Nicholas Lynch, CFE’s Post

Big Pharma's Lament: Medicare Price Caps Will Reduce Innovation Is Big Pharma crying wolf over Medicare's new drug pricing negotiations? Will diminished revenue from Medicare negotiating their cost of drugs, and other drug pricing controls, result in reduced research and development (R&D) and fewer innovative drugs coming to market? But let's not kid ourselves — this narrative conveniently ignores the labyrinthine economics of drug pricing and innovation. https://lnkd.in/eGwgXP-j

Excellent report by Public Citizen demonstrating why the Centers for Medicare and Medicaid Services (CMS) needs to ensure it fully understands how drugmakers’ patenting tactics impact drug prices as it enters into negotiations. Amgen’s Enbrel is a classic example of a patent system gone wrong, allowing drugmakers to extract billions from payers like Medicare by delaying cheaper biosimilars/generics. In our database, The Drug Patent Book, you can review every one of the 154 Enbrel patents our team at I-MAK uncovered: drugpatentbook.i-mak.org https://lnkd.in/eiEJGyVr

Curious about the true effects of federal drug pricing programs? While intended to aid vulnerable patients, recent insights suggest a different outcome. Here are five key insights about the 340B Drug Pricing Program from PhRMA.

Stories making headlines today in the biopharma industry: In a recent compilation of healthcare industry news: UnitedHealth Group's CEO, Andrew Witty, recently faced tough queries from Senators relating to the handling of a major cyber-attack, that eventually resulted in a $22 million payoff. The investigation primarily surrounds concerns about UnitedHealth's significant size and the impact of this recent security lapse, bringing the company's near-monopoly status into question. In other updates, Pfizer's first-quarter report suggests that their cost-cutting initiatives are nearly done, projecting a 'cautiously optimistic' future. The pharmaceutical giant seems to have tempered some audacious future forecasts and indicated that major acquisitions or mergers are not anticipated soon. Another intriguing development is Boehringer Ingelheim's recognition of AbbVie's Humira as a primary competitor for their Humira biosimilar Cyltezo – a recent addition to their product list following FDA approval. Boehringer aims to usurp Humira in PBM formularies to increase Cyltezo's market share. In legal news, Johnson & Johnson (J&J) and Bristol Myers Squibb have appealed against a ruling in a lawsuit keyed on the Inflation Reduction Act. Several pharmaceutical brands are racing against time to prevent new Medicare price negotiations expected in 2026. Senator Maggie Hassan (D-NH) has publicly reproached GlaxoSmithKline (GSK) for allegedly renegading on a prior commitment to cap inhaler prices at $35 monthly. This stems from GSK's discontinuation of a branded pediatric inhaler in favor of an authorized generic version that isn't subject to the said price cap. Lastly, J&J has suggested a $6.5 billion settlement plan aiming to address myriad lawsuits related to its talc products. With the controversy over alleged carcinogenic effects of its talc products, J&J's plan seeks to win approval from claimants before filing for Chapter 11. Stay tuned for more developments in the healthcare market. #pharma #biotech #topstories #biodatastudio

Congrats to Christine Juday and the Real Chemistry Market Access team for our first-ever guest blog with Drug Channels Institute, an HMP Global Company. Chris makes a compelling case for how patients' perceptions of what "counts" as an out-of-pocket cost are more expansive than manufacturers may think. Read the full article to learn more about the implications for biopharma manufacturers' strategies to improve access and affordability. https://lnkd.in/eWcxGTx4

There's good news in the pharmaceutical world today for manufacturers. Although we still don't have a final rule from CMS, yesterday, they released a statement saying that Best Price stacking will not be in this rule. You can read the full press release here: https://lnkd.in/e7amtB3Z. #mdrp #bpstacking #bestprice #goodnews

