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A Q&A With Maria Lopes, MD, MS
AJMC®: What is your experience with determining coverage criteria for patients with atopic dermatitis?
LOPES: As a physician with extensive experience in managed care, I’ve been deeply involved in determining coverage criteria for patients with atopic dermatitis. Serving on P and T (pharmacy and therapeutics) committees, my role is to assess the value of new treatments and their appropriateness for patients. This involves evaluating clinical data, comparing efficacy and safety, and considering factors such as the severity of the condition and unmet patient needs. Budget impact, particularly with biologics, is also a crucial consideration in formulary decisions. Ultimately, we craft authorization criteria that balance clinical effectiveness with fiscal responsibility, ensuring we can justify our decisions to employers and relevant stakeholders.
AJMC: Please describe some of the direct and indirect costs of atopic dermatitis.
LOPES: When it comes to managing atopic dermatitis, the direct costs mainly revolve around the expenses associated with treatments. Moisturizers are usually inexpensive. Moving on to topical corticosteroids and calcineurin inhibitors, however, there are some costs involved, although these agents are often generic and relatively low-priced. However, biologics are frequently used for more severe cases, and they represent a significant expense; thus, we typically manage their usage closely due to their high cost. On the other hand, indirect costs tend to be overlooked. These include lost work time for parents or caregivers due to a child’s itching and scratching as well as lost sleep and out-of-pocket expenses for prescriptions, which can range from moderate to high, particularly for certain agents like crisaborole. Despite these indirect costs being substantial, direct costs tend to be the primary focus. Biologics account for a significant portion despite the relatively low incidence of hospitalizations or antibiotic use related to biologic therapy.
AJMC: Why is it important for payers to keep apprised of updates in treatment guidelines?
LOPES: As a payer, it’s crucial for me to stay informed about updates in treatment guidelines. These guidelines define the standard of care and ensure evidence-based practices. Clear guidelines help in determining appropriate treatments, which, in turn, aids in decision-making regarding coverage and appeals. Updated guidelines grounded in evidence-based care assist in the understanding of the most effective and safe treatments for different populations, thus impacting budgeting and reducing the cost of potential treatment failures. Keeping abreast of these updates ensures that we prioritize the right treatment in the right manner and at the right time and ultimately optimize patient care and resource allocation.
AJMC: How will you incorporate the key recommendations from the 2024 American Association of Dermatology (AAD) guidelines for patients who do not respond to topical therapies for atopic dermatitis?
LOPES: Often, we conduct annual therapeutic class reviews, but if there are updated guidelines referenced in appeals, they prompt us to revisit our criteria and utilization management tools. Discrepancies between our approach and that of the recommended guidelines highlight opportunities for adjustment in our policies. We aim to align our criteria with those of the guidelines while still maintaining effective utilization management controls. Awareness of new guidelines allows us to adapt our processes accordingly and ensure that patients receive appropriate treatments.
AJMC: How are prior authorizations (PAs) and step therapy edits used to help manage the newer medications for atopic dermatitis?
LOPES: The PA typically applies to higher-cost medications with an emphasis on starting with safe and effective lower-cost alternatives first, aligning with evidence-based guidelines. If there’s a need for deviation due to contraindications or intolerance, we facilitate peer-to-peer discussions or appeals. The aim is to minimize overturns while ensuring appropriate utilization. Step therapy protocols guide the progression from lower-cost options like topical corticosteroids and calcineurin inhibitors to higher-cost agents like biologics with considerations for intermediate options such as crisaborole. These steps ensure that cost-effective treatments are explored before resorting to more expensive options, thus balancing efficacy, safety, and cost-effectiveness in managing atopic dermatitis.
AJMC: What other payer considerations go into coverage criteria for branded medications like dupilumab, tralokinumab, and JAK inhibitors?
