2025 Formulary Changes: CVS Caremark

The following is an analysis of the CVS Caremark 2025 formulary changes to be made to the Standard Control with Advanced Control Specialty Formulary (SCF/ACSF), effective 1/1/2025. PSG’s clinical team evaluated the changes, including an impact analysis based on our book of business dataset, to provide an overview of the most important considerations. Sixteen drugs will be excluded, 9 of which are specialty drugs. The majority of the exclusions are single-source brand drugs and 2 are biosimilars. CVS will add 18 drugs to the SCF/ACSF effective 1/1/2025. Many of these were previously excluded under the “new to market” block, a strategy that excludes newly approved drugs from coverage until sufficient information is available for review and formulary placement by the PBM. Some will serve as alternatives to the 2025 exclusions.

Notable Observations

• The overall quantity and impact of CVS’s 2025 formulary exclusions are less than what was observed in past years. The number of specialty drugs impacted is less than half the number that were excluded in 2024.
• Changes made to the diabetes and respiratory category will have the most significant impact. Both were affected by the formulary exclusions made in 2024.
• A larger number of new, higher-cost therapies are being added to the formulary effective 1/1/2025 and will serve as formulary alternatives to drug exclusions.
• CVS will expand indication-based coverage in the anti-inflammatory category for ulcerative colitis and psoriasis.

Some of the notable formulary changes are highlighted below:

*Multisource brand

Diabetes

Similar to previous years, the diabetes category, specifically the DPP-4 inhibitors and incretin mimetic agents, will be impacted by formulary exclusions in 2025. CVS will take advantage of preferring lower-cost generics by excluding two brand drugs (Januvia, Janumet/XR) and a multi-source brand drug (Victoza). However, CVS will also prefer other branded products, including new formulary additions, which could limit the uptake of generic alternatives. Member impact by utilization in this category is the most significant of the 2025 formulary exclusions.

The 2025 exclusions will also impact the diabetic supply category with the exclusion of V-GO, a wearable insulin patch that delivers a continuous infusion of insulin. CVS will prefer the Omnipod and Twiist line of insulin delivery devices. Although all the devices deliver insulin to the body, they differ in their functionality and capabilities; thus, individual patient preferences may cause disruption.

The use of these newer technologies in treating and monitoring diabetes has increased in the past few years. The most recent 2024 American Diabetes Association guidelines strongly recommend the use of insulin pumps and continuous glucose monitors, especially in people with type-1 diabetes. Adoption of these technologies will likely raise the cost of diabetic care. However, this may be balanced by improved disease monitoring and avoidance of disease complications.

Botulinum Toxin

Botulinum toxins treat a wide variety of neurological conditions in addition to their cosmetic uses. Effective 1/1/2025, CVS will exclude Dysport (abobotulinumtoxinA) and instead prefer Xeomin (incobotulinumtoxinA) and Daxxify (daxibotulinumtoxinA), one of the drugs being added to the formulary.  Although the products are clinically similar, each is unique in terms of dosing, potency, and formulation; drug selection is commonly based on availability and provider preferences. The impact of this category should be minimal as the utilization of Dysport is low. Additionally, botulinum toxins are commonly covered under the medical benefit. Based on PSG’s book-of-business, approximately 80% of claims are processed this way.  

Respiratory Category

Consistent with the changes made in 2024, the respiratory category will be impacted by the exclusions effective 2025. CVS will exclude tiotropium bromide inhalation powder and prefer the brand version, Spiriva HandiHaler. Tiotropium bromide, approved for the treatment of chronic obstructive pulmonary disease (COPD), is the first and only generic version of Spiriva launched in the United States. Currently, the generic is priced at only a 10% discount from the brand. With limited generic competition, a modest discount off brand Spiriva, and likely more aggressive rebates on branded respiratory products, CVS preferring the brand drug is not unexpected. CVS also prefers Spiriva Respimat, the aerosol formulation of tiotropium bromide, which is unlikely to have generic competition for several years.

