FDA Updates for Week of April 1, 2024: Approvals for Blood Disorder and Bacterial Infections
April 6th 2024The FDA has approved several new therapies this week, including Voydeya as an add-on therapy for blood disorder PNH; Zevtera for serious bacterial infections; Fanapt for bipolar 1; and the CAR-T therapy Abecma for earlier treatment in multiple myeloma. The agency has also accepted a supplemental BLA for Bimzelx in hidradenitis suppurativa and set a review date for datopotamab deruxtecan in breast cancer.
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Specialty Pharmacist Interventions Result in More Than $150,000 in Cost Avoidance For MS Patients
April 4th 2024Darina Georgieva, Pharm.D., and her colleagues from the department of pharmaceutical services at Vanderbilt University Medical Center, conducted a retrospective observational study to learn the costs avoided through specialty pharmacist interventions for patients at the Vanderbilt MS Clinic. The study results were published in the Journal of Managed Care and Specialty Pharmacy earlier this month.
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New HHS Rule Expands Healthcare Access and Enhances Marketplace Guidelines
April 3rd 2024The efforts of the final rule aim to simplify the enrollment process for low-income consumers, provide states with more flexibility in offering routine adult dental services and set guidelines to create access to in-network providers.
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The IRA’s Impact on Women in Medicare
April 2nd 2024In 2025, the out-of-pocket cap and other Part D related provisions in the Inflation Reduction Act are projected to save women in Medicare an average of 28% in out-of-pocket costs, according to a new analysis from the Office of the Assistant Secretary for Planning and Evaluation.
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FDA Updates for Week of March 25: Two Approvals for PAH
March 30th 2024This week, the FDA approved two therapies for pulmonary arterial hypertension: Merck’s first in class therapy Winrevair and J&J’s oral combination tablet Opsynvi. The agency also approved Vafseo, a new treatment for anemia in kidney disease. The FDA granted full approval to the cancer drug Elahere and extended the indication of Vemlidy to children. Regulators also issued a CRL for odronextamab for lymphoma indications
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Muthu Vaduganathan Gives Insights on the Cost Effectiveness of SGLT2 Inhibitors
March 29th 2024In this second part of a two-part video series, MHE editors spoke with Muthiah “Muthu” Vaduganathan MD, MPH, consultant cardiologist at Brigham and Women's Hospital and a member of faculty at Harvard Medical School, about the cost effectiveness of SGLT2 inhibitors.
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The Departments of Health and Human Services (HHS), Labor, and the Treasury, released final rules on short-term, limited-duration insurance (STLDI) and independent, non-coordinated excepted benefits coverage, addressing issues related to the low-quality insurance, or "junk insurance" plans.
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Muthiah “Muthu” Vaduganathan Discusses the Role of SGLT2 Inhibitors in Heart Failure Treatment
March 27th 2024Editors of Managed Healthcare Executive spoke with Muthiah “Muthu” Vaduganathan MD, MPH, consultant cardiologist at Brigham and Women's Hospital and a member of faculty at Harvard Medical School, about the evolving treatment landscape for heart failure, emphasizing the use of SGLT2 inhibitors alongside other foundational therapies.
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With aging populations, osteoporosis rates are set to increase, and researchers are looking for the next innovative drug to help prevent or manage the bone disease as there is currently no drug that completely does so effectively, according to a recent study published in Advanced Science.
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What States are Doing to Regulate Pharmacy Benefit Managers
March 26th 2024In a poster presented at the 2024 American Pharmacists Association Annual Meeting and Exposition, researchers found that state-level PBM reform focused on more transparent drug pricing, better patient access to prescription drugs, and more stringent auditing and reporting requirements.
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FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 26th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.
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New approvals this week include a $4.25 million gene therapy, a drug that treats hypertension in a new way, a nonsteroidal drug for Duchenne, and an oral drug for aggressive leukemia. The agency has set an action date for resubmitted Lymphir in rare skin cancer, and Celltrion has launched Zymfentra, a subcutaneous form of infliximab.
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How Health Insurers Can Create Remarkable Experiences in a Rapidly Changing Industry
March 22nd 2024The health industry is changing rapidly, and organizations that don’t adapt are going the way of the Model T. By offering new solutions and capabilities, successful organizations are supporting their customers with whole-person, full-journey care.
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