Medicare characteristics, treatment, cost and survival in triple class exposed relapsed or refractory multiple myeloma.

Background: This study describes real-world treatment patterns of Medicare beneficiaries with relapsed or refractory multiple myeloma (RRMM) who are triple class exposed (TCE). Materials & methods: Retrospective analysis of Medicare fee for service claims to identify a cohort age >65 with RRMM + TCE, 1 January 2016 to 30 June 2019. Outcomes: Initiation of a new treatment regimen (TCE1), healthcare resource utilization, cost and mortality. Results: Of 5395 patients with RRMM + TCE, 1672 (31.0%) initiated a new therapy (TCE1). During TCE1, 97 TCE1 drug combinations were observed and RRMM treatments were the largest cost driver. Median time to TCE1 discontinuation was 3.3 months. Few patients received subsequent treatment and 41.3% of study patients died. Conclusion: There is no clear standard-of-care for Medicare patients with RRMM + TCE and prognosis remains poor.

This research study describes outcomes in older Medicare patients with relapse or refractory multiple myeloma (RRMM) who failed three different classes of treatment (triple class exposed [TCE]) between 2016 and 2019. The authors utilized data from Medicare to follow patients who started a new treatment after TCE (this group was labeled 'TCE1'), and this article describes their cancer treatment, hospitalizations, emergency department visits, physician visits, costs of care, and length of survival. The authors identified 5395 Medicare patients with RRMM + TCE during the study period, of which 1672 (31.0%) started a new therapy and were considered TCE1. Patients were 75.6 years old, on average, when they started TCE1 treatment. The authors observed 97 different TCE1 drug combinations, and 50% of patients discontinued TCE1 treatment within 3 months. Few patients received additional treatment, and 41.3% of study patients died during the study period. More than 90% of healthcare costs were related to cancer care (rather than management of other conditions). There is no clear standard-of-care for older Medicare patients with RRMM + TCE, and prognosis remains poor.

Incremental burden of mental health conditions in adult patients with focal seizures.

INTRODUCTION: Clinical research has consistently established mental health conditions (MHCs) as frequent comorbidities of epilepsy. However, the extent of economic burden of comorbid MHC in patients with focal seizures has not been systematically investigated. This retrospective cohort analysis of health plan claims compared healthcare use and costs among adult patients with focal seizures with and without comorbid MHC. METHODS: We utilized the Inovalon Medical Outcomes Research for Effectiveness and Economics (MORE2) Registry, longitudinal data from over 150 commercial, Medicare Advantage, and managed Medicaid health plans for the analysis, and identified a cohort of patients with focal (partial-onset) seizure with relevant ICD9/10 diagnosis codes with and without MHC. Mental health conditions were defined as diagnoses for anxiety, bipolar condition/mania, attention-deficit conduct condition, major depression, schizophrenia, and other psychotic conditions, and patients without MHC were propensity score-matched to patients with preexisting MHC on baseline patient characteristics. The assessment examined a series of outcomes, including 1) direct healthcare resource utilization and 2) total provider reimbursement. RESULTS: Patients with preexisting MHC were more likely to receive adjunctive epilepsy therapy as well as broad-spectrum antiepileptic drugs/antiseizure medications (ASMs). Additionally, patients with focal seizures and MHC were significantly more likely to utilize high-cost healthcare services. The presence of MHC was associated with approximately 50% greater utilization of emergency department (ED), physician, and inpatient services. Consequently, healthcare expenditures were significantly higher among patients with MHC ($17,596 vs. $10,857; 62% higher, p < 0.001), with the trend consistent across all care settings. CONCLUSIONS: This analysis illustrates the health service utilization and cost implications of MHC among patients with focal seizures. The data suggest that patients with MHC have a greater overall clinical burden, which may be associated with higher healthcare resource use and expenditures. Because of the potential burden and costs associated with MHC, neurologists should consider screening patients with focal seizures for mental health disorders to identify and initiate treatment for comorbid mental health disorders.

Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection.

