Scemblix (asciminib) is a new first-line option for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
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Regulators are also reviewing Teva’s application for its Prolia biosimilar candidate. The FDA’s decisions are expected mid-year 2025.
PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.
Prademagene zamikeracel (pz-cel) could be a new treatment for rare genetic disease recessive dystrophic epidermolysis bullosa (RDEB).
Qsymia’s manufacturer also released postmarketing data showing the oral therapy for weight loss was associated with reductions in 24-hour mean systolic blood pressure.
Gavreto used to treat metastatic RET fusion-positive non-small cell lung cancer and RET fusion-positive thyroid cancer.
This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.
Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.
David Joyner has been appointed president and CEO of CVS Health effective immediately.
Imuldose will be marketed in the United States by Accord BioPharma and is expected to launch in the first half of 2025.
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Hympavzi is the first anti-tissue factor pathway inhibitor approved in the United States for hemophilia.
Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination with Ibrance and fulvestrant. It will have a cost of $22,867 for a 28-day cycle.
PBMs are putting weight loss drugs, including Wegovy and Zepbound, on their national formularies, but coverage by plans is uneven. What is needed is more data about whether these drugs can lower overall healthcare costs.
The IQVIA analysis finds that the impact of drug price negotiation on patients’ out-of-pocket spending could also be smaller than expected.
If approved, elinzanetant would be another non-hormonal option for menopausal women seeking hot flash relief.
Sanjula Jain of Trilliant Health talks about how employers are best positioned to demand value for money from the U.S. healthcare system.
UnitedHealthcare is adding deductibles to Part D prescriptions on certain formulary tiers as a result of plan design changes from the Inflation Reduction Act.
Dry eye disease affects up to 15% of the U.S. population and is one of the largest markets in the ophthalmology field.
Otulfi is the fourth Stelara biosimilar to be approved by the FDA.
Blue Shield of California is purchasing Idacio for a net price of $525 per monthly dose, and most plan members will pay $0 out of pocket.
This is the sixth indication for Dupixent and the only biologic approved in the United States to treat COPD.
PSG's Morgan Lee talks about how customers of the Big 3 PBMs report lower satisfaction across most measures, and they are less likely to recommend their PBM.
Clinical data suggests an imbalance in vaso-occlusive crises and fatal events that require further assessment, and the company said it will provide updates in the future.
Aqneursa is the second drug approved within a week to treat Niemann-Pick Disease, Type C.
Novo Nordisk said it’s open to discussions with PBMs based on their commitments that a lower semgalutide list price would not impact formulary coverage.
The FTC said it is focusing on insulin as the “poster child” of a broken system, where PBMs leverage formulary placement to receive higher rebates from pharmaceutical manufacturers.
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