Enhancing Psoriasis Treatment Through Collaborative Decision-Making

AJMC: Please describe the process for the treatment of psoriasis currently at your health system, Emory Healthcare. What guidelines/pathways are involved?

HAUMSCHILD: Our psoriasis treatment approach operates as a collaborative effort driven by disease state working groups that combine academic specialists and community dermatology providers.¹ This approach allows us to stay current with emerging data and guidelines, such as consensus groups’ recommendations. Our internal key opinion leaders refine these guidelines to cater to our context.

Our objective is to establish clear order sets for different lines of therapy and indications. These sets ensure appropriate medication use and are integrated into our EHR (electronic health record). Our clinical pharmacist and pharmacy director contribute by compiling evidence-based recommendations and summaries, presented in a digestible format for leaders’ decision-making. This process also factors in cost-effectiveness to maintain a balanced approach, prioritizing the overall cost of care for both patients and [the] health care system.

Our team-based approach—guided by data, guidelines, and input from experts—ensures that our psoriasis treatment aligns with evidence-based practices and accounts for cost considerations.

AJMC: In the past, how have biologics for psoriasis been evaluated at Emory?

HAUMSCHILD: Traditionally, our evaluation of psoriasis biologics at Emory has centered around clinical efficacy end points. We assess factors such as PASI (Psoriasis Area Severity Index) scores and response rates.² Safety profiles are also a key consideration in our decision-making process. While clinical efficacy and safety remain paramount, our focus has evolved.

Previously, our evaluation might have leaned heavily on acquisition costs, overlooking the broader picture. Comorbidities and the overall cost of care were not as frequently reviewed. We are now broadening our assessment scope to include health care resource utilization associated with treatment. This comprehensive approach ensures that our decisions are grounded in both clinical efficacy and the holistic impact on patients and the health care system.³

AJMC: How much of a priority is it for you to effectively assure appropriate utilization of these agents?

HAUMSCHILD: Effective assurance of appropriate utilization for biologics is a high priority for us. With the expanding biologics landscape, costs are rising while competition intensifies. Ensuring proper utilization is not just crucial for payers but also for our health care provider group.

Our approach has evolved. We are delving deeper into individual patient factors, moving beyond clinical trial data.³ Real-world evidence plays a critical role in evaluating patient compliance, adherence, and potential adverse effects leading to treatment discontinuation.⁴ We recognize that a comprehensive assessment is essential for making informed decisions that benefit both patients and the health care system.

AJMC: What are some of the cost-effectiveness drivers you have been focusing on for biologics in this area?

HAUMSCHILD: Our focus on cost-effectiveness drivers for biologics has highlighted the significance of therapy switching. While initiating patients on biosimilars or anti-TNF agents might seem prudent, the potential for frequent therapy changes has raised concerns. This approach can lead to loading doses, subsequent switching, and suboptimal outcomes.⁵

Patient progression and compromised clinical efficacy are potential consequences. Additionally, substantial costs are incurred without achieving the anticipated therapeutic benefits observed in clinical trials. Recognizing these challenges, we are evolving our approach. We stratify patients based on factors such as metabolic syndrome, which influences proinflammatory elements. This differentiation acknowledges that responses to anti-TNF agents can vary, shaping our treatment strategies to align with individual patient profiles.⁶

AJMC: How do patient-reported outcomes and improvements in quality-of-life factor into treatment selection or creation of pathways?

HAUMSCHILD: Patient-reported outcomes and improvements in quality of life are undeniably influential in our treatment selection and pathway creation. We are looking at absenteeism from work (especially for our health system’s employees), and activities of daily living also factor in, recognizing that psoriasis can severely impact normal functioning and social engagement. The impact of treatment on these outcomes, alongside clinical efficacy, guides our decisions.

Moreover, mental well-being is a crucial facet. Uncontrolled psoriasis can exacerbate anxiety, depression, and mental distress. Acknowledging these broader impacts, we are evolving our approach to treatment, prioritizing not only clinical results but also the tangible improvements in patients’ overall quality of life.⁷

AJMC: Please describe the recent effort/research you’ve been undertaking to optimize care for your patients with psoriasis. What was the inspiration and clinical data to support the effort?

HAUMSCHILD: Our recent efforts have focused on optimizing care for psoriasis patients, driven by a commitment to diversity, equity, and inclusion. Inspired by research presented at the European Academy of Dermatology and Venereology Congress on tildrakizumab, we explored the benefits of IL-23–inhibitor treatment in patients with metabolic syndrome. This subpopulation—with factors like high BMI (body mass index), cardiovascular disease history, and diabetes—often struggles with disease control using traditional approaches.

