Pharmacy Benefit Managers Research Articles

Heartburn Relief Is the Major Unmet Need for Drug Development in Gastroesophageal Reflux Disease: Threshold Value Analysis

Background and AimsHeartburn symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCABs) are under development as a new class of therapy. We performed economic analyses to align GERD drug development with the needs of gastroenterologists, insurers and patients in a value-based environment. MethodsA decision-analytic model was constructed to compare vonoprazan 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared with healthy control subjects. Costs and quality-adjusted life years were reported. ResultsWithout insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts. DiscussionWe demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.

Pharmacy Assistance Programs for Oral Anticancer Drugs: A Narrative Review.

Oral anticancer medications (OAMs) are high priced with a significant cost-sharing burden to patients, which can lead to catastrophic financial, psychosocial, and clinical repercussions. Cost-conscious prescribing and inclusion of low-cost alternatives can help mitigate this burden, but cost transparency at the point of prescribing remains a major barrier to doing so. Pharmacy assistance programs, including co-payment cards and patient assistance programs administered by manufacturers and foundation-based grants, remain an essential resource for patients facing prohibitive co-payments for OAMs. However, access to these programs is fraught with complexities, including lack of trained financial navigators, limited transparency on eligibility criteria, onerous documentation burdens, and limits in available funding. Despite these drawbacks and the potential for such programs to incentivize manufacturers to keep list prices high, assistance programs have been demonstrated to improve financial well-being for patients with cancer. The increasing development of integrated specialty pharmacies with dedicated, trained pharmacy staff can help improve and standardize access to such programs, but these services are disproportionately available to patients seen at tertiary care centers. Multistakeholder interventions are needed to mitigate the burden of cost sharing for OAMs, including increased clinician knowledge of financial resources and novel assistance mechanisms, investment of institutions in trained financial navigation services and centralized platforms to identify assistance programs, and policies to cap out-of-pocket spending and improve transparency of rates charged by pharmacy benefit managers to a health plan.

A primer on brand-name prescription drug reimbursement in the United States.

Branded prescription drug reimbursement in the United States is complex and comprises multiple transactions among the parties involved in the drug supply chain, including manufacturers, wholesalers, pharmacies, health care providers, health plans or insurers, pharmacy benefit managers, and patients. This primer provides an overview of the parties involved in the reimbursement of brand-name drugs under both the pharmacy and medical benefits of an insurance policy and the flow of products and payments among them. Prescription drug spending in the United States grew from $30 billion in 1980 to $335 billion in 2018, and 80% of spending is on brand-name drugs.1,2 Pharmaceutical spending and drug prices have been the focus of intense debate in recent years, which has brought attention to the complexity of the drug supply chain. This primer provides a high-level overview of the distribution and reimbursement of brand-name drugs (italicized words are defined in the Glossary) used in the outpatient setting and covered by health plans or insurers in the United States. The focus is on the parties involved and the flow of products and payments among them. The purchase of drug products outside of insurance and differences in drug reimbursement between private and public insurers are outside of the scope of this primer.

Recently Proposed Federal and State Legislation To Constrain Pharmacy Benefit Managers Would Not Reduce Drug Costs

Recently Proposed Federal and State Legislation To Constrain Pharmacy Benefit Managers Would Not Reduce Drug Costs

ADDRESSING BENZODIAZEPINE PRESCRIBING PRACTICES AMONGST ELDERLY PTSD VETERANS DURING THE COVID-19 PANDEMIC

Abstract Psychotropic medication prescribing amongst elderly veterans has increased over the course of the COVID-19 pandemic despite the fact that psychotropics such as benzodiazepines, when being prescribed for a period over 2 weeks, are considered as relatively contraindicated amongst such patients with an additional Post-Traumatic Stress Disorder (PTSD) diagnosis due to a worsening of disease state symptoms. The objectives of my study are to inform clinicians and healthcare providers regarding the true extent of current benzodiazepine prescribing practices amongst elderly Veterans with PTSD and to provide a clinical aid/tool for education and improvement of such practices within the setting of the Veterans Affairs Medical Center. A one-page summarized aid will be drafted based upon provider feedback as well as from current Pharmacy Benefits Management Network resources to improve clinical practices with regards to the topics of benzodiazepine recommended length of use, risks of use amongst elderly Veterans, and risks amongst PTSD populations. While benzodiazepine prescribing practices have increased recently during the time of the COVID-10 pandemic, clinical tools may be drafted to improve such practices. Further studies are needed to determine the true impacts of such a tool on the national level as well as upon direct patient care.

