Home-based subcutaneous immunoglobulin for chronic inflammatory demyelinating polyneuropathy patients: A Swiss cost-minimization analysis.

PURPOSE: To compare the cost of two patient management strategies with similar efficacies for chronic inflammatory demyelinating polyneuropathy (CIDP) patients in the chronic phase: hospital-based IV immunoglobulin G (IVIg) and home-based subcutaneous immunoglobulin G (SCIg) associated with an interprofessional drug therapy management programme (initial training and follow-up). METHODS: A 48-week model-based cost-minimization analysis from a societal perspective was performed. Resources included immunoglobulin (IVIg: 1 g/kg/3 weeks; SCIg: 0.4 g/kg/week initially and 0.2 g/kg/week in the maintenance phase), hospital charges, time of professionals, infusion material, transport and losses of productivity for patients. Costs were expressed in Swiss francs (CHF) (1 CHF = 0.93€ = US$1.10, www.xe.com, 2020/10/28). RESULTS: The total costs of IVIg were higher than those of SCIg for health insurance and other payers: 114,747 CHF versus 86,558 CHF and 8,762 CHF versus 2,401 CHF, respectively. The results were sensitive to the immunoglobulin doses, as this was the main cost driver. The SCIg daily cost in the initial phase was higher for health insurance than hospital-based IVIg was, but the additional costs were compensated during the maintenance phase (from week 28). The professional costs associated with the switch were not fully covered by the insurance and were borne by the pharmacist and the nurse. CONCLUSIONS: SCIg for CIDP patients reinforced by an interprofessional drug therapy management programme may be a cost-effective and sustainable alternative to IVIg in the Swiss system context. From an economic perspective, this therapy alternative should be more widely supported by healthcare systems and proposed to eligible patients by professionals.

Clinical and economic comparison of an individualised immunoglobulin protocol vs. standard dosing for chronic inflammatory demyelinating polyneuropathy.

BACKGROUND: The clinical and economic implications of an individualised intravenous immunoglobulin (IVIg) protocol for chronic inflammatory demyelinating polyneuropathy (CIDP) are unknown. Comparison with standard dosing regimens has not been performed. METHODS: We retrospectively studied 47 IVIg-treated subjects with CIDP over 4 years with an individualised, outcome-measured, dose-modifying protocol. We evaluated responder and remission rates, clinical improvement levels and dose requirements. We compared clinical benefits and costs with those reported with standard dosing at 1 g/kg every 3 weeks. RESULTS: The IVIg-responder rate was 83% and the 4-year remission rate was 25.6%. Mean IVIg dose requirements were 22.06 g/week (SD:15.29) in patients on ongoing therapy. Dose range was wide (5.83-80 g/week). Mean infusion frequency was every 4.34 weeks (SD:1.70) and infusion duration of 2.79 days (SD:1.15). Mean Overall Neuropathy Limitation Scale improvement was 2.54 (SD:1.89) and mean MRC sum score improvement of 12.23 (SD:7.17) in IVIg-responders. Mean modified-INCAT (Inflammatory Neuropathy Cause and Treatment) score improvement was similar (p = 0.47) and mean MRC sum score improvement greater (p < 0.001) in our cohort, compared to the IVIg-treated arm of the ICE Study. Mean drug costs were GBP 37,660/patient/year (€ 43,309) and mean infusion-related costs of GBP 17,115/patient/year (€ 19,682), totalling GBP 54,775/patient/year (€ 62,991). Compared to standard dosing using recorded weight, mean savings were of GBP 13,506/patient/year (€ 15,532). Compared to standard dosing using dosing weight, savings were of GBP 6,506/patient/year (€ 7,482). CONCLUSION: Our results indicate that an individualised IVIg treatment protocol is clinically non-inferior and 10-25% more cost-effective than standard dosing regimens in CIDP.

Chronic inflammatory demyelinating polyneuropathy: considerations for diagnosis, management, and population health.

First described almost 50 years ago, chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disorder characterized by progressive peripheral neuropathy. CIDP is difficult to diagnose, but early diagnosis can be crucial to prevent permanent nerve damage. Initial treatment options include corticosteroids, immunoglobulin given by intravenous administration, and therapeutic plasma exchange. Subcutaneous administration of immunoglobulin provides a new option for patients with CIDP that has the potential to increase independence and improve tolerability. This article reviews the epidemiology, diagnosis, treatment options for first- and second-line therapy, treatment guidelines, and monitoring parameters for CIDP.

