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Stay Informed, Stay Ahead with Market Access Today the premier platform dedicated to providing comprehensive coverage on the ever-evolving landscape of Market Access and Health Economics and Outcomes Research (HEOR). https://lnkd.in/da8uFR2F #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #pharmacoeconomics #health #pharmaceuticals #medicaldevices #genetherapies #celltherapies #diagnostics #nice #has #iqwig #icer

Diabetes Management Breakthrough: FDA Clears First Automated Insulin Dosing Device for Individuals with Type 2 Diabetes The FDA has cleared Insulet Corporation's SmartAdjust technology for type 2 diabetes patients, marking the first time automated insulin dosing is available for this group. Previously only for type 1 diabetes, SmartAdjust uses an automated glycemic controller to adjust insulin delivery, reducing manual management tasks. Clinical trials showed significant improvements in blood sugar control across diverse participants with no serious adverse events. This breakthrough offers new opportunities to improve glycemic control and reduce the daily burden of insulin management for millions of type 2 diabetes patients. For more details please click the link! https://lnkd.in/gSRDMrcP #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Plans for FDA Feedback on Predetermined Change Control Framework Released for Medical Devices The FDA has introduced draft guidance on predetermined change control plans (PCCPs), allowing medical device manufacturers to implement specified modifications without requiring a new 510(k) or premarket approval supplement. This streamlined process targets devices using artificial intelligence, machine learning, and in-vitro diagnostics. The guidance outlines specific content requirements for PCCP filings and emphasizes a risk-based, least burdensome approach to modifications. Stakeholders have the opportunity to provide feedback on the draft until November 20, which will help shape the final regulatory framework aimed at fostering innovation while ensuring device safety and effectiveness. For more details please click the link! https://lnkd.in/gsPfpg-C #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Knee Cartilage Repair: FDA Approves Arthroscopic Delivery of Vericel® Corporation’s MACI for Knee Cartilage Defects The FDA has approved Vericel® Corporation’s MACI (Matrix-Induced Autologous Chondrocyte Implantation) for arthroscopic delivery, marking a breakthrough in knee cartilage repair. This innovative procedure uses a patient's own cultured cells on a porcine collagen membrane to treat cartilage defects up to 4 cm², offering a less invasive option with quicker recovery times. Vericel® Corporation’s CEO, Nick Colangelo, highlights that this approval will expand MACI’s market reach among orthopedic surgeons who specialize in arthroscopic procedures, benefiting around 20,000 patients annually. Despite its promise, the treatment carries risks, including joint pain and specific contraindications. For more details please click the link! https://lnkd.in/gG6QyYk2 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Comprehensive Review Unveils Risk Factors for Refeeding Syndrome A systematic review found multiple risk factors for refeeding syndrome

Lymphoma Treatment Milestone: Ordspono™ (odronextamab) Approved in the European Union for Relapsed/Refractory Follicular and Diffuse Large B-Cell Lymphoma The European Commission has approved Ordspono™ (odronextamab), a bispecific antibody developed by Regeneron, as a new treatment for relapsed or refractory follicular and diffuse large B-cell lymphoma. Backed by data from Phase 1 and 2 ELM trials, Ordspono has shown high response rates, including complete remission, even for patients who have relapsed after CAR-T therapy. Administered in outpatient settings, it offers a convenient and promising treatment option for lymphoma patients across the European Union. Dr. Stefano Luminari and other experts view Ordspono as a significant advancement in cancer care. For more details please click the link! https://lnkd.in/gC-GZXi7 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Cost Effectiveness of Deprescribing in Multimorbidity Through GP-Delivered Medication Review A study conducted in Irish primary care settings examined the potential benefits of deprescribing for older patients with multiple chronic conditions. The study found that a general practitioner-delivered, individualized medication review aimed at reducing polypharmacy and inappropriate prescriptions showed a trend toward being cost-effective compared to usual care. The intervention resulted in cost savings and health gains, although these were not statistically significant. The probability of the intervention being cost-effective at certain thresholds was high. The study also acknowledged the impact of missing data and the relatively short data collection period on the results. Overall, the study suggests that GP-delivered medication reviews for patients with multimorbidity may offer a cost-effective approach to managing healthcare resources and improving patient outcomes, but further research is needed to confirm these findings. For more details please click the link! https://lnkd.in/d33jdx7m #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Health Funding Boost: Biden-Harris Administration Awards $65.7 Million to Support Mental Health, Substance Use Prevention, and Workforce Development The Biden-Harris Administration has committed $65.7 million to strengthen mental health and substance use disorder prevention and treatment services. The U.S. Department of Health and Human Services (HHS), through Substance Abuse and Mental Health Services Administration (SAMHSA), is allocating $27.5 million to the Strategic Prevention Framework – Partnerships for Success program to support substance use prevention in vulnerable communities. Additional funds include $8 million for Project LAUNCH to address children's behavioral health, $7.2 million for homelessness prevention, $5.7 million for graduate-level substance use disorder training, and $1.6 million to tackle HIV and substance use in minority communities. These efforts are part of a broader strategy to expand care and reduce stigma. For more details please click the link! https://lnkd.in/g-PraqRz #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Health Coverage for the Underserved: Biden-Harris Administration Awards $100 Million to Navigators to Boost Enrollment in Affordable Care Plans The Biden-Harris Administration has awarded $100 million in grants to 44 Navigator organizations, part of a larger $500 million, five-year investment, to help underserved communities enroll in affordable health coverage through HealthCare.gov, Medicaid, and CHIP. These Navigator programs provide free, vetted assistance, particularly targeting rural and minority populations. The initiative aims to improve health care access for millions, contributing to record enrollments and the lowest uninsured rate in U.S. history. The Centers for Medicare & Medicaid Services has streamlined the grant process to encourage more community organizations to participate, further expanding the program’s reach. For more details please click the link! https://lnkd.in/gb6tWqfW #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Elderly Care Interventions: Grant for Recognition of Innovations in Long-Term Care Opens This Fall This fall, intervention developers focused on improving elderly care under the Long-Term Care Act can apply for grants of up to €28,000 through the Vilans recognition committee. Supported by ZonMw programs, the grants target interventions aimed at enhancing care quality for elderly populations, including those with specific conditions like Korsakov or Huntington's, and their caregivers. The call for proposals opens in mid-October 2024, with funding awarded on a first-come, first-served basis. Successful interventions will receive guidance from Vilans and aim to improve care outcomes for vulnerable groups in long-term care. For more details please click the link! https://lnkd.in/gserfE3d #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical