Comparative cost analysis of management of secondary hyperparathyroidism with paricalcitol or cinacalcet with low-dose vitamin D in hemodialysis patients

Abstract

Objective:

The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D, and of phosphate binders, in patients in the IMPACT SHPT study; and to extrapolate those to estimate expected annual maintenance costs.

Methods:

IMPACT SHPT was a 28-week, randomized, open-label trial. Subjects from 12 countries received intravenous (IV) or oral paricalcitol, or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol. The primary end-point was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) value of 150–300?pg/mL during weeks 21–28 (evaluation period). This study compares the costs of study drugs and phosphate binders among participants during the study and annualized. This analysis includes only those subjects that reached the evaluation period (134 in each group).

Results:

The mean total drug costs over the study period were €2606 (SD?=?€2000) in the paricalcitol group and €3034 (SD?=?€3006) in the cinacalcet group (difference €428, p?=?0.1712). The estimated annualized costs were €5387 (SD?=?€4139) in the paricalcitol group and €6870 (SD?=?€6256) in the cinacalcet group (difference €1492, p?=?0.0395). In addition, a significantly greater proportion (p?=?0.010) of subjects in the paricalcitol arm (56.0%) achieved an iPTH of 150–300?pg/mL during the evaluation period compared to the cinacalcet arm (38.2%).

Limitations:

This was a secondary analysis of the IMPACT SHPT study which was not designed or powered for costs as an outcome. The dosing of study drugs and phosphate binders in the IMPACT study may not reflect actual practice, and patients were followed for 28 weeks, while the treatment of SHPT is long-term.

Conclusion:

Patients with SHPT requiring hemodialysis who were treated with a paricalcitol-based regimen for iPTH control had lower estimated annual drug costs compared to those treated with cinacalcet plus low-dose vitamin D.     

Cost per responder analysis in patients with secondary hyperparathyroidism on dialysis treated with cinacalcet

Abstract

Background:

Growing financial pressure on US dialysis providers requires economic efficiency considerations. The objective of this study was to examine short-term economic efficiencies of a cinacalcet-based treatment approach for secondary hyperparathyroidism.

Methods:

This study retrospectively assessed cost per biochemical response of the OPTIMA trial. OPTIMA was conducted in end-stage renal disease patients to compare biochemical control in patients receiving cinacalcet in addition to vitamin D sterols and phosphate binders vs patients receiving vitamin D sterol and phosphate binders alone. It explored three laboratory measurement response definitions from baseline to week 23: (1) decreases in parathyroid hormone (PTH) ≥30%; (2) PTH?≤?300?pg/ml; and (3) PTH?≤?300?pg/mL, calcium <9.5?mg/dL and phosphorus <5.5?mg/dL. Medication use and costs were measured to calculate average costs and incremental cost per responder. Stratification by lower and higher baseline PTH assessed cost per response by disease severity.

Results:

There were 38–77% more responders with cinacalcet vs control, depending on response definition. Mean (SD) per patient total medication costs were $5423 ($3698) for cinacalcet and $2633 ($2334) for control, leading to a mean difference of $2790 over 23 weeks. When response was defined as a decrease in PTH?≥?30% from baseline, the average cost per responder was $11,266 for control vs $7027 for cinacalcet. The incremental cost per incremental responder ranged from $5186–$9168. Across all response measures, cost per responder was lower in patients with lower baseline PTH.

Conclusions:

Representing a more efficient allocation of economic resources over the short-term, cinacalcet-based treatment algorithm led to a lower cost per biochemical response, particularly in patients with lower disease severity, vs vitamin D sterols and phosphate binders alone. These findings should be interpreted alongside the study limitation of converting international trial-based medication utilization into US costs.     

Persistence,adherence, and all-cause healthcare costs in atazanavir- and darunavir-treated patients with human immunodeficiency virus in a real-world setting

Objectives:

Atazanavir (ATV) and darunavir (DRV) are protease inhibitors approved for HIV treatment in combination with ritonavir (/r). The objectives of this study were to compare persistence (time to treatment discontinuation/modification), adherence, and healthcare costs among patients with human immunodeficiency virus (HIV) initiating ATV/r or DRV/r.

