(KPIC) PPO and Out-Of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier
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Long-Acting Cabotegravir: the Future of HIV Prep
Long-Acting Injectable Cabotegravir: the Future of HIV PrEP? Brian R. Wood, MD Associate Professor of Medicine University of Washington Mountain West AIDS Education & Training Center June 4, 2020 Disclosures No conflicts of interest or relationships to disclose. Will be discussing an investigational antiretroviral. Full HPTN 083 study results not yet available. Will be reviewing data from a preliminary DSMB analysis today. See press release and webinar: https://www.hptn.org/news-and-events/announcements/cab- la-proves-be-highly-effective-prevention-hiv-acquisition Outline • General notes about cabotegravir • News from the phase 3 PrEP trial (and why it’s a big deal) • Questions, concerns, and next steps for long-acting PrEP What is Cabotegravir? Cabotegravir (CAB) • Investigational integrase strand transfer inhibitor • Potential infrequent dosing and parenteral administration - Oral half-life: 40 hours - Parenteral nanosuspension (IM, SC) half-life: 21-50 days - Median time from discontinuation to undetectable plasma level (IM, SC): 43-66 weeks • Metabolized by UGT1A1 (main pathway) & UGT1A9 - Minimal CYP metabolism; likely few drug interactions • Relatively low barrier to resistance Aidsinfo.nih.gov/drugs Injectable Long-Acting Cabotegravir Image courtesy of Dr. Raphael Landovitz, UCLA What is the HPTN 083 Trial and What’s the Big News? HPTN 083 A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral TDF/FTC, for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and TranHPTNsgender Women wh o 083have Sex wi thSites Men – Phase 2b/3 Target enrollment: 4,500 HIV- uninfected cisgender men and transgender 45 Sites in 8 Countrieswomen who have sex with men and who are at risk of HIV acquisition Primary outcome: HIV Prevention effectiveness of cabotegravir compared to daily oral TDF/FTC United States India Vietnam Thailand Peru Brazil South Argentina Africa ClinicalTrials.gov Identifier: NCT02720094 Slide courtesy of Dr. -
Treatment of Diabetes Mellitus
TREATMENT OF DIABETES MELLITUS DIABETES is a condition that affects how the body makes energy from food. Food is broken down into sugar (glucose) in the body and released into the blood. When the blood sugar level rises after a meal, insulin responds to let the sugar into the cells to be used as energy. In diabetes, the body either does not make enough insulin or it stops responding to insulin as well as it should. This results in sugar staying in the blood and leads to serious health problems over time. DIAGNOSIS OF DIABETES1 • A1C Test: Lab test measuring average blood sugar over past two to three months • Fasting Blood Sugar Test: Lab test measuring blood sugar after eight hours of no food or drink • Oral Glucose Tolerance Test (OGTT): Measures blood sugar before and two hours after drinking a specific sugary liquid • Random Blood Sugar Test: Measures blood sugar at a moment in time, without any kind of preparation (like fasting) FASTING BLOOD ORAL GLUCOSE TOLERANCE RANDOM BLOOD RESULT A1C TEST SUGAR TEST TEST SUGAR TEST Diabetes ≥ 6.5% ≥126 mg/dL ≥ 200 mg/dL ≥ 200 mg/dL Prediabetes 5.7 – 6.4% 100 – 125 mg/dL 140 – 199 mg/dL N/A Normal < 5.7% ≤99 mg/dL < 140 mg/dL N/A NON-DRUG TREATMENTS2 THERAPY COST WHAT TO EXPECT Diet (Mediterranean diet) and exercise (30 minutes a day, five days a week of moderate- Weight loss $-$$ intensity exercise); 7% weight loss decreases risk of diabetes3 Psychological intervention $$-$$$ Psychotherapy may reduce diabetic distress and improve glycemic control4,5 nationalcooperativerx.com PRESCRIPTION TREATMENTS -
Pros and Cons of Entry and Fusion Inhibitors (Review)
