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Old 04-29-2010, 04:47 PM   #1
gdpawel
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Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

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

Havrilesky LJ, Krivak TC, Mucenski JW, Myers ER.
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, NC.

Objective

We sought to estimate mean costs of chemotherapy treatment for recurrent ovarian cancer with or without use of a chemoresponse assay.

Study design

We estimated mean costs for 3 groups: (1) assay assisted: 75 women who received oncologist's choice of chemotherapy following chemoresponse testing (65% adherence to test results), (2) assay adherent: modeled group assuming 100% adherence to assay results, and (3) empiric: modeled from market share data on most frequently utilized chemotherapy regimens. Cost estimates were based on commercial claims database reimbursements.

Results

The most common chemotherapy regimens used were topotecan, doxorubicin, and carboplatin/paclitaxel. Mean chemotherapy costs for 6 cycles were $48,758 (empiric), $33,187 (assay assisted), and $23,986 (assay adherent). The cost savings related to the assay were associated with a shift from higher- to lower-cost chemotherapy regimens and lower use of supportive drugs such as hematopoiesis-stimulating agents.

Conclusion

Assay-assisted chemotherapy for recurrent ovarian cancer may result in reduced costs compared to empiric therapy.

Key words: chemoresponse assay; cost analysis; ovarian cancer

PMID: 20417480

http://www.ncbi.nlm.nih.gov/pubmed/20417480


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Old 04-29-2010, 04:48 PM   #2
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New Paradigms of Doing Business

It amazes me not only that some private insurance carriers don't like to pay for oncologic in vitro chemoresponse assays but that they don't emphatically mandate it as a requirement for obtaining chemotherapy reimbursement against ill-directed treatments. Evidence in support of these tests is more than sufficient to justify them.

Profit, as we have seen, is a powerful motivating force. Among the private payors, at least, the profit motive is entirely consistent with the goal of the tests, which is to identify efficacious therapies irrespective of drug mark-up rates.

Everyone is scared to death - and rightly so - at what is going to happen to the healthcare economic system with increasingly expensive new drugs that benefit only a small percentage of patients who receive them. Hence the headlong rush to develop companion diagnostic tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drug will be effective for an individual patient.

The pressure, in fact, is so great that these molecular companion diagnostics they've approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies. Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class.

The FDA could benefit too, as they find themselves under increasing pressure to allow new drugs into marketplace while at the same time protecting the safety of potential recipients of those drugs as well as the financial interests of those who will have to pay for them.

I think that in both of these areas - private insurance carriers and the FDA - there is a very real opportunity to make a substantial impact and contribution, an interest in saving the healthcare system perhaps billions of dollars a year by ensuring that expensive treatments are used appropriately.

Committee chairpersons, committee members and persons in congress who may have personal interests not only in discovering new cancer treatments - everybody wants that - but also, in the "here and now," using currently-available cell culture assay technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.

The validaton standard that private insurance companies are accepting from molecular profiling tests is accuracy and not efficacy. The "bar" had been instantly lowered. No longer will it be essential to prove that the use of a diagnostic test improves clinical outcomes, all they have to do for these molecular profiling tests is prove that the test has a useful degree of accuarcy. However, the validation standard wanted for functional tumor cell profiling is efficacy. What's good for the goose is good for the gander.
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Old 04-30-2010, 02:49 PM   #3
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Re: Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

You have to wonder why cash strapped NHS or other socialized med arrangements wouldn't want to avoid costly trial and error medicine.
I do wish these sensitivity tests included hormonal, biological and CAM therapies. Chemo aint the only game in town.
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Old 05-01-2010, 06:04 PM   #4
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Re: Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

The National Comprehensive Cancer Network (NCCN) updated the NCCN Clinical Practice Guidelines for Oncology to include the use of chemoresponse assays.

The NCCN states that chemoresponse assays are being used in some NCCN member institutions for decisions related to future chemotherapy in situations where there are muliple equivalent chemotherapy options available.

Recent studies presented at ASCO and published in the International Journal of Gynecologic Cancer evaluated the association between prediction of response to chemotherapy and progression-free interval and overall survival in ovarian cancer.

The CEO of the Ovarian Cancer National Alliance stated that not only are oncologists recognizing the benefits of using chemoresponse assays when faced with equivalent therapeutic options, they are also paving the way for greater support of personalized medicine in oncology.

NCCN Clinical Practice Guidelines in Oncology are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN member institutions.
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Old 07-02-2010, 02:50 AM   #5
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Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

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.
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Old 09-05-2010, 02:46 PM   #6
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What is the precedent for using cell culture assay tests?

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).
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Old 09-24-2010, 03:36 PM   #7
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More evidence

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
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Old 02-28-2011, 05:21 PM   #8
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Re: Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

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
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Old 02-28-2011, 05:24 PM   #9
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Re: Impact of a chemoresponse assay on treatment costs for recurrent ovarian cancer

Dunno...doesn't show up as a choice. Was told endocrine agents work slower/differently so they won't work in a relatively quick assay.
Yeah..Estradiol levels can be measured and manipulated..but hard to know in advance whether the tumor cares.
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