Written Communication From Pharmacy Benefit Managers: Is It Helpful?

Physicians are experiencing greater burnout due to excessive time spent on paperwork. Pharmacy benefit managers (PBMs) are adding to this problem by sending excessive mail to physicians. This study examined these mailed communications to determine their frequency and if the physician acted upon them. We hypothesized that few of these mailings would be helpful to the physician. From July 2021 to May 2023, we collected all written communications from PBMs to a single geriatrics outpatient physician. We sorted this information by specific PBM, by communication category, if it resulted in an intervention, and if communications were repeated. We found that out of 263 communications, 17 (6%) resulted in interventions made by the physician. Notices of nonformulary prescriptions (35%, N=6/17) and drug-drug interactions (35%, N=6/17) (p=0.001) resulted in interventions most frequently. The Beers list notifications did not result in intervention. Forty-one percent (108/263) of communications were repeated, and almost half of these were for recommendations (N=52/108, 48%), a category that did not result in frequent interventions. Our hypothesis that only a small number of communications were helpful to physicians was supported. A physician will more likely make interventions if the suggestion is regarding a nonformulary prescription or a drug-drug interaction. Interestingly, notification of a medication on the Beers list did not result in a geriatrician's action. Feedback to PBMs on which communications are most helpful may decrease the amount of paperwork received by physicians and aid in combating burnout.

Lawsuits Over the Price of Insulin—State Efforts for Insulin Access

This Viewpoint discusses the litigation strategy of state-initiated lawsuits alleging illegal and immoral conduct regarding the pricing of insulin by pharmaceutical companies and pharmacy benefit managers.

Analysis of Medicare Expenditure for Discarded Infused Cancer Therapeutics From 2017-2020.

To explore patterns in Medicare reimbursement for wasted oncologic and hematologic infusion drugs from 2017 to 2020 and estimate the savings that implementation of the Infrastructure Investment and Jobs Act (IIJA) would have had. Using the publicly available Medicare Part B Discarded Drug Units database, we analyzed reimbursement data for discarded antineoplastic and hematology therapies from 2017 to2020. Medicare Part B utilization data was extracted for 77 therapies. From 2017 to 2020, the median annual dollar value of discarded therapies was $590 million. Every year, bortezomib, azacitidine, cabazitaxel, and decitabine were among the most wasted products, an average 24% waste. The IIJA policy would have impacted a median of 20 oncology agents and resulted in median annual refund of $172 million. Had the top five most discarded therapies been redistributed, they could have treated 18,289 patients. The five most wasted drugs were all dosed by weight and distributed in single-use vials. The IIJA could potentially significantly reduce waste or encourage redistribution to treat thousands of additional patients. We propose that a fusion of fixed and weight-based dosing may help reduce wasteful medication administration by offering doses that better accommodate most patients. We anticipate that manufacturers will adapt to the IIJA perhaps by adjusting fixed doses or simply increasing drug prices. If price changes from dose delivery adjustment occur, rebates offered to pharmacy benefit managers and insurers will likely follow suit and may alter formulary positioning.