Other drugs in the respiratory category, including a combination of steroids and beta-agonists, will be impacted by the 2025 formulary exclusions. In this dense category, CVS will take advantage of multiple, lower-cost generics by preferring them over a brand drug Dulera (mometasone/formoterol) which will be excluded. Clinically, these products are similar for the maintenance of asthma treatment, however, there may be some member disruption due to personal preference of the various inhaler dosage forms.

Hematologic Agents – treatment of Myasthenia Gravis

The exclusion of Soliris (eculizumab) and Ultomiris (ravykuzynab) will only impact members being prescribed the drugs for treatment of myasthenia gravis (MG), a rare autoimmune disorder characterized by muscle weakness and fatigue. Currently, there are 5 FDA-approved drugs to treat MG. CVS will add to the SCF/ACSF and prefer Vyvgart (efgartigimod) and Vyvgart Hytrulo (efgartigimod and hyaluronidase), an emerging market leader. Only members new to treatment will be impacted by this change, as members currently on Soliris and Ultomiris will not be disrupted.

Compared to Soliris and Ultomiris, Vyvgart works differently and is dosed cyclically based on the patient’s symptoms. While these drugs are administered intravenously, Vyvgart Hytrulo offers the advantage of a more convenient subcutaneous dosage form, administered over a shorter period of time. Coverage of these drugs can be through either the medical or pharmacy benefit. Based on PSG’s book-of-business, approximately 94% of claims are processed under the medical benefit. Plans should ensure alignment of coverage requirements under both benefits.

Advances in the diagnosis and treatment of MG have been made over recent years, with several targeted treatments in the drug pipeline. Although lower-cost Soliris biosimilars are expected to be available in 2025, plans should expect to have an increase in utilization and spend in this high-cost specialty category.

Inflammatory Conditions – Indication-Based Formulary Updates

CVS is making changes to the formulary status of select brand anti-inflammatory drugs per indication by switching preferred products. The company will add Bimzelx and exclude Taltz, highly effective branded drugs for the treatment of psoriasis. Lower-cost Stelara biosimilars, when available, and Humira biosimilars can also serve as alternatives. Members currently on Taltz will be required to switch to Bimzelx or other preferred alternatives for the treatment of psoriasis.

Tremfya was recently approved for the treatment of adults with moderately to severely active ulcerative colitis. CVS will add Tremfya as a preferred therapy for ulcerative colitis, expanding an already dense ulcerative colitis indication-based category.  

CVS was the first PBM to exclude Humira from its formularies and prefer the biosimilars. In 2025, eight Stelara biosimilars, some of which are interchangeable, are expected to launch. Consistent with its formulary evaluation process, the formulary status of these biosimilars will be made based on clinical, financial, and market factors. However, the timing of these decisions was not communicated. Additionally, CVS did not comment on the potential status of brand Stelara. Payers should continue to look for savings opportunities in this dense, high-cost anti-inflammatory category. It is important to understand if and where biosimilars can generate savings.

Drugs Added Back to the Formulary

Eighteen drugs will be added to the SCF/ACSF effective 1/1/25, some of which had previously been on the formulary but were removed. Others are being added to the formulary after their removal from CVS’ new-to-market drug block list. Eleven of the 18 drugs added to the formulary are specialty drugs, including two oncology biosimilars to Herceptin (Kanjinti and Trazimera, which were excluded in 2024), replacing Herzuma and Ogivri. Some drugs will expand already dense therapeutic categories, such as Asmanex HFA, Breyna, and budesonide-formoterol in the respiratory category. Other additions offer some therapeutic advantages. Altuviio, for example, is a longer acting factor product and requires less frequent dosing for the treatment of Hemophilia A.

Compared to the 1/1/2024 formulary exclusions, the member and financial impact of CVS’ 1/1/2025 formulary exclusions are expected to be minimal, driven by respiratory and diabetes categories. The number of drugs being added to the formulary are higher than in past years with over half of the additions coming from the new-to-market drug exclusion list.  Some of these additions will replace existing therapies, while others will expand already dense therapeutic categories.

Need help navigating 2025 formulary changes? PSG has the unbiased clinical and market expertise you need. Contact us today to learn more.