Drug Pipeline and Cost Reference: Current and Emerging Therapies Affecting Level Funded Plan Economics

This technical document provides reference data on drugs and therapies discussed throughout Series 09. It is designed for periodic update as approvals and pricing change. Data reflects publicly available information as of early 2026.

GLP-1 Receptor Agonists

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Semaglutide (Ozempic) Manufacturer: Novo Nordisk. Indication: Type 2 diabetes; cardiovascular risk reduction in type 2 diabetes with established heart disease; chronic kidney disease with type 2 diabetes. FDA Status: Approved December 2017; cardiovascular and renal indications expanded October 2025. List Price: $1,028 per month ($12,336 annually); self-pay $349 per month through NovoCare. Novo Nordisk announced list price reduction to $675 per month effective January 1, 2027. Administration: Weekly subcutaneous injection. Plan Design Notes: Prior authorization typical; step therapy through metformin common.

Semaglutide (Wegovy) Manufacturer: Novo Nordisk. Indication: Chronic weight management (BMI 30 or higher, or BMI 27 or higher with comorbidity); cardiovascular risk reduction in adults with obesity and heart disease; MASH with moderate-to-advanced liver fibrosis. FDA Status: Approved June 2021; cardiovascular indication March 2024; MASH indication August 2025; oral tablet (25 mg) December 2025. List Price: $1,349 per month ($16,188 annually); reducing to $675 per month effective January 1, 2027. Administration: Weekly subcutaneous injection or daily oral tablet (25 mg). Plan Design Notes: Prior authorization required; 59 percent of fully insured plans cover for weight loss, only 22 percent of employer-sponsored plans.

Tirzepatide (Mounjaro/Zepbound) Manufacturer: Eli Lilly. Indication: Mounjaro for type 2 diabetes (approved May 2022); Zepbound for chronic weight management (approved November 2023). List Price: $1,023 to $1,060 per month ($12,276 to $12,720 annually). Administration: Weekly subcutaneous injection. Plan Design Notes: Dual GIP/GLP-1 mechanism; similar coverage considerations to semaglutide products.

PCSK9 Inhibitors and Cardiovascular Agents

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Evolocumab (Repatha) Manufacturer: Amgen. Indication: Heterozygous and homozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease. FDA Status: Approved August 2015. List Price: $5,850 per year (reduced from $14,100 in 2018); self-pay $239 per month ($2,868 annually) through AmgenNow. Administration: Every 2 weeks or monthly subcutaneous injection. Plan Design Notes: Prior authorization requiring statin failure or intolerance.

Alirocumab (Praluent) Manufacturer: Regeneron/Sanofi. Indication: Heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease. FDA Status: Approved July 2015. List Price: $5,850 per year (reduced from $14,600 in 2019). Administration: Every 2 weeks subcutaneous injection.

Inclisiran (Leqvio) Manufacturer: Novartis. Indication: Heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease. FDA Status: Approved December 2021. Annual Cost: Approximately $6,500 (two doses annually after loading). Administration: Healthcare provider-administered injection at initial dose, 3 months, then every 6 months. Plan Design Notes: Medical benefit vs. pharmacy benefit classification varies by plan.

Anti-Amyloid Alzheimer’s Therapies

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Lecanemab (Leqembi) Manufacturer: Eisai/Biogen. Indication: Early Alzheimer’s disease with confirmed amyloid pathology. FDA Status: Full approval July 2023; maintenance dosing (every 4 weeks IV) approved January 2025; subcutaneous self-injection (Leqembi Iqlik) approved August 2025. Annual Cost: $26,500. Administration: IV infusion every 2 weeks for 18 months, then maintenance every 4 weeks IV or weekly subcutaneous. Plan Design Notes: Requires amyloid PET ($3,000 to $5,000) or CSF analysis; ARIA monitoring MRIs required; APOE e4 carriers at elevated risk; Medicare covers under registry participation.

Donanemab (Kisunla) Manufacturer: Eli Lilly. Indication: Early symptomatic Alzheimer’s disease with confirmed amyloid pathology. FDA Status: Full approval July 2024. Annual Cost: Approximately $32,000 (treatment discontinued when amyloid clearance achieved; approximately 70 percent of patients reach stopping point by 18 months). Administration: IV infusion every 4 weeks. Plan Design Notes: Time-limited therapy model may reduce cumulative cost versus lecanemab.