BACKGROUND: Cardiac implantable electronic device (CIED) infection is a serious adverse event, but there are limited contemporary real-world data on treatment pathways and associated costs in the Medicare population following diagnosis of CIED infection. Hence, this study evaluates postinfection treatment pathways and associated healthcare expenditures and mortality among Medicare fee-for-service beneficiaries with CIED infection. METHODS: Retrospective cohort analysis of 5,401 beneficiaries who developed a device-related infection in the year following implantation/upgraded CIED (1/1/2010-12/31/2012). Patients were followed-up to 12 months/death following diagnosis of infection and were divided into mutually exclusive groups based on whether they underwent CIED system removal (Group I), or no CIED system intervention (Group II; IIA with or IIB without infection hospitalization). All-cause healthcare resource utilization/expenditures were also measured. RESULTS: In the year following infection, 64.1% of patients underwent device extraction, of who 2,109 (39.0%) had their device replaced (Group IA) and 1,355 (25.1%) had their device extracted without replacement (Group IB); 62.2% of patients were hospitalized and 25.3% of patients died. Mean Medicare payments-per-patient for facility-based services by group were: IA = $62,638 (standard deviation [SD]: $46,830), IB = $50,079 (SD: $45,006), IIA = $77,397 (SD: $79,130), and IIB = $22,856 (SD: $31,167). CONCLUSIONS: Hospitalizations were the largest cost driver; infection-related costs, including cost of extraction/replacement, accounted for >50% of expenditures for patients with surgical/hospital intervention. Management of CIED infection in Medicare beneficiaries is associated with high healthcare expenditures in the year following infection. Additional measures to prevent device infection are needed to improve the outcomes and reduce costs in these patients.

Clinical and economic burden of breakthrough seizures.

PURPOSE: The purpose of this study was to measure health-care resource utilization and costs in treatment-adherent, previously seizure-free patients with epilepsy who were treated in the inpatient/emergency room (ER) setting for new-onset seizures, compared with matched controls. METHODS: The study used a retrospective case/control study design using administrative claims from the IMS PharMetrics™ database. We identified adult patients with epilepsy with 1+ ER visit/hospitalization with primary diagnosis of epilepsy between 1/1/2006 and 3/31/2011, preceded by 6months of seizure-free activity and antiepileptic drug (AED) treatment adherence (≥80% of days covered by any AED); the first observed seizure defined the "breakthrough" seizure/index event. Treatment-adherent patients with epilepsy without any ER/hospital admission for seizures served as controls: an outpatient epilepsy-related medical claim within the selection window was chosen at random as the index date. The following were continuous enrollment requirements for all patients: ≥12-month pre- and ≥6-month postindex. Each case matched 1:1 to a control using propensity score matching. All-cause and epilepsy-related (epilepsy/convulsion diagnosis, AED pharmacy) resource utilization and unadjusted and adjusted direct health-care costs (per person, 2012 US dollars (USD)) were assessed in a 6-month follow-up period. PRINCIPAL RESULTS: There were 5729 cases and 14,437 controls eligible. The final sample comprised 5279 matched case/control pairs. In unadjusted analyses, matched cases had significantly higher rates of all-cause hospitalization and ER visits compared to controls and significantly higher total all-cause direct health-care costs (median $12,714 vs. $5095, p<0.001) and total epilepsy-related costs among cases vs. controls (median $7293 vs. $1712, p<0.001), driven by higher inpatient costs. Among cases, costs increased with each subsequent seizure (driven by inpatient costs). Cases had 2.3 times higher adjusted all-cause costs and 8.1 times higher adjusted epilepsy-related costs than controls (both p<0.001). CONCLUSION: Inpatient/ER-treated breakthrough seizures occurred among 28.4% of our treatment-adherent study sample and were associated with significant incremental health-care utilization and costs, primarily driven by hospitalizations. Our findings suggest the need for better seizure control via optimal patient management and the use of effective AED therapy, which can potentially lower health-care costs.

Burden of illness and treatment patterns among patients with peripheral T-cell lymphoma in the US healthcare setting.