The economic burden and managed care implications of chronic inflammatory demyelinating polyneuropathy.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a symmetric demyelinating peripheral neuropathy with either a progressive or relapsing remitting course. CIDP is both debilitating and degenerative, leaving patients with functional impairment due to nerve damage in their extremities. Along with its medical burden, CIDP has a significant economic impact, with disease-related expenses and the often fairly high costs related to the immune therapies used to treat the disease. Costs for patients with this disorder often exceed those of other immune-mediated neuromuscular diseases. For these reasons, it is necessary for clinicians to better determine optimal long-term treatment strategies for patients with CIDP that are designed to address both the clinical and economic burden of its management and improve patient outcomes and quality of life.

The economic burden of CIDP in the United States: A case-control study.

BACKGROUND: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder of the peripheral nervous system. The economic burden of CIDP is not well understood. OBJECTIVES: To assess the economic and clinical burden of CIDP and to compare the incremental burden relative to a matched control group without CIDP. METHODS: This retrospective case-control analysis was conducted using data from the IQVIA Real-World Data Adjudicated Claims. Adults newly diagnosed with CIDP between 7/1/2010 and 6/30/2014 were identified and direct matched to controls without CIDP. Baseline characteristics were assessed and compared over a 6-month pre-index period. Healthcare resource use, costs and clinical characteristics were assessed and compared over a 2-year follow-up. Total cost differences over the 2-year follow-up were compared between matched cohorts using a generalized estimating equation model. RESULTS: The final sample comprised a total of 790 cases matched to 790 controls. Over the 2-year follow-up, cases more frequently experienced neuropathic pain, back pain and osteoarthritis and more commonly utilized opioids, anti-convulsants and anti-depressants. Compared to controls, more cases had ≥1 hospitalization (26.2% vs. 9.0%), and cases had a higher mean number of outpatient prescription fills (62.8 vs. 32.0) and physician office visits (34.7 vs. 13.0) (all p<0.0001). Cases had 7.5x higher mean total costs ($116,330 vs. $15,586, p<0.0001). Important cost drivers were costs for outpatient ancillary, radiology and HCPCS drugs (mean $76,366 vs. $4,292) and costs for inpatient care (mean $16,357 vs. $2,862) (both p<0.0001). Among cases, CIDP therapy (inclusive of both outpatient pharmacy and medical claims) accounted for 51.2% of mean total costs. After further adjusting for baseline clinical characteristics, cases were associated with a 6.1x increase in total costs compared to controls (p<0.0001). CONCLUSIONS: Our findings suggest a substantial clinical and economic burden among patients with CIDP relative to matched controls over a 2-year follow-up.

Costs of illness in chronic inflammatory demyelinating polyneuropathy in Germany.

INTRODUCTION: Cost of illness studies are essential to estimate societal costs of chronic inflammatory demyelinating polyneuropathy (CIDP) and identify cost-driving factors. METHODS: In total, 108 patients were recruited from 3 specialized neuroimmunological clinics. Costs were calculated for a 3-month period, including direct and indirect costs. The following outcomes were assessed: inflammatory neuropathy cause and treatment disability scale, Mini-Mental State Examination, Beck Depression Inventory, Charlson comorbidity index, EuroQol-5D, World Health Organization quality of life instrument, and socioeconomic status. Univariate and multivariate analyses were applied to identify cost-driving factors. RESULTS: Total quarterly costs were €11,333. Direct costs contributed to 83% of total costs (€9,423), whereas indirect costs accounted for 17% (€1,910) of total costs. The cost of intravenous immunoglobulin (IVIg) was the main determinant of total costs (67%). Reduced health-related quality of life and depressive symptoms were identified as independent predictors of higher total costs. DISCUSSION: CIDP is associated with high societal costs, mainly resulting from the cost of IVIg treatment. Muscle Nerve 58: 681-687, 2018.

Home versus hospital immunoglobulin treatment for autoimmune neuropathies: A cost minimization analysis.

