2026 Summer Prime Therapeutics Report

Prime Therapeutics Report | Summer 2026

IntegratedRx® update

Chronic obstructive pulmonary disease

Ophthalmology

SP EC I A LTY S O LU TI O N S FO R MANAG ED CARE

Prime Therapeutics S U M M E R 2026

Autoimmune update: Expanding biosimilar landscape and payer impact

Report

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Published By Prime Therapeutics 2900 Ames Crossing Road Eagan, MN 55121 PrimeTherapeutics.com Editor Lindsay Speicher, J.D. Sr. Project Manager, Specialty Lindsay.Speicher@PrimeTherapeutics.com

Contents 4

Newsstand

8

Autoimmune update

Advertising, Sales and Distribution Lindsay Speicher, J.D. Sr. Project Manager, Specialty Lindsay.Speicher@PrimeTherapeutics.com

Joe Tavares SVP, Sales and Business Development, Specialty Joe.Tavares@PrimeTherapeutics.com

EXPANDING BIOSIMILAR LANDSCAPE AND PAYER IMPACT

Contributors Steve Cutts, PharmD SVP, Specialty and Clinical Solutions

Haita Makanji, PharmD VP, Clinical Strategy and Innovation, Specialty

18

Joe Tavares

ONCOLOGY AND CYSTIC FIBROSIS SOLUTIONS

SVP, Sales and Business Development, Specialty

Abby Kim, PharmD, BCOP Clinical Oncology Pharmacist Senior Principal

Shelae Cheng Marketing Principal, Brand Marketing Strategy

22

Brian MacDonald, PharmD Sr. Director, Specialty Clinical Strategy and Programs

Alina Young Sr. Legal Counsel

Editorial Advisory Board

Prime Therapeutics IntegratedRx® update

Chronic obstructive pulmonary disease DIAGNOSIS, TREATMENT LANDSCAPE AND PIPELINE

30

Mona Chitre, PharmD

Ophthalmology TREATMENT LANDSCAPE AND PAYER MANAGEMENT

Chief Pharmacy Officer, Lifetime Healthcare Companies

Dennis Bourdette, M.D., FAAN, FANA Chair and Roy and Eulalia Swank Family Research Professor, Department of Neurology, Oregon Health & Science University

Yousaf Ali, M.D., FACR

36

Pipeline

Chief, Division of Rheumatology, Mount Sinai St. Luke's and Mount Sinai West Professor of Medicine, Icahn School of Medicine at Mount Sinai

Steven L. D’Amato, B.S.Pharm.

Founding Partner, Scientia Pharmacy Advisors

Joseph Mikhael, M.D., M.Ed., FRCPC, FACP Chief Medical Officer, International Myeloma Foundation

Steve Marciniak, RPh President, ClarityRX

Saira A. Jan, M.S., PharmD VP and Chief Pharmacy Officer, Horizon Blue Cross Blue Shield of New Jersey

The content of Prime Therapeutics Report — including text, graphics, images and information obtained from third parties, licensors and other material (“content”) — is for informational purposes only. The content is not intended to be a substitute for professional medical advice, diagnosis or treatment. Prime Therapeutics Report does not verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damages incurred by readers in reliance on such content. Developed by D Custom. All brand names are property of their respective owners.

© 2026 Prime Therapeutics LLC

ISSN: 2159-5372

10444M

A note from our SVP Dear managed care colleagues, Welcome to our summer 2026 issue of the Prime Therapeutics Report! We anticipate many exciting advances throughout the year, with a robust pipeline across several categories. Prime Therapeutics is dedicated to bringing our readers valuable updates in managed care trends.

This issue’s cover story (Page 8) explores the broad autoimmune space, focusing on the ever-expanding biosimilar landscape in the category. This high-spend category is always top of mind for Prime and our clients.

Another article (Page 22) focuses on advancements in the chronic obstructive pulmonary disease (COPD) space, including the approvals of the first-ever biologic therapy and the first inhaled therapy with a novel mechanism of action in more than 20 years. We highlight the evolving COPD treatment landscape, pipeline and points of interest for payers navigating this space.

This issue also features Prime’s exciting IntegratedRx solution, an update on the ophthalmology category and the managed care newsstand. As always, we’ve rounded out this issue with the pipeline.

To learn more about how we’re supporting transformative payer initiatives, please feel free to contact us at PTReport@PrimeTherapeutics.com. We value any feedback you may have. Enjoy the report!

Sincerely,

Steve Cutts, PharmD

Senior Vice President, Specialty and Clinical Solutions Prime Therapeutics

Subscribe today!

Stay on top of managed care trends and become a Prime Therapeutics Report subscriber. Subscribe today at www.primetherapeutics.com/prime-therapeutics-report-subscription. Prime Therapeutics Report provides pharmacy and medical management solutions for managed care executives and clinicians. We hope you enjoy the issue; thank you for reading.

PRIMETHERAPEUTICS.COM | 3

Managed care newsstand CAA 2026 establishes new baseline for PBM policy

DOL ERISA PBM feedisclosure proposed rule

After years of incremental activity, Congress enacted comprehensive pharmacy benefit management (PBM) reform through the Consoli­ dated Appropriations Act (CAA) 2026, which was signed into law on Feb. 3, 2026.

On Jan. 30, 2026, the Department of Labor (DOL) issued a proposed rule requiring PBMs to disclose compensation to fiduciaries of Employee Retirement Income Security Act (ERISA)-covered selfinsured group health plans, pursuant to the April 2025 executive order on drug pricing transparency. The proposal is modeled on CAA 2021 broker-disclosure requirements but is more detailed, faster moving (effective 2027 versus 2029 for CAA 2026), and adds DOL/ERISA enforcement authority.

The law establishes a federal frame­ work governing PBM transparency, reporting, rebate pass-through and fiduciary oversight across commercial, Medicare and Medicaid markets. While most provisions take effect for plan years beginning 30 months after enactment, the statute is already influencing contracting, operational planning and regulatory activity.

CAA 2026 establishes a new baseline for PBM economics, accelerates contract renegotiation cycles ahead of formal compliance timelines, and will require continued investment in data, reporting and operational infrastructure. It also establishes the foundation against which subse­ quent federal regulatory actions are being evaluated.

With CAA 2026’s passage, portions of the proposed rule are now superseded by statute. DOL will need to decide whether to proceed, withdraw, or reissue a revised rule harmonized with the new law.

Prime Therapeutics shares the goal that motivated this rule: ensuring plan fiduciaries have meaningful visibility into PBM compensation. Our position is that CAA 2026 achieves that goal more comprehensively and with broader coverage than the proposed rule, making a duplicative regulatory overlay counterproduc­ tive rather than additive.

4 | PRIME THERAPEUTICS REPORT | SUMMER 2026

FTC settlement with Express Scripts and CVS Caremark The Federal Trade Commission’s (FTC) September 2024 lawsuit against the three largest PBMs (Express Scripts, CVS Caremark and OptumRx) and their affiliated group purchasing organizations marked a significant escalation in federal scrutiny of PBM rebate practices. The agency alleged that all three engaged in anticompetitive and unfair practices that artificially

The FTC’s September 2024 lawsuit against the three largest PBMs and their affiliated group purchasing organizations marked a significant escalation in federal scrutiny of PBM rebate practices.

inflated insulin list prices and shifted costs to patients.

Two of the three PBMs have now settled. Express Scripts reached a final settlement in February 2026 and CVS Caremark reached a proposed settlement in March 2026 modeled on similar terms; CVS’ settlement is pending final FTC approval. OptumRx remains in proceedings.

Key elements of the settlements •

•

•

• •

Rooted in insulin pricing, but the Express Scripts settlement applies broadly across drug classes Requires delinking PBM compensation from list pricebased rebate structures Restricts formulary and benefit designs that base cost-sharing on list price Projects up to $7 billion in patient savings over 10 years CVS Caremark final terms are pending but are expected to be substantially similar to Express Scripts’

While these settlements bind only the named parties, the FTC’s actions signal an emerging behavioral standard for the industry’s three dominant players through enforcement rather than rulemaking. These actions suggest a broader enforcement strategy rather than isolated cases, and with OptumRx proceedings still active, it is not yet complete. The practical effect is significant regardless of legal mandate: the contracting and formulary practices targeted by the FTC are under pressure across the market, and clients should expect the settlements to influence industry norms even where no legal obligation exists.

Administration expands drug pricing strategy through tariffs and direct channels Section 232 pharmaceutical tariffs On April 2, 2026, President Donald Trump signed a proclamation impos­ ing a new 100% tariff on patented pharmaceuticals and their active ingredients under Section 232 of the Trade Expansion Act of 1962. The tariff framework introduces a tiered structure tied to most favored nation (MFN) participation and domestic manufacturing commitments: •

•

•

• •

0% tariff: Manufacturers with MFN agreements and U.S. manufacturing commitments 20% → 100% tariff: Manufacturers pursuing U.S. manufacturing without MFN participation (escalating to 100% by 2030) 100% tariff: Manufacturers without MFN agreements or domestic manufacturing commitments Reduced rates: Country-specific carve-outs (e.g., EU, Japan, UK) Exclusions: Generics and biosimilars (subject to future review)

This structure effectively creates a policy-driven pricing gradient, incentivizing manufacturers to align with administration priorities while introducing potential volatility into list price and rebate strategies.

TrumpRx platform expansion The TrumpRx cash-pay platform launched in February 2026, initially offering approximately 40 products from major manufacturers at MFN-aligned prices for uninsured consumers and patients paying

The FTC’s actions signal an emerging behavioral standard for the industry’s three dominant players through enforcement rather than rulemaking. cash outside insurance coverage.

The site has expanded rapidly, reaching 69 drugs from 11 of the top 20 drugmakers as of early April.

As of April 23, the administration has 17 MFN agreements covering 86% of the branded drug market.

Manufacturers with these agreements receive the 0% tariff rate, effectively insulating the dominant players from the tariff’s pricing pressure while smaller manufacturers without deals face the full 100%.

Together, tariffs and TrumpRx represent a potentially new dynamic in federal pricing strategy: a federal pricing environment in which man­ ufacturer behavior is being shaped by executive incentives that oper­ ate entirely outside the traditional rebate and formulary system.

For clients, the practical risks are threefold. First, utilization fragmen­ tation: As patients move between insured and direct-purchase channels, adherence tracking and care coordination become significantly harder. Second, formulary disruption:

PRIMETHERAPEUTICS.COM | 5

MANAGED CARE NEWSSTAND

If manufacturers restruc­ture pricing to qualify for MFN agreements or tariff carve-outs, the list price and rebate assump­tions underlying current formulary designs may shift in ways that are difficult to anticipate.

Third, trend volatility: The 100% tariff structure creates meaningful uncertainty around specialty and brand drug costs, particularly for manufac­ turers without U.S. manufacturing commitments.

Prime is monitoring manufacturer pricing responses and will provide updated guidance as the tariff framework’s real-world impact becomes clearer.

Congressional hearings on PBMs and healthcare affordability House Ways and Means Full Committee (January 2026): Hearing with major insurer and PBMaffiliated parent company CEOs focused on vertical integration, market concentration and the role of intermediaries in drug pricing.

