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Trofile Assay Access Program. Virginia Department of Health Division of Disease Prevention AIDS Drug Assistance Program (ADAP) Revised January 2010 . Presentation Overview. Trofile Program Purpose Client Eligibility Info

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trofile assay access program

Trofile Assay Access Program

Virginia Department of Health

Division of Disease Prevention

AIDS Drug Assistance Program (ADAP)

Revised January 2010

presentation overview
Presentation Overview
  • Trofile Program Purpose
  • Client Eligibility Info
  • Trofile & maraviroc (Selzentry) Exception Criteria-Revised December 2009
  • Trofile Assay Info
  • Trofile Assay Access Program Description & Definition of Duties
  • Contact & Resource Info
purpose of trofile assay access program
Purpose of Trofile Assay Access Program
  • Provides access for all uninsured ADAP clients to receive tropism testing via the Monogram Biosciences Trofile assay if the medical provider deems such testing necessary.
  • Tropism testing is an allowable expenditure under Ryan White Part B funding under medical care/lab services.
what clients are eligible
What clients are eligible?
  • Any uninsured ADAP client (treatment experienced) where the medical provider is considering use of the CCR5 antagonist medication maraviroc (Selzentry).
  • If maraviroc is being considered, client MUST have a tropism test performed and demonstrate a positive result (R5 tropism) before being approved for maraviroc usage.
what about insured clients
What about insured clients?
  • Clients with Medicare, Medicaid, or private insurance must use that coverage to obtain a Trofile test.
trofile exception criteria
Trofile Exception Criteria
  • Clients must exhibit “a viral load greater than 1,000 copies/ml. For maximum accuracy, the viral load should be drawn within two to four (2-4) weeks of the Trofile assay draw.”
trofile assay access
Trofile Assay Access
  • Access to designated laboratory collection sites
    • Began with certain, designated VDH local health department sites properly equipped & staffed for collection
    • Currently have sample collection MOAs with:
      • Peninsula Health Department (Newport News)-until 4/1/2010
      • Roanoke City Health Department (Main location)
    • May utilize any of the 45 LabCorp Patient Service Center locations (PSCs) after completion of VDH pre-authorization phase
labcorp option
Labcorp Option
  • Monogram Biosciences became a subsidiary of Labcorp in August 2009
  • Additional option available for VDH local health departments to use regarding Trofile sample collection
labcorp access option
LabCorp Access Option
  • Labcorp Access Option
    • Two choices for VDH Local Health Departments once pre-authorization steps completed:
      • Collect @ HD if HD has -20C freezer & have Labcorp retrieve, or
      • Process all required paperwork & schedule client to go to Labcorp Patient Service Center (PSC) for Trofile sample collection.
      • Reminder: Ensure Labcorp Test Requisition contains Trofile Test Code 829574 & record “Bill VDH ADAP” in comments in billing section of form
labcorp option cont d
LabCorp Option (cont’d)
  • Reminders for Labcorp Option:
    • Schedule venipunctures with Labcorp PSCs only on Monday-Wednesday (no Thursday or Friday draws due to delivery issues to Monogram)
    • Do not schedule venipunctures during these four holiday weeks: July 4th, Thanksgiving, Christmas, or New Year’s
    • Ensure the client has the fully completed Monogram Test Request Form, signed client consent form copy & the Labcorp requisition form to take to Labcorp
trofile assay access collection sites
Trofile Assay Access Collection Sites:
  • List of currently approved laboratory collection sites found on ADAP website at:
    • http://www.vdh.virginia.gov/epidemiology/DiseasePrevention/Programs/ADAP/support.htm
  • List will be updated as new collection sites come on board.
maraviroc selzentry info how it works
maraviroc (Selzentry) Info & How It Works
  • Maraviroc (Selzentry)-manufactured currently by Pfizer
  • Entry-inhibitor
  • CCR5 antagonist only:
    • Blocks the CCR5 chemokine receptor on the client’s CD4+ T cell to prevent entry of the R5 tropic HIV-1 virus.
    • maraviroc not effective if client’s virus is X4 tropic or Dual/Mixed (D/M) tropic.
maraviroc selzentry exception criteria
maraviroc (Selzentry) Exception Criteria
  • “NRTI and NNRTI experienced or contraindicated and prior experience with 1 or more PIs, or raltegravir, OR intolerance to current regimen AND
  • A positive blood test for the CCR5 co-receptor test (Trofile) within three (3) months.”
  • ADAP Medication/Lab ExceptionForm required only with the initial prescription.
maraviroc exception criteria cont d
maraviroc Exception Criteria cont’d:
  • Note: The exception will be approved for a treatment experienced client if the client has been taking a regimen that included this medication prior to ADAP enrollment, or accessing the medication through clinical trial or expanded access. This may be documented on the VDH ADAP Medication/Lab Exception Form under “Reason for Exception” section.
what is tropism
What is Tropism?
  • Tropism refers to the “affinity” of a virus, or the preferred pathway a virus uses to enter a certain cell type.
  • Specifically for the HIV-1 virus, the type of tropism refers to which co-receptor the client’s virus uses to enter the CD4+ T cell (aka the “helper cell.”)
tropism cont d
Tropism cont’d
  • HIV-1 viruses currently exhibit one of four tropism classifications:
    • R5: Uses CCR5 co-receptor only
    • X4: Uses CXCR4 co-receptor only
    • Dual-tropic (D): Uses either the CCR5 or CXCR4 co-receptor
    • Mixed-tropic (M): HIV-1 virus may be mosaic, wild-type, etc., that may contain combinations of R5, X4, and/or dual tropic viruses; uses either R5 or X4 co-receptor or both co-receptors.
what is the trofile assay1
What is the Trofile Assay?
  • Currently, sole provider for assay: Monogram Biosciences, Inc. (South San Francisco, California), a subsidiary of LabCorp as of August 2009
  • Currently the only CLIA-validated tropism assay available for use to determine client’s tropism before approving for maraviroc usage
  • MUST be performed if clinician is considering use of maraviroc (or in the future, any R5 antagonist) in client’s HAART/ART
trofile assay description
Trofile Assay description
  • Client’s sample containing at least 1000 copies/ml or more of the HIV-1 virus is amplified (via PCR) to generate sufficient copies of the gp160 coding region of the client’s envelope protein contained in the client’s HIV-1 virus.
  • The amplified copies are introduced into a CCR5 “expressing” cell line, and into a CXCR4 “expressing” cell line, resulting in two “infected” cell lines.
  • After “incubation” to allow the viral particles to infect the cell lines, a single round of viral replication occurs.
trofile assay description cont d
Trofile Assay description cont’d:
  • The “infected” cell lines post viral replication are tested in the presence and absence of an antagonist (maraviroc).
  • A reporter gene then expresses its light-emitting indicator gene (luciferase), which emits a visible signal (fluorescence), that identifieswhich tropism the virus exhibits.
trofile assay description cont d1
Trofile assay description cont’d:
  • Results are visualized/expressed as follows:
    • R5 Trophotype (tropism)
      • Fluoresces only with the CCR5 cell line in the absence of the antagonist drug (maraviroc)
    • X4 Trophotype (tropism)
      • Fluoresces only with the CXCR4 cell in the absence of the antagonist
    • D/M (dual/mixed) Trophotype (tropism)
      • Fluoresces in both the CCR5 and CXCR4 cell lines in the absence of the antagonist
trofile assay access program description1
Trofile Assay Access Program Description
  • Provider determination of need for maraviroc usage
  • VDH review process & approval/denial for Trofile draw
  • Scheduling of venipuncture
  • Laboratory collection & initial processing
  • Courier retrieval of frozen sample
  • Result reporting & approval/denial for maraviroc usage
  • Filling of ADAP prescription
  • Reimbursement to collection sites (for sites with an MOA with VDH); or processing of Monogram invoice if direct billed from Monogram
special considerations involved
Special Considerations Involved
  • Specialized laboratory test collection procedures involved
    • Sample must be collected in PPT tubes
    • Sample must be centrifuged and frozen at -20C within two (2) hours of collection
    • Collection sites must be properly staffed and equipped to handle specimen collection
    • Viral load integrity must be maintained, and must be greater than or equal to 1000 copies/ml
    • Most recent viral load must have been measured within 2-4 weeks before Trofile venipuncture collection date.
medical provider responsibilities1
Medical Provider Responsibilities:
  • Medical Provider:
    • Determines if client appears to meet maraviroc exception criteria
    • Either contacts VDH Lab Liaison at (804) 864-8000 or downloads the following from the ADAP website:
      • ADAP Medication/Lab Exception Form
      • Client Consent Form
      • List of VDH contracted lab/collection sites
    • Completes ADAP Medication/Lab Exception Form & signed consent form & faxes both to VDH Lab Liaison at (804) 864-8050
medical provider responsibilities cont d
Medical Provider Responsibilities cont’d
  • Medical Provider upon receipt of approval from VDH Lab Liaison:
    • Contacts Laboratory collection site to set up client’s venipuncture appointment
    • Will complete all sections of Monogram Biosciences Trofile test request form except for date/time collected & date/time separated.
    • Will send two part test request form & signed client consent form with client to take to lab collection site