Methods:

This retrospective cohort study used commercial and Medicaid administrative insurance claims data. Patients initiating ATV/r or DRV/r from 2006–2013 with continuous enrollment for ≥6 months before and ≥3 months after initiation were included. Patients were followed from initiation until discontinuation/modification (≥30 day gap in ATV or DRV or initiation of a new antiretroviral medication), during which time adherence (proportion of days covered [PDC], with PDC ≥80% or 95% considered adherent) and per-patient per-month (PPPM) total healthcare costs were measured. DRV/r patients were propensity score matched to ATV/r patients at a 1:1 ratio to achieve balance on potentially confounding demographic and clinical factors. Commercial and Medicaid samples were analyzed separately, as were antiretroviral (ART)-naïve and experienced patients.

Results:

The final samples comprised 2988 commercially-insured and 1158 Medicaid-insured patients. There were no significant differences in hazards of discontinuation/modification between the ATV/r or DRV/r cohorts. With respect to odds of being adherent, the only marginally significant result was comparing odds of achieving PDC ≥80% among ART-naïve Medicaid patients, which favored ATV/r. All other adherence comparisons were not significant. Although ATV/r cohorts tended to have lower PPPM costs, the majority of these differences were not statistically significant.

Conclusions:

Patients with HIV treated with either ATV/r or DRV/r had similar time to treatment discontinuation/modification, adherence, and monthly healthcare costs. Results were similar across the pre-specified sub-groups. These findings are useful not only as an insight into clinical practice, but also as a resource for healthcare providers and payers evaluating treatment options for HIV+ individuals.     

Healthcare resource use and costs of privately insured patients who switch,discontinue, or persist on anti-muscarinic therapy for overactive bladder

Objectives:

To compare the healthcare costs of patients with overactive bladder (OAB) who switch vs persist on anti-muscarinic agents (AMs), describe resource use and costs among OAB patients who discontinue AMs, and assess factors associated with persisting vs switching or discontinuing.

Methods:

OAB patients initiating an AM between January 1, 2007 and March 31, 2012 were identified from a claims database of US privately insured beneficiaries (n?≈?16 million) and required to have no AM claims in the 12 months before AM initiation (baseline period). Patients were classified as persisters, switchers, or discontinuers, and assigned a study index date based on their AM use in the 6 months following initiation. Baseline characteristics, resource use, and costs were compared between persisters and the other groups. Resource use and costs in the 1 month before and 6 months after the study index date (for switchers, the date of index AM switching; for persisters, a randomly assigned date to reflect the distribution of the time from AM initiation to switching among switchers) were also compared between persisters and switchers in unadjusted and adjusted analyses. Factors associated with persisting vs switching or discontinuing were assessed.

Results:

After controlling for baseline characteristics and costs, persisters vs switchers had significantly lower all-cause and OAB-related costs in both the month before (all-cause $1222 vs $1759, OAB-related $142 vs $170) and 6 months after the study index date (all-cause $7017 vs $8806, OAB-related $642 vs $797). Factors associated with switching or discontinuing vs persisting included index AM, younger age, and history of UTI.

Conclusion:

A large proportion of OAB patients discontinue or switch AMs shortly after initiation, and switching is associated with higher costs.     

Impact of increasing adherence to disease-modifying therapies on healthcare resource utilization and direct medical and indirect work loss costs for patients with multiple sclerosis

Abstract

Objectives:

To estimate the effect of adherence to disease-modifying therapies (DMTs) among patients with multiple sclerosis (MS) on healthcare resource utilization (HRU) and costs, and model the impact of a 10 percentage point increase in adherence on these outcomes.     

A review of biopsychosocial strategies to prevent and overcome early-recognized poor adherence in growth hormone therapy of children

Abstract

Background:

Adherence to growth hormone (GH) therapy among children is variable and remains a problem, possibly affecting growth outcomes and future health, and having economic consequences.

Objective:

To provide a review of the issues related to poor adherence to GH therapy in children and describe integrative strategies that may improve adherence.

