Krystalyn Weaver

CMS told us the prices they’ve set for drugs millions use to stay healthy. We don’t yet know, in spite of what they said, what the impact for patients at the pharmacy counter will be. They didn’t offer specifics about what evidence they used, if they listened to patients or clinicians, or how they’ll protect patient access or out-of-pocket spending. And when they do it may be too late to inform the next round. CMS’s actions impact the entire market, and can affect prices charged by private insurers and investment decisions in new medicines. Our research suggests the IRA will reduce the number of conditions new medicines are approved to treat and limit post-approval research used to establish treatment guidelines, while encouraging plans to limit access. We’ll be watching what happens over the coming months and conducting new research about the impact of this law.  

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A Terrific Article on #IRA “Savings”—As Far as It Goes This Health Affairs article is a must read if you are interested in understanding the Centers for Medicare & Medicaid Services estimate that its price control prices imposed on the first 10 “select drugs” would have generated $6B in “savings” if applied to 2023. The article takes some steps to project the impact of these “savings” forward, making some insightful observations along the way. At the end of the day, though, the article doesn’t quite get to some issues that are likely to have a huge impact on whether “savings” will be achieved—or won’t. What’s Here: The article is quite interesting in offering estimated comparisons between Part D net prices pre-price controlled prices and post-price controls. It also breaks down the $6B #CMS estimate by drug, offering some interesting takes on the winners and losers, and offering some guesses as to why CMS was harsh with some and forgiving with others. It then offers some perspective that doesn’t “look back”, as CMS did in its disingenuous “estimate”, but “looks forward”. Some of the prospective perspective is qualitative (e.g., noting the potential impact of #generic equivalents) and some quantitative. The most notable quantitative “tweak” is the impact, under the revised IRA benefit design, of eliminating select drug manufacturers’ responsibility for 10% of drug costs in the initial coverage phase and 20% in the catastrophic. What’s Missing: As interesting and helpful as this analysis is, it doesn’t get to some key issues. It doesn’t consider, for example: 1) how substantially “savings” may be undermined by #PBMs and plans switching patients from “select drugs” to high list/high rebate alternatives; 2) the likelihood that “second level” players—such as #340B #coveredentities, specialty #pharmacies affiliated with plans or PBMs, and #LTC pharmacies—will be equally committed to such switches; 3) whether, and to what extent, select drug manufacturers will be able to offset the “switch” pressure by supporting #Medicare #PartD grievances and appeals; and 4) PBM, plan, and select drug pharmaceutical manufacturer possible agreements to “copy” recent PBM financial arrangements with biosimilar makers, as a mechanism to offset PBM and plan incentives to engage in switches away from select drugs. Though not necessarily relevant to the government “savings” question, the article has, at turns, a focus on manufacturer sales and the value of those sales. In that regard, the article doesn’t examine the substantial risk of “fair price” and 340B duplicate discounts. That could be the single biggest threat in implementation to select drug manufacturers. Though this is a great analysis, we need to dig deeper yet here. Article in the comments. #lifesciences #biotech #drugs #medications #meds #InflationReductionAcy #MedicareAdvantage #managedcare

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Moving at the speed of government. The pharmacy industry has been saying this for at least 20 years… The origins of this problem can be traced directly back to the FTC‘s disastrous decisions to allow many PBM mergers throughout the 2000s. Something the FTC at times opposed, but then reversed course. At least 1 of these, the 2012 Medco-ESI merger, happened over the dissent of then commissioner Julie Brill. Link to her full statement in the comments. “This $29 billion merger – between two of the largest three pharmacy benefit management providers – is a game changer. I have reason to believe that this merger is, in fact, a merger to duopoly with few efficiencies in a market with high entry barriers – something no court has ever approved.” “I call on the commission to demonstrate that the majority’s hypothesis is true: three years from now, the commission should conduct a thorough analysis of this industry to determine if prices to employers in fact have gone down. While I sincerely hope that I am wrong in the effects of this merger, I believe—with deep sadness and concern—that will not prove to be the case.” She has certainly been proven correct many times since then. #pharmacy #healthcare #pbm #pcma #monopoly #pharmacist https://lnkd.in/gqEPCKUn

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💡 NEW RESOURCE 💡 As federal and state policymakers debate the role of contract pharmacies in #340B, Avalere analyzed how contract pharmacy relationships inform the policy landscape. Read the latest from Kelly Brantley, Milena Sullivan, Ekemini Isaiah, Melissa Morley, and Ashley Flint: https://lnkd.in/e85q_8j7 #drugpricing #340Bprogram #healthpolicy #healthcare

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💡New #Avalere Study 💡Do #340B contract pharmacies serve patients in rural areas? Do 340B hospitals contract with chain or independent pharmacies? Our team crosswalked a couple of data sets to get some snapshots of trends in contract pharmacy use in 340B to inform the ongoing debate in Congress. Reach out to learn how we can help you with policy design and analytics. #drugpricing #drugs #lifesciences

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Great Article on the Problems in the IRA “Year 2” Guidance—I’m Quoted Nyah Phengsitthy’s article lays out the concerns about #CMS’ “year 2” #InflationReductionAct guidance, with an emphasis on the duplicate discount and other consequences that will flow from making #340B claims identification “voluntary”. Quoting me about #CMS’ broader failure to address and take responsibility for crucial aspects of making a #Medicare Transaction Facilitator actually work: “But the guidance ‘pulls back from significant portions of what needs to be done and … dumps those critical activities on #manufacturers, #coveredentities, #contractpharmacies, and the rest of the players in the distribution channel,’ Sarraille said. ‘That’s really unfortunate. It may suggest that the start of this program might be very bumpy, very rocky.’” Here’s hoping my usual pessimism doesn’t prove clairvoyant here. If you are a manufacturer with a selected drug, you need a technology solution of your own—and fast. #lifesciences #drug pricing #MedicareAdvantage #PartD #pharmaceuticals #pharmacies #drugs U.S. Department of Health and Human Services (HHS)Centers for Medicare & Medicaid Services

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Kudos to the Centers for Medicare & Medicaid Services Drug Price Negotiation Program team for updates to their process for IPAY 2027 - it looks like they’ve heard from stakeholders and rather than those “patient listening sessions” they are going to develop much better patient-focused sessions, such as round table sessions or focus groups. I think this revised approach will be much more effective at both engaging patients, caregivers, and advocacy groups AND it will provide CMS with more useful insights for their negotiation efforts! Full May 3rd Guidance below: https://lnkd.in/gM5t9avc

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