Estudio primario

No clasificado

Cost effectiveness and budget impact of natalizumab in patients with relapsing multiple sclerosis.

Año 2009
Autores Chiao E , Meyer K
Revista Current medical research and opinion
Enlaces DOI , Pubmed
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BACKGROUND:

Disease-modifying therapy (DMT) is the largest single-cost item that contributes to the total per-patient cost of multiple sclerosis (MS), a disabling disorder of the central nervous system. Natalizumab is the most recent DMT to be approved for the treatment of relapsing MS and may be an attractive alternative to interferon beta and glatiramer acetate (GA).

OBJECTIVES:

To determine from the perspective of a United States payer (1) the incremental cost effectiveness of natalizumab compared with other DMTs and (2) the budgetary impact of utilization of natalizumab for the treatment of relapsing MS.

METHODS:

A combined cost effectiveness and budget impact model was developed. Model inputs were drug acquisition costs (wholesale acquisition cost), costs of drug administration and monitoring, costs of treating relapses, anticipated reduction in relapse rates after 2 years of therapy, and estimated market utilization of natalizumab. Outcomes included total 2-year costs of therapy per patient, costs per relapse avoided for each treatment, and overall 2-year costs to the health plan and per member per month (PMPM) costs. Drug acquisition costs are in 2008 US dollars, and all other costs were inflated to 2008 US dollars when necessary. Univariate sensitivity analyses were performed to determine the model inputs with the greatest influence on the cost per relapse avoided for natalizumab.

RESULTS:

The overall 2-year cost of therapy per patient was $72,120 for natalizumab, $56,790 for intramuscular (IM) interferon beta-1a (IFNbeta-1a), $56,773 for IFNbeta-1b, $57,180 for GA, and $58,538 for subcutaneous (SC) IFNbeta-1a. The cost per relapse avoided was lowest for natalizumab at $56,594, followed by $87,791 for IFNbeta-1b, $93,306 for IM IFNbeta-1a, $96,178 for SC IFNbeta-1a, and $103,665 for GA. The incremental cost-effectiveness ratios of natalizumab relative to IM IFNbeta-1a, IFNbeta-1b, GA, and SC IFNbeta-1a were $23,029, $24,452, $20,671, and $20,403 per additional relapse avoided, respectively. An increase in natalizumab utilization to 9% resulted in an increase of approximately $61 760 in total 2-year costs to a hypothetical health plan of 1 million members, or a $0.003 PMPM incremental cost. Univariate sensitivity analyses indicated that the model inputs with the most influence on cost per relapse avoided for natalizumab were the weighted average number of relapses before treatment and the anticipated relative relapse rate reduction.

CONCLUSIONS:

Natalizumab was the most cost-effective therapy as measured by total cost per relapse avoided, not withstanding a higher drug acquisition cost versus other DMTs. Entry of natalizumab to the market is likely to result in a minimal increase in health-plan costs on a PMPM basis. Limitations of the study include the use of a surrogate measure, relapse avoided, as an outcome measure; also, adverse events were not included in the model.

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Estudio primario

No clasificado

Natalizumab reduces visual loss in patients with relapsing multiple sclerosis.

Año 2007
Revista Neurology
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OBJECTIVE:

To examine the effects of natalizumab on low-contrast letter acuity as a prespecified tertiary endpoint in two randomized clinical trials and to evaluate the usefulness of low-contrast letter acuity testing as a candidate test of visual function in multiple sclerosis (MS).

METHODS:

AFFIRM and SENTINEL were randomized, doubleblind, placebo-controlled, multicenter, phase 3 clinical trials of natalizumab in relapsing MS. Natalizumab was evaluated as monotherapy in AFFIRM and as add-on to interferon beta-1a in SENTINEL. Vision testing was performed at 100% contrast (visual acuity) and low-contrast (2.5% and 1.25%).

RESULTS:

The risk of clinically significant visual loss (predefined as a two-line worsening of acuity sustained over 12 weeks) at the lowest contrast level (1.25%) was reduced in the natalizumab treatment arms by 35% in AFFIRM (hazard ratio = 0.65; 95% CI.: 0.47 to 0.90; p = 0.008) and by 28% in SENTINEL (hazard ratio = 0.72; 95% CI.: 0.54 to 0.98; p = 0.038, Cox proportional hazards models). Mean changes in vision scores from baseline were also significantly different, reflecting worsening in non-natalizumab groups.

