A study of the healthcare resource use for the management of postpartum haemorrhage in France, Italy, the Netherlands, and the UK.

OBJECTIVE: Postpartum haemorrhage (PPH) complicates approximately 5% of births worldwide and is a leading direct cause of maternal death. Rates of PPH are increasing in many developed countries, particularly PPH related to uterine atony. There is a lack of published up-to-date information about healthcare resource use associated with management of PPH following vaginal birth. The objective of this study was to describe healthcare resource use for the management of minor PPH (blood loss 500-1,000 ml) and major PPH (blood loss > 1,000 ml) compared to uncomplicated birth (no PPH) following hospital vaginal birth in France, Italy, the Netherlands, and the UK. STUDY DESIGN: In-depth interviews with two midwives from each participating country were conducted to establish differences in resource use for the management of minor PPH, major PPH, and uncomplicated birth. A web-survey was then developed and one obstetrician per participating country reviewed the survey. In total, 100 midwives (25 per country) completed the survey. Results were discussed at a multi-professional consensus meeting of midwives and obstetricians/gynaecologists (n = 6). RESULTS AND CONCLUSIONS: Midwives participating in the survey estimated that 80% of women receive Active Management of the Third Stage of Labour (AMTSL) and 93% of participants specified that uterotonics would routinely be used during AMTSL. Most participants (84%) reported that blood loss is routinely measured in their hospital, using a combination of methods. PPH is associated with increased healthcare resource use, including administration of additional uterotonics and use of additional medical interventions, such as urinary catheter, intravenous fluids, and possible requirement for surgery. The number of nurses, obstetricians/gynaecologists, and anaesthetists involved in the management of PPH increases with the occurrence and severity of PPH, as well as the proportion of healthcare personnel providing continuous care. Women may spend an additional 24 h in hospital following major PPH compared to uncomplicated birth. The results of this study highlight the burden of PPH management on healthcare resources. To reduce costs associated with PPH, prevention is the most effective strategy and can be enhanced with the use of an effective uterotonic as part of the active management of the third stage of labour.

Treatment Patterns and Outcomes in Triple-Class Exposed Patients With Relapsed and Refractory Multiple Myeloma: Findings From the Multinational ITEMISE Study.

PURPOSE: Patients with relapsed and refractory multiple myeloma (RRMM) have a poor prognosis and limited treatment options after exposure to an immunomodulatory drug, proteasome inhibitor (PI), and anti-CD38 antibody (triple-class exposure [TCE]). However, current understanding about the management of these patients and associated health care resource use (HCRU) is limited outside the United States. The objective of the International Treatment pattern and resource use Evaluation for Multiple myeloma In a Study of triple-class Exposed patients (ITEMISE) study was to use a physician-developed survey fielded to hematologists across Europe and Canada to assess the treatment, management, HCRU, and end-of-life care for patients with RRMM after TCE. METHODS: The ITEMISE study used a 3-phase Delphi-like approach that consisted of in-depth interviews with 7 hematology experts; the development of a cross-sectional survey fielded to hematologists across Belgium, Canada, France, Germany, Italy, the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom from August to October 2020; and a final workshop of hematology experts to validate the pooled findings. Hematologists were asked to consider the management of patients in the first 3 treatment lines after TCE, including treatment options, treatment duration and outcomes, and frequency of outpatient visits and hospitalizations. FINDINGS: The survey was completed by 202 hematologists (60% from academic hospitals, 38% from other public hospitals, and 2% from private hospitals). Hematologists estimated that 55% of patients would receive active treatment after TCE, the equivalent of fourth-line treatment onward since diagnosis of multiple myeloma. Immunomodulatory drug, anti-CD38 antibody plus immunomodulatory drug, and PI-based regimens (received by 22.5%, 17.8%, and 15.1% of patients, respectively) were reported for first treatment strategy after TCE. Pomalidomide, daratumumab, lenalidomide, bortezomib, and carfilzomib were the most frequently selected antimyeloma agents. Associated outcomes of median overall survival, progression-free survival, and objective response rate for first treatment after TCE were estimated as 12 months, 4 months, and 40%, respectively. HCRU included outpatient visits and unplanned hospitalizations that were commonly reported during treatment after TCE. IMPLICATIONS: Findings indicate an intent to actively treat patients after TCE with a range of combination regimens frequently consisting of immunomodulatory drugs, PIs, and anti-CD38 antibodies, highlighting the lack of standard of care and suggesting a large clinical unmet need. Estimated clinical outcomes are consistent with data from US studies and indicate the poor prognosis for patients after TCE. Substantial HCRU is associated with management of patients after TCE across Europe and Canada, signifying a high patient and societal impact and a need for better treatment options to reduce this burden.

Updated cost-effectiveness analysis of onabotulinumtoxinA for the prevention of headache in adults with chronic migraine who have previously received three or more preventive treatments in the UK.

Aims: OnabotulinumtoxinA is recommended by NICE for the treatment of chronic migraine. This economic evaluation provides updated estimates of the cost-effectiveness of onabotulinumtoxinA for chronic migraine using new utility estimates in an existing model structure.Methods: A previously published model was revised to include EQ-5D utility estimates from a large observational study (REPOSE; n = 633). Efficacy data were taken from the pooled phase III PREEMPT clinical trial program, while resource utilization estimates were obtained from the International Burden of Migraine Study (IBMS). The model estimated costs and quality-adjusted life years (QALYs) gained over 2 years from the UK NHS perspective.Results: OnabotulinumtoxinA treatment resulted in total discounted incremental costs of £1,204 and an incremental discounted QALY gain of 0.07 compared with placebo in patients with chronic migraine who have previously failed three or more preventive treatments, corresponding to an incremental cost-effectiveness ratio (ICER) of £16,306 per QALY gained. Scenario analysis showed that the administration of onabotulinumtoxinA by a specialist nurse rather than a neurology consultant reduced the ICER from £16,306 to £13,832 per QALY gained. Removal of the positive stopping rule recommended in current NICE guidance increased the ICER to £20,768 per QALY for onabotulinumtoxinA vs. placebo. Combining these two scenarios produced an ICER of £17,686 per QALY gained.Conclusion: NICE recommended onabotulinumtoxinA for the prevention of chronic migraine in 2012 amid concerns about the uncertainty of ICER estimates, with a positive stopping rule used to manage some of these uncertainties. Since the publication of the NICE guidance, the REPOSE study provides a more recent source of utility data based on real-world evidence. The results of analyses including these utilities suggest that the application of the positive stopping rule may not be necessary to ensure cost-effectiveness and that this aspect of the current NICE guidance for onabotulinumtoxinA may merit reconsideration.