Increasing the Use of Monoclonal Antibodies in Virginia - Thursday, February 11, 2021 11:00 a.m - 12:00 noon
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Increasing the Use of Monoclonal
Antibodies in Virginia
Thursday, February 11, 2021
11:00 a.m. – 12:00 noon
Housekeeping • Webinar is being recorded • All participants are in listen-only mode • Ask questions or make comments by typing in the Questions box • Slides are available for download in the Handouts section of the webinar control panel • Feedback survey will launch at conclusion of the webinar
AGENDA
1. Welcome and Objectives
– Abraham Segres, VHHA
2. COVID-19 Novel Therapeutics: Update on Monoclonal Antibody Agents
– Dr. Chris Ghaemmaghami, VDH
3. Use Case #1 – Sentara Healthcare
– Dr. Joel Bundy
4. Use Case #2 – Inova
– Dr. John Paul Verderese and Erin Hodson
5. Questions & Answers
6. Closing Remarks
Objectives 1. Provide a status report on the current use of monoclonal antibodies across the Commonwealth. 2. Share experiences and insights from providers currently using monoclonal antibodies in Virginia. 3. Provide guidance on how to increase use of monoclonal antibodies in Virginia.
COVID-19 Novel Therapeutics:
Update on Monoclonal Antibody
Agents
VHHA
2/11/2021
VHHA Bed Capacity Report 6
Clinical background 7
EUA
Latest EUA News
February 09, 2021
• The U.S. Food and Drug Administration issued an
emergency use authorization (EUA) for
bamlanivimab and etesevimab administered
together for the treatment of mild to moderate
COVID-19 in adults and pediatric patients
• Bamlanivimab and etesevimab bind to different
but overlapping sites on the spike protein of the
virus.
9
High Risk Criteria 10
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in
Outpatients with Covid-19: Hospitalization Incidence
Graphic credit: University of Washington
7
6.30
6
Hospitalization Incidence (%)
5
4
3
1.90 2.00
2 1.60
1.00
1
0
700
* An improvement from mg score of2,800
a baseline 2 to 5 tomg 7,000
a score of 6 or mg
7 or from Pooled
a baseline score of Doses
6 to a score of 7.Placebo
Treatment Regimen
Source: Chen P, et al. N Engl J Med. 2020 Oct 28. doi: 10.1056/NEJMoa2029849849Monoclonal Antibodies Treatment Effects
Individual Population
Reduces viral load Reduces rate of transmission
Reduces admission rate Reduces inpatient burden
Reduces ED return rate Reduces ED crowding
No proven mortality reduction Fewer cases Fewer deaths
For 10,000 pts: No drug: 630 admissions & ED visits
With drug: 170 admissions & ED visits
12Program Goals
•Maximize utilization of the allocated drugs
within the appropriate medical indications for
use for the next 3 months (during the current
surge).
•Ensure access of these agents to underserved
populations throughout all geographic regions
of the Commonwealth
13Number Needed to Treat (NNT)
• Bamlanvimab
• 4-10% absolute risk reduction
• NNT = 10 to 25
• Warfarin for A. Fib
• In patients without a history of previous stroke, the NNT for one case of
stroke prevention with warfarin is 25.
• Statins
• In patients without known heart disease receiving daily statin therapy
for 5 years, the NNT for heart attack prevention is 104. Moreover, the
NNT for stroke prevention is 154.
• Antihypertensives for cardiovascular disease
• In people receiving antihypertensive therapy for 5 years, the NNT to
prevent 1 death is 125.