Members also raised questions regarding MFN pricing and treatment of direct-to-consumer drug purchases.

House Energy and Commerce Health Subcommittee (February 2026): Hearing on prescription drug supply chain dynamics featuring PBMs, manufacturers and other stakeholders. Members acknowledged CAA 2026 reforms while signaling interest in additional legislative action, particularly related to affordability and competition.

House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions (April 16): Hearing on the Employee

Prime is monitoring manufacturer pricing responses and will provide updated guidance as the tariff framework’s realworld impact becomes clearer.

Benefit Security Administration (EBSA), which featured the EBSA administrator and focused on the department-proposed ERISA rule, prior authorization and mental health parity.

Senate Committee on Health, Education, Labor and Pensions (April 16): Hearing focused on the need for a more competitive pharmaceutical market, further PBM reforms and biosimilar reform.

Ranking member Bernie Sanders (D-VT) announced the release of a report that found companies that signed drug pricing deals with Trump have raised the cost of hundreds of medications and launched new ones at an average price of $353k/year. Chairman Bill Cassidy (R-LA) announced his new health plan, which calls for the expansion of Trump’s most favored nation policies, for PBM reform and for more price transparency, among other policies.

Health and Human Services Secretary Robert F. Kennedy Jr.

6 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Testimony, House Committee on Ways and Means (April 16, 2026): Testimony on the administration’s FY2027 budget request, including discussion of drug pricing priorities, agency funding levels and broader health policy issues.

Strategic implication: CAA 2026 does not appear to have fully satisfied congressional appetite for PBM reform — it has redirected it. Members are now scrutinizing implementation, pushing vertical integration and signaling interest in affordability measures beyond what the statute requires. Clients should anticipate that the legislative environment will remain active through the 2026 election cycle, and that public hearings will continue to generate reputational and political pressure on PBM practices even absent a new law.

The PBM that stands for

Purpose Beyond Margins

Prime Therapeutics (Prime) believes cost, convenience and access are more important than our bottom line. And we don’t hide behind complexity. Instead, we pass savings back to our customers so they can invest in better care.

With Prime as your PBM, you get clear, compassionate support that puts your people first.

Experience the difference at ReimaginePBM.com

Autoimmune update The expanding biosimilar landscape and payer impact

Mona Chitre, PharmD Chief Pharmacy Director Lifetime Healthcare Companies

A primary function of the body’s immune system is to protect against foreign microorganisms, such as viruses or bacteria, to prevent infection and disease.1 Under normal conditions, it recognizes these foreign invaders and mounts a response by producing antibodies or sensitized lymphocytes to target and destroy them.2 The immune system can typically differentiate between the body’s own cells and foreign substances; however, in individuals with an autoimmune disease, the immune system becomes overactive and mistakenly attacks the body’s own healthy tissues and organs.1,2,3 According to the Autoimmune Association, more than 100 autoimmune diseases have been identified to date.2 Autoimmune diseases affect approximately 23.5 million Americans, and 80% of those diagnosed are women.3 Researchers continue to make progress in understanding the underlying factors of autoimmune disease. Although the exact cause remains unclear, current research suggests a genetic component.

Additionally, viral infections, environmental factors and smoking may trigger the immune system to target and attack normal, healthy cells.1 Estimates of overall prevalence vary depending on the study methodology. Other data suggest autoimmune diseases affect approximately 3% of the U.S. population, or approximately 10 million people.4 Another recent study conducted by Mayo Clinic researchers and collaborators reported a higher prevalence, estimating that approximately 15 million individuals in the United States have one or more of 105 autoimmune diseases, with females being nearly twice as likely to be diagnosed as males.5 The researchers found the five most prevalent autoimmune diseases were

8 | PRIME THERAPEUTICS REPORT | SUMMER 2026

rheumatoid arthritis, psoriasis, Type 1 diabetes, Graves’ disease and autoimmune thyroiditis.5 Notably, another study reported that the prevalence of certain autoimmune diseases, such as systemic sclerosis and systemic lupus erythematosus, is increasing worldwide.6 Overall, the prevalence of autoimmune diseases continues to rise in the United States and across the globe. Individuals living with these chronic diseases experience significant morbidity, reduced survival, and poorer health-related quality of life compared with healthy individuals.7 Due to the increasing prevalence of autoimmune diseases as well as the often-high cost of treatment, this category poses a significant economic burden. The cost of treating autoimmune diseases in the United States is estimated to exceed more than $100 billion annually.8

Recent approvals Deucravacitinib (Sotyktu) In March 2026, the U.S. Food and Drug Administration (FDA) approved deucravacitinib (Sotyktu) for the treatment of adults with active psoriatic arthritis (PsA).9

The cost of treating autoimmune diseases in the United States is estimated to exceed more than $100 billion annually.

This approval represents the first tyrosine kinase 2 (TYK2) inhibitor indicated for PsA. Deucravacitinib inhibits signaling of key cytokines involved in the pathogenesis of some immune-mediated diseases, including psoriasis and PsA.9 Data from multiple studies informed this approval; the recent POETYK PsA-1 and POETYK PsA-2 trials evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adults with active PsA.10 POETYK PsA-1 evaluated 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bdMARD-naïve), while POETYK PsA-2 included 624 patients with active PsA who were

Watch for our 2026 Medical Pharmacy Trend Report editions Available now

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Available summer 2026

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Available fall 2026

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PRIMETHERAPEUTICS.COM | 9

AUTOIMMUNE UPDATE

Table 1. Select autoimmune drug pipeline (by indication) Manufacturer

Route of administration

Mechanism of action

Status

tildrakizumab (Ilumya)

Merck; Sun Pharmaceutical Industries

SC

IL-23 antagonist

Pending (H2 2026)

sonelokimab (M1095)

EMD Serono; Ablynx

SC

IL-17 antagonist

Phase 3

bimekizumab-bkzx (Bimzelx)

UCB

SC

IL-17 antagonist

Phase 3

icotrokinra (JNJ-2113)

Johnson & Johnson; Protagonist Therapeutics

Oral

IL-23 antagonist

Phase 3

zasocitinib (TAK-279)

Nimbus Therapeutics; Takeda Pharmaceuticals

Oral

TYK2 inhibitor

Phase 3

apremilast (Otezla oral suspension)

Celgene; Amgen

Oral

PDE4 inhibitor

Phase 3

infliximab (Zymfentra)

Celltrion

SC

TNF-alpha inhibitor

Phase 3

rosnilimab (ANB030)

AnaptysBio

Injectable

PD-1 agonist

Phase 2

dapirolizumab pegol

Biogen; UCB

Injectable

CD40L inhibitor

Phase 3

litifilimab (BIIB059)

Biogen

SC

BDCA2 antibody

Phase 3

forigerimod (Lupuzor)

ImmuPharma; Avion Pharmaceuticals

SC

Immunomodulators

Phase 3

cenerimod (ACT-334441)

Idorsia; Viatris

Oral

S1P1 receptor modulator

Phase 3

telitacicept (RC18)

RemeGen

SC

BAFF antibody APRIL antibody

Phase 3

upadacitinib (Rinvoq tablet)

AbbVie

Oral

JAK inhibitor

Phase 3

deucravacitinib (Sotyktu tablet)

Bristol Myers Squibb

Oral

TYK2 inhibitor

Phase 3

Drug

Psoriatic arthritis

Rheumatoid arthritis

Systemic lupus erythematosus

10 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Table 1. Select autoimmune drug pipeline (by indication) (cont.)

Drug

Manufacturer

Route of administration

Mechanism of action

Status

ianalumab (VAY736)

Novartis; MorphoSys

IV; SC

BAFF antibody

Phase 3

anifrolumab (Saphnelo SC)

MedImmune; AstraZeneca

SC

Type I interferon inhibitor

Phase 3

rapcabtagene autoleucel (YTB323)

Novartis

IV

CAR T immunotherapy

Phase 2

resecabtagene autoleucel (CABA-201)

Cabaletta Bio

IV

CAR T immunotherapy

Phase 2

avenciguat (BI 685509)

Boehringer Ingelheim

Oral

Guanylate cyclase stimulants

Phase 2

efgartigimod alfa; hyaluronidase-qvfc (Vyvgart Hytrulo)

Argenx; Halozyme Therapeutics

SC

FcRn antagonist

Phase 2

tibulizumab (ZB-106)

Zura Bio

SC

BAFF antagonist IL-17 antagonist

Phase 2

mivocabtagene autoleucel (KYV-101)

Kyverna Therapeutics

IV

CAR T immunotherapy

Phase 2

dersimelagon (MT-7117)

Mitsubishi Tanabe Pharma

Oral

Melanocortin receptor antagonist

Phase 2

nemolizumab (Nemluvio)

Galderma; Roche

SC

IL-31 antagonist

Phase 2

Lilly; Incyte

Oral

JAK inhibitor

Phase 3

ianalumab (VAY736)

Novartis; MorphoSys

IV; SC

BAFF antibody

Pending (H2 2026)

deucravacitinib (Sotyktu)

Bristol Myers Squibb

Oral

TYK2 inhibitor

Phase 3

Systemic sclerosis

Juvenile idiopathic arthritis

baricitinib (Olumiant)

Sjögren’s syndrome

anti-a proliferation-inducing ligand (APRIL); anti-B-cell activating factor (BAFF); blood dendritic cell antigen 2 (BDCA2); chimeric antigen receptor T cell (CAR T); neonatal Fc receptor (FcRn); interleukin (IL); intravenous (IV); Janus kinase (JAK); phosphodiesterase type 4 (PDE4); programmed cell death protein-1 (PD-1); sphingosine-1-phosphate 1 (S1P1); subcutaneous (SC); tumor necrosis factor (TNF); tyrosine kinase 2 (TYK2);

PRIMETHERAPEUTICS.COM | 11

AUTOIMMUNE UPDATE

immunosuppressants.9 Clinical studies have provided up to five years of efficacy and safety data in these patients.9

Icotrokinra (Icotyde) In March 2026, the FDA approved icotrokinra (Icotyde) for the treatment of moderate-to-severe plaque psoriasis in adult and pediatric patients age 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.11 Icotrokinra is an interleukin-23 (IL-23) receptor antagonist; its approval marks the first targeted oral peptide that precisely blocks the IL-23 receptor.11

bdMARD-naïve or had previously received tumor necrosis factor alpha inhibitor treatment.9,10 The trials included a 52-week treatment period consisting of a placebocontrolled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52.10 In both trials, patients treated with deucravacitinib experienced improvements in disease activity, measured by the American College of Rheumatology 20 and minimal disease activity response.9,10 The safety profile of deucravacitinib in individuals with active PsA is consistent with that observed in patients with plaque psoriasis.9 Common adverse reactions include upper respiratory infections, increased blood creatinine phosphokinase, herpes simplex, mouth ulcers, folliculitis and acne.9 There are also warnings and precautions associated with deucravacitinib, including hypersensitivity reactions, infections, tuberculosis, malignancy (including lymphomas), rhabdomyolysis and elevated creatine phosphokinase, laboratory abnormalities, immunizations, and potential risks related to Janus kinase inhibition.9 Deucravacitinib was first approved by the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.9 In this population, deucravacitinib is not recommended for use with other potent

