Pharmaceuticals

Discovery, development, regulation and marketing of the medications that are used in health care and the economics of the pharmaceutical industry.

Oral Anticoagulant Use in Patients With Atrial Fibrillation and Mitral Valve Repair

Nov. 24, 2020

Ashwin S. Nathan, Lin Yang, Zhi Geng, Elias J. DayoubSameed Ahmed M. Khatana, Paul N. Fiorilli, Howard C. Herrmann, Wilson Y. Szeto, Pavan Atluri, Michael A. Acker, Nimesh D. Desai, David S. Frankel, Francis E. Marchlinski, ...

Abstract [from journal]

Background: Patients with atrial fibrillation (AF) who have undergone mitral valve repair are at risk for thromboembolic strokes. Prior to 2019, only vitamin K antagonists were recommended for patients with AF who had undergone mitral valve repair despite the introduction of direct oral anticoagulants (DOAC) in 2010.

Objective: To characterize the use of anticoagulants in patients with AF who underwent surgical mitral valve repair (sMVR) or transcatheter mitral valve repair (tMVR).

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Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

Nov. 20, 2020

Louise B. Russell, Laurie A. Norton, David Pagnotti, Christianne Sevinc, Sophia Anderson, Darra Finnerty Bigelow, Lauren G. Iannotte, Michael Josephs, Ryan McGilloway, Iwan Barankay, Mary E. Putt, Peter P. ReeseDavid A. Asch, Lee R. Goldberg...

Abstract [from journal]

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source

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Association of Retinal Vascular Occlusion With Women Filling a Prescription for Female Hormone Therapy

Brian L. Vanderbeek, MD, MPH
Nov. 12, 2020

Delu Song, Jennifer Nadelmann, Yinxi Yu, Brian L. VanderBeek

Abstract [from journal]

Importance: Oral contraceptives have been associated with cardiovascular disease, ischemic stroke, venous thromboembolic disease, and breast cancer. Retinal vascular occlusions share the same risk factors as cardiovascular and cerebrovascular disease.

Objective: To determine whether filling a prescription of female hormone therapy (FHT) is associated with an increased risk of retinal artery occlusion (RAO) or retinal vein occlusions (RVO).

Design, setting, and participants: 

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Embedding A Linkage To Pre-exposure Prophylaxis (PrEP) Care Intervention In Social Network Strategy And Partner Notification Services: Results From A Pilot Randomized Controlled Trial

Daniel Teixeira da Silva
Oct. 22, 2020

Daniel Teixeira da Silva, Alida Bouris, Arthi Ramachandran, Olivia Blocker, Billy Davis, James Harris, Maria Pyra, Laura K. Rusie, Russell Brewer, Jade Pagkas-Bather, Anna Hotton, Jessica P. Ridgway, Moira McNulty, Ramona Bhatia, John A. Schneider

Abstract [from journal]

Background: Increased pre-exposure prophylaxis (PrEP) uptake among Black men who have sex with men and Black transgender women (BMSM/TW) is needed to end the HIV epidemic. Embedding a brief intervention in network services that engage individuals in HIV transmission networks for HIV/STI testing may be an important strategy to accelerate PrEP uptake.

Setting: Partner Services PrEP (PS-PrEP) study is a pilot randomized control trial to improve linkage to PrEP care among BMSM/TW presenting for

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Association Between A National Insurer's Pay-For-Performance Program For Oncology And Changes In Prescribing Of Evidence-Based Cancer Drugs And Spending

Oct. 6, 2020

Justin E. BekelmanAtul Gupta, Ezra Fishman, David Debono, Michael J. Fisch, Ying Liu, Gosia Sylwestrzak, John Barron, Amol S. Navathe

Abstract [from journal]

Purpose: Cancer drug prescribing by medical oncologists accounts for the greatest variation in practice and the largest portion of spending on cancer care. We evaluated the association between a national commercial insurer's ongoing pay-for-performance (P4P) program for oncology and changes in the prescribing of evidence-based cancer drugs and spending.

Methods: We conducted an observational difference-in-differences study using administrative claims data covering 6.7% of US adults. We

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Effect Of Patient Financial Incentives On Statin Adherence And Lipid Control: A Randomized Clinical Trial

Oct. 1, 2020

Iwan Barankay, Peter P. Reese, Mary E. Putt, Louise B. Russell, George Loewenstein, David Pagnotti, Jiali Yan, Jingsan Zhu, Ryan McGilloway, Troyen Brennan, Darra Finnerty, Karen Hoffer, Sakshum Chadha, Kevin G. Volpp

Abstract [from journal]

Importance: Financial incentives can improve medication adherence and cardiovascular disease risk, but the optimal design to promote sustained adherence after incentives are discontinued is unknown.

