Ashlee Dunston

CMS released the final guidance on how it will run next year's "negotiation" process for medicines that will get price controlled in 2027. (Link in comments) On the big, definitional questions, nothing really changed. There's a lot on how the money will flow through the system, and I look forward to linking to someone else on that. Not really my wheelhouse. But I was interested in how CMS will change how it seeks public input. The relevant bit is captured in the screenshot below, including up to 15 private roundtables and one open town hall meeting. That's far better than the last attempt here, and it aligns somewhat with what Joey Mattingly and others have suggested. I still have questions. CMS has baked in the opportunity for some limited dialogue, but it's not clear how that will work. It's also not clear if there will be continued follow-up with participants. And there's probably reason to be skeptical that a single town hall meeting is going to be sufficient to capture the clinician perspective on 15 wildly diverse meds. So progress ... I guess.

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A study published in Oncology Issues demonstrates the power of integrating somatic and germline testing to identify hereditary cancer syndromes. By focusing on high-risk gene mutations, Hoag Family Cancer Institute ensures that patients receive comprehensive genetic counseling and testing, leading to better-informed treatment decisions and preventive strategies for families. Learn why this process is a game-changer in precision oncology in this article: https://lnkd.in/e-dz6FeD? 

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On the Research in Action podcast, two industry experts share how to make the most out of public, private, and academic clinical research partnerships. Listen here. https://lnkd.in/eQwCxQby

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Thanks for publishing in PharmacoEconomics

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Excited to share some 🚨 new research 🚨 It shines a light on the economic burden and secondary complications of #influenza-related hospitalization among adults in the US. To read the article in full click the link below, or to find out more about the article read on for the plain language summary. 👉 https://bit.ly/4b5PzlV 𝓟𝓛𝓐𝓘𝓝 𝓛𝓐𝓝𝓖𝓤𝓐𝓖𝓔 𝓢𝓤𝓜𝓜𝓐𝓡𝓨 This study described the healthcare resource utilization (HCRU) and costs for US adults ≥18 years old hospitalized with influenza and associated secondary complications such as pneumonia, asthma exacerbation and malignant hypertension between 2016–2023. The researchers analyzed a hospital admission database and found that, for the healthcare system, average cost per influenza-related hospitalization ranged from $11,384 to $14,494, depending on the influenza season and age of the patient. Over 96% of patients admitted to a hospital initially presented at the emergency department, 20–30% of patients required mechanical ventilation (MV) or intensive care unit (ICU) admission, and the median hospital length of stay was 3–4 days. This study adds to the existing evidence by providing economic burden estimates for the 2022/23 influenza season, the most recent influenza season after the COVID-19 pandemic, and found slightly lower HCRU and cost for influenza hospitalizations relative to prior seasons. Also, the study comprehensively analyzed economic burden by patient age groups and found lower HCRU and costs among patients ≥65 years compared to adults 18–49 years and 50–64 years consistently for all seasons. Additionally, the study found that the proportion of patients with MV usage alone, with MV usage and an ICU admission, and average hospitalization costs were greatest among patients 50–64 years, highlighting the potential benefit of increasing rates of seasonal influenza vaccination among this age group. Finally, the study found higher costs among patients with complications related to their influenza infection compared to patients without complications. Overall, the study found that influenza-related hospitalization can contribute to substantial economic burden in the US in the most recent time period. #infectiousdiseases #economicburden #HEOR #healtheconomics #pharmacoeconomics #medicaleconomics Tianyan Hu and Amanda Miles

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So looking forward to hosting this exciting discussion with some of the foremost experts on AI in medical affairs. Join us by registering below!

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I'm expecting to take a lot of heat over this article, but bring it on! I am having difficulty seeing how the Inflation Reduction Act #IRA will significantly affect future #pharmaceuticalinnovation, as claimed by #bigpharma. There are several factors here: Q: Who conducts the bulk of first-in-class drug discovery and research (big pharma or small biotech)? A: Small biotech. Q: Are small biotechs worried about Medicare price negotation 13 years postapproval (for a biologic, 9 years for a small molecule)? A: No, they are more concerned about getting that big pharma buyout. #biotech #biosimilars PhRMA The Brookings Institution #drugresearch https://wp.me/p7gt6c-7MQ

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Join me and your fellow marketers at Digital Pharma East 2024 on September 9-12 in Philadelphia as we shape the future of pharma marketing together. Like & share my social post to help millions living with debilitating migraine. 👉 Join me and register now! https://lnkd.in/eVQyjfvA #DPEAST #DigitalPharma #pharmamarketing #digitalmarketing #marketing #WeAreFierce Digital Pharma Series

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It’s exciting to see how Komodo’s data and technology continue to gain traction in the market. The healthcare and life sciences industry has long needed an insights engine that is timely, dynamic, reliable, and accurate, and the studies published at ISPOR illustrate how our platform is coming to life. Imagine having these kinds of breakthrough insights at your fingertips every day — well, that’s what MapLab has unlocked!

