Bridget Olson’s Post

August 15th IRA Breakthrough Update: What Medicare's Drug Price Negotiations Mean for Pharma. The recent negotiations under the Inflation Reduction Act (IRA) mark a historic shift for Medicare and the pharmaceutical industry. For the first time, Medicare has successfully negotiated drug prices, resulting in significant discounts—up to 79%—for some of the most commonly prescribed medications. When the negotiated prices will go into effect in 2026, people enrolled in Medicare prescription drug coverage would save under the projected defined standard benefit design an estimated $1.5 billion. 💸 💡However, these negotiations present both opportunities and challenges for the pharmaceutical and biotech sectors. While the goal of making life-saving drugs more affordable aligns with public health priorities, the price reductions raise concerns about the future of innovation and the sustainability of R&D investments. Key industry players must now navigate this complex landscape, balancing compliance with the IRA while continuing to drive innovation. The finalized prices for the first 10 drugs, including widely used treatments for diabetes, cardiovascular diseases, immunology and cancer, reflect the evolving dynamics between regulatory authorities and the pharmaceutical industry. For biotech companies, the focus will need to be on strategic adaptation—leveraging innovative approaches and partnerships to sustain growth. Genchrome, can help you understand the implication of IRA in your drug development process to maximize the value of your medicine for your own launch or future acquisition, and help you find the best partners: contact@genchrome.com #IRA #medicare #drugprices #pharma #biotech

📢UPDATE: The recent negotiations under the Inflation Reduction Act (#IRA) mark a historic shift for Medicare and the pharmaceutical industry. For the first time, #Medicare has successfully negotiated drug prices, resulting in significant discounts—up to 79%—for some of the most commonly prescribed medications. When the negotiated prices will go into effect in 2026, people enrolled in Medicare prescription drug #coverage would save under the projected defined standard benefit design an estimated $1.5 billion. 💸 💡However, these negotiations present both opportunities and challenges for the pharmaceutical and biotech sectors. While the goal of making life-saving drugs more affordable aligns with public health priorities, the price reductions raise concerns about the future of innovation and the sustainability of R&D investments. Key industry players must now navigate this complex landscape, balancing compliance with the IRA while continuing to drive innovation. The finalized prices for the first 10 drugs, including widely used treatments for diabetes, cardiovascular diseases, immunology and cancer, reflect the evolving dynamics between regulatory authorities and the #pharmaceutical industry. For biotech companies, the focus will need to be on strategic adaptation—leveraging innovative approaches and partnerships to sustain growth. Genchrome, can help you understand the implication of IRA in your drug development process to maximize the value of your medicine for your own launch or future acquisition, and help you find the best partners: contact@genchrome.com

Gemeinsamer Bundesausschuss (G-BA) Proposes Inclusion of Tapentadol in Fixed Price Group: Public Consultation Outcomes The Gemeinsamer Bundesausschuss (G-BA), Germany's top healthcare decision-making body, has proposed an amendment to the Drug Directive to include Tapentadol in the fixed price group system. This aims to ensure cost-efficiency in the public healthcare system. After extensive public consultation, which involved stakeholders like Grünenthal Group, a producer of Tapentadol, the Gemeinsamer Bundesausschuss (G-BA) decided that Tapentadol meets the criteria for inclusion. Despite concerns about European production costs and rebate contracts, the Gemeinsamer Bundesausschuss (G-BA) emphasized that the fixed price group would ensure affordable access to Tapentadol while maintaining therapeutic effectiveness, with implementation set for September 2024. For more details please click the link! https://lnkd.in/dhrhH2DS #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Prescription medication costs are on the rise, disproportionately affecting communities of color. Recent findings from Patients For Affordable Drugs, reveals that Black and Latino seniors struggle more to afford their medicine, while pharmaceutical companies continuously increase prices for drugs like Enhertu and Revlimid. No one should have to make the difficult choice between essential medications and basic needs. It's time for policy action to counter the greed of Big Pharma and promote health equity. https://lnkd.in/gRjrEV85 #AffordablePrescriptions #AffordableDrugsNow #BigPharma #EndBigPharmaGreed #HealthEquity #OCAP

In May 2023, my Progressive Policy Institute colleagues Michael Mandel, Erin Delaney, and I, published an article that sparked a crucial conversation on the urgent need for #biopharmaceutical companies to rethink their drug pricing strategies. Read the full article 👇 https://lnkd.in/gntcwQGh Our arguments are more relevant today than ever. The Federal Trade Commission report regarding PBM practices and today's announcement of a lawsuit filed by the FTC against the three largest PBMs that control approximately 80% of retail and 70% of specialty drug markets regarding the PBMs inflating insulin prices. In addition to the disclosure of the Inflation Reduction Act prices for the first 10 drugs. And perhaps most importantly, ending the regulation capping Medicaid rebates at 100% of the Average Manufacturer Price (AMP). Now is the perfect time for companies to adjust their prices and thus reduce PBM profitability. Such action will also reduce exposure to inflation penalties aggregated over the years with older brand medicines, thus fixing the insatiable appetite for PBMs and 340B hospitals to profit from the 340B discounts. Most importantly, such action will help patients who are in dire need of out-of-pocket relief at the pharmacy counter. Global Healthy Living Foundation Pioneer Institute for Public Policy Research

