Carbon Stop Loss Solutions

Breaking New Ground: On November 13th, the FDA approved PTC Therapeutics’ gene therapy Kebilidi??(eladocagene exuparvovec), for the treatment of children and adults with aromatic L-amino acid decarboxylase (AADC) deficiency. AADC deficiency is a fatal, extremely rare genetic disorder that typically causes severe disability and suffering from the first months of life, leading to decreased muscle tone, movement disorders, and disruption of the autonomic nervous system with only around?350 cases reported in the literature. The indication covers the full spectrum of disease severity, and the approval constitutes the first gene therapy for direct administration to the brain in the US. Kebilidi ??is delivered to the putamen via a 1-time treatment with a minimally invasive stereotactic neurosurgical procedure and provides a functional copy of DDC, the disease-targeted gene.?It uses a technology developed by ClearPoint Neuro (SmartFlow Neuro Cannula) for infusion into the brain performed by a qualified neurosurgeon in centers specialized in stereotactic neurosurgery. Patients will need to stay in or near the hospital for a few days to monitor recovery and check for any side effects from the surgery or the anesthesia. PTC has not yet disclosed the US list price - In the UK, the therapy has a listed price of about ￡3 million ($3.8 million) not including administration charges. Payers need to explore affordable solutions. Carbon provides specialty financial and clinical resources needed to assess and manage this novel exposure. Contact us to learn how. https://lnkd.in/gdtWR535

Impressive News:?FDA granted approval to AUCATZYL? (obecabtagene autoleucel) by Autolus Therapeutics, marking it as the second ??????-?? ?????????????? on the market for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r ALL), after Tecartus (2021). Both therapies are indicated as third-line treatments.? Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes. AUCATZYL? is to be administered as split dose infusion on Day 1 and Day 10 (±2 days) based on bone marrow blast assessment and preceded by fludarabine and cyclophosphamide lymphodepleting chemotherapy. AUCATZYL? is the ?????????? CAR-T therapy approved by the FDA ?????????????? ?? ???????? (???????? ???????????????????? ?????? ???????????????????? ????????????????) ??????????????????????, signaling FDA confidence in its safety profile as it is?engineered to offer better safety and efficacy than its competition.?The price for AUCATZYL? is $525K (manufacturers invoice price for the infusion) not including administration costs. Having an optimal contract is key to managing this evolving exposure. Carbon?provides specialty financial and clinical resources needed for your protection. Contact Carbon Stop Loss Solutions to learn how. https://lnkd.in/g_-XdUjA

Chronic disease is no longer just an issue for the elderly—its growing prevalence among working-age Americans is forcing self-insured employers to rethink their cost management strategies. To combat rising healthcare expenses, Jakki L., Director of Cost Containment of Carbon Stop Loss Solutions (formerly Sequoia Reinsurance), emphasizes the need for a multifaceted approach that includes claim payment integrity, preventative care programs and strategic contracting in this month’s issue of The Self Insurer from Self-Insurance Institute of America, Inc. Read the full story here: https://lnkd.in/eD2edw88 ? #strongerbydesign ?#medicalbilling?#paymentintegrity #theselfInsurer #managedcare #employerstoploss #stoploss

Welcome to our new chapter! Introducing Carbon.... carbonstoploss.com

Welcome to our new chapter! Introducing Carbon.... carbonstoploss.com

This Happened: The FDA has granted an accelerated approval for Tecelra, afamitresgene autoleucel (afami-cel), for treating patients with advanced synovial sarcoma. Tecelra is also the first FDA-approved T cell receptor (TCR) engineered gene therapy. The product is an autologous T cell immunotherapy composed of a patient's own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4, an antigen (substance that normally triggers your immune system) expressed by cancer cells in synovial sarcoma. The product is administered as a single intravenous dose. Patients received the T cells after leukapheresis and receiving lymphodepleting chemotherapy. The list price for the one-time therapy is $727,000, not including facility administration costs. The addressable patient population in the US is ~400?per year. Adaptimmune plans to have at least six to ten authorized treatment centers (ATCs) up and running this year and to onboard approximately 30 treatment centers within the first two years. Since Tecelra was granted an accelerated approval, continued approval may be contingent upon further clinical trial data. Specialty financial and clinical resources are needed to assess and contain this exposure. Contact Sequoia to assist with management and mitigation strategies for this increased uptake in risk. https://lnkd.in/ekxia_YV

Halfway through 2024 and the U.S. healthcare industry has already experienced some of the most dangerous cyberattacks in history, with unprecedented breaches in terms of stolen health and personal data. ? Jakki Lynch, Director of Cost Containment at Sequoia, was featured in this article in the July edition of Self-Insurance Institute of America, Inc. Self-Insurer Magazine, the leading authority for the self-insurance industry. ? Jakki brings awareness to issues that healthcare organizations should consider addressing to mitigate risk exposure for potential future cybersecurity attacks and data breaches. ? Read the full story here: https://lnkd.in/g3G7fGBk ? ?

With the explosion in popularity of weight-loss drugs, employers are navigating the rise in medical expenses and potential long-term impacts. Jakki Lynch, Director of Cost Containment at Sequoia, was featured in this article in the June edition of The Self-Insurer Magazine, the leading authority for the self-insurance industry. Jakki covers key data and insights around obesity and potential side effects of popular weight-loss drugs. Read the full story at: https://lnkd.in/gcy_-xkH

Breaking: The FDA granted approval of expansion to the label indication for Sarepta’s Elevidys (delandistrogene moxeparvovec), for individuals with Duchenne muscular dystrophy (DMD) who are at least four years of age and have mutations in a specific DMD gene. The FDA grated traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients contingent upon verification of clinical benefit in a confirmatory trial. Elevidys is the first gene therapy for Duchenne muscular dystrophy - a genetic disorder that affects around 1 in 3,500 boys. Children with DMD are unable to make a protein called dystrophin, resulting in progressive muscle degeneration and death around the age of 30 due to heart or respiratory failure. The price for Elevidys is $3.2M (manufacturers invoice price for the one-time infusion) not including administration costs. The Cell & Gene therapy landscape is a significant focus for our health care system as an unprecedented number of treatments for rare and devastating diseases enter the market. Payers face volume uncertainty, clinical effectiveness, and concern for the extraordinary costs. With numerous therapies costing $4M+ not including administration charges, payers need to explore affordable solutions. Sequoia provides specialty financial and clinical resources needed to assess and manage this novel exposure.?Contact us to learn how. https://lnkd.in/g3hGHAPM

Happening: BMS secures another FDA go-ahead for Breyanzi, (lisocabtagene maraleucel), this time for the treatment of relapsed or refractory mantle cell lymphoma in adult patients who have received at least 2 lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Relapsed or refractory mantle cell lymphoma is a rare and aggressive form of mature B-cell non-Hodgkin lymphoma. The condition makes up about 7% of adult-onset non-Hodgkin lymphoma in western countries and has poor long-term survival rates, with a 10-year overall survival rate between 55% and 60%. This brings a new CAR T cell therapy option to patients battling relapsed or refractory MCL. Breyanzi has a US Wholesale Acquisition Cost (WAC) of $487,477 not including facility administration costs. CAR T-cell therapy can be very effective but it can also sometimes cause serious or even life-threatening side effects. Specialty financial and clinical resources are needed to assess and contain this evolving exposure. Sequoia is prepared to assist our clients with management and mitigation strategies. Contact us to learn how. https://lnkd.in/gcNy3J7n