Optimizing Soliris Prior Authorization for Orthopedics

The Intersection of Soliris and Orthopedic Care

Soliris (eculizumab) is a targeted complement inhibitor indicated for specific rare conditions such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). While not a primary orthopedic treatment, patients receiving Soliris for these systemic conditions may require orthopedic intervention due to disease complications or unrelated musculoskeletal issues. Managing Soliris prior authorization for orthopedics thus involves navigating the complexities of rare disease therapy within a surgical specialty.

Clinical Scenarios and PA Considerations

• **Systemic Complications:** Patients with PNH or aHUS may develop avascular necrosis or other musculoskeletal issues requiring orthopedic evaluation and potential surgical intervention.
• **Co-management of Care:** Orthopedic surgeons may need to coordinate care with hematologists or neurologists managing Soliris therapy, ensuring continuity and understanding of the patient's overall medical status for surgical planning.
• **Documentation of Medical Necessity:** Prior authorization for any orthopedic procedure in a patient on Soliris will require meticulous documentation linking the orthopedic need to the patient's overall health status, including their rare disease and its treatment.
• **Payer Policy Review:** Payers will scrutinize both the Soliris PA (often managed by the prescribing specialist) and any associated orthopedic procedure PA, requiring clear justification for both components of care.

Documentation Requirements for Soliris-Treated Orthopedic Patients

For patients undergoing orthopedic care while on Soliris, comprehensive documentation is paramount. Beyond standard orthopedic requirements (as outlined by AAOS Clinical Practice Guidelines and ACR Appropriateness Criteria), the PA submission must clearly articulate the systemic diagnosis, the rationale for Soliris therapy, and how the orthopedic intervention aligns with the patient's overall treatment plan and medical necessity. This often involves integrating records from multiple specialties to provide a holistic patient profile for payer review.

Prior Authorization Challenges for Rare Disease Therapies in Orthopedics

• **Inter-Specialty Coordination:** Ensuring all relevant clinical notes and PA requests from hematology, neurology, and orthopedics are aligned and submitted efficiently.
• **High-Cost Therapy Scrutiny:** Soliris's significant cost leads to rigorous payer review, demanding exhaustive clinical justification for continued use, even when the orthopedic PA is for a separate procedure.
• **Multi-Layered Medical Necessity:** Demonstrating medical necessity for an orthopedic procedure while also justifying ongoing rare disease therapy, especially if the orthopedic issue is a complication of the systemic condition.
• **Payer-Specific Policies:** Navigating diverse and often stringent payer policies for both rare disease drugs and complex orthopedic procedures, which may not explicitly address their intersection.

Klivira's Solution for Complex Orthopedic Prior Authorizations

Klivira's prior authorization automation platform is designed to manage the intricacies of orthopedic PA, including the unique demands presented by patients on high-cost systemic therapies like Soliris. Our platform integrates with EMRs to pull comprehensive patient data, orchestrate multi-step PA cascades, and streamline submissions across various payer portals and specialty benefit management vendors, reducing administrative burden and accelerating approval times.

Enhancing PA Workflows for Orthopedic Practices

• **Comprehensive Data Aggregation:** Automating the collection of clinical documentation, including systemic diagnoses, treatment histories, and orthopedic-specific requirements, from disparate EMR sources.
• **Multi-Step PA Orchestration:** Managing the sequencing of PAs for imaging, surgical procedures, and post-operative DME, while accounting for the patient's ongoing systemic therapy.
• **Payer Policy Integration:** Accessing and applying payer-specific policies, including those for rare disease drugs and complex orthopedic procedures, to ensure complete and accurate submissions.
• **Peer-to-Peer Support:** Facilitating the scheduling and documentation required for peer-to-peer reviews, common for both high-cost drugs and complex orthopedic denials.
• **Reduced Administrative Burden:** Freeing PA coordinators to focus on clinical review and patient care rather than manual data entry and portal navigation.