Highlights

• CVS Caremark announces removal of Humira (adalimumab) from national formularies
• FiercePharma publishes annual “Top 10 most anticipated drug launches of 2024” report
• Clarivate publishes annual “Drugs to Watch” report
• Peterson-KFF publishes annual “Health Cost and Affordability Policy Issues and Trends to Watch in 2024” report

FDA Approvals and Launches

• Prolia (denosumab) receives Boxed Warning from FDA addressing increased risk of hypocalcemia in patients with chronic kidney disease.
• Zelsuvmi (berdazimer topical gel) is approved for the treatment of molluscum contagiosum, a viral skin infection.
• Nilotinib capsules are approved as a generic alternative to chronic myeloid leukemia treatment Tasigna

News

CVS Caremark announces removal of Humira (adalimumab) from national formularies

• The change will go into effect on April 1, 2024 and will apply to plans that have adopted its national commercial template formularies.
• These formularies will instead cover Humira biosimilars and a co-branded version of Humira. The latter is manufactured through a partnership between AbbVie and CVS Health and will be available in Q2 2024.

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FiercePharma publishes annual “Top 10 most anticipated drug launches of 2024” report

• Investigational schizophrenia drug KarXT (xanomeline-trospium) is designated as the most anticipated drug with estimated sales of $2.8 billion by 2028.
• The drug has a Prescription Drug User Fee Act (PDUFA) date in September 2024.
• The report also showcases Alzheimer’s drug donanemab, which was rejected by the FDA in 2023 but was re-filed and is awaiting an additional approval decision in Q1 2024.

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Clarivate publishes annual “Drugs to Watch” report

• The report identifies 13 new-to-market drugs expected to launch in 2024, covering a wide range of indications including hemophilia A, sickle cell disease, Crohn’s disease, and respiratory syncytial virus (RSV).

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Peterson-KFF publishes annual “Health Cost and Affordability Policy Issues and Trends to Watch in 2024” report

• Examples of policies and trends that are discussed include price transparency, the Inflation Reduction Act (IRA) , and the drug development pipeline.

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Lilly launches LillyDirect, a direct-to-consumer, telehealth-based program for patients living with obesity, migraines, and/or diabetes

• The program will include a pathway for patients to receive GLP-1 treatment and other drugs manufactured by Lilly.
• In addition to a digital pharmacy, LillyDirect also offers educational information, telehealth services, and a search tool for in-person care.

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Evernorth launches EncircleRx to help plans manage chronic diseases

• The EncircleRx program is being positioned as a program that helps plans address members with cardiovascular disease, diabetes, and/or obesity.
• The program offers a GLP-1 financial guarantee to plan sponsors.

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Department of Health and Human Services (HHS) reaffirms plans’ responsibility to cover contraceptive options with no member cost-sharing

• The HHS Secretary issued a letter to health plans and issuers and published a frequently asked questions (FAQ) document providing guidance on the topic.
• The Medicare Part D formulary clinical review process was updated for play year 2024 to include additional birth control types such as intramuscular and intrauterine contraceptives.

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Drug manufacturer Alvotech updates status on biosimilar approvals

• Alvotech believes that, in February and April 2024, it will receive FDA approval for its biosimilars to reference products Humira (adalimumab) and Stelara (ustekinumab), respectively.

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SURMOUNT-4 trial finds that patients receiving weight loss treatment with Zepbound (tirzepatide) regained a substantial amount of lost weight after treatment discontinuation

• The phase 3 study examined patients who received treatment for 36 weeks, followed by continued treatment vs. discontinued treatment for 52 weeks.
• Patients in the study experienced a mean weight reduction of 20.9% through week 36; patients discontinuing treatment then experienced a mean weight increase of 14.0%. Patients remaining on treatment experienced an additional 5.5% reduction.

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PIFR-2 trial fails to reach superiority endpoint when comparing Yupelri (revefenacin) to Spiriva (tiotropium) for the treatment of chronic obstructive pulmonary disease

• The phase 4 trial compared the improvement in forced expiratory volume over 12 weeks of treatment using each of the two drugs.

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