12 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Across four Phase 3 studies of 2,500 patients, icotrokinra met all primary efficacy endpoints and demonstrated a favorable safety profile.11 The ICONIC clinical development program simultaneously evaluated icotrokinra in adults and adolescents, in high-impact sites such as scalp and genital psoriasis, and in duplicate head-to-head trials versus an active comparator.11 Approximately 70% of patients achieved clear or almost-clear skin, and 55% of patients achieved a Psoriasis Area and Severity Index 90 response at Week 16 in the head-to-head superiority studies.11,12 Rates of adverse reactions among icotrokinratreated patients were within 1.1% of placebo through Week 16, with no new safety signals identified through Week 52.11

Difamilast (Adquey) The FDA approved difamilast (Adquey) in February 2026 for the treatment of mild-to-moderate atopic dermatitis in patients age 2 and older.13 Difamilast is a topical phosphodiesterase 4 (PDE4) inhibitor that provides an additional nonsteroidal treatment option among topical therapies for atopic dermatitis.13 It serves as an alternative for patients who are intolerant to or inadequately controlled with existing therapies, including topical corticosteroids and other PDE4 inhibitors.13 Phase 3 clinical trial data in adult and pediatric patients with mild-to-moderate atopic dermatitis supported the FDA approval.14 In the trial, patients who applied difamilast twice daily achieved statistically significant improvements in Investigator’s Global Assessment (IGA) scores as compared to vehicle at Week 4, with a meaningful proportion achieving IGA 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline.14 Secondary endpoints included Eczema Area and Severity

Index scores and patient-reported pruritus, which favored difamilast, with itch reductions observed early in treatment.14 The treatment was generally well tolerated, with the most common treatment-emergent adverse effects being application site reactions, including mild burning, stinging and pruritus.13,14

Secukinumab (Cosentyx) Secukinumab (Cosentyx) received an expanded FDA approval in March 2026 for the treatment of pediatric patients age 12 and older with moderate-to-severe hidradenitis suppurativa (HS).15 This marks the approval of the only IL-17A inhibitor for this population and the first differentiated mechanism in nearly a decade.15 This expanded approval was supported by wellcontrolled adult HS trials, including SUNSHINE and SUNRISE, as well as pharmacokinetic modeling and pediatric data from other approved indications.16 The

compilation of these analyses demonstrated that weight-based dosing in pediatric patients achieves drug exposure comparable to that observed in adults with HS.16 The safety profile of secukinumab in pediatric HS is similar to its prior indications, and the most common adverse events include upper-respiratory infections, diarrhea and cold-like symptoms.16 Treatment with secukinumab may increase the risk of infections, including tuberculosis, and requires screening prior to initiation. It also carries risk of hypersensitivity reactions, inflammatory bowel disease exacerbations and rare severe skin reactions.16

Expanding biosimilar landscape Over the past decade, the FDA has approved several biosimilars with the goal of improving access to care and potentially reducing drug costs. According to an April 2026 report, the U.S. biosimilar market is projected to grow from $9.48 billion in 2022 to $100.75 billion by 2029.17

Table 2. Current autoimmune biosimilars status18 Drug

Reference (manufacturer)

Therapeutic areas

Approved biosimilars

Launches

adalimumab

Humira (AbbVie)

RA; JIA; PsA; PsO; AS; CD; UC

10

10

eculizumab

Soliris (Alexion)

PNH; aHUS; gMG; NMOSD

2

2

etanercept

Enbrel (Amgen)

RA; PsO; PsA; AS; pJIA

2

0

infliximab

Remicade (Johnson & Johnson)

CD; UC; RA; AS; PsA; PsO

4

3

natalizumab

Tysabri (Biogen)

Clinically Isolated Syndrome; RRMS; CD

1

0

rituximab

Rituxan (Biogen; Genentech)

RA

3

3

tocilizumab

Actemra (Genentech)

RA; pJIA; systemic JIA

3

3

ustekinumab

Stelara (Johnson & Johnson)

PsO; PsA; CD; UC

8

0

ankylosing spondylitis (AS); atypical hemolytic uremic syndrome (aHUS); Crohn’s disease (CD); generalized myasthenia gravis (gMG); juvenile idiopathic arthritis (JIA); neuromyelitis optica spectrum disorder (NMOSD); plaque psoriasis (PsO); paroxysmal nocturnal hemoglobinuria (PNH); polyarticular juvenile idiopathic arthritis (pJIA); psoriatic arthritis (PsA); relapsing-remitting multiple sclerosis (RRMS); rheumatoid arthritis (RA); ulcerative colitis (UC)

PRIMETHERAPEUTICS.COM | 13

AUTOIMMUNE UPDATE

Specifically, the report projects that the autoimmune category will experience higher growth during this period. The biosimilar market in the autoimmune category is growing rapidly, offering substantial benefits and opportunities for cost savings for both patients and payers. The availability of biosimilars provides a range of therapeutic options that may enable more tailored treatment plans and expanded access to therapies.

Table 3. Currently approved ustekinumab biosimilars Biosimilar name

Manufacturer

ustekinumab-auub (Wezlana)

Amgen

ustekinumab-aekn (Selarsdi)

Teva Pharmaceuticals; Alvotech

ustekinumab-ttwe (Pyzchiva)

Sandoz

ustekinumab-aauz (Otulfi)

Fresenius Kabi

ustekinumab-stba (Steqeyma)

Celltrion

ustekinumab-hmny (Starjemza)

Bio-Thera Solutions; Hikma Pharmaceuticals

ustekinumab-kfce (Yesintek)

Biocon Biologics

ustekinumab-srlf (Imuldosa)

Accord BioPharma

Ustekinumab biosimilars The approval of multiple ustekinumab biosimilars marks a significant turning point, specifically in the treatment of Crohn’s disease (CD).19 There are currently eight FDA-approved ustekinumab biosimilars. Clinical trials have consistently demonstrated therapeutic equivalence, including maintenance of efficacy and safety following single or multiple switches from the reference product.20 Some key considerations for the integration of ustekinumab biosimilars include coordination of intravenous induction and subcutaneous maintenance therapy across medical and pharmacy benefits, and product-specific storage and device differences. Shared decision-making and patient education are critical to mitigating the nocebo effect.20 Ultimately, these biosimilars present an opportunity to expand therapeutic accessibility while supporting cost containment.20 Ustekinumab biosimilars may potentially increase access to advanced treatments, which could improve long-term outcomes in the CD population.19

Table 4. Biosimilar pipeline Drug

Reference drug

Manufacturer

Route of administration

Mechanism of action

Status

Indication

secukinumab (BAT2306)

Cosentyx IV; Cosentyx SC

Bio-Thera Solutions

SC

IL-17 antagonist

Phase 3

Plaque psoriasis

secukinumab (CT-P55)

Cosentyx IV; Cosentyx SC

Celltrion

SC

IL-17 antagonist

Phase 3

Plaque psoriasis

abatacept (DRL_AB IV)

Orencia IV

Dr. Reddy’s Laboratories

IV

Immunosuppressant

Pending 12/2026

RA; JIA; PsA

interleukin (IL); intravenous (IV); juvenile idiopathic arthritis (JIA); psoriatic arthritis (PsA); rheumatoid arthritis (RA); subcutaneous (SC)

14 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Secukinumab biosimilars Reference secukinumab (Cosentyx) is approved in select patients for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, enthesitis-related arthritis and hidradenitis suppurativa. While there are no secukinumab biosimilars currently approved by the FDA, there are two candidates in Phase 3 trials: Bio-Thera Solutions’ BAT2306 and Celltrion’s CT-P55. The potential introduction of biosimilars to the market will introduce competition and may improve access while reducing costs.

Biosimilars offer managed care organizations an opportunity to reduce costs while maintaining or improving outcomes.

by increased spend and utilization in CD and ulcerative colitis.21 Entyvio and Stelara SC also trended higher in 2024 within the Medicare LOB.21 In the autoimmune category, biosimilars offer managed care organizations an opportunity to reduce costs while maintaining or improving outcomes. Step therapy requirements can influence prescribing habits and direct members to lower-cost treatment options. Specifically, criteria can be leveraged to require use of a biosimilar for treatment-naïve members when it is approved for the same indication as the reference biologic. Given the large number of autoimmune therapies with overlapping indications, coupling indication-based management strategies with benefit structure changes that incentivize the use of preferred, cost-effective products may allow payers to prefer the most clinically appropriate therapy for each patient and support more strategic contract negotiations.

Managed care impact Autoimmune diseases carry a significant economic burden in the United States. Costs associated with autoimmune diseases are heavily driven by biologic utilization. According to the 2025 Prime Therapeutics Medical Pharmacy Trend Report, biologic drugs for autoimmune disorders (BDAIDs) accounted for 13.4% of spend for the commercial line of business (LOB) in 2024, with both the CD/ulcerative colitis and the rheumatoid arthritis subcategories placing in the top 10 categories.21 An increased shift to biosimilars lowered costs and utilization for Remicade and Rituxan, thus offsetting some spend.21 While Entyvio remained a top-spend drug in 2024 for CD and ulcerative colitis, its trend is beginning to level off compared to previous years, with a modest per member per month (PMPM) increase that may reflect a shift from the IV to SC formulation.21 In the Medicare LOB, BDAIDs saw an 11.6% PMPM trend, largely driven

PRIMETHERAPEUTICS.COM | 15

AUTOIMMUNE UPDATE

REFERENCES 1.

Cleveland Clinic. (2024, October 22). Autoimmune diseases. my.clevelandclinic.org/health/diseases/21624autoimmune-diseases

2.

American Autoimmune Related Diseases Association Inc. (2018). Autoimmune disease list. aarda.org/diseaselist

3.

Society for Women’s Health Research. (2024, November 8). Autoimmune diseases. swhr.org/health_focus_area/ autoimmune-diseases

4.

Johns Hopkins Medicine Pathology. (n.d.). Prevalence of autoimmune diseases. pathology.jhu.edu/autoimmune/ prevalence

5.

De Widt, L. (2025, January 6). New study calculates autoimmune disease prevalence in U.S. Mayo Clinic News Network. newsnetwork.mayoclinic.org/discussion/newstudy-calculates-autoimmune-disease-prevalence-in-u-s

6.

Bournia, V.K., Fragoulis, G.E., Mitrou, P., Tsolakidis, A., Mathioudakis, K., Vassilopoulos, D., Tektonidou, M., Paraskevis, D., & Sfikakis, P.P. (2024). Increased prevalence of inflammatory arthritis, systemic lupus erythematosus and systemic sclerosis, during 2020–2023 versus 2016–2019 in a nation-wide cohort study. Rheumatology International. doi.org/10.1007/s00296-024-05733-y

7.

McCain, J. (2016). The disease burden of most common autoimmune diseases. Managed Care, 25(7), 28–32. managedcaremag.com/archives/2016/7/ disease-burdenmost-common-autoimmune-diseases

8.

Rosenbulm, M.D., Gratz, I.K., Paw, J.S., & Abbas, A.K. (2012).

