The Cost Effectiveness of Levodopa-Carbidopa Intestinal Gel in the Treatment of Advanced Parkinson’s Disease in England

Abstract

Background Parkinson’s disease is a progressive neurodegenerative disease, which significantly impacts patients’ quality of life and is associated with high treatment and direct healthcare costs. In England, levodopa/carbidopa intestinal gel (LCIG) is indicated for the treatment of levodopa-responsive advanced Parkinson’s disease with troublesome motor fluctuations when available combinations of medicinal products are unsatisfactory. Objective We aimed to determine the cost effectiveness of LCIG compared to the standard of care for patients with advanced Parkinson’s disease in England, using real-world data. Methods A Markov model was adapted from previous published studies, using the perspective of the English National Health System and Personal and Social Services to evaluate the cost effectiveness of LCIG compared to standard of care in patients with advanced Parkinson’s disease over a 20-year time horizon. The model comprised 25 health states, defined by a combination of the Hoehn and Yahr scale, and waking time spent in OFF-time. The base case considered an initial cohort of patients with an Hoehn and Yahr score of ≥ 3, and > 4 h OFF-time. Standard of care comprised standard oral therapies, and a proportion of patients were assumed to be treated with subcutaneous apomorphine infusion or injection in addition to oral therapies. Efficacy inputs were based on LCIG clinical trials where possible. Resource use and utility values were based on results of a large-scale observational study, and costs were derived from the latest published UK data, valued at 2017 prices. The EuroQol five-dimensions-3-level (EQ-5D-3L) instrument was used to measure utilities. Costs and quality-adjusted life-years were discounted at 3.5%. Both deterministic and probabilistic sensitivity analyses were conducted. Results Total costs and quality-adjusted life-years gained for LCIG vs standard of care were £586,832 vs £554,022, and 2.82 vs 1.43, respectively. The incremental cost-effectiveness ratio for LCIG compared to standard of care was £23,649/quality-adjusted life-year. Results were sensitive to the healthcare resource utilisation based on real-world data, and long-term efficacy of LCIG. Conclusions The base-case incremental cost-effectiveness ratio was estimated to be within the acceptable thresholds for cost effectiveness considered for England. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-022-01132-y.

Cost‐Effectiveness of Carbidopa‐Levodopa Enteral Suspension for Advanced Parkinson's Disease in the United States

“…Patient data, obtained during a phase III study (NCT00335153) of CLES, was used to define the baseline distribution of patients (Supplementary Table S1). 12 The model population comprised of patients with aPD and severe motor fluctuations, defined on the Hoehn and Yahr (HY) scale as ≥3 and OFF‐time >4 hours (ie, 25% of 16‐hour waking day) 11 . The model inputs involved the subgroup of the NCT00335153 study that met these criteria and had complete follow‐up data (n = 196).…”

“…A published Markov model was adapted, 11 to determine the average costs, life years (LYs) and quality‐adjusted life years (QALYs) per patient with CLES and SoC, from the US payer perspective (using costs inputs specific for Medicare), thereby calculating the incremental cost‐effectiveness ratio (ICER). The population was redistributed into 25 disease specific health states and a death state as per the adapted model (Fig.…”

“…1). 11 Discount rate was applied annually for both costs and effects (3.0%), as per the Institute for Clinical and Economic Review guidelines 14…”

“…Carbidopa‐levodopa enteral suspension (CLES) was approved by the United States (US) Food and Drug Administration, in 2015, for the treatment of advanced PD (aPD) patients with motor fluctuations 5,6 . It demonstrated significant reduction in OFF‐time 7 and also has the cost‐effectiveness compared to standard‐of‐care (SoC), according to previous studies in the United Kingdom and Ireland 8‐11 . To our knowledge, this is the first study providing a cost‐effectiveness analysis of CLES compared to SoC in aPD patients using up‐to‐date real‐world data from the US healthcare setting 12,13 …”

Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS

“…Likewise, a randomized, crossover design comparator study found that patients generally preferred infusion therapy with LCIG versus oral administration with levodopa ( n = 24) [ 32 ]. Indeed, meta-analyses have found significant improvements in off-time and quality of life or comparable benefits with LCIG versus deep brain stimulation, continuous subcutaneous apomorphine infusion, and best medical treatment [ 33 – 35 ], and similar cost between LCIG and standard of care [ 36 ].…”