OBJECTIVE: Limited real-world information exists on the characteristics or treatment patterns of patients with peripheral T-cell lymphoma (PTCL). We reported demographics, treatments and direct healthcare resource utilization (HRU) in a large cohort of US patients newly diagnosed with PTCL. METHODS: Patients aged ≥18 years with a PTCL diagnosis between January 2011 and December 2016 were identified from the Inovalon MORE2 Registry. Continuous medical/pharmacy enrollment 6-months prior to and ≥1-month after the first PTCL diagnosis was required. The main focus of this study was on newly diagnosed patients receiving cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) versus other chemotherapy. RESULTS: A total 2971 patients with PTCL and chemotherapy information were included in the study; 1706 (57%) received CHOP and 1265 (43%) other chemotherapy. A majority of patients (51.7%) were female; mean (standard deviation) age at index was 61.0 (±16.0), Charlson score was 4.1 (±2.9), and follow-up time was 24.6 (±16.7) months. During the variable follow-up period, HRU was similar for the CHOP and other chemotherapy cohorts; 58.1% and 59.3% had ≥1 all-cause hospitalizations, respectively. The proportion of patients with ≥1 PTCL-related hospitalizations was higher in the CHOP than in the other chemotherapy cohort (40.3% vs. 9.7%, respectively) and mean length of stay was longer (4.6 vs. 3.7 days per patient per month, respectively). CONCLUSIONS: This retrospective analysis of patients with PTCL revealed high levels of comorbidity and HRU; novel interventions that improve patient outcomes and reduce the HRU burden of PTCL are needed.

Calcimimetic Use in Dialysis-Dependent Medicare Fee-for-Service Beneficiaries and Implications for Bundled Payment.

Background: Patients who are dialysis dependent and have secondary hyperparathyroidism (SHPT) may require calcimimetics to reduce parathyroid hormone levels to treatment goals. Medicare currently uses the Transitional Drug Add-on Payment Adjustment (TDAPA) designation under the ESKD Prospective Payment System ("bundled payment") to pay for calcimimetics (the first products eligible for the adjustment); this payment designation for calcimimetics is expected to conclude after 2020. This study explores variability in calcimimetic use across key patient characteristics and its potential effect on policy options for incorporating calcimimetics permanently into the bundle. Methods: This descriptive analysis used the 100% sample of Medicare FFS Part B (outpatient) 2018 claims to describe national-, regional-, and patient-level variation (including race, dual eligibility, and dialysis vintage) in calcimimetic use among beneficiaries who are dialysis dependent. Results: A total of 373,874 beneficiaries were analyzed, 28% had ≥90 days of calcimimetic use during 2018. At the national level, the proportion of patients on dialysis using calcimimetics was roughly 80% higher in Black versus non-Black patients on dialysis, 30% higher in patients on dialysis who were dual eligible versus non-dual eligible, and three times higher in patients with a dialysis vintage ≥3 years versus <3 years (all results unadjusted). Calcimimetic use was similar across census regions, however, substantial variation in calcimimetic use was observed at the facility level. Medicare spending for calcimimetic therapies as a proportion of total Medicare dialysis spending was >10% in approximately 20% of dialysis facilities. Conclusions: Although less than a third of beneficiaries use calcimimetics, certain patient-level characteristics are associated with higher rates of maintenance calcimimetic use. Due to the financial pressure many dialysis facilities face, how calcimimetics are incorporated into the bundle may have a direct effect on facility reimbursement for, and patient access to, therapy. Careful consideration will be required to ensure patients who are vulnerable and require treatment for SHPT do not face barriers to appropriate care.

Are high-risk hypertensive patients being prescribed concomitant statin therapy?: a retrospective cohort study.

BACKGROUND: Treatment guidelines for dyslipidemic patients have focused on lipid levels and risk assessments. However, normolipidemic patients who have multiple risk factors for cardiovascular disease may also benefit from HMG-CoA reductase inhibitor (statin) therapy. OBJECTIVE: We examined the frequency of statin prescriptions in patients initiating antihypertensive drug treatment in a US managed-care setting. STUDY DESIGN AND PATIENT: This retrospective cohort study used the PharMetrics' Patient-Centric Database to identify enrollees initiating antihypertensive treatment (September 2001 to February 2004). Patients newly treated with antihypertensives and with various levels of coronary heart disease (CHD) risk (including dyslipidemia, established CHD, type 2 diabetes mellitus, and no CHD but three or more cardiovascular risk factors) were included in the study. MAIN OUTCOME MEASURE: Cumulative probability of receiving statin therapy each month after antihypertensive initiation. Multivariable logistic regression was used to identify factors associated with receiving concomitant statin therapy. RESULTS: Of 142 389 patients (mean age 51.7 years) newly treated with antihypertensives, 32 056 (22.5%) were prescribed statins within 1 year. The cumulative probability of being prescribed a statin increased with increasing numbers of CHD risk factors, irrespective of dyslipidemia status. After adjusting for age, sex, and other potential predictors, patients were more likely to receive statin therapy if they had a history of dyslipidemia (adjusted odds ratio [AOR] 5.68 [95% CI 5.52, 5.85]), established CHD/congestive heart failure (AOR 3.39 [95% CI 3.16, 3.63]), or three or more additional cardiovascular risk factors but no CHD (AOR 3.01 [95% CI 2.74, 3.30]). CONCLUSION: Among patients beginning antihypertensive treatment, those with established CHD or CHD risk factors were more likely to receive statins, but a substantial fraction did not fill any statin prescription. The increased use of statin therapy could benefit many hypertensive patients with additional CHD risk factors.

