Articles by Denise Myshko
It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.
Blue Shield’s new program will unbundle pharmacy services for increased transparency with the goal of saving $500 million annually. The health plan is also teaming up Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.
Blue Shield is replacing CVS Caremark with Prime Therapeutics as the company that will negotiate with drug manufacturers beginning in January 2025. The insurer is also teaming up with Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.
Sohonos was approved to treat children with fibrodysplasia ossificans progressive, an ultra-rare disease that transforms the body’s soft tissue into bone. It has an annual list price of $624,000.
LucyRx has $500 million in equity it will use for acquisitions and to build technology and infrastructure. It aims to be a national, full-service alternative to the big three PBMs.
Kaiser Permanente has a 95% formulary compliance rate, and this allows the health plan to negotiate with pharmaceutical companies for lower prices.
The FDA has approved Talvey, a new therapy for treating multiple myeloma patients. The agency has also issued a complete response letter for avasopasem for severe oral mucositis and set a PDUFA date for a monthly MS drug.
Payers’ requirements for the use of Camyzos in patients with obstructive hypertrophic cardiomyopathy are generally consistent with the registration study, but they also imposed restrictions beyond the FDA indication or ICER recommendation.
Current treatments urea cycle disorders, which causes ammonia to build up in the blood, have a bitter taste and smell. Pheburane was developed with a special coating that masks the taste of sodium phenylbutyrate. It has a list price of $4,375 per bottle.
Capital Blue Cross uses algorithms to help find drug manufacturer coupon programs. It has saved $4.5 million in the first quarter of 2023.
Almost half of adults surveyed by KFF would be interested in taking a weight-loss drug, including many who say they only want to lose a little weight.
FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.
The specialty pharmacy business is a driver of Cigna’s growth, accounting for 40% of the Evernorth’s revenue.
CVS’s health services segment includes CVS Caremark, but the company would not break out the revenue the PBM business only.
The newly formed Peterson Health Technology Institute was launched with $50 million to analyze clinical benefits and economic impact of new health technologies.
For Magellan’s clients, Ozempic had the highest trend of any product in 2022, and Wegovy was the fifth highest drug in terms of trend. Diabetes as a whole is expected to become the top condition leading pharmacy trend by 2024.
ABBV-RGX-314 delivers a gene encoding a therapeutic antibody fragment to inhibit vascular endothelial growth factor (VEGF). Early results show it is well-tolerated and leads to improved disease.
Patients with geographic atrophy and their caregivers would benefit from support and accommodations related to managing daily life activities and social activities, as well as their mental health, Sophie J. Bakri, M.D., said during her presentation
FDA approvals this week include the second nonprescription naloxone nasal spray for opioid overdose, the first drug for a skin infection from pox virus and a drug to treat an eye infection caused by mites. In addition, the FDA has accepted a supplemental application for Ofev in children with rare lung disease.
MacKay Jimeson of the advocacy organization Patients Rising talks about CMS’ decision to limit coverage for Alzheimer’s drugs to those with full approval.
Renee Rayburg talks about the specialty drug spend, which grew 14.1% in 2022. PSG analysts predict increases will continue to be in the low double-digits for the next three years.
Mental health issues have impacted minorities and at-risk groups the highest. But a new analysis has found that disparities exist within at-risk populations.
Sara Izadi, Pharm.D., of Capital Rx, talks about Rx Reverse, an integrated clinical program designed to help members reverse diabetes and fight obesity.
The FDA has cleared several new products this week, including the first monoclonal antibody for RSV in infants, a novel therapy for newly diagnosed patients with AML and a postexposure anthrax vaccine. Additionally, an FDA decision on donanemab for Alzheimer’s is expected by the end of this year.
An analysis by Biosimilars Council has found that the reference product Lantus accounts for 54% of new prescriptions and is 78% of total market volume but demand for the unbranded interchangeable insulin glargine is increasing.
The newly formed Peterson Health Technology Institute was launched with $50 million to analyze clinical benefits and economic impact of new health technologies.
Donanemab slowed cognitive decline by about 35% for patients at the earliest stages of Alzheimer’s disease.
In the short term, two gene therapies now under review at the FDA — lovo-cel and exa-cel — can reduce the frequency of painful crises in patients with severe sickle cell disease.
Approvals this week include Opill, the first nonprescription oral contraceptive, the use of Veklury for COVID-19 in patients with severe renal impairment, and the earlier use of Leqvio for in heart disease. In addition, Takeda pulled its application for a dengue vaccine.
KFF analysis has found that 10 drugs account for 22% of all Medicare Part D spending in 2021.