Treating human autoimmunity: Current practice and future prospects. Science Translational Medicine, 4(125), 125sr1–125sr1. doi.org10.1126/scitranslmed.3003504

16 | PRIME THERAPEUTICS REPORT | SUMMER 2026

9.

Bristol Myers Squibb. (2026). U.S. FDA approves Bristol Myers Squibb’s Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis. news.bms.com/news/ corporate-financial/2026/U-S--FDA-Approves-BristolMyers-Squibbs-Sotyktu-deucravacitinib-for-theTreatment-of-Adults-with-Active-Psoriatic-Arthritis/ default.aspx

10.

Bristol Myers Squibb. (2025, October 27). Bristol Myers Squibb presents two late-breaking presentations demonstrating Sotyktu (deucravacitinib) efficacy in psoriatic arthritis and systemic lupus erythematosus. news.bms.com/news/details/2025/Bristol-MyersSquibb-Presents-Two-Late-Breaking-PresentationsDemonstrating-Sotyktu-deucravacitinib-Efficacy-inPsoriatic-Arthritis-and-Systemic-Lupus-Erythematosus/ default.aspx

11.

Johnson & Johnson. (2026, March 18). FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. BioSpace. biospace.com/press-releases/ fda-approval-of-icotyde-icotrokinra-ushers-in-new-erafor-first-line-systemic-treatment-of-plaque-psoriasiswith-a-targeted-oral-peptide

12.

Johnson & Johnson. (2025, March 8). Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. jnj.com/media-center/press-releases/ icotrokinra-results-show-potential-to-set-a-newstandard-of-treatment-in-plaque-psoriasis

13.

Valletti, D. (2026, February 18). FDA approves difamilast as new topical PDE4 inhibitor for atopic dermatitis. Pharmacy Times. pharmacytimes.com/view/fda-approves-difamilastas-new-topical-pde4-inhibitor-for-atopic-dermatitis

REFERENCES 14.

15.

16.

17.

Saeki, H., Ito, K., Yokota, D., & Tsubouchi, H. (2022). Difamilast ointment in adult patients with atopic dermatitis: A phase 3 randomized, double-blind, vehicle-controlled trial. Journal of the American Academy of Dermatology, 86(3), 607–614. doi.org/10.1016/j.jaad.2021.10.027 Novartis. (2026, March 13). Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. novartis.com/ news/media-releases/novartis-cosentyx-receives-fdaapproval-pediatric-patients-aged-12-moderate-severehidradenitis-suppurativa Garlewicz, J. (2026, March 17). FDA approves Cosentyx for the treatment of pediatric patients aged 12 years and older with moderate-to-severe hidradenitis suppurativa. HMP Global Learning Network. hmpgloballearningnetwork.com/site/ thederm/fda-alerts/fda-approves-cosentyx-treatmentpediatric-patients-aged-12-years-and-older

18.

The Center for Biosimilars. (2025, December 22). Biosimilar approvals in the United States. centerforbiosimilars.com/ biosimilar-approvals

19.

Bezzio, C. & Armuzzi, A. (2024). The impact of ustekinumab biosimilar on therapeutic strategies in Crohn’s disease: A paradigm shift? United European Gastroenterology Journal, 13(2), 177–178. doi.org/10.1002/ueg2.12717

20.

Piche, S.L., Becker, M.D., Bhat, S., Huang, L.L., & Kane, S.V. (2026). Integration of ustekinumab biosimilars into inflammatory bowel disease care: evidence, implementation, and patient-centered considerations.

Advances in Therapy. doi.org/10.1007/s12325-026-03584-6

21.

Prime Therapeutics. (2025, August 25). Prime therapeutics medical pharmacy trend report 2025 edition. primetherapeutics. com/w/2025-medical-pharmacytrend-report

Fortune Business Insights. (2026, May 4). U.S. biosimilars market size, share & COVID-19 impact analysis, by drug class (filgrastim & pegfilgrastim, monoclonal antibodies, and others), by disease indication (cancer, autoimmune diseases {arthritis, psoriasis, neutropenia, and others}, by distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies), and regional forecast, 2022–2029. fortunebusinessinsights.com/ industry-reports/u-s-biosimilars-market-100990

PRIMETHERAPEUTICS.COM | 17

Prime Therapeutics ® IntegratedRx update Oncology and cystic fibrosis solutions Prime Therapeutics’ (Prime’s) IntegratedRx solution delivers enhanced value for medications and a breakthrough integrated experience for members. Both IntegratedRx – Oncology and IntegratedRx – Cystic Fibrosis offer access to a national network of clinically integrated, provider-based specialty pharmacies. IntegratedRx provides several strategic benefits, including channel independence to avoid conflicts and comply with regulations; cost-saving opportunities through market-competitive rates; more coordinated care; and a highly rated member experience.

Jason Graveline Sr. Director of Innovation and Strategy Prime Therapeutics

Provider-integrated pharmacies Prime contracts with over 500 distinct network pharmacies across the country. Both the prescriber and pharmacist are part of the member’s care team, further enhancing coordination of care. Members can receive prescriptions directly from their provider’s integrated pharmacy, leading to higher satisfaction, and the pharmacy has access to an electronic medical records system, enabling interventions for which other pharmacies lack the capability and capacity.

A study published in the Journal of Managed Care and Specialty Pharmacy in February 2026 showed that patients get their medications faster through an in-house hospital pharmacy, which improves adherence.1 In the analysis, patients who had prescriptions

18 | PRIME THERAPEUTICS REPORT | SUMMER 2026

sent to outside pharmacies had 60% higher odds of not picking up the prescriptions.1 Further, the turnaround time for patients at hospital pharmacies was a median of three days, compared with a median of four days for patients filling at outside pharmacies.1 Enabling provider-based pharmacies to dispense specialty medications has led to plan savings across both the oncology and cystic fibrosis networks — annual plan savings attributable to IntegratedRx were $5,300 for oncology and $26,100 for cystic fibrosis. In addition, utilizing members report a 94% rate of satisfaction and a 9% reduction in medical total cost of care.

With more than 500 provider pharmacies across 47 states, the IntegratedRx national network provides timely coastto-coast access to cancer and cystic fibrosis medications.

IntegratedRx – Oncology According to the 2025 Prime Therapeutics Medical Pharmacy Trend Report, the oncology category accounted for 40.7% of commercial spend in 2024.2 Results from a 2025 analysis of total cost of care in oncology demonstrated a need for targeted interventions in drug management, acute-care reduction and supportive-care optimization.3

Traditional specialty pharmacy model

Both IntegratedRx – Oncology and IntegratedRx – Cystic Fibrosis offer access to a national network of clinically integrated, provider-based specialty pharmacies.

The IntegratedRx – Oncology solution is a strategic management solution for high-cost specialty drug therapies covered under the pharmacy benefit, with better coordinated care and a highly rated member experience. IntegratedRx – Oncology generates plan savings and a differentiated care-delivery model through prescriber and pharmacist coordination. The IntegratedRx – Oncology solution offers a 4.97% more effective rate for brand average wholesale price (AWP)

The IntegratedRx model

Data

Data

Consult

Physician

Pharmacist

Patient

Central fill SP dispense

Prescription

Physician

Prescription

Patient

Pharmacist

In-office and/or hospital dispensing pharmacy

specialty pharmacy (SP)

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PRIME THERAPEUTICS INTEGRATEDRX ® UPDATE

discounts, compared with central fill. IntegratedRx – Oncology achieves an estimated $2.5 million per month in discount savings.

IntegratedRx – Cystic Fibrosis Specialty medication is also driving cost increases in the cystic fibrosis category, fueled by lifetime treatment across longer lifespans. The disease impacts a small population whose life expectancy is improving through the use of long-term, high-cost medications.

Cystic fibrosis care centers, of which there are 130 accredited nationwide, are integral to positive patient outcomes. The IntegratedRx – Cystic Fibrosis program has about 80 in-network specialty pharmacies associated with these care centers. As part of the cystic fibrosis care center model, a multidisciplinary team is assigned to each participating member, and per clinical care guidelines, each member will visit their care team at least four times a year. Collaboration between a cystic fibrosis specialty pharmacy and pharmacist is key to driving better adherence, improving outcomes and preventing waste.

The four in-person clinic visits per year, in addition to the specialty pharmacist calls in between, provide critical patient care and data. Disconnected patient and provider care impacts overall costs. Requiring a cystic fibrosis patient, who is followed by a specialized care team (including a specialty pharmacist), to receive medications from a nonaffiliated pharmacy can result in poor outcomes and increased costs, including hospitalizations, lower adherence, polypharmacy, and low- or no-rebate core-category drugs.

The cystic fibrosis category is driving trend by 4.5%, or $3.01 per member per month. Low adherence is common, leading to increased hospitalizations and total cost of care. The use of multiple drugs per patient is a major contributor to low adherence. Patients with cystic fibrosis take an average of eight to 10 medications per day and, on average, are 45% adherent to medications.4 With the IntegratedRx – Cystic Fibrosis network, members can receive all their medications through their cystic fibrosis care center’s pharmacy, which provides Prime’s negotiated best-in-class pharmacy discount rates. This end-to-end coordination across the treatment pathway uniquely integrates the specialty pharmacy and provider ecosystem to unlock the best value, create better member

20 | PRIME THERAPEUTICS REPORT | SUMMER 2026

and provider experiences, and reduce total cost of care.

The IntegratedRx – Cystic Fibrosis solution offers a 12.38% more effective rate for brand AWP discounts, compared with central fill, and an average annual plan savings of $26,100 per utilizing member. IntegratedRx – Cystic Fibrosis achieves an estimated $600,000 per month in discount savings.

Prime has been able to leverage IntegratedRx to save $150 million since the solution’s broad adoption following its 2022 launch.

Impact The IntegratedRx – Oncology solution has been adopted by 17 of 18 Blues Plans and one non-Blues plan, encompassing an estimated 17 million eligible commercial lives. Meanwhile, IntegratedRx – Cystic Fibrosis has been adopted by 12 of 18 Blues Plans, one non-Blues plan and three national employers, covering an estimated 13 million eligible commercial lives.

IntegratedRx delivered a year-over-year incremental savings growth of about $21.5 million across all implemented clients, accounting for more than 90% growth year over year. Prime has been able to leverage IntegratedRx to save $150 million since the solution’s broad adoption following its 2022 launch.

Moving forward The Prime Therapeutics team is evaluating IntegratedRx expansion possibilities with the goal of continuing to provide value to members, clients and pharmacies across a broader range of specialty medications.

REFERENCES 1.

2.

Cruchelow, K.R., Layne, S., DeClercq, J., Choi, L., & Zuckerman, A.D. (2026). Comparing rates of primary medication nonadherence and turnaround time among patients at a health system specialty pharmacy compared with external specialty pharmacies. Journal of Managed Care & Specialty Pharmacy, 32(3), 300–311. doi.org/10.18553/ jmcp.2026.32.3.300 Prime Therapeutics. Prime therapeutics medical pharmacy trend report 2025 edition. (2025, August 25). primetherapeutics.com/w/2025-medical-pharmacytrend-report

3.

Rainey, A.M., Sabo-Wagner, S., Rahman, A., Mulherin, B.P., Divers, S.G., & Indurlal, P. (2025). Unpacking cost of care: Contributors to total cost of care in oncology episodes.