Trends in Medicare Spending on Multiple Myeloma Drugs, 2013 to 2021

Multiple myeloma is a plasma cell malignancy that, while typically incurable, is now associated with a median life-expectancy of 8-10 years. Myeloma tends to affect older patients, with a prevalence of 0.2% among Medicare beneficiaries. Patients often receive treatment continuously over several years, and guidelines recommend triplet (or quadruplet) combinations, including both oral therapies (covered under Medicare Part D) and intravenous/subcutaneous therapies (covered under Medicare Part B), in both first- and second-line settings. Medicare Part B reimbursement is pegged to average sales prices in commercial markets, while Medicare Part D reimbursement depends on negotiation by individual plans and pharmacy benefit managers (PBMs). Plans and PBMs often lack substantial leverage to negotiate prices for Part D oncology drugs because Medicare is required by law to cover all cancer drugs. We hypothesized that Medicare spending on myeloma drugs has increased over time, and that spending per 30-day supply in Medicare Part D is higher than in Part B. We analyzed trends in Medicare use and spending on these drugs from 2013-2021. Methods We used publicly-available Medicare Part B and Part D data to determine annual spending on myeloma drugs, the number of beneficiaries who received these drugs, and the average spending per 30-day supply. We estimated net spending after rebates as <10%, based on various publicly available reports from Congress, MedPAC and the GAO, and adjusted spending to 2021 US dollars based on the consumer price index for all urban consumers. Institutional review board approval was not required, because the study used public, nonidentifiable data. Results The cohort included 6 oral drugs for myeloma covered under Medicare Part D and 8 intravenous/subcutaneous drugs under Medicare Part B. From 2013-2021, annual net Medicare spending on these 14 drugs increased from $2 billion (B) to $10.2B (432%). Annual net Part D spending increased from $1.8B to $7.8B (428%), and mean spending per 30-day supply increased from $9,971 to $14,154 (42%)(Figure 1). Lenalidomide (68%) and pomalidomide (52%) had the largest price increases. Annual net Part B spending on myeloma drugs increased from $539 million (M) to $2.36B (437%) and mean spending per 30-day supply increased only from $5,828 to $9,683 (66%) (Figure 2). Spending on the three myeloma drugs approved via accelerated approval but subsequently withdrawn from the market following confirmatory trials was $85,328,842 (melflufen: $859,764, belantamab: $31,749,711, panobinostat: $52,719,367). Spending data demonstrate prescriber sensitivity to route-of-administration-specific toxicities: almost no intravenous bortezomib was prescribed, and in 2021, >60% of patients on daratumumab received subcutaneous Darzalex Faspro. Second-in-class anti-CD38 antibody isatuximab offered daratumumab little competition (623 beneficiaries received isatuximab vs 20,573 receiving daratumumab). Discussion Medicare spending on myeloma drugs increased markedly from 2013 to 2021. Most of the rise occurred in Medicare Part D, where increased spending was partly due to increased use as the number of Medicare beneficiaries increased during the study period from 52.4 million people to 63.9 million people and survival for patients with myeloma improved, meaning longer treatment courses. But increased spending was also due to rising prices, particularly for lenalidomide and pomalidomide. By 2021, Medicare spending for a 30-day supply of lenalidomide was $16,650 and for pomalidomide was $18,728. By contrast, no medication for myeloma covered under Medicare Part B exceeded $13,000 per month except melflufen, which only 41 beneficiaries received in 2021. A limitation of using these Medicare databases was that the frequency and duration of maintenance and combination therapy could not be quantified. But our findings highlight how plans and PBMs in Medicare Part D were unable to prevent substantial price increases on myeloma drugs over the past decade. Our analysis underscores why the Inflation Reduction Act-and its key provisions of inflationary rebates and Medicare price negotiation-are vital to rein in Medicare spending. Generic competition, particularly for lenalidomide and bortezomib, whose patents expired recently, may also help reduce the high prices of myeloma drugs.

Trimming the Retail: The investment outlook for CVS’s growth strategy

CVS Health Corporation owns the retail pharmacy chain and also owns CVS Caremark, the pharmacy benefits manager, and the Aetna health insurance provider (Kolakowski, 2023). Recent acquisitions in 2022 and 2023 include Oak Street Health, Inc., and Signify Health. CVS’s proactive growth strategy aims to acquire health care firms across various sectors of health care, yet the management is not averse to divesting the firm of less profitable subsidiaries. In November 2021 the firm announced the closing of 300 stores per year through 2024. A decline in stock price of CVS would suggest analyzing whether the company is still a good long-term investment. A deeper study may be warranted, but seven methods should suffice to either reject CVS immediately or accept CVS for further consideration. The analysis includes the following: The price-to-earnings ratio or P/E multiple approach for validating stock price. Evaluating expected return of the stock with the capital asset pricing model (CAPM). The corporate valuation model using free cash flows for stock-price valuation. A review of the company’s dividend history. Comparison of the company’s capital structure with its peers. Evaluating the company’s historical stock prices. Review of the recent financial statements and the five categories of financial ratios to determine the overall health of the firm. As a company with a large retail business unit, CVS stock would be considered a moderately conservative investment. A decision on long-term investing in CVS stock would consider the risk and potential returns. Subject to further scrutiny, this study accepts CVS as a potential investment choice. Although the acceptance is based on analysis, the author makes no guarantee of future results. This paper is the original work of the author and is not previously published.

