Publications

2016

Radomski, Thomas R, Chester B Good, Carolyn T Thorpe, Xinhua Zhao, Zachary A Marcum, Peter A Glassman, John Lowe, Maria K Mor, Michael J Fine, and Walid F Gellad. (2016) 2016. “Variation in Formulary Management Practices Within the Department of Veterans Affairs Health Care System.”. Journal of Managed Care & Specialty Pharmacy 22 (2): 114-20. https://doi.org/10.18553/jmcp.2016.14251.

BACKGROUND: All Department of Veterans Affairs Medical Centers (VAMCs) operate under a single national drug formulary, yet substantial variation in prescribing and spending exists across facilities. Local management of the national formulary may differ across VAMCs and may be one cause of this variation.

OBJECTIVE: To characterize variation in the management of nonformulary medication requests and pharmacy and therapeutics (P&T) committee member perceptions of the formulary environment at VAMCs nationwide.

METHODS: We performed an online survey of the chief of pharmacy and an additional staff pharmacist and physician on the P&T committee at all VAMCs. Respondents were asked questions regarding criteria for use for nonformulary medications, specific procedures for ordering nonformulary medications in general and specific lipid-lowering and diabetes agents, the appeals process, and the formulary environment at their VAMCs. We compared responses across facilities and between chiefs of pharmacy, pharmacists, and physicians.

RESULTS: A total of 212 chief pharmacists (n = 80), staff pharmacists (n = 78), and physicians (n = 54) responded, for an overall response rate of 49%. In total, 107/143 (75%) different VAMCs were represented. The majority of VAMCs reported adhering to national criteria for use, with 38 (36%) being very adherent and 69 (65%) being mostly adherent. There was substantial variation between VAMCs regarding how nonformulary drugs were ordered, evaluated, and appealed. The nonformulary lipid-lowering drugs ezetimibe, rosuvastatin, and atorvastatin were viewable to providers in the order entry screen at 67 (63%), 67 (63%), and 64 (60%) VAMCs, respectively. The nonformulary diabetes medication pioglitazone was only viewable at 58 (55%) VAMCs. In the remaining VAMCs, providers could not order these nonformulary drugs through the normal order-entry process. For questions about the formulary environment, physician respondent perceptions differed from those of staff pharmacists and chief pharmacists. Compared with pharmacy chiefs and staff pharmacists, physicians were less likely to agree that providers at their VAMC prescribed too many nonformulary medications (47% and 44% vs. 12%, P < 0.001), more likely to agree that providers must jump through too many hoops to prescribe nonformulary medication (5% and 3% vs. 25%, P < 0.001), and more likely to agree that providers make an effort to convert new patients from nonformulary to formulary lipid-lowering (65% and 73% vs. 94%, P <0.02) and diabetic medications (49% and 50% vs. 88%, P < 0.001).

CONCLUSIONS: Although the Department of Veterans Affairs (VA) operates under a single national formulary, we found significant differences among VAMCs regarding their management of nonformulary medication requests. We also found differences among formulary leaders regarding their perception of the environment in which their VAMC's formulary is managed. These findings have important implications not just for VA, but for any organization that develops, implements, and manages drug formularies across multiple facilities.

Chidi, Alexis P, Shari Rogal, Cindy L Bryce, Michael J Fine, Chester B Good, Larissa Myaskovsky, Vinod K Rustgi, Allan Tsung, and Kenneth J Smith. (2016) 2016. “Cost-Effectiveness of New Antiviral Regimens for Treatment-Naïve U.S. Veterans With Hepatitis C.”. Hepatology (Baltimore, Md.) 63 (2): 428-36. https://doi.org/10.1002/hep.28327.