CONCLUSIONS:

Natalizumab reduces visual loss in patients with relapsing multiple sclerosis. Low-contrast acuity testing has the capacity to demonstrate treatment effects and is a strong candidate for assessment of visual outcomes in future multiple sclerosis trials. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

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Resumen estructurado de revisiones sistemáticas

No clasificado

Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis

Año 2011
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Institute for Health and Clinical Excellence. Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis. London: National Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance 127. 2007

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Estudio primario

No clasificado

Cost-effectiveness of natalizumab versus fingolimod for the treatment of relapsing multiple sclerosis.

Año 2011
Revista Journal of medical economics
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BACKGROUND:

With the addition of new agents for the treatment of multiple sclerosis (MS) (e.g., fingolimod), there is a need to evaluate the relative value of newer therapies in terms of cost and effectiveness, given healthcare resource constraints in the United States.

OBJECTIVE:

To assess the cost-effectiveness of natalizumab vs fingolimod in patients with relapsing MS.

METHODS:

A decision analytic model was developed to estimate the incremental cost per relapse avoided of natalizumab and fingolimod from a US managed care payer perspective. Two-year costs of treating patients with MS included drug acquisition costs, administration and monitoring costs, and costs of treating MS relapses. Effectiveness was measured in terms of MS relapses avoided (data from AFFIRM and FREEDOMS trials). One-way and probabilistic sensitivity analyses were conducted to assess uncertainty.

RESULTS:

Mean 2-year estimated treatment costs were $86,461 (natalizumab) and $98,748 (fingolimod). Patients receiving natalizumab had a mean of 0.74 relapses avoided per 2 years vs 0.59 for fingolimod. Natalizumab dominated fingolimod in the incremental cost-effectiveness analysis, as it was less costly and more effective in reducing relapses. One-way sensitivity analysis showed the results of the model were robust to changes in drug acquisition costs, administration costs, and costs of treating MS relapses. Probabilistic sensitivity analysis showed natalizumab was cost-effective 95.1% of the time, at a willingness-to-pay (WTP) threshold of $0 per relapse avoided, increasing to 96.3% of the time at a WTP threshold of $50,000 per relapse avoided.

LIMITATIONS:

Absence of data from direct head-to-head studies comparing natalizumab and fingolimod, use of relapse rate reduction rather than sustained disability progression as primary model outcome, assumption of 100% adherence to MS treatment, and not capturing adverse event costs in the model.

CONCLUSIONS:

Natalizumab dominates fingolimod in terms of incremental cost per relapse avoided, as it is less costly and more effective.

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Resumen estructurado de revisiones sistemáticas

No clasificado

Natalizumab for moderate to severely active Crohn's disease - horizon scanning review

Año 2004
Autores NHSC
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

NHSC. Natalizumab for moderate to severely active Crohn's disease - horizon scanning review Birmingham: National Horizon Scanning Centre (NHSC). 2004

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Estudio primario

No clasificado

MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS.

Año 2007
Revista Neurology
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<b>

BACKGROUND:

</b>In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study.<b>

METHODS:

</b>The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years.<b>

RESULTS:

</b>Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients.<b>

CONCLUSION:

</b>Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.

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Estudio primario

No clasificado

Health-related quality of life during natalizumab maintenance therapy for Crohn's disease

Año 2007
Revista The American journal of gastroenterology
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OBJECTIVES:

We evaluated the effects of treatment on health-related quality of life (HRQoL) during a randomized controlled trial of natalizumab maintenance therapy (ENACT-2) using both disease-specific and generic measures.

METHODS:

Crohn's disease patients who received natalizumab as induction therapy in ENACT-1 (N = 724) and responded (N = 339) were re-randomized to ENACT-2 in which they received natalizumab 300 mg (N = 168) or placebo (N = 171) every 4 wk for 48 additional wk. Outcome measures were the change from baseline on the inflammatory bowel disease questionnaire (IBDQ), the short form-36 (SF-36), the EuroQol-5D (EQ-5D), and a subject global assessment.