JCO Oncology Practice, 21(10_suppl), 22. doi.org/10.1200/ OP.2025.21.10_suppl.22

4.

Tjugum, S.L., Hansen, B.K., & McKinzie, C.J. (2021).

Association of medication regimen complexity with clinical endpoints in pediatric patients with cystic fibrosis. The Journal of Pediatric Pharmacology and Therapeutics, 26(3), 248–252. doi.org/10.5863/1551-6776-26.3.248

PRIMETHERAPEUTICS.COM | 21

Chronic obstructive pulmonary disease Diagnosis, treatment landscape and pipeline Chronic obstructive pulmonary disease (COPD) is a chronic lung condition that restricts airflow, making it difficult to breathe.1 Emphysema and chronic bronchitis are the two most common forms of COPD.1 Both forms of COPD can adversely impact the lungs by reducing the elasticity of airways and air sacs, narrowing the respiratory passages, and causing inflammation and scarring. COPD can also erode the walls between alveoli, causing them to enlarge and trap air.1 Mike Ochowski, RPh Informatics Pharmacist Group Health Cooperative of SouthCentral Wisconsin

People with COPD may experience exacerbations: acute bouts of worsened respiratory symptoms, such as difficult breathing, increased thick-mucus production, coughing and wheezing.1 These symptoms progressively worsen over time, with flare-ups that become increasingly severe and more frequent.1 Progression typically occurs over years or decades, though the timeline varies from case to case.1 In 2023, an estimated 11.1 million adults in the United States were living with COPD — a figure that includes both diagnosed and undiagnosed cases.2 This makes it a leading cause of morbidity and mortality in the United States, affecting nearly 6% of Americans and generating an annual cost of approximately $50 billion.2,3 Worldwide, the number of individuals with COPD is expected to reach nearly 600 million by 2050, with the largest anticipated increases among women and people who live in low- and middle-income countries.3 This represents a 23% relative increase in the number of individuals with COPD compared with 2020.3

Diagnosis Diagnosing COPD can be challenging, as its symptoms can overlap with those of other lung conditions.4 Many individuals do not receive an accurate diagnosis until the disease has reached more advanced stages.4 Diagnosis typically involves a range of tests, including pulmonary function tests such as spirometry, lung volume measurements, diffusion capacity testing, pulse oximetry and exercise stress testing.4 Imaging techniques, such as chest X-rays and computed tomography scans, are used to support diagnosis and monitor disease progression and gauge the patient’s response to treatment.4 The diagnostic

22 | PRIME THERAPEUTICS REPORT | SUMMER 2026

process is complicated by the significant overlap in symptoms that COPD shares with other lung conditions; many individuals are not accurately diagnosed until the disease has reached more advanced stages.4 Providers can use arterial blood gas analysis and blood tests, including those for alpha-1 antitrypsin deficiency, to assist them in making the correct diagnosis.4

Treatment landscape COPD management has shifted toward individualized, targeted therapy combining a bronchodilator regimen with biologic therapies in certain high-risk subgroups.5,6 Additional pharmacological treatment options include dupilumab and the recently approved ensifentrine, and other biologics targeting specific inflammatory pathways are currently in development.5,6 Rehabilitation and digital health tools can be incorporated where appropriate.5,6 The GOLD 2025 report — a key resource for all healthcare professionals involved in COPD management — provides evidence-based recommendations for COPD treatment and care.5 Current guidelines emphasize bronchodilator therapy as the primary treatment for COPD, including long-acting muscarinic antagonists (LAMAs), long-acting

Triple therapy, or LAMA + LABA + ICS, is recommended over dual therapy for patients who exhibit persistent symptoms or have elevated blood eosinophils. β2-agonists (LABAs) and inhaled corticosteroids (ICS).5,6 Triple therapy, or LAMA + LABA + ICS, is recommended over dual therapy for patients who exhibit persistent symptoms or have elevated blood eosinophils.5,6 After one year of stable disease control, de-escalation to LABA/ LAMA can be considered.5,6

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CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Dupilumab (Dupixent) In 2024, the U.S. Food and Drug Administration (FDA) approved dupilumab (Dupixent) as the first-ever biologic therapy for patients with COPD.7 Dupilumab was approved as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.7 The approval was based on data from two landmark pivotal Phase 3 studies: BOREAS and NOTUS, which evaluated the efficacy and safety of dupilumab. The studies compared dupilumab to placebo in adults receiving standard-of-care inhaled therapy with inadequately controlled COPD and blood eosinophils >300 cells per µL.8,9 In both studies, patients who received dupilumab experienced a 30% and 34% reduction in annualized rate of moderate or severe COPD exacerbations over 52 weeks.8,9 Additionally, treatment with dupilumab resulted in greater improvements in post-bronchodilator FEV1 (forced expiratory volume in one second) from baseline, with increases of 74mL and 68mL at 12 and 52 weeks in the BOREAS and NOTUS studies, respectively.8,9 The safety findings in both studies were generally consistent with the established safety profile of dupilumab in its approved indication.7 The most common adverse events were viral infection, headache,

nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache and gastritis.7

Ensifentrine (Ohtuvayre) Ensifentrine (Ohtuvayre) was approved by the FDA in 2024 for the maintenance treatment of COPD in adult patients, marking the first inhaled therapy with a novel mechanism of action to be introduced in more than 20 years.10 It is a first-in-class selective dual inhibitor of the phosphodiesterase 3 and phosphodiesterase 4 enzymes, providing both bronchodilator and nonsteroidal antiinflammatory effects within one molecule.10 The treatment is delivered directly to the lungs via a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.10 The FDA approval was based on data from the Phase 3 ENHANCE trials, during which ensifentrine demonstrated clinical benefits both alone and when used in combination with other maintenance therapies.11 In the trial, patients who received ensifentrine experienced rapid improvements in peak FEV1 as early as Day 1 — improvements that were sustained through Week 24 compared with placebo.11

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24 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Pipeline Drug

Manufacturer

Route of administration

Mechanism of action

Status

Triple therapy inhalers (LAMA-LABA-ICS) budesonide; formoterol fumarate; glycopyrrolate (Breztri Aerosphere HFO)

Pearl Therapeutics; AstraZeneca

Inhaled

Corticosteroid; LAMA; LABA

Phase 3

beclomethasone dipropionate; formoterol fumarate; dihydrate; glycopyrronium bromide (Trimbow)

Chiesi

Inhaled

Corticosteroid; LABA; LAMA

Phase 3

itepekimab (REGN3500)

Regeneron; Sanofi

SC

IL-33 antagonist

Phase 3

tozorakimab (MEDI3506)

AstraZeneca; MedImmune

IV; SC

IL-33 antagonist

Phase 3

asteogolimab (RG6149)

Roche; Genentech

IV; SC

IL-33R antagonist

Phase 3

tezepelumab (Tezspire)

MedImmune; AstraZeneca

SC

TSLP inhibitor

Phase 3

depemokimab (Exdensur)

GSK

SC

IL-5 antagonist

Phase 3

tilrekimig (PF-07275315)

Pfizer

SC

IL-4R antagonist; IL-33 antagonist; TSLP inhibitor

Phase 3

lunsekimig (SAR443765)

Sanofi

SC

IL-13 antagonist TSLP inhibitor

Phase 3

solrikitug

Uniquity Bio

SC

TSLP inhibitor

Phase 2

verekitug (UPB-101)

Upstream Bio

SC

TSLP inhibitor

Phase 2

rademikibart (CBP-201)

Connect Biopharma

SC

IL-4R antagonist

Phase 2

pegtarazimod (RLS-0071)

ReAlta Life Sciences

IV

Complement inhibitors

Phase 2

GB-0895

Generate:Biomedicines

SC

TSLP inhibitor

Phase 3

alpha-1 antitrypsin (Kamada-AAT)

Kamada Pharmaceuticals; PARI

Inhaled

Alpha-1-proteinase inhibitor

Phase 3

Biologics/complement inhibitors

PDE inhibitors and combination products ensifentrine; glycopyrrolate

Verona Pharma; Merck

Inhaled

PDE4 inhibitor

Phase 2

ensifentrine (RPL554 DPI)

Verona Pharma; Ligand Pharmaceuticals

Inhaled

PDE4 inhibitor PDE3 inhibitor

Phase 2

alpha-1 antitrypsin (Kamada-AAT)

Kamada; PARI

Inhaled

Alpha-1-proteinase inhibitor

Phase 3

alpha-1-proteinase inhibitor (alpha-1 15%)

Grifols

SC

Alpha-1-proteinase inhibitor

Phase 3

efdoralprin alfa (INBRX-101)

Inhibrx; Sanofi

IV

Alpha-1-proteinase inhibitor

Phase 2

BEAM-302

Beam Therapeutics; Pfizer

IV

Gene therapy

Phase 2

TSRA-196

Tessera Therapeutics; Regeneron

IV

CRISPR gene editing

Phase 2

KB408

Krystal Biotech

Inhaled

Gene therapy

Phase 1

Alpha-1 antitrypsin deficiency

alpha-1 antitrypsin (AAT); interleukin 33 (IL-33); interleukin 5 (IL-5); intravenous (IV); long-acting beta-2 adrenoreceptor agonist (LABA); long-acting muscarinic antagonist (LAMA); phosphodiesterase (PDE); subcutaneous (SC); thymic stromal lymphopoietin (TSLP)

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CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Significant improvements were also observed across all other lung function parameters, including average FEV1 area under the curve from 0 to 4 hours and 6 to 12 hours, as well as morning and evening trough FEV1.11 Ensifentrine was well-tolerated in a broad population of subjects with moderate-to-severe COPD.11 Adverse reactions associated with ensifentrine are back pain, high blood pressure, bladder infection and diarrhea. More rare, serious side effects

In May 2025, the FDA approved mepolizumab (Nucala) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

26 | PRIME THERAPEUTICS REPORT | SUMMER 2026

include sudden breathing problems immediately after inhaling the medication and mental health disturbances such as suicidal thoughts and behaviors.10 The Institute for Clinical and Economic Review (ICER) released a final evidence report evaluating the use of ensifentrine in COPD.12 The independent appraisal committee voted that current evidence supports superior net health benefits when ensifentrine is added to maintenance therapy compared to maintenance therapy alone.12 ICER estimated a health-benefit price benchmark for ensifentrine between $7,500 and $12,700 per year, whereas the current annual price is approximately $35,400.