    • Will retain a photocopy of both the test request form & the signed client consent form for office records
vdh lab liaison responsibilities
VDH Lab Liaison Responsibilities:
  • Conducts VDH ADAP Trofile Review Process to determine if client meets Trofile assay eligibility criteria
  • Lab Liaison will:
    • Review completed ADAP Medication/Lab Exception Form; contact medical provider for any missing info
    • Verify ADAP enrollment; if not enrolled or eligibility re-determination due, will contact medical provider to send client to local health department to complete enrollment or re-determine eligibility
vdh lab liaison responsibilities cont d
VDH Lab Liaison Responsibilities cont’d:
  • Contact medical provider for identity of provider-selected laboratory collection site
  • Complete applicable sections of VDH Test Authorization Form & forward to Assistant Director of HIV Care Services for approval.
vdh lab liaison responsibilities cont d1
VDH Lab Liaison Responsibilities cont’d:
  • Fax completed/approved Test Authorization Form to Monogram Biosciences
  • Confirm mailing address/contact info for Monogram to send test request form to medical provider if needed
  • Confirm shipping address/contact info for Monogram to send PPT tubes to lab collection site if local health department or independent lab collection site to be used & site does not already have PPT tubes on hand. If using Labcorp PSC, Labcorp already has tubes on hand.
monogram s responsibilities
Monogram’s Responsibilities:
  • Monogram Biosciences:
    • Upon receipt of approved test authorization, sends test request form to medical provider and two PPT tubes to lab collection site (if needed)
    • Will dispatch courier service to retrieve & package client’s frozen sample tubes post venipuncture when notified by lab collection site
    • Provides test result report to VDH ADAP program and to medical provider within 14 days of sample receipt
    • Bills VDH ADAP program for completed Trofile test that yields an actual tropism result
laboratory collection site responsibilities1
Laboratory/Collection Site Responsibilities
  • Laboratory/Collection Site will:
    • Document scheduled venipuncture appointment
    • Perform venipuncture & initial processing services to include checking form completeness, sample collection, centrifugation, freezing, and storage of back copy of test request form and client consent form
    • Will contact Monogram Biosciences for courier service to be dispatched to retrieve frozen sample
lab collection site responsibilities cont d
Lab/Collection Site Responsibilities cont’d
  • If Peninsula or Roanoke City HD, will complete ATV form if local health department site or submit purchase order (for other sites) on monthly basis & submit to VDH Lab Liaison for processing for reimbursement of specimen collection/processing fee
  • Will fax copy of airbill & client consent form to VDH Lab Liaison
  • Will assist courier with initial packaging of frozen samples & ensure compliance with IATA shipping guidelines
test result reporting final processing cont d
Test Result Reporting & Final processing cont’d:
  • Upon receipt of final test report:
    • Lab Liaison will:
      • Document on ADAP Medication/Lab Exception Form approval/denial of maraviroc use
      • Will notify local health department ADAP Coordinator by phone and fax of approval/denial of maraviroc use via Medication Exception Form
      • Will notify medical provider of approval of maraviroc use & to issue prescription request
test result reporting final processing cont d1
Test Result Reporting & Final Processing cont’d:
  • Medical Provider will:
    • Issue prescription for maraviroc (Selzentry)
  • Local Health Dept. ADAP Coordinator will:
    • Process approval & proceed with locality’s usual procedure for filling ADAP prescriptions if patient approved for maraviroc usage
vdh adap trofile website info
VDH ADAP Trofile Website Info
  • VDH ADAP Website:
    • http://www.vdh.virginia.gov/epidemiology/DiseasePrevention/Programs/ADAP/support.htm
    • Contains the following info:
      • VDH ADAP Medication/Lab Exception Form
      • VDH/Monogram Biosciences Client Consent & Release of Information Form
      • List of VDH contracted laboratory/collection sites
      • Frequently Asked Questions Info
      • Links to additional resource information
      • Copy of this Power Point presentation
contact info for vdh adap trofile program
Contact Info for VDH ADAP Trofile Program
additional resource info
Additional Resource Info
  • Trofile Assay Info:
    • http://www.trofileassay.com
  • maraviroc(Selzentry) Info:
    • http://www.fda.gov/bbs/topics/news/2007/new01677.html
questions
Questions?
  • Please contact Phyllis Morris, VDH Lab Liaison, at (804) 864-8000 or via [email protected]
slide44
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