Denise Myshko

Caps on Medicare Part D cost sharing as a result of the Inflation Reduction Act, could reduce members’ financial incentive for switching to a biosimilar, suggests the newest Samsung Bioepis Quarterly Biosimilar Market Report.

The FDA has approved several new therapies this week, including Voydeya as an add-on therapy for blood disorder PNH; Zevtera for serious bacterial infections; Fanapt for bipolar 1; and the CAR-T therapy Abecma for earlier treatment in multiple myeloma. The agency has also accepted a supplemental BLA for Bimzelx in hidradenitis suppurativa and set a review date for datopotamab deruxtecan in breast cancer.

The quality-adjusted life-years tool has been misunderstood, Dr. Joshua Cohen says. QALYs are a measure of the value that comes from restoring a person to health, not about discrimination.

Between 2011 and 2020, 45.6% of new cancer drugs were approved through the accelerated approval pathway, according to a new report from the American Association of Cancer Research.

The FDA is also considering a separate BLA for a 2 mL syringe. Bimzelx is already available to treat plaque psoriasis as a 1 ml syringe; a dose is two subcutaneous injections with a cost of $7,200 per syringe.

In 2025, the out-of-pocket cap and other Part D related provisions in the Inflation Reduction Act are projected to save women in Medicare an average of 28% in out-of-pocket costs, according to a new analysis from the Office of the Assistant Secretary for Planning and Evaluation.

In 2025, the out-of-pocket cap and other Part D related provisions in the Inflation Reduction Act are projected to save women in Medicare an average of 28% in out-of-pocket costs, according to a new analysis from the Office of the Assistant Secretary for Planning and Evaluation.

Researchers found that pancreas volume, coupled with metabolic measures, can better predict disease progression of type 1 diabetes than either MRI imaging or glucose testing alone.

Foluso Agboola discusses the framework that the Institute for Clinical and Economic Review has developed for assessing whether clinical trial populations represent the real-world patient population.

Vafseo, an oral therapy to treat patients with anemia due to chronic kidney, will be available in January 2025. About 40% of patients who could be treated with Vafseo have coverage through Medicare Advantage plans.

Ozempic and Rybelsus could become a target for Medicare price negotiation because of high spending and additional approved uses of the GLP-1 therapies.

Adults and children with atopic dermatitis experience worse anxiety and depression as disease becomes more severe.

Sotatercept — now with the brand name Winrevair — will be available through specialty pharmacies by the end of April. The price of Winrevair is $14,000 per vial.

Medicare Part B beneficiaries may save between $1 and $3,575 per average dose for the 41 drugs whose prices have risen higher than inflation.

Medicare Part B beneficiaries may save between $1 and $3,575 per average dose for the 41 drugs whose prices have risen higher than inflation.

A new study finds that the use of continuous glucose monitoring helps reduce complications from type 1 diabetes, lowering the risk of developing or progressing diabetic retinopathy.

New approvals this week include a $4.25 million gene therapy, a drug that treats hypertension in a new way, a nonsteroidal drug for Duchenne, and an oral drug for aggressive leukemia. The agency has set an action date for resubmitted Lymphir in rare skin cancer, and Celltrion has launched Zymfentra, a subcutaneous form of infliximab.

Medicare and Medicaid will cover Wegovy for its recently approved indication to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and obesity.

This follows AstraZeneca’s and Boehringer Ingelheim’s announcements to also cap their asthma chronic obstructive pulmonary disease drugs at $35.

Tryvio, an oral drug for those with uncontrolled hypertension, will be available in the second half of 2024. The list price has not yet to be determined.

Zymfentra, with a price of $6,181.08 for two shots over four weeks, is approved as maintenance therapy for adults with ulcerative colitis and Crohn’s disease.

Lenmeldy is the first approved gene therapy to treat children with juvenile metachromatic leukodystrophy, a life-threatening inherited disease of the body’s metabolic system.

Lenmeldy is the first approved gene therapy to treat children with juvenile metachromatic leukodystrophy, a life-threatening inherited disease of the body’s metabolic system.

Zymfentra, with a price of $6,181.08 for two shots over four weeks, is approved as maintenance therapy for adults with ulcerative colitis and Crohn’s disease.

The accelerated approval of Iclusig for patients with acute lymphoblastic leukemia and with the Philadelphia chromosome was based on a surrogate endpoint. Iclusig has a list price of $20,831 for 30 tablets.

The accelerated approval of Iclusig for patients with acute lymphoblastic leukemia and with the Philadelphia chromosome was based on a surrogate endpoint. Iclusig has a list price of $20,831 for 30 tablets.

In a recent survey, payers said the Inflation Reduction Act will help lower patients’ out-of-pocket costs, but they were concerned about Medicare’s drug price negotiation and the IRA’s impact on formulary management.

The FDA this week approved a few firsts: the first treatment for NASH and the first CAR-T cell therapy for CLL/SLL. Other approvals include Tevimbra for esophageal cancer; Livmarli for second liver disease indication; and Praluent for children with genetic form of high cholesterol. The FDA also issued a CRL for monthly MS drug. Additionally, Celltrion submitted an application for an interchangeable Xolair biosimilar.

The AI system correctly identified all of the severe cases and accurately detected 80% of the cases with more-than-mild retinopathy of prematurity in a real-world population.