MOLECULAR MEDICINE REPORTS 19: 1987-1995, 2019 Investigational drugs in HIV: Pros and cons of entry and fusion inhibitors (Review) EMMANUELE VENANZI RULLO1,2, MANUELA CECCARELLI1, FABRIZIO CONDORELLI3, ALESSIO FACCIOLÀ1, GIUSEPPA VISALLI4, FRANCESCO D'ALEO1, IVANA PAOLUCCI1, BRUNO CACOPARDO5, MARILIA RITA PINZONE2-5, MICHELE DI ROSA6, GIUSEPPE NUNNARI1 and GIOVANNI F. PELLICANÒ7 1Department of Clinical and Experimental Medicine, Unit of Infectious Diseases, University of Messina, I-90124 Messina, Italy; 2Department of Pathology and Laboratory Medicine, School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; 3Department of Pharmacological Sciences, University of Eastern Piedmont ‘A. Avogadro’, I-13100 Novara; 4Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, I-90124 Messina; 5Department of Clinical and Experimental Medicine, University of Catania, I-95123 Catania; 6Department of Biomedical and Biotechnological Sciences, Human Anatomy and Histology Section, University of Catania, I-95123 Catania; 7Department of Human Pathology of the Adult and the Developmental Age ‘G. Barresi’, Unit of Infectious Diseases, University of Messina, I-98122 Messina, Italy Received September 2, 2018; Accepted November 29, 2018 DOI: 10.3892/mmr.2019.9840 Abstract. Despite the profound changes and improve- 4. Gp41 antagonists ments reached in the field of HIV treatment, tolerability and 5. CD4 antagonists adherence to highly active antiretroviral therapy remains a 6. Discussion challenge. Furthermore, multi-experienced patients could take advantage of drugs with different mechanisms of action to combat the spread of resistance to actual therapy. For these 1. Introduction reasons identification of new HIV drugs is crucial. Among all the molecules that at present are under investigation, entry HIV continues to be an important challenge and a major and fusion inhibitors pose an interesting class owing to their global public health issue. -
LATTE Study Oral Cabotegravir + Rilpivirine Versus Efavirenz + 2 NRTI’S LATTE Study: Design
Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Design Study Design: CAB 10 mg CAB 10 mg + 2 NRTI’s + RPV 25 mg • BacKground: Phase 2b, (n = 60) (n = 52) randoMized, partially blinded study done at Multiple centers CAB 30 mg CAB 30 mg in the U.S. and Canada + 2 NRTI’s + RPV 25 mg (n = 60) (n = 51) • Inclusion Criteria (n = 244) - Age ≥18 years - Antiretroviral-naïve CAB 60 mg CAB 60 mg - HIV RNA >1,000 copies/ML + 2 NRTI’s + RPV 25 mg - CD4 count >200 cells/MM3 (n = 61) (n = 53) - CrCl >50 ML/Min - No hepatitis B Efavirenz 600 mg Efavirenz 600 mg - No significant transaMinitis + 2 NRTI’s + 2 NRTI’s (n = 62) (n = 46) 24-week lead-in phase Source: Margolis DA, et al. Lancet Infect Dis. 2015;15:1145-55. Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Results Cabotegravir + 2NRTIs Cabotegravir + Rilpivirine Efavirenz + 2NRTIs Induction* Maintenance* 100 80 86 82 76 74 71 60 63 40 HIV RNA <50 copies/mL (%) <50 copies/mL HIV RNA 20 156/181 46/62 149/181 44/62 137/181 39/62 0 Week 24 Week 48 Week 96 *Cabotegravir data is composite of all cabotegravir doses Source: Margolis DA, et al. Lancet Infect Dis. 2015;15:1145-55. Oral Cabotegravir + Rilpivirine versus Efavirenz + 2 NRTI’s LATTE Study: Results 100 Induction* Maintenance 80 60 Cabotegravir 10 mg + Rilpivirine 40 Cabotegravir 30 mg + Rilpivirine HIV RNA <40 copies/mL HIV RNA 20 Cabotegravir 60 mg + Rilpivirine Efavirenz 600 mg + 2NRTIs 0 0 12 24 36 48 60 72 84 96 Treatment Week *During induction phase cabotegravir administered with investigator chosen 2NRTIs Source: Margolis DA, et al. -
Drug Information Center Highlights of FDA Activities
Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. -
Attention-Deficit Hyperactivity Disorder (ADHD) Stimulant Step Therapy
Policy: Attention-Deficit Hyperactivity Disorder (ADHD) Annual Review Date: Stimulant Step Therapy Policy 03/18/2021 Last Revised Date: 06/17/2021 OVERVIEW All of the long-acting stimulants are indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Some products are also indicated for the treatment of narcolepsy. Vyvanse is the only stimulant medication indicated for the treatment of binge eating disorder (BED). Approval for this indication was based on two 12-week randomized, double- blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (n = 374 and n = 350) with moderate to severe BED. Patients from both studies on Vyvanse had a statistically significantly greater reduction from baseline in mean number of binge days/week at Week 12. All of these products have abuse potential and are Schedule II controlled substances. POLICY STATEMENT A step therapy program has been developed to encourage use of one Preferred product prior to the use of a Non-Preferred product. If the step therapy rule is not met for a Non-Preferred agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration. Automation: Patients with a history of one Preferred drug within the 130-day look-back period are excluded from step therapy. Preferred Medications: • Generic amphetamine/dextroamphetamine extended-release capsules (generics to Adderall XR) • Generic dexmethylphenidate extended-release capsules (generics -
PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities &
PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs By: Travis Mickle, PhD INTRODUCTION one or more of the ADME categories — Absorption, Distribution, Metabolism, and Excretion — with the goal being the creation of Attention-deficit/hyperactivity disorder (ADHD) is a neuro- a new chemical entity (NCE) that optimizes the performance, util- logical disorder associated with an ongoing pattern of inattention, ity, and potential life-cycle management of the parent drug. hyperactivity, and/or impulsivity that may impede, for example, cognitive and social functioning, and as well as mental growth and development. Since 1937, more than 25 different products ADHD THERAPEUTIC MARKET have been approved by the FDA to treat ADHD. Despite the many pharmacological advances, there is still no optimal treatment of The Centers for Disease Control and Prevention noted in a this condition, leading prescribers and patients to press for im- 2016 report from the National Survey of Children’s Health that provements that address key shortcomings with currently available 6.1 million, or 9.4% of children aged 4 to 17, suffer from ADHD. ADHD medications. Duration of efficacy, consistency of drug ex- Yet, of all children 2 to 17 years of age that may qualify to take posure and effect, onset of action, and lower abuse potential are ADHD medication, only about 317,000 (or 1 in 20) are currently just some of the key attributes that new technologies are seeking being treated. Globally, there are a reported 175 million cases to address. of ADHD in people 5 to 44 years old, and the forecast indicates In the quest for the optimal ADHD medication, leading re- that this number will rise to more than 185 million by 2025. -
Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And
Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations 24487 that authority because it addresses an (1) With a switch unit serial number (S/N) Branch, send it to the attention of the person unsafe condition that is likely to exist or 1413, 1414, 1415, 1424, 1428, 1430, 1432, or identified in paragraph (i)(1) of this AD. develop on helicopters identified in this 1433 installed, or Information may be emailed to: 9-AVS-AIR- rulemaking action. (2) With a missing or illegible switch unit [email protected]. S/N or if the S/N cannot be determined, (2) Before using any approved AMOC, Regulatory Findings installed. notify your appropriate principal inspector, Note 1 to paragraph (c): Helicopters with or lacking a principal inspector, the manager This AD will not have federalism a 206L–1+ designation are Model 206L–1 of the local flight standards district office/ implications under Executive Order helicopters. Helicopters with a 206L–3+ certificate holding district office. 13132. This AD will not have a designation are Model 206L–3 helicopters. (i) Related Information substantial direct effect on the States, on Note 2 to paragraph (c): The switch unit the relationship between the national is located on the aft fuel boost pump (1) For more information about this AD, government and the States, or on the assembly. The P/N and S/N for the switch contact Hal Jensen, Aerospace Engineer, unit could be on the outside face of the Operational Safety Branch, FAA, 950 distribution of power and L’Enfant Plaza N SW, Washington, DC 20024; responsibilities among the various attachment flange, in the cross hatched area of the switch unit. -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
Comparative Review of Oral Hypoglycemic Agents in Adults