The hypothesis stemmed from the potential of IL-23 inhibitors to offer more durable responses and better disease control for these patients. The aim was to reduce the need for frequent therapy cycling. The data presented showed promising outcomes, prompting us to consider leveraging this approach to enhance patient care.^8-10

By utilizing IL-23 inhibitors for patients with metabolic syndrome, we strive to achieve several objectives: lower cost of care, improved adherence, and, ultimately, better treatment outcomes. This research-driven strategy aligns with our commitment to delivering effective and tailored care for all patients.

AJMC: How is the information being collected and analyzed? Who is working on this?

HAUMSCHILD: We initiated a collaborative effort involving our clinical pharmacist, myself as the director of pharmacy, and our disease state working group to establish a quality improvement project. This initiative aims to determine the efficacy of an IL-23 inhibitor as a front-line treatment for patients with metabolic syndrome in comparison with the conventional approach of starting with an anti-TNF agent.

Our focus is on data collection and analysis to assess patient response. We’ll evaluate factors such as the number of treatment cycles, duration of first-line therapy, medication adherence, and disease control. By identifying patients through ICD-10 codes or medication-based criteria, we aim to gain insights into the effectiveness of this tailored approach.

This analysis holds the potential to provide valuable insights that can guide treatment decisions beyond Emory. Our goal is to share our findings widely and contribute to the broader understanding of optimized psoriasis care.

AJMC: As this is a work in progress, what are some preliminary findings? What are some of your expectations to come out of this project?

HAUMSCHILD: Initial data suggested that IL-23 could offer prolonged responses and better disease control in this subset of patients with metabolic syndrome. We are investigating this further by analyzing about a year’s worth of quality improvement data. This retrospective review focuses on patients with metabolic syndrome on IL-23 versus those on other treatments. Our aim is to gather substantial evidence to support our hypothesis, with a focus on outcomes such as therapy switches, disease control, and treatment duration. While retrospective assessment of controlled disease is somewhat challenging, we are utilizing markers like proportion of days covered, therapy switches, and treatment duration to gauge patient response and effectiveness. This ongoing endeavor is guided by our goal to optimize care for all patients, especially those with unique challenges, offering them more sustainable outcomes and improved adherence to treatments.

AJMC: Once complete, how would you expect to use these findings to update or adapt how treatment is provided for patients for psoriasis?

HAUMSCHILD: Absolutely, the goal is to integrate these findings seamlessly into our EHRs to optimize treatment decision-making. By utilizing existing patient data and specific criteria, such as metabolic syndrome diagnosis or related indicators, we aim to automate treatment recommendations. For instance, if a patient meets the criteria for metabolic syndrome, the EHR would prompt an IL-23–based therapy in the order set.

This approach is akin to leveraging EHRs for social determinants of health or tailoring cancer therapies based on patient factors like neuropathy. The idea is to provide decision-making support to health care providers, ensuring they receive guidance aligned with individual patient needs. Additionally, on the prior authorization side, if a patient’s condition meets the criteria, approval for IL-23 therapy could be expedited.

Our focus is on creating a patient-centered approach that’s customized and efficient, removing barriers to optimal care. Ultimately, this integration of clinical criteria into the EHR could revolutionize treatment delivery, enhancing patient outcomes while streamlining the decision-making process for health care providers.

AJMC: Who else at Emory would be involved in evolving your standards and practices?

HAUMSCHILD: We are effectively evolving our standards and practices at Emory by engaging key stakeholders to ensure comprehensive buy-in. Internally, the physician group leaders play a pivotal role in endorsing and implementing these therapeutic updates. Their support is essential for widespread adoption. Socializing the initiative among clinical pharmacy specialists who interact with patients directly and among the disease state working group ensures alignment with our clinical strategies.

Sharing this initiative with payers is valuable. When we unveil the data and its potential advantages, it’s a strategic move toward a triple-win situation. Patients receive optimal treatment, providers achieve excellent outcomes and medication access, while payers realize cost savings. This collective buy-in establishes the initiative as a sustainable standard of care from the outset, benefitting all stakeholders involved.

AJMC: In this clinical space and others, please share some of your insights on developing real-world data/real-world evidence and implementing change in a health system environment.

HAUMSCHILD: Real-world evidence effectively bridges the gap between clinical practice and patient outcomes. While clinical trials are essential, and they set a high standard, they might not always analyze specific aspects like metabolic syndrome in a timely manner. Real-world evidence allows us to tap into patient data for informed decisions without the prolonged timeframes of trials. As we advance in various therapeutic domains, we’re embracing real-world evidence to facilitate quicker and more insightful decision-making, especially in cases in which conducting dedicated clinical trials for certain end points might be impractical due to cost constraints.