Mepolizumab (Nucala) In May 2025, the FDA approved mepolizumab (Nucala), an interleukin-5 (IL-5) inhibitor, as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.13 Notably, mepolizumab is the only approved biologic evaluated in a broad COPD population with an eosinophilic phenotype defined by blood eosinophil count ≥ 150 cells/µL.13 Approval was based on data from the MATINEE and METREX trials, which demonstrated that mepolizumab added to triple inhaled therapy significantly reduced the annualized rate of

moderate-to-severe exacerbations compared with placebo in patients with an eosinophilic phenotype.13,14,15 In the MATINEE trial, the annualized rate of COPD exacerbations requiring emergency room visits and/or hospitalizations was reduced in the mepolizumab group when compared with placebo.14 The time to first moderate or severe exacerbation was longer in patients taking mepolizumab than placebo.14 In the METREX trial, the mean annual rate of moderate or severe exacerbations was 1.40 per year in the mepolizumab group compared to 1.71 in the placebo group.15 The most common adverse reactions associated with mepolizumab in the COPD trials were back pain, diarrhea and cough.13 Other systemic reactions observed in clinical trials include hypersensitivity reactions manifesting as rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, a warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reactions.13

Payer impact According to the Centers for Disease Control, costs associated with COPD have increased 52.6% from 2010 ($32.1 billion) to 2020 ($49 billion).16 The primary drivers of these costs are exacerbations, as they require a healthcare visit and can lead to emergency room visits and hospital admissions.17 Studies have shown that interventions aimed at improving medication adherence are generally cost-effective and result in reduced healthcare resource utilization and associated costs.18

practice.19 IL-5 inhibitors were favored for patients with very high eosinophil counts, with many panelists identifying a threshold of 600 to 800 cells per µL; among these, mepolizumab was the most preferred.19 Panelists also looked at the pipeline, which has the potential to increase biologic treatment options in the category, including IL-33 inhibitors, tezepelumab and emerging bispecifics.19 Clinicians on the panel noted that a significant gap remains despite the current range of available therapies and expanding pipeline, as there is no biomarker equivalent to the eosinophil count that has emerged for the neutrophilic COPD population.19 Patients currently receiving triple inhaled therapy and experiencing repeated exacerbations but who have normal eosinophil levels have no subsequent therapeutic options.19 While there is promise for advances in COPD management, important gaps in both treatment access and available therapeutic options remain. As innovation continues to broaden the pipeline and expand horizons of care in the years to come, the evolving landscape of COPD treatment will remain an area of significant interest, challenge and opportunity for payers and managed care teams willing to explore its potential.

With the introduction of biologic COPD therapies, utilization management measures will be key to ensuring access by the appropriate patient population.

Continued education around this expanding treatment landscape, including guidance on selecting the most appropriate biologic for specific patient populations, will be critical to optimizing care. Identifying the patients who are most likely to benefit from these therapies is critical to achieving positive outcomes while managing the high costs associated with biologic treatment.

In March 2026, HCPLive convened an expert forum to discuss real-world use of biologics in COPD, including treatment preference and ongoing challenges.19 Among panelists, dupilumab emerged as the preferred biologic, driven by factors such as ease of home administration, familiarity and perception of effectiveness in clinical

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CHRONIC OBSTRUCTIVE PULMONARY DISEASE

REFERENCES 1.

Cleveland Clinic. (2024, August 19). Chronic obstructive pulmonary disease (COPD). my.clevelandclinic.org/health/ diseases/8709-chronic-obstructive-pulmonary-diseasecopd

2.

American Lung Association. (2025, September 2).

COPD in your state. lung.org/lung-health-diseases/ lung-disease-lookup/copd/for-health-professionals/ copd-in-your-state

3.

Boers, E., Barrett, M., & Su, J.G. (2023). Global burden of chronic obstructive pulmonary disease through 2050.

JAMA Network Open, 6(12), e2346598. jamanetwork.com/ journals/jamanetworkopen/fullarticle/2812622

4.

Mayo Clinic. (2024, August 30). COPD - diagnosis and treatment. mayoclinic.org/diseases-conditions/copd/ diagnosis-treatment/drc-20353685

5.

Global Initiative for Chronic Obstructive Lung Disease.

(2024, November 15). 2025 GOLD Report. goldcopd.org/2025-gold-report

6.

American Journal of Managed Care. (2025, October 31).

Evolving standards and emerging treatments in COPD care. ajmc.com/view/evolving-standards-and-emergingtreatments-in-copd-care

7.

Sanofi. (2024, September 27). Press release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPD [Press release]. sanofi.com/en/media-room/press-relea ses/2024/2024-09-27-13-35-00-2954551

28 | PRIME THERAPEUTICS REPORT | SUMMER 2026

8.

Bhatt, S.P., Rabe, K.F., Hanania, N.A., Vogelmeier, C.F., Cole, J., Bafadhel, M., Christenson, S.A., Papi, A., Singh, D., Laws, E., Mannent, L.P., Patel, N., Staudinger, H.W., Yancopoulos, G.D., Mortensen, E.R., Akinlade, B., Maloney, J., Lu, X., Bauer, D., Bansal, A., Robinson, L.B., & Abdulai, R.M. (2023). Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. The New England Journal of Medicine, 390(4), 2274–2283. doi.org/10.1056/ NEJMoa2303951

9.

Bhatt, S.P., Rabe, K.F., Hanania, N.A., Vogelmeier, C.F., Bafadhel, M., Christenson, S.A., Papi, A., Singh, D., Laws, E., Patel, N., Yancopoulos, G.D., Akinlade, B., Maloney, J., Lu, X., Bauer, D., Bansal, A., Abdulai, R.M., & Robinson, L.B. (2024).

Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. The New England Journal of Medicine, 390(24), 2274–2283. doi.org/10.1056/NEJMoa2401304

10.

Verona Pharma. (2024, June 26). Verona Pharma announces US FDA approval of Ohtuvayre™ (ensifentrine). veronapharma.com/news/verona-pharma-announcesus-fda-approval-of-ohtuvayre-ensifentrine

11.

Maselli, D.J., Bon, J., Rheault, T., Dixon, A., Reyner, D., Rickard, K., & Lester, M.G. (2025). Lung function and safety outcomes in patients with moderate-to-severe COPD treated with ensifentrine. CHEST Pulmonary, 3(4), 100210. doi.org.10.1016/chpulm.2025.100210

12.

Institute for Clinical and Economic Review. (2024). Chronic obstructive pulmonary disease. icer.org/assessment/ copd-2024

REFERENCES 13.

GSK. (2025, May 22). Nucala (mepolizumab) approved

by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). us.gsk.com/en-us/media/ press-releases/nucala-mepolizumab-approved-byus-fda-for-use-in-adults-with-chronic-obstructivepulmonary-disease-copd

14.

Sciurba, F.C., Criner, G.J., Christenson, S.A., Martinez, F.J., Papi, A., Roche, N., Bourbeau, J., Korn, S., Bafadhel, M., Han, M.K., Kolterer, S., Miller, K., Mouneimne, D., Fletcher, J., Mayer, B., Min, J., & Pavord, I.D. (2025). Mepolizumab to prevent exacerbations of COPD with an eosinophilic phenotype. The New England Journal of Medicine, 392(17) 1710–1720. doi.org/10.1056/NEJMoa2413181

15.

Pavord, I.D., Chanez, P., Criner, G.J., Kerstjens, H.A.M., Korn, S., Lugogo, N., Martinot, J.-B., Sagara, H., Albers, F.C., Bradford, E.S., Harris, S.S., Mayer, B., Rubin, D.B., Yancey, S.W., & Sciurba, F.C. (2017). Mepolizumab for eosinophilic chronic obstructive pulmonary disease. The New England Journal of Medicine, 377(17), 1613–1629. pubmed.ncbi.nlm.nih.gov/28893134

16.

McKenna, J. (2025, April 28). The costs of COPD. WebMD. webmd.com/lung/copd/costs-of-copd

17.

American Journal of Managed Care. (2023, January 18). Cost drivers impacting treatment strategies for COPD. ajmc.com/ view/cost-drivers-impacting-treatment-strategiesfor-copd

18.

van Boven, J.F.M., Lavorini, F., Agh, T., Sadatsafavi, M., Patino, O., & Muresan, B. (2024). Cost-effectiveness and impact on health care utilization of interventions to improve medication adherence and outcomes in asthma and chronic obstructive pulmonary disease: A systematic literature review. The Journal of Allergy and Clinical Immunology: In Practice, 12(5), 1228–1243. doi.org/10.1016/j.jaip.2023.12.049

19.

Johnson, V. (2026, March 20). COPD biologics in practice: Exacerbation reduction is no longer enough. HCPLive. hcplive.com/view/copd-biologics-practice-exacerbationreduction-no-longer-enough

PRIMETHERAPEUTICS.COM | 29

Ophthalmology Treatment landscape and payer management Ophthalmic disorders and diseases Age-related macular degeneration (AMD)

Soumya Vishwanath, PharmD Trade Client Relations Director, Specialty Prime Therapeutics

AMD is an ophthalmic disorder that affects approximately 15 million Americans and occurs when aging causes damage to the macula, leading to vision loss.1 It is the leading cause of vision loss for older adults. Common risk factors include being over the age of 55, having a family history of AMD, being Caucasian and smoking.1 While AMD does not cause complete vision loss, it causes loss of central vision, making it challenging to see faces, read, drive or complete other daily activities.1 Dry AMD (dAMD), or atrophy AMD, occurs when the macula thins with age.1 There are three stages of dAMD — early, intermediate and late — which typically progress slowly over several years.1 Patients with early dAMD generally have no symptoms.1 While some patients with intermediate dAMD have no symptoms, others may notice mild blurriness or trouble seeing in low light. Geographic atrophy (GA) is indicative of late-stage dAMD and manifests as atrophic lesions that start in the outer retina and progressively expand to cover the macula and fovea. GA leads to irreversible vision loss over time.2 The second type of AMD, wet AMD (wAMD) or neovascular AMD, is a less common form of late AMD that causes more rapid vision loss.1 While wAMD is always late stage, any stage of dAMD can develop into wAMD, which occurs when abnormal blood vessels grow in the back of the eye and damage the macula.1 Late AMD, whether wet or dry, can cause straight lines to look wavy or crooked.1 A blurry area near the center of vision may form and grow over time, causing colors to appear less bright and diminishing sight in low lighting.1 There are several available treatment options for wAMD.1

Diabetic macular edema (DME) The leading cause of irreversible blindness in adult Americans is diabetic retinopathy (DR), the most common diabetic eye disease. DME is the result of a buildup of fluid in the macula caused by DR and can occur at any stage of the condition.3 An estimated 7.7 million Americans live with DR, and around 750,000 of those have DME.3 Poor

30 | PRIME THERAPEUTICS REPORT | SUMMER 2026

blood-sugar control and other associated medical conditions, such as high blood pressure, increase the risk of blindness in people with diabetes.3

Retinal vein occlusion (RVO) RVO occurs when a blood clot blocks the main vein through which blood flows out of the retina, typically affecting only one eye. When blood flow is blocked, it causes a lack of oxygen, and the body releases vascular

The leading cause of irreversible blindness in adult Americans is diabetic retinopathy (DR), the most common diabetic eye disease.

endothelial growth factor (VEGF) protein in response.

Excess VEGF protein can cause macular edema (ME).4 Vision loss in people with RVO is often caused by the development of ME.5 People at risk of developing RVO include adults age 50 or older and those with high blood pressure, diabetes, glaucoma or arteriosclerosis.

Treatment landscape These retinal diseases are often treated by anti-VEGF agents. When cells produce excess VEGF, abnormal blood vessels can grow in the eye, causing damage and harming vision. Anti-VEGF agents can slow or stop the damage from these abnormal blood vessels, thus delaying vision loss and sometimes improving vision.

