Cost Effectiveness of Naloxegol for Opioid-Induced Constipation in the UK.

BACKGROUND AND OBJECTIVES: Opioid-induced constipation (OIC) is the most common adverse effect reported in patients receiving opioids to manage pain. Initial treatment with laxatives provides inadequate response in some patients. Naloxegol is a peripherally acting µ-opioid receptor antagonist used to treat patients with inadequate response to laxative(s) (laxative inadequate responder [LIR]). A cost-effectiveness model was constructed from the UK payer perspective to compare oral naloxegol 25 mg with placebo in non-cancer LIR patients receiving opioids for chronic pain, and a scenario analysis of naloxegol 25 mg with rescue laxatives compared with placebo with rescue laxatives in the same patient population. METHODS: The model comprised a decision tree for the first 4 weeks of treatment, followed by a Markov model with a 4-week cycle length and the following states: 'OIC', 'non-OIC (on treatment)', 'non-OIC (untreated)' and 'death'. Two phase III trials with a follow-up period of 12 weeks provided data on treatment efficacy, transition probabilities, adverse event frequency and patient utility. Resource utilisation data were sourced from a UK-based burden of illness study and physician surveys. A UK National Health Service and Personal Social Service perspective was adopted; costs and health-related quality of life gains were discounted at a rate of 3.5 %. The model was run over a time horizon of 5 years, reflecting the average period of opioid use. RESULTS: Naloxegol has an incremental cost-effectiveness ratio of £10,849 per quality-adjusted life-year gained versus placebo, and £11,179 when rescue laxatives are made available in both arms (2014 values). Model outcomes were only sensitive to variations in utility inputs. However, the probabilistic sensitivity analyses indicate that naloxegol has a 91 % probability of being cost effective at a £20,000 threshold when compared with placebo. CONCLUSIONS: Naloxegol is likely a cost-effective treatment option for LIR patients with OIC. This assessment should be supported by further work on the utility of patients with OIC, including how utility varies with more granular measures of OIC.

Long-term cost-effectiveness model of interferon beta-1b in the early treatment of multiple sclerosis in the United States.

BACKGROUND: Multiple sclerosis (MS) is a potentially debilitating autoimmune disease that affects the brain and spinal cord. Disease-modifying therapies have been shown to slow disease progression but were not believed to prolong the survival of patients with MS. The recent 21-Year Long-Term Follow-Up (21Y-LTF) study found a significant survival advantage for patients receiving early treatment with interferon beta (IFNß)-1b compared with placebo (no early treatment). OBJECTIVES: The aim of this study was to conduct cost-effectiveness analyses estimating the long-term benefit of early treatment with IFNß-1b among MS patients from a US societal perspective. METHODS: A Markov model was developed to simulate the experience of patients with MS from the 21Y-LTF study over a lifetime. Patients were randomized to receive either IFNß-1b or placebo for up to 5 years and then receive a variety of MS treatments (including no treatment) thereafter. Survival data reported from the 21Y-LTF study were incorporated into the model. The model assumes that patients' MS was managed in similar ways for both groups during the uncontrolled phase of the 21Y-LTF study (ie, survival difference between the 2 groups is the result of early use of IFNß-1b). Health outcomes were life-years and quality-adjusted life-years (QALYs). Costs included treatments, direct disease management, informal care, and lost productivities and were reported in 2011 US dollars. RESULTS: In the modeled placebo group, the median age at death was predicted to be 63.7 years, and the median survival time from disease onset was 36.7 years. Early treatment with IFNß-1b reduced the lost health benefits by 2.8 life-years and 1.9 QALYs, respectively, after discounting. Total discounted cost for IFNß-1b-treated patients was $86,223 higher than that of patients receiving placebo. The incremental cost-effectiveness ratio was $46,357 per QALY gained and $30,967 per life-year gained. Sensitivity analyses indicate the robustness of the model's results. CONCLUSIONS: Treatment with IFNß-1b during the earlier disease phase of patients with MS significantly increased patient life-years and QALYs. IFNß-1b is likely to be a cost-effective intervention for MS.

Incidence-based cost-of-illness model for metastatic breast cancer in the United States.

OBJECTIVES: This study aims to estimate the annual U.S. societal costs associated with treatment of metastatic breast cancer (MBC) patients using an incidence-based cost-of-illness (COI) framework. METHODS: An incidence-based COI model was constructed in which MBC patients were simulated from diagnosis through active treatment, palliative care, and death over 5 years. Key model parameters included: annual incidence of breast cancer in the metastatic stage, utilization of cancer therapies and other medical care resources, treatment-related adverse events, unit costs, work days missed by patient and caregiver, and wage rates. Overall survival was based on SEER data and costs were assigned to living patients monthly, according to their disease management phase. The outcomes measures were total discounted societal costs, cost/year, and cost/patient-year. RESULTS: The annual incidence of MBC in the United States in 2007 was estimated to be 49,674 patients (de novo and progressed from earlier stages). The total discounted cost to society attributable to MBC was $12.2 billion for the incident cohort, or $98,571 per patient-year. The 5-year direct medical cost of this incident cohort was $9.3 billion, or $75,415 per patient-year. Treatment-related costs (active treatment, toxicity management, and medical follow-up) contributed 44 percent of MBC expenditure, followed by palliative/best supportive care costs (31 percent). Lost productivity accounted for approximately 21 percent of the total cost ($2.6 billion over 5 years or $21,153 per patient-year). CONCLUSIONS: The societal burden of MBC in the United States is substantial. Earlier detection and effective treatment could lead to a significant decrease in costs while improving overall disease prognosis.