ALGLUCOSIDASE ALFA

Guidelines for Use

GUIDELINES FOR USE

INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

Our guideline named ALGLUCOSIDASE ALFA (Lumizyme) requires the following rule(s) be met for approval:

1. You have (infantile onset or noninfantile, late onset) Pompe disease (a type of genetic disorder) confirmed by ONE of the following:
   1. Deficiency of acid alpha-glucosidase (GAA) enzyme
   2. GAA genotyping or gene sequencing
2. Your doctor attests that the requested agent will not be used concurrently (together at the same time) with Nexviazyme (avalglucosidase alfa), Opfolda (miglustat), or Pombiliti (cipaglucosidase alfa)
3. The requested dose does not exceed 20mg/kg (actual body weight) every 2 weeks

RENEWAL CRITERIA

Our guideline named ALGLUCOSIDASE ALFA (Lumizyme) requires the following rule(s) be met for renewal:

1. You have history of the requested agent within the past 90 days, confirmed by claims history, chart documentation, or prescriber attestation including dates of use
2. Your doctor submitted documentation supporting improvement or stabilization in disease state (such as, forced vital capacity, six-minute walk test)
3. Your doctor attests that the requested agent will not be used concurrently (together at the same time) with Nexviazyme (avalglucosidase alfa), Opfolda (miglustat), or Pombiliti (cipaglucosidase alfa)
4. The requested dose does not exceed 20mg/kg (actual body weight) every 2 weeks