The economic impact of implementing a multiple inflammatory biomarker-based approach to identify,treat, and reduce cardiovascular risk

Abstract

Objectives:

To develop an economic model to estimate the change in the number of events and costs of non-fatal myocardial infarction (MI) and non-fatal ischemic stroke (IS) as a result of implementing routine risk-stratification with a multiple inflammatory biomarker approach.     

Budget impact model of a 5-grass sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis

Abstract

Objective:

Allergic rhinitis (AR) is a chronic disease with a substantial clinical and economic burden. This study estimated the potential budget impact (BI) associated with market entry of Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use (‘5-grass SLIT tablet’) for patients aged 10–65 with grass pollen-induced AR.     

Budget impact analysis of niraparib and olaparib for maintenance treatment of platinum-sensitive,recurrent ovarian cancer in the US

Aims: This study aimed to evaluate the budget impact of niraparib and olaparib in patients with platinum-sensitive, recurrent ovarian cancer from a US third party payer perspective.

Materials and methods: A budget impact model was constructed to assess the additional per member per month (PMPM) costs associated with the introduction of niraparib and olaparib, two poly ADP-ribose polymerase ribose polymerase (PARP) inhibitors recently approved to be used in platinum-sensitive, recurrent ovarian cancer patients with and without a gBRCA mutation. The model assessed both pharmacy costs and medical costs. Pharmacy costs included adjusted drug costs, coinsurance, and dispensing fees. Medical costs included costs associated with disease monitoring and management of adverse events from the treatment. Epidemiological data from the literature were used to estimate the target population size. The analysis used 1-year time frame, and patients were assumed on treatment until disease progression or death. All costs were computed in 2017 USD. One-way sensitivity analyses were conducted to evaluate the model robustness.

Results: In a hypothetical plan of 1,000,000 members, 206 patients were estimated to be potential candidates for niraparib or olaparib maintenance treatment after applying all epidemiological parameters. At listed 30-day supply WAC prices of $14,750 for niraparib and $13,482 for olaparib, budget impacts of these two drugs were $0.169 PMPM and $0.156 PMPM, respectively, most of which were contributed by pharmacy costs. Sensitivity analyses suggested that assumptions around market share, platinum-sensitive rate after first treatment, and WAC prices affected results the most.

Limitations: In this model, it was assumed that adopting niraparib and olaparib would not affect utilization of existing medications. Also, the estimated clinical parameters from clinical trials could differ from real-world data.     

Budget impact analysis of a novel gene expression assay for the diagnosis of malignant melanoma

Background:

Traditional pathology techniques alone can be insufficient to reliably distinguish between malignant melanoma, dysplastic nevi, and benign nevi in biopsies of suspicious pigmented lesions. Numerous studies have shown high rates of ambiguity when assessing such samples. A novel gene expression assay has been developed to objectively differentiate malignant melanoma from benign nevi.

Objective:

The purpose of this study was to quantify the economic impact of the gene expression assay on a US commercial health plan.

Methods:

The clinical paradigm of care was modeled for a hypothetical cohort of patients with suspicious pigmented lesions that are difficult-to-diagnose. Costs were assigned to each unit of care provided based on 2013 Medicare fee-for-service rates. Patients were followed for 10 years and were modeled to progress according to the natural history of their disease. The total cost of care was calculated for two scenarios: a Reference Scenario, representing current clinical practice, and a Test Scenario, in which each lesion was tested with the gene expression assay and diagnosed. Total cost of care was compared between the two scenarios to determine overall budget impact. Sensitivity analyses were performed to test the robustness of the model.

Results:

The gene expression assay reduces costs by $1268 per patient tested over 10 years, a decrease of 8.3%, after accounting for the cost of the assay. For a health plan with 10 million members, this would translate to over $8 million in savings. The largest portion of this saving comes from reducing the number of missed melanomas, which would otherwise progress to advanced disease. In sensitivity analyses, no single model input changed within a reasonable range of values caused the model to show that the assay was not cost-saving.

Conclusion:

In addition to improving the diagnosis of melanoma, this gene expression assay would likely reduce costs for health plans that choose to cover it.     

Budget impact model of tobramycin inhalation solution for treatment of Pseudomonas aeruginosa in cystic fibrosis patients

Abstract

Background:

Pseudomonas aeruginosa (PA) is the most common airway pathogen in cystic fibrosis (CF) patients. The objective of this analysis was to determine the costs of managing PA infection in CF patients with a chronic regimen of tobramycin inhalation solution (TIS).

