Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
NOVEMBER 18, 2020
Update: Allocation and Distribution of OWS Therapeutics
National Healthcare and Medical Associations/Organizations
1
Context
Veklury (remdesivir) remains the only FDA-approved product for the treatment of COVID-19.
A spectrum of therapeutics is currently under consideration as part of the U.S. government’s (USG) Operation Warp Speed initiative.
EUA granted for Eli Lilly and Company’s bamlanivimab Nov 9, 2020
USG will oversee allocation and distribution of bamlanivimab in two phases.
We are leveraging and refining the process used with remdesivir allocation and distribution.
Topics for today
• Provide overview of Eli Lilly and
Company’s monoclonal antibody -
bamlanivimab
• Summarize process for allocation and
distribution of bamlanivimab
• Discuss unique drug administration
requirements and anticipated
challenges
• Gain feedback regarding Week 1
bamlanivimab distribution and
administration
2
AboutMonoclonal Antibodies
Monoclonal antibodies (mAbs) directly neutralize the
COVID-19 virus and are intended to prevent
progression of disease
mAbs likely to be most effective when given early in
infection
Product delivered via single administration (e.g., IV
infusion)
Early evidence suggested promise of mAb products
in outpatient settings
• Early evidence from Lilly mAb showed potential
to reduce hospitalization for infected people if
given early in infection in BLAZE-1 clinical trial
• FDA granted Emergency Use Authorization for
bamlanivimab on Nov 9, 2020
3
About Bamlanivimab
EUA authorizes use of Bamlanivimab for treatment of high-risk* COVID-19 outpatients (ages ≥12 y/o, weight ≥40 kg) with mild-to-moderate symptoms at risk for progressing to severe disease/hospitalization
*high risk criteria listed on next slidehttps://www.fda.gov/media/13766/downloadhttps://www.fda.gov/media/135757/download
4
Direct SARS-CoV-2 test (e.g., PCR, rapid antigen
test) must be positive
Administered as soon as possible after positive test
result and within 10 days of symptom onset
Provider to review EUA fact sheet
Patient/caregiver to be provided with EUA fact
sheet
Administered in a setting where healthcare
providers have direct access to medications to
manage severe reactions
1
2
3
4
5
4
• All Patients (who meet at least 1 of the
following criteria):
• BMI ≥35
• Chronic kidney disease
• Diabetes
• Immunosuppressive disease
• Receiving immunosuppressive treatment
• Age ≥ 65 years
• Age ≥ 55 years AND have any of the
following
• Cardiovascular disease
• Hypertension
• COPD/other chronic respiratory
disease
• Adolescents (Age 12-17 years) who
meet at least 1 of the following criteria:
• BMI ≥85th percentile for age/gender
• Sickle cell disease
• Congenital or acquired heart disease
• Neurodevelopmental disorders (e.g.
cerebral palsy)
• Medical-related technological
dependence [e.g., tracheostomy,
gastrostomy, or positive pressure
ventilation (not related to COVID-19)]
• Asthma, reactive airway, or other
chronic respiratory disease that
requires daily medication for control
Bamlanivimab (Lilly) EUA – High-Risk Criteria
5
Characteristics Requirements
Dose 700mg in 200mL 0.9% NaCl IVPB over at least 60 minutes (PVC infusion set with
0.20/0.22 micron filter)
Monitoring Monitor during infusion (no specified interval) and for 1 hour after completion
Storage Requirements 700mg/20mL vial – store in original carton to protect from light at 2-8℃; do not freeze,
shake, or expose to direct light or heat
Stability Once
Reconstituted
24 hours at 2-8℃ OR up to 7 hours (including infusion time) at room temperature
Required Chart
Documentation
- That patient/caregiver has been given fact sheet
- Informed patient of treatment alternatives to bamlanivimab
- Inform patient that bamlanivimab is an unapproved drug used under the auspices of
EUA
Adverse Effects (in
<3% of pts)
Hypersensitivity reactions, nausea, diarrhea, dizziness, headache, pruritis, vomiting
Bamlanivimab
Dosing and Characteristics
6
Phase 2 Trial Results: Bamlanivimab in Outpatients with Covid-19
All study-patients, Hospitalization or ED
visit within 29 days of administration
– Treatment group (n=309), 1.6%
– Placebo group (n=143), 6.3%
– Number needed to treat (NNT) to
avoid hospitalization/ED = 21.3
Study-patients with BMI >35 or Age >65,
Hospitalization/ED within 29 days
– Treatment group (n=95), 4.2%
– Placebo group (n=48), 14.6%
– NNT = 9.6
Chen P, et al, for the BLAZE-1 Investigators.SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with
Covid-19.N Engl J Med. Oct 28, 2020. DOI:10.1056/NEJMoa2029849
7
Overview of Veklury (remdesivir) experience
• May through September 2020, federal
government led fair and equitable distribution
of donated and commercially available Veklury
• Distributed more than 320,000 treatment courses
to hospitals across states, territories and federal