Combination Therapy Use and Associated Events in Clinical Practice Following Dissemination of Trial Findings: A De-Implementation Study Using Interrupted Time Series Analysis

PurposeIt takes 17 years, on average, for trial results to be implemented into practice. Using data from the Department of Veterans Affairs (VA), this study assessed the potential impact on clinical practice of the dissemination of findings from a randomized, controlled trial reporting harm with the use of combination therapy. Communication between research and VA Pharmacy Benefits Management Services (PBM) provided the impetus for communication from the PBM about the findings of the trial in accordance with policy. MethodsIn this de-implementation study, interrupted time series analysis was used for assessing prescribing patterns and adverse clinical events before and after the dissemination of the trial findings. The de-implementation strategy was multicomponent and multilevel. Strategies were aligned with categories outlined in the Expert Recommendations for Implementing Change: train and educate stakeholders, use evaluative and iterative strategies, develop stakeholder inter-relationships, change infrastructure, provide interactive assistance, and engage consumers. VA patients with type 2 diabetes mellitus, chronic kidney disease stages 1 to 3, and a moderate or severe albuminuria who received care between July 2008 and November 2017 were included. Patients were subgrouped according to treatment with an angiotensin-converting enzyme inhibitor + angiotensin receptor blocker. The primary end point was the prevalence of combination therapy use. Secondary end points were the incidences of acute kidney injury and hyperkalemia. FindingsThis study followed 712,245 patients, 9297 of whom used combination therapy. Data were available from 428,535 and 283,710 patients pre- and post-intervention, respectively; among these, 8324 and 973 patients used combination therapy, the median ages were 66 and 68 years, and 96.92% and 98.82% were men. One month following communication from the PBM, the reductions in combination therapy users, acute kidney injury events, and hyperkalemia were 331.94 (95% CI, 500.27–163.32), 36.58% (95% CI, 31.90%–41.95%), and 25.49% (95% CI, 14.17%–36.07%) per 100,000 patients per month, respectively (all, P < 0.001), whereas before the communication, these changes were +14.84 (95% CI, 10.27–19.42), –3.46% (95% CI, 3.18–3.74), and –3.27% (95% CI, 2.66%–3.87%) (all, P < 0.001). ImplicationsThe apparent speed and impact of the implementation of changes resulting from the dissemination of trial findings into VA clinical practice are encouraging. The speed of implementation was much faster than average for health care providers in the United States. Established communications between research and clinical practice, as well as established policy and communications between PBM and clinical practice, may be a model for other health care organizations.

Building Quality Improvement Initiatives through Anti-Cancer Stewardship in the Veterans Health Administration (VHA): CML Pilot

