How to Address Key Unmet Needs for Lupus Biologics Access Strategy

How to Address Key Unmet Needs for Lupus Biologics Access Strategy 

Patients with systemic lupus erythematosus (SLE) often face significant barriers to accessing FDA-approved biologics, and these challenges vary across insurance types, payer practices, and healthcare settings. A well-defined access strategy is crucial for minimizing these barriers and improving patient outcomes. Below are some of the most pressing unmet needs identified through comprehensive data collected from over 18,000 healthcare providers via SamaCare's prior authorization platform.

1. Analyze Denial Rate Data for Lupus Biologics

Review recent prior authorization data to identify high denial rates. Focus on new patient starts, where denial rates are typically highest.

Data from SamaCare’s network shows that prior authorization denials for Lupus biologics are a major access hurdle. Specifically:

• Average Denial Rates: 13% of all prior authorization requests for Lupus biologics are denied across both commercial insurance and Medicare Advantage plans.
  
  
• New Patients vs. Continuation of Care: Denials are higher for new patients initiating treatment compared to those continuing treatment. New patients face a denial rate of 17.7%, while continuation of care sees a lower rate of 10.6%.
  
  

These denial rates highlight a critical area of unmet need—ensuring that patients starting new treatments have equal access to biologics as those already on therapy.

2. Build Documentation on Payer Requirements

Build a consistent documentation process that meets the most stringent payer requirements. Include diagnosis, treatment history, and formulary status.

Prior authorization outcomes are heavily influenced by payer-specific policies, including:

• Documentation and Step Therapy Requirements: Different payers have varying documentation requirements and step therapy protocols, leading to inconsistent approval rates across the same biologic. The denial rate among top 10 commercial payers varies from as low as 2% to as high as 20%, underscoring the need for standardized practices across payers.
  
  
• Formulary Preferences: Payer preferences for specific biologics, such as Benlysta vs. Saphnelo, can also lead to denials, contributing to fragmented access to optimal care.
  
  

3. Create Educational Materials to Mitigate Delays in Approval Impacting Patient Outcomes

Sometimes, delays in approval are caused by friction in the process that HCPs do not have the resources to troubleshoot on their own. The first step toward removing unnecessary friction is identifying how long the prior authorization process take on average -- and then isolating circumstances where the process is taking longer that it should.

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Based on SamaCare's data, on average, it takes:

• 5 Days for Commercial Plans: Patients with commercial insurance experience an average wait time of 5 days for prior authorization approval.
  
  
• Faster Approvals for Off-Label and Biosimilar Treatments: Surprisingly, off-label biologics like Rituxan experience quicker approval times (average of 4 days), while biosimilars see even faster turnaround times (1.5 days).
  
  

Delays in approval are linked to worsened patient outcomes, including increased morbidity and mortality. These delays can contribute to severe health complications, such as organ damage, highlighting the critical need for faster authorization processes.

4. Analyze Medicare and Medicaid Challenges

Treat Medicare and Medicaid patient access strategy as a separate but related part of your overall market access plan. Medicare and Medicaid plans can vary significantly from commercial plans when it comes to treatment of medical benefit drugs.

While Medicare Advantage patients generally experience fewer denials (9.5%) and faster approvals (2.6 days), Medicaid patients face significant barriers:

• Higher Denial Rates for Medicaid: Medicaid patients face an 18.9% denial rate, making access to biologics a particularly significant challenge for this population.
  
  

The disparity in access between different insurance programs emphasizes the need for tailored strategies to ensure equitable access for all patients.

5. Identify Root Causes of Denials

In order to ultimately prevent erroneous denials, identify the root cause of denials by analyzing a prior authorization data set. Based on SamaCare's prior authorization data set, the following issues contribute to preventable denials and provide opportunities for intervention:

• Confusion Between Pharmacy vs. Medical Benefits: Clearer guidance is needed to prevent denials stemming from incorrect benefit coding.
  
  
• Incomplete Documentation: Denials often result from missing documentation, which can be avoided with better education for healthcare providers.
  
  
• Site of Care Preferences: Some plans have specific site-of-care preferences, such as outpatient hospital infusion centers, which can lead to denials if not properly adhered to.
  
  

Additional Recommendations for Improving Access

To address these unmet needs, healthcare providers (HCPs) must:

• Understand the Pain Points: Identifying specific friction points in the prior authorization process is essential to minimizing barriers to biologic access. According to Nancy Ellis, practice administrator at Piedmont Arthritis Clinic, “We identified that a single payer responsible for less than 1% of our business was responsible for 90% of our buy-and-bill denials.”
  
  
• Leverage Data-Driven Insights: Data platforms like SamaCare can help HCPs and payers track prior authorization metrics (e.g., approval times, denial rates) and identify opportunities for improvement.
  

Conclusion

A comprehensive access strategy for Lupus biologics must address both the high denial rates and the delays in approval that negatively impact patient outcomes. Through a better understanding of payer practices, clearer documentation processes, and faster approval times, healthcare providers can ensure that Lupus patients receive timely and effective treatments. Additionally, leveraging data from platforms like SamaCare, which track denial rates, approval times, and patient access metrics, is critical for identifying areas where access barriers can be reduced.