Garner Health’s Post

GLP-1 drugs have enormous implications not only for healthcare but also for the entire economy. You don't want to miss this important webinar on 7/23 to learn more about our findings.

Brief explanation of the variable in the Concomitant Medication (CM) domain:- Follow 👉Pankaj Salapurkar for more 🕊️ 1.CMTRT (Reported Name of Drug):- This variable records the specific name of the medication that the participant is taking. It's crucial to identify the exact drug being used for accurate analysis. 2.CMINDC (Indication):- This captures the reason or condition for which the medication is being taken. Understanding why a medication is used helps in analyzing its potential impact on the study. 3.CMDOSE (Dose per Administration):- This specifies the exact amount of the medication that is administered each time. Accurate dosing information is key for assessing drug effects and safety. 4.CMROUTE (Route of Administration):- This details the method by which the medication is given, such as orally, intravenously, etc. The route can influence the drug's effectiveness and side effects. 5. CMSTDTC (Start Date of Medication):- This records the date when the participant started taking the medication. The timing is essential for understanding how the medication might interact with the investigational product during the trial. Follow 👉Pankaj Salapurkar for more 🕊️ #clinicaldata #sas #newpost #connections #linkedinfamily #knowledge #pharma #jobs #sharing #clinicalmanagement #CM #variables #SDTM #adam #tlf

**Isn't "Under the Table" Illegal? Let’s Talk About Doctor Commissions in Medicine** We all know it’s illegal to take or give money under the table. Yet, we still hear about cases where doctors recommend specific medicines from certain pharmaceutical companies in exchange for commissions. This raises a critical question: **How is this allowed?** How is it acceptable for companies to offer commissions and for doctors to take them, especially when it directly impacts patients' healthcare costs? If this practice is illegal in other industries, why do we turn a blind eye when it comes to something as essential as healthcare? These hidden commissions don’t just inflate the cost of medicine—they add unnecessary financial pressure on patients who are already suffering. It’s time we address these unethical practices and work towards a more transparent, fair, and affordable healthcare system. Patients should only pay for the actual cost of their treatment—not for hidden commissions. Let’s start asking the hard questions. **If you agree, please support this message by sharing it in your stories or reposting it. Together, we can raise awareness and push for change.** #HealthcareTransparency #EthicalHealthcare #PatientFirst #MedicalEthics #AffordableHealthcare #StopHiddenCosts #HealthcareReform #PharmaEthics

Take two and call me in the morning...except, we can't find two to take. In the first three months of 2024, there were 323 active drug shortages, the highest number since 2001. The ongoing drug supply chain crisis continues to put people at risk. “I think a lot of people are still not getting their treatments." Comparable only to "I've never seen this before," that's not what you want to hear from physicians and pharmacists. But that's exactly what the situation is with ongoing drug shortages. And we're not talking about aspirin either. These are essential medications, which include chemotherapy agents, antibiotics, medications for attention-deficit/hyperactivity disorder and pain medications. And the problem isn't unique to the U.S. either. Parts of Europe including England, France, Italy and Germany are facing similar challenges and even at more critical levels that are putting patients at risk. As you guessed, this has everything to do with global supply and manufacturing problems. Medications with lower prices are more susceptible to supply shortages because tight profit margins may incentivize manufacturers to discontinue production. That feeds into another issue: quality. Because the manufacturing of certain drugs is limited to only a few facilities, a shutdown by the FDA due to QA issues will almost certainly result in a shortage. Drug shortages are becoming the norm and unfortunately, more frequent. And it will likely worsen. Here's a dose of reality: the average duration of shortages is typically more than three years https://lnkd.in/e3-d_C6X #supplychain #drugs #pharmacy #healthcare #hospitals #medicine #unitedstates #europe

No issues with compliance here! I learned a new term, too: 'GLP1 Discontinuation Anxiety' A Few KTs: 💉 Missed doses may set back progress 🔃 Switching may not be a feasible option, given Managing Care restrictions and 📅 titration ramp-up schedule, which could take months to re-establish The answer may seem as simple as 'just make more'...but it's not! 📈 The few manufacturers cannot keep up with global demand, which this linked study states is to the tune of over 25K NRxs/week 🔎 New manufacturing that comes online requires time to pass inspections and undergo validations; which could take many months to years 💊 Yes, orals are coming but the API needed to formulate an oral version may be much higher than the liquid injections, so orals may not necessarily be priced competitively Any takers on innovative solutions to this global demand quandary? #GLP1s #WeightLoss #AntiObesity #Lilly #NovoNordisk #Pharma #Healthcare