Results:

Poor adherence may be caused by various factors, affecting both the children and their families. The key reasons for adherence difficulties are psychological/emotional problems, social/everyday problems and technical handling issues of the drug delivery device. Correspondingly a broad range of strategies to address adherence to GH therapy often revolve around counseling and education, not just for the patient but also for the family giving care.

Limitations:

This review is intended as a general survey of strategies which could help, in clinical practice, to overcome poor adherence to growth hormone therapy in children; it summarizes the representative literature but it does not aim to be a rigorous database literature search in every aspect.

Conclusions:

If poor adherence is recognized early on during treatment, appropriate steps may be taken to identify barriers that are amenable to change for encouraging the child to adhere to the treatment regimen. A preventative approach may also be considered; for example, doctors could address adherence issues early and train families of children treated with GH to recognize the resources as well as the barriers to adherence. The broad range of different causes for poor adherence demands a great variety of interventions, making it important to individualize optimal treatment behavior. Additionally, economic studies are required to quantify the cost of poor adherence to GH therapy and to show the financial benefits of good adherence.     

Medical costs and healthcare resource use in patients with lupus nephritis and neuropsychiatric lupus in an insured population

Abstract

Objective:

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organ systems, including the kidneys (lupus nephritis) and the central nervous system (neuropsychiatric lupus, or NPSLE). The healthcare costs and resource utilization associated with treating lupus nephritis and NPSLE in a large US managed care plan were studied.

Methods:

SLE subjects ≥18 years of age and with claims-based evidence of nephritis or neuropsychiatric conditions were identified from a health plan database. An index date was set as a randomly drawn date from all qualifying claims during 2003–2008 for study subjects. Subjects were matched on the basis of demographic and clinical characteristics to unaffected controls. Costs and resource use were determined during a fixed 12-month post-index period.

Results:

Nine hundred and seven lupus nephritis subjects were matched to controls, and 1062 subjects with NPSLE were matched to controls. Mean overall post-index healthcare costs were significantly higher among subjects with lupus nephritis in comparison to matched controls ($33,472 vs $5347, p?<?0.001). Similarly, mean overall post-index healthcare costs were significantly higher among subjects with NPSLE compared to controls ($30,341 vs $4646, p?<?0.001). Subjects with lupus nephritis or NPSLE had higher mean post-index numbers of ambulatory visits, specialist visits, emergency department visits and inpatient hospital stays, compared to controls (all p?<?0.001).

Limitations:

Additional research, such as medical chart review, could provide validation for the claims-based identification of lupus nephritis and NPSLE subjects. Also, indirect costs were not evaluated in this study.

Conclusion:

Subjects with lupus nephritis or NPSLE have high costs and resource use, compared to unaffected controls.     

Adalimumab,etanercept, and infliximab utilization patterns and drug costs among rheumatoid arthritis patients

Abstract

Objectives:

To evaluate the utilization patterns of the anti-tumor necrosis factor (anti-TNF) agents Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab) in patients with rheumatoid arthritis (RA) and compare medication costs during the first year of treatment. (Humira is a registered trademark of Abbott Laboratories, IL; Enbrel is a registered trademark of Immunex Corporation, CA; and Remicade is a registered trademark of Janssen Biotech, Inc., PA).

Methods:

This retrospective analysis of medical and pharmacy claims included patients who were aged ≥18 years, had ≥2 RA diagnosis codes, and had ≥365 days of persistence with the index anti-TNF. Patients excluded had claims for anti-TNF agents within 6 months before the index date. Refill patterns for adalimumab and etanercept, number of infliximab infusions, time between infusions, and dose per infusion were analyzed for 12 months. Direct anti-TNF medication costs were compared among anti-TNFs for the initial treatment year.

Results:

Infliximab-treated patients (n?=?457) were significantly older than adalimumab- (n?=?337) or etanercept-treated patients (n?=?902). Time between refills was longer than recommended for 28% and 30% of adalimumab and etanercept refill periods, respectively. Potential cumulative time without therapy was 33 days for adalimumab and 43 days for etanercept. Statistically significant differences in mean per-patient anti-TNF medication costs for the first year were reported for adalimumab, etanercept, and infliximab ($14,991, $13,361, and $18,139, respectively; p?<?0.0001); however, a cost assessment using labeled dosing of the anti-TNF agents with optimal treatment compliance yielded comparable annual medication costs.