Stay Informed: Certara’s Caitlin Verrilli, MBA discusses the Inflation Reduction Act's profound impact on payers, patients, and providers. Elevate your understanding by exploring her expert analysis in our comprehensive blog. https://ow.ly/IsAT50PQGkK #Certara #Medicare #MedicarePartD #HealthcareCosts #ManagedCare #HealthcareTrends #Pharmaceutical

Is CMS about to Violate the “Limiting Definition”? Katie provides a terrific update on the Medicaid Drug Rebate rule, and Deborah makes the point that the “limiting rule” proposal is inconsistent with the statute. It sure is; the proposal is contrary to the plain language of the law. But CMS probably doesn’t care, and some there actually may WANT the fight. The Limiting Definition: Sec. 1927k(3) carves out certain covered outpatient drugs from Medicaid rebates. The provision “limits” the drugs subject to rebates. The provision says: “The term ‘covered outpatient drug’ does not include any drug…provided as part of, or as incident to and in the same setting as, any of the following (and for which payment may be made under this subchapter…and not as direct reimbursement for the drug).” It goes on to then cite a bunch of service types, like inpatient services, physician services, etc. So, if a drug is bundled in with one of these devices for payment purposes and a payment is not made “directly” for the drug, no rebate is owed. The Proposal: CMS proposes to “clarify” what “direct reimbursement” means: “Direct reimbursement for a drug may include both reimbursement for a drug alone, or reimbursement for a drug plus the service, in one inclusive payment if the drug and the itemized cost of the drug are separately identified on the claim”. Ridiculous: You know you are going to get some sophist gobbledygook when CMS uses the word “clarify”, and the Agency is true to form here. CMS proposes to “clarify” that a bundled, entirely indirect payment for a drug, is, magically, actually the exact opposite, so long as the “cost” of the bundled claim appears on the claim. It’s hard to know where to begin. The plain language of the statute states, clearly, that a “payment” is not “direct” when the “payment” includes reimbursement for any of the other non-drug services. CMS’ proposed “clarification” is directly contrary to the statute because it specifically targets where the payment is for a “drug-plus service” and is all “inclusive”—exactly what the statute forbids. The fact that the “cost” of the drug (not a “payment”) is included on the “claim”, which is a request for payment and not a payment, is irrelevant under the statute. So Surely CMS Won’t Finalize This? I think it will. It’s hard to look at the arc of what CMS is doing—and how aggressively it is pursuing its goals—without seeing it as waging “a war on drug price”. But Aren’t They Afraid of a Lawsuit? They aren’t—as we have seen in the IRA implementation. Well, the Office of General Counsel is probably not excited about this, but the policy and political folks are, I think, spoiling for fights. But Why? Three reasons: (1) they are hoping to win the lawsuit, but even if they don’t, they will (2) earn the political points of a fight with “Big Pharma”, and (3) they will have “shown” Congress the statute “needs” to be changed. #medicaid #drugpricing #bundledpayments

Implications of IRA, GLP-1s, CGTs Are Top of Mind for Payers: The pharmaceutical industry continues to bring innovative therapies to market, but payers are continuing to grapple with how they can manage their financial impact. And while the Inflation Reduction Act (IRA) may bring some relief to Medicare benefic... Read More #marketaccess #lifesciences #pbm

Did you see it??? CMS submitted the Final Rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434),” to the OMB on March 22, 2024, with a Final Action date of June 2024, although it could be finalized and released sooner. This is related to the Proposed Rule that included a number of significant changes, including: • The stacking of discounts for the determination of Best Price,  • A limit on manufacturers’ ability to dispute state rebate claims to 12 quarters,  • Requires all affiliated entities to participate in the MDRP if one entity participates, and • Would make a physician-administered drug that is included in a bundled payment a Covered Outpatient Drug for purposes of the MDRP if the drug is itemized separately on the claim. If you have any questions or would like a copy of the Proposed Rule, please let me know. The Final Rule will be released AFTER it has been reviewed and scored by the OMB. And of course, as soon as the Final Rule is released, The Pricing Group will provide updates.