CAR-T Cell Therapies

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Tisagenlecleucel (Kymriah): Novartis. ALL and DLBCL and follicular lymphoma. $373,000 to $475,000 per treatment.

Axicabtagene ciloleucel (Yescarta): Gilead/Kite. Large B-cell lymphoma and follicular lymphoma. $373,000.

Brexucabtagene autoleucel (Tecartus): Gilead/Kite. Mantle cell lymphoma and ALL. $373,000.

Lisocabtagene maraleucel (Breyanzi): Bristol Myers Squibb. Large B-cell lymphoma and CLL/SLL (accelerated approval March 2024). $410,000.

Idecabtagene vicleucel (Abecma): Bristol Myers Squibb. Multiple myeloma. $419,500.

Ciltacabtagene autoleucel (Carvykti): Janssen/Legend Biotech. Multiple myeloma. $465,000.

All CAR-T therapies are one-time treatments requiring specialized cancer centers. Total episode costs including hospitalization, monitoring, and adverse event management commonly exceed $500,000 per patient.

Gene Therapies

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Onasemnogene abeparvovec (Zolgensma): Novartis. Spinal muscular atrophy in infants under 2. $2,250,000. Single IV infusion.

Valoctocogene roxaparvovec (Roctavian): BioMarin. Severe hemophilia A. $2,900,000. Single IV infusion. Replaces ongoing factor VIII replacement ($200,000 to $500,000 annually).

Exagamglogene autotemcel (Casgevy): Vertex/CRISPR Therapeutics. Sickle cell disease and transfusion-dependent beta-thalassemia. $2,200,000. CRISPR-based gene editing. Approved December 2023.

Lovotibeglogene autotemcel (Lyfgenia): Bluebird Bio. Sickle cell disease. $3,100,000. Lentiviral gene therapy. Approved December 2023.

Key Biosimilar Categories

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Adalimumab (reference: Humira): Nine FDA-approved biosimilars as of 2025; seven with interchangeable designation. Products include Amjevita (Amgen), Cyltezo (Boehringer Ingelheim), Hadlima (Samsung Bioepis/Organon), Hyrimoz (Sandoz), Yuflyma (Celltrion), Hulio (Biocon), Abrilada (Pfizer), Yusimry (Coherus), Simlandi (Alvotech/Teva). Humira removed from all three major PBM formularies as of 2025. PBMs favor private-label biosimilars through Cordavis (CVS), Quallent (Express Scripts), and Nuvaila (Optum). Savings: 50 to 85 percent below reference list price. Evernorth documented $4,505 per patient per year in savings and over $200 million total from January 2024 through March 2025.

Infliximab (reference: Remicade): Biosimilars include Inflectra, Renflexis, Avsola. Savings: 15 to 35 percent below reference. Medical benefit; IV infusion.

Ustekinumab (reference: Stelara): Multiple biosimilars launched in early 2025; four with interchangeable designation by May 2025. Significant savings expected as Stelara loses exclusivity.

Rituximab, trastuzumab, bevacizumab, pegfilgrastim: Biosimilars available across oncology and autoimmune indications. Savings range 15 to 40 percent.

Pipeline Therapies to Monitor

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Oral semaglutide (Wegovy tablet, 25 mg): Approved December 2025. May expand GLP-1 access through oral administration.

Orforglipron (Eli Lilly): Oral non-peptide GLP-1 agonist in Phase 3. Potential to reduce GLP-1 manufacturing costs.

Retatrutide (Eli Lilly): Triple agonist (GLP-1/GIP/glucagon) in Phase 3. Weight loss exceeding current GLP-1s in trials.

Additional gene therapies: Late-stage development for hemophilia B, Duchenne muscular dystrophy, inherited retinal dystrophies. Expected pricing above $1 million per treatment.

Enbrel (etanercept) biosimilar: FDA-approved biosimilar (Erelzi) exists but is not expected to launch until 2029 due to patent litigation.