SECTION 18.5 Comparative Review of Oral Hypoglycemic Agents in Adults Harinder Chahal For WHO Secretariat Table of Contents Acronyms: ............................................................................................................................................................................... 3 I. Background and Rationale for the review: ....................................................................................................................... 4 II. Medications under comparative review: ......................................................................................................................... 4 Table 1 - New oral hypoglycemic agents for comparison with current EML agents .......................................................... 5 III. Literature searches and methodology: ............................................................................................................................ 5 1. Title Search Results: .................................................................................................................................................... 6 2. Statement about quality of evidence: ........................................................................................................................ 6 IV. Clinical efficacy and safety evaluation: ............................................................................................................................ 6 1. DPP-4 Inhibitors (Sitagliptin, Saxagliptin) and Metformin: ........................................................................................ -
Traditional Open Drug List
Traditional Open Drug List Drug list — Four Tier Drug Plan Your prescription benefit comes with a drug list, which is also called a formulary. This list is made up of brand-name and generic prescription drugs approved by the U.S. Food & Drug Administration (FDA). Here are a few things to remember about the list: o You and your doctor can use it as a guide to choose drugs that are best for you. Drugs that aren’t on this list may not be covered by your plan and may cost you more out of pocket. o Your coverage has limitations and exclusions, which means there are certain rules about what's covered by your plan and what isn't. To find out more, view your Certificate/Evidence of Coverage or your Summary Plan Description by logging in at anthem.com and go to My Plan ->Benefits-> Plan Documents. o To help you see how the drug list works with your drug benefit, we've included some frequently asked questions (FAQ) about how the list is set up and what to do if a drug you take isn't on it. o This booklet is updated on a quarterly basis. To view the most up-to-date list of drugs for your plan - including drugs that have been added, generic drugs and more - log in at anthem.com and choose Prescription Benefits. If you have questions about your pharmacy benefits, we're here to help. Just call us at the Pharmacy Member Services number on your ID card. 05374MUMENABS Traditional Open Drug List What is a drug list? The drug list, also called a formulary, is a list of prescription medicines your plan covers. -
Antivirals: HIV –Cabotegravir/Rilpivirine (Cabenuva) Medical Policy No
Antivirals: HIV –Cabotegravir/rilpivirine (Cabenuva) Medical policy no. 12.10.99.AB-1 Effective Date: June 1, 2021 Related medical policies: • 12.10.99 Antivirals- HIV Combinations • 12.10.99.AA Antivirals – HIV: emtricitabine-tenofovir (Descovy) Note: New-to-market drugs included in this class based on the Apple Health Preferred Drug List (AHPDL) are non-preferred and subject to this prior authorization (PA) criteria. Non-preferred agents in this class require an inadequate response or documented intolerance due to severe adverse reaction or contraindication to at least ONE preferred regimen. If a drug within this policy receives a new indication approved by the Food and Drug Administration (FDA), medical necessity for the new indication will be determined on a case-by-case basis following FDA labeling. To see the list of the current AHPDL, please visit: https://www.hca.wa.gov/assets/billers-and-providers/apple-health-preferred-drug-list.xlsx Before authorization of Cabenuva will be approved, documentation from TheraCom specialty pharmacy showing the patient has been established on Vocabria must be included. Documentation must include patient’s name, patient’s date of birth, NDC, quantity/days supply, and date patient received the medication. TheraCom Pharmacy contact information: TheraCom Mailing Address: TheraCom VIIV Specific Team numbers (Used to locate TheraCom in e-Prescribing systems) Phone: 1-844-276-6299 TheraCom Fax: 1-833-904-1881 345 International Blvd Ste 200 Brooks, KY 40109 Background: Human immunodeficiency virus (HIV) is a single-stranded RNA retrovirus that attacks the immune system, specifically CD4+ T-helper cells, causing a progressive decrease in CD4+ T cell count and increased susceptibility of a person to infections.