agencies
• Building upon experience, USG to manage
allocation of bamlanivimab in manner that is fair,
accessible, and understandable to American
public
8
Principles for USG allocation and distribution
Maximize use of existing infrastructure within USG,
as well as manufacturer and distributor channels
• Lilly (manufacturer) and AmerisourceBergen
(distributor)
Allocations must ensure both temporal and
geographic equity
USG to allocate to state and territorial health
departments based on:
• Confirmed Hospitalizations (7- Day Incident)
• Confirmed Cases (7- Day Incident)
States/Territories responsible for allocation to final
points of care
Manufacturer tracks pharmacovigilance and follows
mandatory reporting guidance
1
2
3
4
5
9
Federal allocation decision informed by two data sources provided by hospitals/health departments to HHS Protect*
• All confirmed cases
• Contributes overall magnitude of case
load
• Captures emerging cases in near real
time
Confirmed Hospitalizations
(7- Day Incident)Confirmed Cases (7- Day Incident)
• Entered daily via TeleTracking (HHS
Protect) at hospitals: “How many
confirmed COVID-19 cases admitted in
last 24h period?”
• Data has a known lag, as it typically
takes 1-2 weeks for hospitalization of
patients
• Complete and timely (99% of facilities
report at least once weekly; 92% report
daily)
1 2
10
Allocation and distribution concept of operations
• Manages EUA submission and updates
• Prepares product fact sheet
• Notifies FDA on any reported safety issues
• BARDA provides regulatory support for PCTs
• Determines allocation & consults with NIH
• Pays for distribution costs via contract with
manufacturer
• Informs distributor and state/territorial health
departments of allocations
• Tracks product is delivered
• Direct products to appropriate county/parish
districts & hospitals
Nursing homes
VA
Federal Agencies
Pharmacies
Other
• Reviews EUA application
• Monitors ongoing AE reporting from sites
Hospitals
Manufacturer
State governmentsUSG
Key Flow of material
Flow of info
Contracted relationship
• Contracted directly by manufacturer
• Manages storage of USG product
• Ships directly to sites id'ed by
states/territories
• Reports delivery data back to USG
Distributor
• Sites vary by use case
• Hospitals report
admissions data
• HCPs report AEs
Potential
administration
sites
11
Two Phases of Allocation
• Phase 1: states and territories allocate
bamlanivimab to hospitals and hospital-
affiliated locations only
• Phase 2: states and territories allocate to
additional outpatient facilities
o Phase 2 begins Nov 24, 2020
In addition to allocations to states and territories,
bamlanivimab is being allocated to the Department of
Defense, the Veterans Health Administration, the Indian
Health Service, the Bureau of Prisons, the Department
of State, and the National Institutes of Health for
distribution within those healthcare systems.
12
Current Allocations
• Currently in Week 2 of allocations
• 119,730 treatment courses (vials) allocated to date
• Week 1 (Nov 9-17): 79,350
• Week 2 (Nov 18-23): 40,380
• 1 vial = 1 dose = 1 treatment course
• View allocation dashboard for state/territory
allocation amounts and updated resources at
www.phe.gov/bamlanivimab
13
Allocation/Shipment Rhythm:Allocations expected to take place on Wednesday mornings, with first distribution beginning on Wednesday afternoons*
Allocations to
states/territories
determined
Notification to
stakeholders
States/territories
work with
distributor to
identify final
delivery
location(s)
States/territories
continue to work
with distributor to
identify final
delivery
location(s)
All delivery
locations
confirmed by CoB
First shipments
received by states
Delivery of
product continues
Wednesday Thursday Friday Saturday Sunday Monday Tuesday
Data for allocation
model closes for
next allocation
cycle
Key
Allocation to states finalized
First delivery of products
*NOTE: Week 3 allocations will take place TUESDAY, NOV 24th
14
Allocation DashboardMaintained
https://www.phe.gov/Bamlanivimab
15
Unique challenges to Bamlanivimab administration
Appropriate
healthcare staffingTraining and equipment to
accommodate IV infusionAdditional
prep time
16
This playbook is intended to support sites interested in administering
COVID-19 treatment under EUA including:
• Existing hospital or community-based infusion centers
• Existing clinical space (e.g. urgent care, emergency depts)
• Ad hoc new infusion sites (e.g. "hospitals without walls”)
Initial version of playbook focused on:
• Monoclonal antibody treatment
• Delivery via infusion
• Outpatient setting
This playbook will continue to evolve as other treatments and
administration methods become available. We hope this playbook will
be used to help healthcare facilities plan for the implementation of
monoclonal antibody treatments in outpatient settings for those with
COVID-19.
