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Esperoct (antihemophilic factor [recombinant], glycopegylated-exei)United Healthcare

hemophilia A

Preferred products

  • Advate
  • Kogenate FS
  • Kovaltry
  • NovoEight
  • Nuwiq
  • Recombinate

Initial criteria

  • Diagnosis of hemophilia A
  • AND one of the following:
  • (a) Submission of documentation showing failure to meet clinical goals (e.g., continuation of spontaneous bleeds, inability to achieve appropriate trough level) after a trial of three of the following recombinant factor products: Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, Recombinate
  • OR (b) Submission of documentation showing history of hypersensitivity to three of the following recombinant factor products: Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, Recombinate
  • OR (c) Prescriber attestation that patient would preferentially benefit from Esperoct based on one of the following: 1. Patient is at high risk for the development of inhibitors (e.g., family history of inhibitors and success with product, current treatment less than 50 days, high risk genetic mutation, history of initial intensive therapy greater than 5 days); 2. Patient has developed inhibitors; 3. Patient has undergone immune tolerance induction/immune tolerance therapy
  • AND one of the following dosing conditions:
  • (a) Patient is not to receive routine infusions more frequently than 2 times per week
  • OR (b) Both of the following: 1. Patient is less than 12 years of age AND 2. Pharmacokinetic (PK) testing results suggest that more frequent than 2 times per week dosing is required

Reauthorization criteria

  • Documentation of positive clinical response to Esperoct therapy
  • AND one of the following:
  • (1) Patient is not to receive routine infusions more frequently than 2 times per week
  • OR (2) Both of the following: (a) Patient is less than 12 years of age AND (b) PK testing results suggest that more frequent than 2 times per week dosing is required

Approval duration

12 months