Cost-effectiveness of romosozumab for the treatment of postmenopausal women with osteoporosis at high risk of fracture in Belgium.

This study evaluated the cost-effectiveness of sequential treatment with romosozumab-to-alendronate compared to alendronate monotherapy and teriparatide-to-alendronate, in postmenopausal osteoporotic women from a Belgian healthcare perspective. Romosozumab-to-alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide-to-alendronate for osteoporotic women at high risk of fracture in Belgium. PURPOSE: This study aimed to evaluate the cost-effectiveness of sequential treatment with romosozumab followed by alendronate compared to alendronate monotherapy and teriparatide followed by alendronate, in postmenopausal osteoporotic women at high risk of fracture, from a Belgian healthcare perspective. Romosozumab is reimbursed in Belgium since December 2021. METHODS: A Markov microsimulation model was used to evaluate the cost-effectiveness of romosozumab-to-alendronate compared to alendronate monotherapy and to teriparatide-to-alendronate over a lifetime horizon. Patients transition between five different health states every 6 months based on fracture risks or death. The model was populated with Belgium-specific epidemiological and cost data, where available. The fracture risk reduction of romosozumab treatment was collated from the ARCH study, and from a published network meta-analysis. Costs were included from a healthcare perspective (NIHDI). Cost-effectiveness was reported in terms of costs per quality-adjusted life year (QALY), reported in Euro (€) 2022. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed. RESULTS: Romosozumab-to-alendronate was associated with 0.12 additional QALYs at an additional cost of €2314 compared to alendronate monotherapy, resulting in an ICER of €19,978. Compared to teriparatide-to-alendronate, romosozumab-to-alendronate was found to be dominant, with higher QALYs and lower costs. The base-case results were robust to uncertainty in the input parameters when conducting the sensitivity analysis. CONCLUSION: Sequential treatment with romosozumab followed by alendronate was found to be cost-effective compared to alendronate monotherapy and dominant compared to teriparatide followed by alendronate for postmenopausal women with osteoporosis at high risk of fracture in Belgium.

Cost-effectiveness of romosozumab for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture in Sweden.

Romosozumab is a novel bone-building drug that reduces fracture risk. This health economic analysis indicates that sequential romosozumab-to-alendronate can be a cost-effective treatment option for postmenopausal women with severe osteoporosis at high risk of fracture. PURPOSE: To estimate the cost-effectiveness of sequential treatment with romosozumab followed by alendronate ("romosozumab-to-alendronate") compared with alendronate alone in patients with severe osteoporosis at high risk of fracture in Sweden. METHODS: A microsimulation model with a Markov structure was used to simulate fractures, costs, and quality-adjusted life years (QALYs), for women treated with romosozumab-to-alendronate or alendronate alone. Patients aged 74 years with a recent major osteoporotic fracture (MOF) were followed from the start of treatment until the age of 100 years or death. Treatment with romosozumab for 12 months was followed by alendronate for up to 48 months or alendronate alone with a maximum treatment duration of 60 months. The analysis had a societal perspective. Efficacy of romosozumab and alendronate were derived from phase III randomized controlled trials. Resource use and unit costs were collected from the literature. Cost-effectiveness was estimated using incremental cost-effectiveness ratio (ICER) with QALYs as effectiveness measures. RESULTS: The base case analysis showed that sequential romosozumab-to-alendronate treatment was associated with 0.089 additional QALYs at an additional cost of €3002 compared to alendronate alone, resulting in an ICER of €33,732. At a Swedish reference willingness-to-pay per QALY of €60,000, romosozumab-to-alendronate had a 97.9% probability of being cost-effective against alendronate alone. The results were most sensitive to time horizon, persistence assumptions, patient age, and treatment efficacy. CONCLUSION: The results of this study indicate that sequential romosozumab-to-alendronate can be a cost-effective treatment option for postmenopausal women with severe osteoporosis at high risk of fracture.

