Methodology and results of cost-effectiveness of LDL-C lowering with evolocumab in patients with acute myocardial infarction in China.

BACKGROUND: According to the Chinese guidelines for lipid management (2023), evolocumab in combination with statins was recommended as secondary prevention of cardiovascular disease. However, because of the variation in the price of evolocumab and its different methods of confirming clinical efficacy, it was necessary to explore its economics and the impact of different methods of confirming efficacy on its economic studies. OBJECTIVE: The purpose of this paper was to assess the cost-effectiveness of evolocumab with statins versus statins alone for patients with acute myocardial infarction(AMI) in China and to investigate the impact of different clinical effectiveness modeling approaches on economic outcomes. METHODS: A Markov cohort state-transition model was used to estimate the incremental cost-effectiveness ratio (ICER) based on Chinese observational data on cardiovascular event rates, efficacy from the Asian subgroup of the FOURIER trial, cost and utility from the Chinese Yearbook of Health Statistics, health insurance data, and published studies conducted in China. This study conducted subgroup analyses for different populations and dosing regimens; sensitivity analyses for parameters such as cost, utility, and cardiovascular event rates; and scenario analyses on hospital hierarchy, time horizon, starting age, and price for statins. RESULTS: ICERs ranged from 27423 to 214777 Chinese yuan(CNY) per QALY gained, all below the willingness-to-pay threshold of CNY 257094. Only when the time horizon became small, the ICERs were greater than the willingness-to-pay. The probabilities that adding evolocumab to statins was cost-effective ranged from 76 to 98%. When the time horizon became small, i.e. evolocumab was discontinued before the age of 75 (after conversion), the corresponding ICERs were almost always greater than the willingness-to-pay. ICERs for modelling approaches based on clinical endpoints were 1.34 to 1.95 times higher than ICERs for modelling approaches based on reduced LDL-C levels. CONCLUSIONS: From the Chinese healthcare and private payer perspectives, adding evolocumab to statin therapy in AMI patients is more likely to be a cost-effective treatment option at the current list price of CNY 283.8. However, evolocumab may not be cost-effective if used for shorter periods of time. The results based on different clinical effectiveness modeling approaches were significantly different.

A systematic review of cost­effectiveness analyses of sequential treatment for osteoporosis.

Sequential treatment of osteoporosis has been increasingly mentioned in recent years. However, the corresponding systematic review has not been reported. This study aims to systematically review and assess all full-text pharmacoeconomic studies of sequential treatment for osteoporosis. A comprehensive literature search was performed using PubMed, EMBASE (Ovid), CNKI, and Wanfang Database to identify original articles, published before June 17, 2022. The quality of included articles was evaluated by the updated Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases International Osteoporosis Foundation (ESCEO-IOF). In general, ten articles were included in this review. For the comparison between sequential treatment and bisphosphonate monotherapy, more than 75% of studies demonstrated the sequential treatment was cost-effective or dominant, with the exception of sequential treatment involving teriparatide. When the comparisons occurred between the two sequential treatment groups, the sequential treatments associated with either abaloparatide or romosozumab were cost-effective or dominant compared to the sequential treatment involving teriparatide. Several major key drivers of cost-effectiveness included drug cost, medication persistence and adherence, drug effect on fracture risk, offset effect, time horizon, and baseline fracture risk. The most of studies were identified as high quality in CHEERS (2022) and ESCEO-IOF. The cost-effectiveness of sequential treatment for osteoporosis is influenced by multiple factors. Generally, the sequential treatments involving abaloparatide, romosozumab, denosumab, and bisphosphonates may be considered as the preferred option for osteoporosis with high fracture risk, while the sequential treatment with teriparatide was not a cost-effectiveness strategy. The ESCEO-IOF and CHEER (2022) increase the transparency, comparability, extrapolation, and quality of research, engage patients and the general public in research on health services and policies, and help improve the quality of health technology assessment.

Which injected antiosteoporotic medication is worth paying for? A cost-effectiveness analysis of teriparatide, zoledronate, ibandronate, and denosumab for postmenopausal osteoporotic women in China.

OBJECTIVE: The purpose of this study was to evaluate the cost-effectiveness of four injected antiosteoporotic medications including teriparatide, zoledronate, ibandronate, and denosumab for postmenopausal osteoporotic women in China. METHODS: A Markov microsimulation model was used to compare the cost-effectiveness of the four drugs above in Chinese postmenopausal osteoporotic women with no fracture history of hip, vertebral, or wrist at various ages (65, 70, 75, and 80) of therapy initiation from the health care payer perspective. RESULTS: Denosumab was dominant (ie, lower costs and greater quality-adjusted life-years [QALYs]) compared with other strategies at all ages studied. The incremental cost-effectiveness ratios (ICERs) of zoledronate or ibandronate versus no treatment were $4,482.88/ QALYs or $11,378/QALYs, respectively, at age 65 years, and the results at other ages were similar. In contrast, the incremental cost-effectiveness ratio of teriparatide strategy compared with no treatment exceeded the pre-determined threshold of a willingness-to-pay of $31,512/QALY regardless of the adoption of the patient assistance program at all ages studied, and a threshold analysis showed that teriparatide without patient assistance program became cost-effective when the annual drug cost is decreased to $1,644.87 (current cost: $8,764.65). The cost-effectiveness decision did not change in most of the one-way sensitivity analyses. A scenario analysis considering no offset effect of denosumab showed that zoledronate had the potential to become the optimal option relative to denosumab. In probabilistic sensitivity analyses, the probabilities of denosumab being cost-effective compared with other strategies were 100% at a willingness-to-pay of $31,512/QALY. CONCLUSIONS: Among postmenopausal osteoporotic women in China, denosumab therapy is cost-effective at all ages examined from the health care payer perspective, compared with teriparatide, zoledronate, or ibandronate. This study will help clinicians and policymakers make better decisions about the relative economic value of osteoporosis treatments in China.

Associations between the 1438A/G, 102T/C, and rs7997012G/A polymorphisms of HTR2A and the safety and efficacy of antidepressants in depression: a meta-analysis.

The correlations between hydroxytryptamine receptor 2A (HTR2A) gene polymorphisms (1438A/G, 102T/C, and rs7997012G/A) and the safety and efficacy of antidepressants in depression patients were constantly reported, but conclusions are debatable. This meta-analysis ascertained forty-two studies on the efficacy (including response and remission) and side-effect issued before February 2020. Pooled analyses indicated significant associations of 1438A/G polymorphism (16 studies, 1931 subjects) and higher response within dominant model (OR: 1.40, 95% CI: 1.12-1.76); rs7997012G/A polymorphism (nine studies, 1434 subjects) and higher remission in overall models (dominant model: OR: 1.30, 95% CI: 1.01-1.66; recessive model: OR: 2.20, 95% CI: 1.53-3.16; homozygote model: OR: 2.73, 95% CI: 1.78-4.17); 102T/C polymorphism (eight studies, 804 subjects) and reduced risk of side-effect within recessive (OR: 0.57, 95% CI: 0.4-0.83) and homozygote models (OR: 0.54, 95% CI: 0.29-0.99). For depression patients, genotyping of HTR2A polymorphisms is a promising tool for estimating the outcome and side-effect of antidepressants.

Pharmacokinetic study on lovastatin sustained-release tablet and sustained-release capsule in Beagal dogs.

This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet, Tp; sustained-release capsule, TJ and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. Tmax, Cmax and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5 +/- 16.9% (Tp) and 110.4% +/- 9.6% (Tj). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, Tmax, Cmax MRT and DF had significant difference (P < 0.05); Cav, Cmin and AUC0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.