By - October 03, 2022
In the coming months, pathologists will hear a lot more about Enhertu, a promising new treatment for patients with HER2-positive breast cancer. Approved this spring by the Food and Drug Administration, Enhertu has been found to reduce the risk of progression of the disease or death by 50 percent versus chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-negative disease.
“Pathologists need to know about Enhertu and its indications, as well as how patients are determined eligible to receive this drug,” says Ali Brown, MD, FASCP, ASCP Chief Officer, Medical Quality. “This is an exciting development that further emphasizes the vital role pathologists play in the care of patients with breast cancer.”
For decades, the drug Herceptin has been used to target tumor cells with HER2 overexpression and has been very effective in treating patients with breast cancers that have HER2 amplification.
“Pathologists have assessed HER2 status for patients with breast cancer for decades,” Dr. Brown explains. “Patients with tumors showing HER2 overexpression were then eligible to receive Herceptin. Fast forward to today. Enhertu is different from Herceptin. It not only targets cells with HER2 overexpression, but it also has a mechanism to deliver chemotherapy selectively to the tumor cells. It takes this tailored therapy and marries it to a more typical cytotoxic chemotherapeutic drug. Additionally, studies found patients who did not meet the current criteria for HER2 positivity actually benefited from Enhertu as well.”
In recent studies, patients with a low-level of HER2 expression (1+ or 2+ by immunohistochemistry with no amplification by in situ hybridization), though not enough to be considered positive—or eligible to receive Herceptin—those patients still showed a benefit. Since approximately 50 percent of all breast cancers fall into the 1+ or 2+ categories, this drug opens the door for so many more patients to receive effective treatment in the clinically advanced setting, where it was shown to significantly delay tumor progression.
Going forward, pathologists will hear more of an emphasis from their oncology colleagues on reporting negative HER2 immunohistochemistry results as either 0 or 1+, since patients with a 1+ result are eligible for Enhertu treatment. For patients with a HER2 2+ result, in situ hybridization is required to ensure that patients do not have HER2 gene amplification.
Over the past year, ASCP’s academic journal, AJCP, expedited the publication of cutting-edge scientific papers about COVID-19 so health experts could quickly access timely and relevant information during the pandemic. That effort has resulted in more than doubling the journal’s impact factor, ranking AJCP as No. 17 within the field of peer-reviewed pathology journals.
AJCP’s impact factor—a measure of the importance that an academic journal has within its field—rose from 2.4 in 2021 to 5.400 in 2022. An impact factor measures the average number of citations of recent articles published in a specific journal. The 2022 impact factor for AJCP was listed in Journal Citation Reports™ by Clarivate in late spring. To celebrate this success, Oxford University Press (OUP), which publishes AJCP, has curated a collection of the most cited papers recently published in AJCP, which is available to the general public to read until the end of 2022.
Director of Scientific Publications, Joshua Weikersheimer, PhD, cites the Society’s and OUP’s efforts to streamline and expedite the publication of scientific articles about COVID-19 during the past year as a key driver for the higher impact factor.
“AJCP had significant articles related to COVID-19 already published worldwide before most other pathology and laboratory medicine journals were able to respond,” Dr. Weikersheimer says. Other articles on important topics unrelated to COVID-19 also figured into the new impact factor.
Dr. Weikersheimer credits AJCP’s core editorial team—led by Editor-in-Chief and ASCP Past President Steven H. Kroft, MD, MASCP, Executive Editor Kelly Swails, MT(ASCP), Senior Editor, Journals, Phil Rogers, and himself—along with OUP’s publishing team, with making the rapid release of AJCP articles possible.
Dr. Kroft says, “The impact factor citation is a measure of success in delivering timely research that is most needed, most quickly. It has always been AJCP’s intent to provide cutting-edge scientific papers for those practicing pathology and laboratory medicine. This ensures our members and others are always aware of the latest clinical science to help inform decisions that are made on behalf of patients.”
In a huge win for ASCP members, the Centers for Medicare & Medicaid Services (CMS) announced in July that it has adopted data from ASCP’s 2019 Wage Survey to update labor costs for laboratory personnel. The advocacy win was revealed in CMS’s calendar year 2023 Physician Fee Schedule (PFS) Proposed Rule.
The policy change affects the proposed labor costs associated with services performed by histotechnologists. The policy change came as a result of research and advocacy by ASCP and College of American Pathologists staff. CMS will have an important impact on the payment rates for pathology services, particularly those with significant technical component work by histotechnologists.
As a result of CMS adopting ASCP’s wage rate for histotechnologists, CMS also increased the clinical labor expenses associated with a second laboratory personnel category used by CMS, the “lab technician/histotechnologist.”
Prior to CMS proposing to update clinical labor costs, the labor costs for histotechnologists were set at 0.37¢ per minute for CY 2021. CMS will update the rate for histotechnologists to 0.64¢ per minute, an increase of 73 percent over the CY 2021 rate. For the lab technician/ histotechnologist category, CMS will raise its clinical labor costs from 0.35¢ per minute to 0.60¢ per minute, a 70-percent increase.