UNLABELLED: Recently approved, interferon-free medication regimens for treating hepatitis C are highly effective, but extremely costly. We aimed to identify cost-effective strategies for managing treatment-naïve U.S. veterans with new hepatitis C medication regimens. We developed a Markov model with 1-year cycle length for a cohort of 60-year-old veterans with untreated genotype 1 hepatitis C seeking treatment in a typical year. We compared using sofosbuvir/ledipasvir or ombitasvir/ritonavir/paritaprevir/dasabuvir to treat: (1) any patient seeking treatment; (2) only patients with advanced fibrosis or cirrhosis; or (3) patients with advanced disease first and healthier patients 1 year later. The previous standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon/ribavirin, was included for comparison. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die. Complications were less likely after sustained virological response. We calculated the incremental cost per quality-adjusted life year (QALY) and varied model inputs in one-way and probabilistic sensitivity analyses. We used the Veterans Health Administration perspective with a lifetime time horizon and 3% annual discounting. Treating any patient with ombitasvir-based therapy was the preferred strategy ($35,560; 14.0 QALYs). All other strategies were dominated (greater costs/QALY gained than more effective strategies). Varying treatment efficacy, price, and/or duration changed the preferred strategy. In probabilistic sensitivity analysis, treating any patient with ombitasvir-based therapy was cost-effective in 70% of iterations at a $50,000/QALY threshold and 65% of iterations at a $100,000/QALY threshold.

CONCLUSION: Managing any treatment-naïve genotype 1 hepatitis C patient with ombitasvir-based therapy is the most economically efficient strategy, although price and efficacy can impact cost-effectiveness. It is economically unfavorable to restrict treatment to patients with advanced disease or use a staged treatment strategy. (Hepatology 2016;63:428-436).

Cunningham, Francesca E, Kwan Hur, Diane Dong, Donald R Miller, Rongping Zhang, Xiangming Wei, Madeline McCarren, et al. (2016) 2016. “A Comparison of Neuropsychiatric Adverse Events During Early Treatment With Varenicline or a Nicotine Patch.”. Addiction (Abingdon, England) 111 (7): 1283-92. https://doi.org/10.1111/add.13329.

AIMS: We compared the risk of mental health episodes requiring hospitalization (primary aim) or out-patient clinic visits (secondary aim) associated with varenicline versus the nicotine patch (NP) in an era prior to psychiatric boxed warnings.

DESIGN: Retrospective cohort.

SETTING: Department of Veterans Affairs (VA), USA.

PARTICIPANTS: VA patients with or without psychiatric comorbidities and a new prescription for varenicline (15 255) were propensity score-matched (1 : 2) to new users of NP (123 054) between 1 May 2006 and 30 September 2007, resulting in 11 774 and 23 548 patients in the varenicline and NP groups, respectively.

MEASUREMENTS: The primary outcomes were hospitalizations with a primary discharge diagnosis of a range of mental health disorders: depression, schizophrenia, bipolar disorder, suicide attempt, post-traumatic stress disorder, other psychosis and drug-induced mental disorders. Secondary outcomes were out-patient clinic visits with a primary diagnosis of the above list of mental health disorders.

FINDINGS: Background characteristics of the treatment groups were similar after matching. There was no statistically significant difference in risk of hospitalization for any of the studied mental health disorders with varenicline compared with NP. Among secondary outcomes there was an increased risk of out-patient clinic visits for schizophrenia among patients who received varenicline [hazard ratio (HR) = 1.27; 95% confidence interval (CI) = 1.07, 1.51], this increase being evident only in those with a pre-existing mental health disorder.

CONCLUSION: In US VA patients studied prior to the boxed warning being implemented, use of varenicline for smoking cessation was not associated with a detectable increase compared with nicotine patches in hospitalization for any mental health outcomes. There was an increased rate of out-patient attendances with a primary diagnosis of schizophrenia amounting to five per 100 person years of treatment. This increase was found only in patients with a pre-existing mental health disorder.

Waljee, Akbar K, Wyndy L Wiitala, Shail Govani, Ryan Stidham, Sameer Saini, Jason Hou, Linda A Feagins, et al. (2016) 2016. “Corticosteroid Use and Complications in a US Inflammatory Bowel Disease Cohort.”. PloS One 11 (6): e0158017. https://doi.org/10.1371/journal.pone.0158017.