Limitations:

This analysis only evaluated utilization patterns for selected anti-TNF agents and was not inclusive of other medications that patients may have been using for RA. Absolute patient adherence could not be assessed due to lack of information on how patients were self-administering adalimumab and etanercept or if samples of the agents were made available.

Conclusions:

This study identified gaps in patients’ refills compared with prescriber recommendations. The infliximab-treated group had infusion patterns consistent with prescribing information. Potential clinical and economic implications of dose attenuation with adalimumab and etanercept should be explored further.     

Healthcare costs,treatment patterns,and resource utilization among pancreatic cancer patients in a managed care population

Abstract

Background:

Pancreatic adenocarcinoma has few effective treatment options and poor survival. The objective of this study was to characterize treatment patterns and estimate the costs and resource use associated with its treatment in a commercially-insured US population.

Methods:

In this retrospective claims-based analysis, individuals ≥18 years old with evidence of pancreatic adenocarcinoma between January 1, 2001 and December 31, 2010 were selected from a managed care database. Treatment phase (either initial non-metastatic or metastatic) was determined using a claims-based algorithm. Patients in the pancreatic cancer population were matched 1:3 to a control population. Resource use (events/person-years), treatment patterns, and healthcare costs (per-patient per-month, PPPM) were determined during a variable length follow-up period (from first pancreatic cancer diagnosis to earliest of death, disenrollment, or study end).

Results:

In this study, 5262 pancreatic cancer patients were matched to 15,786 controls. Rates of office visits, inpatient visits, ER visits, and inpatient stays, and mean total all-cause healthcare costs PPPM ($15,480 vs $1001) were significantly higher among cancer patients than controls (all p?<?0.001). Mean inpatient costs were the single largest cost driver ($9917 PPPM). Also, mean total all-cause healthcare costs were significantly higher during the metastatic treatment phase vs the initial treatment phase of non-metastatic disease ($21,637 vs $10,358, p?<?0.001).

Conclusions:

These results indicate that pancreatic cancer imposes a substantial burden on the US healthcare system, and that treatment of more advanced disease is significantly more costly than initial treatment of non-metastatic disease.

Limitations:

Additional research is needed to validate the accuracy of the claims-based algorithms used to identify the treatment phase.     

Resource utilization and healthcare costs for acute coronary syndrome patients with and without diabetes mellitus

Abstract

Objective:

This study compared differences in healthcare costs and resource utilization for acute coronary syndrome (ACS) patients with and without diabetes mellitus (DM).

Methods:

A retrospective cohort study of a large, US employer-based claims database identified adults hospitalized for ACS between 01/01/2005 and 12/31/2006 and categorized them based on DM status. Resource utilization and costs during the index hospitalization and in the 12-month follow-up period were compared for ACS patients with and without DM using the propensity score stratification bootstrapping method, adjusting for differences in demographic and clinical characteristics.

Results:

Of 12,502 patients who met selection criteria, 3,040 (24%) had a history of DM and 9,462 (76%) did not. Patients with DM were older, female, and had higher rates of previous cardiovascular and renal diseases. After the propensity score stratification, patients with DM incurred higher index hospitalization costs ($32,577 vs. $29,150, p?<?0.01) as well as higher total follow-up healthcare costs ($35,400 vs. $24,080, p?<?0.01), including higher inpatient ($17,278 vs. $11,247, p?<?0.01), outpatient ($12,357 vs. $8,853, p?<?0.01), and pharmacy costs ($5,765 vs. $3,980, p?<?0.01).

Limitations:

General limitations exist with any retrospective claims database analysis including potential diagnostic or procedural coding inaccuracies. Additionally, the patient population was representative of a working-age population with employer-sponsored health insurance and results may not be generalizable to other patient populations.

Conclusions:

DM is significantly associated with increased healthcare resource utilization and costs for ACS patients.     

The prevalence of complications and healthcare costs during pregnancy

Abstract

Objective:

To study the economic burden of pregnancy in the US, common complications during pregnancy, and the incremental costs attributable to these complications.