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Pipeline Report May 2021

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Pipeline Report May 2021 Pipeline Report May 2021 Pipeline Report FebruaryMay 2021 2021 © 2021 AcariaHealth. All rights reserved. | Data is current as of 5/17/2021 Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug InformationPipeline team to Report Table of Contents increase your understanding of the drug pipeline, ensuring you are equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you will learn more about key themesMay centered 2021 on COVID-19, rare and ultra-rare conditions, CAR-T and gene therapies, as well as notable drugs such as Miplyffa, RVT-802, and aducanumab. 1 COVID-19 The treatment and vaccine landscape for COVID-19 is continually evolving. Comirnaty (Pfizer COVID-19 vaccine) has been granted Emergency Use Authorization (EUA) for adolescents 12-15 years of age, Recent Drug Approvals1 expanding on its previous authorization for people 16 years of age and older. The Ad26.COV2-S vaccine 5 (J&J/Janssen COVID-19 vaccine) was temporarily held from the market due to blood clotting concerns, but has since been returned to use. Bamlanivimab, when used alone, had its EUA revoked. Meanwhile, Upcoming Products the FDA may require increased monitoring for SARS-CoV-2 viral variants for the bamlanivimab+etesevimab combination, as well as 10 for the combination product REGEN-COV (casirivimab+imdevimab). The past quarter saw the approval of two breakthrough therapies for rare or ultra-rare conditions which previously had very limited Biosimilars or no FDA-approved treatments – Amondys 45 for Duchenne muscular dystrophy with gene mutations amenable to exon 45 23 skipping and Nulibry for molybdenum cofactor deficiency (MoCD) type A. The CAR-T therapy arena was also busy, with approvals of Abecma as the first anti-BCMA CAR-T therapy to be FDA-approved for Generic Specialty Agents relapsed or refractory multiple myeloma and Breyanzi as the third CAR-T therapy to be approved for large B-cell lymphomas, after 24 Kymriah and Yescarta. Speaking of Yescarta, it also gained its own newly approved indication for relapsed or refractory follicular lymphoma. While representing some clinical advances over existing therapies for their respective indications, the high cost of CAR-T therapies will remain in the forefront of discussions on how to optimize use of these agents. 25 Glossary Other notable pipeline developments during the last quarter include gene therapies AMT-061 and LentiGlobin. AMT-061 previously had a clinical hold imposed on its development program by the FDA in response to one reported case of liver cancer, which has since been deemed unlikely to be related to the gene therapy. The clinical hold has been lifted. LentiGlobin has also been in the 2 spotlight for serious hematologic adverse effects observed in its clinical trials for sickle cell disease, from which it too has since been exonerated. Additionally, Miplyffa (arimoclomol) is awaiting an FDA decision to become the first approved therapy for Niemann- Pick type C disease, and RVT-802, a one-time allogeneic thymic tissue regenerative therapy, expects to hear from the FDA in October on its approval for the treatment of complete DiGeorge syndrome. In the interim, we are still waiting for the FDA to make its final decision onaducanumab for mild or prodromal Alzheimer’s disease. Speculation abounds in both directions regarding this agent’s prospects for approval, to be silenced only once the FDA finally speaks. To prepare this report, our team accesses a wide range of clinical resources. This information is then analyzed, resulting in updates across multiple disease states including recent and anticipated drug approvals, key changes in the biosimilar agent landscape, and notes on recent and anticipated generic product launches. Our pipeline report is just one of many ways we are committed to providing helpful tools and resources to our clients and partners. We look forward to sharing more updates with you in the months ahead. Ross Hoffman, MD To provide comments, feedback or requests for report enhancements, please email us at [email protected]. © 2021 AcariaHealth. All rights reserved. | Data is current as of 5/17/2021 Page 2 COVID-19 Pipeline Report May 2021 FDA-APPROVED AGENTS FDA Drug Name Manufacturer(s) Approval Therapeutic Class Comments Cost (WAC) Date • 5/1/2020 - Veklury is available through an FDA Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged $520 for a 100 mg EUA: <12 years and weighing ≥3.5 kg single dose vial Veklury 5/1/2020 • 10/22/2021 - FDA-approved for the treatment of adults and $3,120 for a 5-day remdesivir Gilead FDA Treatment - antiviral pediatric patients ≥ 12 years old and weighing ≥ 40 kg requiring course intravenous infusion Approval: hospitalization for COVID-19 $5,720 for a 10-day 10/22/2020 • Veklury should