Merith Basey’s Post

Sometimes two things that seem opposing can be true. The Hill has an article about how pharmaceutical CEOs are hinting that the negotiated prices may not be so bad. And then you have this quote, “There also is just the reality that they have been saying that the sky has been falling. And if CMS comes out with a completely reasonable price, that does a lot to their credibility" (AARP.) Let's pause and chew on that. Yes, this round of prices might fit within what CEOs and investors anticipated (more or less). Many of these products are already subject to intense negotiations. But let's not let that fool us into believing there's no harm done, now or later. This was never about a single round of "pseudo-negotiation." The ceaseless clock of negotiations chips away at innovation, particularly on follow-on indications that get caught in the small molecule clock. That's no idle speculation. https://lnkd.in/eBtFD28w

✨ Navigating Pharma Regulatory Changes for 2024 The regulatory landscape for drug manufacturers is shifting, with new and revised guidance impacting participation in key government programs like the 340B Drug Pricing Program, Medicaid Drug Rebate Program, Medicare Part B and D, and more. Our latest blog post offers a comprehensive summary of these changes and explores the implications for manufacturers. Read the full article for a deep dive into the latest developments and how they might impact your organization 💡 #FCSinsights #pharma #drugpricing Richard Moore Jeff Blake Nicholas Lynch, CFE Jake Keenan Jim Flowers

🚨 Breaking News: Federal Judge Tosses Pharmaceutical Group's Lawsuit Against Medicare Drug Price Negotiations! 🚨 In a significant victory for affordable healthcare, a federal judge has dismissed a lawsuit challenging Medicare's new powers to negotiate drug prices. This decision is a crucial win for the Biden administration's efforts to make medications more affordable for seniors and tackle skyrocketing prescription drug costs. 💊💰 Key Points: The lawsuit, brought by a major pharmaceutical lobbying group and two other organizations, argued that Medicare's price negotiations were unconstitutional. U.S. Judge David Ezra sided with the Biden administration, dismissing the suit and emphasizing that the court does not have jurisdiction over certain legal challenges. While this ruling won't end the legal battle, it's a pivotal step forward in the fight for accessible healthcare. What's Next: The pharmaceutical industry may appeal the decision, hoping to obtain conflicting rulings from federal courts and escalate the issue to the Supreme Court. Meanwhile, Medicare has already issued initial drug price offers to manufacturers, with final negotiated prices set to take effect in 2026. Stay Informed: As the healthcare landscape evolves, stay tuned for updates on this critical issue. Affordable medication is essential for everyone, and this ruling marks a significant milestone in ensuring access to vital treatments. 💪💊 #Medicare #DrugPrices #HealthcareAccessibility

In the evolving biopharma landscape, U.S. and European manufacturers face increasing regulatory pressures. The U.S. Inflation Reduction Act (IRA) allows Medicare to negotiate drug prices, impacting net revenues and pricing strategies significantly. Additional proposed legislation could further influence the market, potentially leading to substantial job losses and fewer FDA approvals. In Europe, the new EU Health Technology Assessment Regulation, effective January 2025, marks a shift in drug and device introductions, emphasizing a joint clinical perspective. Check out this article to learn more! https://lnkd.in/g5m_uxQP #Pharma #MedicalAffairs

Legal Update: Boehringer Ingelheim v. HHS Ruling The District Court of Connecticut recently ruled on the summary judgment motions in Boehringer Ingelheim Pharmaceuticals, Inc. v. United States Department of Health & Human Services. Boehringer Ingelheim challenged the Inflation Reduction Act’s Drug Price Negotiation Program, claiming it violated their rights under several constitutional provisions. However, the court granted summary judgment in favor of HHS, denying all of Boehringer’s claims. Key Takeaway: The court upheld the Drug Price Negotiation Program, emphasizing that participation in Medicare and Medicaid is voluntary. Thus, companies like Boehringer Ingelheim can opt out if they do not agree with the terms, ensuring the program’s legality under current statutes. For those in the pharmaceutical and healthcare industries, this ruling underscores the importance of understanding the legal frameworks surrounding drug pricing and government health programs. 🔗 Read the full court document #Healthcare #Pharmaceuticals #LegalUpdate #DrugPricing #Medicare #Medicaid #PBMs

