COVID-19 MonoclonalAntibodiesThursday, February 11, 2021

Introduction (IDPH) - 5 minutesExperiences from hospitals:Outline CHI Health Missouri Valley (KathyStone) - 20 minutesUniversity of Iowa Health Care (LisaMascardo) - 20 minutesQuestion and Answer Panel - 15 minutes Kathy Stone, PharmD, RPh, BCSCP(CHI Health Missouri Valley) Lisa Mascardo, PharmD, FASHP(University of Iowa Health Care) Alexis Beyer, PharmD, MPH, CPH (U.S.Department of Health and HumanServices) Ronald Rideman, PharmD(Regeneron)

DisclosuresLisa Mascardo, Kathy Stone, and Alexis Beyer report no actual or potential conflicts of interest inrelation to this continuing pharmacy education activity.Ronald Rideman reports he is employed by Regeneron. CEImpact has taken appropriate action forconflict resolution, including external peer review.

Objectives Discuss how to implement an outpatient monoclonal antibody infusion service within anestablished healthcare organization.Describe how to access bamlanivimab and/or casirivimab/imdevimab and identify theappropriate contact(s) who can assist with the process.List strategies to increase provider awareness and patient acceptance of COVID-19 monoclonalantibody therapies.Identify anecdotal treatment trends and outcomes realized by sites that have alreadyimplemented infusion services for monoclonal antibodies.Discuss opportunities for treating long-term care residents with COVID-19 monoclonalantibodies.

Monoclonal Antibodies (mAbs) Bamlanivimab (Eli Lilly) and casirivimab/imdevimab (Regeneron) are available underEUAmAbs directly neutralize the COVID-19 virus and are intended to preventprogression of diseaseLikely most effective when given early in infectionProduct delivered via single administration (i.e., IV infusion) 16 to 60-minute administration duration60-minute observation period

Monoclonal Antibody Patients Not authorized for use in patients:owho are hospitalized due to COVID19, ORowho require oxygen therapy due toCOVID-19, ORowho require an increase in baselineoxygen flow rate due to COVID-19 inthose on chronic oxygen therapydue to underlying non-COVID-19related comorbidity. ooEUAs for the treatment of mild tomoderate COVID-19 in adults andpediatric patients (12 years of ageand older weighing at least 40 kg):with positive results of directSARS-CoV-2 viral testing, andwho are at high risk ofprogressing to severe COVID-19and/or hospitalization.See EUAs for additional information, including high risk definitions.

Allocation Processes for Existing SitesHospitals andclinicsvia State allocationsevery two weeksLong-term carefacilities, FQHCs,dialysis centers,home infusionproviders, andcorrectional facilitiesvia Special Projects forEquitable and EfficientDistribution (SPEED)USGDetermines stateallocations based onconfirmed cases andhospitalizationsIDPHDetermines allocationsfor sites based on usageand on-hand informationUSG/USG PartnerOrganizationsReceive requestsdirectly or via IDPHand place orders todistributorDistributorShips directly to sitesidentified by IDPHDistributorShips directly tosites. SPEEDcurrently onlyreceivebamlanivimab.

New Sites Direct ordering option available for “new” sites, including infusion centers, dialysis care centers,physician’s offices, etc.Sites required to: Provide AmerisourceBergen with board of pharmacy license or physician letter of authorizationAttest to their designated class of trade and that they will administer authorized product according to theEUAProvide utilization data via Teletracking or NHSNTo submit a direct 834793b4ab549e160941e8

Monoclonal Antibody Locator ToolsHHS LocatorNational Infusion Center Association Locator

Monoclonal Antibodies and Long-Term CareAdministering monoclonal antibodies tolong-term care patients: At a hospital At long-term care facility by hospitalstaff At long-term care facility by long-termcare facility staffFor more information, see the recording forthe long-term care webinar from January 25,2021: Webinar Slides

COVID-19 Monocolonal AntibodiesCHI Health Missouri ValleyKathy Stone, PharmD, RPh, BCSCPFebruary 11, 2021

CHI Health Missouri Valley Critical Access Hospital located in Harrison County in Southwest Iowa Pharmacy Services provided: Drug regimen reviews and medication reconciliationRenal dosingAnticoagulation monitoringAmbulatory Infusion Center, which includes OncologyDrug information for the hospital and rural clinicsMedical Surgical, Outpatient Surgery, and Emergency ServicesTherapeutic Medication Decision Support

Monoclonal Antibody Planning Multi-discipline approach: PharmacyNursing – Surgery, Quality, InfusionRegistrationProvider service line for Primary Care and Emergency Services IT Services “Covid” infusion space separate from “well” infusion space with separate entrance from wellpatientsIT BuildPharmacy – drug build with universal ordering capabilities in Electronic Medical Record(EMR) and infusion pumpsRegistration – mAb “chair” additionsUpdates as the Emergency Use Authorization (EUA) total volume changed

Monoclonal Antibody Planning Available through Iowa Department of Public Health (IDPH) weekly or biweeklyallocations. Provided at no cost to the facility at this time, however, this means no patientcharge for the drug. Only charge is for the administration fee. In January, direct ordering became available for additional doses. Refrigerated single-dose vials require significant space. Resource allocation while simultaneously rolling out Covid vaccine to Tier 1A withthe same staff.

