Pipeline Report November 2020 Pipeline Report November 2020 © 2020 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, Table of Contents ensuring you’re equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you’ll learn more about key themes and notable drugs: Recent Specialty Drug Approvals1 1 > On COVID-19, the FDA granted full approval to Veklury (remdesivir) for the treatment of COVID-19. Veklury is approved for use in hospitalized adults and pediatric patients (≥ 12 years of age and weighing ≥ 40 Recent Non-Specialty Drug Approvals 6 kg), and represents the very first therapy to garner full FDA approval for COVID-19. Other therapies will follow, gaining market access through EUA (LLY’s Bamlanivimab and Olumiant, and <likely> Regeneron’s Upcoming Specialty Products 7 REGN-COV2). With the US crossing the 11 million total coronavirus infection mark, demand for these agents will be high while supply of the antibody treatment will be especially tight. The vaccine race accelerates as there are now two m-RNA based candidates both showing greater than 94% Upcoming Non-Specialty Products 15 efficacy in study populations. Both vaccines require 2 doses. Neither has FDA approval, and EUA reviews are pending. Supplies will be limited for months to come. Pfizer has stated it could produce 50 million doses by the end of 2020, and Moderna has promised up to 20 million doses in the same time frame. During 2021 Pfizer Biosimilars 18 forecasts 1.3 billion doses while Moderna states between 500 million and 1 billion. > Other therapies approved promise to expand and enhance patient options over currently available therapies, including Sogroya for growth hormone deficiency, Kesimpta for multiple sclerosis, and Enspryng for neuromyelitis Generic Specialty Agents 19 optica spectrum disorder. > Looking forward, we are awaiting FDA action on several key pipeline agents that each represent first-time therapies for rare or ultra-rare conditions, including Hutchinson-Gilford Progeria syndrome, Niemann-Pick type Generic Non-Specialty Agents 21 C disease, genetically mediated obesity, and molybdenum cofactor deficiency type A. > Additionally, aducanumab is another potential new treatment for a much more common condition – mild or prodromal Alzheimer’s disease. Despite a recent FDA Advisory Committee vote against FDA approval, the FDA is not required to take the advice of the Committee, and as such there remains the possibility of FDA approval in light of the intense unmet need identified in the treatment armamentarium for Alzheimer’s disease. 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’re 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]. Pipeline Report Recent Specialty Drug Approvals November 2020 FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date ENDOCRINOLOGY • Approved for the treatment of adults. Sogroya • Once weekly dosing. somapacitan-beco • Growth hormone • NovoNordisk 8/28/20 Pending launch • Estimated prevalence of adult GHD: 2-3 per Pending launch subcutaneous deficiency (GHD) 10,000 people. injection • Projected impact: cost replacement of existing therapies. INFECTIOUS DISEASES Inzameb • For the treatment of infection caused by Zaire atoltivimab, ebolavirus in adult and pediatric patients, • Zaire ebolavirus maftivimab, • Regeneron 10/14/20 Pending launch including neonates born to a mother who is RT- Pending launch infection odesivimab-ebgn PCR positive for Zaire ebolavirus infection. intravenous infusion • Projected impact: cost increase. $3,120/5-day • Approved for adults and pediatric patients (≥ course of Veklury • Coronavirus 12 years of age and weighing ≥ 40 kg) requiring therapy remdesivir • Gilead disease 2019 10/22/20 Limited access hospitalization due to COVID-19. intravenous infusion (COVID-19) $5,720/10- • Projected impact: cost increase. day course of therapy © 2020 Envolve. All rights reserved. Continued Page 1 Pipeline Report Recent Specialty Drug Approvals November 2020 FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date • An Emergency Use Authorization (EUA) was granted for the emergency treatment of mild to moderate disease in adults and pediatric patients with positive results of direct SARS- CoV-2 viral testing who are 12 years of age and older weighing ≥ 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The U.S. Note: an EUA is not the same as full FDA government will LY-CoV555 approval. cover the cost of bamlanivimab • Eli Lilly • COVID-19 11/9/20 Limited access the first 300,000 intravenous infusion • Eli Lilly will ship the first 300,000 doses of bamlanivimab bamlanivimab to AmerisourceBergen, which will doses. distribute it as directed by the U.S. government's allocation program. Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days. • Projected impact: cost increase after U.S. government cost coverage ends • An EUA was granted for emergency use of Olumiant, in combination with remdesivir (Veklury), for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized Age 2-8 years: adults and pediatric patients 2 years of age or $1,057/14- older requiring supplemental oxygen, invasive day course of Olumiant mechanical ventilation, or extracorporeal therapy baricitinib • Eli Lilly • COVID-19 11/19/20 AH has access membrane oxygenation. oral tablets Note: an EUA is not the same as full FDA Age 9 years and approval. older: $2,114/14- • Under the EUA, inpatient pharmacies in the U.S. day course of may order Olumiant through Lilly authorized therapy specialty distributors. A current list of Lilly's authorized distributors of record for the EUA is available at lillytrade.com. © 2020 Envolve. All rights reserved. Continued Page 2 Pipeline Report Recent Specialty Drug Approvals November 2020 FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date MUSCULOSKELETAL CONDITIONS • Approved for the treatment of SMA Types 1, 2, and 3. Evrysdi • PTC Therapeutics • Spinal muscular $100,000 - risdiplam 8/7/20 Limited access • Is the first daily oral therapy approved for SMA. • Roche atrophy (SMA) $340,000/year oral solution • Will compete with Spinraza and Zolgensma. • Projected impact: incremental cost increase. • Exon 53 skipping agent. • Antisense oligonucleotide. Viltepso • Duchenne • For the treatment of DMD amenable to exon viltolarsen • NS Pharma muscular 8/12/20 Pending launch 53-skipping. $733,000/year intravenous infusion dystrophy (DMD) • Will compete with Vyondys 53. • Projected impact: cost replacement of existing therapy. NEUROLOGY • For the treatment of adults with relapsing forms of MS. • Will compete with multiple other approved Year 1: $103,000 Kesimpta agents for clinically isolated syndrome and • Multiple sclerosis ofatumumab • Novartis 8/20/20 AH has access relapsing remitting disease. Year 2 and (MS) intravenous infusion • Will compete with Ocrevus and Mayzent for beyond: secondary progressive disease. $83,000/year • Projected impact: cost replacement of existing therapies. © 2020 Envolve. All rights reserved. Continued Page 3 Pipeline Report Recent Specialty Drug Approvals November 2020 FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date ONCOLOGY • For patients who have failed at least four prior therapies including an anti-CD38 monoclonal Blenrep antibody, a proteasome inhibitor, and an belantamab immunomodulatory agent. • GlaxoSmithKline • Multiple myeloma 8/5/20 Limited access $281,000/year mafodotin-blmf • Approved with a Black Box Warning intravenous infusion re: ocular toxicity. • Projected impact: cost replacement of existing therapies. • Approved for continued treatment of adults who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and Onureg are not able to complete intensive • Acute myeloid azacitidine • Bristol-Myers Squibb 9/1/20 AH has access curative therapy. $254,000/year leukemia (AML) oral tablets • Oral dosing allows for extended drug exposure during each treatment cycle to prolong therapeutic activity. • Projected impact: cost replacement of existing therapies. • Approved for the treatment of adults with metastatic rearranged during transfection (RET) Gavreto fusion-positive NSCLC. • Non-small cell lung pralsetinib • BluePrint Medicines 9/4/20 Limited access • Will compete with Retevmo for RET-positive $234,000/year cancer (NSCLC) oral capsules NSCLC. • Projected impact: cost replacement of existing therapy. © 2020 Envolve. All rights reserved. Continued Page 4 Pipeline Report Recent Specialty Drug Approvals