Impact of pill burden on adherence to hepatitis C medication.

Objective: To describe pill burden before and after hepatitis C virus (HCV) treatment initiation among patients newly treated for HCV infection, and to evaluate the association between HCV pill burden and gaps in HCV therapy. Methods: This was a retrospective administrative claims study of patients treated with direct-acting antivirals (DAAs) for HCV from 1 November 2013 to 31 July 2016. HCV pill burden was defined as the pill count per day for the index HCV regimen. Mean overall pill burden (HCV medications plus non-HCV medications) was calculated in the 90 days before and after DAA initiation. Gaps in the index HCV regimen were assessed in the 6 months after DAA initiation. Multivariable logistic regression was used to compare the odds of a gap in HCV therapy across HCV pill burden categories (1 pill/day, 2 pills/day, and ≥3 pills/day). Results: Among 9815 patients who met the study criteria, mean overall pill burdens before and after DAA treatment initiation were 5.4 and 7.7, respectively (p < .001). The adjusted odds ratio (OR) of a ≥15-day gap in HCV therapy was 1.75 (95% confidence interval [CI] = 1.38-2.22) for patients with 2 HCV pills/day and 2.11 (95% CI = 1.78-2.51) for patients with ≥3 pills/day, compared with patients with 1 HCV pill/day. Conclusions: Patients with HCV have a substantial pill burden even before initiating HCV treatment. As higher HCV pill burden was associated with lower medication adherence, pill burden should be an important consideration in HCV treatment selection.

Disease burden in patients with asthma before initiating biologics: A retrospective cohort database study.

Background: Real-world data on the characteristics and burden of disease among patients with asthma before receiving asthma-specific biologics would improve the understanding of the use of these therapies in a clinical setting. Currently, limited data are available on the use of mepolizumab and omalizumab for the treatment of asthma. Objective: To determine the characteristics and disease burden among patients with asthma before initiating treatment with mepolizumab or omalizumab. Methods: This was a retrospective cohort analysis of commercial and Medicare Advantage Plan members from a medical claims database with a new claim for mepolizumab or omalizumab between January 1, 2015, and March 31, 2017 (GSK ID: HO-17-18283). Eligible patients had a diagnosis of asthma and continuous enrollment in the health plan, with clinical and pharmacy benefits for 12 months before initiating asthma-specific biologic treatment (baseline period), and no diagnosis of chronic idiopathic urticaria during the baseline period. Patient characteristics, exacerbations, and asthma-related health care resource utilization and costs were assessed during the baseline period. Results: Overall, 188 and 901 patients prescribed mepolizumab and omalizumab, respectively, were included. In the 12 months before initiating asthma-specific biologic therapy, the patients prescribed mepolizumab were older, had higher blood eosinophil counts, more-frequent exacerbations (2.9 versus 2.0 exacerbations/year; p < 0.001), and more inhaled corticosteroid and systemic corticosteroid use compared with those prescribed omalizumab. Overall, asthma-related health-care resource utilization and costs were similar across both treatment cohorts, although patients prescribed mepolizumab had more pharmacy fills, higher pharmacy costs, and lower clinic costs compared with patients prescribed omalizumab (20.8 versus 16.9 fills, $4504 versus $3102, and $1816 versus $2709, respectively; all p < 0.001). Conclusion: In the 12 months before initiating asthma-specific biologic therapy, the patients prescribed mepolizumab may have a greater disease burden than those prescribed omalizumab. Overall, health-care resource utilization and costs were broadly similar across both treatment cohorts.

Impact of the 2013 Cholesterol Guideline on Patterns of Lipid-Lowering Treatment in Patients with Atherosclerotic Cardiovascular Disease or Diabetes After 1 Year.

BACKGROUND: The 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults emphasizes evidence-based treatment with moderate- to high-dose statins for patients at high risk for atherosclerotic cardiovascular disease (ASCVD). Whether this new guideline influenced patterns of treatment 1 year after its dissemination is unknown. OBJECTIVE: To compare patterns of lipid-lowering treatment before and 1 year after the release of the 2013 cholesterol guideline in 2 high-risk groups: patients with ASCVD and patients with diabetes mellitus. METHODS: Using pharmacy and medical claims from a large U.S. health insurance organization, 610,535 patients with ASCVD (n = 301,440) or diabetes mellitus (n = 309,095) were identified, and statin treatment rates and statin intensity were examined before and 1 year after the dissemination of the 2013 cholesterol guideline. A standardized difference of at least 10% was required to declare the effect size meaningful. RESULTS: Overall, there was no change in statin treatment rates for patients with ASCVD (48.0% before guideline vs. 47.3% after, standardized difference 1.4%) or diabetes (50% vs. 51.5% after, standardized difference 2.4%). Statin initiation rates among patients not on statins before the 2013 guideline were 10.1% in patients with ASCVD and 14.3% in patients with diabetes, but these gains were offset by 13.0% and 12.2% statin discontinuation rates among ASCVD and diabetes patients, respectively. Among patients taking statins 1 year after the guideline was issued, 80% of patients with ASCVD and aged ≤ 75 years were not on guideline-recommended high-intensity statin therapy, whereas most patients with ASCVD and aged > 75 years or patients with diabetes were on moderate- or high-intensity statin treatment. CONCLUSIONS: One year after dissemination of the 2013 cholesterol guideline, overall treatment rates with statins among patients with ASCVD and diabetes did not change appreciably, and many patients remained either untreated or undertreated. DISCLOSURES: No outside funding supported this research. Chan is supported by grants from the National Heart Lung and Blood Institute (1R01HL123980 and K23HL102224). Tran, Stockl, Lew, and Solow are employed by Optum. Kao and Caglar were employed by Optum when this study was conducted. Chan serves as an advisor and consultant to OptumRx but received no compensation for work on this manuscript. Stockl is also employed by the Journal of Managed Care & Specialty Pharmacy. Spertus reports personal fees from United Healthcare and grants from Lilly, outside of the submitted work. None of the authors have any other financial conflicts of interest to report. Tran and Chan supervised this study, had full access to all of the data in the study, and take responsibility for the integrity of the data and the accuracy of the data analysis. Study design and concept were contributed by Tran and Chan. Tran and Kao collected the data, with analysis and interpretation performed by all the authors. Statistical analysis was performed by Caglar and Kao, and Tran and Chan drafted the manuscript. All authors were involved in the critical revision of the manuscript.

