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Journal of Managed Care & Specialty Pharmacy

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https://www.readbyqxmd.com/read/28944734/outcomes-based-contracting-experience-research-findings-from-u-s-and-european-stakeholders
#1
Tara Nazareth, John J Ko, Rahul Sasane, Christian Frois, Stephen Carpenter, Sebastian Demean, Ashok Vegesna, Eric Wu, Robert P Navarro
BACKGROUND: Outcomes-based contracts (OBCs), a type of risk-sharing arrangement (RSA), have emerged as a promising avenue for payers to engage with pharmaceutical manufacturers to share risk and improve patient access to medicines via evaluation of real-world outcomes. OBJECTIVE: To assess the level of recent OBC activity and stakeholder perceptions of these arrangements, as well as the outlook for future OBC activity from a payer and manufacturer perspective in the United States and EU-5 (France, Germany, Italy, Spain, and the United Kingdom)...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944733/performance-based-risk-sharing-arrangements-for-pharmaceutical-products-in-the-united-states-a-systematic-review
#2
Justin S Yu, Lauren Chin, Jennifer Oh, Jorge Farias
BACKGROUND: Value for money is a growing necessity in today's U.S. health care system in which drug spending is expected to increase by an average rate of 6.7% yearly through 2025. In response to uncertainty about real-world clinical and economic outcomes for many drugs, health insurers and pharmacy benefit managers (PBMs) have implemented various contracts and arrangements with drug manufacturers that can collectively be described as performance-based risk-sharing arrangements (PBRSAs)...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944732/patient-centered-drug-approval-the-role-of-patient-advocacy-in-the-drug-approval-process
#3
T Joseph Mattingly, Linda Simoni-Wastila
Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944731/the-fda-unapproved-drugs-initiative-an-observational-study-of-the-consequences-for-drug-prices-and-shortages-in-the-united-states
#4
Ravi Gupta, Sanket S Dhruva, Erin R Fox, Joseph S Ross
BACKGROUND: Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944730/optimization-of-medication-use-at-accountable-care-organizations
#5
Chrisanne Wilks, Erik Krisle, Kimberly Westrich, Kristina Lunner, David Muhlestein, Robert Dubois
BACKGROUND: Optimized medication use involves the effective use of medications for better outcomes, improved patient experience, and lower costs. Few studies systematically gather data on the actions accountable care organizations (ACOs) have taken to optimize medication use. OBJECTIVES: To (a) assess how ACOs optimize medication use; (b) establish an association between efforts to optimize medication use and achievement on financial and quality metrics; (c) identify organizational factors that correlate with optimized medication use; and (d) identify barriers to optimized medication use...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944729/using-performance-based-risk-sharing-arrangements-to-address-uncertainty-in-indication-based-pricing
#6
Kai Yeung, Meng Li, Josh J Carlson
BACKGROUND: The rise in pharmaceutical expenditures in recent years has increased health care payer interest in ensuring good value for the money. Indication-based pricing (IBP) sets separate, indication-specific prices paid to the manufacturer according to the expected efficacy of a drug in each of its indications. IBP allows payers to consistently pay for value across indications. While promising, a limitation of IBP as originally conceived is that efficacy estimates are typically based on clinical trial data, which may differ from real-world effectiveness...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944728/performance-based-risk-sharing-arrangements-u-s-payer-experience
#7
Joseph A Goble, Brian Ung, Sascha van Boemmel-Wegmann, Robert P Navarro, Andrew Parece
BACKGROUND: As a result of global concern about rising drug costs, many U.S. payers and European agencies such as the National Health Service have partnered with pharmaceutical companies in performance-based risk-sharing arrangements (PBRSAs) by which manufacturers share financial risk with health care purchasing entities and authorities. However, PBRSAs present many administrative and legal challenges that have minimized successful contract experiences in the United States. OBJECTIVE: To (a) identify drug and disease characteristics and contract components that contribute to successful PBRSA experiences and the primary barriers to PBRSA execution and (b) explore solutions to facilitate contract negotiation and execution...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944727/changing-the-way-we-pay-for-health-care-is-value-the-new-plastic
#8
Robert P Navarro
Navarro is a clinical professor in the College of Pharmacy at the University of Florida, Gainesville, and is an assistant editor with the Journal of Managed Care and Specialty Pharmacy. Navarro reports consulting fees from Analysis Group, Amgen, Novartis, and Allergan.