Methods:

A budget impact model of CF patients was developed to evaluate the costs of TIS from a US managed-care organization (MCO) perspective. The Microsoft Excel model compared TIS treatment plus standard care with standard care alone over a 4-year time horizon and included the cost of drugs, medical care, and annual probabilities of hospitalization and IV anti-pseudomonal (anti-PA) antibiotics administration.

Results:

For an MCO with 5,000,000 members, 389 members 6 years of age or older were estimated to have CF, and 218 (56%) had PA infection. Assuming that use of TIS increased from 20% to 25%, the 1-year budget increased $231,251 or from $0.049 to $0.053 per member per month (PMPM). The net drug budget increase was $243,919, while medical costs associated with exacerbation management decreased $12,669 over the first year. Increasing utilization of TIS, from 20% to 40% over 4 years resulted in an incremental overall budget increase of $925,002, a 3% decrease in hospitalizations, and a 4% decrease in administrations of IV anti-PA antibiotics. These reductions translated to a medical care cost saving of $50,676 over 4 years. Limitations of this study include that the clinical data for the model are from clinical trials conducted in 1996 and the estimation of TIS use for CF patients with chronic PA infections can be impacted by TIS adherence.

Conclusion:

Model results suggest that increasing the use of TIS decreases medical care costs due to decreased hospital admissions and the use of IV anti-PA antibiotics at the expense of higher drug costs.     

Budget impact analysis of darbepoetin alfa every 3 weeks versus epoetin alfa every week for the treatment of chemotherapy-induced anaemia from a US payer's perspective

Abstract

Objective: This analysis was conducted to compare the direct medical costs of treatment with darbepoetin alfa every 3 weeks (Q3W) and epoetin alfa every week (QW) in patients with chemotherapy-induced anaemia (CIA) from the payer's perspective.

Methods: An analysis was conducted from a US health plan perspective to compare the annual budget impact for CIA with darbepoetin alfa Q3W and epoetin alfa QW over a 16-week treatment period. Dosing regimens were obtained from registration clinical trials.

Results: Mean doses, including dose adjustments, were 375.6 μg Q3W for darbepoetin alfa and 43,187 U QW for epoetin alfa. Costs of medical resources included drug acquisition and administration costs. The base case analysis resulted in a per-patient budget impact of $8,544 and $8,667 for darbepoetin alfa and epoetin alfa, respectively. Per member per month cost was $0.90 for darbepoetin alfa and $0.91 for epoetin alfa, based on an estimate of 2,735 CIA patients in a health plan population of 2.17 million. The analysis was most sensitive to drug dose, treatment period and drug price.

Conclusions: Results suggest that per-patient direct medical costs of CIA treatment, when initiated at labelled starting doses, are comparable for darbepoetin alfa Q3W and epoetin alfa QW.     

Budget impact of netupitant/palonosetron for the prevention of chemotherapy-induced nausea and vomiting

Background: Chemotherapy-induced nausea and vomiting (CINV) are among the most common and debilitating side-effects patients experience during chemotherapy, and are associated with considerable acute care use and healthcare cost. It is estimated that 70–80% of CINV could be prevented through appropriate use of CINV prophylaxis; however, suboptimal CINV compliance and control remains an issue in clinical practice. Netupitant/palonosetron (NEPA) is a fixed combination of serotonin-3 (5-HT₃) and neurokinin-1 (NK₁) receptor antagonists (RAs), respectively, indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Phase 3 clinical trials showed a significantly higher complete response rate in both acute and delayed CINV in chemotherapy-naïve patients receiving NEPA compared to patients receiving palonosetron.

Objective: The objective of this study was to estimate the budgetary impact of adding NEPA to a US payer or practice formulary for CINV prophylaxis.

Methods: A model was developed to estimate the impact of adding NEPA to the formulary of a hypothetical US payer with 1.15 million members, including 150,000 (13%) Medicare beneficiaries. The model compared the annual total costs of CINV-related events and CINV prophylaxis in two scenarios: base year (no NEPA) and comparator year (10% and 5% NEPA usage in HEC and MEC patients, respectively). A univariate sensitivity analysis was conducted to explore the effect of variability in model parameters on the budget impact.

