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Tegsedi — Medical Mutual

Polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR)

Initial criteria

  • Patient age ≥ 18 years; AND
  • Documented transthyretin (TTR) mutation confirmed through genetic testing [documentation required]; AND
  • Presence of polyneuropathy characterized by ONE of the following: Baseline polyneuropathy disability (PND) score < IIIb OR Baseline FAP Stage 1 or 2; AND
  • Will not receive Tegsedi in combination with ANY of the following: Anti-transthyretin small interfering ribonucleic acid agents (e.g., Onpattro, Amvuttra) OR Tetramer stabilizers (e.g., tafamidis, diflunisal); AND
  • Tried or currently receiving at least one systemic agent for symptoms of polyneuropathy from ONE of the following pharmacologic classes: gabapentin-type product (e.g., gabapentin, pregabalin), duloxetine, or a tricyclic antidepressant (e.g., amitriptyline, nortriptyline); AND
  • Platelet count > 100 x 10^9/L; AND
  • No history of acute glomerulonephritis caused by Tegsedi; AND
  • Prescribed by or in consultation with a neurologist, geneticist, or physician who specializes in the treatment of amyloidosis; AND
  • Both patient and physician enrolled in and follow the Tegsedi REMS program; AND
  • Site of care medical necessity is met

Reauthorization criteria

  • Patient has previously received treatment with Tegsedi; AND
  • Documented transthyretin (TTR) mutation confirmed through genetic testing; AND
  • Experienced a positive clinical response to Tegsedi (e.g., improved neurologic impairment, motor function, cardiac function, quality of life, serum TTR levels, etc.); AND
  • Improvement from baseline or stabilization of ONE of the following: Baseline polyneuropathy disability (PND) score < IIIb OR Baseline FAP Stage 1 or 2; AND
  • Will not receive Tegsedi in combination with ANY of the following: Anti-transthyretin small interfering ribonucleic acid agents (e.g., Onpattro) OR Tetramer stabilizers (e.g., tafamidis, diflunisal); AND
  • Platelet count > 100 x 10^9/L; AND
  • No history of acute glomerulonephritis caused by Tegsedi; AND
  • Prescribed by or in consultation with a neurologist, geneticist, or physician who specializes in the treatment of amyloidosis; AND
  • Both patient and physician enrolled in and follow the Tegsedi REMS program; AND
  • Site of care medical necessity is met

Approval duration

initial 6 months; reauth 12 months