BACKGROUND AND AIMS: Corticosteroids are effective for the short-term treatment of inflammatory bowel disease (IBD). Long-term use, however, is associated with significant adverse effects. To define the: (1) frequency and duration of corticosteroid use, (2) frequency of escalation to corticosteroid-sparing therapy, (3) rate of complications related to corticosteroid use, (4) rate of appropriate bone density measurements (dual energy X-ray absorptiometry [DEXA] scans), and (5) factors associated with escalation and DEXA scans.

METHODS: Retrospective review of Veterans Health Administration (VHA) data from 2002-2010.

RESULTS: Of the 30,456 Veterans with IBD, 32% required at least one course of corticosteroids during the study time period, and 17% of the steroid users had a prolonged course. Among these patients, only 26.2% underwent escalation of therapy. Patients visiting a gastroenterology (GI) physician were significantly more likely to receive corticosteroid-sparing medications. Factors associated with corticosteroid-sparing medications included younger age (OR = 0.96 per year,95%CI:0.95, 0.97), male gender (OR = 2.00,95%CI:1.16,3.46), GI visit during the corticosteroid evaluation period (OR = 8.01,95%CI:5.85,10.95) and the use of continuous corticosteroids vs. intermittent corticosteroids (OR = 2.28,95%CI:1.33,3.90). Rates of complications per 1000 person-years after IBD diagnosis were higher among corticosteroid users (venous thromboembolism [VTE] 9.0%; fragility fracture 2.6%; Infections 54.3) than non-corticosteroid users (VTE 4.9%; fragility fracture 1.9%; Infections 26.9). DEXA scan utilization rates among corticosteroid users were only 7.8%.

CONCLUSIONS: Prolonged corticosteroid therapy for the treatment of IBD is common and is associated with significant harm to patients. Patients with prolonged use of corticosteroids for IBD should be referred to gastroenterology early and universal efforts to improve the delivery of high quality care should be undertaken.

Radomski, Thomas R, Xinhua Zhao, Carolyn T Thorpe, Joshua M Thorpe, Chester B Good, Maria K Mor, Michael J Fine, and Walid F Gellad. (2016) 2016. “VA and Medicare Utilization Among Dually Enrolled Veterans With Type 2 Diabetes: A Latent Class Analysis.”. Journal of General Internal Medicine 31 (5): 524-31. https://doi.org/10.1007/s11606-016-3631-4.

BACKGROUND: Many Veterans treated within the VA Healthcare System (VA) are also enrolled in fee-for-service (FFS) Medicare and receive treatment outside the VA. Prior research has not accounted for the multiple ways that Veterans receive services across healthcare systems.

OBJECTIVE: We aimed to establish a typology of VA and Medicare utilization among dually enrolled Veterans with type 2 diabetes.

DESIGN: This was a retrospective cohort.

PARTICIPANTS: 316,775 community-dwelling Veterans age ≥ 65 years with type 2 diabetes who were dually enrolled in the VA and FFS Medicare in 2008-2009.

METHODS: Using latent class analysis, we identified classes of Veterans based upon their probability of using VA and Medicare diabetes care services, including patient visits, laboratory tests, glucose test strips, and medications. We compared the amount of healthcare use between classes and identified factors associated with class membership using multinomial regression.

KEY RESULTS: We identified four distinct latent classes: class 1 (53.9%) had high probabilities of VA use and low probabilities of Medicare use; classes 2 (17.2%), 3 (21.8%), and 4 (7.0%) had high probabilities of VA and Medicare use, but differed in their Medicare services used. For example, Veterans in class 3 received test strips exclusively through Medicare, while Veterans in class 4 were reliant on Medicare for medications. Living ≥ 40 miles from a VA predicted membership in classes 3 (OR 1.1, CI 1.06-1.15) and 4 (OR 1.11, CI 1.04-1.18), while Medicaid eligibility predicted membership in class 4 (OR 4.30, CI 4.10-4.51).

CONCLUSIONS: Veterans with diabetes can be grouped into four distinct classes of dual health system use, representing a novel way to characterize how patients use multiple services across healthcare systems. This classification has applications for identifying patients facing differential risk from care fragmentation.

Rogal, Shari, Gautham Mankaney, Viyan Udawatta, Chester B Good, Matthew Chinman, Susan Zickmund, Klaus Bielefeldt, et al. (2016) 2016. “Association Between Opioid Use and Readmission Following Liver Transplantation.”. Clinical Transplantation 30 (10): 1222-29. https://doi.org/10.1111/ctr.12806.

