Panelists discuss how the GALAXI-2 and GALAXI-3 trials represented a landmark study design for Crohn’s disease research through their rigorous triple-dummy active comparator methodology, treat-through model without rerandomization, inclusion of both bio-naive and bio-experienced patients, composite primary end points measured at individual patient levels, and the unique ability to conduct pooled analyses comparing guselkumab directly with ustekinumab as an active comparator.
An expert discusses how systemic treatments for vitiligo often have better patient adherence than topical treatments, though they require blood work monitoring and careful consideration of cardiovascular and other health risks.
HHS Secretary Robert F. Kennedy Jr.’s vaccine policies, the federal government shutdown, most-favored-nation drug pricing and the future of Medicare Advantage were among the topics discussed by a panel of Washington, D.C., healthcare policy professionals during a Managed Healthcare Executive webinar. Ryann Hill, M.P.H., of Indigo Hill Strategies; Patrick Cooney of The Federal Group; and Lindsay Greenleaf, J.D., MBA, of ADVI Health, provided insights and observations about the Trump administration’s approach to healthcare and drug pricing policy. Peter Wehrwein, managing editor of Managed Healthcare Executive, moderated the discussion.
Panelists discuss how bimekizumab treatment preserves workforce participation and productivity while maintaining a favorable safety profile. Oral candidiasis is the main distinguishing side effect compared with other IL-17 inhibitors, although it is rarely encountered in clinical practice.
Panelists discuss how bimekizumab showed significant improvements across multiple health-related quality of life measures, including the Psoriatic Arthritis Impact of Disease (PsAID)-12, Psoriatic Arthritis Quality of Life measure, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), demonstrating comprehensive benefits beyond just physical symptoms.
An expert discusses how BCG-unresponsive NMIBC patients have heterogeneous clinical needs requiring individualized treatment strategies, while P&T committees evaluate new therapies by assessing unmet needs and comparing real-world evidence across single-arm trials.
Panelists discuss how the expanding treatment landscape for Crohn’s disease includes multiple mechanisms of action such as anti-tumor necrosis factor (TNF) agents, anti-integrin agents, interleukin inhibitors, and Janus kinase (JAK) inhibitors, with particular focus on guselkumab’s unique dual-acting mechanism as an IL-23 p19 inhibitor that also reduces CD64 expression on intestinal macrophages, although the clinical significance of this dual action compared with other p19 inhibitors remains to be fully determined.
Panelists discuss how maintaining patients on effective single therapies for Crohn’s disease is preferable to switching between different mechanisms of action, while addressing access challenges created by insurance step-therapy requirements and biosimilar policies that can interfere with optimal treatment selection.
An expert discusses how primary and secondary prevention differ in atherosclerotic cardiovascular disease, with secondary prevention targeting patients who have already had events such as heart attacks or strokes and primary prevention addressing high-risk patients with multiple risk factors. He explains that statin intolerance can be complete (due to severe complications such as rhabdomyolysis) or partial (ranging from mild to severe muscle aches), while statin resistance occurs when patients tolerate the medication but don’t achieve expected LDL cholesterol reductions.
Panelists discuss how bimekizumab demonstrated significant improvements in pain scores (from baseline levels around 60/100) and fatigue measures, with meaningful percentages of patients achieving clinically important reductions that translate to noticeable real-world benefits.
Panelists discuss how the clinical trial populations, characterized by middle-aged males with elevated body mass index (BMI) and moderate disease burden, accurately reflect real-world patients with psoriatic arthritis seen in clinical practice, including those with oligoarticular disease.
Robert Gamble, CEO of RxBenefits, shares how Illuminate Rx does specialty, plus the areas they will continue to innovate on.
An expert discusses how payers face multiple access challenges including high treatment costs exceeding $100,000 per patient, coverage restrictions through prior authorization and operational barriers requiring specialized administration facilities, and proposes solutions like value-based contracting and enhanced patient selection tools.
An expert discusses how health plans prioritize the lowest net cost with positive outcomes when comparing administration differences, ultimately focusing on member experience when deciding between quarterly intravesical treatments and more frequent systemic infusions.
A large percentage of patients starting a medication take expensive brand-name products instead of biosimilars, even as health plans and PBMs work on converting existing brand-name prescriptions to biosimilars.
New prescriptions weren’t needed because Selarsdi (ustekinumab-aekn) and Pyzchiva (ustekinumab-ttwe) interchangeable with Stelara (ustekinumab)
Scripius removed Stelara (ustekinumab) from its large employer formulary and replaced it with Pyzchiva (ustekinumab-ttwe) and Selarsdi (ustekinumab-aekn)
RxBenefits is aiming to fill gaps in the PBM market with a new option for self-funded employers and brokers, called Illuminate Rx.
Panelists discuss how the BE OPTIMAL study enrolled biologic-naive patients, whereas BE COMPLETE enrolled TNF inhibitor-inadequate responders. Both populations showed similar response rates despite the typical expectation of blunted effects in biologic-experienced patients.
Panelists discuss how bimekizumab’s dual IL-17A and IL-17F inhibition mechanism distinguishes it from other biologics and may provide effective treatment options for patients who have lost response to TNF inhibitors or IL-17A-only inhibitors.
RxBenefits has released Illuminate Rx, a new PBM aiming to fill gaps in the current PBM market, according to Robert Gamble, CEO of RxBenefits.
An expert discusses how health plans currently don’t utilize real-world evidence for decision-making due to lack of common standards and limited data at drug launch, but explains that AMCP is developing an RWE framework with different protocols for various drug life cycle phases.
An expert discusses how health plans evaluate high-cost NMIBC therapies by examining total cost of care, weighing risk versus reward for treatments like gene therapy that can cost over a million dollars, and using frameworks from NCCN guidelines and ICER to perform comparative effectiveness analyses.
Panelists discuss how patients with psoriatic arthritis primarily present with pain in joints and enthesial sites, along with debilitating morning stiffness and fatigue that severely impacts their ability to perform daily activities and work functions.
Panelists discuss how patient-reported outcomes (PROs) are critical in psoriatic arthritis clinical trials because the disease affects multiple domains, including skin, joints, entheses and spine, creating a complex symptom burden that significantly impacts patients’ pain, fatigue and quality of life.
Scripius formulary executive Cody Olsen, Pharm.D., discusses some of the key ingredients to a successful switch to biosimilars.
An expert discusses how the future of vitiligo treatment includes multiple oral JAK inhibitors in phase 3 trials for extensive disease, procedural therapies such as melanocyte grafting for resistant patches, and an overall promising outlook with increased disease awareness, broader therapeutic options, and improved patient outcomes expected over the next 5 years.
An expert discusses how health plans must defend all formulary decisions with clinical evidence and use NCCN/AUA guidelines to create treatment pathways rather than traditional tier placements, with BCG-unresponsive cases following a step-therapy approach from gemcitabine/docetaxel to nadofaragene based on cost and toxicity profiles.
