Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Department of Palliative Care, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
J Palliat Med. 2021 Aug;24(8):1236-1239. doi: 10.1089/jpm.2021.0021. Epub 2021 Apr 19.
Opioid-induced constipation (OIC) remains the most common adverse event associated with opioid use. Treatment with more novel and costly agents (such as peripheral μ-opioid receptor antagonists [PAMORAs]) may be indicated in patients with laxative-refractory OIC. Three PAMORAs are U.S. Food and Drug Administration approved for managing OIC-methylnaltrexone (FDA approved in 2008), naloxegol (in 2014), and naldemedine (in 2017). These drugs are indicated only in limited scenarios. Their contemporary patterns of use and burden of spending remain unknown. To evaluate the trends in use and expenditures for the three PAMORAs approved for treating OIC. Retrospective cross-sectional study using the 2014-2018 Medicare Part D Prescription Drug Event data and the 2018 Part D Prescriber Public Use File. Prescribers and beneficiaries using PAMORAs. The annual spending, number of beneficiaries, number of claims, and spending per beneficiary and claim for each PAMORA. The distribution by prescriber specialty using PAMORA. From 2014 to 2018, aggregate spending on PAMORAs increased, from $13.6 to $150.9 million, and use increased, from 4221 to 72,592 beneficiaries. After FDA approval in 2014, naloxegol overtook methylnaltrexone in the number of users in 2015 and spending in 2016. In 2018, 6989 unique prescribers used any PAMORA. Among them, the most common specialties/professions were family practice (20.2%), internal medicine (18.0%), and nurse practitioner (15.4%). Our findings-significant and increasing expenditure on PAMORAs, and broad use across specialties-serve as a call for defining and implementing appropriate use of PAMORAs.
阿片类药物引起的便秘(OIC)仍然是与阿片类药物使用相关的最常见不良反应。对于便秘治疗药物反应差的患者,可能需要使用新型和昂贵的药物(如外周 μ 型阿片受体拮抗剂 [PAMORAs])进行治疗。三种 PAMORAs 已获得美国食品和药物管理局(FDA)批准用于治疗 OIC:美沙酮(2008 年批准)、纳洛酮(2014 年批准)和纳美芬(2017 年批准)。这些药物仅在有限的情况下适用。它们的当代使用模式和支出负担仍不清楚。评估三种批准用于治疗 OIC 的 PAMORAs 的使用趋势和支出情况。使用 2014-2018 年医疗保险处方药物事件数据和 2018 年处方药物提供者公共使用文件进行回顾性横断面研究。使用 PAMORAs 的医生和患者。每种 PAMORA 的年支出、受益人数、索赔数、每位受益人和每项索赔的支出以及按医生专业分布的使用情况。从 2014 年到 2018 年,PAMORAs 的总支出从 1360 万美元增加到 1.509 亿美元,使用人数从 4221 人增加到 72592 人。在 2014 年获得 FDA 批准后,纳洛酮在 2015 年的使用人数和 2016 年的支出方面超过了美沙酮。2018 年,有 6989 名独特的医生使用了任何一种 PAMORA。其中,最常见的专业/职业是家庭医生(20.2%)、内科医生(18.0%)和执业护士(15.4%)。我们的发现——PAMORAs 的支出显著增加且不断增加,以及在各个专业广泛使用——呼吁我们定义和实施 PAMORAs 的合理使用。