The Department of Veterans Affairs (VA) Pharmacy Benefits Management (PBM) Services created a national stewardship with focus on anti-cancer therapeutics within a disease-specific cohort . Directing stewardship initiatives to a cohort of Veterans with a common malignancy is a novel approach. A multidisciplinary team with National PBM and VISNs (Veterans Integrated Service Network) promotes standardization of practice with accountability to monitor outcomes as a continual quality improvement process. A toolkit was built to support stewardship activities and includes: near-real-time process to identify a national disease-specific Veteran cohortdisease validation processcentralized MUE data collectioneducational resourcessite for communication and training materials Tyrosine Kinase Inhibitors (TKIs) account for the second highest utilization among outpatient oral anti-cancer therapies in VHA . Imatinib has demonstrated persistent efficacy and is the preferred TKI on the VA National Formulary. Utilizing our toolkit, we developed two MUEs for our national CML cohort to determine why Veterans were not prescribed imatinib as 1L therapy and reasons for switching from first to second line therapy. Methods Business rules identified VISN CML cohorts by using data sources and diagnostic coding from the VA Electronic Health Record (EHR): primary care and hematology/oncology visits (ICD-10), inpatient stays (ICD-10), and problem lists (ICD-10; SNOMED CT). Retrospective chart review of two subsets: Veterans who received a drug other than imatinib as their initial VA prescriptionVeterans who received at least two unique drugs to treat CML Data abstracted for MUE #1: Disposition of TKI prescriptionIf new initiation, documented reason(s) for drug selectionIf continuation, prior drug therapy history Data abstracted for MUE #2: Documented reason(s) for switch to 2LIf adverse drug reaction (ADR) included as a reason, is it documented in the EHR? Analysis combined responses with prescription data from the EHR. Results Of the 18 VISNs, 9 participated in MUE data collection. 365 patients were identified as not having received imatinib 1L and 360 were identified as having received at least two unique drugs to treat CML. These counts are each approximately 30% of the total CML patient cohort. In the total cohort, ~50% of patients received imatinib 1L and have not switched to 2L. Responses for 1L TKI therapy (N=365) 199 (55%) continued therapy originally started outside VA with 67% of these patients (n=133) without documentation of prior imatinib therapy166 (45%) were newly initiating CML therapy with top documented reasons for drug selection: Intermediate or high risk (e.g., SOKAL risk scoring): 77 (46%)46 (28%)18 (11%)Dasatinib was the most prescribed 1L therapy in this cohort (64%; 235), followed by nilotinib (23%; 85), which had a higher prevalence when therapy was continuation (30%).53 patients (15%) had subsequent imatinib therapyResponses for switch from 1L to 2L therapy (N=360) Top documented reasons for switch from 1L to 2L therapy 215 (60%)81 (23%)Resistance / inadequate response: 69 (19%)Only 37 (17%) who experienced an ADR had it documented in the EHRThe most common 2L drug was dasatinib (55%;198). The median number of days between 1L and 2L initiation was 275 (range: 7 - 2, 573)136 patients (38%) received third line therapy or beyond Conclusions A formalized oncology stewardship with focus on disease-specific initiatives within a national healthcare system is feasible. Responses from our 1L MUE indicate that despite geography, imatinib remains the preferred TKI and accounts for the highest utilization. Most veterans not receiving imatinib as 1L therapy, received dasatinib or nilotinib. Continuation of therapy due to transition of care to VA was the primary reason for 1L therapy with a non-preferred TKI. Other reasons included: FDA indication and SOKAL risk scoring. In our pilot 1L to 2L MUE, ADRs were the most common reason for CML patients to be switched to 2L (45%) followed by resistance/inadequate response and disease progression . Most ADRs were not documented in the EHR. Further interventions in TKI prescribing may be instituted in select sites . Following initiatives for CML, Anti-Cancer Stewardship will be expanded to other oncologic diseases.

Pharmacy Benefit Managers in the Eye of the Storm: Growing Multipartite Scrutiny.

The high cost of prescription drugs in the U.S. remains an ongoing national challenge. A recurring focal point in discussions over this distressing steady state is the role(s) played by Pharmacy Benefit Managers (PBMs) who negotiate drug prices with pharmaceutical manufacturers, conduct drug utilization reviews, engage in disease management, and see to formulary creation. At their inception, the multiple newly established PBMs were arguably intent on constraining the rise of prescription drug prices. At the time of this writing, however, the lion share of a far less competitive PBM market is controlled by CVS Caremark, Express Scripts, and OptumRx. It is this evolving reality which could be interpreted to mean that the PBMs may have become part of the problem, rather than part of the solution. Expanded scrutiny of the PBMs by Federal and State authorities as well as by Professional Medical Associations must not be delayed with an eye toward affording the public with relief from the high cost of prescription drugs.

Impact of medically integrated pharmacies on oral anticancer medication prescription abandonment.