Predictors of adherence to concomitant antihypertensive and lipid-lowering medications in older adults: a retrospective, cohort study.

BACKGROUND: Many older individuals have concomitant hypertension and dyslipidaemia--two conditions that, together with age, increase the risk of adverse cardiovascular events. Adherence to antihypertensive (AH) and lipid-lowering (LL) therapy is therefore particularly important in older patients with concomitant hypertension and dyslipidaemia. OBJECTIVE: To determine patterns and predictors of adherence to concomitant AH and LL therapy among an older Medicare-eligible population. METHODS: Enrolees (n=4052) aged>or=65 years who initiated treatment with both AH and LL therapy within a 90-day period were studied in this retrospective cohort study conducted in a US managed care organization. Adherence to AH and LL medications was measured as the proportion of days covered by any AH and/or LL medication in each 3-month interval, from the start of concomitant therapy for up to 36 months (mean follow-up 19.5 months). In each interval, patients were considered 'adherent' to AH and LL therapy if they had filled prescriptions sufficient to cover>or=80% of days with both medication classes. A multivariable regression model evaluated potential predictors of adherence to concomitant therapy, including patient demographics, clinical characteristics and health services use patterns at baseline. RESULTS: The percentage of patients adherent to both AH and LL therapy declined rapidly, before stabilizing, with 40.5%, 32.7% and 32.9% adherent at 3, 6 and 12 months, respectively. At each timepoint, an additional 27.8-35.0% of patients were adherent to either AH or LL therapy, but not both. Adherence was on average greater to AH than LL therapy. After adjusting for age, sex and other potential predictors, patients were more likely to be adherent if AH/LL therapies were initiated closer together in time (adjusted odds ratio [AOR] 1.13 for 0-30 days vs 61-90 days, p=0.0563), had a history of cardiovascular disease (AOR 1.27, p=0.0004), took fewer additional medications (AOR 0.43 for six or more medications vs zero or one medication, p<0.0001) or had more outpatient physician visits in the prior year (AOR 1.26 for four to six visits vs zero to one visit, p<0.0027). CONCLUSION: Adherence to concomitant AH and LL therapy among older adults is poor. Modifiable factors that may improve adherence in Medicare-eligible patients include initiating therapy concurrently and reducing patients' overall pill burden.

Utilization of fetal fibronectin testing and pregnancy outcomes among women with symptoms of preterm labor.

OBJECTIVES: To identify pregnant health plan members triaged through the emergency department (ED), including labor and delivery (ELD) units, with symptoms of preterm labor (PTL), and evaluate the use of fetal fibronectin (fFN) testing; and to calculate the rate of hospitalization and timing of delivery in relation to the ED visit. METHODS: Retrospective cohort study using Medical Outcomes Research for Effectiveness and Economics Registry®, a national multipayer claims database. A cohort of pregnant women evaluated in an ELD with a diagnosis of PTL from June 2012 through November 2015 was identified. The proportion of women with PTL who received fFN testing was calculated. RESULTS: A total of 23,062 patients met the criteria for inclusion in the study. The rate of fFN testing prior to delivery was 12.0%. Of the 23,062 patients included in the analysis, 75.9% were discharged home. Of those who were discharged from the emergency room, one in five went on to deliver within 3 days and almost 96% of this group was not screened for the presence of fFN. Of the remaining 24.1% of patients admitted to the hospital, 91.3% delivered during their stay. In a sensitivity analysis, the percentage of women who delivered within 3 days of the ELD encounter was lower for women who received fFN testing only (6.6%) versus those who had a history of transvaginal ultrasound (TVUS) only (21.6%). Furthermore, the rate of delivery within 3 days was lowest among patients who had both fFN testing and TVUS (4.7%). CONCLUSION: The utilization of fFN testing is 12%. The majority of pregnant patients triaged through the ELD with symptomatic PTL do not receive an fFN test. As part of PTL evaluation, fFN testing may identify women at increased risk for preterm delivery and help determine appropriate patient management.

