Health Management Associates’ Post

An important and exciting update hot off the press! The FDA is holding a joint advisory meeting 11/9/24 to re-evaluate the clozapine REMs. I am hopeful that they recognize the need to reduce clinical and administrative barriers to #clozapine and will soon put in place a process that promotes access and optimal management. Kuddo's to Schizophrenia & Psychosis Action Alliance, American Psychiatric Association , TEAM DANIEL Running for Recovery from Mental Illness, theangrymoms.com and others for collaborating with the FDA to help them better understand the unintended consequences of the clozapine REMs and for partnering to create opportunities for meaningful change. #advocacy #mentalhealth #schizophrenia #schizoaffectivedisorder #psychosis

How Do Pharmacy Benefit Managers (PBMs) Keep Beating the System? Shame on you! "In two case studies of old cancer drugs, the FTC showed how PBMs steered patients to their own pharmacies and away from unaffiliated ones. They did so even when that meant patients would be charged up to 200 times what they could pay for the same drug at Costco...[resulting] in the parent companies pocketing an extra $1.6 billion over three years for just those two drugs, according to the FTC." The below WSJ article reiterates why it is so important to have a benefits consultant that is knowledgeable and has your back. Although many PBMs operate in an opaque environment, there are good PBMs who are transparent and do not strategize to to hide rebates. I am happy to provide insight on the good ones!

#340B RESOURCE ROUNDUP: #AvalereExperts work closely with stakeholders of the 340B drug pricing program on federal and state policy tracking, advocacy, and strategic planning efforts. To learn more about the state of the 340B program and potential impacts of proposed reforms, read our latest work below and connect with us: https://lnkd.in/ezrnTzTT 📰 Contract Pharmacy Trends May Help Inform 340B Reform Debate: https://lnkd.in/e85q_8j7 📰 Can Comprehensive 340B Reform Generate Federal Savings? https://lnkd.in/eaz9srNy 📰 How Will 340B Discounts Interact with Negotiated Drugs’ #MFP? https://lnkd.in/e2JrqbgP 📰 340B Stakeholders Consider Impacts of Duplicate Discounts https://lnkd.in/ehYCEkuf #drugpricing #IRA #InflationReductionAct #healthpolicy

The opioid crisis has been devastating for patients across the US. Businesses all across the pharmacy supply chain have been blamed. A new investigation looks into if PBMs may have played a role as well. --- Two weeks ago, Barron's released an investigation looking into PBMs and the sales of opioids (in the comments). While pharmacies, physicians, consulting groups, and wholesalers have signed settlements, this investigation presents PBMs as potentially another piece of the #OpioidCrisis It was thanks to Brian Reid that I came across this, because as he mentions in his newsletter, almost no one else covered the investigation at the time I looked into it. It seems there has been more momentum since then. --- The investigation found that between the 12-month period from the end of 2016 through the end of 2017, the big 3 #PBMs received about $400 million in rebates and fees from Purdue Pharma. That $400 million was coming from a combination of 10%-19.75% in rebates, and 4%-5% in services fees (aka manufacturer administrative fees) for every OxyContin prescription. As one would expect, the rebate levels are higher for more unrestricted access, which could financially disincentivize utilization management tools such as quantity limits and step therapy. --- As the opioid crisis unfolded, most payors created restrictions within their formularies for opioid products. However, Purdue was able to re-attain unrestricted status on some formularies by offering higher rebates. While this investigation was about Purdue and opioids, this negotiation for access happens with every drug. --- I recommend reading the whole story to get more of the context and nuance, including some PBM responses and how the change to limit the day supply of first-time #opioids helped to slow the epidemic in 2017. PBM rebate deals are complex and offer conflicting incentives for many entities in the #pharmacy supply chain. I plan on watching how this investigation unfolds. What info do you have to add about this investigation?

Sandoz UK & Ireland is supporting #GlobalBiosimilarsWeek to raise awareness of the value of biosimilars for patients, healthcare professionals and health systems.  This year's theme, ‘Advancing access to biosimilars’, is particularly relevant to the UK, where lower prices from biosimilars have not only delivered £800m in annual savings to the NHS but also widened access, including for 25,000 more people with rheumatoid arthritis. And this is just the start. With more biologics than ever expected to lose patent protection over the next five years, biosimilars will play an ever-greater role in supporting the NHS to boost population health while achieving efficiencies. Let’s support the IGBA - International Generic and Biosimilar medicines Association, which organises the week, by highlighting the impact of biosimilars in the NHS and beyond. #GlobalBiosimilarsWeek #AdvancingAccess #SandozUKI

Summa Health, a nonprofit integrated healthcare delivery system in Northeast Ohio, is more committed than ever to conquering the opioid crisis. To support this commitment, it has set a goal to eliminate opiates from its operating rooms completely. While Summa Health has already made significant headway on achieving this goal, additional help combating opioid use came from Thomas Mark, M.D. Chair, Department of Anesthesia, with the concept of a compounded multi-drug nerve block using three non-opioid drugs: bupivacaine HCI, dexamethasone sodium phosphate, and epinephrine.   Initially, Dr. Mark collaborated with his pharmacy colleagues to compound this formulation in-house. However, as demand for the combination product increased, it brought new challenges for the hospital and pharmacy. Ultimately the decision was made to outsource the compounding to Leiters Health, an FDA-registered 503B facility.  Click below to read the full case study.   Visit https://lnkd.in/efSYP85 to learn more about our compounded medications and pharmacy services. #leiters #health #503B #503b #quality #compounding #pharmacy #syringes https://lnkd.in/gdNAU44t

For anyone who has interest in studying how the 340B Drug Discount program is being implemented in their state, I wanted to share the analysis I did for ours. The below map shows that Arizona’s 340B healthcare entities have pharmacy contract relationships with pharmacies in 33 states across the country. You have to ask, does selling these drug treatments, which were provided at a huge discount for the state’s most vulnerable populations, really end up helping Arizonans? #340B https://lnkd.in/g38v4Gs7

🚨 RAAP PDAB Pres Release: PDAB in Virginia The Wrong Prescription for Rare Disease Patients 🚨 Virginia’s proposed Prescription Drug Affordability Board (PDAB) might sound like a win for healthcare affordability, but it’s a misguided approach that could hurt the very patients it claims to help—especially those with rare diseases. While the goal is to reduce drug costs, PDABs rely on arbitrary price controls that could limit access to life-saving treatments for rare and orphan diseases. These measures may lead to higher patient costs and fewer treatment options. As Michael Eging, Executive Director of RAAP, highlights: “Lawmakers should prioritize reforms that genuinely lower out-of-pocket costs without compromising access to critical treatments.” RAAP supports proven, bipartisan solutions like: ✔️ Capping out-of-pocket copay alternatives ✔️ PBM transparency reforms ✔️ Protecting patients from copay accumulator and maximizer programs Let’s focus on real solutions that protect innovation, patient access, and affordability. Virginia lawmakers, please vote NO on HB 1724. #RareDiseases #HealthcarePolicy #PatientAdvocacy #Innovation #VirginiaLegislation #RAAP

Ashley Nee ’22 MD’26 led a groundbreaking study at Brown, revealing that Medicare spending on anticancer drugs often doesn’t reflect their clinical value. The study highlights a “misalignment” between drug pricing and therapeutic benefits, raising questions about how drug prices are determined and their impact on affordability. Explore the findings and implications for health policy. How can we ensure drug prices align with patient outcomes? Join the conversation below. #HealthPolicy #CancerResearch #MedicareReform