Pharmacy Prior Authorization Criteria

Sohonos (palovarotene)

Indications for Prior Authorization

Sohonos (palovarotene)

• For diagnosis of Fibrodysplasia Ossificans Progressiva (FOP)
  Indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).

Criteria

Sohonos

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)

• Diagnosis of Fibrodysplasia Ossificans Progressiva (FOP)
AND
• Disease is confirmed by the presence of ACVR1 gene mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Both of the following:
• Patient is female
• Patient is 8 years of age or older
OR
• Both of the following:
• Patient is male
• Patient is 10 years of age or older
AND
• Prescribed by or in consultation with one of the following: [8]
• Geneticist
• Orthopedic physician
• Rheumatologist
• Endocrinologist

Sohonos

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reduction of volume in new abnormal bone growth)

P & T Revisions

2025-12-09, 2024-10-11, 2023-10-31

References

1. Sohonos Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. March 2025.
2. ClinicalTrials.gov. An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. (MOVE). Available at: https://www.clinicaltrials.gov/study/NCT03312634?term=nct03312634&rank=1.
3. UptoDate. Fibrodysplasia ossificans progressiva. Available at: https://www.uptodate.com/contents/fibrodysplasia-ossificans-progressiva?search=sohonos&source=search_result&selectedTitle=1~1&usage_type=default&display_rank=1. Accessed September 30, 2023.
4. Kaplan, F., Mukaddam, M. et al. The Medical Management of Fibrodysplasia Ossificans Progressiva: Current Treatment Considerations. July 2024. Available at: https://assets.nationbuilder.com/ifopa/pages/1042/attachments/original/1721244354/FOP-GUIDELINES-FINAL-2024.pdf?1721244354. Accessed December 5, 2025.
5. Kitok, H. Clinical Aspects and Current Therapeutic Approaches for FOP. September 2020. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7555688/. Accessed September 30, 2023.
6. Fibrodysplasia Ossificans Progressiva. Available at: https://rarediseases.org/rare-diseases/fibrodysplasia-ossificans-progressiva/. August 2023. Accessed September 30, 2023.
7. Shaikh, U., Khan, A., et al. Novel Therapeutic Targets for Fibrodysplasia Ossificans Progressiva: Emerging Strategies and Future Directions. July 2023. Available at: https://www.cureus.com/articles/172507-novel-therapeutic-targets-for-fibrodysplasia-ossificans-progressiva-emerging-strategies-and-future-directions#!/. Accessed September 30, 2023.
8. Clinical Consult. October 27, 2023.

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Revision History

• 2025-12-09: 2025 UM Annual Review. Background changes. Updated verbiage for ACVR1 gene mutation to standard "Disease is confirmed by the presence of ACVR1 gene mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) "
• 2024-10-11: 2024 UM Annual Review. No changes
• 2023-10-31: New UM PA Criteria

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