Drug Utilization Data Research Articles

The Impact of a Workforce Mental Health Program on Employer Medical Plan Spend: An Application of Cost Efficiency Measurement for Mental Health Care.

Mental health issues often result in significant impairment and financial challenges, both at home and in the workplace. Solutions vary widely in their usage and cost-effectiveness. This study presents an analysis of medical and prescription drug spending and utilization data for the employees of 4 companies who were eligible for an evidence-based workforce mental health program (WMHP). A variation of coarsened exact matching paired WMHP users to nonusers, based on demographics, location, and medical factors. Individuals included 2791 pairs of members whose medical claims were incurred in 2018 and 3883 pairs with claims in 2019. Using a cost efficiency measurement process, mean cost and utilization per person per year (PPPY) were compared. WMHP users had lower medical (-$2295 in 2018; -$2304 in 2019) and prescription drug spending (-$295 in 2018; -$312 in 2019). Over half of the cost reduction (-$1252 in 2018; -$1211 in 2019) resulted from shifting therapy services from the medical benefit to WMHP. WMHP users attended about 12 sessions PPPY, whereas the comparison group of nonusers attended about 7 mental health office visits PPPY under the medical benefit. WMHP users had more mental health-related visits in both years, but had fewer visits on the medical plan, and fewer emergency department visits for mental health than comparison group members. These results provide evidence that high-quality, evidence-based mental health services can reduce total expenditures and change utilization patterns. Evidence-based WMHP may represent a prudent investment for employers in providing mental health care to employees.

Observational Analysis of the Costs Associated with Acute Treatment of Breakthrough Migraine Attacks in Medicaid Patients Using Preventive Therapies.

Medications for preventive treatment of migraine reduce migraine frequency, usually measured by a reduction in monthly migraine days (MMD), but generally do not eliminate the need for acute treatment. To assess the economic impact of treatment-related reductions in frequency, methodological guidance recommends capturing cost differences along the spectrum of MMD. Characterize monthly migraine medication costs along the spectrum of MMD for patients using calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) for prevention. Medicaid State Drug Utilization Data (SDUD) were used to identify formulations and per-unit costs for oral, intranasal, and parenteral migraine-specific medications for acute and preventive treatment used by fee-for-service (FFS) Medicaid enrollees in 2020. National drug codes of relevant therapies were used to match SDUD to formulation characteristics including substance, route of administration, and branded/generic marketing status. Mean per-unit cost and the formulation's share of total prescriptions were estimated. Monthly medication costs were modeled based on formulations' per-unit costs and frequency of acute medication use during clinical trials of CGRP mAbs. In the SDUD, there were 563,338 prescriptions for migraine-specific acute medications; triptans accounted for 97.37%. Triptan formulations prescribed were 83.78% oral tablet, 10.89% orally disintegrating tablet, 2.60% intranasal, and 2.73% parenteral. Dihydroergotamine accounted for < 1% of total prescriptions and had the highest per-unit cost ($443.50, branded intranasal). There were 97,119 prescriptions for CGRP mAbs, the majority for erenumab (45.73%) or galcanezumab (45.24%). Modeled monthly acute and preventive medication costs ranged from approximately $550 in patients with the fewest MMD treated with oral triptans to > $1500 in patients with the most MMD treated with dihydroergotamine. In consideration of the migraine-specific acute medications used in FFS Medicaid 2020, for patients using CGRP mAbs for prevention, medication costs may vary significantly with the number of breakthrough attacks treated per month and the type of migraine-specific acute therapy used.

Estimates of Medicaid and Non-Medicaid Net Prices of Top-Selling Brand-name Drugs Incorporating Best Price Rebates, 2015 to 2019

