Comparing the Cost-Effectiveness of Disease-Modifying Drugs for the First-Line Treatment of Relapsing-Remitting Multiple Sclerosis

Goldberg, Lawrence D; Edwards, Natalie C; Fincher, Contessa; Doan, Quan V.; Al‐Sabbagh, Ahmad; Meletiche, DM

doi:10.18553/jmcp.2009.15.7.543

Cited by 96 publications

(65 citation statements)

References 35 publications

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“…Notwithstanding these factors, HSCT was cost effective, using a yardstick of other treatments considered to be cost-effective in the United Kingdom. For comparison, current MS drug therapy cost effectiveness has been estimated to be between $80,000 to $168,000 per avoided relapse [66,67] or upwards of $73,000 per incremental quality-adjusted life year [68,69].…”

Section: Lesson 10: Information On the Economics And Health Resource mentioning

confidence: 99%

Hematopoietic Stem Cell Therapy for Multiple Sclerosis: Top 10 Lessons Learned

Atkins

Freedman

2013

Neurotherapeutics

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Reports from more than 600 hematopoietic stem cell transplants (HSCT) have appeared in the medical literature for the last 1 and one-half decades. The patient's own stem cells are harvested and stored temporarily while high doses of chemotherapy and biologics are used to destroy the auto-destructive immune system. The immune system is regenerated from the infused autologous hematopoietic stem cells. Increasing clinical experience has refined patient selection criteria and management in the peri-transplant period leading to a reduction in treatment-related complications. HSCT, when used to treat patients with aggressive highly active multiple sclerosis, can reduce or eliminate ongoing clinical relapses, halt further progression, and reduce the burden of disability in some patients, in the absence of chronic treatment with disease-modifying agents. The top 10 lessons learned from the growing experience using HSCT for the treatment of multiple sclerosis are discussed.Keywords Hematopoietic stem cell transplantation . Multiple sclerosis . Autoimmunity . Immune ablation There are published reports of more than 600 bone marrowbased transplants performed primarily for the treatment of multiple sclerosis (MS). This review will focus on why and how the hematopoietic stem cell transplantation (HSCT) procedure is used and discuss some of the lessons that can be gleaned from the experience of using HSCT to treat MS.MS is an organ-specific autoimmune disease that results in exclusive central nervous system (CNS) demyelination and axonal damage. Early on, multifocal localized pockets of inflammation lead to transient neurologic dysfunction manifesting as a series of relapses followed by remissions, usually with complete recovery owing to adequate CNS repair. However, as the damage accumulates, repair becomes inadequate and leads to incomplete resolution of disability, culminating in a neurodegenerative process amid a sea of smoldering and changing inflammation. This is probably the underlying state for the clinical stage of secondary progressive MS (SP-MS), a phase characterized by relentless and progressive accumulation of neurological disability with dwindling evidence of discrete relapses [1].Targeting inflammation with interferon-β, glatiramer acetate, natalizumab, fingolimod, and other immune-modulating agents reduces the frequency of relapses, but the impact on delaying the onset, preventing or slowing the tempo of SP-MS remains uncertain [2][3][4]. Several other drugs are in late stage clinical trials and may provide new alternatives for some patients with relapsing-remitting MS (RR-MS). However, despite these therapeutic advances, a subset of patients seem refractory and rapidly develop severe neurological impairment, whereas other patients may have a slower progression of illness that ultimately results in marked functional disabilities. Only a single agent, mitoxantrone, has been shown to temporarily halt or slow the tempo of SP-MS [5,6], but even then, this occurs only in SP-MS patients who have highly act...

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Section: Lesson 10: Information On the Economics And Health Resource mentioning

confidence: 99%

Hematopoietic Stem Cell Therapy for Multiple Sclerosis: Top 10 Lessons Learned

Atkins

Freedman

2013

Neurotherapeutics

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“…The time horizon was chosen for 2 reasons: (1) this was the closest approximation to the median duration of the Phase 3 trial; 14 and (2) U.S. payers typically prefer a shorter time horizon for economic evaluations. 18 A 3-year time horizon was also included as a co-primary outcome because some payers may be interested in the results with a longer time frame. We chose the 1-year instead of 3-year time horizon as the base case because zoledronic acid (Zometa) is expected to be available in a less expensive generic form by March 2013.…”

Section: Model Structurementioning

confidence: 99%

Economic Evaluation of Denosumab Compared with Zoledronic Acid in Hormone-Refractory Prostate Cancer Patients with Bone Metastases

