The True Value of Pathology: Providing Expertise Across the Cancer Pathway

Curtis Stratman

As cancer rates increase, the conversation surrounding the economic impact of cancer continues to grow. The financial impact of cancer has already reached $895 billion, and cancer rates are expected to increase by 70 percent globally in the next two decades.1,2

The right diagnosis is critical to providing appropriate treatment. And deviations from the optimal path can result in treatment that is costly without benefit to the patient. Pathologists render the diagnoses in all cancer cases, and the tests that they perform as part of this process can actually determine which treatment will be most effective for a patient. However, the current reimbursement model in the United States often places significantly more value on the treatment over the diagnosis. Here are two examples in breast and prostate cancers.

The HER2 test, performed by pathologists, can determine the presence of a specialized breast cell protein. If the HER2 protein is present, the patient is likely to respond to a drug treatment that blocks these specific proteins, dramatically influencing the outlook for a breast cancer patient. The HER2 test reimbursement is $98.83 (for both the technical and professional fee in the U.S.).3  Conversely, Herceptin® (trastuzumab)—the drug that HER2 positive patients often take—is costly, coming in at roughly $70,000 (in the U.S.) for a year of treatment.4

The most common form of the HER2 scoring uses immunohistochemistry (IHC) technology. However, this test is not black and white. Proper scoring requires calibration by the pathologist to determine staining classification between intense (3+), moderate/weak (2+), and faint/bare imperceptible (0 and 1+).  [See examples here: http://www.dako.com/38602_19feb10_herceptest_scoring_guidelines-breast_ihc.pdf]

By its nature, there are edge cases, highlighting the importance of a pathologist’s expertise and his or her access to precision tools. If the test presents a false-positive, the patient potentially shoulders an unnecessary expense and the potential negative side-effects of the drug treatment. A false-negative results in the patient not benefiting from treatment.

The challenge with the reimbursement model noted above—the diagnostic test being reimbursed orders of magnitude less that the treatment—is that it creates the perception that the pathology diagnosis have little value relative to the treatment.  This provides healthcare systems with little motivation to invest into technologies for the pathology department when there is actually an opportunity to save significantly on treatment costs by doing so.

Another example: Gleason scoring is a key criteria in classifying between Stage I and Stage II prostate cancer, the common division between active surveillance and more direct treatment options. The difference between these two paths is on the line between a Gleason score of 6 or 7. A score of 6 is generally treated as Stage I, and a score of 7 is generally treated as Stage II.5

Like a HER2 test, the distinction between a 6 or 7 Gleason score is not always distinct. Gleason grading requires the pathologists to translate pattern arrangements of carcinoma cells into numerical classifications of between 1 and 5 and then add the results of primary and secondary patterns together, resulting in a score of between 2 and 10.6 [See examples here: http://www.nature.com/modpathol/journal/v17/n3/fig_tab/3800054f1.html#figure-title]

Like the HER2 example, this pattern matching has a degree of subjectivity, especially when it comes to edge cases. Over-scoring results in unnecessary treatment, and beyond the financial costs, the patient has to endure the side-effects of surgery, chemotherapy and/or radiation. Under-scoring results in patients not receiving the necessary treatment, setting the stage for the cancer to spread untreated.

Improving the precision of cancer diagnosis can potentially make treatment more cost-effective. Armed with the best information, care teams are better equipped to deliver the right treatment, saving all stakeholders from the emotional and financial strain of inefficient treatment. Regardless of the type of cancer, pathology cannot be separated from treatment. There are many cases where the pathologist’s diagnosis directly determines the course of treatment that follows.

To truly value pathology, we must consider the actual value of its role and the impact it has across the entire cancer pathway and not just the direct reimbursement for tasks. This is particularly important to keep in mind when considering which investments will have the greatest impact on cancer care. For example, there are new digital tools and computer-assisted algorithms that can aid pathologists in quantifying the HER2 classifications, thus identifying more precisely the patients who are most likely to benefit from Herceptin. We should invest in pathology with the same urgency that we invest in other parts of the care cycle.

Herceptin® is a registered trademark of Genentech, Inc.

  1. The Global Economic Cost of Cancer. American Cancer Society, 2010.
  2. World Health Organization. www.who.int/mediacentre/factsheets/fs297/en/. Accessed June 2015.
  3. CMS 2015 Physician Schedule. https://www.cms.gov/apps/physician-fee-schedule/search/search-results.aspx?Y=0&T=0&HT=0&CT=3&H1=88342&M=1. Accessed June 4 2015.
  4. Nordqvist, Christian. One Year on Herceptin for Breast Cancer Ideal. Medical News Today. 2012. Accessed June 2015. http://www.medicalnewstoday.com/articles/250912.php
  5. American Cancer Society. Prostate Cancer. http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-treating-by-stage. Accessed June 4 2015.
  6. 6.  Humphrey, Peter A. Gleason grading and prognostic factors in carcinoma of the prostate. Modern Pathology (2004). 17, 292-306. http://www.nature.com/modpathol/journal/v17/n3/full/3800054a.html

Leave a Reply

Your email address will not be published. Required fields are marked *