The US spends far more on brand-name prescription drugs than other comparable countries. However, studies of prescription drug spending in the US are often limited because there can be substantial differences in the confidential rebates that drug manufacturers pay to Medicaid vs other payers. To demonstrate an approach for improved estimation of Medicaid rebates through case studies of 18 top-selling drugs to better understand trends in net Medicaid and non-Medicaid spending and prices for brand-name drugs. This was a cross-sectional study of US pricing data from 2015 to 2019 derived from Medicaid State Drug Utilization data SSR Health, Medi-Span, the Federal Supply Schedule, and IQVIA. Pricing data for 18 top-selling brand-name drugs measured consistently in both SSR Health, which captures US sales reported by publicly traded companies, and IQVIA's top US prescription drugs by nondiscounted spending in 2015 to 2019. Data were accessed and analyzed from January 2019 to June 2021. Gross and net Medicaid and non-Medicaid drug spending for the sample of 18 drugs and prices corresponding to a 30-day supply of medication. Medicaid aggregate gross spending for the 18 drugs in the sample increased 173%, from $3.6 billion in 2015 to $9.9 billion in 2019, and estimated net spending after discounts increased by 119%, from $1.4 billion to $3.0 billion. Medicaid inflation-linked rebates reduced average gross price per 30-day supply by an estimated 43% in 2019, and up to 67% for individual drugs. In addition to the basic rebate, the best price provision reduced the average gross price per 30-day supply by an estimated 3% in 2019 and up to 54% for individual drugs. Between 2015 and 2019 across all study drugs, estimated average non-Medicaid net 30-day prices were between 1.9 and 2.6 times higher than Medicaid net prices. Excluding adalimumab-a spending anomaly because of the entry of a new high-cost formulation-net prices weighted by average gross spending decreased annually by 1% from 2015 through 2019 for Medicaid, while increasing by 2% for non-Medicaid payers. In this cross-sectional study of 18 top-selling brand-name drugs, excluding 1 anomaly, Medicaid average net prices declined from 2015 to 2019. Simultaneously, for non-Medicaid payers, net price increased more than previously published marketwide growth rates, raising the importance of restraining drug price growth in non-Medicaid markets. Rigorous and transparent methods to estimate Medicaid discounts are imperative to understand patterns in Medicaid and non-Medicaid prices and develop policies that better align drug prices with clinical benefits.

Real-world impact of a subsidy decision of sofosbuvir-velpatasvir for treatment of chronic hepatitis C on clinical practice and patient outcomes.

Sofosbuvir-velpatasvir was recommended for subsidy to treat chronic hepatitis C in Singapore in 2018. We measured the impact of the subsidy decision on clinical practice and patient outcomes. Specifically, we looked at pre- and post-subsidy changes in the utilization and prescribing pattern of chronic hepatitis C treatment and the real-world clinical effectiveness. Utilization trends and prescribing patterns were assessed using aggregated drug utilization data from public hospitals' dispensing systems and clinical data from the national electronic health record database, respectively. An audit was conducted to evaluate sustained virological response rate 12 weeks post treatment (SVR12). Use of sofosbuvir-velpatasvir increased sharply since its subsidy listing and dropped subsequently, whereas the utilization of comparator drugs remained low. Prescribing rate of sofosbuvir-velpatasvir increased from 13.7% in the pre-subsidy period to 90.2% in the post-subsidy period; 39.1% of patients previously on pegylated interferon and ribavirin switched to sofosbuvir-velpatasvir following its subsidy listing. In the audit, 365 out of 375 patients (97.3% [95% confidence interval: 95.1-98.6%]) achieved SVR12. The subsidy decision led to increased accessibility to patients and intended changes in clinical practice. Sofosbuvir-velpatasvir was also clinically effective in the real world. These findings augur well for the continued eradication of chronic hepatitis C infection in Singapore.

Trends in utilization, reimbursement, and price for DOACs and warfarin in the US Medicaid population from 2000 to 2020.

The use of direct oral anticoagulants (DOACs) is widely increasing in the United States (US). Warfarin has been the conventional anticoagulant used in the past few decades, but it has been gradually replaced by DOACs. The objective of the study was to analyze trends in utilization, reimbursement, and price for those anticoagulants in the US Medicaid population. Retrospective data analysis was conducted using the National Summary Files for the Medicaid State Drug Utilization Data. Study drugs included dabigatran, rivaroxaban, apixaban, edoxaban and warfarin. The study assessed secular trends of utilization, reimbursement, and per-prescription price. The data was collected from the first quarter of 2000 through to the second quarter of 2020 restricted for outpatient prescriptions only. During the 21-year study period, a substantial rise in total expenditures on warfarin and DOACs was observed from $144 million in 2000 to $694 million in 2020. Moreover, the utilization of DOACs has increased significantly since the first approval of Xarelto in 2010 from 1079 in 2011 to 1.5 million in 2019. The per-prescription price of DOACs increased from an average of $200 in 2011 to $407 in 2020. Conversely, the total number of prescriptions of Warfarin and branded Coumadin decreased from 2.4 million to 1.4 million and from 3.9 million to less than a million, respectively. The present study demonstrated a change in the trends of US expenditure and utilization for warfarin and DOACs with DOACs representing the majority of market share of both spending per prescription and reimbursement.