Results: A total of 2,021 patients were eligible to receive CINV prophylaxis. With NEPA, CINV prophylaxis costs increased by 0.7% ($3,493,630 vs $3,518,760) while medical costs associated with CINV events decreased by 3.9% ($15,118,639 vs $14,532,442), resulting in a net cost saving of $561,067 (3.0%) for the health plan ($18,612,269 vs $18,051,202), or Background: Chemotherapy-induced nausea and vomiting (CINV) are among the most common and debilitating side-effects patients experience during chemotherapy, and are associated with considerable acute care use and healthcare cost. It is estimated that 70–80% of CINV could be prevented through appropriate use of CINV prophylaxis; however, suboptimal CINV compliance and control remains an issue in clinical practice. Netupitant/palonosetron (NEPA) is a fixed combination of serotonin-3 (5-HT₃) and neurokinin-1 (NK₁) receptor antagonists (RAs), respectively, indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Phase 3 clinical trials showed a significantly higher complete response rate in both acute and delayed CINV in chemotherapy-naïve patients receiving NEPA compared to patients receiving palonosetron.

Objective: The objective of this study was to estimate the budgetary impact of adding NEPA to a US payer or practice formulary for CINV prophylaxis.

Methods: A model was developed to estimate the impact of adding NEPA to the formulary of a hypothetical US payer with 1.15 million members, including 150,000 (13%) Medicare beneficiaries. The model compared the annual total costs of CINV-related events and CINV prophylaxis in two scenarios: base year (no NEPA) and comparator year (10% and 5% NEPA usage in HEC and MEC patients, respectively). A univariate sensitivity analysis was conducted to explore the effect of variability in model parameters on the budget impact.

Results: A total of 2,021 patients were eligible to receive CINV prophylaxis. With NEPA, CINV prophylaxis costs increased by 0.7% ($3,493,630 vs $3,518,760) while medical costs associated with CINV events decreased by 3.9% ($15,118,639 vs $14,532,442), resulting in a net cost saving of $561,067 (3.0%) for the health plan ($18,612,269 vs $18,051,202), or $0.04 per member per month. This was equivalent to saving $5,011 per patient moved to NEPA. Among all 5-HT₃ RA?+?NK₁ RA regimens, NEPA was associated with the lowest CINV-related costs, leading to the lowest total cost of care.

Conclusions: Adding NEPA to a payer or practice formulary results in a net decrease in the total budget due to a substantial reduction in CINV event-related resource utilization and medical costs, and an increase in pharmacy costs <1%, saving over $5,000 per patient.     

Budget impact of erlotinib for maintenance therapy in advanced non-small cell lung cancer

Abstract

Objective:

Assess the budgetary impact of adding erlotinib for maintenance therapy (MTx) in advanced non-small cell lung cancer (NSCLC) from a US health plan perspective.

Methods:

A budget impact model was developed to analyze the costs (drug, administration, adverse events) associated with adding erlotinib MTx to a hypothetical 500,000 member US health plan. Treatment durations and dosing were derived from randomized controlled trials, FDA labeling, and National Comprehensive Cancer Network guidelines. Treatment patterns and assumptions were based on market research data, the SEER registry, and published literature. Cost data were obtained from Centers for Medicare and Medicaid Services payment rates and a drug pricing database. Sensitivity analyses were conducted to assess uncertainty.

Results:

Overall health plan expenditures increased by $0.010 per member per month (PMPM). The main driver of additional cost was the erlotinib drug cost (～$66,000) with the administration ($464) and side-effect ($47) costs being relatively modest. One-way sensitivity analyses showed that the results were most sensitive to the proportion of members receiving MTx; however, the PMPM did not exceed $0.013.

Conclusions:

The overall budget impact to a health plan of expanding the use of erlotinib from the 2nd/3rd-line advanced NSCLC setting to include the maintenance setting was relatively small. This was primarily due to the proportion of patients who would receive erlotinib MTx, the low cost of side-effects and minimal cost of drug administration. Additional research may be warranted to estimate the relative clinical and economic impacts of erlotinib MTx versus alternative MTx treatments.     

Budget impact analysis of adjunctive therapy with lacosamide for partial-onset epileptic seizures in Belgium

Summary

Objective:

This study aims to compute the budget impact of lacosamide, a new adjunctive therapy for partial-onset seizures in epilepsy patients from 16 years of age who are uncontrolled and having previously used at least three anti-epileptic drugs from a Belgian healthcare payer perspective.

Methods:

The budget impact analysis compared the ‘world with lacosamide’ to the ‘world without lacosamide’ and calculated how a change in the mix of anti-epileptic drugs used to treat uncontrolled epilepsy would impact drug spending from 2008 to 2013. Data on the number of patients and on the market shares of anti-epileptic drugs were taken from Belgian sources and from the literature. Unit costs of anti-epileptic drugs originated from Belgian sources. The budget impact was calculated from two scenarios about the market uptake of lacosamide.

