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2024 Evolution of ADA Guidelines

2024 Evolution of ADA Guidelines hero image

The American Diabetes Association (ADA) emphasizes the use of GLP-1 and GIP/GLP-1 receptor agonists in patients with type 2 diabetes who would benefit from weight and glycemic lowering benefits.  As the ADA guidelines have evolved, GLP-1 RA or GIP/GLP-1 RAs have been suggested earlier in treatment. With an update to the 2024 type 2 diabetes diagnostic criteria, ProAct will be updating its clinical criteria for clients with the standard prior authorization offering in place for patients new to therapy:

  • Submission of two abnormal screening test results (A1C ≥6.5%; fasting plasma glucose [FPG] ≥126 mg/dL, 2-hour plasma glucose [2hPG] ≥200 mg/dL, per the 2024 T2D diagnostic criteria; and
  • Documentation of random plasma glucose ≥200 mg/dL in an individual with classic symptoms of hyperglycemia or hyperglycemic crisis, measured either at the same time or at two different time points

The above will be added to the criteria requiring a trial and failure to a metformin-containing drug therapy, unless patients with diabetes have documentation of comorbidities, which require treatment with a GLP-1 RA or a GIP/GLP-1 RA or a contraindication.

Biogen to discontinue manufacturing of Aduhelm™

Biogen to discontinue manufacturing of Aduhelm™ hero image

Drug manufacturer, Biogen, has decided to discontinue the manufacturing of Aduhelm™ (aducanumab-avwa) injection and to terminate the clinical trial that was being conducted for its full approval. In June 2021, Aduhelm™ was awarded the FDA’s Accelerated Approval and became a landmark event for the Alzheimer’s field, providing hope for the millions of people living with early Alzheimer’s, as it was the first FDA-approved treatment to address one of the underlying causes of the disease. The accelerated approval was surrounded by controversy as many payers did not cover the medication due to lack of clinical trial data to ensure its benefits outweighed its risk. Biogen made the decision based on business purposes and will refocus efforts and financial resources on its Leqembi® (lecanemab-irmb) injection and on investigational drugs still in clinical trials for the disease. Leqembi® was fully approved by the FDA to treat mild Alzheimer’s disease on July 6, 2023. Aduhelm™ and Leqembi® are currently excluded on ProAct’s Advantage formulary.

Eli Lilly Launches Digital Healthcare Experience through LillyDirect™

Eli Lilly Launches Digital Healthcare Experience through LillyDirect™ hero image

On January 3, 2024, Eli Lilly and Company announced LillyDirect™, a digital healthcare experience for patients in the U.S. living with obesity, migraine and diabetes. LillyDirect™ offers a pharmacy fulfillment solution, disease state management and educational resources, access to telehealth providers, as well as, a search tool for local healthcare professionals. There are 14 drugs available through LillyDirect™ including Basaglar, Lyumjev, Rezvoglar, and multiple formulations of Humalog and Humulin. Patients can also access Zepbound for chronic weight management, but Mounjaro for type 2 diabetes is not currently offered. Emgality for migraine is also available on the platform. Some healthcare experts worry offering medications direct from the drug manufacturer may make it easier for pharmaceutical companies to target consumers, regardless of whether the medication is the appropriate treatment for the patient. Other drug manufacturers, especially those with chronic weight management medications, will most likely follow suite as they look for ways to get their medications to more patients.

ICER Identifies Significant Unsupported U.S. Drug-Price Hikes

ICER Identifies Significant Unsupported U.S. Drug-Price Hikes hero image

On December 11, 2023, the Institute for Clinical and Economic Review (ICER) published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. Among the top 10 drugs with net price increases in 2022 that had substantial effects on U.S. spending, ICER determined that eight lacked adequate new evidence to support any price increase. These included, AbbVie’s Humira, Janssen’s Darzalex, Pfizer’s Ibrance, Amgen’s Prolia, Salix Pharmaceuticals’ Xifaxan, Amgen’s Xgeva, Roche/Genentech’s Perjeta, and Seagen’s Adcetris. The increase in spending on these drugs due to the net price change ranged from $63 million for Adcetris to $386 million for Humira. Overall, these increases accounted for $1.27 billion in additional drug costs. One of the provisions of the Inflation Reduction Act of 2022 is aimed at lowering prescription drug prices by requiring drug companies to pay rebates to Medicare if prices rise faster than inflation for drugs used by Medicare beneficiaries, beginning in 2023.

FDA Authorizes First Section 804 Importation Program in the U.S.

FDA Authorizes First Section 804 Importation Program in the U.S. hero image

On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step toward Florida facilitating importation of certain prescription drugs from Canada. The authorization holds for 2 years, beginning when Florida notifies the FDA of the first imported drug shipment. This is the first authorization of a section 804 importation program (SIP) in the United States. Although several other states have passed bills that establish drug importation programs, none are certified yet by the FDA. While drug importation on a large scale has the potential to lower prices for cash-paying patients, it is likely not a viable means to an overall lowering of drug prices in the United States, given concerns regarding safety, cold chain logistics, and uncertainty around cost savings.

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