American Society of Clinical Oncology (ASCO)’s Post

We have seen the approval of two groundbreaking treatments for Sickle Cell Disease (SCD) in 2024. And we now have more clarity on how these types of therapies will be funded. Announced last week, the Centers for Medicare & Medicaid Services (CMS) will use SCD as the first focus of its new Cell and Gene Therapy (CGT) Access Model. By focusing on direct negotiations with manufacturers, this model will aim to increase access, improve care, and lower spending in the high-cost field of CGT. Centering on establishing outcomes-based agreements between CMS and manufacturers, each state Medicaid plan may elect to participate starting in 2025. Over 100,000 Americans are impacted by SCD, with more than 50% enrolled in Medicaid. At a current cost of $3 billion to the health system, the hope is that these new gene therapies may reduce long-term spending by improving outcomes—a definite win for all involved. We’ve been on the forefront of #cellandgenetherapy since the beginning and are actively working in the #sicklecell space. Our Medicaid experts, Samantha and Emma, and the rest of the DKP team are watching closely as this exciting area of medicine continues to evolve. #medicaid #sicklecell #sicklecelldisease #cms #crispr #cellandgenetherapy #celltherapy #genetherapy #cgt

In the UK alone, 367,000 new cancer cases are diagnosed each year. The impact of cancer on the health system is further complicated by varying standards of coverage by the NHS and private insurers. Promising but expensive treatments like gene and cell therapies are now available in the UK, contributing to rising costs. Employers are struggling with costly treatment options that are not covered by the NHS, causing employees to opt for private plans. Read our new article to gain further insight into how employers can manage high-cost medical claims: https://aon.io/4ccswXU #HealthcareManagement #MedicalTrends #CostMitigationStrategies

In the UK alone, 367,000 new cancer cases are diagnosed each year. The impact of cancer on the health system is further complicated by varying standards of coverage by the NHS and private insurers. Promising but expensive treatments like gene and cell therapies are now available in the UK, contributing to rising costs. Employers are struggling with costly treatment options that are not covered by the NHS, causing employees to opt for private plans. Read our new article to gain further insight into how employers can manage high-cost medical claims: https://aon.io/4ccswXU #HealthcareManagement #MedicalTrends #CostMitigationStrategies

In the UK alone, 367,000 new cancer cases are diagnosed each year. The impact of cancer on the health system is further complicated by varying standards of coverage by the NHS and private insurers. Promising but expensive treatments like gene and cell therapies are now available in the UK, contributing to rising costs. Employers are struggling with costly treatment options that are not covered by the NHS, causing employees to opt for private plans. Read our new article to gain further insight into how employers can manage high-cost medical claims: https://aon.io/4ccswXU #HealthcareManagement #MedicalTrends #CostMitigationStrategies

BGOH's 2025 Employer Health Care Strategy Survey is out - anyone surprised that cancer remains the top condition driving cost?... 🦗 🦗 🦗 HR leaders - what are you doing upstream to combat downstream outcomes & claims? “Concerns about the cost of cancer care may be further fueled by increased prevalence in younger populations. Furthermore, the growing cost of cancer treatments, including gene and cell therapies currently in the pipeline, leaves employers questioning how their plans will be impacted. While it is imperative that employers adopt strategies to address treatment cost, it is equally important that they amplify efforts to increase cancer prevention and early detection via screening approaches.” https://lnkd.in/gBwNfvNH

🌙Early this morning, I was rehearsing my 3-minute public comment for today's pivotal NV Medicaid meeting, where decisions on adopting prior authorization for two newly FDA-approved gene therapies for Sickle Cell Disease (SCD)—Lyfgenia and Casgevy—will be made. Despite the challenging logistics of my schedule, coming straight from a trip and amidst preparations for personal commitments, I knew my presence was crucial. 🌙It’s vital for those making life-altering decisions to see and acknowledge our dedicated NV SCD community. We’re not here just to be seen; we’re here to advocate for real, tangible change. To that end, we've sent out a newsletter to hundreds of our community members and partners, urging them to support this move by submitting a public comment. Just 3-5 sentences are enough to demonstrate our unity and determination. 🌙The commitment we've shown goes beyond mere events or financial aid; it’s about engaging directly with medical professionals, lawmakers, and supporting our community members in their most challenging times—even saving them from eviction. We've done this without significant funding, relying instead on modest grants and sheer determination to support our community. 🌙I ask, if not plead, with those who have supported us, and those who have yet to engage: If you find a moment before 1 PM today, please email a public comment to [email protected]. The details of the meeting can be found in the attached photo, and I encourage you to look up Lyfgenia and Casgevy for context. 🌙This is not just another call to action—it's a plea for recognition and support for those who depend on us. Your voice can significantly influence the adoption of these therapies and truly save lives. We’ll continue to host free events and provide support, because at the end of the day, what matters is the health and well-being of those we serve in Nevada. Let's stand together. #SCD #Healthcare #PublicHealth #GeneTherapy #NVMedicaid #CommunitySupport #MakeSickleCellPopular ❤️🌙❤️🌙❤️🌙❤️🌙❤️🌙❤️🌙❤️🌙❤️🌙❤️