Background: Prior clinical trials have suggested that home-based Ig treatment in multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and its variant Lewis-Sumner syndrome (LSS) is safe and effective and is less costly than hospital-administered intravenous immunoglobulin (IVIg). Methods: A French prospective, dual-center, cost minimization analysis was carried out to evaluate IVIg administration (5% concentrated) at home versus in hospital with regard to costs, patients' autonomy, and patients' quality of life. The primary endpoint was the overall cost of treatment, and we adopted the perspective of the payer (French Social Health Insurance). Results: Twenty-four patients aged 52.3 (12.2) years were analyzed: nine patients with MMN, eight with CIDP, and seven with LSS. IVIg (g/kg) dosage was 1.51 ± 0.43 in hospital and 1.52 ± 0.4 at home. Nine-month total costs per patient extrapolated to 1 year of treatment were €48,189 ± 26,105 versus €91,798 ± 51,125 in the home and hospital groups, respectively (p < .0001). The most frequently reported factors for choosing home treatment were the good tolerance and absence of side effects of IVIg administration, as well as a good understanding of the advantages and drawbacks of home treatment (75% of respondents). The mRankin scores before and after switch to home treatment were 1.61 ± 0.72 and 1.36 ± 0.76, respectively (p = .027). Discussion: The switch from hospital-based to home-based IVIg treatment for patients with immune neuropathy represents potentially significant savings in the management of the disease.

Subcutaneous immunoglobulin treatment in CIDP and MMN. Efficacy, treatment satisfaction and costs.

Subcutaneous administration of immunoglobulin (SCIG) in chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) has been reported in several case reports and in a few randomized trials during the last decade. In this review we present the studies on SCIG in CIDP and MMN with special focus on the clinical effects. Moreover, the effect on quality of life, side effects to SCIG and the health economic perspectives are reviewed. Nine case studies, three randomized trials and six long-term, follow-up studies were identified. Most of the studies are conducted in patients switched from regular IVIG to SCIG treatment; one study involves treatment-naïve patients. The review shows that none of the studies have been powered to demonstrate an effect on disability. SCIG can maintain muscle strength for a period of 1 to 2years and ability seems preserved for a similar period. Quality of life is generally unchanged or improved after switch to SCIG and generalized side-effects seem fewer, whereas local reactions at the injection site occur. Health economic analyses favour SCIG at the doses used in the reviewed studies.

Economic Evaluation of Intravenous Immunoglobulin plus Corticosteroids for the Treatment of Steroid-Resistant Chronic Inflammatory Demyelinating Polyradiculoneuropathy in Thailand.

BACKGROUND AND OBJECTIVE: Intravenous immunoglobulin (IVIG) has been recommended for steroid-resistant chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The treatment, however, is very costly to healthcare system, and there remains no evidence of its economic justifiability. This study aimed to conduct an economic evaluation (EE) of IVIG plus corticosteroids in steroid-resistant CIDP in Thailand. METHODS: A Markov model was constructed to estimate the lifetime costs and outcomes for IVIG plus corticosteroids in comparison with immunosuppressants plus corticosteroids in steroid-resistant CIDP patients from a societal perspective. Efficacy and utility data were obtained from clinical literature, meta-analyses, medical record reviews, and patient interviews. Cost data were obtained from list prices, an electronic hospital database, published source, and patient interviews. All costs [in 2015 US dollars (US$)] and outcomes were discounted at 3 % annually. One-way and probabilistic sensitivity analyses were conducted. RESULTS: In the base-case, the incremental costs and quality-adjusted life years (QALYs) of IVIG plus corticosteroids versus immunosuppressants plus corticosteroids were US$2112.02 and 1.263 QALYs, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of US$1672.71 per QALY gained. Sensitivity analyses revealed that the utility value of disabled patients was the greatest influence on ICER. At a societal willingness-to-pay threshold in Thailand of US$4672 per QALY gained, IVIG plus corticosteroids had a 92.1 % probability of being cost effective. CONCLUSIONS: At a threshold of US$4672 per QALY gained, IVIG plus corticosteroids is considered a cost-effective treatment for steroid-resistant CIDP patients in Thailand.

Patient demographics and health plan paid costs in chronic inflammatory demyelinating polyneuropathy.

INTRODUCTION: We determined health plan paid costs and healthcare resource usage of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS: CIDP patients from 9 U.S. commercial health plans with claims in 2011 were identified from the Accordant Health Services claims database. We examined demographics, prevalence of comorbidities, prescribed drugs, place of service, and mean annual health plan paid costs per patient. RESULTS: From 6.5 million covered lives, 73 (56% men; mean age 47) met study entry criteria. The most prescribed therapies were intravenous immunoglobulin (IVIg) (26% of patients), gabapentin (26%), and prednisone (16%). The annual health plan paid cost was $56,953. Pharmacy cost was the major cost driver (57% of the total), and IVIg totaled 90% of the pharmacy costs. CONCLUSIONS: Healthcare costs for CIDP patients are substantial, with a large burden in pharmacy usage. Studies are needed to determine optimal long-term treatment strategies for CIDP, particularly related to IVIg.