CMS will be phasing in these new labor rates over several years. For CY 2023, the rate for histotechnologists will be 0.505¢ per minute, rising to 0.5725¢ per minute in CY 2024 and 0.64¢ per minute in CY 2025. For the lab technician/histotechnologist category, the rate will be 0.473¢ per minute in CY 2023, to 0.5365¢ per minute in CY 2024, and 0.60¢ per minute in CY2025.
ASCP will be submitting formal comments to CMS to lock in these proposals, and we will also be looking at opportunities to increase the clinical labor allowances for other categories of laboratory personnel used in the PFS.
Legislation has been introduced in both the U.S. Senate and House of Representatives to reform the way Medicare pays for clinical laboratory services. The measure, known as the Saving Access to Laboratory Services Act, is intended to fix flaws in the payment rate methodology adopted by the Centers for Medicare & Medicaid Services (CMS) when it established regulations to implement the Protecting Access to Medicare Act (PAMA). PAMA was intended to revamp the Medicare Clinical Laboratory Fee Schedule (CLFS) so that payment rates reflected market prices.
Unfortunately, flaws in CMS’s rate-setting methodology heavily weighted data from large reference labs, which tend to receive lower payment rates due to their economies of scale. The result was sub-market pricing, a result that has had a significant effect on clinical laboratories, particularly those at hospitals and smaller regional labs. ASCP is currently reviewing the legislation.
Laboratory medicine plays a critical role in the diagnosis and treatment of disease in the United States and other high-income countries around the globe. Yet in many under-resourced countries, laboratory medicine is a neglected part of the healthcare system. Joshua Klonoski, MD, PhD, a neuropathology fellow at the University of Utah Medical School, and a colleague flew to Ghana in February to provide neuropathology training to medical students there, with the support of an ASCP Trainee Global Health Fellowship.
Ghana is one example of a West African nation with few laboratory medicine resources. The country has more than 31 million people and approximately 15 neurosurgeons. However, it has no dedicated neuropathologists. While the number of neurosurgeons has increased in all geographic regions over the last decade, there are over 22 million additional needed neurosurgical procedures in low- and middle-income countries (LMICs).
Given the relative scarcity of neurosurgical specimens and lack of fellowship training, there are no dedicated neuropathologists. Furthermore, there are few pathologists with international fellowship training in neuropathology and even fewer board-certified neuropathologists.
To address this situation, Dr. Klonoski and Professor Emeritus and Medical Director at ARUP Laboratories Cheryl Palmer, MD, flew to Ghana in February to provide neuropathology training to roughly 30 pathologists and pathology trainees at two hospitals in the country. In addition, invited clinical colleagues from the neurosurgery and neurology departments were present. They were supported virtually by an adjunct faculty member from the Utah Office of the Medical Examiner, Andrew Guajardo, MD, (FP/NP), as well as a chief pathology resident, Eric Goold, MD. Their medical outreach was supported by two ASCP Trainee Global Health Fellowships that Drs. Klonoski and Goold received from ASCP.
ASCP Trainee Global Health Fellowships are intended to offer pathology residents and fellows the opportunity to expand their knowledge and experience by going beyond the training received at their local institutions. It provides exposure to the practice of pathology in a low- to middle-income country setting as part of ASCP’s Partners for Cancer Diagnosis and Treatment in Africa initiative.
In Ghana, Drs. Klonoski and Palmer performed one month of neuropathology outreach services at Komfo Anokye Teaching Hospital (KATH) in Kumasi and the Korle-Bu Teaching Hospital (KBTH) in Accra. (Kumasi is several hours northwest of the capital city of Accra.) In all, they presented 40 neuropathology instructional and interactive lessons at the two hospitals.
During their two weeks at each hospital site, they presented educational sessions covering the World Health Organization 2021 brain tumor classification system, neuroautopsy, neuroinfectious disease, neurodegenerative disease, neuromuscular disease, forensic neuropathology, neurodevelopment, and unknown case conferences. Eight brains were examined at four neuroautopsy conferences and 10 case consultations were performed upon request. Meanwhile, Dr. Goold worked remotely to organize 10, one-hour virtual general pathology lectures and develop continuing outreach for KATH and KBTH.
“For pathologists and pathology trainees at KBTH, the outreach was the first of its kind in neuropathology and afforded all the opportunity to have a structured review of neuropathology covering the 2021 WHO Brain Tumour Classification as well as other aspects of neuropathology,” said Afua Abrahams, MBChB, FWACP, FGCPS, Head of the Pathology Department at KBTH, in Accra, Ghana.
A survey of 16 questions, including 12 multiple choice questions and four short answer questions, was used to assess each component and the overall satisfaction of the outreach.
Following his return, Dr. Klonoski said, “We are inspired to continue our outreach in Western Africa. I think our trip has inspired the Ghana programs to start putting a list of consulting pathologists together and realize the potential of their whole slide imagers.”
As neurosurgical care and neuropathology expertise continue to grow in need in Western Africa, continued neuropathology outreach will be required. The team asserts that the recent effort in Ghana is an imitable model for future neuropathology outreach. To highlight these efforts and resources for others in neuropathology and the pathology community at large, a platform presentation was delivered at the American Association of Neuropathlogy 2022 meeting in Florida, June 9-12. An abstract was also submitted to the ASCP 2022 Annual Meeting in September.
ASCP communications writer