Results:

The Belgian target population is expected to increase from 5333 patients in 2008 to 5522 patients in 2013. Assuming that the market share of lacosamide increases linearly over time and is taken evenly from all other anti-epileptic drugs (AEDs), the budget impact of adopting adjunctive therapy with lacosamide increases from €5249 (0.1% of reference drug budget) in 2008 to €242,700 (4.7% of reference drug budget) in 2013. Assuming that 10% of patients use standard AED therapy plus lacosamide, the budget impact of adopting adjunctive therapy with lacosamide is around €800,000–900,000 per year (or 16.7% of the reference drug budget).

Conclusions:

Adjunctive therapy with lacosamide would raise drug spending for this patient population by as much as 16.7% per year. However, this budget impact analysis did not consider the fact that lacosamide reduces costs of seizure management and withdrawal. The literature suggests that, if savings in other healthcare costs are taken into account, adjunctive therapy with lacosamide may be cost saving.     

Budget impact analysis of everolimus for the treatment of hormone receptor positive,human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer in the United States

Abstract

Objective:

To estimate the budget impact of everolimus as the first and second treatment option after letrozole or anastrozole (L/A) failure for post-menopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer (ABC).     

Economic impact of using inhaled corticosteroids without prior exacerbation among elderly patients with chronic obstructive pulmonary disorder

Abstract

Objective:

To assess the economic impact of initiating inhaled corticosteroids (ICS) without evidence of prior exacerbation among elderly patients with chronic obstructive pulmonary disease (COPD) in the US.

Methods:

This retrospective study used administrative claims to identify newly diagnosed COPD patients between 1/1/2005 and 6/30/2006 who were dispensed ICS. The dispense date of the first ICS was set as the index date. Patients with prior diagnoses for asthma, cystic fibrosis, or lung cancer were excluded. Cohorts were constructed based on whether ICS therapy was concordant with recommended guidelines of having prior COPD exacerbation. Each COPD patient with prior exacerbation was matched to four patients without exacerbation based on age, gender, Charlson Comorbidity Index, and whether COPD diagnosis code was not elsewhere specified (i.e., 496). Multivariate regressions were estimated to assess the association between use of ICS therapy without prior exacerbation and total healthcare costs, controlling for demographics and clinical characteristics.

Results:

The study included 3650 patients: 730 with prior exacerbation and 2920 without prior exacerbation. Patients were 76 years of age and 54% were male. Those with prior exacerbation were more likely to have inpatient stays both prior to (74.4 vs. 44.1%, p?<?0.05) and following (37.0 vs. 33.1%, p?<?0.05) the index date. Controlling for patient characteristics, patients who were dispensed ICS without prior exacerbation had $1859 higher in total costs (p?<?0.05) compared to patients with prior exacerbation during the 12 months following ICS initiation.

Limitations:

The retrospective design of this study limits the interpretation of findings as association and not causality. This study is subject to selection bias due to unobservable confounders.

Conclusions:

Among COPD patients, initiation of ICS without prior exacerbation appears to be associated with increased healthcare costs. These findings suggest that ICS initiation without evidence of exacerbation as consistent with guidelines is associated with adverse economic consequences.     

Comparing treatment adherence of lisdexamfetamine and other medications for the treatment of attention deficit/hyperactivity disorder: a retrospective analysis

Abstract

Objective:

To assess treatment adherence in attention deficit/hyperactivity disorder (ADHD) patients initiated on Lisdexamfetamine (LDX) vs other FDA-approved stimulants and non-stimulant medications.

Methods:

ADHD patients initiated on an ADHD medication (index medication) were selected from a large US administrative claims database. Based on age and previous treatment status, patients were classified into treatment-naïve children and adolescents (6–17 years old), previously treated children and adolescents, treatment-naïve adults (over 18 years old), and previously treated adults. Furthermore, based on their index medication, patients were classified into seven mutually exclusive treatment groups: LDX, atomoxetine (ATX), osmotic release methylphenidate hydrochloride long acting (OROS MPH), other methylphenidate/dexmethylphenidate long acting (MPH LA) and short acting (MPH SA), and amphetamine/dextroamphetamine short acting (AMPH SA) and long acting (AMPH LA). Treatment adherence (proportion of days covered by the index medication ≥0.8) over a 12-month period was compared across treatment groups using multivariate logistic regression models.