Subcutaneous vs intravenous administration of immunoglobulin in chronic inflammatory demyelinating polyneuropathy: an Italian cost-minimization analysis.

Prior researches have suggested that home-based subcutaneous immunoglobulin (SCIG) is equally effective and can be less expensive than hospital-based intravenous immunoglobulin (IVIG) in treating chronic inflammatory demyelinating polyneuropathy (CIDP) patients. This economic evaluation aims at comparing costs of SCIG vs IVIG for CIDP patients in Italy. A 1-year model-based cost-minimization analysis basically populated via neurologists' opinion was undertaken from a societal perspective. Health care resources included immunoglobulin; drugs for premedication and complications (rash, headache, and hypertension) management; time of various health care professionals; pump for SCIG self-administration; infusion disposables. Non-health care resources encompassed transport and parking; losses of working and leisure time for patients and caregivers. Unit or yearly costs for resources valuation were mainly obtained from published sources. Costs were expressed in Euro () 2013. An extensive one-way sensitivity analysis (OWSA) and a scenario SA tested the robustness of the base case findings. Overall costs per patient amount to 49,534.75 (SCIG) and 50,895.73 (IVIG); saving in favour of SCIG reaches 1360.98. For both SCIG and IVIG, the cost driver was immunoglobulin (94.06 vs 86.06 % of the overall costs, respectively). Sensitivity analyses confirmed the consistency of the baseline results. SCIG may be a cost-saving therapy for Italian CIDP patients.

Economic costs and quality of life in chronic inflammatory neuropathies in southeast England.

BACKGROUND AND PURPOSE: Cost-of-illness studies and health-related quality of life (HRQoL) measurements are needed to assess the effects of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal motor neuropathy (MMN) and paraproteinaemic demyelinating neuropathy (PDN) on society. METHODS: This study was conducted in 2008 in a southeast England population of 3,557,352 people. Data on service use and treatment were collected with a client service receipt inventory and service costs were calculated by combining these data with national unit costs. The EuroQol was used to calculate utility scores, a measurement of HRQoL. RESULTS: The total annual cost-of-illness per patient was £22,085 for CIDP, £22,812 for MMN and £7566 for PDN. The annual total cost per patient was £49,430 for individuals on intravenous immunoglobulin (IVIg) and £9046 for those not on IVIg (P < 0.01). The mean (SD) utility scores were 0.62 (0.23) for CIDP, 0.63 (0.22) for PDN and 0.72 (0.14) for MMN (P = 0.52). The mean (SD) utility score for those on IVIg was 0.65 (0.16) and those not on IVIg 0.63 (0.23) (P = 0.77). CONCLUSION: The use of IVIg was the most important determinant of cost in all three diseases and the higher frequency of its use in CIDP and MMN accounted for the much greater average cost per patient in these diseases. There was no significant difference in HRQoL amongst the three diseases or between those receiving or not receiving IVIg.

Cost-utility analysis of intravenous immunoglobulin and prednisolone for chronic inflammatory demyelinating polyradiculoneuropathy.

The aim of this study was to provide an incremental cost-effectiveness analysis comparing intravenous immunoglobulin (IVIg) and prednisolone treatment for chronic inflammatory demyelinating polyradiculoneuropathy. Patients were recruited to a double-blind randomized crossover trial from nine European centres and received either prednisolone or IVIg during the first 6-week treatment period on which the economic evaluation was based. A societal perspective was adopted in measuring service use and costs, although the costs of lost employment were not included. The main outcome measure in the economic evaluation was the number of quality adjusted life years (QALYs) gained, with change in a 11-point disability scale used to measure clinical outcomes. Service use and quality of life data were available for 25 patients. Baseline costs were controlled for using a bootstrapped multiple regression model. The cost difference between the two treatments was estimated to be euro 3754 over the 6-week period. Health-related quality of life, as measured by the EuroQol EQ-5D instrument, increased more in the IVIg group but the difference was not statistically significant. Using a net-benefit approach it was shown that the probability of IVIg being cost-effective in comparison with prednisolone was 0.5 or above (i.e. was more likely to be cost-effective than cost-ineffective) only if one QALY was valued at over euro 250 000. The cost-effectiveness of IVIg is greatly affected by the price of IVIg and the amount administered. The impact of later side-effects of prednisolone on long-term costs and quality of life are likely to reduce the cost per QALY of IVIg treatment.