Costs associated with follicular lymphoma among individuals diagnosed with non-Hodgkin lymphoma: a longitudinal analysis using SEER-Medicare data.

There is limited information on the cost burden associated with follicular lymphoma (FL) and how it compares to other non-Hodgkin lymphoma (NHL) subtypes. We examined the direct medical costs associated with FL and estimated the incremental 3-year cost of FL compared to other NHL subtypes. Using the linked Surveillance, Epidemiology and End Results-Medicare dataset, we identified 16,691 NHL patients aged 66 years or older who were diagnosed with NHL between 2007 and 2013. The mean 3-year cost among the full NHL sample was $120,120 (standard error (SE) 839). The mean 3-year cost per patient was $114,443 (SE 1738) for FL and $121,402 (SE 950) for non-FL subtypes. The incremental 3-year cost of FL compared to non-FL was US$-5458 (95% confidence interval: US$-9325 to US$-1590). Longitudinally, FL was less costly than other NHL subtypes in the first year only, and became more expensive in the second and third years.

A Budget Impact Analysis of the Introduction of Copanlisib for Treatment of Relapsed Follicular Lymphoma in the United States.

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.S. third-party payer. METHODS: A budget impact model was developed over a 1-year horizon. The model considered a hypothetical population of 1 million people enrolled in a commercial health plan; patients with relapsed FL were identified based on epidemiology data. Treatments included copanlisib and approved and off-label therapies used for management of relapsed FL. Treatment distributions within the target population were based on a market research survey. Drug acquisition, administration, prophylaxis, and monitoring costs were based on prescribing information, clinical trials, literature, and expert opinion. All costs were inflated to 2017 U.S. dollars. Total costs were compared between 2 scenarios, 1 without and 1 with copanlisib on a formulary. A deterministic sensitivity analysis (DSA) was conducted to evaluate the robustness of the model. RESULTS: Within the 1 million-member health care plan, 18 patients had relapsed FL and had received at least 2 previous systemic therapies. Over 1 year, the addition of copanlisib and an increase in the use of obinutuzumab + bendamustine (from 9.0% without copanlisib to 13.1% with copanlisib) and lenalidomide + rituximab (from 0.3% to 12.0%) were estimated to increase drug acquisition costs by $238,536, drug administration and prophylaxis costs by $3,565, and monitoring costs by $539. The increase in total budget was $242,641, corresponding to $0.02 per member per month; 21.8% of this increase was attributable to copanlisib, 12.9% to obinutuzumab + bendamustine, and 65.3% to lenalidomide + rituximab. Results were generally robust in the DSA. CONCLUSIONS: Over a 1-year period, the model found that the addition of copanlisib to a formulary resulted in a small increase in total budget of $242,641, corresponding to $0.02 per patient per month and taking into account a concurrent increase in the use of obinutuzumab + bendamustine and lenalidomide + rituximab. Therefore, adding copanlisib to a formulary appears to be an affordable option for payers. Further studies should be conducted to more comprehensively assess the clinical and economic implications of adding copanlisib to the treatment armamentarium of relapsed FL. DISCLOSURES: This study was funded by Bayer HealthCare Pharmaceuticals. The study sponsor was involved in study design, data interpretation. and data review. All authors contributed to the development of the manuscript and maintained control over the final content. Appukkuttan, Yaldo, Gharibo, and Babajanyan report employment with Bayer HealthCare Pharmaceuticals at the time of this study. Duchesneau, Zichlin, Bhak, and Duh report employment with Analysis Group, which received research funds from Bayer HealthCare Pharmaceuticals for work on this study. A synopsis of the current research was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Validation of a claims-based algorithm to identify patients with chronic thromboembolic pulmonary hypertension using electronic health record data.

This study aimed to validate an algorithm developed to identify chronic thromboembolic pulmonary hypertension (CTEPH) among patients with a history of pulmonary embolism. Validation was halted because too few patients had gold-standard evidence of CTEPH in the administrative claims/electronic health records database, suggesting that CTEPH is underdiagnosed.

Persistence with migraine prophylactic treatment and acute migraine medication utilization in the managed care setting.