Xie¹,

Namjoshi²,

Wu³

et al. 2011

JMCP

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• Bone metastases are prevalent in patients with hormone-refractory prostate cancer and are associated with substantial economic burden in the United States ($1.9 billion in 2004).• Skeletal-related events (SREs) are frequently seen in hormonerefractory prostate cancer patients with bone metastases. Lage et al. (2008) found that approximately one-half of patients with hormone-refractory prostate cancer and bone metastases in their study sample had at least 1 SRE. SREs are associated with increased health care costs and decreased quality of life.• Reed et al. (2004) showed that compared with placebo, zoledronic acid was associated with an incremental cost per SRE avoided of $12,300 and cost per quality-adjusted life year of In a study of autopsies of patients with prostate cancer, 65%-75% had bone metastases. Bone metastases place a substantial economic burden on payers with estimated total annual costs of $1.9 billion in the United States. Skeletal-related events (SREs), including pathologic fractures, spinal cord compression, surgery to bone, and radiation to bone, affect approximately 50% of patients with bone metastases. They are associated with a decreased quality of life and increased health care costs. Zoledronic acid is an effective treatment in preventing SREs in solid tumors and multiple myeloma. Recently, denosumab was FDA-approved for prevention of SREs in patients with bone metastases from solid tumors. A Phase 3 clinical trial (NCT00321620) demonstrated that denosumab had superior efficacy in delaying first and subsequent SREs compared with zoledronic acid. However, the economic value of denosumab has not been assessed in patients with hormone-refractory prostate cancer.

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“…[37][38][39] One cost-effectiveness study found that the cost to prevent an MS relapse exceeded $80,000 for several IFNs and glatiramer acetate. 40 Dramatic increases in the cost of MS DMTs without significant improvements in efficacy will only further reduce the cost-effectiveness of these drugs. Sensitivity analyses suggest that incremental costeffectiveness ratios for MS DMTs would approach accepted thresholds if US drug costs were reduced to levels similar to the United Kingdom.…”

Section: -25mentioning

confidence: 99%

The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail?

Tischner

Rittenhouse²,

Hartung³

et al. 2015

Neurology

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Objective: To examine the pricing trajectories in the United States of disease-modifying therapies (DMT) for multiple sclerosis (MS) over the last 20 years and assess the influences on rising prices. Methods:We estimated the trend in annual drug costs for 9 DMTs using published drug pricing data from 1993 to 2013. We compared changes in DMT costs to general and prescription drug inflation during the same period. We also compared the cost trajectories for first-generation MS DMTs interferon (IFN)-b-1b, IFN-b-1a IM, and glatiramer acetate with contemporaneously approved biologic tumor necrosis factor (TNF) inhibitors.Results: First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%-60% higher than existing DMTs. Significant increases in the cost trajectory of the first-generation DMTs occurred following the Food and Drug Administration approvals of IFN-b-1a SC (2002) and natalizumab (reintroduced 2006) and remained high following introduction of fingolimod (2010). Similar changes did not occur with TNF inhibitor biologics during these time intervals. DMT costs in the United States currently are 2 to 3 times higher than in other comparable countries.Conclusions: MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class. There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs. 2 Currently, the average annual cost for interferon (IFN)-b-1b (Betaseron; Bayer HealthCare Pharmaceuticals, Whippany, NJ) is over $60,000.3 Although high drug costs are a hallmark of specialty pharmaceutical classes, such as DMTs, the unexplained escalation in costs for older, first-generation MS therapies such as IFN-b-1b, IFN-b-1a IM (Avonex; Biogen Idec, Cambridge, MA), and glatiramer acetate (Copaxone; Teva Pharmaceuticals, North Wales, PA) has caused concern in the neurology community. 4,5 The objectives of this study were to (1) investigate our impression that costs for all MS DMTs have increased dramatically since 2002, (2) explore the relationship between the release of newer

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Comparing the Cost-Effectiveness of Disease-Modifying Drugs for the First-Line Treatment of Relapsing-Remitting Multiple Sclerosis

Cited by 96 publications

References 35 publications

Hematopoietic Stem Cell Therapy for Multiple Sclerosis: Top 10 Lessons Learned

Hematopoietic Stem Cell Therapy for Multiple Sclerosis: Top 10 Lessons Learned

Economic Evaluation of Denosumab Compared with Zoledronic Acid in Hormone-Refractory Prostate Cancer Patients with Bone Metastases

The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail?

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