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944726/paying-for-cures-how-can-we-afford-it-managed-care-pharmacy-stakeholder-perceptions-of-policy-options-to-address-affordability-of-prescription-drugs
#9
Kai Yeung, Kangho Suh, Anirban Basu, Louis P Garrison, Aasthaa Bansal, Josh J Carlson
BACKGROUND: High-priced medications with curative potential, such as the newer hepatitis C therapies, have contributed to the recent growth in pharmaceutical expenditure. Despite the obvious benefits, health care decision makers are just beginning to grapple with questions of how to value and pay for curative therapies that may feature large upfront cost, followed by health benefits that are reaped over a patient's lifespan. Alternative policy options have been proposed to promote high value and financially sustainable use of these therapies...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854079/identification-of-patients-with-statin-intolerance-in-a-managed-care-plan-a-comparison-of-2-claims-based-algorithms
#10
Brandon K Bellows, Amy M Sainski-Nguyen, Cody J Olsen, Susan H Boklage, Scott Charland, Matthew P Mitchell, Diana I Brixner
BACKGROUND: While statins are safe and efficacious, some patients may experience statin intolerance or treatment-limiting adverse events. Identifying patients with statin intolerance may allow optimal management of cardiovascular event risk through other strategies. Recently, an administrative claims data (ACD) algorithm was developed to identify patients with statin intolerance and validated against electronic medical records. However, how this algorithm compared with perceptions of statin intolerance by integrated delivery networks remains largely unknown...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854078/changes-in-treatment-patterns-and-incremental-health-care-utilization-due-to-p2y12-associated-complications-in-patients-with-acute-coronary-syndrome
#11
Ami Vyas, Lori D Bash, Mehul D Patel, Ross J Simpson
BACKGROUND: P2Y12 antiplatelet therapy (APT) is highly efficacious in reducing the incidence of ischemic events in patients with acute coronary syndrome (ACS); however, it is associated with several adverse complications. Data on P2Y12-associated complications and adherence to APT are sparse. OBJECTIVE: To describe the characteristics, frequency of P2Y12-associated complications, adherence and persistence to P2Y12 APT, and health care utilization among ACS patients on P2Y12 APT...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854077/adherence-to-rivaroxaban-dabigatran-and-apixaban-for-stroke-prevention-for-newly-diagnosed-and-treatment-naive-atrial-fibrillation-patients-an-update-using-2013-2014-data
#12
Joshua D Brown, Anand R Shewale, Jeffery C Talbert
BACKGROUND: Few studies have assessed adherence to non-vitamin K antagonist oral anticoagulants (NOACs), especially using contemporary data now that multiple NOACs are available. OBJECTIVE: To compare adherence and treatment patterns among NOACs for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). METHODS: Incident and treatment-naive NVAF patients were identified during 2013-2014 from a large claims database in this retrospective cohort study...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854076/estimation-of-missed-statin-prescription-use-in-an-administrative-claims-dataset
#13
Rolin L Wade, Jeetvan G Patel, Jerrold W Hill, Ajita P De, David J Harrison
BACKGROUND: Nonadherence to statin medications is associated with increased risk of cardiovascular disease and poses a challenge to lipid management in patients who are at risk for atherosclerotic cardiovascular disease. Numerous studies have examined statin adherence based on administrative claims data; however, these data may underestimate statin use in patients who participate in generic drug discount programs or who have alternative coverage. OBJECTIVE: To estimate the proportion of patients with missing statin claims in a claims database and determine how missing claims affect commonly used utilization metrics...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854075/adherence-to-rivaroxaban-compared-with-other-oral-anticoagulant-agents-among-patients-with-nonvalvular-atrial-fibrillation
#14
Colleen A McHorney, Veronica Ashton, François Laliberté, Guillaume Germain, Willy Wynant, Concetta Crivera, Jeffrey R Schein, Patrick Lefebvre, Eric D Peterson
BACKGROUND: Adherence to oral anticoagulant (OAC) agents is important for patients with nonvalvular atrial fibrillation (NVAF) to prevent potentially severe adverse events. OBJECTIVE: To compare real-world adherence rates and time to discontinuation for rivaroxaban versus other OACs (apixaban, dabigatran, and warfarin) among patients with NVAF using claims-based data. METHODS: Health care claims from the IMS Health Real-World Data Adjudicated Claims database (July 2012-June 2015) were analyzed...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854074/implementation-of-a-new-clinic-based-pharmacist-managed-pcsk9-inhibitor-consultation-service
