Background: Psoriasis is a chronic inflammatory condition associated with considerable morbidity and economic burden. Objectives: To estimate and compare the costs of home phototherapy versus biologics over a 3-year time horizon in patients with moderate to severe plaque psoriasis. Methods: The biologics compared were adalimumab, etanercept, infliximab, ustekinumab, and secukinumab. Average wholesale prices of biologics were obtained through Lexicomp. Home phototherapy costs were estimated by obtaining quotes from phototherapy device manufacturers. Three-year cost horizon, 3-month cost, and cost per success were calculated. To assess cost-effectiveness, Psoriasis Area Severity Index (PASI) 75 rates served as the surrogate for the rate of treatment success. Cost per success represents the cost for 3 months of treatment relative to the percent of patients who achieved PASI 75. Results: Secukinumab is the most expensive biologic with a 3-year cost of $182,718 compared with a 3-year cost of $5,000 for phototherapy. Limitations: Studies on the efficacy of home phototherapy tended to have small sample sizes. Larger studies would be useful to improve the generalizability of the data. The cost estimates are an average, which may not accurately represent the costs different insurance companies negotiate. These limitations were considered to have minimal effect on analysis. Conclusions: The economic burden of psoriasis is substantial. It is important to consider the costs to the healthcare system over a patient's lifetime when they start biologics or home phototherapy. Phototherapy is an effective and economical option for the treatment of moderate to severe plaque psoriasis.
Objectives: To compare the estimated direct costs of onabotulinumtoxinA with other overactive bladder syndrome (OAB) interventions for patients inadequately managed by an anticholinergic. Study Design: A cost analysis compared the direct annual costs of 12 common pharmaceutical treatments, including branded and generic anticholinergics, and mirabegron; 1 injection procedure (intravesical injection of onabotulinumtoxinA); and 2 devices (sacral nerve stimulation [SNS] device implantation and percutaneous tibial nerve stimulation [PTNS]). Methods: Direct medical treatment costs were assessed from a United States payer perspective and included costs of drugs and/ or procedures, administration (if applicable), and routine follow-up care. Drug acquisition costs were based on average wholesale price minus 15% and maximum allowable cost. Results: During year 1, costs of pharmaceutical treatment ranged from $500 (oxybutynin) to $3472 (Detrol LA [long acting]); the cost for an injection procedure was $1892 (onabotulinumtoxinA); and costs for devices were $3395 (PTNS) and $19,443 (SNS). At years 5 and 10, respectively, costs were $2500 to $17,360 (oxybutynin) and $5000 to $34,720 (Detrol LA) for pharmaceutical treatments; $9458 to $18,916 for onabotulinumtoxinA; $11,849 to $21,316 for PTNS; and $21,316 to $33,801 for SNS. Conclusions: This analysis suggests that short-and long-term costs of OAB treatment vary considerably. Pharmaceutical therapies were not necessarily less costly than injection procedures or devices. Among the injection procedure and device treatments, onabotulinumtoxinA was the least costly option at all time points. Although cost is an important component when comparing these treatments, aspects such as efficacy and safety must be considered when deciding on an appropriate treatment for OAB.
Objectives: Opioid dependency is a significant societal burden. Buprenorphine has improved access and safety for outpatient detoxification services. The objectives of this study were to determine, based on assessment of administrative medical and pharmacy claims, if use of buprenorphine induction (with or without naloxone) in an opioid-dependent population with commercial benefit coverage improved clinical and cost outcomes compared with buprenorphine without induction and with no use of buprenorphine. Study Design: This is a retrospective observational claims review with a 4-month pre- and posttreatment study design and analysis of medical, behavioral health, and pharmacy utilization patterns for all levels of service. Methods: We analyzed claims data from a sample of 648 Cigna customers using analyses of variance to assess differences before and after treatment among groups (buprenorphine with induction, buprenorphine without induction, and no buprenorphine) and general linear regression to compare adjusted cost ratios. Results: Induction and noninduction buprenorphine treatment were associated with significantly reduced inpatient utilization (81.8% reduction in hospitalizations vs 43.1% reduction in the no-treatment group; P < .05) and lower total medical, behavioral health, outpatient, and pharmacy costs (cost ratio, 0.52: 1; P < .001). There was a cost and utilization shift from inpatient toward outpatient, and we observed a shift in pharmacy claims from medical to behavioral health services; we observed a cost ratio of 1.58: 1 for total pharmacy (P < .05) and 2.26: 1 for nonpsychotropic pharmacy (P < .0001). Conclusions: Our findings support the use of buprenorphine with and without induction to decrease inpatient utilization and substantially lower total medical, behavioral health, and pharmacy costs.
