Earlier this week, Sen. Tammy Baldwin (D-Wis.) sent a letter to the four largest inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline GSK and Teva) to cease the inappropriate listing of patents in the Food and Drug Administration (FDA) database. This practice can delay more affordable generic alternatives from entering the market. Inhaler prices will continue to be a primary focus of the Senate Committee on Health, Education, Labor and Pensions (HELP) to start 2024. Other focuses of the HELP Committee this week were Sen Bernie Sanders (I-Vt.) working on a legislation that would increase resources for long COVID.

On Wednesday, the House Energy & Commerce’s Subcommittee on Health held a hearing “Health Care Spending in the Untied States: Unsustainable for Patients, Employers, and Taxpayers.” Lowering healthcare costs is a bipartisan issue. As such, a major point of discussion at the hearing surrounded H.R. 5378 “Lower Costs, More Transparency Act”. This bill passed the House with bipartisan support at the end of 2023 and is waiting a vote in the Senate. 

On Wednesday, Biogen announced the discontinuation of the once groundbreaking Alzheimer’s Disease drug Aduhelm. Back in the summer of 2021, Aduhelm gained fame as the first new FDA-approved drug for treating Alzheimer’s in nearly two decades. However, its initial approval raised skepticism among experts due to the lack of proof of efficacy, with many considering the approval premature. 

Following Aduhelm, the more successful drug Leqembi, developed by Eisai, received FDA approval in the summer of 2023 to treat Alzheimer’s Disease. Leqembi stands out as the first drug known to slow the cognitive decline associated with the deadly disease. 

Another promising drug in the fight against Alzheimer’s, Eli Lilly’s Donanemab, is expected to receive their FDA-approval decision in Q1 2024. Donanemab demonstrated the highest rates of slowing the spread of Beta Amyloid plaque in the brain, the hallmark feature of Alzheimer’s Disease, compared to any other drug on the market in its clinical trials. Despite its effectiveness, the FDA denied accelerated approval due to the limited number of patients receiving at least 12 months of the drug during the trial period. If approved, Donanemab, along with Eisai’s Leqembi, could revolutionize how physicians treat the disease. 

It’s essential to note that other innovative strategies are also in the pipeline for slowing the spread of the disease. GLP-1 receptor agonists, a class of injectable medications known for aiding weight loss, are being tested for treating Alzheimer’s. Additionally, Cognito Therapeutics recently raised a $35 million Series B extension for a new device that utilizes combinations of light and sound to treat Alzheimer’s. The first data readout on the clinical trial is expected in 2025. While still in its early stages, more innovative strategies are anticipated to come to market for treating Alzheimer’s Disease. 

These significant developments have captured the attention of lawmakers. During an interview at the POLITICO live event titled “How Fast Can We Solve Alzheimer’s” on Wednesday evening, Sen. Tim Kaine (D-Va.) discussed that members of the Senate HELP Committee are hoping to consolidate their two bipartisan priorities from recent months, overhauling the operations of pharmacy benefit managers and enhancing the health workforce, into one health package. 

Sen. Kaine expressed hope for the reauthorization of the 2018 “BOLD Infrastructure for Alzheimer’s Act” to be included as part of broader health policy legislation. The Act, which increased care and research for those with Alzheimer’s Disease, is seen as a vital component in the fight against the condition. House Rep. Brett Guthrie (R-Ky.), Chair of the Energy and Commerce Health Subcommittee, echoed Sen. Kaine’s sentiments during the event, signaling strong parallel interest from the House in reauthorizing the BOLD Infrastructure for Alzheimer’s Act in 2024. 

As lawmakers continue to focus on Alzheimer’s Disease, CAI is watching to see if federal funding for Alzheimer’s research and care will be incorporated into a broader bipartisan healthcare bill at some point this year. 

The Biden Administration announced on Tuesday that Sickle Cell Disease treatments will be the first priority of the Cell and Gene Therapy Access Model. SCD disproportionately impacts Black Americans and has very limited treatment options.

On Wednesday, January 31st, CMS released its Draft Calendar Year (CY) 2025 Part D Redesign Program. The final program instructions will be published on April 1, and the overhaul to the Part D program will take effect on January 1, 2025. CMS concurrently released CY 2025 Advance Notice for the Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs. The advanced notice updates payment policies for the MA and Part D programs. The release of the proposed rules was met with strong opinions from lawmakers.

Syphilis cases are rising in the United States, reaching levels not seen in over 70 years.

At the end of last week, HHS issued a request for information regarding transparency and data in Medicare Advantage. The RFI comment period is open for 120 days.

Cigna is selling its Medicare business to Health Care Service Corp. for $3.7 billion. The majority of the deal is its Medicare Advantage business, worth $3.3 billion.

The Biden administration made its offers to pharmaceutical companies for the first ten drugs in its Medicare drug price negotiation program. Offers will be kept private unless a pharmaceutical company voluntarily discloses. The final prices will be set on September 1^st this year and will go into effect in January 2026.

The Supreme Court will hear oral arguments in March for FDA v. Alliance for Hippocratic Medicine, regarding the abortion medication mifepristone. Also in March, the Supreme Court will hear oral arguments in Murthy v. Missouri, related to censoring of Covid-19 misinformation online.

Last week, HHS, through ASPR, released voluntary cybersecurity performance goals aimed at strengthening cybersecurity within the healthcare industry.

The FDA published its guidance on CAR T-cell products this week. Guidance includes both clinical and nonclinical recommendations.

On Monday, the FDA revised emergency use of Paxlovid through March 8, 2024. After March 8^th, all EUA-labeled Paxlovid should be returned to the manufacturer or disposed of properly.