Anti-VEGF treatments that have been widely adopted for use by ophthalmologists include compounded bevacizumab (Avastin), ranibizumab (Lucentis) and aflibercept (Eylea). Recent developments in the anti-VEGF space have focused on biosimilars: Several biosimilars have gained Food and Drug Administration (FDA) approval in recent years, and many others are on the horizon. Table 1 shows currently approved biosimilars in this space, and Table 2 shows the biosimilar pipeline.

PRIMETHERAPEUTICS.COM | 31

OPHTHALMOLOGY

Table 1. Currently approved anti-VEGF biosimilars Biosimilar

Manufacturer

Indication

Approval

Launched?

ranibizumab-nuna (Byooviz)*

Biogen; Samsung Bioepis

wAMD; RVO; mCNV

2021

Yes

ranibizumab-eqrn (Cimerli)*

Sandoz

DME; DR; wAMD; RVO; mCNV

2022

Yes

ranibizumab-leyk (Nufymco)**

Formycon

wAMD; DME; DR; RVO; mCNV

2025

No

aflibercept-boav (Eydenzelt)

Celltrion

wAMD; RVO; DME; DR

2025

No

aflibercept-jbvf (Yesafili)**

Biocon

wAMD; RVO; DME; DR

2024

No

aflibercept-yszy (Opuviz)**

Samsung Bioepis

wAMD; RVO; DME; DR

2024

No

aflibercept-ayyh (Pavblu)

Amgen

wAMD; RVO; DME; DR

2024

Yes

aflibercept-mrbb (Ahzantive)

Formycon

wAMD; RVO; DME; DR

2024

No

aflibercept-abzv (Enzeevu)

Sandoz

wAMD; RVO; DME; DR

2024

No

ranibizumab (Lucentis)

aflibercept (Eylea)

diabetic macular edema (DME); diabetic retinopathy (DR); myopic choroidal neovascularization (mCNV); retinal vein occlusion (RVO); wet age-related macular degeneration (wAMD) *As of January 2026, there has been a pause in commercialization of Byooviz. **Interchangeable

Table 2. Anti-VEGF biosimilar pipeline Manufacturer

Route of administration

Status

Potential indication

SCD411

Sam Chun Dang Pharm; Fresenius Kabi

Intravitreal

Pending (October 2026)

wAMD; ME following RVO

RBS-001

Rophibio; Amicogen

Intravitreal

Phase 3

wAMD

Sam Chun Dang Pharm; Fresenius Kabi

TBD

Developing

DR; wAMD; DME

LUBT010

Lupin

Intravitreal

Pending (June 2026)

wAMD

Lucamzi

Xbrane

Intravitreal

Pending (October 2026)

mCNV; wAMD; RVO

Drug aflibercept (Eylea)

aflibercept (Eylea HD) SCD411 HD ranibizumab (Lucentis)

diabetic retinopathy (DR); retinal vein occlusion (RVO); vascular endothelial growth factor (VEGF); wet age-related macular degeneration (wAMD)

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Table 3. Broad ophthalmology pipeline Drug

Manufacturer

Route of administration

Mechanism of action

Status

Indication

Anti-VEGF agents

bevacizumab (Lytenava)

Outlook Therapeutics

Ophthalmic

VEGF inhibitor

Phase 3

wAMD; DME; RVO

tarcocimab tedromer (KSI-301)

Kodiak Sciences

Intravitreal

VEGF inhibitor

Phase 3

RVO; DR; wAMD

bevacizumab (TAB014)

Tot Biopharm

Intravitreal

VEGF inhibitor

Phase 3

wAMD

bevacizumab (HLX04-O)

Shanghai Henlius Biotech

Intravitreal

VEGF inhibitor

Phase 3

wAMD

tabirafusp alfa (KSI-101)

Kodiak Sciences

Intravitreal

IL-6 antibody; VEGF inhibitor

Phase 3

ME

tabirafusp tedromer (KSI-501)

Kodiak Sciences

Intravitreal

IL-6 antibody; VEGF inhibitor

Phase 3

wAMD

surabgene lomparvovec (ABBV-RGX-314)

Phase 3

wAMD

Regenxbio; AbbVie

Injectable

Gene therapy Phase 2

DR; DME

axitinib (Axpaxli)

Ocular Therapeutix

Intravitreal

Tyrosine kinase inhibitor

Phase 3

wAMD; DR

EyePoint Pharmaceuticals; Equinox Science

wAMD; DME

Intravitreal

Tyrosine kinase inhibitor

Phase 3

vorolanib (EYP-1901)

Phase 2

DR

vamikibart (RG6179)

Genentech; Roche

Intravitreal

IL-6 antagonist

Phase 3

ME

DME

EyeBio; Merck

Intravitreal

Wnt signaling pathway activator

Phase 3

remigromig (Restoret)

Phase 2

wAMD

Phase 3

wAMD

Phase 2

DME; DR

Phase 3

wAMD

Phase 2

DME

Other agents

ixoberogene soroparvovec (ADVM-022)

Adverum Biotechnologies

4D-150

4D Molecular Therapeutics

Intravitreal

Intravitreal

Gene therapy

Gene therapy

diabetic macular edema (DME); diabetic retinopathy (DR); interleukin 6 (IL-6); macular edema (ME); retinal vein occlusion (RVO); vascular endothelial growth factor (VEGF); wet agerelated macular degeneration (wAMD); Wingless-related integration site (Wnt)

PRIMETHERAPEUTICS.COM | 33

OPHTHALMOLOGY

Recent approvals Ranibizumab biosimilar (Nufymco) In December 2025, the FDA approved ranibizumab-leyk (Nufymco) as an interchangeable ranibizumab biosimilar to Lucentis.6 As an interchangeable biosimilar, Nufymco is approved for the following indications: wAMD, DME, DR, ME due to RVO and myopic choroidal neovascularization.6

Aflibercept biosimilar (Eydenzelt) Also in late 2025, aflibercept-boav (Eydenzelt) was approved for the treatment of wAMD, ME following RVO, DME and DR.7 This approval was based on data from a 52-week, randomized, multicenter, Phase 3 study assessing the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt compared with reference aflibercept.8 The study measured the change in bestcorrected visual acuity calculated at Week 8 from baseline.

The results demonstrated that aflibercept-boav met all preferred equivalence criteria — along with secondary endpoints of efficacy, safety and immunogenicity — demonstrating similar results to the reference product.8

The emergence of biosimilars in this category presents the potential for cost management and increased therapeutic access. the country continue to leverage the bevacizumabfirst strategy, as it is clinically recommended and costs considerably less than other therapies. Due to recent approvals, the launch of several biosimilars and the imminent introduction of many others, some payers may choose to add an additional step after bevacizumab and prioritize biosimilars based on established efficacy and lower cost compared to reference products.

Payer impact A 2024 analysis of the economic burden of vision loss and blindness in the United States estimated 2017 costs at $134.2 billion, with medical costs making up the largest portion of that burden at $53.5 billion.9 As one of the top 10 drug therapy categories by per member per month (PMPM) spend for 2024, ophthalmic injections demonstrated one of the highest PMPM growth rates (6%) among these top categories.10 The emergence of biosimilars in this category presents the potential for cost management and increased therapeutic access. Utilization management, prior authorization and step therapy policies can be helpful in encouraging biosimilar uptake in this category.11 A 2022 statement from the American Academy of Ophthalmology noted the potential value of biosimilars for improving care for patients with eye disease.12 The advent of these biosimilars presents an opportunity for improved patient access and cost savings for this population.

While there are several treatment options available and the space is growing, many health plans across

34 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Monthly news Get insights from Prime’s clinicians and thought leaders

REFERENCES 1.

National Eye Institute. (2021, June 22). Agerelated macular degeneration (AMD). National Institutes of Health. nei.nih.gov/learn-abouteye-health/eye-conditions-and-diseases/ age-related-macular-degeneration

7.

Ferruggia, K. (2025, October 10). FDA approves Celltrion’s Eydenzelt, biosimilar to aflibercept, to treat ocular conditions. Pharmacy Times. pharmacytimes.com/view/ fda-approves-celltrion-s-eydenzelt-biosimilar-toaflibercept-to-treat-ocular-conditions

2.

Bakri, S.J., Bektas, M., Sharp, D., Luo, R., Sarda, S.P., & Khan, S. (2023). Geographic atrophy: Mechanism of disease, pathophysiology, and role of the complement system.

Journal of Managed Care & Specialty Pharmacy, 29(5-a Suppl), S2–S11. doi.org/10.18553/jmcp.2023.29.5-a.s2

8.

Celltrion. (2023, December 5). Study to compare efficacy and safety of CT-P42 in comparison with Eylea in patients with diabetic macular edema [Clinical Trial: NCT04739306].

ClinicalTrials.gov. clinicaltrials.gov/study/NCT04739306

3.

National Eye Institute. (2019, July 8). Macular edema.

National Institutes of Health. nei.nih.gov/learnabout-eye-health/eye-conditions-and-diseases/ macular-edema

9.

Centers for Disease Control. Vision and eye health economic studies. (2024, May 15). cdc.gov/vision-health/ php/data-research/index.html

10.

Prime Therapeutics. Prime Therapeutics medical pharmacy trend report 2025 edition.

(2025, August 25). primetherapeutics. com/w/2025-medical-pharmacy-trend-report

11.

Williams, G.A., Repka, M.X., & Glasser, D.B. (2022). The promise and perils of biosimilars in ophthalmology. Ophthalmology Retina, 6(7), 537–539. doi.org/10.1016/j.oret.2022.03.018

12.

American Academy of Ophthalmology. The use of biosimilars in ophthalmic practice - 2022. (2022, January 1). aao.org/education/clinical-statement/ use-of-biosimilars-in-ophthalmic-practice

4.

National Eye Institute. (2023, November 15).

Central retinal vein occlusion (CRVO). National Institutes of Health. nei.nih.gov/eye-healthinformation/eye-conditions-and-diseases/ central-retinal-vein-occlusion-crvo

5.

Rhoades, W., Dickson, D., Nguyen, Q.D., & Do, D.V. (2017).

Management of macular edema due to central retinal vein occlusion – The role of aflibercept. Taiwan Journal of Ophthalmology, 7(2), 70–76. doi.org/10.4103/tjo.tjo_9_17

6.

McGovern, G. (2025, December 23). FDA approves Nufymco, interchangeable ranibizumab biosimilar, for retinal diseases. Pharmacy Times. pharmacytimes.com/view/ fda-approves-nufymco-interchangeable-ranibizumabbiosimilar-for-retinal-diseases

PRIMETHERAPEUTICS.COM | 35

Pipeline Pipeline drug list Drug

Manufacturer

Clinical use

Dosage form

Development status

Expected decision date

allogeneic T cell (Orca-T)

Orca Bio

Hematological malignancies

IV

BLA – OD, PR, RMAT

07/06/2026

atacicept

Vera Therapeutics; Bristol Myers Squibb

Immunoglobulin A nephropathy (Berger’s disease)

SC

BLA – BT, OD, PR, seeking AA

07/07/2026

fam-trastuzumab deruxtecan-nxki (Enhertu)

Daiichi Sankyo; AstraZeneca

Breast cancer (HER2+, residual invasive disease postneoadjuvant therapy)

IV

sBLA – BT, FT, PR

07/07/2026

gedatolisib

Celcuity; Pfizer

Breast cancer (HR+, HER2-, PIK3CA wild-type)

IV

NDA – BT, FT, PR, RTOR

07/17/2026

isatuximab-irfc (Sarclisa) SC

Sanofi

MM

SC

BLA – OD

07/23/2026

rivoceranib

Elevar

Hepatocellular carcinoma (unresectable or metastatic, in combination with camrelizumab)

Oral

NDA – OD

07/23/2026

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Pipeline drug list (cont.)

