Pharmacy Prior Authorization Criteria

Pasatru (garetosmab-grts) - PA, NF

Indications for Prior Authorization

Pasatru (garetosmab-grts)

• For diagnosis of Fibrodysplasia Ossificans Progressiva (FOP)
  Indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).

Criteria

Pasatru

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Fibrodysplasia Ossificans Progressiva (FOP)
AND
• Disease is confirmed by clinical signs and symptoms of FOP (e.g., malformation of the great toes, episodic soft tissue swelling, progressive heterotopic ossification [HO])
AND
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming the presence of ACVR1 gene mutation
AND
• Provider attests mutation was detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Used to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups
AND
• Patient is 18 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Geneticist
• Orthopedic physician
• Rheumatologist
• Endocrinologist
AND
• Requested drug will not be used in combination with Sohonos

Pasatru

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reductions in the number of new heterotopic ossification [HO] lesions)
AND
• Requested drug will not be used in combination with Sohonos

Pasatru

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Fibrodysplasia Ossificans Progressiva (FOP)
AND
• Submission of medical records (e.g., chart notes) confirming disease by clinical signs and symptoms of FOP (malformation of the great toes, episodic soft tissue swelling, progressive heterotopic ossification [HO])
AND
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming the presence of ACVR1 gene mutation
AND
• Provider attests mutation was detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Used to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups
AND
• Patient is 18 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Geneticist
• Orthopedic physician
• Rheumatologist
• Endocrinologist
AND
• Requested drug will not be used in combination with Sohonos

P & T Revisions

2026-10-12

References

1. Pasatru Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. August 2026.
2. 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 29, 2026.
3. ClinicalTrials.gov. Phase 3 randomized, placebo-controlled study to assess safety, tolerability, and efficacy of garetosmab in patients with fibrodysplasia ossificans progressiva. ClinicalTrials.gov identifier: NCT05394116. Updated July 17, 2026. Accessed September 29, 2026. https://clinicaltrials.gov/study/NCT05394116.

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Revision History

• 2026-10-12: New Program

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