From August 15, 2021, to July 31, 2022, a detailed examination and analysis were performed on the publicly released data from HTA agency reports and official documents. Our research involved collecting data on the decision-making criteria used by the national HTA agency; the HTA reimbursement status for 34 medicine-indication pairs linked to 15 unique top-selling US cancer medicines; and the HTA reimbursement status for an additional 18 medicine-indication pairs (with 13 unique medications) that displayed little to no clinical benefit (assessed at 1 on the European Society of Medical Oncology's Magnitude of Clinical Benefit Scale). The eight countries were analyzed using descriptive statistics to compare HTA decision criteria and drug reimbursement recommendations, or the final reimbursement decision for Germany and Japan.
The new medicine's influence on clinical results, assessed for therapeutic effect across all eight countries, demonstrated uniform standards; conversely, the quality of evidence supporting this impact, and issues of fairness, were scarcely referenced. Solely the German HTA agency required the validation of surrogate endpoints within therapeutic impact evaluations. All HTA reports, excluding those from Germany, contained formal cost-effectiveness analyses. England and Japan uniquely identified a cost-effectiveness cutoff point. In the reimbursement of US top-selling cancer medicine-indication pairs, Germany led with 100% reimbursement, followed by Italy (94% recommended), Japan (82% reimbursed), and a group of six countries (Australia, Canada, England, France, New Zealand) which recommended reimbursement for 79% (27 pairs). New Zealand recommended reimbursement for 35% (12 pairs). Among the 18 cancer medicine-indication pairs with marginal clinical outcomes, Germany reimbursed 15 (83%) and Japan reimbursed 12 (67%). France led the way in recommending reimbursements with nine (50%), followed by Italy's seven (39%) recommendations; Canada's five (28%) recommendations trailed behind; and a shared 17% was achieved by both Australia and England, each securing three reimbursements. The New Zealand reimbursement process did not consider medications with only marginal clinical value. Across all eight countries, the total cumulative percentage shows that a substantial number of top-selling US medicines (58 of 272, or 21%) and marginally beneficial medicine-indications (90 of 144, or 63%) were not recommended for reimbursement or reimbursed.
Our research reveals discrepancies in public reimbursement policies across countries with similar economic profiles, even though their HTA decision criteria overlap. The need for greater transparency regarding the complexities of the criteria is evident to guarantee broader access to valuable cancer treatments and prioritize less beneficial ones. Comparative analysis of HTA decision-making processes in other countries can inform and improve the methods utilized in national health systems.
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The meta-analysis of chemotherapy for nasopharynx carcinoma, undertaken by the MAC-NPC collaborative group previously, highlighted that, in the context of nasopharyngeal carcinoma treatments, the strategic addition of adjuvant chemotherapy to concomitant chemoradiotherapy generated the most substantial survival benefit. optical fiber biosensor Recent induction chemotherapy trials prompted a recalibration of the network meta-analysis.
This network meta-analysis, focusing on individual patient data, sought to identify and collect data from radiotherapy trials, including those involving chemotherapy, for patients with non-metastatic nasopharyngeal carcinoma who had completed enrollment prior to January 1, 2017. PubMed and Web of Science, along with Chinese medical literature databases, were both consulted for data. A-485 cost The primary focus of this research was on determining overall survival rates. Employing a two-step random effects model, stratified by trial, and the Peto estimator for hazard ratios, a frequentist network meta-analysis was performed. Homogeneity and consistency were examined utilizing the Global Cochran Q statistic; treatment effectiveness was determined via p-scores, where higher scores indicated greater therapeutic benefit. Treatment regimens were grouped into categories: radiotherapy alone; induction chemotherapy, followed by radiotherapy; induction chemotherapy excluding taxanes, before chemoradiotherapy; induction chemotherapy with taxanes, subsequently followed by chemoradiotherapy; chemoradiotherapy alone; chemoradiotherapy followed by adjuvant chemotherapy; and radiotherapy, followed by adjuvant chemotherapy. This study's PROSPERO registration is clearly defined by the identification CRD42016042524.
8214 patients were enrolled in a network of 28 trials, conducted between January 1, 1988, and December 31, 2016. This included 6133 men (747% of the total), 2073 women (252% of the total), and 8 patients with missing data. The median follow-up period was 76 years, with an interquartile range (IQR) spanning from 62 to 133 years. There was no indication of heterogeneity, as evidenced by the p-value of 0.18; inconsistency was also marginally insignificant, with a p-value of 0.10. Chemoradiotherapy, administered after adjuvant chemotherapy, demonstrated a noteworthy survival advantage in comparison with concurrent chemoradiotherapy, with a hazard ratio of 0.88, 95% confidence interval 0.75-1.04, and p-value of 72%.
