OMAKASE CONSULTING’s Post

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfalls associated with oral treatments.   Now, after multiple delays, the Illinois pharma giant has a new offering on the table as it has scored FDA approval for its more convenient, subcutaneous follow-up Vyalev. Vyalev, previously known as ABBV-951, features foscarbidopa and foslevodopa, which are the prodrugs for standard-of-care medicines carbidopa and levodopa. Prodrugs are drug derivatives that become active after entering the body. The therapy is delivered as a 24-hour continuous infusion to treat motor fluctuations in adults with advanced Parkinson’s. AbbVie already markets a carbidopa and levodopa combination with Duopa. That med launched in 2015 as a novel delivery system meant to skirt common downfalls of oral carbidopa/levodopa treatment. Duopa is administered directly to the small intestine through a stomach tube that requires a surgical procedure to put it into place... #parkinsonsdisease #parkinsonsdrug #levodopa #neurodegenerativedisease

This is not the fault of “biosimilar hesitant” physicians, nor is it because there is a lack of very low priced adalimumab biosimilars. We have a formulary construction crisis in the United States where 80% of formularies constructed are done by 3 companies that have convinced many of “the powers that be” including self insured companies, that they choose the lowest “net cost drugs” for their client’s formularies. This actually means these PBMs choose the drugs that make themselves the most money. The biosims just don’t make them as much money. They continue to have a “very good relationship” with AbbVie and continue to offer preferred placement to Skyrizi and Rinvoq. PBMs no longer make most of their money on rebates. It is now on fees and the specialty pharmacies they own & Skyrizi and Rinvoq do not let them down in those areas. (I don’t mean to say that Skyrizi and Rinvoq are not good drugs, because they are.) I think PBMs shifted revenue source from rebates, as they could see the handwriting on the wall with rebate transparency and pass through happening, at some point the future, The sad truth is all of that money they’re making from the manufacturer still is not benefiting the patient in terms of their cost share. The bottom line is we have to somehow incentivize “he who creates the formulary“ to choose lower priced drugs for formularies, not just the ones that make them the most money based on their high list price.

I’ll share a discussion I had with Alan Pannier, Pharm D,MBA about biosimilars last month. He highlighted the case of a Humira biosimilar coming to market at $500. Here’s the thing, the big guys are used to making $1,000 per script on Humira. Did the competition get on the market? Only in very limited ways because they actually wanted to deliver a low cost product to the market. This is only one example where Express Scripts by Evernorth, Optum, and CVS Caremark have increased prices for employers and everyday Americans. It’s a shame the company didn’t report these “negotiation” tactics to the Federal Trade Commission. I hope for the Big Three there’s something missing from this story, because otherwise, refusing to cover a lower priced, equally effective drug seems like it could be a problem.

𝗡𝗼𝘃𝗲𝗹 𝗣𝗮𝘁𝗶𝗲𝗻𝘁-𝗙𝗿𝗶𝗲𝗻𝗱𝗹𝘆 𝗢𝗿𝗼𝗱𝗶𝘀𝗽𝗲𝗿𝘀𝗶𝗯𝗹𝗲 𝗙𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗜𝘃𝗲𝗿𝗺𝗲𝗰𝘁𝗶𝗻 𝗶𝘀 𝗔𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲𝗱 𝗪𝗶𝘁𝗵 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗣𝗮𝗹𝗮𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆, 𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗔𝗯𝘀𝗼𝗿𝗽𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗟𝗲𝘀𝘀 𝗩𝗮𝗿𝗶𝗮𝗯𝗶𝗹𝗶𝘁𝘆: 𝗛𝗶𝗴𝗵 𝗣𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗳𝗼𝗿 𝗣𝗲𝗱𝗶𝗮𝘁𝗿𝗶𝗰 𝗨𝘀𝗲 by Dao, K., Buettcher, M., Klervi Golhen, PharmD, Jonas Kost, Schittny, A., Duthaler, U., Atkinson, A., Haefliger, D., Guidi, M., Bardinet, C., Chtioui, H., Boulekbache, A., Buclin, T., Jörg Huwyler, J., Marc Pfister M.D. and Rothuizen, L.E. Ivermectin has been used since the 1980s as an anthelmintic and antiectoparasite agent worldwide. Currently, the only available oral formulation is tablets designed for adult patients. A patient-friendly orodispersible tablet formulation designed for pediatric use (CHILD-IVITAB) has been developed and is entering early phase clinical trials. To inform the pediatric program of CHILD-IVITAB, 16 healthy adults were enrolled in a phase I, single-center, open-label, randomized, 2-period, crossover, single-dose trial which aimed to compare palatability, tolerability, and bioavailability and pharmacokinetics of CHILD-IVITAB and their variability against the marketed ivermectin tablets (STROMECTOL) at a single dose of 12 mg in a fasting state. Read more in the article. #pharmaceutical #TIPtechnology

