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Taliglucerase Alfa (Elelyso®)

BCBS Tennessee·TN · Genetics, Pediatrics, Internal Medicine·Medical Policy
Effective date
Oct 31, 2026
We identified it
Aug 13, 2026
Days to comply
79 days

Summary

BlueCross BlueShield of Tennessee is implementing a new medical policy for Taliglucerase Alfa (Elelyso®) covering Gaucher disease types 1, 2, and 3 in patients 4 years and older. The policy requires prior authorization with specific diagnostic documentation (enzyme assay or genetic testing) and clinical evidence of disease, with 12-month authorizations for both initial and continuation therapy. This policy does not take effect until October 31, 2026, allowing practices time to prepare systems and provider workflows.

Action Required

Before Oct 31, 2026
Before October 31, 2026: (1) Billing and prior authorization teams must configure the practice management system to require prior authorization for all Taliglucerase Alfa (Elelyso®) claims for Gaucher disease diagnoses. (2) Create or update prior authorization request templates to require submission of: (a) Beta-glucocerebrosidase enzyme assay or genetic testing results, and (b) chart notes documenting baseline clinical signs/symptoms (bone disease, splenomegaly, hepatomegaly, or cytopenia). (3) For continuation authorizations, ensure templates require documentation of therapeutic benefit (improvement in organ volumes, hemoglobin, or platelet counts). (4) Verify that prescribing providers are specialists in metabolic disease or lysosomal storage disorders; flag non-specialist submissions for denial. (5) Update internal billing guidelines to reflect the 60 Units/kg IV every 2 weeks dosing limit. (6) Providers should note this policy applies only to BlueCross BlueShield of Tennessee members; verify patient plan before applying these requirements. Failure to obtain prior authorization per this policy will result in claim denials effective 10/31/26.