Another Monoclonal Antibody Granted EUA to treat COVID-19.

The Food and Drug Administration has granted emergency use authorization to sotrovimab for the treatment of mild to moderate COVID-19 in patients at increased risk for progression to severe illness.Sotrovimab is a monoclonal antibody that works directly against the spike protein of SARS-CoV-2 to block its attachment and entry into a human cell.

Spillover effects of state medicaid antipsychotic prior authorization policies in US commercially insured youth.

PURPOSE: To evaluate spillover effects of Medicaid antipsychotic prior authorization (PA) policies among commercially insured youth. METHODS: Commercially insured youth residing in nine US states that implemented PA exclusively for antipsychotics in 2011 or 2012 were identified using a 10% random sample of enrollees in the IQVIA PharMetrics Plus database spanning 2007 to 2015. Youth were included if they were ≤18 years, met the age criteria of the PA at the time of dispensing, and had at least 1 month of prescription drug coverage from 2007 to 2015. The primary outcome of interest was the monthly prevalence of antipsychotics. We implemented segmented regression of interrupted time series analysis to estimate changes in the monthly prevalence of targeted medications, overall and stratified by age. Trends were compared in the 4-year period before and the 3-year period after implementation of PA policies. RESULTS: Antipsychotics prescribing significantly decreased 6.74/10 000 (95% CI, -9.04 to -4.44) enrollees per month immediately after PA implementation. However, PA was not associated with significant long-term trend changes (-0.06; 95% CI, -0.16 to 0.03). Antipsychotic prescribing in children <12 years-old significantly decreased 0.14/10 000 (95% CI, -0.21 to -0.07) enrollees per month after PA implementation, while prescribing in adolescents 12 to 18 years-old significantly increased 0.32/10 000 (95% CI, 0.16 to 0.47) enrollees per month. CONCLUSION: While Medicaid PA polices for antipsychotic oversight did not affect overall prescribing, there were spillover effects in U.S. commercially insured children <12 years-old. This suggests that state-level Medicaid policies intended to improve the quality of care and safe use of antipsychotics can have broad reach.

Transparency in Prior Authorization: The Under-recognized Precedent Set by Arkansas.

Prior Authorization (PA) is an insurance policy that requires providers to obtain permission before delivery of certain medical services. The aim is to ensure appropriate utilization of health care on the basis of clinical guidelines and to minimize costly procedures. The overall impact of PAs has not been well studied; however, many arguments exist in support and opposition to this practice. The Prior Authorization Transparency Act and the Healthcare Transparency Initiative are legislations enacted by the state of Arkansas to study and mitigate the effects of PAs. These legislations are particularly relevant to orthopedic surgery, as many orthopedic procedures and services require PA. There is limited evidence regarding the effects of PAs on the field of orthopedics. Studying these effects is critical to ensuring high-quality care for patients and reducing administrative and provider burden associated with PAs.

Association of Formulary Prior Authorization Policies With Buprenorphine-Naloxone Prescriptions and Hospital and Emergency Department Use Among Medicare Beneficiaries.

Importance: Prior authorization requirements may be a barrier to accessing medications for opioid use disorder treatment and may, therefore, be associated with poor health care outcomes. Objective: To determine the association of prior authorization with use of buprenorphine-naloxone and health care outcomes. Design, Setting, and Participants: This comparative interrupted time series analysis examined enrollment and insurance claims data from Medicare beneficiaries with an opioid use disorder diagnosis or who filled a prescription for an opioid use disorder medication between 2012 and 2017. Over this period, 775 874 members were in 1479 Part D plans that always required prior authorization, 113 286 members were in 206 plans that removed prior authorization, 189 461 members were in 489 plans that never required prior authorization, and 619 919 members were in 485 plans that added prior authorization. Data analysis was performed from April 2019 to February 2020. Exposures: Removal or addition of prior authorization and new prescriptions filled for buprenorphine-naloxone. Main Outcomes and Measures: Buprenorphine-naloxone use, inpatient admissions, emergency department visits, and prescription drug and medical expenditures. Results: The study population in 2012 included 949 206 Medicare beneficiaries (mean [SD] age, 57 [15] years; 550 445 women [58%]). Removal of prior authorization was associated with an increase of 17.9 prescriptions (95% CI, 1.1 to 34.7 prescriptions) filled for buprenorphine-naloxone per plan per year, which is a doubling of the number of prescriptions, on average. Each prescription filled was associated with statistically significant decreases in adverse health care outcomes: substance use disorder-related inpatient admissions decreased by 0.1 admission per plan per year (95% CI, -0.2 to -0.1 admission per plan per year), and substance use disorder-related emergency department visits decreased by 0.1 visit per plan per year (95% CI, -0.13 to -0.03 visit per plan per year) (all P < .001). Combining these results, removal of prior authorization was associated with a reduction in substance use disorder-related inpatient admissions by 2.0 admissions per plan per year (95% CI, -4.3 to -0.1 admissions per plan per year) and substance use disorder-related emergency department visits by 1.4 visits per plan per year (95% CI, -3.2 to -0.1 visits per plan per year). Conclusions and Relevance: Removing prior authorization for buprenorphine-naloxone was associated with an increase in the medication use and decreases in health care utilization and expenditures.