Medicaid Spending on Antiretrovirals From 2007 Through 2019.

Antiretroviral (ARV) medications to treat human immunodeficiency virus (HIV) are a major contributor to Medicaid prescription drug spending. Despite having been used for over 3 decades, the first generic ARVs only recently became available, and many newer versions continue to be sold at high prices despite within-class competition. We estimated Medicaid spending on ARVs from 2007 through 2019. Using public Medicaid State Drug Utilization data, we identified trends in ARV spending and use from 2007 through 2019. We estimated net spending and average prices (spending per 30-day supply), accounting for statutory Medicaid rebates, including a 15%-23% base rebate plus additional rebates if a drug's price increased faster than inflation. Among 48 ARVs, estimated net Medicaid spending from 2007 through 2019 was $25 billion for 17 million 30-day supplies. Annual use increased 118%, from 0.7 million 30-day supplies in 2007 to 1.6 million in 2019. During this time, estimated annual net spending increased 178%, from $1.1 billion to $3.0 billion, and average net prices increased 28%, from $1432 to $1830 per 30-day supply. Annual Medicaid net spending on ARVs nearly tripled from 2007 to 2019, due to a combination of expanded use and rising prices. Medicaid did not extract expected benefits from its mandatory inflationary rebates because they were offset by use of newer, more expensive ARVs. To better control spending related to products with incremental innovation, the US government should be authorized to assure that launch prices for new drugs are aligned with the added benefit they offer over existing therapies.

Effect of the direct healthcare professional communication on citalopram and escitalopram drug utilization for inpatient treatment of anxiety disorders

In 2011, direct healthcare professional communication (DHPC) letters on citalopram and escitalopram were sent out to address the risk of QTc prolongation in the ECG. Healthcare professionals were informed about areduction of the maximum recommended daily dose. Furthermore, acontraindication for QTc-prolonging co-medication was given. Previous studies noted that these instructions were implemented incompletely. For the first time, this study analyzed how the DHPC affected the prescription of citalopram and escitalopram in patients with anxiety disorders. Drug utilization data from the project "Arzneimittelsicherheit in der Psychiatrie e. V." (AMSP) was used to examine whether the proportion of patients treated with ahigher-than-recommended daily dose ("high dose") and the proportion of patients with QTc-prolonging co-medication would decrease post-DHPC (combined category of citalopram/escitalopram). Drug utilization data of n = 364patients pre- and n = 262patients post-DHPC were compared. The proportion of patients with high dose declined from 10.7% to 5.4% (p = 0.019). The proportion of patients with QTc-prolonging co-medication did not change significantly from pre- (54.7%) to post-DHPC (51.5%, p = 0.437). In accordance with previous studies, the proportion of high-dose patients decreased after DHPC publication while the proportion of patients with QTc-prolonging co-medication remained widely unchanged. The specific recommendation on daily dosage seems to have been better implemented than the broadly formulated contraindication of QTc-prolonging co-medication. Hence, DHPCs should be written precisely and give advice for specific clinical situations.

Trends in opioid utilization in Hungary, 2006-2020: A nationwide retrospective study with multiple metrics.