RESULTS:

At entry into ENACT-1, scores indicated substantially impaired HRQoL for both the disease-specific and general measures. Natalizumab responders showed clinically meaningful improvement in HRQoL over the course of the ENACT-1 study. During maintenance therapy, IBDQ and SF-36 scale scores of patients who responded to natalizumab induction and were re-randomized to receive the drug in ENACT-2 (N = 168) remained stable, while those re-randomized to placebo (N = 171) worsened. At week 60, 48 wk after the initiation of maintenance therapy, the mean change from ENACT-1 baseline of all scales of the IBDQ and the SF-36 was significantly higher for those who continued to receive natalizumab (P < 0.001 for all scales). The scores of patients who received maintenance natalizumab treatment were not statistically different from those of a cross-section of the U.S. population for 6 of 8 scales of the SF-36.

CONCLUSIONS:

The substantial improvement in HRQoL experienced by patients who responded to natalizumab induction therapy was maintained during an additional 48 wk of maintenance therapy. © 2007 by Am. Coll. of Gastroenterology.

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Resumen estructurado de revisiones sistemáticas

No clasificado

Efficacy and safety of natalizumab for multiple sclerosis and Crohn's disease: a meta analysis

Año 2011
Autores Li YY , Li YP , Sun X , Wang L , Wen J , Cheng L
Revista Database of Abstracts of Reviews of Effects (DARE)
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Estudio primario

No clasificado

Cost effectiveness of glatiramer acetate and natalizumab in relapsing-remitting multiple sclerosis.

Año 2009
Revista Applied health economics and health policy
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BACKGROUND:

Disease-modifying drugs are a significant expenditure for treating multiple sclerosis. Natalizumab (NZ) has been shown to be effective in reducing relapses and disease progression. However, assessment of the cost effectiveness of NZ compared with other disease-modifying drugs in the presence of long-term data has been limited.

OBJECTIVE:

To assess the lifetime cost effectiveness from the US healthcare and societal perspectives of glatiramer acetate (GA) and NZ (both given with symptom management) relative to symptom management alone in patients with relapsing-remitting multiple sclerosis (RRMS) using evidence from long-term published studies.

METHODS:

A Markov model was developed with patients transitioning through health states based on Kurtzke's expanded disability status scale (EDSS). Patients were >/=18 years of age with RRMS, EDSS <6.0 and receiving treatment. Treatment effects were obtained from clinical trials for years 1 and 2 of therapy and long-term clinical assessments thereafter. Transitions were adjusted for discontinuation and persistent NZ antibodies. Patients incurred drug, other medical and lost worker productivity costs. Patient quality of life was considered in the form of utilities, which were taken from assessments of patients with MS. Costs were valued in 2007 $US, and costs and outcomes were discounted at 3% per annum. Various parameters and assumptions were tested in one-way sensitivity analyses, and scenario-based analyses were also performed.

RESULTS:

Remaining lifetime, direct medical costs for patients receiving GA or NZ versus symptom management were $US408 000, $US422 208 and $US341 436, respectively. Patients receiving GA or NZ benefited from increased years in EDSS 0.0-5.5 (1.18 and 1.09, respectively), years relapse-free (1.30 and 1.18) and QALYs (0.1341 and 0.1332). The incremental cost per QALY for GA or NZ compared with symptom management was $US496 222 and $US606 228, respectively, excluding lost worker productivity costs. GA was associated with a cost saving compared with NZ. The incremental cost per QALY results were sensitive to changes in time horizon, disease progression and drug costs. Improved QALYs for NZ were sensitive to changes in the clinical effect of NZ on disease progression and discontinuation over time.

CONCLUSIONS:

GA or NZ in RRMS patients is associated with increased benefits compared with symptom management, albeit at higher costs. Although year 1 and 2 disease progression and relapse rates were better for NZ than GA, long-term evidence may show GA to have similar, if not improved, clinical benefit.

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Resúmenes estructurados de estudios primarios

No clasificado

Natalizumab increased clinical remission and clinical response in moderate-to-severe Crohn disease.

Año 2003
Autores Irvine EJ
Revista ACP journal club
Enlaces Pubmed
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