Mark Gruenhaupt’s Post

I always love learning! Have you ever wondered the process that #CMS and & #HHS are taking when they are negotiating with drug manufactuers for maximum fair price (MFP)? Well I did and found this document on CMS website called: "Maximum Fair Price (MFP) Explanation for Imbruvica" "The MFP explanation contains the following components: • MFP Explanation Narrative for Imbruvica o Summary of the Negotiation Process o Indications for Imbruvica o Factors Applied o Manufacturer-Specific Data o Evidence about Imbruvica and Therapeutic Alternatives to Imbruvica  Therapeutic Alternatives  Outcomes and Additional Considerations o Citations to Data Reviewed during the Negotiation Process for Imbruvica • Redacted Negotiation Meeting Summaries for Imbruvica • Redacted Data Submitted by the Primary Manufacturer and Other Interested Parties for Imbruvica I was surprised that they take into consideration "Therapeutic Alternatives". (Page8). Example: CLL/SLL • Acalabrutinib • Zanubrutinib • Combination regimen of venetoclax with obinutuzumab • Combination regimen of venetoclax with rituximab Anyways, I thought I would share so we can all understand this process. #beintheknow #IRA #drugpricing #cms #medicare #medicarepartd #medicareinsurance #patientadvocate #frm #pharma

Biden’s 2025 budget includes several legislative proposals supporting the FDA's efforts to protect American consumers and patients. A main suggestion from the budget is to eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products. This distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding among patients and health care providers about the safety and effectiveness of biosimilars. The new suggested policy may have significant implications for the US biosimilars markets for patients and providers alike. Read more here: https://lnkd.in/eGGVCEZ3 #biosimilars #USA #Biden #pharma  #news

In 2023, #generics and #biosimilars represented a whopping 90% of all prescriptions filled and only 13% of all drug spending in the U.S. In fact, generic & biosimilar medicines are the only aspect of healthcare that CONSISTENTLY deliver lower costs for patients! Learn more in AAM’s 2024 Savings Report: https://lnkd.in/e9xGNTfW #GRxBiosimsSavingsReport

If you're at the TABA Spring Conference, catch our Clinical Account Executive, Kevin Shores, PharmD, as he presents "How to Divert from Biosimilars/Pharmacy/Specialty Drugs." at 1:30 pm Central Time. Kevin's presentation will cover biosimilars, including their unique approval process, challenges in adoption such as interchangeability concerns and prescriber reluctance, and cost implications, with a focus on adalimumab. He'll also discuss Pharmacy Benefit Managers' strategy to promote biosimilar utilization and emphasize the importance of proactively integrating them into healthcare plans. Additionally, the session will explore future biosimilar developments to enhance participants' understanding of how biosimilars impact healthcare costs and access. If you want to explore how we can help your clients maximize the value of biosimilars, schedule a meeting with Dan Falter during the conference. #TABA #BenefitsAdministrators #TPAs #TPA #Networking

Our community of experts continues to amaze us. In our whitepaper with Nuwae, we predicted that AbbVie's Humira would continue to capture 95% of the market over new biosimilars—and we were right on target. 🎯 Read more about this development below and check out our full biosimilars whitepaper at: https://hubs.li/Q01DTxcy0

During a recent webinar we cohosted with the @Medical Review Institute of America, we discussed proven strategies for achieving a remarkable 15:1 ROI through their effective High-Cost Specialty Drug Reviews™ program. Whether you're new to managing high-cost specialty drugs or looking to enhance your existing processes, these insights are sure to empower you to make informed decisions. Reach out to sales@urmedwatch.com with any lingering questions, or watch the full webinar here if you missed it: https://lnkd.in/gm7aCfnM #SpecialtyDrugs #PopulationHealth #HealthcareSavings

Our predictions for the Humira biosimilars market are proving accurate! A year after the introduction of biosimilars, AbbVie still commands 96% of the market, but the use of biosimilars is continuing to rise. Our whitepaper with Goodroot forecasted that biosimilars would capture up to 5% initially and grow to 20-25% by 2026. https://hubs.li/Q02vcQpd0 ❓Why did #Humira continue to dominate? Our experts say that's because it was already included on formularies at a parity position by the "big 3" PBMs that control 80% of the market. As other #biosimilars are now being prioritized in some of these PBMs, we predict that biosimilars will rise dramatically over the rest of the year. Stay tuned as we continue to monitor these developments and read our full whitepaper at: https://hubs.li/Q02vcGfj0