Provider Education Created a presentation and spent 1 hours going over the process with ourMedStaff. Highlights: Symptom onset documentation – must be given within 10 days of SYMPTOMS. Date of positive test documentation if not within our system. Providing Emergency Use Authorization info to the patient/caregiver and documenting theeducation and CONSENT. Provider decision to offer at testing visit pending positive or when resulted. Once positive and patient consents, contact scheduling/MAC office for them to contact the patientwith an appointment time. Place Referral to Ambulatory Infusion for bamlanivimab. At our site, pharmacy then placed theorder set on the infusion encounter.

Bamlanivimab Infusions The majority given in the infusion center with a 3-hour encounter planned 30 minutes for vitals, IV start, and medication preparation1 hour for infusion1 hour for monitoring30 minutes built in for any delays Few given in ED at our location, but some locations do give in ED if nursing andbeds available Average weekly infusions: 12 Nursing contacts ED provider to evaluate patients with O2 below 92% or out ofrange vitals prior to giving the infusion in the case that the patient condition mayhave deteriorated to needing hospitalization.

Challenges Administration understanding of the process at some locations Weekend/after-hours nursing and pharmacy availability Complexity of original EUA preparation instructions Vial must sit for 20 minutes prior to preparation to come to room tempWithdraw 70ml from 250ml bag- largest available syringe is 50mlAdd 20ml of medication for total volume of 200ml 1 FT pharmacist and 1 PT pharmacist We did not want to further burden nursing by having them have to prepare the infusion alsoMaintain work/life balance with 24/7 calls

Outcome Trends As of January 25, 2021, CHI Health Missouri Valley has given 98 bamlanivimabinfusions. Positive case count for the county from November 19, 2020 throughJanuary 25, 2021 733. 13% of positive cases during that time received themonocolonal antibody. 1 reaction – hive on face and systemic itching. The infusion was stopped. 6 have been admitted – 2 of those were within 72 hours of symptoms (1 of the 2unrelated to Covid) – 4 were 1 week from symptom onset. 2 have passed away (to my knowledge).

Long Term Care Patients With our nursing home outbreak, after bamlanivimab was available, wecoordinated with the facility to schedule residents as they tested positive. The facility brought patients to our hospital for the infusions in groups. The facility relied on CHI Health Missouri Valley for expertise and experience forinfusions and care for these patients.

Takeaways & Future Planning Multidisciplinary Support (nursing, provider, administration, pharmacy) Infection control and planning Patient scheduling vs given in ED Future planning: With the leveling off of case counts anticipated with vaccinations, we are planning tocontinue to offer on an as needed basis. Nursing leadership continues to assign a nurse eachday to be available.Weekend doses for those who are able to travel may be offered a sister location that has24/7 pharmacy staffing with nursing staff already allocated.Possibly more infusions in the ED vs dedicated staff/unit due to less complex compounding.Clinical research review of impact of mAb therapy versus those who did not receive.

COVID-19 MonoclonalAntibodies – UIHC ExperienceLisa Mascardo, PharmD, FASHPDirector, Ambulatory Pharmacy Services, UIHCFebruary 11, 2021CHANGING MEDICINE.CHANGING LIVES.

University of Iowa HealthCareAcademic medical center serving patients from all 99counties.845-bed Hospital56,000 Emergency Department visits200 Outpatient Clinics accommodate morethan 1 million clinic visits annually

Space Evaluation 4 potential locations Considerations:– Air handling– Transport of patients (distance, amount of contact with others)– Staffing (nursing, provider oversight)– Emergency response– Patient drop-off/parking– Drug prep/delivery/storage– EHR build– Power/data/infrastructure– Patient scheduling– Capacity/number of patients who could be infused daily

Patient Evaluation for Therapy EHR report built that identified COVID-19 patients who metEUA criteria Leveraged workflows built by Influenza-Like-Illness (ILI) andHome Treatment Team (HTT) groups to identify eligible patients Expert panel evaluated literature and approved process– Limited to patients 18 and older– Available to pregnant patients after consult with OB Originally concerned that Demand Supply, so addedadditional qualifying criteria Pharmacists called qualifying patients to offer Ab therapy

COVID Risk Score Criteria and Stratification


Patient Conversations Early experience – most patients wanted to discuss with familybefore calling back to be scheduled Reasons for hesitation:– Mild symptoms– Young (18-40 yrs/old)– Few antibody qualifiers (often only BMI 35)– Concerns about adverse effects– Cost– Not wanting an “experimental” drug