Fetal fibronectin testing and pregnancy outcomes among Texas Medicaid patients at risk for preterm birth.

OBJECTIVES: Fetal fibronectin (fFN) testing between the 24th and 34th weeks of pregnancy in patients with symptomatic preterm labor (PTL) helps assess the risk of spontaneous preterm birth (sPTB), yet the extent of its use is unknown. We assessed use of fFN testing among Texas Medicaid enrollees with symptomatic PTL and evaluated time to infant delivery and healthcare utilization/costs. STUDY DESIGN: Retrospective cohort study using medical and pharmacy claims for Texas Medicaid enrollees. METHODS: We identified pregnant women triaged through the emergency department (ED) and hospital labor-and-delivery units with symptomatic PTL between January 1, 2012, and May 31, 2015. Patients with fFN testing prior to delivery were propensity score matched 1:1 to patients without fFN testing. Primary outcomes included time to delivery from initial PTL encounter and all-cause maternal healthcare utilization and costs. RESULTS: A total of 29,553 women met the criteria for analysis, of whom 14% had a record of receiving fFN testing. Each matched cohort included 4098 patients. Compared with those who did not, patients who underwent fFN testing had significantly more clinical risk factors (mean [SD]: 1.7 [1.1] vs 1.1 [1.0]; P <.0001) and were less likely to deliver during the initial hospital stay (odds ratio [OR], 0.539; 95% CI, 0.489-0.594), deliver ≤3 days following the hospital/ED encounter (OR, 0.499; 95% CI, 0.452-0.551); and receive their first PTL diagnosis during the initial hospital/ED encounter (OR, 0.598; 95% CI, 0.539-0.665). Patients who had an fFN test, compared with those who did not, had 17.5% higher total costs (P <.0001) during the 5 months prior to delivery, but had gestation lengths 9.4 days longer (24.6 vs 15.2 days) than those without testing. CONCLUSIONS: Frequency of fFN testing was low in Texas Medicaid enrollees with symptomatic PTL. Patients with fFN testing had longer gestation periods and were less likely to deliver within ≤3 days of a hospital/ED encounter for PTL. These results support the role of fFN in screening for risk for sPTB among women with symptomatic PTL.

Predictors of adherence with antihypertensive and lipid-lowering therapy.

BACKGROUND: Patients with comorbid hypertension and dyslipidemia are at high risk for cardiovascular disease, which can be considerably mitigated by treatment. Adherence with prescribed drug therapy is, therefore, especially important in these patients. This study was undertaken to describe the patterns and predictors of adherence with concomitant antihypertensive (AH) and lipid-lowering (LL) therapy. METHODS: This retrospective cohort study examined 8406 enrollees in a US managed care plan who initiated treatment with AH and LL therapy within a 90-day period. Adherence was measured as the proportion of days covered in each 3-month interval following initiation of concomitant therapy (mean follow-up, 12.9 months). Patients were considered adherent if they had filled prescriptions sufficient to cover at least 80% of days with both classes of medications. A multivariate regression model evaluated potential predictors of adherence. RESULTS: The percentage of patients adherent with both AH and LL therapy declined sharply following treatment initiation, with 44.7%, 35.9%, and 35.8% of patients adherent at 3, 6, and 12 months, respectively. After adjustment for age, sex, and other potential predictors, patients were more likely to be adherent if they initiated AH and LL therapy together, had a history of coronary heart disease or congestive heart failure, or took fewer other medications. CONCLUSIONS: Adherence with concomitant AH and LL therapy is poor, with only 1 in 3 patients adherent with both medications at 6 months. Physicians may be able to significantly improve adherence by initiating AH and LL therapy concomitantly and by reducing pill burden.

Relapse rates in patients with multiple sclerosis switching from interferon to fingolimod or glatiramer acetate: a US claims database study.