OBJECTIVE: The aim of this study was to describe persistence with migraine prophylactic treatment and acute migraine medication utilization in patients prescribed migraine prophylaxis. METHODS: For this retrospective cohort study, the Health Core Integrated Research Database provided pharmacy/medical claims data from 5 commercial health insurance plans (ie, excluding Medicare and Medicaid) on adult patients with migraine. Eligible patients had >or=1 pharmacy claim for a migraine prophylactic medication between July 1, 2000, and May 31, 2005, and >or=12 U of any combination of acute treatment (serotonin receptor agonist [triptan], ergotamine, or ergotamine combination) dispensed during the 180-day period preceding a first pharmacy claim for a prophylactic medication (index date). The prophylactic medication identified at index date was used for categorizing patients into 1 of 4 cohorts: amitriptyline, propranolol/timolol, divalproex sodium, or topiramate (reference). Kaplan-Meier curves were used for evaluating unadjusted risk for discontinuation over time, and a multivariate Cox proportional hazards model was developed to analyze factors associated with discontinuation of prophylactic medication. RESULTS: A total of 12,783 patients met the inclusion criteria and were included in the analysis (amitriptyline, 3749; propranolol/timolol, 2718; divalproex sodium, 1644; and topiramate, 4672). The mean (SD) ages were not significantly different across cohorts (43.9 [11.3], 42.0 [11.1], 43.1 [11.3], and 43.9 [10.6] years, respectively). The mean duration of treatment was significantly longer (131 [184] days) with topiramate compared with amitriptyline (94 [152] days), propranolol/ timolol (119 [180] days), and divalproex sodium (109 [158] days) (P < 0.001, P = 0.005, and P<0.001,respectively). The risks for discontinuing prophylactic treatment were 23%, 6%, and 11% higher with amitriptyline, propranolol/timolol, and divalproex sodium, respectively, compared with topiramate (P<0.001, P = 0.024, and P <0.001). Patients prescribed topiramate had a higher mean consumption rate of triptans preindex; postindex, decreases in triptan use were observed in all cohorts, although the magnitude of the decrease was greatest in patients prescribed topiramate compared with the other cohorts. CONCLUSIONS: In this study, prescription of topiramate was associated with greater persistence with prophylactic treatment than the other prophylactic drugs. Furthermore, greater reductions in acute treatment utilization, particularly triptans, were observed among patients prescribed topiramate compared with the other prophylactic cohorts.

Twelve-month discontinuation rates of levonorgestrel intrauterine system 13.5 mg and subdermal etonogestrel implant in women aged 18-44: A retrospective claims database analysis.

OBJECTIVE: To investigate the 12-month discontinuation rates of levonorgestrel intrauterine system 13.5 mg (LNG-IUS 13.5) and subdermal etonogestrel (ENG) implant in the US. STUDY DESIGN: We identified women aged 18-44 who had an insertion of LNG-IUS 13.5 or ENG implant from the MarketScan Commercial claims database (7/1/2013-9/30/2014). Women were required to have 12 months of continuous insurance coverage prior to the insertion (baseline) and at least 12-months after (follow-up). Discontinuation was defined as presence of an insurance claim for pregnancy-related services, hysterectomy, female sterilization, a claim for another contraceptive method, or removal of the index contraceptive without re-insertion within 30 days. Using Cox regression we examined the potential impact of ENG implant vs. LNG-IUS 13.5 on the likelihood for discontinuation after controlling for patient characteristics. RESULTS: A total of 3680 (mean age: 25.4 years) LNG-IUS 13.5 and 23,770 (mean age: 24.6 years) ENG implant users met the selection criteria. Prior to insertion, 56.6% of LNG-IUS 13.5 and 42.1% of ENG implant users had used contraceptives, with oral contraceptives being most common (LNG-IUS 13.5: 42.1%; ENG implant: 28.5%). Among users of LNG-IUS 13.5 and ENG implant, rates of discontinuation were similar during the 12-month follow-up (LNG-IUS 13.5: 24.9%; ENG implant: 24.0%). Regression results showed that women using LNG-IUS 13.5 vs. ENG implant had similar likelihood for discontinuation (hazard ratio: 0.97, 95% confidence interval: 0.90-1.05, p=.41). CONCLUSION: In the real-world US setting, women aged 18-44 using LNG-IUS 13.5 and ENG implant have similar discontinuation rates after 12 months. IMPLICATIONS: In the United States, women aged 18-44 using levonorgestrel intrauterine system (13.5 mg) and subdermal etonogestrel implant have similar discontinuation rates after 12 months.

