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Coverage criteria policies

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

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 healthpartners.com

Coverage

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

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).

Definitions

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 1 Gaucher’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.

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.

HCPCS Codes

Codes

Description

J1786

Injection, imiglucerase, 10 units (Cerezyme)

J3060

Injection, taliglucerase alfa, 10 units (Elelyso)

J3385

Injection, velaglucerase alfa, 100 units (Vpriv)

NDC Codes

Codes

Description

58468466301

Cerezyme 400 unit single use solution

54092070104

Vpriv 400 unit single dose solution

00069010601

Elelyso 200 unit single use solution

ICD-10-CM code category

Codes

Description

E78

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.

Products

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.

References

  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. July 2016.
  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

  • 01/01/2017 - Date of origin
  • 01/01/2017 - Effective date
Review date
  • 11/2017

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