only be administered in a hospital or healthcare course setting capable of providing acute care comparable to inpatient hospital care AGENTS GRANTED FDA EMERGENCY USE AUTHORIZATION (EUA) EUA Drug Name Manufacturer(s) Approval Therapeutic Class Comments Cost (WAC) Date • Current EUA is for the use of high titer convalescent plasma Original: for the treatment of hospitalized patients early in the disease Convalescent plasma U.S. Dept of Health and 8/23/2020 Treatment - blood course and to those hospitalized patients who have impaired Unknown at this time intravenous infusion Human Services Revised: product humoral immunity and cannot produce an adequate antibody 2/4/2021 response • 4/16/2021 - FDA revoked the EUA for bamlanivimab when administered alone • The EUA for combination use of bamlanivimab and etesevimab Original: $1,250 single dose LY-CoV555 remains unchanged 11/9/2020 Treatment - infusion bamlanivimab Eli Lilly Revoked: monoclonal antibody • EUA was for the treatment of mild to moderate COVID-19 in $450 administration intravenous infusion 4/16/2021 adults and pediatric patients with positive results of direct cost SARS-CoV-2 viral testing who are ≥ 12 years old and weighing ≥ 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization © 2021 AcariaHealth. All rights reserved. | Data is current as of 5/17/2021 CONTINUED Page 1 COVID-19 Pipeline Report May 2021 EUA Drug Name Manufacturer(s) Approval Therapeutic Class Comments Cost (WAC) Date • EUA for use in combination with Gilead’s Veklury (remdesivir) for treating hospitalized patients with COVID-19 infection in patients Olumiant aged two years or older, with suspected or laboratory confirmed $2,553 for 14-day baricitinib Eli Lilly 11/19/2020 Treatment - ARDS COVID-19 requiring supplemental oxygen, invasive mechanical course oral tablet ventilation, or extracorporeal membrane oxygenation $91.17 per 2 mg tablet • 4 mg once daily for 14 days or until hospital discharge • 2/25/2021 - If a patient is hospitalized for reasons other than COVID-19 and the patient reports mild to moderate symptoms of COVID-19, confirmed with positive results of a direct SARS- CoV-2 viral test, then it may be appropriate for treatment with casirivimab and imdevimab, administered together, if the patient is also at high risk for progressing to severe COVID-19 and/or hospitalization and the terms and conditions of the Original: authorization are met $1,500 single dose REGEN-COV 11/21/2020 Treatment - • FDA may require Regeneron to assess the activity of the infusion casirivimab + imdevimab Regeneron Reissued: monoclonal antibody authorized REGEN-COV against any global SARS-CoV-2 $450 administration intravenous infusion 2/3/2021; variant(s) of interest cost 2/25/2021 • EUA is for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are ≥ 12 years old and weighing ≥ 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization • No cost to patients, although healthcare facilities may charge fees related to administration Original EUA: • 5/10/2021: EUA expansion approved by the FDA for use in Comirnaty 12/11/2020 children 12-15 years of age tozinameran Pfizer Expanded Vaccine $19.50 per dose* • mRNA vaccine that expresses SARS-CoV-2 spike protein intramuscular injection EUA: 5/10/2021 • No cost to patients mRNA 1273 • mRNA vaccine that expresses SARS-CoV-2 spike protein Moderna 12/18/2020 Vaccine $15-37 per dose* intramuscular injection • No cost to patients *Initially, the federal government will supply the vaccine at no cost to providers. © 2021 AcariaHealth. All rights reserved. | Data is current as of 5/17/2021 CONTINUED Page 2 COVID-19 Pipeline Report May 2021 EUA Drug Name Manufacturer(s) Approval Therapeutic Class Comments Cost (WAC) Date • 2/25/2021 - FDA may require Lilly to assess the activity of the authorized bamlanivimab and etesevimab against any global SARS-CoV-2 variant(s) of interest. bamlanivimab: $1,250 LY-CoV555 + LY- • EUA is for the emergency use of bamlanivimab and etesevimab Original: etesevimab: pending CoV016 administered together for the treatment of mild to moderate 2/9/2021 Treatment - launch bamlanivimab + Eli Lilly coronavirus disease 2019 (COVID-19) in adults and pediatric Reissued: monoclonal antibody etesevimab patients ( ≥ 12 years of age and weighing ≥ 40 kg) with positive 2/25/2021 $450 administration intravenous infusion results of direct SARS-CoV-2 viral testing, and who are at high cost risk for progressing to severe COVID-19 and/or hospitalization • Outpatient only - no cost to patients, although healthcare facilities may charge fees related to administration • 4/23/2021 - EUA Fact Sheet for Recipients and Caregivers has been updated to include information about the remote risk of blood clots. Most people who developed these blood clots and Original: low levels of platelets were females ages 18 through 49 years.
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