Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

[Liaidarutrica]

This looks great to me and not a bad price. If it does indeed mate with the HPX170 Ill get one. Thanks for the review.

[gdpawel]

There isn't one paper, or two, which by itself, makes a case for or against cell-based assays. Nor does the proposition that the whole thing depends on one study or even one review. You've got to consider the body of literature as a whole.

The fact that none of this exists as one neat, convenient paper in the New England Journal of Medicine does not, in any way, negate the existence of this body of information. It has been found that newer methods of "cell-death" assays have an overall predictive accuracy of 98.2% concerning treatment response, which compares favorably with older, previously published data ranging from 75% to 92%. (Staib,P.et al. Br J Haematol 128 (6):783-781, March 2005)

We have tests such as estrogen receptor, progesterone receptor, Her2/neu, BCR-ABL, C-KIT, CD-20, etc., and panels of immunohistochemical stains for subclassifying tumors. All of these tests are used to select chemotherapy in precisely the same manner as cell culture assay tests are used.

Also, we have the use of additional medical tests, such as serial CT, MRI, and PET scans, performed for the purpose of monitoring the size of the tumor to determine if it is shrinking or growing with chemotherapy. The purpose of this testing is to determine if chemotherapy with specific drugs should be continued or changed to different drugs. These radiographic tests are also used as an aid in making clinical decisions about the choice of chemotherapy.

So yes, there is precedent for using cell culture assays.

The June issue of Oncology News International (June 2010, V 19, No 6) quotes a Duke University study of the use of high-tech cancer imaging, with one representative finding being that the average Medicare lung cancer patient receives 11 radiographs, 6 CT scans, a PET scan, and MRI, two echocardiograms, and an ultrasound, all within two years of diagnosis. A study co-author (Dr. Kevan Schulman) asks: "Are all these imaging studies essential? Are they all of value? Is the information really meaningful? What is changing as a result of all this imaging?"

Why is it that oncologists are so accepting of high tech, expensive imaging studies, yet so reluctant to consider the use of cell culture diagnostic tests? For one thing, clinical trials virtually always have time to disease progression as a primary endpoint. Without the imaging studies, one can't get accurate time to progression data. So these are tests performed for the benefit of drug companies seeking new drug approval, for clinical investigators seeking contracts and publications, and for clinicians seeking an easy way to make clinical decisions (and, occasionally, seeking income enhancement).

In the absence of information provided by cell culture testing, oncologists have complete freedom to choose between a myriad of drug regimens. The proven basis on which they make these selections, by and large, is on the benefit a given regimen provides to the oncologist (or academic institution). Cell culture testing threatens this freedom of choice. There's absolutely nothing in it for the oncologist or academic medical center (unlike, for example, imaging studies).

[gdpawel]

There has been more evidence that wide-scale adoption of chemoresponse assays would help not just patients, but consumers and insurance companies as well.

In June 2009, DiaTech Oncology presented a paper on this topic at the annual meeting of the American Society for Clinical Oncology (ASCO).

The studied the claims for lung, breast, colon or ovarian cancer patients among the 48,927 employees of a large self-insured corporatlion. There were 196 patients who developed these forms of cancer during a three and a half year period.

The total treatment cost was $5,647,165, of which the cost of anticancer drugs was $1,149,404. But when only drugs that were active in their proprietary form of assay, the average savings was impressive.

The authors reported that treatment with the assay could save a high percentage of chemotherapy costs as well as a substantial percentage of overall costs of cancer care for such organizations.

The savings varied from 9.9% to 62.7% depending on effectiveness and duration of the treatment for different types and stages of cancer. But the true economic value of treatment that is guided by the assay would be higher, since use of active chemotherapy could increase quality of life and employment and reduce disability and side effects.

The value of personalized treatment (Rx) planning (PTP): Cost savings (sav) by the microculture kinetic (MiCK) chemosensitivity (CS) assay, evidence from a large American self-insured company (ASIC)

Sub-category: Health Services Research

Category: Health Services Research

Meeting: 2009 ASCO Annual Meeting

Session Type and Session Title: abstract not presented at the 2009 ASCO Annual Meeting but has been published in conjunction with the meeting.

Abstract No: e17541

Citation: J Clin Oncol 27, 2009 (suppl; abstr e17541)

Author(s): R. G. Latimer, C. A. Presant, A. E. Hallquist, M. Perree, D. Agapitos; DiaTech Oncology, Brentwood, TN; Wilshire Oncology Medical Group Inc., West Covina, CA; DiaTech Oncology, Montreal, QC, Canada

Abstract:

Background:

Costs of cancer (CA) patient (PT) Rx are high. A novel CS assay MiCK was predictive of chemotherapy (CT) activity and survival in leukemia PTs (Blood. 2001;98:241b) and is in solid tumor testing. We performed a cost sav analysis for CS assay in a large ASIC population.

Methods:

An ASIC of 48,927 employees submitted 3.5 years claims data on all PTs with diagnoses of CA lung, breast, colon or ovary. Analysis of average Rx costs was made based upon total CT usage, Rx of selected PTs including therapeutic drug administration (admin), CT admin, supportive care (SC) drugs, CT drugs, biotherapy (BT) drugs, growth factors, home infusion costs, and cost of the MiCK assay. Average CT and BT drug costs were determined. We assumed high MiCK predictability for CT activity from solid tumor pilot studies and leukemia results. 4 models were evaluated: CT with a single active drug from MiCK for the duration actually given (ASC); CT with active drugs for the entire time (AC100); CT for 50% of the time period (AC 50) assuming a CT "holiday" for the other 50% of time; and CT with active drugs plus BT for 50% of the time (ACB 50). The costs in these 4 models were compared to actual claims payments.

Results:

196 PTs had CA during the 3.5 year period. 55 had CT. Total costs for CT were $5,647,165. Costs for IV CT drugs, SC drugs and drug admin were $1,149,404. Assuming the use only of active CT selected by MiCK assay, under model ASC average sav/PT was 85.3% of CT, SC and admin costs. Under model AC100, the average sav/PT were 26.0%. Under model ACB 50, the sav were 48.6%. In model AC 50, the sav were 62.7%. When the overall costs were evaluated, model ASC sav were 17.4%, model AC 100 5.3% , model ACB 50 9.9% and model AC 50 12.8%.

Conclusions:

PTP using the MiCK CS assay could save a high percentage of CT costs, and a substantial percentage of overall costs of CA care in an ASIC. Sav varied from 9.9% to 62.7% depending on effectiveness and duration of Rx, and necessity for continuing BT not testable by MiCK. The true value of PTP with MiCK could be higher, since use of active CT would increase quality of life and employment, and reduce disability and side effects.

http://www.asco.org/ASCOv2/Meetings/...stractID=30508

[gdpawel]

Rich

Rational Therapeutics does test the aromatase inhibitors. Their mode of action is to decrease the synthesis of estradiol in the body tissues and as such do not give a measureable signal in the body.

Greg