Kymriah
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As Cell Therapy Gains Ground, Efforts Emerge to Improve CAR T-Manufacturing
Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.
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Novartis plans to seek approval for CAR-T in slow-growing lymphoma after Phase II success
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Outpatient use of CAR-Ts is enticing, but it comes with significant challenges too
Data on multiple CAR-Ts presented at the recent ASCO meeting have raised the prospect of outpatient use of the therapies, which is favorable for reimbursement as well as for patients. But experts pointed to significant infrastructure challenges that centers face.
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Data show early signs of efficacy for CRISPR-edited cell therapy in cancers
A team at UPenn led by CAR-T pioneer Carl June used CRISPR/Cas9 to engineer T cells for treating multiple myeloma and sarcoma. Data on three patients were published in Science. All the patients’ cancers ultimately progressed, though none had cytokine release syndrome.
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Novartis’ CAR-T shows real-world performance consistent with clinical trials at ASH
More than years after its initial approval, Kymriah has shown comparable efficacy and an apparently better safety profile than it demonstrated in the studies that led to its leukemia and lymphoma approvals. Another therapy, made by BMS, is a potential competitor.
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CMS goes for liberal approach in Medicare CAR-T coverage
The Medicare coverage decision, issued Wednesday evening after a nearly three-month delay, removes several requirements that some had feared would limit access to the cell therapies, while also allowing for some off-label use.
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CMS delays national coverage determination for CAR-T therapies
In a statement, the agency said that a decision on whether to have Medicare cover the cell therapies would not be issued Friday, but would be forthcoming.
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MorphoSys posts positive data for lymphoma drug, but will it compete with CAR-Ts?
A spokesperson for the company noted that patients in the Phase II L-MIND trial of the CD19-targeting drug tafasitamab would be too old and frail to be candidates for CAR-T therapies.
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CMS proposes continuing new technology add-on payments for CAR-T cell therapies next year
The agency also proposed increasing the maximum new technology add-on payment from 50 percent to 65 percent for fiscal year 2020.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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‘Off-the-shelf’ CAR-Ts have an important role to play – but are they ready for prime time?
Allogeneic CAR-Ts could serve an important niche – particularly for patients who can’t receive autologous CAR-Ts – but the earliness of the data makes conclusions tough to draw.
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Medicare could start covering CAR T-Cell therapy under new CMS proposal
The lack of an overarching CMS reimbursement policy on CAR T-Cell therapy has meant that coverage decisions have generally landed on the desk of local Medicare Administrative Contractors.
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UK drug-pricing watchdog recommends Novartis CAR-T for leukemia in final draft guidance
NICE recommends Kymriah to the Cancer Drugs Fund due to remaining questions about evidence to support it, but believes those questions will be resolved.
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Devices & Diagnostics, BioPharma, Pharma
Novartis, Gilead, Celgene/Agios blood cancer treatments sweep Prix Galien awards
Along with Boston Scientific’s Watchman in the technology category, Novartis and Gilead’s Kite shared the biotechnology award for CAR-T therapy, while Celgene/Agios’s Idhifa won the pharmaceutical prize.
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Novartis CAR-T likely improves long-term survival and is cost-effective, study finds
Still, despite costs largely in line with the therapy’s benefits, the study’s author and another expert said reimbursement models have not kept up and need improvement.
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Recently published CAR-T mishap could pose challenges for Novartis, Gilead and others
A manufacturing error during a clinical trial of Kymriah, now marketed by Novartis, is less likely today, but could be an issue as CAR-Ts move into earlier therapy lines.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