Objective: To determine whether 6-month interventions involving different financial incentives to encourage statin adherence reduce low-density lipoprotein cholesterol (LDL-C) levels from baseline to 12 months.

Design, setting, and participants: This 4-group, randomized

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In The Era Of Direct-Acting Antivirals, Liver Transplant Delisting Due To Clinical Improvement For Hepatitis C Remains Infrequent

Therese Bitterman, MD, MSCE
Sep. 21, 2020

Therese Bittermann and K. Rajender Reddy

Abstract [from journal]

Background/aims: Studies have suggested marked increases in transplant delisting due to clinical improvement for patients with hepatitis C virus (HCV) associated cirrhosis in the era of direct acting antivirals (DAAs). This study provides a 'real world' assessment of waitlist dynamics for HCV transplant candidates in the current era.

Methods: This was a retrospective cohort study of adults waitlisted for liver transplant (LT) alone between 1/1/2005-12/31/2018 using national US data. The post-

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Gaps in the Use of Long-Acting Opioids Within Intervals of Consecutive Days Among Cancer Outpatients Using Electronic Pill Caps

Salima Meghani, RN, PhD, Penn Nursing School researcher
Sep. 16, 2020

Salimah H. Meghani, Amelia L. Persico, Jeffrey Fudin, George J. Knafl

Abstract [from journal]

Objective: This study describes individual cancer patients’ nonuse of extended-release or long-acting (ER/LA) opioids, including periods of gap between opioid doses taken.

Design: Secondary analysis of a three-month observational study of prescribed ER/LA opioids monitored using electronic pill caps.

Setting: Two outpatient oncology clinics of a large health system in the Mid-Atlantic region.

Participants: Inclusion was based on self-identified African Americans and...

FDA Restrictions on Mifepristone: Time for a Change?

Issue Brief
Sep. 10, 2020

Mifepristone, a drug used to manage early miscarriage or end an early pregnancy, carries unique restrictions imposed by the U.S. Food and Drug Administration (FDA). Patients are required to pick up the drug in person
from a doctor or a clinic, even though they can take the drug at home. In July, a federal court ruled that the FDA must suspend these restrictions during the COVID-19 pandemic, for patients seeking an early abortion,
although the ruling did not apply to women with an early pregnancy loss. But the challenges to FDA restrictions on mifepristone predate the pandemic. This Issue Brief provides the context for this ongoing controversy, and
reviews recent evidence on the clinical and cost effectiveness of mifepristone for the medical management of first trimester miscarriage.

Impact Of Hospitalization And Medication Switching On Post-Discharge Adherence To Oral Anticoagulants In Atrial Fibrillation Patients

Allison Willis, MD
Sep. 1, 2020

Thanh Phuong Pham Nguyen, Yong Chen, Dylan Thibault, Charles E. Leonard, Sean Hennessy, Allison Willis

Abstract [from journal

Background: Adherence to chronic medications remains poor in practice. There is limited evidence on how hospitalization affects post-discharge adherence to oral anticoagulants (OACs) in individuals with atrial fibrillation (AF). The aim of this study is to examine the impact of hospitalization and medication switching on post-discharge adherence to OACs in the AF population.

Methods: A quasi-experimental pre-post observational study was conducted using United States commercial insurance

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Olaparib And Durvalumab In Patients With Germline BRCA-Mutated Metastatic Breast Cancer (MEDIOLA): An Open-Label, Multicentre, Phase 1/2, Basket Study

Aug. 6, 2020

Susan M. Domchek, Sophie Postel-Vinay, Seock-Ah Im, Yeon Hee Park, Jean-Pierre Delord, Antoine Italiano, Jerome Alexandre, Benoit You, Sara Bastian, Matthew G. Krebs, Ding Wang, Saiama N. Waqar, Mark Lanasa, Joon Rhee, Haiyan Gao, Vidalba Rocher-Ros, Emma V. Jones, Sakshi Gulati...

Abstract [from journal]

Background: Poly (ADP-ribose) polymerase inhibitors combined with immunotherapy have shown antitumour activity in preclinical studies. We aimed to assess the safety and activity of olaparib in combination with the PD-L1-inhibitor, durvalumab, in patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer.

Methods: The MEDIOLA trial is a multicentre, open-label, phase 1/2, basket trial of durvalumab and olaparib in solid tumours. Patients were enrolled into four initial

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