• The NNT to prevent heart attack is 100, and to prevent stroke, 67Cost • The federal government has bought hundreds of thousands of doses • This is a SUNK COST. • Patients are not charged for the drug, but they may be charged for their clinic visit/infusion services
For Questions or More Information
Contact:
Chris Ghaemmaghami, MD
VDH Clinical Consultant
chris.ghaemmaghami@vdh.virginia.gov
cg3n@virginia.edu
16Joel Bundy, MD Chief Quality Officer Sentara Healthcare Feb 10, 2021
Linked/proximity to hospital/ED (hospital without
walls) Scheduling & Notifying Patient Leaders
Location Region Address to provide to Patient Days of Service Hours of service
SI Infusion Center (In the Gym) HR - Southside SI (beside the ED) Infusion Center at SI Ops: Christine Ladd Sentara Independence
Pharmacy: Amanda Lang & Tyler Martinson 800 Independence Blvd
Virginia Beach, VA 23455
SAMC Infusion Center Albemarle In Hospital Infusion Center at SAMC Ops: Paula Copeland Sentara Albemarle Medical Center
Pharmacy: Kathryn Wheeler 1144 N Road Street
Elizabeth City, NC 27909
SWRMC Transition Unit (next to the Williamsburg In Hospital Infusion Center at SWRMC Ops: Jill Yates Sentara Williamsburg Regional Medical
ED) Pharmacy: Terri Sim Center
100 Sentara Circle
Williamsburg, VA 23188
SCH Hampton In Hospital Infusion Center at SCH Ops: Chandra Hubbard Wright Sentara Careplex Hospital
Outpatient Infusion Center Pharmacy: June Javier 3000 Coliseum Drive
Hampton, VA 23666
SOH Infusion Center Western Tidewater In hospital Infusion Center at SOH Ops: Christy Lynch & Amy Taylor Sentara Obici Hospital
Pharmacy: Sherri Dupart 2800 Godwin Blvd
M-F 8-4:30
Suffolk, VA
SMJH Minor Medical Procedures Charlottesville In Hospital Central Scheduling – Blue Ridge Ops: Ladonna Winegar & Danielle Schrader Sentara Martha Jefferson Hospital
beside ED Pharmacy: Doug Paige 500 Martha Jefferson Drive
Charlottesville, VA 22911
SRMH OP Fusion Center (Treatment Rockingham In Hospital Central Scheduling – Blue Ridge Ops: Jill Bryd & Tracey Gentry Sentara SRMH Medical Center
Center) Pharmacy: Jamin Engel 2010 Health Campus Drive
Harrisonburg, VA 22801
SNVMC Infusion Center /Bronch Room NoVa In Hospital Infusion Center at SNVMC - Ops: Dawn Byrne Sentara Northern Virginia Medical Center
Pharmacy: Diane Buckey 2300 Opitz Blvd
Woodbridge, VA 22191
SHRH ED Treatment Room (3 chairs) Halifax In Hospital Infusion Center at SHRH Ops: Joni Woltz Sentara Halifax Regional Hospital
Pharmacy: David Fitts 2205 Wilborn Ave.
South Boston, VA 24592Outpatient Pathway
Patient gets Patient
Monoclonal AB contacted and
Patient with infusion scheduled for
symptoms Limited Hours infusion
Evaluated for
Calls approval
PCP *all cases meeting EUA
criteria are approved
Review cases M-F
Patient contacted with
+ test results
Tele-med visit or If pt meets criteria,
office visit + test Physician discusses
Open 1 to 3 days with pt about
Limited Hours Monoclonal AB and Paperwork faxed
provides fact sheet -
patient agreesMost doses given in last few days…
Number of doses
Days between symptom onset and administrationProblem: how do we get it to the patients? • Infusion should be done within 10 days of onset of symptoms-difficulty to arrange this as outpatient. • Infusion Centers have patient space and medication available but limited hours and need to ensure separation of COVID+ patients from others • Multi step process is leading to missed opportunity • PCR and antigen test accepted • Population SNF, transportation issues/homebound, dialysis patients, difficulty IV access patients-are not able to access the Infusions Centers
ED Pathway Patient gets
Monoclonal AB Patient
infusion contacted and
scheduled for
Patient develops
infusion
symptoms
Given in
the ED if
Comes
out of time Evaluated for approval
to ED
and/or
transport
issues,
paperwork
faxed
Suspect COVID-Patient meets criteria for infusion, Rapid
Referred to OPIC if Paperwork faxed
PCR + information sheet given and discussion with
within time range
patient about infusion
and has
transportationCOVID-19 ED OBS
.XOBSADMIT .XOBSDCCOVID19
Language added to ED OBS Admit Note Dedicated ED observation discharge note
• Observation Course Summary: *** Patient was found to be a
candidate for COVID-19 monoclonal antibody infusion. Pt
received the IV infusion of Covid-19 monoclonal antibody and
tolerated without any significant side effects or allergic reaction.
