation of safety interventions addressing inappropriate opioid use.

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Section: Discussionmentioning

confidence: 99%

Impact of Three Safety Interventions Targeting Off-Label Use of Immediate-Release Fentanyl on Prescription Trends: Interrupted Time Series Analysis

et al. 2022

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“…29 The frequent co-prescription of muscle relaxants with other pain relievers, including opioids or their derivatives, also introduces side effects such as central nervous system suppression. 30 This is particularly problematic in those with CKD; for example, baclofen confers a higher risk of encephalopathy in patients with CKD. 31 In addition, the direct effect of therapeutic muscle relaxant use, the relief of painful skeletal muscle contraction, may simultaneously raise the probability of decreasing muscular activities involving uninflamed muscles.…”

Section: Discussionmentioning

confidence: 99%

Muscle relaxant use and the associated risk of incident frailty in patients with diabetic kidney disease: a longitudinal cohort study

Lee

Wang

Tsai

et al. 2021

Therapeutic Advances in Drug Safety

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Background: Patients with diabetic kidney disease (DKD) are at an increased risk of frailty. The exposure to muscle relaxants frequently leads to adverse effects despite their modest therapeutic efficacy, but whether muscle relaxants predispose users to frailty remains unclear. Methods: Patients with DKD from a population-based cohort, the Longitudinal Cohort of Diabetes Patients, were identified between 2004 and 2011 ( N = 840,000). Muscle relaxant users were propensity score-matched to never-users in a 1:1 ratio based on demographic features, comorbidities, outcome-relevant medications, and prior major interventions. Incident frailty, the study endpoint, was measured according to a modified FRAIL scale. We used Kaplan–Meier analyses and Cox proportional hazard regression to analyze the association between cumulative muscle relaxant use (⩾ 28 days) and the risk of incident frailty. Results: Totally, 11,637 users and matched never-users were enrolled, without significant differences regarding baseline clinical features. Cox proportional hazard regression showed that patients with DKD and received muscle relaxants had a significantly higher risk of incident frailty than never-users [hazard ratio (HR) 1.26, 95% confidence interval (CI) 1.04–1.53]. This increase in frailty risk paralleled that in cumulative muscle relaxant dosages (quartile 1 versus 2 versus 3 versus 4, HR 0.91 versus 1.22 versus 1.38 versus 1.45, p = 0.0013 for trend) and in exposure durations (quartile 1 versus 2 versus 3 versus 4, HR 1.12 versus 1.33 versus 1.23 versus 1.34, p = 0.0145 for trend) of muscle relaxants. Conclusion: We found that cumulative muscle relaxant exposure might increase frailty risk. It is prudent to limit muscle relaxant prescription in patients with DKD. Plain language summary Does cumulative muscle relaxant exposure increase the risk of incident frailty among patients with diabetic kidney disease? Background: Frailty denotes a degenerative feature that adversely influences one’s survival and daily function. Patients with diabetes and chronic kidney disease are at a higher risk of developing frailty, but whether concurrent medications, especially muscle relaxants, aggravate this risk remains undefined. Methods: In this population-based study including 11,637 muscle relaxant users and matched never-users with diabetic kidney disease, we used a renowned frailty-assessing tool, FRAIL scale, to assess frailty severity and examined the incidence of frailty brought by muscle relaxant exposure. Results: We found that users exhibited a 26% higher risk of developing incident frailty compared with never-users, and the probability increased further if users were prescribed higher doses or longer durations of muscle relaxants. Conclusion: We concluded that in those with diabetic kidney disease, cumulative muscle relaxant use was associated with a higher risk of incident frailty, suggesting that moderation of muscle relaxant use in this population can be of potential importance.

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“…4,5 One important mechanism by which access could be restricted is through increasingly restrictive prescription formulary designs for opioids. 6 Coverage exclusions, prior authorization, quantity limits, and higher costsharing tiers are common utilization management strategies shown to be associated with changes in opioid prescriptions in the United States 7,8 and Canada. 9,10 Because formulary design is not delineated along cancer versus noncancer lines, shifts toward more restrictive coverage terms for opioids may have inadvertently restricted access to opioids for patients with cancer-related chronic pain, especially in absence of deliberate policies or procedures to exempt patients with cancer pain.…”

mentioning

confidence: 99%

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021

Bao

Zhang

Hartung

et al. 2022

JCO Oncology Practice

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PURPOSE: Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. METHODS: We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. RESULTS: Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids ( P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered ( P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% ( P < .001). For the same four opioids, median OOP costs doubled to quadrupled ( P < .001). CONCLUSION: Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

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Association of Formulary Exclusions and Restrictions for Opioid Alternatives With Opioid Prescribing Among Medicare Beneficiaries

Cited by 5 publications

References 19 publications

Impact of Three Safety Interventions Targeting Off-Label Use of Immediate-Release Fentanyl on Prescription Trends: Interrupted Time Series Analysis

Impact of Three Safety Interventions Targeting Off-Label Use of Immediate-Release Fentanyl on Prescription Trends: Interrupted Time Series Analysis

Muscle relaxant use and the associated risk of incident frailty in patients with diabetic kidney disease: a longitudinal cohort study

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021

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