Objectives: To identify patient characteristics predictive of all-cause healthcare costs among individuals with newly diagnosed non-valvular atrial fibrillation (NVAF) who initiated oral anticoagulant therapy with dabigatran or warfarin. Study Design: Retrospective analysis of administrative claims data of patients with newly diagnosed NVAF. Methods: Dabigatran and warfarin cohorts were identified by first claim (index date) during 10/1/2010 to 11/30/2012. Episode-based costs (all-cause) were determined using Episode Treatment Group (ETG) methodology and computed as per-patient-per-month. Baseline predictors of cost included baseline characteristics and baseline Episode Risk Group (ERG) risk score, which was grouped into 6 categories. To assess cohort differences in subgroups of patients, predictor variables representing the interaction of treatment cohort with patient characteristics were of primary interest. Cost ratios were then computed for subgroups of patients with different characteristics. Results: Cohorts included 4150 dabigatran- and 11,032 warfarin-treated patients. Compared with warfarin, dabigatran patients were younger (mean age: 67.3 vs. 72.5 years; P<0.001) and had lower mean ERG risk scores (4.1 vs. 5.6, P<0.001). Treatment cohort was not a statistically significant predictor of costs. Compared with warfarin, dabigatran was associated with higher cost at ERG risk scores of 2.1 to 4.0 and lower cost at scores of 6.1 to 8.0. Conclusions: Adding to existing evidence that treatment with dabigatran (vs warfarin) for NVAF would not incur higher all-cause healthcare costs, this study found that differences in all-cause healthcare costs did not follow a trend across subgroups of patients with NVAF based on different ERG risk score categories, favoring either therapy.
Objectives: To examine predetermined characteristics of patients who require increases in basal insulin dose compared with those requiring no increase following conversion from insulin glargine to insulin detemir.Study Design: This retrospective chart review of patients converted from insulin glargine to insulin detemir was conducted at a Veterans Affairs Medical Center.Methods: Characteristics of patients who required an increase in basal insulin dose were compared with patients who did not require an increase after the conversion. The following patient characteristics were evaluated: age, body mass index, and tobacco use, and diagnoses of heart failure, hypertension, hyperthyroidism, and hypothyroidism.Results: A total of 330 patients were included in this study, and these individuals were categorized into groups for comparison. Group 1 (n = 73) contained patients who did not require an increase in dose following conversion. Group 2 (n = 116) contained patients who required an increase in dose. The 2 groups (Group 1 vs Group 2) did not significantly differ in any of the characteristics studied (P >. 05). The remaining patients (Group N; n = 141) did not meet criteria for Group 1 or Group 2.Conclusions: There were no statistically significant differences in the studied characteristics of patients who required an increase in basal insulin dose when compared with those of patients who did not require an increase in dose after conversion. Further studies are needed to discern the factors shared by a subset of patients who require an increase in basal insulin dose following conversion.
Objectives: To characterize clinical trials supporting FDA approval of new cancer therapeutics and of supplementary indications and off-label indication inclusions on DRUGDEX, a Medicare-referenced compendium, each of which can guarantee reimbursement by Medicare. Methods: Cross-sectional study using publicly available documents for cancer therapeutics initially approved by the FDA from 2005-2012. Trials supporting approval were identified, characterizing randomization, blinding, comparator, end point, number of patients, and duration. Results: Between 2005-2012, FDA approved 37 new cancer therapeutics for 39 indications, based on 50 supportive trials. These therapeutics subsequently received 21 FDA supplementary indication approvals and 16 DRUGDEX off-label indication inclusions, based on 22 and 37 supportive trials, respectively. Of 109 total trials, 53.2% (95% CI, 43.9%-62.3%), 28.4% (95% CI, 20.8%-37.5%), and 53.2% (95% CI, 43.9%-62.3%) were randomized, double-blinded, and used a comparator, respectively. There was a median of 383 (interquartile range, 178 to 623) patients among aggregated supportive trials, whereas 38.2% (95% CI, 28.1%-50.6%), 69.7% (95% CI, 58.7%-78.9%), and 18.4% (95% CI, 11.3%-28.6%) were supported by at least 1 trial that lasted >= 6 months, used a comparator group, or used overall survival as a primary end point, respectively. There were few substantive differences in the aggregated clinical trial evidence supporting FDA new drug and supplementary indication approvals and DRUGDEX off-label indication inclusions. Conclusions: The evidence supporting DRUGDEX off-label indications was similar to that used for FDA approval of new and supplementary cancer therapeutic indications, all of which had limitations for informing clinical decision making.