• Discharge Assessment & Plan: *** Patient tolerated their infusion
of Covid-19 monoclonal antibody without incidence. They were
observed for 1hr after the infusion and there was not any
evidence of clinical decompensation, will discharge home
• Discharge Instructions and follow-up as noted in system-Patient
or caregiver was given the Patient fact sheet for COVID-19
monoclonal antibody therapy. patient or caregiver aware they
must continue to self-isolate and use infection control measures
according to the CDC guidelines, and return for rash, swelling,
increased shortness of breath, change in mental status, severe
headache, fever, or inability to tolerate PO.COVID-19: several weeks in… ED lessons learned- over 30 infusion Pharmacy to dose order: Doses Monoclonal antibody and additional PRN medications for allergic reaction. • Added 2 to 3 hours to ED stay • Patient centered-almost every patient referred to the Infusion Center asked if it could be done in ED • Area of opportunity is to have the ED be able to schedule patient’s appointments in the infusion center for those that can get to one (this is already done for rabies vaccines) • Fully staffed ED with nurses is essential to provide this service • Requires coordination with ED leadership, PCS, hospital pharmacy, administration, lab, providers and patient/family
COVID-19 Antibody Summary
27
Inova Extended COVID-19 Care Clinic (ECCC) Erin Hodson, MSN – Inova Medicine Service Line Vice President John Paul Verderese, MD – Inova Translational Services Medical Director
Table of Contents
Program Summary
Timeline
Referral Workflow
Questions to Consider Going Forward
AppendixOperationalizing the Inova MAB Infusion Clinic
• Over 1,000 COVID Patients treated in two months
• Scheduling provided through our central scheduling team
• Telemedicine consults provided through ED providers to qualify patients for
the infusion and provide appropriate follow up for COVID patients
• Three Clinic Locations open throughout the Northern Virginia region
- Co-Located the clinics within existing sites of care through the Hospital
without Walls waiver
- Lorton (co-located within the offsite Emergency Room)
- Reston (co-located within the offsite Emergency Room)
- Fairfax (opening within the Research Clinic location)
• Extended the MAB infusions at all Inova EDs in mid January
- Regeneron mixed by our pharmacy team at our onsite ED locationsClinic Demographic Data as of 2/8/2021
MAB Infusion Volumes as of 2/9/2021
Inova Extended COVID-19 Care Clinic Workflow
Patients eligible for monoclonal antibody infusion:
• Positive COVID test and symptom onset within 10 days AND
Non-Inova online • At high risk for progressing to severe COVID-19 and/or hospitalization (see below)
Inova ED, PCP, UCC referral form submitted
to High Risk is defined as patients who meet at least one of the following criteria:
Referrals via Epic • Have a body mass index (BMI) BMI ≥ 35
ExtendedCOVID19CareC
• Have chronic kidney disease
Referral order name
linicSchedulingLeaderSu • Have diabetes
pport@inova.org • Have immunosuppressive disease
Inova.org/COVIDCLINIC • Are currently receiving immunosuppressive treatment
• Are age ≥65
• Are age ≥ 55 AND have
Patient calls • cardiovascular disease OR
571-472-4502 • hypertension, OR
to schedule • chronic obstructive pulmonary disease/other chronic respiratory disease.
appointment
Stable & Recovering
Routine follow-up @ Primary Care
Scheduling team schedules telemedicine visit. Telemedicine visit for
Patient eligible for
Team reaches out to patients on work-que or assessment with
Extended Care
receives incoming calls. Transitional Clinic
COVID Clinic High Risk Decompensating
Led by Jenny Renee / Scheduling provider NO
Send to Hospital ER:
Transitional Clinic provider calls ER ahead of
patient arrival to discuss case
Scheduling team
schedules at Extended Transitional Clinic provider Research
Care COVID Clinic and places medication infusion Patients will be referred to Stephanie
provides: order after confirmed Garafalo’s team via Epic in-basket.
• On Arrival Instructions Patient calls COVID+ test (3 hr visit)
• Verify expected 571-472-4502
charges, insurance info to schedule
YES
• Confirm interpretation appointment Transitional Clinic provider
needs – note in Epic. places order for Extended
See Patient on Arrival Slide
COVID Care Clinic follow
Led by Jenny Renee / up visit (1 hr visit)
Scheduling
See Pharmacy workflow See Nursing workflow
Reminder Call (Nurse) Patient Arrival
• Confirm COVID+ results morning Clinical Infusion (Nurse) Transition back to
• Reston: Call on
of or night before • Education: risk and benefits community provider
arrival: 703-668-8334 Assessment by
• Confirm patient instructions, and • Provide fact sheet (link in order-set) Monitoring
• Lorton: Call on APP or MD or Transitional
check interpretation needs. • Charting requirements for first two steps
arrival: 703-982-8370
• Release infusion order
Services Clinic if no
• Confirm drug availability before
patient arrival. Lorton or Reston Lorton or Reston medical home.
Lorton or Reston Lorton or Reston
Lorton or RestonAmbulatory Referral to Extended COVID-19 Care Clinic Assessment
Community Referrals
Inova.org/COVIDCLINIC
•Undiscoverable online referral form for
community providers.
•Qualifying screening questionnaire &
patient/provider information.
•Submissions will be reviewed by
Jenny’s scheduling team who will
schedule patients for telemedicine
visits.