Patient Characteristics and Prescribing Patterns Associated with Sofosbuvir Treatment for Chronic HCV Infection in a Commercially Insured Population.

BACKGROUND: In December 2013, the US Food and Drug Administration (FDA) approved sofosbuvir (Sovaldi) for the treatment of patients with chronic hepatitis C virus (HCV) infection. Given the potential "warehousing" of patients before the launch of sofosbuvir and the possibility that some patients and providers may have elected to continue deferring treatment in anticipation of more promising, interferon-free therapies in the pipeline, the early landscape for sofosbuvir treatment is difficult to ascertain. OBJECTIVE: To describe the demographics, clinical characteristics, and prescribing patterns associated with members requesting treatment with sofosbuvir in a commercially insured population in the United States. METHODS: A descriptive analysis was conducted using a randomly selected sample of commercially insured members who were identified as having a prior authorization request for sofosbuvir between March and June 2014. Member and provider characteristics, as well as treatment information, were collected using a prior authorization database from OptumRx, a national pharmacy care services company. The results were analyzed using descriptive statistics. RESULTS: A total of 338 members were selected for inclusion in the analysis. Chronic HCV genotype 1 infection was present in 74.3% of the members. Chronic HCV genotype 2, 3, or 4 was identified in 13.9%, 9.5%, and 1.2% of the members, respectively. Gastroenterologists and hepatologists accounted for 90% of providers. Among the 251 members with chronic HCV genotype 1, an interferon-free regimen was requested for 59.4% (N = 149) of them; the most frequently requested (51.4%) regimen for members with chronic HCV genotype 1 was the off-label combination of sofosbuvir plus simeprevir. Of the members with chronic HCV genotype 1, 19.1% had liver fibrosis equivalent to METAVIR stage F0 to F2 fibrosis, and 24.7% had liver fibrosis equivalent to METAVIR stage F3 to F4 fibrosis. For the remaining 56.2%, the degree of liver fibrosis was not known or could not be determined. Of the members with documented liver fibrosis, 49.6% were determined by liver biopsy. CONCLUSION: The results show that the initial prescribing of sofosbuvir often included the off-label interferon-free regimen of sofosbuvir plus simeprevir during the study period (of note, this combination regimen was approved by the FDA in November 2014, after the completion of the study period). The off-label prescribing pattern may be attributable to "warehousing" of patients who were awaiting more tolerable therapies. Furthermore, the limited utilization of noninvasive tests to assess liver fibrosis suggests that providers may benefit from additional education on these methods. Although this analysis provides insight into the treatment of patients with chronic HCV immediately after the launch of sofosbuvir in the United States, future research should reevaluate the treatment patterns of chronic HCV infection to capture recent advances in the treatment of this disease.

Impact of the New ACC/AHA Guidelines on the Treatment of High Blood Cholesterol in a Managed Care Setting.

BACKGROUND: In November 2013, the American College of Cardiology (ACC) and the American Heart Association (AHA) together issued new guidelines for the treatment of patients with high cholesterol, providing a new paradigm for the management of cholesterol in the primary and secondary prevention of coronary artery disease. OBJECTIVE: To examine the impact of the 2013 ACC/AHA cholesterol treatment guidelines on pharmacy utilization of cholesterol-lowering drugs in a real-world managed care setting. METHODS: Pharmacy claims from OptumRx, a national pharmacy benefit management provider, for the period between January 1, 2013, and December 31, 2013 (baseline period), were used to identify candidates for cholesterol-lowering therapy and to estimate the number of potential patients who will be starting or intensifying statin therapy based on the updated cholesterol treatment guidelines. Potential candidates for cholesterol-lowering treatments included patients with diabetes or hypertension aged 40 to 75 years who were not already receiving a cholesterol-lowering medication, as well as patients receiving cholesterol-lowering therapies during the baseline period. The baseline cholesterol-lowering medication market share was used to project changes in pharmacy utilization over the next 3 years. RESULTS: Based on the 2013 ACC/AHA cholesterol treatment guidelines, there will be a 25% increase in the proportion of the overall population that is treated with statins over the next 3 years, increasing from 3,909,407 (27.7%) patients to 4,892,668 (34.7%) patients. The largest proportion of the increase in statin utilization is projected to be for primary prevention in patients aged 40 to 75 years who were not receiving any cholesterol-lowering treatment at baseline. These projected changes will increase the overall number of statin prescriptions by 25% and will decrease the number of nonstatin cholesterol-lowering medication prescriptions by 68% during the next 3 years. CONCLUSION: The new 2013 ACC/AHA cholesterol treatment guidelines are projected to have a significant impact on the utilization of cholesterol-lowering drugs by increasing the overall proportion of the population receiving statin therapy and by decreasing the utilization of nonstatin cholesterol-lowering medications.