OWS Therapeutics: Monoclonal Antibody Playbook
*This playbook was updated on
November 10, 2020 based on
FDA guidance. This guidance
should be used to help with
preparedness.
17
OWS Therapeutics Monoclonal Antibody Playbook:Based on what we have learned to date -early administration of treatment needs fast testing turn-aroundand patient scheduling
Onset of
symptoms
Clinical visit and
diagnostic test
≤ 3 days post
symptom onset
Confirmed
positive test
≤ 2 days post
diagnostic test
Treatment
≤3 days post
positive test
result
Treatment needed within 10 days of symptom onset
Testing sites should recommend COVID+ patients that are
high risk confer with their HCP on potential suitability for Tx
Example timeline
• Treatment likely most beneficial to patients if given early in symptom
progression
• EUA requires administration of treatment as soon as possible after
confirmed positive test result and within 10 days of symptom onset
• Strong partnership and communication between patients and HCP to
get right treatment to right patients at right time
• Fast testing turnaround needed, to efficiently identify positive tests and
schedule for treatment
Overview
Please reference the EUA factsheet for specific treatment
guidelines including recommended treatment window
18
Readiness Checklist: Administration of Outpatient mAbs under EUA
Allocate dedicated space and develop plan to manage patient flow
Clear process for patients that are coming to clinical site including scheduling requirements
Admission process for COVID-19 positive patients designed to minimize risk of spread per facility
requirements / directions / guidelines
Dedicated room available for treatment
Ensure dedicated source of supplies; which may be difficult to procure
Needed infusion components obtained
Example: IV kits, infusion chair, IV pole, vital sign monitoring equipment, emergency medications
Assign sufficient personnel to meet expected demand
Sufficient staffing plans in place for Nurse/IV tech, Physician, Pharmacist
– Likely need dedicated team to treat patients
Prepare for drug administration process
Pre–visit: Clear treatment and monitoring plan developed for during infusion
Treatment: 1-hour treatment and up 1-hour post-treatment observation
Emergency protocol defined for addressing potential infusion reactions or complications
Post-treatment: Clear process for patient follow-up defined using telemedicine as possible
Ensure process for reimbursement in place (non-drug administrative costs)
Prepare for reporting needs for adverse events and record keeping
19
Infusion Supplies
250 ml
0.9% NaCl
IV Insertion
Supplies
IV
Infusion
Tubing
0.2/0.22 µm
Filter
20 ml
Syringe x2
18g
Sterile
Needle x2
Alcohol
Wipes
20
InfusionSetup
Infusion
with IV
Pump
0.2/0.22
µm filter
Gravity Infusion• Utilize flow limiting
device or
• Calculate drip rate*
Drip Rate Table
*See pg.18 of OWS Playbook
https://www.covid19.lilly.com/
assets/pdf/bamlanivimab/lilly-
antibodies-playbook.pdf
Solution Stability
• 7 hours at room
temperature, including
infusion time
• 24 hours at 2-8◦C
21
Helpful Information
https://www.phe.gov/bamlanivimabcurrent EUA, allocation dashboard,
background information, additional resources
• Public Website
• NIH COVID-19 Treatment Guidelines
https://covid19treatmentguidelines.nih.gov
• ASPR Regional Teams
consult the ASPR Regional Team in your area
should you have bamlanivimab or other COVID-19
medical countermeasures-related questions
• Weekly Stakeholder Calls
Wednesdays: 3:15 - 4:00pm ET | 888-233-9140, 9027159#
(Week 3 call will occur on Tuesday, Nov 24th)
• Weekly Zoom Office Hours (No call on Nov 26th)
Tuesdays
1-2pm EThttps://hhsasproea.zoomgov.com/j/1604329034?p
wd=dGRwZTBETTJzWFliQW83TXZSOFVNQT09
Meeting ID: 160 432 9034
Passcode: 897674
Thursdays
2-3pm EThttps://hhsasproea.zoomgov.com/j/1604329034?p
wd=dGRwZTBETTJzWFliQW83TXZSOFVNQT09
Meeting ID: 160 432 9034
Passcode: 897674
Thank you!