In the most recent episode of #OverTheCounter, Johnny Ray Garcia, senior director of policy at the Pharmaceutical Care Management Association (PCMA), sat down with Drug Topics to discuss the common misconceptions surrounding his organization and #PBMs as a whole, as well as the work they do to support 17 of the 73 PBMs in the #market today. While PBMs and the #PCMA are currently on the hot seat when it comes to #reform within the #prescription drug market, Garcia tried to shed some light on what exactly he thinks is the root cause of rising #drug costs. https://lnkd.in/eJd2jQqa

While selecting semaglutide in the next round of IRA negotiation is not surprising, the potential of having Victoza picked as well could have an interesting effect in the next phase of "Battle for the Planet of the GLP-1s" between Novo and Eli Lilly. Let's also not miss the predictions that we could have 4+ oncology products selected in the second round. If Imbruvica's MFP is of any indication to CMS negotiation skills, both payers and manufacturers should prepare themselves on how Round 2 will shape up drug access in this protected class.

The US biosimilar market has lagged behind Europe due to significant challenges. Biosimilars for AbbVie’s Humira (adalimumab) have finally launched in the US, ending Humira’s 20-year reign as the best-selling biologic. Amgen’s Amjevita, the first Humira biosimilar, launched in February 2023. Seven more FDA-approved biosimilars are expected later this year, with two more under review, anticipated to launch in 2023. The US market has faced delays from patent disputes, a narrow approval pathway, and the lack of automatic interchangeable status. Settlement agreements kept biosimilars off the US market until 2023. In contrast, Europe saw Humira biosimilars enter over four years ago, leading to significant price reductions and higher uptake. In the US, while 40 biosimilars are FDA-approved, only 25 have launched, compared to Europe's 86 EMA-approved biosimilars. The first US biosimilar was approved in 2015, five years after establishing the regulatory pathway, delayed primarily by extensive patent protections and litigation, including AbbVie’s over 100 patents for Humira. Despite Europe's success with biosimilars leading to significant cost reductions, obstacles such as slow uptake, formulary exclusivity strategies, rebate schemes, limited formulary access, insurers' contracting practices, patient reluctance, and limited physician incentives impede biosimilar adoption in the US. Despite these challenges, Humira and its biosimilars’ prices are expected to fall over time in the US. Competition among biosimilars, including high-concentration and citrate-free versions, could transform the US market. The success or failure of Humira biosimilars will be a critical test for the US biosimilars market, potentially reducing healthcare spending and improving public health. check👇 https://lnkd.in/d247iMFe #BiosimilarChallenge #HumiraLaunch #HealthcareTransformation #InviMedsHealth

Biosimilars offer safe, effective and more affordable treatment options for patients, while also generating competition and lowering prices for health systems. It's a win-win. Teva Pharmaceuticals recently announced the FDA approval of a biosimilar for the treatment of multiple autoimmune diseases, in partnership with Alvotech. And this is just the beginning for Teva. We have 16 biosimilars in our pipeline, many as part of strategic partnerships that make us even stronger. I’ll keep sharing more as these treatments become available, helping to improve access to medicines for patients around the world. Learn more about biosimilars at Teva: https://lnkd.in/dHZaUhyq #tevapharm #pivottogrowth #biosimilars #accesstomedicines #tevaproud

Let's talk #Stelara® (ustekinumab) for a moment. It will be the next higher-cost biological with biosimilars coming in 2025. And the next big one for self-funded plans to manage. If you're a plan fiduciary, you should be asking your #PBMs how they're going to handle it now in prep for the biosimilars coming in 2025. -According to the brand manufacturer's website, the list price of Stelara® is $25,497.12 every 8 weeks for the 90 mg dose as of March 2022. After initial doses and based upon the indication, it's used every 8 or 12 weeks. FDA Biosimilars thus far: 1. Wezlana (ustekinumab-auub) - The first Stelara biosimilar to be approved by the FDA, Wezlana is interchangeable with Stelara and is manufactured by Amgen.  2. Selarsdi (ustekinumab-aekn) - Developed and manufactured by Alvotech and Teva Pharmaceuticals, Selarsdi is approved for both adults and children. It is expected to be marketed in the US in February 2025.  3. Ustekinumab-ttwe - Sandoz will commercialize this biosimilar in the US, and it is expected to be one of the first to launch in the US. *Indications may vary Ask your PBMs: 1. If you have access to your data as a self-funded plan (you should, it's your data) - check and see if you have any on the plan now. If not, ask if there's any Stelara on the plan at present. 2. Which biosimilar will be on formulary? 3. By when? (Hint - the PBM should have it coming early in 2025.) 4. Will it be a high cost with drug rebates, or low cost without--or worst of both worlds, both, and then which one is the PBM choosing? (They'll probably be going high with drug rebates...) 5. If there are rebates, what will be coming back to the plan? 6. What will the members' copays be? 7. What will be the plan's cost? -Note: There is a high dose form of Stelara that hides out over in your medical benefits, because it is IV. Ask your PBM about that one too.... https://lnkd.in/geecGUnR Last, if you're a large employer with 1000+ employees, consider hiring a #pharmacist to manage your healthcare benefits plan and #prescriptiondrug spend. They are worth their weight in gold! #pharmacy