- |||||||||| Repatha (evolocumab) / Amgen, Astellas
P4 data, Journal, Real-world evidence, Real-world: Safety and Effectiveness of Low-Density Lipoprotein Cholesterol-Lowering Therapy With Evolocumab for Familial Hypercholesterolemia/Hypercholesterolemia in Japan: A Real-World, Postmarketing, Single-Arm Study. (Pubmed Central) - Nov 5, 2024 P=N/A There is a need to consider each case individually when introducing or changing Biologics with reference to complications, improvement in pulmonary function tests, andso on. Evolocumab was well tolerated, and real-world patients with familial hypercholesterolemia and hypercholesterolemia with high risk in Japan had sustained low-density lipoprotein cholesterol reduction.
- |||||||||| Repatha (evolocumab) / Amgen, Astellas
Retrospective data, Journal, Real-world evidence, Real-world effectiveness, Real-world: Real-world effectiveness of monoclonal antibody inhibitors of PCSK9 in patients with heterozygous familial hypercholesterolemia: A retrospective cohort study. (Pubmed Central) - Nov 5, 2024 In a real-world cohort of HeFH patients, most of which were intolerant to statins, a high majority were able to achieve a ?50% reduction in LDL-C after 12?months of PCSK9 inhibitor therapy (mean reduction of approximately 59%), which is similar to clinical trial data of patients with ASCVD. A significant reduction in non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) were also observed.
- |||||||||| deflazacort / Generic mfg.
Review, Journal: Deflazacort-induced Steven-Johnson syndrome: a case report and literature review (Pubmed Central) - Nov 5, 2024 A significant reduction in non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) were also observed. Complete remission of SJS was achieved after treatment with intravenous immunoglobulin (IVIG, total 1.4 g/kg), 2 doses of etanercept (0.9 mg/kg, once), subcutaneous injection and intravenous methylprednisolone (0.7 mg/(kg
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis
Enrollment open: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study (clinicaltrials.gov) - Nov 5, 2024 P3, N=500, Recruiting, Complete remission of SJS was achieved after treatment with intravenous immunoglobulin (IVIG, total 1.4 g/kg), 2 doses of etanercept (0.9 mg/kg, once), subcutaneous injection and intravenous methylprednisolone (0.7 mg/(kg Not yet recruiting --> Recruiting
- |||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Fruzaqla (fruquintinib) / Takeda, Stivarga (regorafenib) / Bayer
Survival Benefit of Oral Systemic Monotherapy Treatment in Heavily Pre-Treated Metastatic Colorectal Cancer: A Meta-Analysis () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3212; Oral systemic monotherapy treatments provide significant survival benefits for heavily pre-treated mCRC, including when used in the fourth-line setting and beyond. In this meta-analysis, the improvement in mOS following active treatment versus placebo+BSC was <2 months, indicating that the increases in mOS with oral systemic monotherapies versus placebo+BSC observed in RCTs, in heavily pre-treated mCRC, are meaningful.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Cost-Effectiveness of Tezepelumab in Taiwan for Severe Asthma () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3190; Patients who experience an exacerbations result in either a burst in OCS, an A&E visit or hospitalization, the latter resulting in the largest cost and quality of life burden. The results from the analysis show that tezepelumab is dominant and is a cost-effective treatment when compared to the other biologics.
- |||||||||| Siliq (brodalumab) / Bausch Health, Humira (adalimumab) / AbbVie
Induction Cost Per Responder of Brodalumab Compared With Other Biologic Therapies for Patients With Moderate to Severe Plaque Psoriasis in Canada () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3175; The CPR was estimated as the drug acquisition costs during the induction period multiplied by the number needed to treat (NNT) for achieving PASI 75, 90, or 100 for the following treatments: adalimumab (innovator and SEB), brodalumab, bimekizumab, certolizumab pegol, etanercept (innovator and SEB), guselkumab, infliximab (innovator and SEB), ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab (innovator and SEB). These results demonstrate that brodalumab has the lowest induction CPR across all PASI outcomes compared to other biologic therapies, including SEB therapies, thus providing the best value for money for patients, prescribers, and payers.
- |||||||||| Strategies of Operational Savings in an Integrated Care Clinic for Immune-Mediated Skin Diseases () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2778;
The drugs managed were mainly 29.8% omalizumab, 21.8% adalimumab, 16.8% dupilumab, 7.7% ixekizumab, 7.4% guselkumab, 4.9% ustekinumab, 4.2% secukinumab, 2.1% etanercept, 2.1% risankizumab, and 3.2% other drugs. CLIPSO generates a relevant economic impact on the appropriate prescription and scaling of biological therapies for patients with immune-mediated skin diseases.
- |||||||||| Humira (adalimumab) / AbbVie
Evaluating the Effectiveness of Switching Treatments in Chronic Psoriasis: A Targeted Literature Review () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2628; Switching biologic treatments can enhance psoriasis disease control, but it is unclear if this is because of desensitization to the initial treatment or the introduction of newer, more effective treatments. To address this research gap, studies that swap between parallel treatment arms should be conducted to determine the most effective treatment strategy.
- |||||||||| Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
Meta-Analysis of Lipid-Lowering Efficacy and Cardiovascular Safety of PCSK9i in Treating ACS () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2450; In terms of safety, there was no statistically significant difference in the incidence of cardiovascular adverse events between the experimental and control groups. However, given the small number and quality variations among the included studies, the above conclusions still need to be confirmed by large-scale, high-quality randomized controlled trials.
