Saving Medicare through Patient-Centered Changes - The Case of Injectables
Department of Critical Care, M.D. Anderson Cancer Center, Houston, USA. New England Journal of Medicine
(Impact Factor: 55.87).
04/2013; 368(17):1572-3. DOI: 10.1056/NEJMp1213485
Available from: Andrew Blauvelt
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Secukinumab, a fully human anti–IL-17A monoclonal antibody, demonstrated efficacy and safety in moderate-to-severe plaque psoriasis when administered via subcutaneous injection. Self-administration by pre-filled syringe (PFS) can offer patients clinical benefits of a drug, with increased convenience.Objectives
Assess efficacy, safety, and usability of secukinumab administration via PFS in subjects with moderate-to-severe plaque psoriasis.Methods
Subjects in this phase 3 trial were randomized 1:1:1 to secukinumab 300 or 150 mg or matching placebo. Results to Week 12 are presented here. Each treatment was delivered using a PFS once-weekly to Week 4, and again at Week 8. Co-primary endpoints were secukinumab superiority over placebo for Week 12 PASI 75 and IGA mod 2011 0/1 response rates. Secondary endpoints included PFS usability, determined by observer rating of successful, hazard-free self-injection and subject rating of acceptability by the Self-Injection Assessment Questionnaire (SIAQ).ResultsCo-primary endpoints were met, with demonstration of superiority for each secukinumab dose vs. placebo at Week 12 (PASI 75: 75.9%, 69.5%, and 0% for secukinumab 300 mg and 150 mg and placebo; IGA mod 2011 0/1: 69.0%, 52.5%, and 0%, respectively; P<0.0001 for all comparisons vs. placebo). PFS usability was high: 100% of subjects successfully self-administered treatment at Week 1, and subjects reported high SIAQ-assessed acceptability of the PFS throughout the trial. No new/unexpected safety signals were observed.Conclusions
Secukinumab administration by PFS was effective, with an acceptable safety profile and high usability. The PFS provides a reliable, convenient form of secukinumab administration in subjects with moderate-to-severe plaque psoriasis.This article is protected by copyright. All rights reserved.
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ABSTRACT: Medicare Part D prescription benefits cover injected medications, normally covered under Part B, when administered outside of physician offices. Erythropoiesis-stimulating agents (ESAs) used for chronic anemia management in patients with myelodysplastic syndromes (MDS) are commonly injected in a physician office but can be administered safely at home. In this study, we explored out-of-pocket (OOP) costs and receipt of Part D-covered ESAs in Medicare beneficiaries with MDS.
Patients with MDS enrolled in Medicare Parts A, B, and D were identified using diagnosis codes from 100% claims from 2006 to 2008. OOP costs for the mean erythropoietin alfa claim were compared for Parts B and D. Multivariable models examined the effect of low-income subsidy (LIS) and other Part D cost sharing on receipt of any ESA and any Part D-covered ESA.
A total of 13,117 (62.9%) of 20,848 patients received ESAs, but only 1,436 (6.9%) had any Part D claim. OOP payment was $348 under Part D versus $161 under Part B. Among patients with ESA use, those with LIS were 4× more likely to receive Part D ESAs (P < .01).
Few patients with MDS received ESAs through Part D. OOP payments required under Part D were substantially higher than under Part B. Cost sharing, as reflected by LIS receipt, likely affected decisions to prescribe ESAs outside of the physician office. Improved coordination between Part B and D benefits regarding issues of home injection of medications may create incentives that improve patient access and convenience and reduce costs associated with administration.
Copyright © 2015 by American Society of Clinical Oncology.
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