AJMC: What are some ways that health systems can help generate real-world evidence to better improve patient care?

HAUMSCHILD: Health systems possess a wealth of data, making them valuable sources for generating real-world evidence to enhance patient care. We can leverage innovative data collection methods, partnering with entities like the American Academy of Dermatology or other foundations to conduct thorough studies. This might involve using data accumulators or collaborating with societies to analyze our own data. Quality improvement projects can also be initiated internally to align with population health goals. By assessing patient outcomes, medication utilization, and procedural trends by therapy type, we can identify areas for improvement and highlight treatment patterns. This collaborative approach enables us to harness real-world evidence effectively and enhance patient care strategies.

AJMC: What are the cost-effectiveness considerations and budget impact of different biologic agents used in managing plaque psoriasis?

HAUMSCHILD: When assessing different biologic agents for plaque psoriasis management within health systems, cost-effectiveness considerations encompass various factors. This includes not only the drug acquisition cost but also the broader total cost of care. This involves evaluating patient outcomes, such as clinic visits, readmissions, and imaging procedures. Additionally, patient-reported outcomes, absenteeism, and daily functioning play a crucial role. To be effective stewards of health care expenses, it’s essential to weigh all these aspects.

Furthermore, the potential impact of treatment-related toxicities should be taken into account. Patients experiencing these toxicities might require more expensive therapies with increased adverse effects, adding to both acquisition costs and total cost of care. The goal is to maintain patients on the most suitable therapy for a longer duration and to achieve better disease control, manageable adverse effects, and predictable treatment outcomes. This approach enhances treatment adherence and supports patients in experiencing durable, long-lasting responses similar to those observed in clinical trials.

AJMC: How do treatment sequencing and switching strategies influence the selection of first-line options and optimize outcomes for nonresponders or inadequate responders?

HAUMSCHILD: Initially, our approach hinges on evidence and cost-effectiveness, favoring the most well-established and economical options. However, as we encounter patients who exhibit inadequate responses, a shift occurs. We aim to streamline treatment sequencing, particularly for nonresponders. Instead of initiating therapies that historically lead to inadequate outcomes, we seek to circumvent this cycle.

Starting with a nonresponsive treatment may result in costly loading doses and intensified adverse effects. Consequently, the patient’s condition worsens, prompting a shift to subsequent therapies. To break this cycle, we consider patient-specific factors. For instance, if proinflammatory factors are at play or if sustained responses are unlikely, we pivot toward therapies that require only 1 loading dose. This strategic approach aims to minimize the need for multiple dose ramp-ups and subsequent therapies.

Our goal is to disrupt the traditional sequencing method by targeting patients with unique attributes that may render them more responsive to initially higher-cost treatments. In the long run, this approach can lead to reduced overall costs along the treatment continuum.

AJMC: What considerations should payers and health systems have in terms of formulary management, coverage policies, and utilization management strategies?

HAUMSCHILD: Payers should effectively manage their formularies to control health care costs, which is a crucial endeavor. However, it’s important to avoid fixating solely on drug acquisition costs and overlook the broader patient perspective. To strike a balance, formulating medical policies and utilization management strategies is key. These strategies should incorporate flexibility for unique patient populations.

For instance, patients with conditions like metabolic syndrome might require earlier access to therapies for optimal disease resolution. Rather than a one-size-fits-all approach, tailored criteria can allow for exceptions that align with evolving data. This patient-centric approach empowers providers to make informed decisions while potentially reducing therapy cycling frequency, which holds cost implications.

By adopting such adaptable policies, payers can better accommodate changing patient needs and potentially optimize outcomes, all while ensuring cost-effectiveness.

AJMC: What are the key considerations for clinicians and plan sponsors when determining the most effective biologic agent for patients with plaque psoriasis, and how can collaborative decision-making enhance patient outcomes?

HAUMSCHILD: Collaborative decision-making between clinicians and plan sponsors is pivotal for optimizing patient outcomes. Both sides must recognize the impact of health care expenditures and utilization management criteria on treatment access. This partnership helps identify trends, especially in diverse patient populations, ensuring inclusive medical policies. Providers can contribute evidence to demonstrate value and help influence payer criteria updates. This relationship prioritizes patient benefits as new therapies emerge and comorbidities grow, ultimately achieving optimal outcomes regardless of management criteria.

References

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