Formulary Watch |

Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”

The FDA granted the EUA based on the PANAMO phase 3 clinical trial results demonstrating that vilobelimab improved survival compared to placebo, with a 23.9% relative reduction in all-cause mortality at 28 days.

The combination of Padcev with Merck’s Keytruda has a potentially large market: approximately 8,000 to 9,000 U.S. patients would be eligible for this combination in the U.S.

A study funded by Genentech showed that the assistance programs substantially reduce prescription abandonment regardless of race or income level.

State officials say the new NYRx program will mean fewer restrictions and create a largest pharmacy network in the state.

A bipartisan Senate bill, Affordable Insulin Now Act of 2023, would require plans to cover insulin for no more than $35 per month.

Members of the Senate Finance Committee want to modernize the rules around PBM business practices to lower out-of-pocket costs and increase competition.

Emergent BioSolutions hasn’t provided a price for the nonprescription Narcan but said the product will be available by late summer.

If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.

The suit alleges that Express Scripts, Prime and Prime customer Humana Pharmacy Solutions are able to share drug pricing and rebate information to increase prices for insulins, biologics and cancer drugs.

Out-of-pockets costs were higher among those using branded or more recently launched drugs.

RxBenefits helps patients in self-funded plans find and apply for alternative sources of funding for specialty medicines and facilitates enrollment.

Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.

Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.

The proposed legislation, sponsored by Sens. Chuck Grassley and Maria Cantwell, aims to increase transparency of PBM business practices.

CalRx will work with Civica to provide the most commonly used short- and long-acting insulins at planned prices of no more than $30 a vial and $55 for a box of five pre-filled pens.

Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.

The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance.

The patient groups say the insurer is cutting off access to important medications. The Tennessee Blues plans say many of the drugs that it excluded from coverage have zero utilization.

The lower prices will take effect on Jan. 1, 2024, on both pre-filled pens and vials of basal, bolus and pre-mix insulins, including Levemir, Novolin, NovoLog and NovoLog Mix 70/30.

The VA’s guidelines would exclude anyone who has had a stroke or seizure within the last year, as well as those who have MRIs that show evidence of microhemmorrhages, aneurysms, lesions or tumors.