her2neu, Herceptin, HercepTest and Medicare!!!

From:Phyllis Davie <pdavie@phenopath.com>

Dear Histonetters,
  Please allow me to address some of the her2-neu information being put
forth here.  This is too important a patient care issue to allow
misinformation to continue to circulate.

 "Is the Herceptest the only test approved that will allow the patient to
receive the Herceptin therapy?"       NO, but....
  1)    If the patient is a Medicare patient, the Herceptin THERAPY (i.e.
the genetically engineered monoclonal antibody trastuzumab used for the
treatment of patients with metastatic breast cancer -- i.e. the
multi-thousand-dollars-worth-of-therapy product) WILL NOT BE PAID by the
Medicare program UNLESS HercepTest was the product used to determine
her2-neu overexpression.  Not FISH, not any other antibody method, ONLY
    This decision was published in Medicare  B News, Issue 171, February
1999, (This applies to the following states:  Alaska, Arizona, Colorado,
Hawaii, Iowa, Nevada, North Dakota, Oregon, South Dakota, Washington and
Wyoming.)  (Other states may or may not have the same ruling.) The decision
     "....The HCPCS-CPT code, 88342, immunocytochemistry (including tissue
immuno-peroxidase), each antibody, is the code that represents the test used
in the initial studies on Herceptin.  This test was called the Clinical
Trial Assay (CTA):  The test available from commercial laboratories is the
DAKO HercepTest and is also represented by CPT code 88342.  It is reported
as 0, 1+, 2+, or 3+.  Only the 2+ and 3+ results correlated with significant
benefit to the patient from Herceptin therapy.  Further, this test is the
only test approved by the FDA for determining eligibility for Herceptin
therapy.  Accordingly, this carrier will cover the cost of Herceptin therapy
only when the results of the HercepTest were either 2+ or 3+."
   " The HCPCS-CPT code 88365, Tissue in situ hybridization, interpretaion
and report, represents a different testing method commonly called FISH,
fluorescence in situ hybridization.  The FDA has approved this test for
determining the response of breast cancer to a three-drug regimen, but not
for determining the eligibility of the patient for Herceptin therapy.
Accordingly, this carrier will not accept the result of the FISH test as
justification for giving Herceptin."

    Please note, the laboratory may be paid for doing the testing (by any
mechanism), but Medicare will not pay for the Herceptin (and that is where
the BIG MONEY is from the patient's point of view/pocketbook.)
    Now, whether or not Ventana's application for FDA approval for their
antibody will affect the decision of the insurance carrier for Medicare is
not a question I can answer.

This is a decision by the insurance carrier for Medicare for the western
states.  However, whether or not there is a scientifically valid support for

  2)    If the patient is NOT Medicare      or,
        If the patient is not being considered for Herceptin therapy....
Then none of the above really applies.  BUT.... check with your insurance
carriers (or your oncology groups--they are the front line, really dealing
with the patients on this critical issue)

This is NOT a pathology issue (either for reimbursement, or scientific
This is an ONCOLOGY issue (a therapy and reimbursement issue for THEM!!!!!)

I can go on and on, but this is already a lengthy e-mail.  The pathologists
in our laboratory (Dr. Allen M. Gown and Dr. Hadi Yaziji) have published and
spoken extensively on her2-neu.  We have been involved in research and
clinical patient testing for her2-neu since 1990.  I recognize that this is
a complicated and controversial topic, with many issues involved.  Please
feel free to contact any of us here at PhenoPath if you have any questions,
or if you would like to receive any of our published material on the topic.

Phyllis Davie
Clinical Laboratory Supervisor
PhenoPath Laboratories
3000 First Ave., #1
Seattle, WA 98121
phone  (206)374-9000
fax    (206)374-9009
e-mail:  pdavie@phenopath.com   or  lab@phenopath.com

> Date: Fri, 22 Sep 2000 13:03:28 -0600
> To: DWilson@brookdale.edu, histonet@pathology.swmed.edu
> Subject: Re: ventana nexes - her2neu
> Hi Denise,
> I was recently at the NSH and that specific question came up......is the
> Herceptest the only test approved that will allow the patient to receive the
> Herceptin therapy.  The answer was a resounding no!  Any test that proves
> there is over amplification of the protein or a test that proves one has the
> gene qualifies the patient to recieve Herceptin therapy.
> Ventana hope to have their CB-11 antibody FDA approved within a very short
> period of time.  The CB-11 has been shown to have very good correlation with
> FISH Her2.
> Dr. Allred who spoke at the Culling Memorial lecture had some very good
> statistics on this.  I believe you may contact him thru his email for this
> info:
> "dcallred@bcm.tmc.edu"  The lecture was about prognostic & predictive factors
> on breast cancers.
> Ann
> Ann Maruska
> Fairview-University Medical Center
> Mpls. MN  55454
> amarusk1@fairview.org
> 612-672-4005

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