CommercialPrior AuthMedium impact
Galsulfase (Naglazyme®)
BCBS Tennessee·TN · Genetics, Pediatrics, Internal Medicine·Medical Policy
Effective date
Sep 30, 2026
We identified it
Jul 17, 2026
Summary
BlueCross BlueShield of Tennessee has established a new prior authorization policy for Galsulfase (Naglazyme®) effective 9/30/2026. Coverage is limited to FDA-approved indication of Mucopolysaccharidosis VI (MPS VI) when diagnosis is confirmed by enzyme assay or genetic testing and clinical symptoms are documented. Initial authorization is for 12 months; continuation requires documented clinical response (improvement, stabilization, or slowing of disease progression). All prescriptions must be from or in consultation with a metabolic disease or lysosomal storage disorder specialist.
Action Required
By 9/30/2026: Billing and Prior Authorization teams must implement the following: (1) Establish prior authorization workflow requiring submission of enzyme assay or genetic testing results confirming N-acetylgalactosamine-4-sulfatase (arylsulfatase B) deficiency for initial requests; (2) Require baseline clinical documentation including signs/symptoms (decreased growth velocity, coarse facial features, skeletal deformities, upper-airway infections, hepatosplenomegaly, hearing loss, joint stiffness, coarse hair); (3) For continuation requests, require chart documentation of clinical response using objective measures (12-minute walk test, 3-minute stair climb test, urinary GAG levels, or growth rate); (4) Verify prescriber specialty (metabolic disease or lysosomal storage disorder specialist) before authorization; (5) Grant initial and continuation authorizations for 12-month periods only; (6) Deny all non-MPS VI indications as experimental/investigational; (7) Update prior authorization system templates and denial letter language. Claims submitted without proper prior authorization for Naglazyme will be denied. Providers should be notified of these requirements immediately despite the future effective date to allow time for compliance preparation.