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Clinical Insights: February 14, 2024

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug/Vaccine Approval

Eohilia™ (budesonide) Oral Suspension – New Drug Approval – February 9, 2024 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved Eohilia™ (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February. Eohilia™ is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE. Developed specifically for EoE, Eohilia™’s novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed. <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

February 07, 2024

February 06, 2024

Updated Drug Shortage

February 13, 2024

February 09, 2024

February 08, 2024

February 07, 2024

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Sky High Prescription Drug Prices Have Md. Legislators Looking for Consumer Relief – February 12, 2024 – Skyrocketing prescription drug prices are forcing Maryland legislators to look at several solutions to try to bring those costs down for citizens. One man who testified before Maryland’s Senate Finance Committee last week said he has to pay around $800 for just an ounce of medication. “How many of us, like me, are making decisions whether to eat, heat or treat a condition like I have?” he told the committee. “It’s neurodegenerative and there’s no cure.” Patients like him voiced their support for a bill that may one day limit the pricing on specific medications. Introduced in both chambers of the General Assembly, the Lowering Prescription Drug Costs for All Marylanders Act of 2024 would allow the state’s Prescription Drug Affordability Board to set up “upper payment limits” for drugs that they deem unaffordable. <Read More>

New AAD Acne Guidelines Warn About High Cost, Access to New Treatments – February 5, 2024 – The American Academy of Dermatology has issued updated guidelines for the treatment of acne that strongly recommend many of the mainstays of acne care but also boost some new expensive treatments that may challenge payer coverage policies. The guidelines include some cautionary language about the use of systemic antibiotics leading to antibiotic resistance and other antibiotic-associated complications, noting that in 2021 dermatologists prescribed more oral antibiotics per clinician than any other specialty group and that most of the antibiotics were for acne treatment. <Read More>

Group of Transparent Pharmacy Benefit Managers Form Transparency-Rx to Advocate for Clarity and Reform in Pricing of Prescription Drugs – January 26, 2024 – Increased transparency that lets consumers see prices charged by hospitals, physicians, and clinical laboratories in advance of service is an important goal of healthcare policymakers and self-insured employers. But greater transparency has yet to affect how prescription drugs are first priced, marked up, and charged to the final purchasers. Now a group within the pharmaceutical industry has issued a call for greater transparency in the pricing of prescription drugs. A number of smaller Pharmacy Benefit Managers (PBMs) have formed a coalition against the often confusing and overly complex pricing of prescription drugs in hopes that their efforts will give healthcare consumers more clarity when it comes to comparison shopping for pharmaceuticals. <Read More>

Drugmakers Hiking Prices for More Than 700 Medications, Including Ozempic® and Mounjaro™ – January 18, 2024 – Pharmaceutical companies are hiking prices for more than 700 medications, including popular weight-loss drugs Ozempic® and Mounjaro™, industry research shows. The average price increase at year start was about 4.5%, the analysis from 46 Brooklyn found. That represents a slightly slower pace compared with the five prior years, when drug prices rose about 5% each year on average, the data shows. <Read More>

Implementing Technological Workflow May Usher in New Era of Pharmacy – January 9, 2024 – Placing telepharmacy at the forefront of outdated workflows could transform the traditional pharmacy setting. Everyone knows the statistic: Pharmacists are considered the most accessible health care professional. Everyone also knows that pharmacists are experiencing more burnout than ever before. Although external factors such as the COVID-19 pandemic have contributed to this burnout, factors within the pharmacy, such as outdated workflows that incorporate manual practices that increase workload and cut into pharmacists’ valuable time, are also to blame. Incorporating telepharmacy models into these outdated pharmacy workflows may mitigate the harms associated with burnout and create a more efficient, safe, and lucrative pharmacy setting. <Read More>

340B in the News

Gang of Six Introduces Historic 340B “Discussion Draft” Legislation – February 9, 2024 – On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program—introduced a discussion draft of a bill that would modify the program that provides safety net providers with access to low-cost medications from participating manufacturers. The 340B statute has not been modified since 2010. If enacted, the bill would codify for the first time contract pharmacy and child site arrangements in the 340B statute, but would do so in exchange for certain program integrity reforms. As a discussion draft, the bill includes placeholders, to be addressed in response to certain requests for information (RFIs) released alongside the draft bill. <Read More>