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Wainua™

DrugWainua™ (eplontersen) [AstraZeneca Pharmaceuticals LP]

January 2025

Therapeutic area - Transthyretin Agents

Initial approval criteria

  • Patient is ≥ 18 years of age; AND
  • Patient has a diagnosis of polyneuropathy of hereditary transthyretinmediated amyloidosis confirmed by testing (e.g., genetic testing, biopsy); AND
  • The patient has clinical manifestations of polyneuropathy (e.g., neuropathic pain, altered sensation, numbness, tingling, impaired balance, motor disability); AND
  • The patient will NOT be using in combination with inotersen (Tegsedi®), tafamidis (Vyndamax®), tafamidis meglumine (Vyndaqel®), patisiran (Onpattro®) or vutrisiran (Amvuttra®); AND
  • Prescriber will supplement vitamin A at the recommended daily allowance as appropriate and refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness, dry eyes) occur; AND
  • The patient has NOT received a liver transplant; AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist, neurologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient has demonstrated a clinical benefit based on improvement in clinical manifestations of polyneuropathy from baseline (e.g., neuropathic pain, altered sensation, numbness, tingling, impaired balance, motor disability); AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., severe ocular symptoms related to vitamin A deficiency).

Quantity limits

  • 104 tablets per 34 days* 1 pen per 30 days (max dose of 45 mg once monthly)

Questions?

Provider Call Center (844) 575-7887

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