Roche announced today that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect more than nine million people in the European Union (EU) and can have a devastating impact – physically, emotionally, and economically – on those affected, their families and caregivers. “Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.” The Vabysmo PFS provides ophthalmologists with the first and only CE-labelled needle for intravitreal injection. Vabysmo PFS delivers the same medicine as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format. More than five million doses of Vabysmo have been distributed globally since its initial US approval in 2022. Vabysmo PFS was first approved for nAMD, DME and RVO by the United States Food and Drug Administration in July 2024. Vabysmo PFS will be the European Union’s first and only prefilled syringe containing a bispecific antibody to treat retinal conditions that can cause blindness.   #ophthalmology #nAMD #DME #RVO #faricimab #VabysmoPFS #Vabysmo #Roche

Heart medication: Beta Blockers Beta-blockers vary in their specificity towards different receptors, and accordingly, the effects produced depend on the type of receptor(s) blocked as well as the organ system involved. Some beta-blockers also bind to alpha receptors to some degree, allowing them to induce a different clinical outcome when used in specific settings. The negative chronotropic and inotropic effects lead to a decreased oxygen demand; that is how angina improves after beta-blocker usage. These medications also prolong the atrial refractory periods and have a potent antiarrhythmic effect. Beta-blockers classify as either non-selective or beta-1 selective. There are also beta-blocking drugs that affect both beta-2 and/or beta-3 selectively; neither has a known clinical purpose to date. Non-selective agents bind to both beta-1 and beta-2 receptors and induce antagonizing effects via both receptors. Examples include propranolol, carvedilol, sotalol, and labetalol. Beta-1 receptor-selective blockers like atenolol, bisoprolol, metoprolol, and esmolol only bind to the beta-1 receptors; therefore, they are cardio-selective. Traditionally, beta-blockers have been contraindicated in asthmatic patients. However, recommendations have aligned for allowing cardio-selective beta-blockers, also known as beta-1 selective, in asthmatics but not non-selective beta-blockers. Non-selective beta-blockers should not be used in patients with asthma. Patients who have either acute or chronic bradycardia and/or hypotension have relative contraindications to beta-blocker usage.  Specific beta-blockers are contraindicated depending on the patient's past medical history. Patients diagnosed with long QT syndrome or who have had torsades de pointes in the past should not use the drug sotalol. Patients with the Raynaud phenomenon should avoid beta-blockers due to the risk of exacerbation. My comment: The selectivity of drugs (chemical) is dose dependant, in therapeutic range is selective for receptor that It supposed to action on, but if you increase the concentration further this "selectivity" is lost.

AOP Orphan Pharmaceuticals' Rapiblyk™ (landiolol) is now FDA-approved for rapid heart rate reduction in US hospitals! This ultra-short-acting drug offers a new treatment option for adults with supraventricular tachycardia (SVT), including atrial fibrillation and atrial flutter, requiring immediate intervention. Clinical trials demonstrated a significant heart rate decrease in 40-90% of patients within 10 minutes, with minimal blood pressure reduction. This approval is a major milestone for AOP Health, expanding access to vital critical care solutions and fulfilling our mission of helping patients with rare diseases. We're thrilled to bring this innovative therapy to US patients! #AOPHealth #Rapiblyk #FDAapproved #SupraventricularTachycardia #AtrialFibrillation #AtrialFlutter #CriticalCare #Cardiology #Innovation

