Pharmacy Prior Authorization Criteria

Onpattro (patisiran) & Tegsedi (inotersen)

Indications for Prior Authorization

Onpattro (patisiran), Tegsedi (inotersen)

• For diagnosis of Hereditary transthyretin-mediated amyloidosis
  Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Criteria

Onpattro or Tegsedi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with polyneuropathy
AND
• Presence of a transthyretin (TTR) mutation (e.g., V30M) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [1-4]
AND
• One of the following [2, 4]:
• Patient has a baseline polyneuropathy disability (PND) score less than or equal to IIIb
• Patient has a baseline familial amyloidotic polyneuropathy (FAP) stage of 1 or 2
• Patient has a baseline neuropathy impairment score (NIS) between 5 and 130 for Onpattro or a baseline neuropathy impairment score (NIS) between 10 and 130 for Tegsedi
AND
• Presence of clinical signs and symptoms of the disease (e.g., peripheral/autonomic neuropathy) [2, 4]
AND
• Patient has not had a liver transplant
AND
• Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Vyndaqel)
AND
• Prescribed by or in consultation with a neurologist

Onpattro or Tegsedi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., improved neurologic impairment, slowing of disease progression, quality of life assessment)
AND
• One of the following [2, 4]:
• Patient continues to have a polyneuropathy disability (PND) score less than or equal to IIIb
• Patient continues to have a familial amyloidotic polyneuropathy (FAP) stage of 1 or 2
• Patient continues to have a neuropathy impairment score (NIS) between 5 and 130 for Onpattro or a neuropathy impairment score (NIS) between 10 and 130 for Tegsedi
AND
• Patient has not had a liver transplant
AND
• Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Vyndaqel)

P & T Revisions

2025-02-06, 2024-08-16, 2024-03-14, 2023-03-06, 2022-03-03, 2021-09-27, 2021-05-21, 2021-03-31, 2020-04-01

References

1. Onpattro Prescribing Information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. January 2023.
2. Adams D, Suhr OB, Dyck PJ, et al. Trial design and rationale for APOLLO, a phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy. BMC Neurol. 2017;17:181.
3. Tegsedi Prescribing Information. Akcea Therapeutics, Inc. Boston, MA. June 2022.
4. Benson MD, Waddington-Cruz M, Berk JL, et al. Inotersen treatment for patients with hereditary transthyretin amyloidosis. N Engl J Med. 2018;379(1):22-31.

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Revision History

• 2025-02-06: Updated to standard ORx language with no change to clinical intent.
• 2024-08-16: update guideline.
• 2024-03-14: 2024 Annual Review
• 2023-03-06: 2023 Annual Review.
• 2022-03-03: 2022 Annual Review
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-31: Annual review: Background updates.
• 2020-04-01: Annual review: reauthorization, cosmetic, and background updates.

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