Results:

In children and adolescents, LDX patients were more likely to be adherent compared to patients in each of the other treatment groups, except in treatment-naïve patients where LDX patients had a similar likelihood (p?=?0.6925) and were less likely (p?=?0.0004) to be adherent compared to ATX and OROS MPH patients, respectively. In adults, the LDX treatment group was also more likely to be adherent compared to each of the other treatment groups, except compared to AMPH LA, where statistically insignificant differences were observed (previously treated: p?=?0.6471, treatment-naïve: p?=?0.0733).

Limitations:

ADHD severity information was not available in the database. Accordingly, this study did not control for ADHD severity.

Conclusion:

Overall, LDX-treated patients demonstrated a better treatment adherence compared to patients initiated on other ADHD medications, except for AMPH LA in adult and OROS MPH and ATX in treatment-naïve children and adolescents.     

The management of acid-related disorders: the burden of disease and the need for effective treatment

Summary

A large and increasing number of people suffer from acid-related disorders such as dyspepsia, gastro-oesophageal reflux disease (GORD), and peptic ulcer disease. In 1994 alone, about 2 million patients consulted their family doctor for an acid-related disorder. Treatment of these patients represents a high cost to the NHS in terms of medications, consultations, referrals and treatment of complications. UK government statistics also indicate that there is a huge economic burden associated with acid-related disorders in terms of lost productivity.

Effective management of acid-related disorders is required to ensure that the available resources are used efficiently and to the benefit of the NHS, society and the patient.

Proton pump inhibitors are the most effective and predictable therapy available for acid-related disorders and many clinical studies have demonstrated their superior efficacy over H2-receptor antagonists in the management of these conditions. These therapeutic advantages translate into economic gains. Several economic studies have shown that it is more cost-effective to treat GORD and peptic ulcer disease with the proton pump inhibitor omeprazole than with H2-receptor antagonists.     

Targeted erlotinib for first-line treatment of advanced non-small cell lung cancer: a budget impact analysis

Objectives:

A recent phase III trial showed that patients with advanced non-small cell lung cancer (NSCLC) whose tumors harbor specific EGFR mutations significantly benefit from first-line treatment with erlotinib compared to chemotherapy. This study sought to estimate the budget impact if coverage for EGFR testing and erlotinib as first-line therapy were provided in a hypothetical 500,000-member managed care plan.

Methods:

The budget impact model was developed from a US health plan perspective to evaluate administration of the EGFR test and treatment with erlotinib for EGFR-positive patients, compared to non-targeted treatment with chemotherapy. The eligible patient population was estimated from age-stratified SEER incidence data. Clinical data were derived from key randomized controlled trials. Costs related to drug, administration, and adverse events were included. Sensitivity analyses were conducted to assess uncertainty.

Results:

In a plan of 500,000 members, it was estimated there would be 91 newly diagnosed advanced NSCLC patients annually; 11 are expected to be EGFR-positive. Based on the testing and treatment assumptions, it was estimated that 3 patients in Scenario 1 and 6 patients in Scenario 2 receive erlotinib. Overall health plan expenditures would increase by $0.013 per member per month (PMPM). This increase is largely attributable to erlotinib drug costs, in part due to lengthened progression-free survival and treatment periods experienced in erlotinib-treated patients. EGFR testing contributes slightly, whereas adverse event costs mitigate the budget impact. The budget impact did not exceed $0.019 PMPM in sensitivity analyses.

Conclusions:

Coverage for targeted first-line erlotinib therapy in NSCLC likely results in a small budget impact for US health plans. The estimated impact may vary by plan, or if second-line or maintenance therapy, dose changes/interruptions, or impact on patients’ quality-of-life were included.     

A two-part model of treatment for benign prostatic hyperplasia and the impact of innovation

Benign prostatic hyperplasia (BPHs) affects more than half of men who are at least 60 years old. Transurethral resection of the prostate (TURP) is the most common treatment. This article estimates the average costs of providing a TURP to a patient that chooses the procedure and the expected cost of a TURP irrespective of the actual treatment decision. It utilizes a modified two-part model. It first estimates the likelihood of receiving the TURP given a BPH diagnosis using a logit regression. The second step is to estimate the (log of) TURP cost for the population that actually received the procedure. For the TURP decision, data were extracted from the National Health Interview Survey (NHIS) 1986–1994 on 502 men with a diagnosis of BPH. For the cost model, HCIA discharge abstract data were used from five states on 26640 men who actually received a TURP in 1994. TURP was identified via CPT codes in the NHIS data. The cost of TURP was constructed using patient hospital charges and hospital-specific cost to charge ratios. It was found that patient characteristics and comorbidities are important determinants of the decision to receive, and costs of, TURP. Pharmacological alternatives to TURP significantly affect the likelihood that a person will choose the procedure. The predicted unconditional cost of TURP ranged from US$8908 to US$3832 (by state); the predicted conditional cost of TURP ranged from US$1163 to US$750. The results suggest that the cost associated with providing a TURP for the average man with BPH would be US$492 to US$1163, depending on the state of residence. It was found that estimating the costs using simple regression or ANOVA techniques will lead to biased results due to sample selection (which in this case range from US$3832 to US$8908).     