#15
Adenike Atanda, Nancy L Shapiro, JoAnn Stubbings, Vicki Groo
BACKGROUND: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab were approved by the FDA in 2015. In anticipation of provider interest and a potential increase in referrals to the on-site specialty pharmacy, we created a pharmacist-managed consultation service. PROGRAM DESCRIPTION: The development of a clinic-based pharmacist-managed consultation service for the management of the PCSK9 inhibitor agents alirocumab and evolocumab is described...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854073/major-bleeding-risk-during-anticoagulation-with-warfarin-dabigatran-apixaban-or-rivaroxaban-in-patients-with-nonvalvular-atrial-fibrillation
#16
Gboyega Adeboyeje, Gosia Sylwestrzak, John J Barron, Jeff White, Alan Rosenberg, Jacob Abarca, Geoffrey Crawford, Rita Redberg
BACKGROUND: The use of non-vitamin K oral anticoagulants (NOACs) has increased steadily following marketing approval; however, their relative safety in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice remains unclear. OBJECTIVE: To compare the risk of major bleeding during anticoagulation therapy between warfarin and NOACs. METHODS: This retrospective cohort study analyzed administrative claims data on new NVAF users of warfarin, dabigatran, apixaban, or rivaroxaban in routine clinical care from November 2010 to February 2015 in a commercially insured population in the United States...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28854072/acclimating-to-the-increase-in-statin-use-in-accountable-care-organizations-based-on-changes-in-quality-measures-a-report-from-the-accountable-care-organization-research-network-services-and-education
#17
Leah Bensimon, Genevieve Hale
The Accountable Care Organization Research Network, Services, and Education (ACORN SEED), founded by faculty members at Nova Southeastern University College of Pharmacy, is a group of pharmacists that provides unique pharmacy services to accountable care organizations (ACOs), patient-centered medical homes, and management services organizations to help maximize shared savings and target medication-related issues, while promoting the pharmacy profession and unique learning experiences for pharmacy students within these settings...
September 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28737994/impact-of-a-patient-support-program-on-patient-adherence-to-adalimumab-and-direct-medical-costs-in-crohn-s-disease-ulcerative-colitis-rheumatoid-arthritis-psoriasis-psoriatic-arthritis-and-ankylosing-spondylitis
#18
David T Rubin, Manish Mittal, Matthew Davis, Scott Johnson, Jingdong Chao, Martha Skup
BACKGROUND: AbbVie provides a free-to-patient patient support program (PSP) to assist adalimumab-treated patients with medication costs, nurse support, injection training, pen disposal, and medication reminders. The impact of these services on patient adherence to adalimumab and direct medical costs associated with autoimmune disease has not been assessed. OBJECTIVE: To quantify the relationship between participation in a PSP and outcomes (adalimumab adherence, persistence, and direct medical costs) in patients initiating adalimumab treatment...
August 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28737993/the-effect-of-formulary-restrictions-on-patient-and-payer-outcomes-a-systematic-literature-review
#19
Yujin Park, Syed Raza, Aneesh George, Rumjhum Agrawal, John Ko
BACKGROUND: Formulary restrictions are implemented to reduce pharmacy costs and ensure appropriate use of pharmaceutical products. As adoption of formulary restrictions increases with rising pharmacy costs, there is a need to better understand the potential effect of formulary restrictions on patient and payer outcomes. OBJECTIVE: To conduct a systematic literature review that assesses the effect of formulary restrictions on the following outcomes: medication adherence, clinical outcomes, treatment satisfaction, drug utilization, health care resource utilization, and economic outcomes...
August 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28737992/temporal-trends-in-use-of-biologic-dmards-for-rheumatoid-arthritis-in-the-united-states-a-cohort-study-of-publicly-and-privately-insured-patients
#20
Rishi J Desai, Daniel H Solomon, Yinzhu Jin, Jun Liu, Seoyoung C Kim
BACKGROUND: Ten biologic disease-modifying antirheumatic drugs (bDMARDs) are available as treatment for rheumatoid arthritis (RA), but relatively little is known about population-level time trends in the use of these agents. OBJECTIVE: To describe time trends in the use of bDMARDs in RA patients with private or public insurance in the United States. METHODS: Claims data from private (Optum Clinformatics, 2004-2015) and public (Medicaid Analytic eXtract [MAX], 2000-2010) insurance programs were used...
August 2017: Journal of Managed Care & Specialty Pharmacy
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