Opioid Use Among Metastatic Prostate Cancer Patients With Skeletal-related Events.

PURPOSE: The development of skeletal-related events (SREs) (pathologic fracture, need for surgery and/or radiation to bone, spinal cord compression, and hypercalcemia of malignancy) in metastatic prostate cancer (MPC) is associated with worsened pain and compromised quality of life. Opioids are frequently used throughout the course of SRE treatment. This study describes the treatment patterns and incremental use of opioids in MPC patients diagnosed with SREs. METHODS: PC patients with bone metastases newly diagnosed with an SRE between January 1, 2005, and September 30, 2014, were identified using MarketScan Commercial and Medicare databases. Included patients were aged ≥40 years, had medical/pharmacy benefits for ≥12 months before (preindex) and ≥6 months after (postindex) diagnosis, and were without evidence of other primary cancers. Patients were categorized as nonusers of opioids (<10 days), short-term users (≥10 and <60 days), or long-term users (≥60 days) and further by SRE type. Opioid type, proportion of time on opioids, morphine-equivalent dose, adjuvant medications, and radiation use before and after SRE diagnosis were evaluated. FINDINGS: A total of 1071 eligible patients were identified (mean age, 71 years; 10.8% had chronic pain at baseline). The most common SRE types present were radiation (60.2%), radiation and bone surgery (15.0%), pathologic fracture (7.2%), and bone surgery (6.5%). Opioid use increased from 49.9% preindex to 53.3% postindex (P < 0.0001). The proportion of time on opioids doubled after SRE (pre, 0.3 vs post, 0.6; P < 0.0001). A greater percentage of patients used only opioids after an SRE (pre, 11.0%; post, 46.1% [P < 0.0001]), while a lesser percentage of patients used only radiation after an SRE (pre, 36.0%; post, 4.7% [P < 0.0001]). An increase was observed in patients using neither radiation nor opioids (pre, 14.5%; post, 42.0% [P < 0.0001]). An increase of ~50% was noted in long-term opioid users (from 22.1% to 32.1%). The use of monotherapy with a short-acting opioid decreased (pre, 35.1%; post, 32.5% [P < 0.0001]), while use of mixed opioids increased (pre, 13.7%; post, 19.1% [P < 0.0001]). Mean morphine-equivalent dose increased from pre- to post-SRE (9.1 vs 13.1 mg). Bisphosphonate and NSAID users decreased from before to after an SRE diagnosis (bisphosphonates, 40.2% vs 8.6%; NSAIDs, 26.7% vs 17.5% [both, P < 0.0001]). IMPLICATIONS: Long-term opioid use and dose were significantly increased after SRE development in MPC. The high percentage of patients not treated with an opioid or radiation potentially supports the need for additional treatment options for controlling pain if medically necessary and/or to prevent SREs.

The cost of absenteeism and short-term disability associated with colorectal cancer: a case-control study.

OBJECTIVE: Examine the incremental impact of absenteeism and short-term disability associated with colorectal cancer (CRC). METHODS: Absenteeism and short-term disability data were used for a case-control analysis of a healthy cohort (controls) compared with CRC patients (cases). Cases were matched to controls on the basis of age, sex, and region of residence. Multivariate regression models examined the costs of absenteeism and short-term disability, controlling for patient characteristics, prior medical costs, and patient general health. RESULTS: Compared with controls, CRC patients experience significantly higher short-term disability costs (mean, $45,716 vs $7367 [P < 0.0001]; median, $35,827 vs $7365 [P < 0.0001]), as well as significantly higher absenteeism costs (mean, $8841 vs $4596 [P < 0.0001]; median, $9971 vs $4795 [P < 0.0001]) in the 1 year after diagnosis of CRC. CONCLUSIONS: Colorectal cancer is associated with significant work-related productivity loss costs in the first year after diagnosis.

Budgetary Impact of Adding Riociguat to a US Health Plan for the Treatment of Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension.

