Denise Myshko

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.

Prime Therapeutics’ analysis of claims data suggests patients require support to ensure continued use and lifestyle modification.

Opill will be available in stores and online in the first quarter of 2024.

About half of Navitus’ commercial clients saw a drug spend decrease compared with 2021.

Governor Phil Murphy has signed three pieces of legislation that would require PBMs to use prescription drug rebates to lower premiums and out-of-pocket costs for consumers and prevent the practice of spread pricing.

This week, the FDA granted full approval to the Alzheimer’s drug Leqembi, set an action for review of zolbetuximab to treat gastric cancers and rejected Amneal’s new drug application (NDA) Parkinson’s disease treatment.

Most of the Humira biosimilars are available with two pricing options. Of the larger PBMs, only Optum Rx so far has weighed in on a coverage decision.

Approvals this week include: a $2.9 million gene therapy for hemophilia A; a pediatric growth hormone; the first cell therapy for type 1 diabetes; a new alopecia drug; a therapy for generalized myasthenia gravis; and full approval for Blincyto in B-cell ALL. The agency also rejected a higher dose of Eylea and set an action for hemophilia B gene therapy.

BioMarin is offering an outcomes-based warranty that will reimburse payers up to 100% of the cost if a patient does not respond to Roctavian.

Sarah Emond will continue with ICER’s efforts to assess drug cost-effectiveness and health plan access policies that began with founder Steve Pearson, M.D., who will transition to an advisor role in 2024.

The National Alliance of Healthcare Purchaser Coalitions has issued a playbook to help companies navigate what they see as a flawed PBM contracting model and lack of competition.

The FDA’s approvals this week include: a $3.2 million gene therapy, the first anti-inflammatory drug for cardiovascular disease, a subcutaneous version of Vyvgart for myasthenia gravis and Jardiance and Synjardy for kids with type 2 diabetes. Three rejections by the agency include: a therapy for NASH, for retinal cancer, and for rare fungal infections. In addition, Geron has submitted an NDA for first-in-class therapy for MDS.

Optum Rx will include the three biosimilars on its standard formulary at parity with Humira.

Employers and plans need to prioritize clinical efficacy over drug price, look for price reductions — and not rebates — on biosimilars, and advocate for a public option to cover gene therapies. These are just a few of ideas that consultant Alex Jung put forward at a meeting of the Midwest Business Group on Health.

New analyses shed light on decreased hearing in people with Graves’ disease and thyroid eye disease.

PBMs have imposed accumulators and maximizers to counteract pharma’s copay assistance programs. Drug manufacturers have retaliated by reducing the amount of patient assistance available.

The FDA has approved a second bispecific antibody to treat patients with diffuse large B-cell lymphoma, as well as Linzess to treat children with constipation. Additionally, an FDA advisory committee recommends approval of Sanofi/AstraZeneca’s RSV vaccine for infants.