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I'll be moderating a free webinar September 25 addressing key differences in EU vs. US clinical data requirements and considerations, featuring the deep knowledge and real-world experience of Maria E. Donawa, M.D. and Tom Melvin. You can register to attend live and get a recording here: https://lnkd.in/ggmZNZNK I learned a lot during a recent planning session for the webinar with Maria and Tom, and I look forward to continuing the conversation. The presentations and discussion will feature historical context for US/EU differences, modern-day challenges, strategic advice, and maybe some hope for future improvements. Presented by MedTech Leading Voice, Sean Smith, Market Pathways, and Donawa Lifescience Consulting Please join us! #MedTech #ClinicalData #FDA #RegulatoryStrategy #MedicalDevices

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Our joint G2 Intelligence / Today's Clinical Lab webinar on the FDA's final LDTs rule is just over 24 hours away! I recently chatted via email with one of our speakers, regulatory expert Shannon Bennett, to get his initial thoughts on the final rule. Here's what he had to say about what was most surprising about the rule, what labs may find most challenging, and what labs should do right away to prepare: https://lnkd.in/gw3WuQjM #LDTs #FDA #ClinicalLaboratory #MedicalLaboratory

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If you're a small/medium-sized MedTech/Biopharma, consider an RFI response to 21st Century Cures Act/Cures 2.0. Representatives Diana DeGette (D-CO) and Larry Bucshon MD (R-IN) released a letter requesting stakeholder input (request for information or RFI) on the progress of the Cures 2.0 Act, legislation that seeks to continue the efforts of the 21st Century Cures Act to promote innovation in biomedical research and access to health care. Representatives DeGette and Bucshon, specifically seek your input on key questions: 𝟭. Do the policies included in Cures 2.0 that have advanced through legislation or executive action meet the needs that the original Cures 2.0 bill aimed to address? 𝟮. What elements might be missing that are essential for further progress? 𝟯. What additional reforms, support mechanisms, or incentives are needed to enhance or improve the effectiveness of the steps already taken, including any structural reform to agencies, offices, or programs involved? I've drafted my response today and I urge you to let your voice for small and medium-sized MedTech, Biopharma and Digital health businesses be heard. Thank you to MILMED Fellow Paloma Greenwald RN, BSN, MA for sending me this information!

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#Largelanguagemodels offer both opportunities and challenges in the medical setting. They have the potential to unlock insights within the healthcare landscape, particularly in #RWE; however, appropriate #regulation and human oversight of their use is essential. In this interview, Lori Klein, PharmD, Partner, Medical & Scientific Affairs Practice Lead (Putnam, Boston, US), discusses the current applications of #LLMs in healthcare, strategies for optimization, and the potential future landscape of this rapidly evolving field, a topic she recently presented at the World Evidence, Pricing and Access Congress 2024. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #healthdata #AI #artificialintelligence

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🧠 With 24% of pharma respondents having innovation departments working to revolutionize AI applications in R&D, product development and regulatory content, pharma is leading the charge when it comes to implementing gen AI. Dive deeper into industry insights by downloading Reuters Events latest whitepaper today: https://bit.ly/3RTP8Ve #PharmaTech #AI #Marketing #Medical #Customer Engagement

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It's heartening to see there's an increased focus on developing more sustainable practices across healthcare as a whole, but sustainable procurement in clinical labs remains in its infancy. Vizient, Inc's Mellissa Nguyen and Yoav Einy argue that we can, and should, harness the potential of environmental stewardship to evolve current laboratory practices. Here's their advice on how to get started: https://lnkd.in/gDQCQ9RB

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The FTC has voted to ban noncompetes, without an exception for doctors. The final rule (which could face a legal challenge as soon as tomorrow) has sweeping ramifications on the healthcare sector - along with lowering healthcare costs by an estimated $194 billion over ten years, it’s also expected to cause wages to rise by freeing up medical workers to switch between employers. Read more on Tuesday’s 3-2 vote, including how banning noncompetes includes an interesting wrinkle for nonprofit hospitals - and tell me what you think. Is this a good thing for the healthcare sector?

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