Increasing Awareness and Uptake All patients with positive COVID-19 tests who meet criteria areoffered therapy Information created for employee website and sent directly toproviders from CMO Article in local newspaper As numbers of positive cases declined, the minimum COVID-19risk score was lowered to increase uptake

Infusion Data to Date (2/2/21) Patients infused: 368 Average patient age: 57.7yrs Average # days from symptom onset to infusion: 4.77 # admissions post infusion: 13 (not necessarily COVID related) Infusion stopped for 1 patient for possible reaction (laterdeemed unrelated to infusion) Average # days from infusion to admission: 6.23 Infusions by COVID risk score (graph on next slide)

Infusions by COVID risk score

Administrations per WeekDoses Administered6050Doses403020100123456Week78910

Challenges and Responses Differences in preparation requirements of products (requestedmore bamlanivimab) Availability of transportation for patients Ability to predict number of infusions (and staffing needs) Outside referrals/test results (including LTC patients) – routethrough ILI clinic/telemedicine process for referral for infusion

Planning and Management TeamsProviders: Dr. Rami Boutros, Executive Medical Director, Off-site Ambulatory Programs Dr. Andy Bryant, Director – COVID-19 HomeTreatment Team Dr. Katie Imborek, Medical Director – Influenza LikeIllness (ILI) Telemedicine and Respiratory Clinic Dr. Dilek Ince, Clinical Associate Professor of InternalMedicine – Infectious DiseasesIowa River Landing Management Team: Dr. Rami Boutros, Executive Medical Director, Off-site Ambulatory Programs Heather Day, Nurse Manager, Iowa River Landing Michelle Turner, Associate Director, NursingServices, Iowa River Landing Steve Woodward, Director, Clinical Services, IowaRiver LandingPharmacy Team: Mike Brownlee, Chief Pharmacy Officer Angela Hunter, IRL Pharmacy Practice Specialist Lisa Mascardo, Director, Ambulatory Pharmacy Heidi Wood, Interim Ambulatory ClinicalPharmacy ManagerHealth Care Information Systems Team: Nathanael Adam, Assistant Director,Administrative Applications, Health CareInformation Systems Sarah Hacker, Lead Application Developer, HealthCare Information Systems Keri Semrau, Associate Director, Ambulatory CareServices

Q & A SessionKathy Stone, PharmD, RPh, BCSCP (CHI Health Missouri Valley)Lisa Mascardo, PharmD, FASHP (University of Iowa Health Care)Alexis Beyer, PharmD, MPH, CPH (U.S. Department of Health and Human Services)Ronald Rideman, PharmD (Regeneron)

Helpful LinksGeneral ResourcesOperation Warp Speed Monoclonal AntibodyPlaybookNational Infusion Center Association COVID-19Antibody Treatment Resource CenterIDPH Monoclonal AntibodiesHHS ASPR Outpatient Therapeutics Mini-SeriesBamlanivimab (Eli Lilly)Bamlanivimab Letter of Authorization (EUA)Bamlanivimab Provider Fact SheetFDA Frequently Asked Questions on the EUA forBamlanivimabLilly Bamlanivimab InformationLilly Bamlanivimab Antibody PlaybookBamlanivimab Pocket Resource CardBamlanivimab Overview, Allocation, and DistributionCasirivimab/Imdevimab (Regeneron)Casirivimab/imdevimab Letter of Authorization (EUA)Casirivimab/imdevimab Provider Fact SheetFDA Frequently Asked Questions on the EUA forCasirivimab ImdevimabImportant Prescribing Information: A Letter fromRegeneron to Healthcare Providers on PreventingMedication ErrorsRegeneron Casirivimab/imdevimab InformationRegeneron Casirivimab/imdevimab GuidebookCasirivimab/imdevimab Overview, Allocation andDistributionBilling and CodingCOVID-19 Frequently Asked Questions on Medicare Feefor-Service BillingCMS Monoclonal Antibody COVID-19 InfusionInsurance Coverage of Monoclonal Antibody TreatmentDrug Supply Chain Security Act (DSCSA)

Continuing EducationContinuing Pharmacy Education (CPE) for “COVID-19Monoclonal Antibodies” has been accredited by CEimpact, anACPE-accredited provider of continuing pharmacy education.Although you attended the live session, you MUST completethe online requirements to obtain your CPE Credit. Thedeadline for obtaining your CPE credit is March 11, 2021.Login at Complete the Course Exam andEvaluation, then follow the instructions to access yourcompletion certificate or your CPE Statement of Credit on CPEMonitor.AccessPractice RoleCodeEmergency and Trauma y TechniciansNt7pvFPhysicians7X5mAbPhysician AssistantsFEcSKc

ContactVisit tion-for-Providers.For questions, please contact CassieKennedy at [email protected] (515) 330-5755.

Identify anecdotal treatment trends and outcomes realized by sites that . Monoclonal Antibody Locator Tools. HHS Locator National Infusion Center Association Locator . At a hospital At long-term care facility by hospital staff At long-term care facility by long -term care facility staff