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Journal of Managed Care & Specialty Pharmacy

Louis P Garrison, Tristen Jackson, Douglas Paul, Mike Kenston
While one-time gene replacement therapies may offer transformative innovation for the management of ultrarare, health-catastrophic diseases, they also pose challenges to the current U.S. health care system. Historically, the United States and other countries have demonstrated a willingness to support higher prices for health gains in rare diseases. However, payers may be ill-prepared to address reimbursement based on single administrations associated with gene therapies. As yet, there is no consensus on how to appropriately reward gene therapy innovation...
February 20, 2019: Journal of Managed Care & Specialty Pharmacy
Swapna Karkare, Moshe Fridman, Tam Dang-Tan, Jingsong Lu, B Gabriel Smolarz, Mitch DeKoven, Neeraj N Iyer
BACKGROUND: Previous studies report weight loss to be associated with significantly lower total health care costs among patients with type 2 diabetes mellitus (T2DM). The effect of weight change on health care costs, independent of glycemic control and after controlling for time-varying covariates among T2DM patients, remains unknown. OBJECTIVE: To evaluate the effect of weight change, independent of glycemic control, on all-cause and T2DM-related health care resource utilization (HCRU) and costs among T2DM patients in the United States...
February 7, 2019: Journal of Managed Care & Specialty Pharmacy
Roger Dmochowski, Benjamin M Brucker, Emily Cole, Steve Kawahara, Riya Pulicharam, Caroline Burk, Amy Tung, Douglass Hale
BACKGROUND: Nocturia is considered to be a very bothersome lower urinary tract disorder. Yet, to date, the economic burden attributable to this poor health condition remains less well known. OBJECTIVE: To compare differences in health care resource utilization (HCRU), health care costs, and work productivity in adult patients with differing frequencies of nocturia episodes (i.e., < 2 vs. ≥ 2 nocturia episodes per night). METHODS: Adult patients with nocturia enrolled in an integrated proprietary database were recruited to complete a survey on their demographics, nocturia characteristics, and work productivity...
January 24, 2019: Journal of Managed Care & Specialty Pharmacy
Mitchell Reitsma, John Fox, Pierre Vanden Borre, Matthew Cavanaugh, Yakov Chudnovsky, Rachel L Erlich, Thomas E Gribbin, Rachel Anhorn
BACKGROUND: Comprehensive genomic profiling (CGP) is a next-generation sequencing-based methodology that detects 4 classes of genomic alterations, as well as gene signature biomarkers such as microsatellite instability and tumor mutational burden. In the context of precision oncology, CGP can help to direct treatment to genomically matched therapies. OBJECTIVE: To describe the results of a 3-year observational analysis of patients undergoing testing with CGP assays (either FoundationOne or FoundationOne Heme) at a community oncology practice after a regional health plan implemented a medical policy that enabled coverage of CGP...
January 11, 2019: Journal of Managed Care & Specialty Pharmacy
Sreevalsa Appukkuttan, Emilie Duchesneau, Miriam L Zichlin, Rachel H Bhak, Avin Yaldo, Mecide Gharibo, Svetlana Babajanyan, Mei Sheng Duh
BACKGROUND: Copanlisib was recently granted accelerated approval by the FDA for the treatment of adult patients with relapsed follicular lymphoma (FL) after 2 previous systemic therapies. It is important to assess the effect that this and other changes in the treatment landscape of relapsed FL have on a payer's budget to inform formulary decisions. OBJECTIVE: To assess the budget impact associated with the addition of copanlisib to a formulary as third- or higher-line treatment for adult patients with relapsed FL who have received at least 2 previous systemic therapies, from the perspective of a U...
January 4, 2019: Journal of Managed Care & Specialty Pharmacy
Steven R Feldman, Haijun Tian, Xinyue Wang, Rebecca Germino
BACKGROUND: Discontinuation or switching of biologic treatment among patients with psoriasis imposes a great economic burden. OBJECTIVE: To assess the health care utilization and costs associated with nonswitchers, switchers, and discontinuers of biologics among patients with moderate to severe psoriasis. METHODS: Patients aged ≥ 18 years with ≥ 1 pharmacy claim for a biologic (adalimumab, etanercept, infliximab, and ustekinumab) between January 1, 2012, and June 30, 2015 (identification period), were identified in the Truven Health Analytics MarketScan Commercial and Medicare Supplemental databases...