 In 1 year over a quarter of the adult population in the USA had a prescription dispensed for antidepressants, opioids (for non-cancer pain), gabapentinoids, benzodiazepines, or Z-drugs. Given evidence from clinical studies and patients' experiences, sudden cessation of these medicines can lead to physical and psychological withdrawal symptoms. I work in pharma and the ability to re-shore pharma production, or make these drugs here in the USA, will take 3-5 years to ramp up, not an overnight possibility. https://lnkd.in/gWz-U7_d doi: 10.1016/S2215-0366(19)30373-6

Adverse drug reactions (ADRs) are unintended, harmful responses that occur when a drug is administered at normal doses for the purpose of prophylaxis, diagnosis, or treatment. These reactions can range from mild to severe and may affect various organs and systems of the body. ADRs are a significant concern in clinical practice because they can impact patient safety, lead to additional medical treatment, and increase healthcare costs. They are distinct from side effects, which are known and often expected secondary effects of a drug. Adverse drug reactions (ADRs) can be classified into several types based on various factors, including their predictability, mechanism, and severity. Here are the main types of ADRs: Type A (Augmented) Reactions: Predictable: These reactions are dose-dependent and related to the pharmacological action of the drug. Examples: Side effects like nausea from antibiotics, hypoglycemia from insulin, and bleeding from anticoagulants. Type B (Bizarre) Reactions: Unpredictable: These reactions are not dose-dependent and are often unrelated to the pharmacological action of the drug. Examples: Allergic reactions, anaphylaxis, and idiosyncratic reactions like drug-induced lupus. Type C (Chronic) Reactions: Long-term Effects: These reactions occur as a result of prolonged drug use. Examples: Tardive dyskinesia from long-term use of antipsychotics, nephrotoxicity from prolonged use of NSAIDs. Type D (Delayed) Reactions: Delayed Onset: These reactions occur after a long time of drug exposure or after the drug has been discontinued. Examples: Carcinogenic effects like secondary cancers from chemotherapy, teratogenic effects like birth defects from drugs taken during pregnancy. Type E (End of use) Reactions: Withdrawal Effects: These reactions occur when a drug is suddenly discontinued. Examples: Withdrawal symptoms from stopping corticosteroids, opioids, or benzodiazepines. Type F (Failure of therapy) Reactions: Therapeutic Failure: These reactions occur when a drug fails to produce the intended therapeutic effect. Examples: Antibiotic resistance, contraceptive failure due to enzyme induction by other medications. Understanding these types of ADRs helps healthcare professionals, including pharmacists, in identifying, managing, and preventing them effectively. #pharmacist #drug #adversedrugreaction #bpharm #linkedin #reactions

🔍 Ulcerative Colitis Clinical Pearls 🔍   Here’s a brief overview of the latest UC clinical guidelines:   1. Induction & Maintenance Therapy: Most medications effective for inducing remission in UC are continued as maintenance therapy, except for corticosteroids and cyclosporine. 🩺   2. Treatment Selection: Choose induction and maintenance therapies based on disease extent, severity, and prognosis. 🧑⚕️   3. First-Time Biologic Users: For moderate to severe UC patients new to biologics, the AGA recommends infliximab or vedolizumab over adalimumab for inducing remission. 🌟   4. Managing Non-Response to Anti-TNF Agents:   - Background: 20% of patients may not respond to anti-TNF agents, and 10-15% may lose response annually due to factors like infections or low drug levels.   - Management Strategies:     - If there’s no initial response, consider switching to a different drug class.     - For loss of efficacy, try an alternative anti-TNF agent (not a biosimilar).     - Tofacitinib and upadacitinib are reserved for those with inadequate response to anti-TNF therapies.   5. Alternative Options: For moderate to severe UC patients unresponsive to infliximab, the AGA suggests ustekinumab or tofacitinib over vedolizumab or adalimumab for inducing remission. 💊   6. Therapeutic Drug Monitoring: Consider this to guide therapy choices effectively. 🔬 For updated information, see the following:  2019 ACG Clinical Guideline: Ulcerative Colitis (UC) in Adults: https://lnkd.in/gKdtji7F American Gastroenterological Association (AGA) 2020 Clinical Practice Guideline on the Management of Moderate to Severe UC: https://lnkd.in/g7zr9DMD     #UlcerativeColitis #ClinicalGuidelines #Gastroenterology #IBD #HealthcareInnovation #SpecialtyPharmacy