- |||||||||| An Evaluation of Non-Randomized Evidence (NRE) Used in HTA Decision-Making: A Case Study Review () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2318;
These case studies illustrate that NRE can be a critical component in HTA and regulatory decision-making, particularly when RCTs are not feasible. NRE can provide robust evidence to support the efficacy and safety of treatments, facilitating access to innovative therapies for patients with high unmet medical needs.
- |||||||||| No Demand-Side Policies, No Expenditure Savings () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2309;
NRE can provide robust evidence to support the efficacy and safety of treatments, facilitating access to innovative therapies for patients with high unmet medical needs. METHODS : This study analyzed the trends of the originators
- |||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
A Cost-Effectiveness Analysis of Erythropoietin Alfa Versus Darbepoetin Alfa in Chronic Kidney Disease Patients () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2113; Continued HTA methods advancements, like CDA-AMC's "Time-Limited Reimbursement Recommendations", could enhance accessibility and affordability of these therapies, ensuring timely and effective treatment for patients with RBDs. Darbepoetin alfa emerges as a more cost-effective option for managing anemia in CKD patients compared to Erythropoietin alfa.
- |||||||||| Utilizing Generative AI Technology for Comprehensive HTA Report Analysis () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1493;
Primary and secondary endpoints varied: Cabozantinib focused on overall survival (OS) with PFS and ORR as secondary, while Atezolizumab plus Bevacizumab and Regorafenib emphasized OS and PFS with additional endpoints like ORR, TTP, DCR, and quality of life...All Generative-AI responses were validated by human-in-the-loop. CONCLUSIONS : Generative-AI technology can provide valuable insights and comprehensive analysis of HTA reports and makes navigating the complex landscape of global health technology assessments easy.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen, Cosentyx (secukinumab) / Novartis, Cimzia (certolizumab pegol) / Astellas, UCB
Cost of Biologics in Patients Suffering From Psoriasis in Greece: A Retrospective Longitudinal Cohort Study () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1158; The study highlights significant variability in biologic treatment costs for PsO, influenced by drug, persistence, and prior treatment history. These findings underscore the importance of balancing clinical efficacy and economic impact in treatment decisions for PsO, ensuring effective care while managing healthcare resources efficiently.
- |||||||||| Comparison of Methods for Extrapolation of Drug Survival of Biologics in Psoriasis NICE Submission Cost-Effectiveness Analyses () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1001;
Differences observed in DS extrapolations may result in substantially different predictions of treatment line distributions over time, and therefore calculation of the most cost-effective treatment sequences. Further research should be conducted into comparisons of overall DS for newer biologic therapies and compared against NICE submission model drug survival extrapolations, and methods for more accurate DS prediction from short-term trial data.
- |||||||||| Biosimilars: The Key to Lowering Access Barriers to Omalizumab Across Europe () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_660;
The disparities highlighted in this study underscore the need for improvement in access to omalizumab across Europe. This study highlights the need for comprehensive policy reforms and the introduction of omalizumab biosimilar to ensure equitable access to omalizumab across Europe, enhancing patient care and potentially solving shortage issues and expanding treatment options for off-label indications su ch as urticarial vasculitis and food allergy.
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Clinical Benefits of CDK 4/6 Inhibitors in HR+ HER2- Metastatic Breast Cancer: A Systematic Review () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_558; There is no compelling evidence of the superiority of one CDK4/6 inhibitor over others. A preference for a specific drug within the class can only be made after conducting direct RCTs or accumulating sufficient RWE on the use of such drugs.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Budget Impact of Tezepelumab for the Treatment of Severe Asthma in the Brazilian Private Healthcare System () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_95; In Brazil, available medications include omalizumab for severe allergic asthma (SAA), mepolizumab and benralizumab for severe eosinophilic asthma (SEA), and dupilumab for T2-high asthma. The inclusion of tezepelumab led to significantly lower medical expenses, highlighting its dual clinical and cost-saving impact.
- |||||||||| Journal, CAR T-Cell Therapy, IO biomarker: CAR-T cells for the treatment of pediatric chronic myeloid leukemia in repeatedly relapsed lymphoid blast phase. (Pubmed Central) - Nov 4, 2024
Olverembatinib-based treatment led to promising outcomes in de novo Ph?+?ALL patients but warranted further studies to investigate the best-combined strategy. He was treated with shortened acute lymphoblastic leukemia induction plus the tyrosine kinase inhibitor (TKI) imatinib followed by dasatinib...Multiple therapeutic approaches including ponatinib, blinatumomab, a 2nd HSCT from a different donor, donor lymphocyte infusions, and high-dose asciminib all resulted in subsequent relapse...In this situation, CD19-directed CAR-T cells (Kymriah
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
Review, Journal: Teprotumumab Related Hearing Loss: A Large-Scale Analysis and Review of Voluntarily Reported Patient Complaints to the Food and Drug Administration (FDA). (Pubmed Central) - Nov 4, 2024 He was treated with shortened acute lymphoblastic leukemia induction plus the tyrosine kinase inhibitor (TKI) imatinib followed by dasatinib...Multiple therapeutic approaches including ponatinib, blinatumomab, a 2nd HSCT from a different donor, donor lymphocyte infusions, and high-dose asciminib all resulted in subsequent relapse...In this situation, CD19-directed CAR-T cells (Kymriah Patients treated with teprotumumab should receive warnings regarding the increased risk of hearing-related impairments and receive audiometry before, during, and after treatment.
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