💡 Can you go from a 15% to 85% site response rate? Confidence Pharmaceutical Research, a leading CRO, achieved this with TrialHub in a complex study on Binge Eating Disorder (BED). The challenge? Identifying experienced sites and investigators for an underdiagnosed condition like BED. Typically, site response rates hover around 15-25%, requiring massive outreach efforts. Enter TrialHub. By leveraging our Site Feasibility module, Confidence Research identified top-performing sites, cutting through inefficiencies and reaching the right investigators. The result? An exceptional 85% response rate, with over 50% expressing interest in participation. That's 3x the usual outcomes! 🎯 When precision meets innovation, results follow. Read the rest of the story (link in a comment below 👇 ). #ClinicalResearch #Innovation #clinicaltrialsdata #clinicaltrialsites #BingeEatingDisorder

𝘼𝙘𝙘𝙤𝙧𝙙𝙞𝙣𝙜 𝙩𝙤 Polaris Market Research & Consulting , 𝙩𝙝𝙚 𝙜𝙡𝙤𝙗𝙖𝙡 𝙩𝙧𝙖𝙣𝙨𝙙𝙚𝙧𝙢𝙖𝙡 𝙙𝙧𝙪𝙜 𝙙𝙚𝙡𝙞𝙫𝙚𝙧𝙮 𝙨𝙮𝙨𝙩𝙚𝙢𝙨 𝙢𝙖𝙧𝙠𝙚𝙩 𝙨𝙞𝙯𝙚 𝙖𝙣𝙩𝙞𝙘𝙞𝙥𝙖𝙩𝙚𝙙 𝙩𝙤 𝙜𝙧𝙤𝙬 𝙛𝙧𝙤𝙢 𝙐𝙎𝘿 𝟐𝟖.𝟓𝟓 𝙗𝙞𝙡𝙡𝙞𝙤𝙣 𝙞𝙣 𝟐𝟎𝟐𝟒 𝙩𝙤 𝙐𝙎𝘿 𝟒𝟎.𝟎𝟏 𝙗𝙞𝙡𝙡𝙞𝙤𝙣 𝙗𝙮 𝟐𝟎𝟑𝟐, 𝙚𝙭𝙝𝙞𝙗𝙞𝙩𝙞𝙣𝙜 𝙩𝙝𝙚 𝘾𝘼𝙂𝙍 𝙤𝙛 𝟒.𝟑% 𝙙𝙪𝙧𝙞𝙣𝙜 𝙩𝙝𝙚 𝙛𝙤𝙧𝙚𝙘𝙖𝙨𝙩 𝙥𝙚𝙧𝙞𝙤𝙙. 𝙈𝙤𝙧𝙚 𝙍𝙚𝙥𝙤𝙧𝙩 𝘿𝙚𝙩𝙖𝙞𝙡𝙨: https://lnkd.in/duERU7Rp Rising healthcare spending and heightened awareness of alternative drug delivery methods are propelling the transdermal drug delivery systems market. With increasing global healthcare expenditures, there's a growing need for cost-effective treatments offering improved patient outcomes. #TransdermalDrugDeliverySystemsMarket #TransdermalDrugDeliverySystemsIndustry #TransdermalDrugDeliverySystems #marketresearch #marketresearchreports #polarismarketresearch

🚀 Acrux Limited (ASX: ACR) Announces U.S. Commercial Launch of NitroglycerinOintment 🚀 Acrux Limited (ASX: ACR) announce the successful commercial launch of NitroglycerinOintment, 0.4%, in the U.S. market. This marks a major milestone for the company as its sixth FDA-approved Abbreviated New Drug Application (ANDA) since 2021. The ointment, a generic version of Rectiv, is designed to treat moderate to severe pain from chronic anal fissures, addressing a critical need in patient care. With the U.S. market for this product now exceeding US$23 million annually, Acrux’s generic is well-positioned to compete effectively. This launch represents Acrux's fourth successful U.S. commercialization, reflecting the company's continued strength in in-house research and development. The collaboration with TruPharma as Acrux's licensee further bolsters the company's strategy in developing and commercializing topical products. #Acrux #FDAApproval #PharmaceuticalInnovation #GenericDrugs #Healthcare #BusinessGrowth #TopicalProducts #GlobalExpansion #U.S. Market * Click here to subscribe for free 7-day access to our daily market insights and analysis: https://lnkd.in/gzhTXvNT