BackgroundOpioid use is well documented in several countries: some countries struggle with overuse, whereas others have almost no access to opioids. For Europe, limited data are available. This study analysed Hungarian opioid utilization in ambulatory care between 2006 and 2020.MethodsWe obtained national drug utilization data on reimbursed opioid analgesics (ATC code: N02A) from a national health insurance database for a 15‐year period. We investigated utilization trends, using three volume‐based metrics [defined daily dose per 1000 inhabitants per day (DID), oral morphine equivalent per 1000 inhabitants per day, packages dispensed per 1000 inhabitants per year]. We stratified data based on administration routes, analgesic potency and reimbursement categories.ResultsTotal opioid utilization increased during the study period according to all three metrics (74% in DID) and reached 5.31 DID by 2020. Upward trends were driven by an increase both in weak and strong opioid use (79% vs. 53%). The most commonly used opioids were fentanyl (in the strong category; 0.76 DID in 2020) and tramadol (in the weak category; 2.62 DID in 2020). Overall, tramadol was also the most commonly used opioid throughout the study period. Oral administration of opioid medications was dominant. Based on reimbursement categories, musculoskeletal pain was becoming a more frequent indication for opioid use (1552% increase in DID), while opioid use for cancer pain declined significantly during the study period (−33% in DID).ConclusionsOur low utilization numbers might indicate underuse of opioid analgesia, especially for cancer pain.SignificanceThis study was one of the recent opioid utilization studies using three volume‐based metrics, covering a long time period. To our knowledge, this was also the first national, population level study describing opioid utilization in Hungary. National opioid utilization data suggested not an overuse but rather an underuse of opioid analgesics in a developed, Central European country.

Estimation of tuberculosis incidence at subnational level using three methods to monitor progress towards ending TB in India, 2015–2020

ObjectivesWe verified subnational (state/union territory (UT)/district) claims of achievements in reducing tuberculosis (TB) incidence in 2020 compared with 2015, in India.DesignA community-based survey, analysis of programme data and anti-TB drug...

Buprenorphine Use Trends Following Removal of Prior Authorization Policies for the Treatment of Opioid Use Disorder in 2 State Medicaid Programs

State Medicaid programs have implemented initiatives to expand treatment coverage for opioid use disorder (OUD); however, some Medicaid programs still require prior authorizations (PAs) for filling buprenorphine prescriptions. To evaluate the changes in buprenorphine use for OUD among Medicaid enrollees in states that completely removed buprenorphine PA requirements. This retrospective cross-sectional study analyzed the immediate and trend changes on buprenorphine use during 2013 to 2020 associated with removal of PA requirements using a controlled interrupted time series analysis to account for autocorrelation. Data were collected from Medicaid State Drug Utilization Data for 2 states (California and Illinois) that completely removed a buprenorphine PA during the study period, and buprenorphine prescriptions for OUD treatment were identified among Medicaid enrollees. Quarterly total number of buprenorphine prescriptions for each state was calculated, and stratification analyses were conducted by dosage form (films and tablets). Among the 2 state Medicaid programs (California and Illinois) that removed buprenorphine PAs, there was a total of 702 643 and 415 115 eligible buprenorphine prescription claims, respectively. After removing PA requirements for buprenorphine, there was an immediate increase that was not statistically significant (rate ratio [RR], 1.11; 95% CI, 0.76-1.61) in the number of all buprenorphine prescriptions in California and a statistically significant increase (RR, 6.99; 95% CI, 4.67-10.47) in the number of all buprenorphine prescriptions in Illinois relative to the change in the control states (Alabama, Florida, Idaho, Kansas, Mississippi, Nevada, South Dakota, and Wyoming). Additionally, there was a statistically significant decreasing trend in the number of all buprenorphine prescriptions in California (RR, 0.88; 95% CI, 0.82-0.94) and a statistically significant increasing trend in Illinois (RR, 1.11; 95% CI, 1.05-1.19) relative to the trend in control states. In this cross-sectional study, removal of buprenorphine PA requirements was associated with a statistically significant increase in the number of buprenorphine prescription fills among Medicaid populations in 1 of the 2 included states.

