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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

  • VDH Laboratory Liaison

    • Phyllis Morris, (804) 864-8000

    • [email protected]

  • VDH ADAP Coordinator

    • Rachel Rees, (804) 864-7919

    • [email protected]


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]



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