[BREAKING] The Biden administration has revealed today, the first set of 10 prescription drugs that will undergo price negotiations between their manufacturers and Medicare. This initiative is a part of President Biden’s 𝐈𝐧𝐟𝐥𝐚𝐭𝐢𝐨𝐧 𝐑𝐞𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐀𝐜𝐭, aiming to make expensive medications more accessible to older Americans. The prices agreed upon for this initial set of drugs are slated to be effective from 2026. 𝗠𝗲𝗱𝗶𝗰𝗮𝗿𝗲'𝘀 𝗱𝗿𝘂𝗴 𝗽𝗿𝗶𝗰𝗲 𝗻𝗲𝗴𝗼𝘁𝗶𝗮𝘁𝗶𝗼𝗻 𝗶𝘀 𝗮 𝗽𝗶𝘃𝗼𝘁𝗮𝗹 𝗺𝗼𝘃𝗲 𝘁𝗼 𝗰𝗼𝘂𝗻𝘁𝗲𝗿𝗮𝗰𝘁 𝘀𝗼𝗮𝗿𝗶𝗻𝗴 𝗨.𝗦. 𝗽𝗿𝗲𝘀𝗰𝗿𝗶𝗽𝘁𝗶𝗼𝗻 𝗰𝗼𝘀𝘁𝘀. Targeting high-expenditure drugs promises immediate relief for seniors. However, a potential repercussion is diminished #RandD investment by #pharmaceuticals, possibly stalling future drug innovations. As legal challenges emerge, striking a balance between #affordability and #innovation becomes paramount. These negotiation outcomes will be instrumental in shaping subsequent healthcare reforms. The drugs listed for the initial negotiations are listed in the comments. Read more on this developing topic at the links below. #HLWFAlliance #HLWF #HLWFEXpert

Since the Inflation Reduction Act was signed into law in August 2022, questions have persisted about the implications of key drug pricing provisions. 💊💰 These pricing provisions include: - Medicare drug price negotiation - Inflation-based rebate payments to Medicare - Medicare Part D benefit redesign These provisions aim to reduce drug spending and increase access to pharmaceutical drugs in the U.S., but what are the unintended consequences? 👉 The latest from Mosaic Group | An IPG Health Company breaks down the various implications these provisions may have on market access stakeholders:

Learn more about the market access implications of the Inflation Reduction Act by reading our most recent Access Talk POV. Thank you to our amazing strategy team for their great work on our Access Talk series! #OurMosaic #AccessTalk #MarketAccess

🔍 US Senate Committee Questions Pharma CEOs on High Drug Prices 🔍 #USHealthPolicy #PharmaPricing In a pivotal moment on February 8, 2024, the Senate Health, Education, Labor, and Pensions (HELP) Committee took a firm stance against what Senator Friends of Bernie Sanders referred to as "the outrageously high cost of prescription drugs" in the United States. The committee's hearing saw top executives from the pharmaceutical industry, including Joaquin Duato of Johnson & Johnson, Rob Davis of Merck & Co, and Chris Boerner of Bristol Myers Squibb, defending their pricing strategies under rigorous questioning from US senators. 🏛️💬 The central issue debated was the significant disparity in drug prices between the US and other countries, with the list price for drugs like Merck’s Keytruda being nearly $79,000 more expensive in the US than in Canada. Despite the heated discussion, the pharmaceutical CEOs made no solid commitments to reducing prices in the US, asserting that the current pricing is essential for sustaining innovation within the healthcare sector. 🌍💸 Senators also raised concerns over the practice of filing numerous patents to stave off generic competition, with Robert Davis defending Merck's 168 patents for Keytruda and Chris Boerner denying Bristol Myers Squibb's opposition to generic competition despite ongoing lawsuits to block generics. 🔒📈 Joaquin Duato pointed to "burdensome" copay obligations as a significant barrier to drug access, highlighting Johnson & Johnson's efforts to assist patients through copay assistance programs. Yet, the overarching narrative was one of steadfast adherence to current pricing models, citing the value these medicines bring to patients and the healthcare system. 💊🛡️ This intense scrutiny comes amidst ongoing negotiations with the Centers for Medicare and Medicaid Services (CMS) regarding the prices of ten selected drugs under the Inflation Reduction Act, with the aim of implementing updated prices by 2026. The hearing underscores the growing tension between the need for pharmaceutical innovation and the imperative to make life-saving drugs more affordable for Americans. 📉🤝 #DrugPricingDebate #SenateHearing #PharmaceuticalIndustry #HealthcareInnovation #PatientAccess