Pharmacological treatment of major depressive disorder according to severity in psychiatric inpatients: results from the AMSP pharmacovigilance program from 2001–2017

The International Classification of Diseases (10th Version) categorizes major depressive disorder (MDD) according to severity. Guidelines provide recommendations for the treatment of MDD according to severity. Aim of this study was to assess real-life utilization of psychotropic drugs based on severity of MDD in psychiatric inpatients. Drug utilization data from the program “Drug Safety in Psychiatry” (German: Arzneimittelsicherheit in der Psychiatrie, AMSP) were analyzed according to the severity of MDD. From 2001 to 2017, 43,868 psychiatric inpatients with MDD were treated in participating hospitals. Most patients were treated with ≥ 1 antidepressant drug (ADD; 85.8% of patients with moderate MDD, 89.8% of patients with severe MDD, and 87.9% of patients with psychotic MDD). More severely depressed patients were more often treated with selective serotonin–norepinephrine reuptake inhibitors and mirtazapine and less often with selective serotonin reuptake inhibitors (p < 0.001 each). Use of antipsychotic drugs (APDs), especially second-generation APDs, increased significantly with severity (37.0%, 47.9%, 84.1%; p < 0.001 each). APD + ADD was the most used combination (32.8%, 43.6%, 74.4%), followed by two ADDs (26.3%, 29.3%, 24.9%). Use of lithium was minimal (3.3%, 6.1% ,7.1%). The number of psychotropic drugs increased with severity of MDD—patients with psychotic MDD had the highest utilization of psychotropic drugs (93.4%, 96.5%, 98.7%; p < 0.001). ADD monotherapy was observed to a lesser extent, even in patients with non-severe MDD (23.2%, 17.1%, 4.4%). Findings reveal substantial discrepancies between guideline recommendations and real-life drug utilization, indicating that guidelines may insufficiently consider clinical needs within the psychiatric inpatient setting.

Pharmacovigilance in low- and middle-income countries: A review with particular focus on Africa.

Low- and middle-income countries (LMIC) face unique challenges with regard to the establishment of robust pharmacovigilance systems capable of generating data to inform healthcare policy and practice. These include the limited integration and reliability of pharmacovigilance systems across LMIC despite recent efforts to harmonize pharmacovigilance rules and regulations in several regional economic communities. There are particular challenges relating to the need to translate reporting tools into numerous local languages and the low numbers of healthcare providers relative to number of patients, with very short consultation times. Additional factors frequent in LMIC include high uptake of herbal and traditional medication, mostly by self-medication; disruptive political conflicts jeopardizing fragile systems; and little or no access to drug utilization data, which makes it difficult to reliably estimate the true risks of medicines use. Pharmacovigilance activities are hindered by the scarcity of well-trained personnel with little or no budgetary support from national governments; high turnover of pharmacovigilance staff whose training involves a substantial amount of resources; and little awareness of pharmacovigilance among healthcare workers, decision makers and consumers. Furthermore, little collaboration between public health programmes and national medicines regulatory authorities coupled with limited investment in pharmacovigilance activities, especially during mass drug administration for neglected tropical diseases and mass vaccinations, produces major challenges in establishing a culture where pharmacovigilance is systematically embedded. Very low spontaneous reporting rates with poor quality reports hinders robust signal detection analyses. This review summarises the specific challenges and areas of progress in pharmacovigilance in LMIC with special focus on the situation in Africa.

Coverage of genetic therapies for spinal muscular atrophy across fee-for-service Medicaid programs.

BACKGROUND: Genetic therapies are a promising treatment for children born with spinal muscular atrophy (SMA); however, their high price tags can evoke coverage restrictions. OBJECTIVE: To assess variation in coverage guidelines across fee-for-service state Medicaid programs for 2 novel genetic therapies, nusinersen and onasemnogene abeparvovec, that treat SMA. We also assessed the association of these coverage guidelines with use of the 2 genetic therapies. METHODS: We evaluated fee-for-service Medicaid coverage policies for nusinersen and onasemnogene abeparvovec from publicly available websites for the period February 2020-March 2020. We then documented areas of agreement and disagreement across 4 key coverage domains. We used 2018 and 2019 state Medicaid drug utilization data to calculate the use of nusinersen across Medicaid programs and assessed that use against the restrictiveness of the coverage guidelines. RESULTS: We identified 19 state Medicaid coverage guidelines for nusinersen. Most states agreed on diagnostics requirements; however, there were disagreements based on ventilator status. We identified 17 state Medicaid coverage guidelines for onasemnogene abeparvovec. There was more discordance in these coverage guidelines compared with nusinersen, notably in domains of SMN2 gene count and ventilator status. When comparing utilization of nusinersen with coverage restrictions, we found that the more restrictive states had considerably lower utilization of nusinersen. CONCLUSIONS: There was significant variation across fee-for-service Medicaid coverage policies for nusinersen and onasemnogene abeparvovec. Although states can impose individual coverage guidelines for each drug, we presented policy options that could reduce variation and potentially decrease the cost burden of these drugs. DISCLOSURES: This study was funded by Arnold Ventures. The authors have no conflicts of interest to disclose.