December 17, 2018: Journal of Managed Care & Specialty Pharmacy
Reed F Beall, Aaron S Kesselheim, Ameet Sarpatwari
BACKGROUND: After new prescription drugs reach the market, manufacturers sometimes create modified versions of them. These new formulations can expand patient treatment options, but they may also be protected by later-expiring patents or data exclusivities, which can lead to later generic entry for the new formulations compared with the original product. OBJECTIVE: To quantify how frequently manufacturers introduce new formulations of existing drugs and how often these new formulations earn additional years of market exclusivity beyond that of the original product...
February 2019: Journal of Managed Care & Specialty Pharmacy
Anna E Wallace, Shuchita Kaila, Valentina Bayer, Asif Shaikh, Mayura U Shinde, Vincent J Willey, Mark B Napier, Joseph R Singer
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and is associated with substantial economic burden. There is a lack of data regarding COPD outcomes and costs in a real-world setting, particularly by Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity. OBJECTIVES: To (a) characterize a commercially insured U.S. population with COPD and (b) assess prevalence of exacerbations, health care resource utilization (HCRU), costs, and treatment patterns in a cohort of patients with confirmed COPD, overall and stratified by GOLD stage...
February 2019: Journal of Managed Care & Specialty Pharmacy
Chi Nguyen, David R Lairson, Michael D Swartz, Xianglin L Du
BACKGROUND: No study has investigated the cost and effectiveness of androgen deprivation therapy (ADT) and other curative treatment therapies among the Medicare population, and no study has taken into consideration the long-term side effects associated with ADT. OBJECTIVE: To examine if adding ADT was cost-effective when accounting for ADT-related long-term side effects in men with prostate cancer. METHODS: For this cost-utility analysis, we used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to estimate and compare patient survival, costs from a health payer's perspective, and cost-effectiveness of 3 treatment modalities for advanced prostate cancer patients, including radiation therapy, radiation plus ADT, and active surveillance...
February 2019: Journal of Managed Care & Specialty Pharmacy
Bruce L Zuraw
No funding supported the writing of this commentary. The author reports personal fees from BioCryst, CSL Behring, Shire, and Pharming and grants from Ionis. He is chair of the US HAEA Medical Advisory Board and scientific advisor for HAE International.
February 2019: Journal of Managed Care & Specialty Pharmacy
Christian Frois, Andrew Howe, John Jarvis, Kathryn Grice, Ken Wong, Christopher Zacker, Rahul Sasane
BACKGROUND: The U.S. health care system's transition to a value-based reimbursement model holds important implications for medical innovation, care delivery, and value-based assessments of therapeutic interventions. This transition has been especially noteworthy in oncology, with substantial ongoing changes to payer reimbursement and the provider landscape, as well as the introduction of value frameworks to guide drug treatment decision making. The implications of these changes for provider assessments of drug value and evidence needs remain unclear...
February 2019: Journal of Managed Care & Specialty Pharmacy
Michael Polson, Todd Lord, Themmi Evangelatos, Anne Kangethe, Lindsay C Speicher, Servi Barrientos, Christopher Zacker
BACKGROUND: Innovative health care reimbursement models are gaining attention as a way to move away from a payment system that rewards quantity of service over quality of care. One such alternative payment model is episode-based payment, such as the Oncology Care Model (OCM) being piloted by the Center for Medicare & Medicaid Innovation. OBJECTIVE: To adapt the OCM methodology to a commercially insured population to understand the challenges and potential implications of implementing an episode-based payment model in a commercial health plan...
February 2019: Journal of Managed Care & Specialty Pharmacy
(no author information available yet)
High-investment medications, such as gene therapy and innovative specialty medications, offer breakthrough treatments that can greatly improve outcomes to patients with serious health conditions. However, many of these therapies are associated with significant costs that create barriers to patient access and affordability. Such innovative treatments have higher short-term costs, compared with current standards of care, but are anticipated to deliver substantial benefits that may persist over a long period of time, such as reduced mortality, improved health and quality of life, reduced health care costs, improved productivity, and reduced disability...