LOPES: Several factors influence coverage criteria for branded medications like dupilumab, tralokinumab, and JAK inhibitors. First, we consider comparative efficacy, often relying on indirect comparisons across trials to assess clinical significance. Safety is paramount, especially when using products associated with risk evaluation and mitigation strategies. Despite lower prices, safety concerns may influence step therapy decisions. Typically, PAs align across high-cost products, progressing through corticosteroid and calcineurin inhibitor steps before potentially leaving options open, especially for preferred products like JAK inhibitors or TNF inhibitors. Contracting also plays a role, with market share and product indications impacting decisions. Use of multiple biologics is typically restricted for safety and cost considerations. PAs for preferred products require meeting with step criteria; such products include topical corticosteroids, calcineurin inhibitors, and, possibly, crisaborole. Beyond these steps, prescribers may have more flexibility in choosing subsequent treatments provided that safety and efficacy standards are met and contractual obligations are considered.
AJMC: How can barriers to access of medications for atopic dermatitis be overcome?
LOPES: Overcoming barriers to accessing medications for atopic dermatitis involves understanding and addressing several key factors. First, navigating PA and step therapy requirements can be challenging. Patients may face different cost-sharing structures from nominal co-pays for common treatments to substantial co-insurance for high-cost medications, potentially hindering access. Education and updates to treatment guidelines can help refine step therapy protocols and reduce barriers. Additionally, consideration of the cost of treatment failure is crucial; inadequate management may lead to costly consequences like hospitalizations or emergency department visits. While bypassing steps may be challenging, safety concerns or medical justifications can prompt peer-to-peer discussions or appeals. Payers prioritize evidence-based approaches and lower total costs of care, and they respond to appeals when evidence suggests a deviation from established guidelines. Effective communication, education, and data-driven decision-making are essential in overcoming access barriers for atopic dermatitis medications.
AJMC: How do you incorporate safety and efficacy of JAK inhibitors as you develop coverage criteria?
LOPES: JAK inhibitors are significant in our treatment options; they span autoimmune, inflammatory bowel disease, and atopic dermatitis realms. Safety concerns exist but are being addressed. As a payer, I may have preferred JAK inhibitors, although they’re costly, due to contractual agreements. We typically implement PA to ensure appropriate usage in moderate to severe cases, and we step through lower-cost alternatives. However, if costs are comparable, we often leave the choice to the provider. Safety and efficacy are paramount in developing coverage criteria, as they ensure patient well-being and effective treatment.
AJMC: How do you use Institute for Clinical and Economic Review (ICER) reports as you develop coverage criteria for agents used in atopic dermatitis?
LOPES: Payers like me find ICER reports valuable as a reference point as we develop coverage criteria for agents used in atopic dermatitis. We appreciate ICER’s increasing transparency in methodology and stakeholder perspectives. However, while ICER reports can influence our decision-making, they are just 1 aspect that we consider in our overall assessment. We primarily focus on evidence-based care, total costs, and contractual negotiations. If an ICER report provides clear guidance on cost versus value, it can significantly impact our approach to PA criteria and contracting strategies. Yet if the report is less conclusive, we may rely more on our internal analysis and comparisons across treatment options. Ultimately, our decisions prioritize efficacy, safety, and net cost with contracting playing a significant role in formulary placement and utilization rather than solely relying on ICER reports.
AJMC: What are other payer considerations when determining a therapy for patients with atopic dermatitis?
LOPES: When determining therapy for patients with atopic dermatitis as a payer, I find it crucial to consider potential overlaps in indications, especially in pediatric cases. Atopic dermatitis often intersects with conditions like asthma, respiratory issues, and skin infections. Assessing whether a drug addresses multiple conditions can offer additional benefits and potential cost offsets, particularly if use of the agent reduces the need for multiple treatments. This holistic view becomes significant, especially in pediatric patients in whom comorbidities like food allergies and asthma are prevalent. Real-world data play a crucial role in evaluating these considerations to ensure comprehensive care and optimal cost management for patients with atopic dermatitis.
For other articles and videos in this AJMC® Perspectives publication, please visit "Managing Atopic Dermatitis: Clinical Considerations, Payer Perspective, and 2024 Guidelines"