Tegsedi (inotersen) — CareFirst (Caremark)

Initial criteria

• Diagnosis is confirmed by detection of a mutation in the TTR gene
• Member exhibits clinical manifestations of ATTR-FAP (e.g., amyloid deposition in biopsy specimens, TTR protein variants in serum, progressive peripheral sensory-motor polyneuropathy)
• Requested medication will not be used in combination with any other medication approved for the treatment of hereditary transthyretin-mediated amyloidosis (e.g., Amvuttra, Onpattro, Vyndamax, Vyndaqel, Wainua)
• Medication must be prescribed by or in consultation with a neurologist, geneticist, or physician specializing in the treatment of amyloidosis

Reauthorization criteria

• Member must have met all initial authorization criteria
• Member must have demonstrated a beneficial response to treatment with the requested medication compared to baseline (e.g., improvement of neuropathy severity and rate of disease progression as demonstrated by mNIS+7 composite score, Norfolk Quality of Life-Diabetic Neuropathy total score, PND score, FAP disease stage, manual grip strength)

Approval duration

12 months