A novel economic framework to assess the cost-effectiveness of bone-forming agents in the prevention of fractures in patients with osteoporosis.

A novel cost-effectiveness model framework was developed to incorporate the elevated fracture risk associated with a recent fracture and to allow sequential osteoporosis therapies to be evaluated. Treating patients with severe osteoporosis after a recent fracture with a bone-forming agent followed by antiresorptive therapy can be cost-effective compared with antiresorptive therapy alone. Incorporating these novel technical attributes in economic evaluations can support appropriate policy and reimbursement decision-making. PURPOSE: To develop a cost-effectiveness model accommodating increased fracture risk after a recent fracture and treatment sequencing. METHODS: A micro-simulation cost-utility model was developed to accommodate both treatment sequencing and increased risk with recent fracture. The risk of fracture was estimated and simulated using the FRAX® algorithms combined with Swedish registry data on imminent fracture relative risk. In the base-case cost-effectiveness analysis, a sequential treatment starting with a bone-forming agent for 12 months followed by an antiresorptive agent for 48 months initiated immediately after a major osteoporotic fracture (MOF) in a 70-year-old woman with a T-score of 2.5 or less was compared to an antiresorptive treatment alone for 60 months. The model was populated with data relevant for a UK population reflecting a personal social service perspective. RESULTS: The cost per additional quality-adjusted life year (QALY) gained in the base-case setting was estimated at £34,584. Sensitivity analyses revealed the sequential treatment to be cost-saving compared with administering a bone-forming treatment alone. Without simulating an elevated fracture risk immediately after a recent fracture, the cost per QALY changed from £34,584 to £62,184. CONCLUSION: Incorporating imminent fracture risk in economic evaluations has a significant impact on the cost-effectiveness when evaluating fracture prevention treatments in patients with osteoporosis who sustained a recent fracture. Bone-forming treatment followed by antiresorptive therapy can be cost-effective compared to antiresorptive therapy alone depending on treatment acquisition costs.

Importance of Recent Fracture as Predictor of Imminent Fracture Risk.

PURPOSE OF REVIEW: To examine the importance of recent fracture as a predictor of imminent fracture risk, review the importance of prior fracture type and timing, and identify risk factors for recurrent osteoporotic fracture. RECENT FINDINGS: Prior fracture type and timing impact risk of subsequent fracture that is largely independent of bone mineral density. Site of re-fracture is similar to original major osteoporotic fracture. Incidence of recurrent major osteoporotic fracture is greatest within the first year. Other risk factors include those that pertain to individual characteristics. Approved osteoporosis therapies reduce risk of recurrent fracture. Prior fracture timing, type, and individual characteristics are important components of predicting the risk of future fracture. Initiation of osteoporosis medication therapy should be started after initial fracture to reduce the risk of future fracture, though these medications typically take 6-12 months to have an effect, during which time is the highest rate of imminent re-fracture.

Economic evaluation of four treatment strategies for postmenopausal patients with osteoporosis and a recent fracture in mainland China: a cost-effectiveness analysis.

Postmenopausal patients with osteoporosis who have a recent fracture are at very high risk of fracture, and this study finds that stratified treatment based on fracture risk would be a cost-effective treatment option for this population. PURPOSE: To evaluate the cost-effectiveness of four anti-osteoporosis medications (denosumab, zoledronate, teriparatide, and alendronate) for postmenopausal osteoporotic women in mainland China, using a stratified treatment strategy recommended by the American Association of Clinical Endocrinologists and the American College of Endocrinology (AACE/ACE). METHODS: A microsimulation Markov model was used to compare the cost-effectiveness of the four treatments in postmenopausal osteoporotic patients of different ages (65, 70, 75, and 80 years), with a recent fracture from the Chinese healthcare perspective. The primary outcome was the incremental cost-effectiveness ratio (ICER), which represent the incremental cost per quality-adjusted life-year (QALY) obtained. One-way deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed to assess the robustness of model findings. RESULTS: Alendronate was dominated by denosumab-to-alendronate and zoledronate at all ages examined, indicating that the costs of the two drugs were lower, but QALYs was greater. However, teriparatide-to-alendronate yielded an ICER of $76,432.07/ QALY, compared with alendronate at age 65, which exceeded the pre-determined willingness-to-pay threshold of $37,653/ QALY. The results were similar at other ages. The DSA showed that the most sensitive parameters were drug efficacy for vertebral and wrist fractures, the relative risk of vertebral fractures, and the persistence of the drugs. The PSA showed that zoledronate had a 100% probability of being the most cost-effective treatment, with a willingness-to-pay threshold of $37,653/ QALY. CONCLUSION: Stratified treatment based on very high fracture risk is more cost-effective than conventional pills in mainland China. Among the stratified treatments, zoledronate is the optimal option.