Objectives: To evaluate the differences in mean costs per woman of the use of 2 levonorgestrel-releasing intrauterine devices (IUDs)-Mirena (LNG-M) and Liletta (LNG-L)-from a US payer perspective. Study Design: A decision analytics model. Methods: Total healthcare costs associated with IUDs included device cost, costs of insertion and removal, and costs of pregnancy-related outcomes. Pregnancy event rates and costs were obtained from published literature and IUD prescribing information. Total costs of IUDs at 3, 5, and 10 years of use were estimated. A 1-way sensitivity analysis was conducted, as was a Monte Carlo simulation, in which the impact of model parameter variations were evaluated. Results: At 5 years of contraception use, the mean costs per woman were estimated to be lower for LNG-M than LNG-L ($1089 vs $1614). After 3 and 10 years, the differences in total costs of use of LNG-M and LNG-L were estimated at $69 and -$1160 per woman, respectively. The 1-way sensitivity analysis showed that the device costs of LNG-M and LNG-L have the most impact on the cost differences. The Monte Carlo simulations showed, within a hypothetical cohort of 10,000 women with randomly distributed contraception durations, that approximately 70% are estimated to have cost savings with use of LNG-M versus LNG-L at a mean cost difference of -$335 per woman. Conclusions: Compared with LNG-L, the use of LNG-M was associated with a slightly higher cost at 3 years, but a cost savings of more than $500 per woman at 5 years and more than $1000 at 10 years.
Objectives: To assess rates of monitoring of liver, thyroid, and pulmonary function in the 6 months before and after initiation of a quality improvement project, and to evaluate the effect of pharmacist-managed dual warfarin and amiodarone monitoring on maintaining target international normalized ratio (INR).Study Design: Retrospective electronic chart review.Methods: Rates of monitoring according to current guidelines for amiodarone monitoring were evaluated. Patients who filled prescriptions for a) amiodarone AND b) warfarin OR any of the following direct oral anticoagulants: apixaban, rivaroxaban, or dabigatran between May 1, 2014, and April 30, 2015, were reviewed. Percent time spent in target therapeutic INR range (% TTR) was used as an outcome parameter to evaluate effect on maintaining target INR.Results: Seventy-three subjects were in the pre-intervention group and 69 patients were in the post intervention group. All rates of 6-month monitoring increased in the post intervention group as compared with the pre-intervention group. Both the rates of monitoring of alanine aminotransferase (P = .03) and free thyroxine (P < .001) were found to be significantly higher in the post intervention group, as compared with the pre-intervention group. The % TTR was 64% in the pre-intervention group and 58% in the post intervention group.Conclusions: Collaboration with pharmacists in an outpatient setting leads to improved rates of recommended laboratory tests for amiodarone monitoring. This study demonstrated the effectiveness of an established anticoagulation clinic in maintaining target INR.
Objectives: The purpose of this study was to evaluate the impact of pharmacist-delivered medication therapy management (MTM) services via telephone (enhanced MTM intervention) versus the impact of an informative detailed medication letter sent via mail (minimal MTM intervention) on patients' acceptance of guideline-recommended pharmacotherapies, specifically angiotensin-converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARBs) and statins. Study Design: A retrospective database analysis was completed using pharmacy claims and enrollment data from 1 national pharmaceutical benefits manager. Methods: Medicare Part D beneficiaries with diabetes, managed by 1 pharmacist-based medication management center, received either: 1) a pharmacist's recommendation, delivered via telephone, to add an ACE inhibitor or ARB and/or a statin to existing therapy, or 2) an informative letter detailing current therapies. The primary outcome measure was acceptance of guideline-recommended therapy determined by the presence of at least 1 prescription claim for the target drug in the post-intervention period. Propensity score matching and conditional logistic regression methodologies were used to assess the comparative effectiveness of the interventions. Results: Patients who received the telephone intervention were 6.33 times more likely to be taking both medications during the postintervention period compared with those who received the letter intervention (P < .001). A greater proportion of patients who received the telephone intervention were taking both drugs during the postintervention period, with the greatest difference in those initially receiving a statin to which ACE inhibitor/ARB therapy was added (41.18% vs 7.23%). Conclusions: Telephone-based MTM services provided to Medicare Part D beneficiaries with diabetes positively impacted acceptance of guideline-recommended ACE inhibitor/ARB and/or statin therapies relative to the letter intervention.