BACKGROUND: Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are chronic, debilitating, and life-threatening conditions. Riociguat is the first and only pharmacotherapy approved by the US Food and Drug Administration (FDA) for the treatment of PAH and for CTEPH in patients who are either inoperable or have persistent pulmonary hypertension after surgery. OBJECTIVE: To estimate the budgetary impact of adding riociguat to a US health plan's formulary for the treatment of patients with PAH or CTEPH using a budget impact analytic model. METHODS: A customizable, Microsoft Excel-based decision analytic tool was developed to estimate the impact of riociguat on per-member per-month (PMPM) and per-member per-year (PMPY) bases in Medicare and non-Medicare health plans. The economic impact was calculated based on 1 million insured lives, published prevalence estimates of PAH and CTEPH, pharmacotherapy-eligible patients with PAH or CTEPH, administration costs, and monitoring costs related to pharmacotherapy. The drug costs were based on wholesale acquisition costs, and the medical costs were derived from Truven Health MarketScan claims data and the Medicare 2013 Clinical Diagnostic Laboratory Fee Schedule and Physician Fee Schedule. The market share for approved treatments was based on a tracking study of physicians treating patients with PAH or CTEPH. A sensitivity analysis was used to test the model's robustness. RESULTS: In a hypothetical plan population of 1 million members, the model estimated that 7 patients with PAH and 2 patients with CTEPH would be suitable for pharmacotherapy. Overall, 3 patients (1 with PAH and 2 with CTEPH) were receiving riociguat in a health plan consisting of patients with commercial and with Medicare insurance coverage. The incremental PMPY and PMPM costs for providing insurance coverage for riociguat were $0.27 and $0.02, respectively, for non-Medicare and Medicare health plans. Sensitivity analyses indicated that the budget impact increased by $0.01 PMPM, with a 25% increase in base-case parameter values. CONCLUSION: Riociguat is a first-in-class and the only FDA-approved treatment for patients with PAH or CTEPH-2 debilitating, chronic, and life-threatening conditions with poor prognosis. This drug offers health plans an effective and safe treatment option, with a minimal economic impact. The financial impact to a health plan of providing coverage for riociguat in the first year of treatment was as low as $0.02 PMPM. The real-world budget impact of riociguat needs to be measured using real-world evidence to validate our results.

Resource utilization impact of topiramate for migraine prevention in the managed-care setting.

OBJECTIVE: To determine the pattern of headache-related resource utilization and costs before and after initiation of preventive migraine treatment with topiramate in a sample of a large managed-care population. METHODS: This study was a retrospective, longitudinal, cohort study analysis of medical and pharmacy claims using The HealthCore Integrated Research Network Database. Patients were required to have had at least one pharmacy claim for topiramate between 7/1/00 and 11/30/04, and at least 12 dosage units dispensed of any combination of acute migraine treatments (triptan, ergotamine, or ergotamine combination) during the 6-month period preceding the first pharmacy claim for topiramate (the index date). Headache-related inpatient and outpatient resource utilizations were compared pre-index vs. post-index period 1 (months 1-6) and pre-index vs. post-index period 2 (months 7-12). Statistical analyses included McNemar tests for categorical variables and paired t-tests for continuous variables. RESULTS: A total of 3246 patients met the inclusion criteria. The mean (+/- SD) age was 44 +/- 10 years and 88% were female. From pre- to post-index period 2, outpatient visits significantly decreased by 30% (p < 0.0001), diagnostic procedures decreased by 74% (p = 0.0013), emergency room (ER) visits decreased by 27% (p < 0.0001), and abortive prescriptions decreased by 25% (p < 0.0001). No significant differences were found in mean number of hospitalization days. Total headache-related inpatient costs and outpatient costs decreased (p < 0.01) during post-index period 2 (43 and 46%, respectively). Headache-related pharmacy costs increased from pre- to post-index period 2. CONCLUSION: Topiramate treatment for migraine prevention was associated with significantly lower healthcare resource use (ER visits, diagnostics, acute treatment) in the first 6 months of treatment, with continuing decreases, including physician office visits, during the second 6 months of treatment. LIMITATIONS: Since this study is a claims-based analysis there is the potential introduction of non-claims identifiable factors that might influence resource use such as lifestyle modifications and over-the-counter medications. In addition, adherence to topiramate treatment was not accounted for in this study. Nonetheless, this study provides important insights into the benefit of preventive migraine treatment in actual clinical practice.