The aim of this study was to assess the independent association between pre-transplant prescription opioid use and readmission following liver transplantation. We reviewed the medical records of all patients at a single medical center undergoing primary, single-organ, liver transplantation from 2004 to 2014. We assessed factors associated with hospital readmission 30 days and 1 year after hospital discharge using multivariable competing risk regression models. Among 1056 transplant recipients, 49 (4.6%) were prescribed pre-transplant prescription opioids. Readmission occurred in 421 (40%) patients within 30 days and 689 (65%) within 1 year. Patients with pre-transplant opioid use had a significantly higher risk of readmission at 30 days (HR 1.7; 95% CI 1.1-2.5) and a non-significantly elevated risk at 1 year (HR 1.4; 95% CI 1.0-1.9) when controlling for other potential confounders. Although pain was the major reason for readmission in only 12 (3%) patients at 30 days and 33 (6%) patients at 1 year, pre-transplant opioid use was significantly associated with pain-related readmission at both time points. In conclusion, prescription opioid use pre-transplantation was significantly associated with all-cause 30-day readmissions and pain-related readmissions at 30 days and 1 year.

Aspinall, Sherrie L, Mariscelle M Sales, Chester B Good, Vincent Calabrese, Peter A Glassman, Muriel Burk, Von R Moore, et al. (2016) 2016. “Pharmacy Benefits Management in the Veterans Health Administration Revisited: A Decade of Advancements, 2004-2014.”. Journal of Managed Care & Specialty Pharmacy 22 (9): 1058-63. https://doi.org/10.18553/jmcp.2016.22.9.1058.

UNLABELLED: Over the past decade, the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services (PBM) has enhanced its formulary management activities and added programs to ensure that the national drug plan continues to meet the pharmacy needs of veterans and to promote safe and appropriate drug therapy in the face of rising medication expenditures. This article describes the broad range of services provided by the VA PBM that work in partnership to deliver a high-quality and sustainable pharmacy benefit for veterans. In support of formulary management, VA PBM pharmacists prepare extensive clinical guidance documents (e.g., drug monographs and criteria for use) that are used by physicians and pharmacists with operational and clinical oversight of the VA national formulary. The VA PBM has utilized various contracting techniques and continually evaluates drug utilization data to identify opportunities for potential savings. Remarkably, since before 2004, the average acquisition cost for a 1-month supply of medication has remained fairly stable at approximately $13-$15. Two new VA PBM programs are the VA Center for Medication Safety (VA MedSAFE) and the Clinical Pharmacy Practice Office (CPPO). VA MedSAFE is a comprehensive pharmacovigilance program focused on the detection, assessment, and prevention of adverse drug events, and CPPO is dedicated to improving safe and appropriate medication use by supporting and expanding clinical pharmacy practice. Moving forward, the VA PBM will consider new initiatives to stay at the forefront of providing quality care while maintaining economic viability.

DISCLOSURES: No outside funding supported this research. This work was supported by VA Pharmacy Benefits Management Services (VA PBM), Hines, Illinois, and VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania. Glassman is co-director of the VA Center for Medication Safety, which is part of the VA PBM. He is also part of the Medical Advisory Panel for the VA PMB. All other authors are employed by the VA PBM. The views expressed in this article are those of the authors, and no official endorsement by the U.S. Department of Veteran Affairs or the U.S. government is intended or should be inferred. Study concept and design were contributed by Valentino, Cunningham, Good, Aspinall, and Sales. Calabrese and Ourth took the lead in data collection, along with Good, Cunningham, Aspinall, Sales, Burk, Moore, Neuhauser, and Golterman. Data interpretation was performed by Burk, Newhauser, and Golterman, along with Glassman, Calabrese, Moore, and Ourth. The manuscript was written by Aspinall and Sales, along with Burk, Newhauser, Golterman, Ourth, and Cunningham. Good, Glassman, and Moore revised the manuscript, along with Calabrese, Valentino, and Aspinall.