Takhzyro (lanadelumab-flyo) — United Healthcare

Prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older

Initial criteria

Diagnosis of hereditary angioedema (HAE) as confirmed by one of the following:
(1) C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) as documented by one of the following (per laboratory standard):
(a) C1-INH antigenic level below the lower limit of normal
(b) C1-INH functional level below the lower limit of normal
OR
(2) HAE with normal C1 inhibitor levels and one of the following:
(a) Confirmed presence of variant(s) in the gene(s) for factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, and heparan sulfate-glucosamine 3-O-sulfotransferase 6
(b) Recurring angioedema attacks refractory to high-dose antihistamines with confirmed family history of angioedema
(c) Recurring angioedema attacks refractory to high-dose antihistamines with unknown background de-novo mutation(s) (i.e., no family history) (HAE-unknown)
AND For prophylaxis against HAE attacks
AND Not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo)
AND Prescriber attests that patient has experienced attacks of a severity and/or frequency such that they would clinically benefit from prophylactic therapy with Takhzyro
AND Documentation of baseline HAE attack rate ≥ 1 attack per 4 weeks
AND Prescribed by Immunologist or Allergist

Reauthorization criteria

Documentation of positive clinical response while on Takhzyro therapy
AND Reduction in the utilization of on-demand therapies used for acute attacks (e.g., Berinert, Ruconest, Firazyr, Kalbitor) as determined by claims information while on Takhzyro therapy
AND Prescribed by Immunologist or Allergist
AND For prophylaxis against HAE attacks
AND Not used in combination with other products indicated for prophylaxis against HAE attacks (e.g., Cinryze, Haegarda, Orladeyo)
AND One of the following:
(1) Patient is less than 6 years of age (Takhzyro 150 mg every 4 weeks for 12 months)
OR
(2) Documentation of number of acute HAE attacks in previous 6 months while on Takhzyro:
(a) Patient experienced no acute HAE attacks in previous 6 months:
Adult and pediatric patients ≥12 years: 300 mg every 4 weeks for 12 months
Pediatric 6 to <12 years: 150 mg every 4 weeks for 12 months
(b) Patient experienced one or more acute HAE attacks in previous 6 months:
Adult and pediatric patients ≥12 years: 300 mg every 2 weeks for 6 months
Pediatric 6 to <12 years: 150 mg every 2 weeks for 6 months

Approval duration

Initial: 8 months (adults and ≥12y every 2 weeks; 6 to <12y every 2 weeks) or 12 months (<6y every 4 weeks); Reauth: 6–12 months based on response and age