Denise Myshko

The FDA has requested an additional study. ARS Pharmaceuticals plans to appeal the decision.

Even though committee members supported use of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, they had questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.

A workshop of the International Agency for Research on Cancer looked at the gaps in knowledge of four different cancers associated with HIV: Kaposi sarcoma, cervical, lung and anal cancer.

Most commercial payers cover remote physiologic monitoring, but coverage of electronic consults and electronic visits is less consistent. Commercial plans also have different levels of transparency.

The week, the FDA approved Aphexda for use in stem cell mobilization. The agency also assigned action dates for resmetirom to treat patients with NASH and Libervant Film for young children and extended the review for lifileucel to treat melanoma. Additionally, an FDA advisory committee backed the use of Onpattro in cardiomyopathy of ATTR amyloidosis.

Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.

CMS has included an additional 34 drugs on the list on products subject to rebates if their price increases are higher than inflation.

Akili executives said a focus on non-prescription digital therapies removes the barriers payers place on access and creates a more sustainable business.

The assessment framework developed by Peterson Health Technology Institute and the Institute for Clinical and Economic Research will prioritize products’ clinical benefits and economic impact of digital health technologies. The companies will announce the first set of health technologies to be reviewed by mid-October.

Cell and gene therapies can be used for patients with cancer and serious diseases who have limited or no treatment options — but at a cost.

Addressing drug affordability and accessibility will involve tackling the interrelated problems of high prices and problematic pharmacy benefit manager practices, says Benjamin N. Rome, M.D., with Brigham and Women’s Hospital in Boston.

The tentative approval by the FDA is through the President’s Emergency Plan for AIDS Relief (PEPFAR) program and is supposed to ease regulatory authority submissions, production and distribution in low- and middle-income countries.

About 65% of adults in the United States drink sugar-sweetened beverages daily, which increases the risk for liver cancer and mortality in women.

In total, Medicare beneficiaries paid $21 billion for 100 drugs that receive the most rebates, while health plans paid $5.3 billion after rebates.

In total, Medicare beneficiaries paid $21 billion for 100 drugs that receive the most rebates, while health plans paid $5.3 billion after rebates.

This House bill combines aspects of previously submitted bills — specifically on transparency related to prices on hospital services, laboratory tests, healthcare coverage and PBMs — into one package.

This House bill combines aspects of previously submitted bills — specifically on transparency related to prices on hospital services, laboratory tests, healthcare coverage and PBMs — into one package.

There is a huge opportunity for savings from the recently launched Humira biosimilars and others expected to reach the market in the next few years. But plans and PBMs will need to step into the role that pharmaceutical manufacturers once did in supporting patients and prescribers.

Payers are trying to figure out how to provide access to patients who would benefit from weight loss drugs such as semaglutide but also control costs.

The decision by Scripius (previously Select Health Prescriptions) was made based on the cost of Dupixent, as well as because of an increased demand to use Dupixent for mild atopic dermatitis when the primary patient population is those with moderate to severe disease.

As cell- and gene-based therapies become available for new and expanded indications with a higher incidence of patients, payers will be challenged to find ways to provide access to patients.

PBM transparency and data reporting requirements are likely to be part of a larger healthcare bill that Congress will work on this fall.

The FDA has approved Reblozyl as first-line treatment in MDS-related anemia and the first generics of ADHD drug Vyvanse. The agency also issued a CRL for bevacizumab to treat wet AMD. Additionally, two companies have submitted supplemental applications. These include Janssen, which is seeking full approval for Balversa for urothelial carcinoma, and AbbVie, which is seeking approval of Skyrizi for ulcerative colitis.

Magellan Rx Management has begun providing a multi-state solution in which they negotiate with drug manufacturers for value-based contracts for high-cost gene and cell therapies.

Magellan Rx Management has begun providing a multi-state solution in which they negotiate with drug manufacturers for value-based contracts for high-cost gene and cell therapies.

Researchers at Mass Eye and Ear and Dana-Farber Cancer Institute have developed a new technique for growing stem cells harvested from the eye that meets the FDA’s regulatory requirements for tissue engineering.

The anti-cancer drug bevacizumab is used off-label to treat wet AMD. Outlook Therapeutics had developed an ophthalmic formulation of bevacizumab for intravitreal injection.

Nonprescription Narcan will be available beginning in September in pharmacies and grocery stores, as well as online retailers and have a suggested cost of $44.99.

Experts expect more lawsuits challenging CMS’s authority to negotiate drug prices for Medicare Part D.

Topping the list is Eliquis, which accounted for $16.48 billion in spending for the 3.7 million people in Medicare Part D who take the blood thinner.