66 Background: Due to the high cost of oral anticancer medications, financial toxicity may limit patient access to treatment. Abandonment occurs when a patient does not fill a prescription. Higher out of pocket costs have been associated with higher rates of prescription abandonment of treatment across cancers with national abandonment rates typically reported as 18%. An integrated patient assistance process within the care team as occurs in a medically integrated pharmacy is postulated to lower abandonment rates. We measured prescription abandonment rates in the Texas Oncology (TXO) medically integrated pharmacy (MIP). Methods: We reviewed prescription data from the electronic health record (EHR) and our pharmacy dispensing system, for all new oral anticancer medications prescribed from January 2022 to December 2022. Prescriptions that were sent electronically from the EHR but did not have a corresponding dispense in the pharmacy dispensing software were classified as having a barrier to fill. Among the prescriptions that had a barrier to fill, we randomly selected cases for further detailed review to identify cause of barrier. By reviewing the EHR, we also examined whether patients filled any alternate oral or injectable anticancer agent within 60 days due to a formulary block, patient choice or physician choice. Abandonment was defined when patients did not receive their treatment or appropriate alternative treatment within 60 days of the written prescription date. Results: 17,442 prescriptions for oral anticancer medications were prescribed by Texas Oncology physicians. Of those 8460 were filled by the TXO MIP without extensive barriers. 8982 of prescriptions were not filled at our TXO MIP and of those 2895 (32%) prescriptions were further reviewed to determine cause of barrier to fill. 1435 (49.5%) prescriptions had a pharmacy benefit manager (PBM) design that routed the prescription to an external pharmacy and out of the continuity of care of the MIP. 827 (29%) of patients experienced financial toxicity and received free drug assistance with the help of the MIP patient assistance team. 72 (1.3 %) of patients were started on an appropriate alternative therapy with input from the medically integrated care team. 15 patients did not start their oral anticancer treatment which resulted in an abandonment rate of less than 1%. Conclusions: National abandonment is reported as high as 18% largely due to high out of pocket costs. The Texas Oncology MIP has a dedicated patient assistance team. Within the MIP, although 29% of patients had a financial barrier to fill, the prescription abandonment rate was &lt;1%. Oral anticancer medications filled in the MIP led to decreased prescription abandonment due to the integrated patient assistance, pharmacy, and clinical teams. A medically integrated pharmacy should be the preferred approach for specialty cancer medications.

Reforming Pharmacy Benefit Managers - A Review of Bipartisan Legislation.

Reforming Pharmacy Benefit Managers - A Review of Bipartisan Legislation.

Pharmacy Benefit Manager Pricing and Spread Pricing for High-Utilization Generic Drugs

This cross-sectional study uses Medicare Part D claims for high-utilization generic drugs to analyze gross profits accumulated by pharmacy benefit managers, pharmacies, wholesalers, and manufacturers in the pharmaceutical supply chain.

Venous Thromboembolism Chemoprophylaxis Adherence Rates After Major Cancer Surgery

Venous thromboembolism (VTE) represents a major source of preventable morbidity and mortality and is a leading cause of death in the US after cancer surgery. Previous research demonstrated variability in VTE chemoprophylaxis prescribing, although it is unknown how these rates compare with performance in the Veterans Health Administration (VHA). To determine VTE rates after cancer surgery, as well as rates of inpatient and outpatient (posthospital discharge) chemoprophylaxis adherence within the VHA. This retrospective cohort study within 101 hospitals of the VHA health system included patients aged 41 years or older without preexisting bleeding disorders or anticoagulation usage who underwent surgical treatment for cancer with general surgery, thoracic surgery, or urology between January 1, 2015, and December 31, 2022. The VHA Corporate Data Warehouse, Pharmacy Benefits Management database, and the Veterans Affairs Surgical Quality Improvement Program database were used to identify eligible patients. Data analysis was conducted between January 2022 and July 2023. Inpatient surgery for cancer with general surgery, thoracic surgery, or urology. Rates of postoperative VTE events within 30 days of surgery and VTE chemoprophylaxis adherence were determined. Multivariable Poisson regression was used to determine incidence-rate ratios of inpatient and postdischarge chemoprophylaxis adherence by surgical specialty. Overall, 30 039 veterans (median [IQR] age, 67 [62-71] years; 29 386 men [97.8%]; 7771 African American or Black patients [25.9%]) who underwent surgery for cancer and were at highest risk for VTE were included. The overall postoperative VTE rate was 1.3% (385 patients) with 199 patients (0.7%) receiving a diagnosis during inpatient hospitalization and 186 patients (0.6%) receiving a diagnosis postdischarge. Inpatient chemoprophylaxis was ordered for 24 139 patients (80.4%). Inpatient chemoprophylaxis ordering rates were highest for patients who underwent procedures with general surgery (10 102 of 10 301 patients [98.1%]) and lowest for patients who underwent procedures with urology (11 471 of 17 089 patients [67.1%]). Overall, 3142 patients (10.5%) received postdischarge chemoprophylaxis, with notable variation by specialty. These findings indicate the overall VTE rate after cancer surgery within the VHA is low, VHA inpatient chemoprophylaxis rates are high, and postdischarge VTE chemoprophylaxis prescribing is similar to that of non-VHA health systems. Specialty and procedure variation exists for chemoprophylaxis and may be justified given the low risks of overall and postdischarge VTE.

