From Washington DC,
- The Washington Examiner points out that four special elections for the House of Representatives will be held in 2024 before the national election on November 5, 2024. Three of the seats are being vacated by Republicans, and one by a Democrat. Due to the Republican’s already slim margin in the House, every vote does count.
- The American Hospital News reports that the No Surprises Act regulators plan to the public comment deadline for the Federal Independent Dispute Resolution Operations proposed rule, which is currently set for next Tuesday, January 2, 2024. The FEHBlog found the referenced regulator’s notice of this decision on the CMS No Surprises Act website. The official notice, however, has not been posted in the Federal Register yet.
From the public health and medical research front,
- Bloomberg reports,
- “Cytokinetics Inc. said its experimental drug helped patients with a genetic heart ailment in a closely watched trial.
- “The drug improved exercise capacity and oxygen uptake in patients with the heart condition, compared with those getting a placebo, Cytokinetics said Wednesday in a statement. * * *
- “Aficamten is a once-daily pill for hypertrophic cardiomyopathy, or HCM, a genetic disease in which abnormally thick heart muscle interferes with pumping. As many as 1 in 500 people have it, though many go undiagnosed, according to the American Heart Association, and it’s regarded as the most common cause of sudden cardiac death in young people and competitive athletes. * * *
- “Cytokinetics plans to submit the drug for clearance in the second half of 2024, Chief Executive Officer Robert Blum said on a conference call.”
- Medscape tells us,
- “Glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, liraglutide, and the newly US Food and Drug Administration–approved tirzepatide, not only are gaining popularity among the public for weight loss but also are the focus of considerable attention from gastroenterology researchers.
- “The robust interest in GLP-1 agonists was on full display here at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting [held in mid-December], with investigators sharing results on which agent is most effective for weight loss, how they compare to bariatric surgery for weight loss or prevention of metabolic dysfunction–associated steatotic liver disease, and their potential role to prevent regain after weight-loss surgery.”
From the U.S. healthcare business front,
- STAT News presents three issues to “watch in pharma in 2024.”
- Paying for gene and cell curative therapies, and
- Drug pricing
- The journalist raises an interesting point on the second topic.
- “One possibility may be so-called value-based or outcomes-based agreements, in which coverage and reimbursement are linked to the extent to which a drug is actually effective. Simply put, the manufacturer and the payer take on a level of risk. If the drug does not do as well as expected, the manufacturer reimburses the payer for a portion or all the costs.
- “This approach is not new. Over the past few years, more drug companies and payers have explored such deals, although they do not always work. Disputes can emerge over the way data is collected and evidence of effectiveness is captured, disagreements over incentive mechanisms and financial terms, and the availability of useful outcome measures.
- “Another issue is the Medicaid Best Price requirement. This refers to the stipulation that a pharmaceutical company must offer its best price to Medicaid and other U.S. government health programs. But this can pose a dilemma for a drugmaker if its value-based agreement lowers the price to a payer and, therefore, must be lowered to Medicaid and others, diminishing its revenue.”