BACKGROUND: Approximately one-third of patients with multiple sclerosis (MS) are unresponsive to, or intolerant of, interferon (IFN) therapy, prompting a switch to other disease-modifying therapies. Clinical outcomes of switching therapy are unknown. This retrospective study assessed differences in relapse rates among patients with MS switching from IFN to fingolimod or glatiramer acetate (GA) in a real-world setting. METHODS: US administrative claims data from the PharMetrics Plus™ database were used to identify patients with MS who switched from IFN to fingolimod or GA between October 1, 2010 and March 31, 2012. Patients were matched 1∶1 using propensity scores within strata (number of pre-index relapses) on demographic (e.g. age and gender) and disease (e.g. timing of pre-index relapse, comorbidities and symptoms) characteristics. A claims-based algorithm was used to identify relapses while patients were persistent with therapy over 360 days post-switch. Differences in both the probability of experiencing a relapse and the annualized relapse rate (ARR) while persistent with therapy were assessed. RESULTS: The matched sample population contained 264 patients (n = 132 in each cohort). Before switching, 33.3% of patients in both cohorts had experienced at least one relapse. During the post-index persistence period, the proportion of patients with at least one relapse was lower in the fingolimod cohort (12.9%) than in the GA cohort (25.0%), and ARRs were lower with fingolimod (0.19) than with GA (0.51). Patients treated with fingolimod had a 59% lower probability of relapse (odds ratio, 0.41; 95% confidence interval [CI], 0.21-0.80; p = 0.0091) and 62% fewer relapses per year (rate ratio, 0.38; 95% CI, 0.21-0.68; p = 0.0013) compared with those treated with GA. CONCLUSIONS: In a real-world setting, patients with MS who switched from IFNs to fingolimod were significantly less likely to experience relapses than those who switched to GA.

Fesoterodine prescription fill patterns and evaluation of the YourWay patient support plan for patients with overactive bladder symptoms and physicians.

BACKGROUND: Adherence with oral medication for overactive bladder syndrome is suboptimal. To improve adherence, the YourWay plan was developed to assist patients and health care providers in defining treatment expectations and facilitating communication. OBJECTIVE: To evaluate medication adherence among patients with overactive bladder syndrome enrolled in the YourWay patient support plan, patient adoption of behavioral interventions, patient satisfaction with the plan, and physician experience with the plan. METHODS: In this 13-week, single-arm, open-label, multicenter, noninterventional study, fesoterodine-naïve patients received a prescription for fesoterodine 4 or 8 mg and a packet including a 14-day fesoterodine sample, educational materials, and progress tracker. Patients registered for the YourWay plan, which included an educational resource kit, interactive voice-response calls, and optional online and mail support. The primary end point was the proportion of patients who filled a prescription for a ≥ 90-day supply of fesoterodine within 90 days of enrollment. Secondary end points were the proportion of patients who filled ≥ 1 prescription and ≥ 2 prescriptions (post hoc), patient evaluation of their experience and satisfaction with the YourWay plan, and differences between prescription fillers and nonfillers in plan adoption and assessment (post hoc). We surveyed an independent sample of physicians to assess their experience with YourWay. RESULTS: Of 500 study completers, 10.4% filled a prescription for a ≥ 90-day supply of fesoterodine. Of those filling a prescription, 26.2% filled ≥ 1 prescription and among those, 61.0% refilled their prescription at least once. Many behavioral recommendations were adopted by 82% to 94% of patients. Fillers were more likely to take fesoterodine as directed, whereas adoption of behavioral recommendations or plan satisfaction did not differ between fillers and nonfillers. Most patients reported that the plan was informative and feasible to implement, and that they were satisfied with various aspects of the plan. Physicians also reported positive experiences. CONCLUSION: Most patients adopted YourWay components and viewed the plan positively, although adherence remained a challenge.

Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis.