Associations Between Copays, Coverage Limits for Naloxone, and Prescribing in Medicaid.

Aims:To describe naloxone dispensing in Medicaid fee-for-service (FFS) and examine relationships between copays and coverage limits for naloxone and its dispensing rates.Methods:Cross-sectional study using Medicaid FFS State Drug Utilization Data to quantify the use of naloxone in 2018. The primary outcomes of this study were the proportion of naloxone prescriptions relative to all prescriptions and all opioid prescriptions dispensed in each state. We obtained drug benefit design information from the Medicaid Behavioral Health Services Database. The primary analysis examined the influence of copays (yes/no), copay amounts, and coverage limits on medication dispensing using simple linear regression, excluding states with no measurable use or less than 5% Medicaid FFS.Results:We found substantial variability across 50 states and DC in the proportion of prescriptions dispensed for Narcan and generic naloxone. We found a positive relationship between copay and copay amount and dispensing of generic naloxone. However, a sensitivity analysis including the broadest possible cohort of states failed to confirm this relationship. We found no other relationships between copays or coverage limits and dispensing of any naloxone formulation.Conclusions:Substantial variation exists between the rates of naloxone dispensing across the US for Medicaid patients, but we did not find a meaningful relationship between plan design and dispensing. Whether drug benefit designs in Medicaid influence naloxone use requires further evaluation to avoid limiting access to this life-saving medication.

Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on state Medicaid programs. To identify the number and class of drugs approved through the FDA's accelerated approval pathway and analyze state Medicaid programs' use and spending on these drugs from 2015 through 2019. In this cross-sectional study, biannual FDA reports were used to identify products granted accelerated approval and their associated indications approved between December 1992 and December 2020. State Medicaid Drug Utilization Data files available for 1992 through 2019 were used to estimate national totals for spending and use of outpatient drugs. National Medicaid use and gross and net spending on drugs with accelerated approval from 2015 through 2019. Since the inception of the FDA's accelerated approval pathway in 1992 through 2020, 216 product-indication pairs granted accelerated approval were identified, comprising 149 unique products. The composition of drugs approved through the pathway has changed over time, with 28 of 30 (93.3%) product-indication pairs receiving accelerated approval in 2020 being indicated for cancer. Relative to all outpatient prescription drugs paid for by Medicaid, products with accelerated approval ranged from 0.2% to 0.4% of use (1.3-2.4 million prescriptions annually). Despite their infrequent use, drugs with accelerated approval represented a minimum annual net spending on all drugs covered by Medicaid of 6.4% ($2.2 billion of $34.6 billion) in 2015 and a maximum of 9.1% ($2.5 billion of $27.6 billion) in 2018. Estimated annual gross spending on drugs with accelerated approval ranged from $4.2 billion to $4.9 billion over 2015 through 2019, and estimated net spending from $2.2 billion to $2.6 billion. In this cross-sectional study of 216 drugs granted accelerated approval, state spending on drugs approved through the FDA's growing accelerated approval program represented an outsized amount of spending relative to use. Because drugs with accelerated approval have come to market on the basis of trials using surrogate end points, considerable amounts of this spending may have been attributable to products with unproven clinical benefits.