Cost utility of tumour necrosis factor-α inhibitors for rheumatoid arthritis: an application of Bayesian methods for evidence synthesis in a Markov model.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease that affects approximately 1.5 million people in the US. Tumour necrosis factor (TNF)-α inhibitors have been shown to effectively treat and maintain remission in patients with moderately to severely active RA compared with conventional agents. The high acquisition cost of TNF-α inhibitors prohibits access, which mandates economic investigations into their affordability. The lack of head-to-head comparisons between these agents makes it difficult to determine which agent is the most cost effective. OBJECTIVE: This study aimed to determine which TNF-α inhibitor was the most cost-effective agent for the treatment of moderately to severely active RA from the US healthcare payer's perspective. METHODS: A Markov model was constructed to analyse the cost utility of five TNF-α inhibitors (in combination with methotrexate [+MTX]) versus MTX monotherapy using Bayesian methods for evidence synthesis. The model had a cycle length of 3 months and an overall time horizon of 5 years. Transition probabilities and utility scores were based on published studies. Total direct costs were adjusted to year 2009 $US using the medical component of the Consumer Price Index. All costs and QALYs were discounted at a rate of 3% per year. Patient response to the different strategies was determined by the American College of Rheumatology (ACR)50 criteria. One-way and probabilistic sensitivity analyses (PSAs) were performed to test the robustness of the base-case scenario. The base-case scenario was changed to ACR20 criteria (scenario 1) and ACR70 criteria (scenario 2) to determine the model's robustness. Cost-effectiveness acceptability curves and cost-effectiveness frontiers were used to estimate the cost-effectiveness probability of each treatment strategy. A willingness-to-pay (WTP) threshold was defined as three times the US GDP per capita ($US139,143 per additional QALY gained). Primary results were presented as incremental cost-effective ratios (ICERs). RESULTS: Etanercept+MTX was the most cost-effective treatment strategy in the base-case scenario up to a WTP threshold of $US2 185,497 per QALY gained. At a WTP threshold of greater than $US2 185,497 per QALY gained, certolizumab+MTX was the most cost-effective treatment strategy. One-way analyses showed that the base-case scenario was sensitive to the probability of achieving ACR50 criteria for MTX and each TNF-α inhibitor, and changes in the utility score for patients who achieved the ACR50 criteria. With the exception of infliximab, all of the TNF-α inhibitors were sensitive to drug cost per cycle. In the scenario analyses, certolizumab+MTX was a dominant treatment strategy using ACR20 criteria, but etanercept+MTX was a dominant treatment strategy using ACR70 criteria. CONCLUSIONS: Etanercept+MTX was a cost-effective treatment strategy in the base-case scenario; however, the model was sensitive to parameter uncertainties and ACR response criteria. Although Bayesian methods were used to determine transition probabilities, future studies will need to focus on head-to-head comparisons of multiple TNF-α inhibitors to provide valid comparisons.

Retrospective evaluation of inpatient celecoxib use after total hip and knee arthroplasty at a Veterans Affairs Medical Center.

A retrospective cohort study (1.5 years) was performed to investigate the efficacy of celecoxib vs non-celecoxib use in patient who underwent total knee arthroplasty (TKA) and total hip arthroplasty (THA). Study time frame encompassed a pre and post period of a local policy decision opening access to short-term celecoxib use after TKA/THA. Primary end point was the amount of opioid use during their inpatient stay postprocedure. The TKA (n = 81) and THA (n = 60) groups were analyzed independently. Both celecoxib groups used significantly less opioids during their inpatient stay vs noncelecoxib groups, given in oral morphine milligram equivalents (TKA: 203 vs 337 mg, P = .002; THA: 214 vs 336 mg, P = .005). Other secondary outcome measures showed that the celecoxib groups also reported reduction in pain scores, total as needed (PRN) opioid doses, PRN opioid doses per day, average dose of PRN opioids, total PRN opioids, use of intravenous opioids, and rehabilitation facility admissions (in the TKA group only). Linear regression analysis showed a statistically significant inverse relationship between opioid consumption and age. Short-term celecoxib use after TKA/THA may lead to a reduction in overall opioid use and improved pain scores; however, further studies will be required to validate the results of this study.