OBJECTIVE: Achieving therapeutic goals in multiple sclerosis (MS) requires strict adherence to treatment schedules. This retrospective study analyzed persistence with, and adherence to, fingolimod compared with injectable/infusible disease-modifying therapies (DMTs) in patients with MS. METHODS: Patients in the PharMetrics Plus™ US administrative claims database with at least one prescription for, or administration of, fingolimod, glatiramer acetate (GA), interferon (IFN), or natalizumab (index DMT) between October 1, 2010 and September 30, 2011 were included. Patients were naïve to index DMT (no claim in the previous 360 days) and had an MS diagnosis code within 360 days of the first index DMT prescription. Outcomes were persistence, risk of discontinuing index DMT (evaluated by a Cox proportional hazards model), adherence (measured using the medication possession ratio [MPR] and proportion of days covered [PDC] in patients with at least two index DMT prescriptions), and the risk of being non-adherent (MPR <80% and PDC <80%, assessed using a logistic regression model). RESULTS: The study included 3750 patients (fingolimod, n = 889; GA, n = 1233; any IFN, n = 1341; natalizumab, n = 287). Discontinuation rates (fingolimod, 27.9%; GA, 39.5%; IFN, 43.7%; natalizumab, 39.5%; all p < 0.001) and risk of discontinuation were significantly higher (hazard ratios vs fingolimod [95% confidence interval]: GA, 1.75 [1.49-2.07]; IFN, 2.01 [1.71-2.37]; natalizumab, 1.53 [1.22-1.91]) for patients receiving other DMTs compared with fingolimod. The risk of being non-adherent was also lower for patients in the fingolimod cohort than the other treatment cohorts, irrespective of whether non-adherence was defined as MPR <80% (p < 0.05 for all) or PDC <80% (p < 0.05 for GA and IFN). LIMITATIONS: As with all studies assessing real-world treatment patterns it is unclear if medications were used as prescribed. CONCLUSIONS: In a real-world setting, persistence with, and adherence to, oral fingolimod was higher than for injectable and infusible DMTs.

Association between prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy.

PURPOSE: The association between prescription burden and medication adherence in patients initiating antihypertensive and lipid-lowering therapy was studied. METHODS: Patients enrolled in managed care organizations who initiated antihypertensive therapy coincident with lipid-lowering therapy (no more than 90 days apart) between January 1, 1997, and April 30, 2000, were eligible for inclusion. Analysis was limited to new users of antihypertensive and lipid-lowering therapy. The proportion of days covered (PDC) by antihypertensive and lipid-lowering therapy was calculated for the first year after therapy initiation; patients with a PDC of > or =80% for both drug classes were considered adherent. Prescription burden was defined as the number of prescription medications taken in the year prior to starting antihypertensive and lipid-lowering therapy. Demographic, clinical, and health-service-use variables associated with both prescription burden and medication adherence were measured using medical and pharmacy claims data from the year before initiation of antihypertensive and lipid-lowering therapy. RESULTS: Among 5759 patients, the mean +/- S.D. prescription burden was 3.6 +/- 3.7 (median, 3) medications, and the mean +/- S.D. PDC with antihypertensive and lipid-lowering therapy was 53.9% +/- 31.9% (median, 58.5%). Among patients with 0, 1, and 2 prior medications, 41%, 35%, and 30% of patients were adherent, respectively, to antihypertensive and lipid-lowering therapy. Among patients with 10 or more prior medications, 20% were adherent. CONCLUSION: Among patients in a managed care database taking antihypertensive and lipid-lowering medications, adherence to those regimens became less likely as the number of prescription medications increased. The reduction in adherence with additional prescription medications was greatest in patients with the fewest preexisting prescriptions.

Estimated prevalence of uncontrolled hypertension and multiple cardiovascular risk factors and their associated risk of coronary heart disease in the United States.

This study determined the prevalence of primary prevention patients aged 40 to 79 years with uncontrolled hypertension (HTN) and low/moderate cholesterol levels, and the clinical and economic consequences of their cardiovascular risk levels stratified by additional cardiovascular risk factors. Prevalence was estimated from the 1999 to 2002 National Health and Nutrition Examination Survey (NHANES) datasets. Framingham risk equations were used to calculate the 4-year risk of coronary heart disease (CHD). HTN and cholesterol levels were then statistically "controlled" to ideal levels and risks were recalculated. Prevalence of uncontrolled hypertension was 15.2 million cases (13.7%). Of those, 12.9 million (84.8%) had low/moderate cholesterol levels, and 2.2 million (16.7%) had >/=3 additional risk factors with no history of CHD. Nearly 200,000 coronary events are expected to occur within 4 years, incurring over $2.5 billion in direct medical costs. Statistical estimation suggests that 64% of 4-year risk was attributable to uncontrolled blood pressure and lipids. The large number and high cost of CHD events expected to occur within the next 4 years in primary prevention patients with uncontrolled hypertension and >/=3 additional risk factors justifies aggressive screening to ensure that these patients are identified and properly managed.