Association of Medicaid Managed Care Drug Carve Outs With Hepatitis C Virus Prescription Use

Medicaid enrolls a disproportionate share of US adults with hepatitis C virus (HCV), and most receive Medicaid benefits through managed care organizations (MCOs). Medicaid MCOs often impose stricter requirements to access HCV medications than traditional fee-for-service Medicaid, which may inhibit use. Though Medicaid MCOs generally cover prescription drugs, several states have carved out direct-acting antiviral HCV medications from MCO coverage and opted to cover them under fee-for-service. Whether these carve outs were associated with changes in medication use is unknown. To examine the association between Medicaid-covered HCV medication fills and carve outs of these medications from MCO coverage. This cross-sectional study examined changes in fills of Medicaid-covered direct-acting antiviral HCV medications in 4 states (Indiana, Michigan, New Hampshire, and West Virginia) that carved out these drugs from Medicaid MCOs between 2015 and 2017. A synthetic control approach was used to compare changes in HCV prescription fills between states that did and did not carve out these medications from MCO prescription drug coverage. Data of direct-acting antiviral HCV prescription fills were obtained from the Medicaid State Drug Utilization Data files, January 2015 to June 2020. Data analysis was conducted from November 2020 to June 2021. Carve outs of direct-acting antiviral HCV medications from Medicaid MCO prescription drug coverage. Direct-acting antiviral HCV prescriptions filled per 100 000 Medicaid enrollees. In this cross-sectional study, carve outs were associated with a mean quarterly increase of 22.1 (95% CI, 12.7-34.1) HCV prescriptions per 100 000 Medicaid enrollees, a relative increase of 86.3% compared with synthetic control states. Compared with each state's respective synthetic control, HCV prescription fills were associated with an increase of 11.5 (95% CI, 5.1-19.0) HCV prescription fills per 100 000 Medicaid enrollees per quarter in Indiana, 36.6 (95% CI, 23.5-53.9) in Michigan, 20.7 (95% CI, 11.1-32.8) in West Virginia, and 43.6 (95% CI, 25.9-68.4) in New Hampshire. In this cross-sectional study of data from 39 states and the District of Columbia, carve outs of direct-acting antiviral HCV medications from Medicaid MCO prescription drug coverage were associated with significant increases in HCV medication use. Given their clinical benefits, greater uptake of HCV medication may help improve the health of Medicaid enrollees with HCV and reduce the economic burden of untreated HCV on the US health care system.

Medicaid Subscription-Based Payment Models and Implications for Access to Hepatitis C Medications

Hepatitis C virus (HCV) can be cured with direct-acting antiviral medications, but state Medicaid programs often restrict access to these lifesaving medications owing to their high costs. Subscription-based payment models (SBPMs), wherein states contract with a single manufacturer to supply prescriptions at a reduced price, may offer a solution that increases access. Whether SBPMs are associated with changes in HCV medication use is unknown. To estimate changes in Medicaid-covered HCV prescription fills after Louisiana and Washington implemented SBPMs on July 1, 2019. This cross-sectional study examined trends in prescription fills of Medicaid-covered direct-acting antiviral HCV medications in Louisiana and Washington after implementation of SBPMs. A synthetic control approach was used to compare changes in HCV prescription fills between states that did and did not implement SBPMs. The unit of analysis was state-quarter. Outpatient direct-acting antiviral HCV prescription fills from the Medicaid State Drug Utilization Data files were obtained from all 50 US states and the District of Columbia from January 1, 2017, to June 30, 2020. Implementation of SBPMs for Medicaid-covered direct-acting antiviral HCV medications. Direct-acting antiviral HCV prescriptions filled per 100 000 Medicaid enrollees. In the year preceding SBPM implementation, the mean (SD) rate of quarterly HCV prescription fills per 100 000 Medicaid enrollees was 43.1 (8.6) prescriptions in Louisiana and 50.1 (4.1) in Washington. After SBPM implementation, the mean (SD) rate of quarterly HCV prescription fills per 100 000 enrollees was 206.0 (51.2) prescriptions in Louisiana and 53.9 (11.0) in Washington. In synthetic control models, SBPM implementation in Louisiana was associated with an increase of 173.5 (95% CI, 74.3-265.3) quarterly prescription fills per 100 000 Medicaid enrollees during the following year, a relative increase of 534.5% (95% CI, 228.7%-1125.0%). Washington did not experience a significant change in prescription fills following SBPM implementation. In this cross-sectional study, Louisiana experienced substantial increases in HCV medication use among its Medicaid-enrolled population following SBPM implementation, whereas Washington did not. These differences may partially be explained by state-level variation in SBPM implementation, historical restrictions on access to HCV medications, and responses to the COVID-19 pandemic.