Drug

Manufacturer

Clinical use

Dosage form

Development status

Expected decision date

centanafadine

Otsuka

ADHD

Oral

NDA – PR

07/24/2026

furosemide (Furoscix) ReadyFlow autoinjector

MannKind Corporation

Edema (adults with CKD or CHF)

SC

sNDA

07/26/2026

adrabetadex

Mandos Health

Neimann-Pick disease type C

Intrathecal

NDA – BT, OD, PR, RPD

08/17/2026

enfortumab vedotin-ejfv (Padcev)

Astellas; Pfizer

Bladder cancer (muscle invasive, in combination with pembrolizumab)

IV

sBLA – BT, PR

08/17/2026

iberdomide

Bristol Myers Squibb

MM (R/R, in combination with daratumumab and dexamethasone)

Oral

NDA – BT, OD, PR

08/17/2026

deramiocel (CAP-1002)

Nippon Shinyaku; Capricor Therapeutics

DMD cardiomyopathy

IV

BLA – OD, RPD, RMAT

08/22/2026

pariglasgene brecaparvovec (DTX401)

Ultragenyx

Glycogen storage disease (type 1a)

IV

BLA – FT, OD, PR, RMAT, RPD

08/23/2026

dasatinib (amorphous formulation)

Handa Pharma

AML; CML

Oral

505(b)(2) NDA – OD

08/25/2026

ropeginterferon alfa-2bnjft (Besremi)

Pharmaessentia

Essential thrombocytopenia

SC

sNDA – OD

08/30/2026

garetosmab

Regeneron

Fibrodysplasia ossificans progressiva

IV

sBLA – FT, OD, PR

August 2026

ustekinumab (Stelara)

Johnson & Johnson

UC (ages 2-17 years)

IV; SC

sBLA – OD

August 2026

PRIMETHERAPEUTICS.COM | 37

PIPELINE DRUG LIST

Pipeline drug list (cont.)

Drug

Manufacturer

Clinical use

Dosage form

Development status

Expected decision date

potassium hydrogen carbonate/potassium citrate

Advicenne

Renal tubular acidosis

Oral

505(b)(2) NDA – OD

09/03/2026

zidesamtinib

Nuvalent

NSCLC (advanced ROS1+, prior TKI therapy)

Oral

NDA – BT

09/18/2026

rebisufligene etisparvovec (UX1111)

Ultragenyx

Mucopolysaccharidosis IIIA (Sanfilippo syndrome type A)

IV

BLA – FT, OD, PR, RMAT, RPD, seeking AA

09/19/2026

sotatercept-csrk (Winrevair)

Merck

PAH (newly diagnosed, intermediate and high-risk)

SC

sNDA – BT, OD

09/21/2026

zilganersen

Ionis Pharmaceuticals

Alexander disease

Intrathecal

NDA – FT, OD, PR

09/22/2026

lirafugratinib

Elevar

Cholangiocarcinoma (FGFR2 fusion or rearrangement, second-line)

Oral

NDA – BT, OD, PR

09/27/2026

relutrigine

Praxis Medicines

Developmental and epileptic encephalopathy

Oral

NDA – BT, OD, PR, RPD

09/27/2026

aminolevulinic acid (Ameluz)

Biofrontera

Basal cell carcinoma (skin, in combination with photodynamic therapy)

Topical

sNDA

09/28/2026

tiratricol (Emcitate)

Egetis Therapeutics

Monocarboxylate transporter 8 deficiency

Oral

NDA – BT, FT, OD, PR, RPD

09/28/2026

condoliase

Ferring Pharmaceuticals

Sciatica

Intravertebral disc injection

BLA

September 2026

omalizumab (biosimilar to Genentech’s Xolair)

Amneal Pharmaceuticals

Asthma; chronic spontaneous urticaria; chronic rhinosinusitis with nasal polyps; food allergies

SC

BLA

September 2026

38 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Pipeline drug list (cont.)

Drug

Manufacturer

Clinical use

Dosage form

Development status

Expected decision date

tavapadon

AbbVie

Parkinson’s disease

Oral

NDA

September 2026

apixaban oral film

Taho Pharma

Thrombotic disorders

Oral

505(b)(2) NDA

3Q 2026

atezolizumab (Tecentriq)

Genentech

Bladder cancer (high risk, muscle invasive, ctDNA)

IV

sBLA – BT

3Q 2026

beclomethasone/ formoterol/glycopyrrolate

Chiesi

Asthma

Inhaled

NDA

3Q 2026

brepocitinib

Priovant Therapeutics; Pfizer

Dermatomyositis

Oral

NDA – OD, PR

3Q 2026

denecimig

Novo Nordisk

Hemophilia A (routine prophylaxis)

SC

BLA – OD

3Q 2026

insulin efsitora alfa

Lilly

Type 2 diabetes mellitus

SC

NDA

3Q 2026

oveporexton

Takeda Pharmaceuticals

Narcolepsy type 1

Oral

NDA – BT, OD, PR

3Q 2026

ifinatamab deruxtecan

Daiichi Sankyo; Merck

SCLC (extensive stage, prior platinum-based therapy)

IV

sBLA – BT, OD, PR, RTOR

10/10/2026

phentolamine ophthalmic solution 0.75% (Ryzumvi)

Viatris

Presbyopia

Ophthalmic

sNDA – FT

10/17/2026

tildrakizumab-asmn (Ilumya)

Sun Pharma

PsA

SC

sBLA

10/29/2026

PRIMETHERAPEUTICS.COM | 39

PIPELINE DRUG LIST

Pipeline drug list (cont.)

Drug

Manufacturer

Clinical use

Dosage form

Development status

Expected decision date

doruxapapogene ralaplasmid (INO-3107)

Inovio Pharmaceuticals

Recurrent respiratory papillomatosis

IM

BLA – BT, OD, seeking AA

10/30/2026

aflibercept (biosimilar to Regeneron’s Eylea)

Sam Chun Dang Pharm; Fresenius Kabi

DME; DR; ME following RVO; wAMD

Intravitreal

BLA

October 2026

dexmedetomidine (Igalmi)

Bioxcel Therapeutics

Agitation associated with schizophrenia and bipolar disorder (at-home use)

Oral

sNDA – BT, FT

11/14/2026

ivonescimab

Akeso; Summit Therapeutics

NSCLC (nonsquamous, EGFR mutated, post-TKI therapy)

IV

BLA – FT

11/14/2026

molgramostim

Savara

Acute pulmonary alveolar proteinosis

Inhaled

BLA – BT, FT, OD, PR

11/22/2026

olanzapine long-acting injection

Teva Pharmaceuticals

Schizophrenia

SC

505(b)(2) NDA

4Q 2026

povetacicept

Vertex Pharmaceuticals

Immunoglobulin A nephropathy (Berger’s disease)

SC

NDA – BT, PR, seeking AA

4Q 2026

pritelivir

Aicuris Antiinfective Cures

Herpes simplex virus treatment (refractory immunocompromised patients)

Oral

NDA – BT, FT, PR

4Q 2026

remibrutinib (Rhapsido)

Novartis

Symptomatic dermographism

Oral

sNDA

4Q 2026

ribitol (BBP-418)

Bridgebio

Limb-girdle muscular dystrophy (type 2I/R9)

Oral

NDA – BT, OD, RPD

4Q 2026

baricitinib (Olumiant)

Lilly

Alopecia areata (adolescents)

Oral

sNDA

2H 2026

40 | PRIME THERAPEUTICS REPORT | SUMMER 2026

Pipeline drug list (cont.)

Drug

Manufacturer

Clinical use

Dosage form

Development status

Expected decision date

meloxicam (fast-acting)

Viatris

Acute pain

Oral

505(b)(2) NDA

2H 2026

pembrolizumab (Keytruda)

Merck

Breast cancer (TNBC, metastatic, unresectable, first-line, with sacituzumab govitecan-hziy)

IV

sNDA – BT

2H 2026

pembrolizumab/ berahyaluronidase alfapmph (Keytruda Qlex)

Merck

Breast cancer (TNBC, metastatic, unresectable, first-line, with sacituzumab govitecan-hziy)

SC

sNDA – BT

2H 2026

pimicotinib

Merck

Tenosynovial giant cell tumor

Oral

NDA – BT, FT

2H 2026

sacituzumab govitecanhziy (Trodelvy)

Gilead

Breast cancer (TNBC, metastatic, first-line, with pembrolizumab)

IV

sBLA

2H 2026

tirzepatide (Mounjaro)

Lilly

Type 2 diabetes mellitus (cardiovascular risk reduction)

SC

sNDA

2H 2026

Accelerated Approval (AA); attention-deficit/hyperactivity disorder (ADHD); age-related macular degeneration (AMD); Biologics License Application (BLA); Breakthrough Therapy (BT); chronic heart failure (CHF); chronic kidney disease (CKD); circulating tumor deoxyribonucleic acid (ctDNA); diabetic macular edema (DME); diabetic retinopathy (DR); epidermal growth factor receptor (EGFR); fibroblast growth factor receptor 2 protein (FGFR2); fast track (FT); human epidermal growth factor receptor 2-negative (HER2-); human epidermal growth factor receptor 2-positive (HER2+); hormone receptor-positive (HR+); intramuscular (IM); intravenous (IV); macular edema (ME); multiple myeloma (MM); new drug application (NDA); non-small cell lung cancer (NSCLC); orphan drug (OD); phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA); Priority Review (PR); psoriatic arthritis (PsA); relapsed/refractory (R/R); Regenerative Medicine Advanced Therapy (RMAT); ROS proto-oncogene 1 positive (ROS1+); Rare Pediatric Disease (RPD); Real-Time Oncology Review (RTOR); retinal vein occlusion (RVO); supplemental Biologics License Application (sBLA); subcutaneous (SC); small cell lung cancer (SCLC); supplemental New Drug Application (sNDA); triple negative breast cancer (TNBC); tyrosine kinase inhibitor (TKI)

THE MERCK ACCESS PROGRAM (MAP)

Actor Portrayal

MAY BE ABLE TO HELP ANSWER QUESTIONS ABOUT Benefit investigations

Co-pay assistance for eligible patients

Billing and coding

The prior authorizations and appeals process

Product distribution

Referral to the Merck Patient Assistance Program for eligibility determination (provided through the Merck Patient Assistance Program, Inc.)

CONTACT THE MERCK ACCESS PROGRAM

VISIT

merckaccessprogram-keytruda.com/ keytrudaqlex/

CALL

855-257-3932, Monday through Friday, 8 am to 8 pm ET

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