•ExtendedCOVID19CareClinicScheduli
ngLeaderSupport@inova.orgAmbulatory Referral to Extended COVID-19 Care Clinic for Scheduling
Pulse Oximeter Distribution
• Each Inova ER, Inova Urgent Center, and Primary Care Office, will receive a
distribution of pulse oximeters as they are available to provide to patients at
discharge that meet referral criteria to Inova’s Extended COVID-19 Care Clinics.
• These are not continuous pulse oximeters.
• Contact:
- Patti Hoch from Inova Supply Chain (Pat Davis from case management will
provide initial supply).
- Please provide Patti Hoch with your point of contact for pulse oximeter
distribution.
• InovaNet – Patient Instructions for Pulse Ox Meters for Ambulatory Patients
- https://www.inova.org/sites/default/files/for_employees/covid-
19/patient_instructions_for_pulseox_meter_062320.pdf
- Where should we include this link?Reston COVID Clinic Team
Lorton Clinic Team
Dr. Homeyer helping out in the Lorton Clinic in between telemedicine consults
Fairfax Clinic Team
Media Coverage o February 8th
Extended COVID-19 Clinic Timeline
Mid November Mid December Mid January
- Scheduling considerations - Communication Plan to the - Gained Clinic Efficiencies
Community and Employed by moving patients out of
Providers chairs after one hour
- Legal/Regulatory Review of infusion
where Clinics could be
located - Clinic Go Live at Reston
and Lorton - Determined how to pull
positive COVID test results
- Epic Build out of Epic & bulk refer high
- Troubleshooting Clinic risk patients for telemedicine
Operations referrals
- Professional Billing/Clinic
Billing/Managed Care
Contracts - Lab Testing Delays - Expanded Lorton Clinic into
addressed ACS space to accept 60
patients a day
- Determined Staffing ratios
- Expanded into Inova EDs
- Provider Telemedicine
Training
- Opened third Clinic in
Research spaceQuestions to Consider Going Forward
Topic Detail
• Can the infusion time be safely decreased?
Appointment Times range from 2-3 hours • Can the time to monitor a patient post infusion be decreased or
eliminated?
• Should we allow patients to self refer for a telemedicine consult?
Self Referral
• Should we continue with a Clinic Model or transition to ED site based
Co-Locate Long Term
infusions only?
• When the drug becomes available for purchase, will the MAB be
Reimbursement profitable to continue long term? $309/administration reimbursement is
not enough to sustain the program.
Readmission Prevention • Do the MABs really prevent readmissions?
• How can we expand this service into the home health and SNF
Home and SNF Infusions
environments?Appendix
After Visit Summary
After Visit Summary – Use Smart Phrase “.COVIDCLINICINSTRUCTIONS”
You have been referred to the Inova Extended COVID-19 Care Clinic. All patients must have a positive COVID-19 test prior
scheduling their Extended COVID-19 Care Clinic telemedicine assessment. Please give us a call at 571-472-4502 as soon
as you have a confirmed positive COVID test. The fastest way you can view your results is by signing up for MyChart at
https://mychart.inova.org/mychart/signup.
During your telemedicine assessment, a provider will assess your condition and make further recommendations with regard to
your care. The provider will:
- Assess to see if you are clinically eligible for monoclonal antibody therapy and arrange for an infusion if you
qualify and consent to the treatment
- Arrange an in-person evaluation at one of our clinic sites or direct you to the emergency room if needed
- Continue your treatment until you are stable enough to return back into the care of your primary care physician.
If you were given an oxygen pulse oximeter or already have one at home, check your oxygen level at least twice a day while
at rest as well as if you develop worsening or the onset of shortness of breath. Review those readings with your provider
during your telemedicine visit. If your oxygen saturation remains higher than 90%, you can continue to self-monitor and
discuss any changes to your care plan during your next follow up visit. If your oxygen level drops below 90%, go to the
emergency room as soon as possible.
If at any point you develop severe chest pain, severe shortness of breath, confusion or any other concerning symptom that
warrants immediate evaluation, please go the nearest emergency room for an assessment.Pharmacy Logistics
• Pharmacy to provide 4 to 5 doses per day supply at both sites with labels.
• Tip sheets will be provided on how to mix and administer.
• Both locations label products when they hang IV bags at the site.
• Both locations have 0.2/0.22-micron low protein binding in-line filters
o Both locations need more supplied by pharmacy.
• Storage capacity is in their fridges for volume?
o Lorton has empty fridge (lockable) not connected to omnicell.
o Reston – will need fridge.