The cost effectiveness and budget impact of natalizumab for formulary inclusion

Abstract

Background: Crohn's disease (CD) and multiple sclerosis (MS) are debilitating autoimmune diseases, which represent a substantial cost burden in the context of managed care. As a corollary, there is an unmet pharmacotherapeutic need in patient populations with relapsing forms of MS, in addition to populations with moderately to severely active CD with evidence of inflammation who have experienced an inadequate response to other mainstream therapies. The purpose of this study was to analyze the clinical and economic data associated with natalizumab (Tysabri) and to determine the potential impact of its formulary inclusion in a hypothetical health plan.

Findings: Regarding MS, the implemented cost-effectiveness and budget-impact models demonstrated an anticipated reduction in relapse rate of 67% over 2 years, and a total therapy cost of $72,120 over 2 years, equating to a cost per relapse avoided of $56,594. With respect to the model assumptions, the market share of natalizumab would experience an increase to 8.5%, resulting in a total per-member, per-month healthcare cost increase of $0.003 ($0.002 for pharmacy costs and $0.001 for medical costs).

Regarding CD, over a 2-year period outlined by the model, natalizumab produced the highest average time in remission, steroid-free remission, and remission or response in comparison to the other agents. The mean total costs associated with the initiation of natalizumab, infliximab, and adalimumab were $68,372, $62,090, and $61,796, respectively. Although natalizumab's costs were higher, the mean time spent in remission while on this medication was 4.5 months, as opposed to 2.4 months for infliximab and 2.9 months with adalimumab. This shift in market share was used to estimate the change in total costs (medical + pharmacy), and the per-member per-month change for the model's base case was calculated to be $0.035.

Limitations: The aforementioned cost-effectiveness results for natalizumab in the treatment for CD and MS were limited by the model's predetermined assumptions. These assumptions include anticipated reduction in relapse rate after 2 years of therapy and acquisition costs in the MS model, as well as assuming a certain percentage of patients were primary and secondary failures of TNFα inhibitor therapy in the CD model.

Conclusion: The evidence presented here demonstrates that natalizumab provides clinical practitioners with another tool in their fight against both MS and CD, albeit by way of a different mechanism of action. After a thorough review of the evidence, the authors find that natalizumab has been shown to be relatively cost effective in the treatment of both conditions from a payer perspective; the therapy adds a new option for those patients for whom conventional treatment was unsuccessful.     

Attainment of combined optimal lipid values and the impact of lipid medication on cardiovascular outcomes and costs in a commercially insured population in the US

Abstract

Objective: To determine factors associated with the achievement of optimal lipid values (OLVs) and subsequent impact on clinical and economic outcomes.

Methods: An observational managed care database analysis was conducted among treatment-naïve adults with elevated cardiovascular (CV) risk, ≥12 months follow-up and full lipid panel from the 1st January 2002 to the 28th February 2005. Achievement of guideline-based levels for low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides was evaluated via laboratory data. Annual CV-attributable resource utilisation was assessed via medical and pharmacy claims data. Clinical and economic outcomes associated with the achievement of OLVs were assessed using multivariate regression.

Results: A total of 52,778 patients were followed for a mean (standard deviation) of 27 (10) months with 13% achieving combined OLVs at baseline and 23% after 4 years. Of patients, 69% did not initiate lipid-modifying medication. The achievement of combined OLVs reduced the risk of CV event (odds ratio = 0.86; 95% confidence interval 0.78–0.95), resource utilisation (inpatient visits: 3.36 vs. 4.41 per 100 patient years, p<0.0001; emergency department visits: 1.1 vs. 2.4 per 100 patient years, p<0.05) and costs: $703 vs. $903 per patient year, p<0.0001.

Conclusions: Simultaneous achievement of OLVs was rare in this patient population. Physicians should be encouraged to manage multiple risk factors aggressively to improve clinical and economic outcomes associated with CV disease.