Prior authorization and its impact on access to obstetric ultrasound.

Prior authorization is a process requiring health care providers to obtain advance approval from a payer before a patient undergoes a procedure for the study to be covered. Prior authorization was introduced to decrease overutilization of ultrasound procedures. However, it has led to unanticipated consequences such as impeding access to obstetric imaging, increased administrative overhead without reimbursement, and contribution to physician frustration and burnout. Payers often use intermediary radiology benefit management companies without providing specialty-specific review in a timely manner as is requisite when practicing high-risk obstetrics. This article proposes a number of potential solutions to this problem: (1) consider alternative means to monitor overutilization; (2) create and evaluate data regarding providers in the highest utilization; (3) continue to support and grow the educational efforts of speciality societies to publish clinical guidelines; and (4) emphasize the importance of practicing evidence-based medicine. Understanding that not all health plans may be willing or able to collaborate with health care providers, we encourage physicians to advocate for policies and legislation to limit the implementation of prior authorization within their own states.

Insurance: Network Solutions.

TMA went into this session looking to attack insurer network inadequacy and health plans' use of care-impeding prior authorization demands. On both fronts, medicine scored solid legislative wins that will make it easier for patients and physicians to know who's in network, and provide needed transparency on preauthorization requirements. And on surprise billing, medicine turned what could've been a disastrous bill into something more palatable.

The effectiveness of formulary restriction and preauthorization at an academic medical center.

The impact of formulary restriction and preauthorization (FRPA) on prescribing trends was examined over a 5-year period at an academic medical center. Ordinary least squares regression was used to identify hospital units demonstrating statistically significant trends in prescription of restricted agents. Significant decreases in restricted drug use were seen on 2 of 7 medicine units subject to FRPA, whereas a significant increase was seen in 1 of 4 surgical units subject to FRPA.

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers.

BACKGROUND: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) are an innovative treatment option for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein cholesterol. However, the high costs of these agents have spurred payers to implement utilization management policies to ensure appropriate use. We examined prior authorization (PA) requirements for PCSK9is across private and public US payers. METHODS AND RESULTS: We conducted an analysis of 2016 formulary coverage and PA data from a large, proprietary database with information on policies governing >95% of Americans with prescription drug coverage (275.3 million lives) within 3872 plans across the 4 major insurance segments (commercial, health insurance exchange, Medicare, and Medicaid). The key measures included administrative PA criteria (prescriber specialty, number of criteria in PA policy or number of fields on PA form, requirements for medical record submission, reauthorization requirements) and clinical/diagnostic PA criteria (approved conditions, required laboratories or other tests, required concomitant therapy, step therapy requirements, continuation criteria) for each of 2 Food and Drug Administration-approved PCSK9is. Select measures (eg, number of PA criteria/fields, medical record submission requirements) were obtained for 2 comparator cardiometabolic drugs (ezetimibe and liraglutide). Between 82% and 97% of individuals were enrolled in plans implementing PA for PCSK9is (depending on insurance segment), and one third to two thirds of these enrollees faced PAs restricting PCSK9i prescribing to a specialist. For patients with familial hypercholesterolemia, diagnostic confirmation via genetic testing or meeting minimum clinical scores/criteria was also required. PA requirements were more extensive for PCSK9is as compared with the other cardiometabolic drugs (ie, contained 3×-11× the number of PA criteria or fields on PA forms and more frequently involved the submission of medical records as supporting documentation). CONCLUSIONS: PA requirements for PCSK9is are greater than for selected other drugs within the cardiometabolic disease area, raising concerns about whether payer policies to discourage inappropriate use may also be restricting access to these drugs in patients who need them.