Denise Myshko

ICER has weighed in on two of the 10 drugs selected for negotiations: Eliquis and Xarelto, which are among Medicare Part D’s highest spending drugs.

Even though the Inflation Reduction Act will require plans to justify formulary placement of negotiated drugs, payers have more of an incentive to steer patients to lower-cost alternatives.

The FDA indicated there were no concerns about the safety or labeling of lebrikizumab, which is being reviewed to treat patients with moderate-to-severe atopic dermatitis.

The FDA has approved several new therapies this week, including a new two-component Pompe therapy, an extended-release drug for major depression without sexual side effects, and an eye drop for drug-induced dilation. Additionally, the agency has set review dates for several products, including odronextamab for blood cancers, sotatercept for pulmonary arterial hypertension, and Dupixent in young children with eosinophilic esophagitis.

ICER adds a more formal process to evaluate the diversity of clinical trials and an assessment of a product’s impact on patient and caregiver productivity. ICER also plans to evaluate how newer methods — which would consider the change of a drug’s price over time and disease severity — can be applied to its value assessment.

The FDA has approved GSK’s myelofibrosis drug, as well as a new indication for Jardiance and a new dosing regimen for Talicia. The agency has also issued a complete response letter for epinephrine nasal spray and assigned a review date for the gene therapy atidarsagene autotemcel.

An analysis by 3 Axis Advisors has found that there is a large variability in pharmacy reimbursement of prescription drugs depending on PBM contracts with insurers. This creates a system with huge inconsistences on the prices of both generics and branded products.

MSU researchers are hopeful that this new insight about cholesterol crystals in the retina could provide an opportunity for earlier diagnosis and treatment of diabetic retinopathy.

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.

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.

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.

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.

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.

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.

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.

The FDA has approved the first biosimilar of MS drug Tysabri and granted additional approvals to Abrysvo to prevent RSV in infants, to a higher dose Eylea, and to Ingrezza for a disorder associated with Huntington’s disease. The agency has also set a review date for first-in-class therapy for MDS and granted priority review to Xtandi for earlier treatment in prostate cancer.

Cigna Healthcare has removed prior authorization requirements for a wide range of tests, treatments and medical equipment, but not prescription drugs.

Optical coherence tomography was found to be comparable with MRI in detecting changes to the retina in patients with multiples sclerosis and is non-invasive, inexpensive, fast, and easy to perform.