Wainua™
Drug - Wainua™ (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?
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