Assessment of racial and ethnic inequities in copay card utilization and enrollment in copay adjustment programs.

BACKGROUND: Increases in consumer cost sharing lead to decreases in the use of both high- and low-value care. Copay assistance was designed to reduce out-of-pocket (OOP) cost burden. Commercial insurers have recently instituted copay adjustment programs (CAPs), which exclude copay assistance from deductibles and OOP cost maximums, thereby effectively increasing the financial burden on patients. The utilization of these programs by specific demographic populations is unknown. OBJECTIVE: To assess utilization of copay assistance and CAP exposure in a commercially insured patient population and examine potential differences in the use of each of these programs by non-White and by White patients. METHODS: A retrospective, cross-sectional study using IQVIA Longitudinal Access and Adjudication Data, linked to Experian Marketing Solutions, LLC consumer data, identified unique patients who were younger than 65 years, covered by commercial insurance, had at least 1 pharmacy claim for treatment within prespecified therapeutic areas, and had full financial data visibility on paid claims (ie, nonmissing data on costs associated with the pharmacy claim and the secondary payer) between January 1, 2019, and September 30, 2021. Analyses of copay card use or CAP exposure (defined as the likelihood to be included in the accumulator or maximizer program) between non-White and White patient populations were adjusted for age, gender, household income, patient state of residence, pharmacy benefit manager, state-level CAP policy, and overall drug cost. RESULTS: In total, 4,073,599 unique patients (5.6% of the total database population) were included in the copay card analysis. In adjusted analyses, there were no significant differences in copay card utilization between non-White patients and White patients (odds ratio [OR] = 0.995, 95% CI = 0.99-1.00; P = 0.0964). However, among copay card users, non-White patients were significantly more likely to be exposed to CAPs, as either maximizers (OR = 1.27, 95% CI = 1.22-1.33; P < 0.0001) or accumulators (OR = 1.31, 95% CI = 1.26-1.36; P < 0.0001), compared with White patients. CONCLUSIONS: In an adjusted analysis of this selected sample of a commercially insured population, there was no difference in the use of copay cards between non-White and White patients. CAP exposure, however, was significantly higher among non-White patients. This increased exposure suggests a disproportionate effect due to this reduction in copay assistance benefits, which has the potential to exacerbate racial and ethnic disparities in access to medications. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs, LLC. Mr Ingham, Dr Sadik, and Dr Song are employees of Janssen Scientific Affairs, LLC. Dr Zhao is an employee of IQVIA. Dr Fendrick is a consultant for AbbVie, Amgen, Bayer, CareFirst BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, Freedman Health, GRAIL, Harvard University, Health & Wellness Innovations, Health at Scale Technologies, HealthCorum, Hygeia, MedsIncontext, MedZed, Merck, Mercer, Montana Health Cooperative, Pair Team, Penguin Pay, Phathom Pharmaceuticals, Proton Intelligence, Risalto Health, Risk International, Sempre Health, Silver Fern Health, State of Minnesota, Teladoc Health, US Department of Defense, Virginia Center for Health Innovation, Wellth, Wildflower Health, Yale New Haven Health System, and Zansors; received research funds from Agency for Healthcare Research and Quality (AHRQ), Boehringer-Ingelheim, Gary and Mary West Health Policy Center, Arnold Ventures, National Pharmaceutical Council, Patient-Centered Outcomes Research Institute (PCORI), Pharmaceutical Research and Manufacturers of America (PhRMA), Robert Wood Johnson (RWJ) Foundation, State of Michigan/The Centers for Medicare & Medicaid Services (CMS); and has an outside position at the American Journal of Managed Care (AJMC; co-editor), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) member, VBID Health (partner).