Data resource profile: Norwegian Databases for Drug Utilization and Pharmacoepidemiology

In this article we aim to give researchers and other users of drug utilization data a current overview of the twonationwide Norwegian drug databases located at the Norwegian Institute of Public Health (NIPH), withreference to some historical background. The first database, “The Norwegian Drug Wholesales Statistics”,dating back to 1974, provides total sale figures of all medicines on the market. The second database, “TheNorwegian Prescription Database” (NorPD), dates back to 2004 and covers prescription drugs dispensed bypharmacies. This database will be modernized during 2021 and renamed (“The Norwegian Prescribed DrugRegistry”, name not finally decided), and all historical data will be migrated to the modernized registry. In thefuture, the most valuable add-on to the modernized prescription database will be individual level data fromin-patients in hospitals and health care institutions, and the possibility to obtain aggregated data from eachinstitution. Together, the two nationwide databases will continue to be the cornerstones of drug utilization data in Norway and should be used more extensively to improve health to the best for individuals and society. Development in national e-health programs will play a key role in providing easier and less time-consuming access to data and improve conditions for linkage of drug data to other health registries in the near future.

Mandatory use of prescription drug monitoring program and benzodiazepine prescribing among U.S. Medicaid enrollees

Background In the past two decades, the U.S. saw an alarmingly increasing trend of benzodiazepine prescribing. Mandatory use of Prescription Drug Monitoring Programs (PDMPs) was suggested to have the potential to reduce opioid prescribing, but little is known about its impacts on benzodiazepines. This study examined whether PDMP data use mandates were associated with changes in benzodiazepine prescribing in the U.S. Methods: Aggregate state quarterly prescription drug records of benzodiazepines for Medicaid enrollees during 2010–2017 were obtained from the U.S. Medicaid State Drug Utilization Data. Three population-adjusted outcome variables were evaluated, including quantity, dosage, and Medicaid spending of benzodiazepine prescriptions per quarter per 100 Medicaid enrollees. The primary policy variable was the state-wide implementation of PDMP data use mandates for benzodiazepines. To account for between-state variations in mandates, an additional policy variable was considered to indicate strong mandates on PDMP data use, which required all prescribers to query a patient’s PDMP records for first prescribing and subsequent prescribing at least every 12 months. Linear regressions with difference-in-difference approach were used to assess the associations between PDMP data use mandates and benzodiazepine prescribing, controlling for state-level time-varying policy and socioeconomic covariates. Results: The state-wide implementation of PDMP data use mandates for benzodiazepines was not associated with quantity, dosage, or Medicaid spending of benzodiazepine prescriptions. Strong mandates on PDMP data use were not associated with any benzodiazepine prescribing outcomes, either. Conclusions: There was no evidence for the associations between PDMP data use mandates for benzodiazepines and changes in benzodiazepine prescribing among Medicaid enrollees. Future research is warranted to replicate the study in other populations using individual patient records and continuously monitor the trends in benzodiazepine prescribing in association with PDMPs.

Data transparency for building a stronger healthcare system: A case study from Argentinean administrative drug utilization data sources.

In order to compile an inventory of national data sources for drug utilization research (DUR) in Argentina and to verify publicly available data sources, we performed a cross-sectional study that sought to identify national and provincial databases of drug use. In July 2020, we searched the websites of government institutions, carried out a systematic query of bibliographic databases for "drug utilization research" conducted in Argentina, and conducted a survey with local experts. Data collected included: the institution responsible for the database, population covered, accessibility, source of the data, healthcare setting, geographic information, and whether data were individual or aggregated. Descriptive analyses were then performed. We identified 31 data sources for DUR; only one was publicly and conveniently accessible. Five published aggregated data and provide more detailed access by formal request. Only seven sources (23%) reported national data, and most (n=29) included only data from the public healthcare sector. Although data sources for DUR have been found in Argentina, limited access by researchers and policymakers is still an significant obstacle. Increasing health data transparency by making data sources publicly available for the purpose of analyzing public health information is crucial for building a stronger health system.