BILKING THE BILKERS AND SHAMING THE SHAMERS CAN ONLY GO SO FAR!: THE FREE MARKET ANSWERS TO NO GOVERNMENT OR COMPANY. THE LIMITS OF PRICE CONTROL BY GOVERNMENT MANIPULATION, ARE NOW ALL TOO EVIDENT. MEDICAID PATIENTS IN THE POOREST SECTIONS OF THE AFRICAN AMERICAN COMMUNITY WILL BE DEPRIVED OF LIFE SAVING/LIFE CHANGING GENE THERAPIES. AS BIDEN TRIES TO PUT GENE THERAPY DRUG COMPANIES IN A HALF NELSON BY SHAMING THEM INTO ARTIFICAL NON-VIABLE PRICE REDUCTIONS, MEDICAID PATIENTS SUFFER. MAYBE HE COULD STOP EGREGIOUSLY FORGIVING STUDENT DEBT FOR THE LESS NEEEDY AND START SAVING REAL HUMAN LIVES? It is estimated that: SCD affects approximately 100,000 Americans. SCD occurs among about 1 out of every 365 Black or African-American births. SCD occurs among about 1 out of every 16,300 Hispanic-American births. "Yet state Medicaid officials have been slow to cover the treatments because of their high upfront costs—some upward of $1 million. Hence, CMS is seeking to bludgeon gene-therapy developers into accepting lower prices that don’t take into account their lasting therapeutic value and would limit access to treatments. A proposed rule would require manufacturers with the highest drug Medicaid spending per claim to turn over confidential information justifying their prices. CMS would post the information online, seek public comment, and compel manufacturers to “address” their pricing in a public forum. The goal is to browbeat companies to reduce prices. As the Alliance for Regenerative Medicine noted in a comment on the rule, “the improper disclosure of confidential, proprietary and competitively sensitive information can pose significant risks to a company’s commercial viability.” CMS would let manufacturers avoid the public show trial and disclosures by paying state Medicaid programs “supplemental rebates,” on top of the program’s mandatory statutory 23.1% discount. Such payments in Medicaid are supposed to be prohibited. The Alliance for Regenerative Medicine rightly notes that CMS is trying “to administer de facto price controls on behalf of state Medicaid programs.” But manufacturers may decide it’s not worth selling drugs to Medicaid because the prices are too low. About a quarter of gene and cell therapies approved in Europe have been withdrawn from that market because they weren’t commercially viable at the prices that government payers demanded. That could happen with Medicaid if CMS finalizes its rule as it is expected to do. The victims in the case of sickle cell will mostly be minority children." #medicaid #genetherapy #bidenadministration #cms

The Government’s Plans for Sickle Cell Treatment Will Establish Tactics that Will Affect Dozens of Treatments to Come: It’s Going to Be a Bitter Fight Big news: yesterday, the Biden Administration announced its plans to use an “innovative” model to provide Medicaid access to gene therapy for sickle cell disease patients—the Administation promises to deliver that access equitably and cost effectively by “negotiating” Medicaid program-wide “additional” outcomes-based rebates. That’s a mighty big promise, with 100,000 patients, 60% being on Medicaid. And that promise inevitably frames a clash between the Administration’s commitment to equity and its war on drug prices. The Admimistration hopes to thread that needle with large “additional” rebates, beyond those required by current law. But can that needle be thread? Well, there are a lot of layers to that question. It’s no accident that two therapies were approved on the same day. That sets up a mechanism to play one against the other, at least as long as they perform comparatively. The Administration will also likely play for time, hoping, as it has said, to find “more shots on goal”—just as the government did in the earlier hepatitis fight. The “negotiation” here will be as bare-knuckled as it will be in the IRA context. Expect march-in rights saber-rattling, or worse. Senate hearings on the price of the treatments will just be a table setting exercise. But the Administration is under pressure here, too. An election looms and, for an important selection of voters, this issue is a test of the Administration’s health equity promises. The stakes are even higher because, as the Administration concedes, the model used here will de facto set the stage for a cascade of other treatments in development and all the patients that care about those diseases. As a rare disease patient myself, I’ll be one of the voters watching. I understand the stakes here, all too well. #scd #healthequity #drugpricing #rarediseases #access

The Centers for Medicare & Medicaid Services launched a new Cell and Gene Therapy (CGT) Access Model. This groundbreaking initiative aims to improve health outcomes for people with #Medicaid living with rare and severe diseases by increasing their access to treatments, starting with sickle cell disease. We've distilled down the details of this initiative, giving you a closer look at historical challenges, the CGT process, eligible therapies, and potential expansion considerations. 👉 https://bit.ly/4bkOs2i By Palak Desai, Jessica Naber, Prachi Bhatt, PharmD, MPH, BCPS, BCCCP, and Tyler Engel. #healthcare #healthinsurance #milliman

Tremendous perspective from Julie Kanter MD regarding the implementation of recent FDA-approved and groundbreaking treatments for #sicklecelldisease. "I think it's going to be very complicated because we need to support sickle cell disease centers in delivering this product, as well as the product itself... But I think the patients that I have taken care of would tell you it is absolutely worth it. It is truly a transformative therapy.” #cellandgenetherapy #apheresis #celltherapymanufacturing