Background: In US healthcare, individual payers create their own prescription drug coverage policies. This can lead to differences in how payers cover multiple sclerosis (MS) drugs and can thus affect patients' access to them. Objectives: To examine how the largest private payers cover MS drugs relative to their corresponding FDA approvals and to the evidence that payers report reviewing when formulating their policies. Methods: We identified coverage policies for disease-modifying MS drugs issued by the 10 largest private payers that make their policies publicly accessible. We categorized each policy relative to the drug's corresponding FDA approval as consistent, more restrictive, less restrictive, or "mixed," ie, more restrictive than the approval in 1 way, but less restrictive in another. We then categorized the evidence that the payers reported reviewing in their policies into 6 categories: randomized controlled trials (RCTs); other clinical studies (eg, non-RCTs or observational studies); clinical reviews; health technology assessments; clinical guidelines; or cost-effectiveness analyses. Results: Forty-six percent of coverage policies were more restrictive than the corresponding FDA approval, 38% consistent, 12% less restrictive, and 3% mixed. The payers reported reviewing an average of 1.1 RCTs, 0.4 technology assessments, 0.4 other clinical studies, 1.3 clinical reviews, and 0.8 clinical guidelines per policy. Only 1 payer reported reviewing cost-effectiveness analyses. Payers reported reviewing varying numbers of studies and reviewing differing study types in their coverage policies. Conclusions: We found variation in how the included payers cover MS drugs and in the evidence that they report reviewing in their coverage policies.
Objectives: We studied the independent association of adherence to oral hypoglycemic medications with poor glycemic control among a population of adults with type 2 diabetes (T2D), adjusting for demographics, health behaviors, and clinical and treatment characteristics. Study Design: This was a retrospective cohort design. Methods: We studied a population of Kaiser Permanente Northwest (KPNW) members with T2D who either had: 1) good glycemic control (glycated hemoglobin [A1C] <8.0%; n = 15,891) or 2) poor glycemic control (A1C >9.0%; n = 3709). The primary independent variable was medication adherence to 1 or more oral hypoglycemic medications. High medication adherence was defined as at least 80% of days covered in the 12 months prior to the A1C test date (yes vs no). Multiple logistic regression was used to analyze the independent association of medication adherence with poor glycemic control, adjusting for demographics, health behaviors, medical comorbidities, healthcare utilization, receipt of diabetes care management services, and intensity of diabetes treatments. All measures were constructed via KPNW's electronic heath record. Results: Increased adherence to oral hypoglycemic medications was associated with a lower likelihood (OR, 0.54; 95% CI, 0.50-0.59; P < .0001) of having poor glycemic control, after adjusting for demographics, health behaviors, comorbidities, healthcare utilization, receipt of diabetes care management services, and intensity of diabetes treatments. Conclusions: Higher adherence to oral hypoglycemic medications is independently associated with a lower likelihood of having poor glycemic control among an adult population with T2D. Studies of the effects of measures to improve medication adherence on population-level glycemic control are needed.
Objectives: Prolonged treatment of Parkinson's disease (PD) with immediate-release (IR) carbidopa-levodopa (CD-LD) often leads to motor fluctuations, including dyskinesia and reemergence of PD symptoms ("off" time). Adding entacapone (E) to IR CD-LD (to create CL+E) improved efficacy; however, recent clinical studies demonstrated improved efficacy with extended-release carbidopa-levodopa (IPX066) compared with CL+E. This study evaluated the long-term cost-effectiveness of IPX066 versus branded and generic CL+E from the US payer perspective. Study Design: State-transition Markov analysis. Methods: A Markov model (6-month cycle, 3% annual discount rate) was developed to simulate PD progression over 5 years through 3 health states: <= 25% "off" time, >25% "off" time, and death. Dosing and efficacy data were from a phase 3 study comparing IPX066 with CL+ E (administered either as IR CD-LD [Sinemet 25/100 mg] + entacapone [Comtan 200 mg] or CL+ E combination tablet [branded]) and an open-label extension study. Health state utilities were from published literature. Total direct costs and quality-adjusted life-years (QALYs) were evaluated. One-way sensitivity analyses evaluated input uncertainty ranges and identified inputs that most affected the results. Results: Total 5-year costs with IPX066, branded CL+ E, and generic CL+ E therapy were $68,703, $91,949, and $79,332, respectively. Intervention-related costs for IPX066 treatment were less than those for branded CL+ E and slightly more than those for generic CL+ E. The analysis showed cost savings with IPX066 of $166,044 per QALY gained, compared against branded CL+ E, and $75,920 per QALY gained against generic CL+ E. One-way sensitivity analyses demonstrated dominance with IPX066 in the majority of scenarios. Conclusions: IPX066 was cost-effective compared with both branded and generic CL+ E and was expected to lower total 5-year costs and increase QALYs for patients with PD.