The entire drug middlemen system needs an overhaul and there appears to be bipartisan support in the Corgress for reforming the system - hopefully they can get their act together and push through the legislation soon! Here are excerpts from the article: “Pharmacy-benefit managers are outsmarting regulators by adapting their opaque business models and keeping data from the public”.. “Drug middlemen, known as pharmacy-benefit managers, have accomplished something rare in Washington: Their business practices have led to a bipartisan consensus of sorts around the need for more regulation. Yet successfully cracking down on the tactics that drive health costs higher won’t be easy. That is because PBMs operate in a highly complex and opaque world where key information is kept from the public.” “[A]s scrutiny of their business practices has intensified, PBMs have evolved, changing the way they make their profits in such a way that might shield them from new regulations. About a decade ago, PBMs made about 46% of their gross profits from rebates paid by pharmaceutical companies, according to a Nephron Research report. Drug companies pay PBMs to be included in benefit formularies and PBMs would essentially pocket some of those rebates. To avoid running afoul of potential regulatory actions targeting those rebates, PBMs have started passing on most of those rebates to employers. By 2022, rebates had declined to just 13% of gross profits, according to Nephron.”… “PBMs have managed to unite a whole lot of people in the healthcare industry as well as in regulatory and legislative bodies, many of whom blame them for driving up healthcare prices. But the latest revelations show that outrage is unlikely to translate into an existential threat to the industry.” https://lnkd.in/eDWBTqgC

This recent BioCentury Inc. article highlights one of the potential consequences of the #InflationReductionAct: tighter formularies for Part D drugs as plans look for mechanisms to manage their increased liability under the redesigned Part D benefit beginning in 2025. The question is – will tighter formularies mean plans take a "more of the same" approach, using tried and true utilization management (UM) techniques currently allowed by CMS versus more draconian measures that spark calls of drug rationing. (Remember, CMS must approve plans’ UM strategies – and if plans go too far, CMS can make them change their criteria.) While the article specifically calls out oncology as an area to watch, we'd bet big moves first in areas like immunology and inflammation, where management is already more palatable and there is less perceived differentiation between many agents. There's another key point to consider, one that is largely left unaddressed in the BioCentury article: how will rebates inform plans' calculus? Given their increased financial liability, plans seem likely to seek higher rebates where possible to mitigate their risk in the catastrophic coverage phase. And they have an incentive to do so, since they get to keep a greater percentage of rebate dollars now than in years past. (The fact that negotiated drugs are not required to pay statutory manufacturer discounts in either the initial or catastrophic coverage phases intensifies this need as well.) All of which is to say ... formularies may get tighter, but there will still be room for alternates, especially branded versions paying big rebates to approximate the lowest net cost of negotiated drugs. #PatientAccess #Medicare #Pharmaceuticals #HealthcarePolicy #UtilizationManagement #drugpricing #pharmaceuticals #IRA cc Roger Longman Jeff Berkowitz Susan Raiola Ryan Walsh Rob O'Brien Jane F. Barlow, MD, MPH, MBA Julia Murphy Morgan Robinson

The adoption of the International Recognition Procedure (IRP) signals another important step in trying to increase access to biosimilars by expediting #biosimilar approval; and therefore the opportunity for biosimilar prescribing.   Although undoubtedly positive in intent, challenges will remain. In particular, persistent apprehensions in a significant block of clinicians regarding the regulatory approval of biosimilars, notably those expecting head-to-head comparisons with the originator.   While seeking to improve #access, without maintaining a strong, ongoing focus on physician education, IRP could instead perpetuate existing concerns. Clinician response, particularly as biosimilars are approved via this process into less biosimilar familiar therapy areas, will be intriguing. https://lnkd.in/d5Cxb2JT #medcomms #meded #medicaleducation

2023 Fresenius Kabi research shows that Directors of Pharmacy identify drug shortages as the top issue that their institution is facing. As a manufacturer of essential medicines, we share their concerns, have made significant investments in the U.S. and are at the forefront of legislation and solutions that work to resolve the issue of drug shortages – paving a path forward where every patient has access to the medication and care that they need. Find out what we’re doing to bring #MoreSupply to America: https://lnkd.in/e79iJiZu #EndDrugShortages #MoreInAmerica

Comparative effectiveness looks beyond cost… we maximize drug savings by maximizing clinical value. Using evidence-based research, we compare drugs created to treat a specific condition based on cost and clinical value factors. Ideally, the drugs that offer the highest value come at a lower cost… but knowing that a pricier drug offers high value is better than paying less for an ineffective medication. Knowing the cost tells you nothing about a drug’s value, but comparative effectiveness can tell you exactly what you need to know. Click below to learn more today.