Neonatal leg fracture and constriction ring syndrome: A case report and literature review.

Congenital constriction of the limbs is usually due to amniotic band syndrome, which often causes damage to the skin and soft tissues. We report an unusual case in which a neonate had recent fractures of both leg bones with an amniotic band encircling the limb. Non-operative treatment was successful. Challenges to the management of neonatal limb constriction include the absence of a consensus about the best treatment and the high frequency of damage to vessels and nerves.

Assessment of patient's pain-related behavior at physical examination may allow diagnosis of recent osteoporotic vertebral fracture.

BACKGROUND CONTEXT: Although innumerable studies have analyzed the multiple aspects of osteoporotic vertebral fractures, no study has focused on the clinical features related to spine pain in patients with recent osteoporotic vertebral compression fractures (VCFs). PURPOSE: To determine whether the assessment of pain-related behavior (P-RB) of patients with osteoporotic VCFs of recent onset may allow the fracture to be strongly suspected, or even diagnosed, at physical examination. STUDY DESIGN: Pain-related behavior of elderly patients attending an outpatient spine clinic was evaluated on the basis of six consecutive movements made on the examining table. PATIENT SAMPLE: Fifty-six patients complaining only of lumbar or thoracic pain. The fractured patients (FPs), representing the fracture group (FG), were the 19 who had a recent VCF, whereas the control group (CG) consisted of the remaining 37 patients. METHODS: Assessment of P-RB was based on six parameters: grimacing, sighing, clenching or blocking eyelids, gaping or strongly tightening the lips, need for help to take positions, and extreme difficulty to turn in the prone position. A score of 1 or a decimal was assigned to each parameter, the final score to each patient being 0 to 6. Three types of injury, acute (I), subacute (II), or chronic (III), were identified on the basis of the time elapsed from the probable occurrence of the fracture. The diagnosis of recent fracture was based on magnetic resonance images. Patients were videotaped during their movements. An examiner, unaware of the clinical history and diagnosis, gave a P-RB score to all patients and indicated whether they had to be placed in FG or CG, and also their presumable type of fracture. Subsequently, a DVD with the videotapes of all patients was given to three independent examiners, not specifically expert of spine conditions, who were asked to make the same evaluations as the first examiner. RESULTS: The mean scores for P-RB given by the first examiner were 4.6 to FG and 0.7 to CG (p<.01). He identified as FPs 89% of those who were in FG. The type of fracture was indicated correctly in 88% of patients identified as FPs. The mean scores for the three types of fracture ranged from 5.4 (Type I) to 3.3 (Type III) (p<.001). The mean scores for P-RB given by the independent examiners to FG and CG were similar to those of the first examiner. The rates of correctness in identifying the type of fracture in patients indicated as FPs varied from 87% to 80%. The mean scores assigned to the patients included in the three types of fracture ranged from 5.4 to 2.8. CONCLUSIONS: Pain-related behavior evaluation of patients with osteoporotic VCF during their movements on the examining table may allow to suspect, or even diagnose, the presence of a fracture, particularly in the initial 4 to 6 weeks after the occurrence. Even orthopedic surgeons not particularly familiar with spine care may be able to suspect the injury during physical examination.