• Contacts:
o Laura Monroe-Duprey is the contact for Lorton
o Ruth Wright is the contact for Reston.
o Melanie also available if issues or challenges arise.Risks/Concerns from Late November
Full Capacity for Infusions at Clinics
• Lorton – 60 infusions/day (20 bays)
• Reston – 13 infusions/day (4 bays)
• Total = 14 infusions/day, 7 days/week (9 am – 5:30 pm)
Current Patient Discharges with COVID Pending tests
• ED: 50 high risk discharges tested/day with 10 positives
• UC: 60 high risk tested/day with 12 positives
• Primary care: 20 high risk tested/day with 4 positives
Timing of scheduled Telemedicine Assessments and Pending Tests
• Potential for 130 referrals per day with only 26 COVID positive rate
• Testing turnaround time will impede patients from getting the
monoclonal antibody treatment
Potential Solution: Trying to work with Sean McCleary to expedite
testing for patients with Extended COVID Care Clinic ReferralOverview
• ECCC’s will not be advertised.
• No signage for COVID Clinic at
Lorton ECC and Reston ECC.
Signage will be limited to
“Infusion Clinic” signage for
parking.
• Inova and community providers
will receive communication with
guidance on how to refer eligible
patients.
• Team member health will be
able to refer to ECCC’s. Team
members can be flagged for cost
avoidance.Inova Referral Communication – Selection Criteria
Eligibility for Monoclonal Antibody Infusion:
Patients eligible for monoclonal antibody infusion:
• Positive COVID test and symptom onset within 10 days
AND
• At high risk for progressing to severe COVID-19 and/or
hospitalization (see below)
High Risk is defined as patients who meet at least one of the
following criteria:
• Have a body mass index (BMI) BMI ≥ 35
• Have chronic kidney disease
• Have diabetes
• Have immunosuppressive disease
• Are currently receiving immunosuppressive treatment
• Are age ≥65
• Are age ≥ 55 AND have
• cardiovascular disease OR
• hypertension, OR
• chronic obstructive pulmonary disease/other chronic
respiratory disease.Standard Work – Reston (Page 1)
Standard Work – Reston (Page 2)
Patient Info on Arrival
Patient Handoff from Transitional Care Provider to Extended Care COVID-19 Clinic Transitional Care provider talking points for patient next steps after telemedicine visit: • Call the Extended COVID-19 Care Clinic Scheduling Call Center at 571-472-4502 to schedule an Infusion/Follow Up appointment at either Lorton or Reston. • Instructions for Jenny’s Team – scan/upload online form submission into Epic patient record • For assistance, email the PFS Scheduling Team: ExtendedCOVID19CareClinicSchedulingLeaderSupport@inova.org Inbound Phone Line, 2-3 dedicated Inova PFS Scheduling Team members: (Jenny Renee’s team) Greeting Message: Thank you for calling the Inova Extended COVID19 Care Clinic Scheduling Call Center. If this is a life threatening emergency, please hang up and dial 911. For all non- emergent medical questions, please contact your primary care doctor. To schedule a COVID19 Telemedicine Assessment appointment, COVID19 Infusion Treatment and/or Follow Up, our normal call center business hours are 8:00am-4:30pm, 7 days a week, Monday-Sunday including holidays. Your call is important to us. Please hold for the next available agent, thank you! Closed Message: The Inova Extended COVID-19 Care Clinic Scheduling Call Center is now closed. If this is a life threatening emergency, please hang up and dial 911. For all non-emergent medical questions, please contact your primary care doctor. Normal Call Center business hours to schedule appointments or treatments are 8:00am-4:30pm, 7 days a week, Monday-Sunday including holidays. Your call is important to us. Please try your call again during normal business hours. Thank you! Call Center Hours of Operation: 7 Days a Week (Including Holidays) 8 am-4:30 pm Voicemail – None
Estimated Volumes COVID+ patients seen in primary care or urgent care (top graph) or ED (bottom graph) and not admitted over the last 14 days. Note that the value for the last few days will rise as more test results come back positive. Also note that ED graph is good for directionality but overestimates because it falsely detects people who arrived in ED on one day and were admitted the next. The actual rate for ED is about 40/day. Provided by Andrew Miner
Estimated Volumes COVID+ patients seen in primary care or urgent care (top graph) or ED (bottom graph) and not admitted over the last 14 days. Note that the value for the last few days will rise as more test results come back positive. Also note that ED graph is good for directionality but overestimates because it falsely detects people who arrived in ED on one day and were admitted the next. The actual rate for ED is about 40/day. Provided by Andrew Miner Note: this graph is an overestimate—the actual number of discharged ED patients with COVID is approximately 40/day:
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