Exact Sciences’ newly FDA-approved Cologuard Plus colorectal cancer test offers a significant upgrade, boasting improved sensitivity and specificity over its predecessor. With 95% sensitivity and 94% specificity, this non-invasive stool-based test could set a new standard in cancer screening, reducing false positives. Although Exact Sciences missed out on a Medicare price premium initially, analysts remain optimistic about future pricing increases. As Exact Sciences prepares for a 2025 launch, it aims to improve its margins and defend market share amidst rising competition from blood-based tests by rivals like Guardant Health. Could this test reshape cancer screening?
Author: Abhay Panchal
The “obesity first” approach in healthcare is gaining traction as clinicians focus on addressing obesity as the root cause of many chronic conditions, such as heart disease and diabetes. The advent of GLP-1 medications like Ozempic and Wegovy has shifted attention toward treating obesity directly, resulting in improvements in various health conditions. However, challenges remain, including access to affordable medications and potential long-term treatment implications.
A new teleoperated, magnetically steered robotic endoscope has the potential to make endoscopy safer and more accessible, especially in underserved areas. Controlled remotely via joysticks and magnetic fields, this system was successfully tested on a sedated pig, allowing precise navigation. The technology could revolutionize procedures like gastrointestinal cancer screenings, but widespread adoption depends on reliable, low-latency internet infrastructure.
Gastroenterology is poised for growth with key opportunities including expanded screening for younger populations, higher demand for quality colonoscopy procedures, technological advancements in endoscopy, increased focus on patient experience, and value-based care models. Dr. Mel Ona and Dr. Shaibal Mazumdar emphasize that these factors are set to drive improvements in both patient outcomes and industry practices.
Blue Cross Blue Shield of Massachusetts is promoting colorectal cancer screening options for members aged 45 to 75. To support this, they’ve introduced a new page on the MyBlue member portal that explains screening choices, including colonoscopy and at-home tests. The insurer is also making at-home kits more accessible and encourages shared decision-making between patients and physicians to improve screening rates. Additionally, Blue Cross is working with healthcare networks like Beth Israel Lahey Health to improve screening outcomes through collaboration.
Pharmacy benefit managers (PBMs) influence access to prescription drugs by negotiating rebates from manufacturers in exchange for formulary placement. While insurers benefit from these rebates, they often disadvantage GI practices by restricting access to biosimilars, impacting patient care. The Federal Trade Commission has acknowledged the significant power PBMs hold, and the medical community is advocating for change.
The FDA has approved ustekinumab-aauz (Otulfi), a biosimilar to Stelara by Johnson & Johnson, for treating conditions like Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This marks the fourth biosimilar approval for ustekinumab. Otulfi, from Formycon and Fresenius Kabi, will launch in February 2025 due to a settlement agreement. Clinical trials have shown that Otulfi’s efficacy and safety are comparable to Stelara.
UnitedHealthcare’s national prior authorization gold-card program went into effect on Oct. 1, offering reduced pre-certification requirements for providers who meet specific eligibility criteria. Providers must maintain a high prior authorization approval rate and be in-network with UnitedHealthcare plans to qualify. The program aims to streamline the approval process, though it has drawn criticism from the American Gastroenterological Association and American College of Gastroenterology. Some physicians are cautiously optimistic about its potential benefits for patients and providers.
The American Society of Anesthesiologists (ASA) filed a trademark complaint against the American Association of Nurse Anesthesiology (AANA) over the latter’s use of the term “anesthesiology,” claiming it could confuse patients. AANA argues that nurse anesthetists have a long history of safely administering anesthesia. The case reflects broader tensions around professional titles and scope of practice between physicians and nurse practitioners. The decision will be made by the Trademark Trial and Appeal Board but could escalate to federal court.
In this episode of the MGC podcast, Dr. Laurie Keefer discusses her work in brain-gut behavior therapies for GI conditions like Crohn’s disease, ulcerative colitis, IBS, and GERD. She highlights the resistance within the medical community toward nonpharmacological treatments and explores how she selects appropriate behavioral interventions for individual patients. As a key figure in the Rome Foundation and with over 250 peer-reviewed publications, Dr. Keefer shares insights on the growing role of psychological therapies in managing GI disorders.