In recent years, many state Medicaid programs have moved from carve-out financing for behavioral health (BH) services to carve-in ones. A new article in Health Affairs covers this trend, which is driven in part by growing recognition that integrating care for physical health (PH) and BH improves care outcomes and lowers premature death.
The US Food and Drug Administration (FDA) has denied Biocon and Viatris’ application for their biosimilar to Avastin, a monoclonal antibody therapy for multiple cancer types. The agency cited issues related to cleaning procedures and anti-contamination protocols it noted during facility inspections in Bengalaru, India, and Johor, Malaysia, last August. The company intends to address the issues and provide the agency with a Corrective and Preventative Action (CAPA) plan.
The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to GSK’s Benlysta (belimumab). The designation applies to the use of Benylsta in treating the interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a rare autoimmune connective tissue disorder. The drug is currently approved for treating active lupus and lupus nephritis.
A recently published study in Neurology Clinical Practice found that Medicaid patients were less likely to be prescribed newer third-generation antiseizure medications (ASMs) if they were Black, Latino, Pacific Islander, or Native Hawaiian. These drugs tend to perform better and have less side effects, but are underutilized in the aforementioned populations compared to white Medicaid recipients.
ANVISA, Brazil’s health regulatory body, has approved PTC Therapeutics’ Waylivra for the treatment of family partial lipodystrophy (FPL). The approval marks the first of its kind worldwide for the disease. The drug is already approved in Brazil and the EU for the treatment of patients living with Familial Chylomicronemia Syndrome.
Two sickle cell gene therapies will be assessed for value and efficacy by the Institute for Clinical and Economic Review (ICER), according to an announcement today, November 23rd. The institute will investigate lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) and exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics). Public discussions will take place at a June 2023 CTAF meeting.
Spain’s Comisión Nacional de Los Mercados y la Competencia (CNMC) has fined Leadiant Biosciences €10.3 million for jumping the price of a therapeutic for the rare disease cerebrotendinous xanthamatosis (CTX). The company is accused by regulators of increasing the cost of chenodeoxycholic acid (CDCA), used to treat CTX, far faster than increases in similar drugs.
Biovac, a vaccine producer located in South Africa, has produced its first batch of Pfizer and BioNTech’s mRNA vaccine. The company was added to Pfizer and BioNTech’s vaccine manufacturing network just over a year ago. The South African Health Regulatory Products Authority still needs to inspect the vaccines before they can be distributed.
Eli Lilly’s tirzepatide was recently approved for weight loss by the US FDA. A newly published study in the New England Journal of Medicine shows that the drug has similar effects to gastric bypass surgery. The data further supports the use of the drug to treat obesity, which is associated with conditions like cardiovascular disease, diabetes, and some cancers. Patients with a BMI 30 or greater that took the drug and got counseling for healthy eating and exercise lost 20.9% of their body weight in 72 weeks, compared to 3% body weight loss in the placebo group. This has big implications for patients, providers, and payers.