Integrating new trials led to a revised perspective on the prior network meta-analysis's conclusions. This updated network meta-analysis on nasopharyngeal carcinoma demonstrates that the incorporation of either induction or adjuvant chemotherapy into chemoradiotherapy regimens leads to improved overall survival when compared to chemoradiotherapy alone.
Institut National du Cancer, in conjunction with the Ligue Nationale Contre le Cancer.
The National Cancer Institute and the National League Against Cancer.
Lutetium-177 radioligand therapy, directed at the prostate-specific membrane antigen (PSMA), is a component of the VISION treatment.
The administration of vipivotide tetraxetan (Lu]Lu-PSMA-617) in conjunction with the approved standard of care protocol for metastatic castration-resistant prostate cancer produced positive outcomes in radiographic progression-free survival and overall survival. Our supplementary analysis encompasses health-related quality of life (HRQOL), pain experiences, and the occurrence of symptomatic skeletal events.
Eighty-four cancer centers, distributed across nine nations in North America and Europe, participated in this multicenter, open-label, randomized, phase 3 clinical trial. antibacterial bioassays The criteria for eligibility included patients who were 18 years or older, who had progressive PSMA-positive metastatic castration-resistant prostate cancer, whose Eastern Cooperative Oncology Group (ECOG) performance status was 0 to 2, and had previously been treated with at least one androgen receptor pathway inhibitor and one or two taxane-based regimens. Patients were randomly divided (21) into two cohorts, one receiving the treatment, and the other a different treatment.
Within the protocol, Lu/Lu-PSMA-617 plus standard of care, as permitted ([Lu/Lu-PSMA-617 plus protocol-permitted standard of care[)]
Patients were randomly assigned to either the Lu]Lu-PSMA-617 group or the control group, which received standard care, and assessed via permuted blocks. Randomization was categorized by baseline lactate dehydrogenase levels, presence of liver metastases, ECOG performance status, and the inclusion of androgen receptor pathway inhibitors within the standard of care. Patients who are found in the [
Participants in the Lu-Lu-PSMA-617 group received intravenous infusions totaling 74 gigabecquerels (GBq; 200 millicuries [mCi]).
Every six weeks for four cycles, patients receive Lu-PSMA-617, plus an extra two cycles as an option. Bisphosphonates, approved hormonal treatments, and radiotherapy were part of the encompassing standard of care. Reported are the alternate primary endpoints of radiographic progression-free survival and overall survival. This report highlights the key secondary outcome of time to the first symptomatic skeletal event, and further secondary measures including health-related quality of life (HRQOL), assessed through the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-5L questionnaires, and pain levels, as measured by the Brief Pain Inventory-Short Form (BPI-SF). The analysis of patient-reported outcomes and symptomatic skeletal events included all patients randomly selected following the initiation of dropout reduction strategies in the control group (on or after March 5, 2019). Safety was evaluated for all patients who received at least one dose of treatment based on the treatment administered. The trial is listed on ClinicalTrials.gov with its registration details. NCT03511664, an ongoing clinical trial, is not accepting new participants at this time.
Between June 4, 2018, and October 23, 2019, the cohort of 831 enrolled patients included 581 who were randomly assigned to the
Health-related quality of life, pain, and the time to the first symptomatic skeletal event were analyzed for the Lu]Lu-PSMA-617 group (n=385) or the control group (n=196), which were enrolled on or after March 5, 2019. The patients' median age was 71 years, with an interquartile range of 65 to 75 years, in the [
The Lu-PSMA-617 group encompassed 720 individuals, and the control group spanned 66 to 76 years. The median time taken for the first symptomatic skeletal event or death was 115 months (confidence interval 103-132) within the [ cohort.
Within the Lu]Lu-PSMA-617 treatment arm, patient follow-up spanned 68 months (52-85), demonstrating superior outcomes relative to the control group (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.40-0.62). The impending decline was delayed in [
The Lu]Lu-PSMA-617 group's FACT-P scores (hazard ratio 0.54, 0.45-0.66) and subdomains, BPI-SF pain intensity scores (0.52, 0.42-0.63), and EQ-5D-5L utility scores (0.65, 0.54-0.78) differed from those of the control group.