Potential drug-drug interactions with phentermine among long-term phentermine consumers: A retrospective analysis.

Phentermine is an internationally recognised amphetamine derivative with significant appetite-suppressing properties. The drug is indicated for the short-term management of obesity, as the long-term (LT) use of phentermine may potentially be associated with severe cardiovascular side-effects, abuse and dependence. The LT use hereinafter describes periods exceeding 12consecutive weeks. This use may also be associated with potential drug-drug interactions (PDDIs), which may result in adverse drug reactions (ADRs). The literature reports that phentermine is often prescribed LT and for several other off-label indications, increasing the risk for individuals to experience adverse drug events (ADEs) and drug-drug interactions (DDIs). There are, to our knowledge, no South African (SA) studies investigating the prevalence of co-prescribing LT phentermine with drugs that may potentially cause DDIs. To determine the prevalence of mild, moderate and severe DDIs with phentermine use when the duration of therapy in private healthcare exceeded 12consecutive weeks. A cross-sectional drug utilisation review (DUR) was done by using data obtained from a SA pharmacy benefit management (PBM) company's database. Retrospective data of medicine claims for phentermine, from 1 January 2015 to 31 December 2019, were extracted for analysis. The number of days phentermine was supplied was used to identify the study population, in other words, those patients who received the drug LT. A drug interaction checker (Drugs.com) was used to identify potential mild, moderate and severe DDIs when using phentermine and co-prescribed drugs concurrently. A total of 889 patients received phentermine LT. The top 20 drugs identified as being frequently co-prescribed in this study population demonstrated no mild PDDI, 15 (75%) moderate PDDIs and 5 (25%) severe PDDIs. The most common co-prescribed drug in the moderate group was dextromethorphan (n=282, 31.72%) and the least co-prescribed was formoterol (n=52, 5.85%). Among the drug group 'severe PDDIs', tramadol (n=416, 46.79%) was most frequently prescribed, whereas phenylpropanolamine (n=69, 7.76%) was the least prescribed to patients in this group. There are patients who receive LT phentermine therapy despite the potential severe consequences that may result. These patients may receive concomitant therapy with phentermine and other pharmaceutical constituents, which may potentially cause DDIs, more specifically, moderate and severe DDIs. As such, these patients are not only confronted with the consequences of DDIs but are also at risk to experience ADRs as the residual effect of PDDIs.

Changes In Net Prices And Spending For Pharmaceuticals After The Introduction Of New Therapeutic Competition, 2011-19.

Previous research has demonstrated that the introduction of a new brand-name pharmaceutical competitor does not lower list prices for existing competitive therapies. However, no study has systematically evaluated the impact of new therapeutic competition on net prices of pharmaceutical products. We identified new therapies approved during the period 2013-17 that were competitors for existing treatments. We used a novel peer-reviewed algorithm to estimate the net prices of existing therapies. We implemented regression models to estimate changes in these net prices after the approval of the new therapeutic competition during the period 2011-19. Across twelve therapeutic classes with new drug entrants in 2013-17, the introduction of new therapeutic competition was associated with a 4.2percent decrease in annual net price growth. The introduction of new brand-name therapies in twelve therapeutic classes reduced net commercial spending on existing therapies by $10.4 billion-an 18.5percent reduction in projected spending absent therapeutic competition. Our findings demonstrate that new therapeutic competition allows pharmacy benefit managers to use formulary management to decrease net prices and reduce drug spending, contrary to observed trends in list price increases.