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Coverage criteria policies

Type I Gaucher Disease Intravenous Enzyme Replacement Therapy: imiglucerase (Cerezyme®), velaglucerase (Vpriv®), and telaglucerase (Elelyso®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Enzyme replacement therapies for Gaucher disease require prior authorization from Pharmacy Administration. This policy provides coverage criteria for intravenous therapies.

Coverage criteria for oral therapies are available in the Pharmacy section of

The setting of drug administration will be reviewed as part of the prior authorization.


For all inquiries, transfer to the Medical Injectable Line (ext 26135).


Enzyme replacement therapy for Gaucher’s disease is generally covered when:

  1. Prescribed by a specialist; and
  2. Prescribed for pediatric and adult patients with a confirmed diagnosis of Type I Gaucher disease resulting in one or more of the following conditions: moderate to severe anemia, thrombocytopenia with bleeding tendency, bone disease, significant hepatomegaly or splenomegaly and when the FDA-approved regimen of 60 units/kg administered every other week as a 60-minute intravenous infusion. A current weight is required; and
  3. The patient and/or guardian has attested that they will adhere to the treatment plan; and
  4. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial approvals will be for twelve months.

Annual reauthorizations will require medical chart documentation that the patient has been seen within the past 12 months and that markers of disease are improved by therapy. These include but may not be limited to hemoglobin, platelet count, and liver and/or spleen volumes by MRI (when MRI is clinically indicated).


Gaucher Disease is caused by a deficiency of the enzyme glucocerebrosidase, which helps the body metabolize the fatty substance glucocerebroside. Accumulation of glucocerebroside in various body organs prevents their normal function.

Three subtypes of Gaucher disease exist. Type I includes 99% of all Gaucher diagnoses and results in the non-neuropathic symptoms indicated above. Type II is characterized by neurologic symptoms and death within the first 18 months of life. Type III is similar to Type II but the onset of symptoms is later in life and the progression of disease over a longer period of time.

Cerezyme (imiglucerase) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, or hepatomegaly or splenomegaly.

Vpriv (velaglucerase) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric patients 4 years of age and older and adult patients with type 1 Gaucher disease.

Elelyso (taliglucerase) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients with a confirmed diagnosis of Type 1Gaucher’s disease in adults and pediatric patients 4 years of age and older.

Ceredase (alglucerase), the original replacement therapy derived from human placental tissue, is not included in this policy as it is only available for limited use through compassionate use protocols.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.





Injection, imiglucerase, 10 units (Cerezyme)


Injection, taliglucerase alfa, 10 units (Elelyso)


Injection, velaglucerase alfa, 100 units (Vpriv)

NDC Codes




Cerezyme 400 unit single use solution


Vpriv 400 unit single dose solution


Elelyso 200 unit single use solution

ICD-10-CM code category




Disorders of lipoprotein metabolism and other lipidemias

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.


  1. Cerezyme Prescribing Information. Genzyme Corporation, Cambridge, MA. December 2012.
  2. Vpriv Prescribing Information. Shire Human Genetic Therapies, Inc. Cambridge, MA April 2015
  3. Elelyso Prescribing Information. Pfizer Inc. New York, NY. January 2017.
  4. Zimran A, Altarescu G, Philips M, et al., PhaseI/II and extension study of velaglucerase alfa (gene-activated human glucocerebrosidease) replacement therapy in adults with type 1 gaucher disease: 48 month experience. Blood 2010; 115 (23):4651.
  5. Anderson H, Charrow J, Kaplan P, et al., Individualization of long-term enzyme replacement therapy for Gaucher disease. Genetic Medicine 2005:7(2):105-110.
  6. Barton NW, Brady RO, Dambrosia JM, et al. Replacement therapy for inherited enzyme deficiency- macrophage-targeted glucocerebrodiase for Gaucher’s disease. N Engl J Med 1991; 324:1464-147.
  7. Zimran, A. How I treat Gaucher disease. Blood 2011; 118:1463-1471.

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Policy activity

  • 07/01/2011 - Date of origin
  • 09/01/2011 - Effective date
Review date
  • 11/2017
Revision date
  • 10/01/2016

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