February 2019: Journal of Managed Care & Specialty Pharmacy
Cho-Han Lee, Jerry Chang, Jeffery McCombs
BACKGROUND: The federal 340B Drug Discount Program provides access to significant drug price discounts for health care organizations in the United States that serve a disproportional share of disadvantaged patients. OBJECTIVE: To analyze trends over a 10-year period (2006~2016) in the price of specialty drugs, contrasting the market price with the price paid under the 340B program. METHODS: Pharmacy purchase records, including the 340B drug price and the wholesale acquisition cost (WAC), were collected from a 340B-contract pharmacy group in Southern California between 2006 and 2016...
February 2019: Journal of Managed Care & Specialty Pharmacy
Diana Brixner, Tatia C Woodward, Nik Seifter, Joseph Biskupiak, Martin Marciniak, Peter Neumann, Gary Oderda
BACKGROUND: Preapproval information exchange (PIE) is the communication of clinical and health care economic information (HCEI) on therapies in development between U.S. population health decision makers (PHDMs) and drug manufacturers before regulatory approval. Early access to HCEI can help PHDMs plan budgets, inform formulary coverage decisions, and accelerate policy development to improve patient access to innovative health technologies. While recent FDA guidelines and proposed legislation aim to clarify definitions and execution of PIE, the level of U...
February 2019: Journal of Managed Care & Specialty Pharmacy
(no author information available yet)
No abstract text is available yet for this article.
February 2019: Journal of Managed Care & Specialty Pharmacy
Foluso Agboola, Solomon Lubinga, Josh Carlson, Grace A Lin, William B Dreitlein, Steven D Pearson
Funding for this summary was contributed by the Laura and John Arnold Foundation, Blue Shield of California, and California Health Care Foundation to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, AHIP Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, Cambia Health Solutions, United Healthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, National Pharmaceutical Council, Prime Therapeutics, Sanofi, Spark Therapeutics, Health Care Service Corporation, Editas, Alnylam, Regeneron, Mallinkrodt, Biogen, HealthPartners, and Novartis...
February 2019: Journal of Managed Care & Specialty Pharmacy
Shaoman Yin, Laurie Barker, Jianglan Z White, Ruth B Jiles
BACKGROUND: Chronic hepatitis C (CHC) is a leading cause of morbidity and mortality and has imposed a high health care burden in the United States. Direct-acting antiviral (DAA) regimens are well tolerated and highly effective for CHC therapy but were initially marketed at a high price. Studies of their real-world use with a nationwide population are limited. OBJECTIVE: To examine patient characteristics, treatment adherence, effectiveness, and health care costs in a large U...
February 2019: Journal of Managed Care & Specialty Pharmacy
Anne Runyan, Jordan Banks, Daniele Severi Bruni
BACKGROUND: The cost of treating cancer patients is high and rising in the United States. Payers are exposed to cost through doctor visits, laboratory tests, imaging tests, radiation treatment, drugs, hospital stays, surgery, home care, transportation and travel, and caregiving. This study focuses on the cost of medication from the viewpoint of U.S. payers. Although new tools for managing these costs have been gaining attention, prices continue to rise, and challenges to managing costs remain high...
February 2019: Journal of Managed Care & Specialty Pharmacy
Fahim Faruque, Heejung Noh, Arif Hussain, Edward Neuberger, Eberechukwu Onukwugha
BACKGROUND: Pharmacogenetic testing can provide predictive insights about the efficacy and safety of drugs used in cancer treatment. Although many drug-gene associations have been reported in the literature, the strength of evidence supporting each association can vary significantly. Even among the subgroup of drugs classified by the PharmGKB database to have a high or moderate level of evidence, there is limited information regarding the economic value of pharmacogenetic testing. OBJECTIVES: To: (a) summarize the available pharmacoeconomic evidence assessing the value of pharmacogenetic testing for cancer drugs with clinically relevant drug-gene associations; (b) determine the quality of the studies that contain this evidence; and (c) discuss the quality of this evidence with respect to the level of evidence of the drug-gene associations...
February 2019: Journal of Managed Care & Specialty Pharmacy
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