Sohonos ( palovarotene)

SOHONOS (palovarotene)

Self-Administration – oral capsules

Diagnosis considered for coverage:

• 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)

Coverage Criteria:

For diagnosis of Fibrodysplasia Ossificans Progressiva (FOP):

• Diagnosis of Fibrodysplasia Ossificans Progressiva (FOP) AND

• Prescribed in consultation with one of the following: Geneticist, Orthopedic physician, Rheumatologist, Endocrinologist AND
• Molecular genetic testing confirms mutation in the ACVR1 gene AND
• One of the following:
  • Patient is female and 8 years of age or older OR
  • Patient is male and 10 years of age or older

Reauthorization Criteria:

For diagnosis of Fibrodysplasia Ossificans Progressiva (FOP):

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

Coverage Duration: 

• Initial: 3 months
• Reauthorization: 12 months

Dosing: 

For diagnosis of Fibrodysplasia Ossificans Progressiva (FOP):

• Daily dose: 
  • Recommended dosage for adults and pediatric patients 14 years and older is 5mg once daily, stop daily dosing when flare-up dosing begins
• Flare up dose: 
  • Recommended flare up dosage for adults and pediatric patients 14 years and older is 20mg daily for 4 weeks, followed by 10mg daily for 8 weeks (total 12 weeks), even if symptoms resolve earlier, then return to daily dose of 5 mg
  • If during the course of flare-up treatment, the patient experiences marked worsening of the original flare-up site or another flare-up at a new location, restart the 12-week flare-up dosing at 20 mg daily.
  • For flare-up symptoms that have not resolved at the end of the 12-week period, the 10 mg daily dosage may be extended in 4-week intervals and continued until the flare-up symptoms resolve. If new flare-up symptoms occur after the 5 mg daily dosing is resumed, flare-up dosing may be restarted.
  • Recommended dosage for pediatric patients aged 8-13 years for females and aged 10-13 years for males:

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Palovarotene is contraindicated in patients during pregnancy and has a boxed warning for embryo-fetal toxicity and PPC in growing pediatric patients.

Policy Updates:

• 3/1/2024 (policy effective date)- New Sohonos Criteria (P&T 2/20/2024) (P&T meeting February) 

References:

1.    Sohonos Prescribing Information. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. August 2023. 
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. August 2021. Available at: https://d3n8a8pro7vhmx.cloudfront.net/ifopa/pages/1042/attachments/original/1628698995/Guidelines_%28full_document%29.pdf?1628698995. Accessed September 30, 2023. 
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.    Ipsen Biopharmaceuticals, Inc. Sohonos (palovarotene) capsule. 2023. [Updated 2023 Aug]. In: DailyMed[Internet].[2023]- National Library of Medicine (US). Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=67dce406-7cc4-4d66-92de-ad18b6df0625