CurrentAetnaPolicy N/A

VPRIV (velaglucerase alfa) — Precertification and Coverage Criteria

Precertification request form and requirements for coverage of VPRIV (velaglucerase alfa) for patients with Gaucher disease; intended for providers seeking authorization from Aetna.

Policy Summary

PayerAetna

PolicyVPRIV (velaglucerase alfa) — Precertification and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a complete precertification form with confirmation of Gaucher disease (enzyme assay or genetic testing) and documentation of prior Elelyso response/intolerance for initiation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Precertification requiredMedication authorization

Clinical documentation requiredFor all requests

Enzyme assay/geneticDiagnosis confirmation

Prior ERT documentedStep therapy

Coverage Criteria for VPRIV (velaglucerase alfa)

inv-01: Initial Therapy

Covered when ALL of the following are met for initiation requests

Initial VPRIV coverage: 1) Diagnosis of Gaucher disease confirmed by an enzyme assay demonstrating deficiency of beta-glucocerebrosidase activity or by genetic testing; 2) Documentation of Gaucher disease type (Type 1, 2, 3, or other); 3) For initiation, documentation stating whether the patient had an ineffective response, contraindication, or intolerance to Elelyso (imiglucerase); 4) Required clinical safety information provided (site of administration, history of infusion-related adverse events and whether they responded to conventional interventions, presence of severe venous access issues, behavioral/caregiver concerns, and medical stability such as cardiopulmonary, respiratory, or renal conditions).

Source: precertification form clinical information sections

inv-02: Continuation Therapy

Covered when ALL of the following are met for continuation requests

Continuation VPRIV coverage: 1) Date of last treatment provided (indicate continuation of therapy and date of last treatment); 2) Documentation that the patient is responding to therapy or, if not, specify inadequate response or intolerable adverse events from VPRIV; 3) Ongoing clinical information relevant to infusion safety and site of care (any recent infusion-related adverse events and whether they required hospital setting, current venous access status, behavioral/caregiver considerations, and medical stability).

Policy Summary

PayerAetna

PolicyVPRIV (velaglucerase alfa) — Precertification and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Source: precertification form start/continuation fields and clinical information continuation section

No explicit exclusion criteria are listed on the VPRIV precertification form. The form requires completion of the clinical information section for all requests but does not provide any discrete fields labeled as exclusions or list conditions that automatically preclude coverage.

While the form does not state specific "not medically necessary" scenarios, requests may be denied if essential diagnostic or clinical documentation is missing. Specifically, failure to confirm the diagnosis of Gaucher disease by an enzyme assay or genetic testing, or omission of the required clinical information fields (including infusion setting, history of infusion-related adverse events, venous access status, behavioral/caregiver concerns, and Gaucher disease type) would preclude a medical necessity determination and may result in denial.

For initiation requests, absence of documentation about prior enzyme replacement therapy — namely whether the patient had an ineffective response, contraindication, or intolerance to Elelyso — also undermines the initiation criteria and may lead to denial of the request.

Initial Therapy Requirements

inv-13: Initiation Therapy Requirements

Initiation requests must document prior intolerance/ineffectiveness to Elelyso when applicable and confirm diagnosis.

Initiation: Confirm Gaucher disease by enzyme assay demonstrating beta-glucocerebrosidase deficiency or by genetic testing; indicate Gaucher disease type; document whether the patient had an ineffective response, contraindication, or intolerance to Elelyso (imiglucerase) for initiation requests; include baseline safety information relevant to initiation (history of infusion reactions and response to interventions, venous access, behavioral/caregiver issues, and medical stability).

Form initiation section requires these items

Continuation Therapy Requirements

inv-14: Continuation Therapy Requirements

Continuation requests require documentation of treatment history and response.

Continuation: Provide date of last treatment and indicate continuation of therapy; document whether the patient is experiencing inadequate response or intolerable adverse events from VPRIV; supply current clinical information relevant to infusion safety and site of care (infusion reaction history and management, venous access status, behavioral/caregiver considerations, and medical stability).

Form continuation section

Billing and Diagnosis Codes

Administration codesCPT

Administration code(s) (CPT)

Administration CPT codes to be provided by requestor (document lists a field for administration codes)

Diagnosis codesICD-10

Primary ICD Code

Primary ICD code for diagnosis (requestor to indicate)

Provider Actions and Documentation Requirements

Prior Authorization

Precertification required

Precertification is required for VPRIV (velaglucerase alfa) requests. Indicate whether this is a start of treatment (include start date) or a continuation of therapy (include date of last treatment). Provide product name and dose, directions for use, and complete contact information for the precertification requester.

Use Aetna Precertification Notification contact: Phone 1-866-752-7021 (TTY: 711); Fax 1-888-267-3277
For Medicare Advantage Part B: use the Medicare request form
Indicate: Start of treatment (start date) OR Continuation of therapy (date of last treatment)

Documentation Required

Prior enzyme replacement therapy

For initiation requests, documentation must state whether the patient had an ineffective response, a contraindication to, or intolerance of Elelyso (imiglucerase).

For Initiation Requests: confirm if patient had ineffective response, contraindication, or intolerance to Elelyso (imiglucerase)

Documentation Required

Required documentation

Complete and legible precertification form with required clinical information must be provided for ALL requests. Required elements include confirmation of Gaucher disease by enzyme assay demonstrating deficient beta‑glucocerebrosidase activity or by genetic testing; type of Gaucher disease (Type 1, 2, 3, or other); infusion setting and any reasons for outpatient hospital infusion (severe adverse event history, severe venous access issues, significant behavioral/physical/cognitive impairments without caregiver, or medical instability with cardiopulmonary/respiratory/renal concerns); and for continuation requests, documentation of response or any intolerable adverse events on VPRIV.

Confirmation of diagnosis by enzyme assay or genetic testing (Yes/No)
Specify Gaucher disease type: Type 1 / Type 2 / Type 3 / Other
Infusion setting and justification (if outpatient hospital): adverse events, venous access issues, behavioral/physical/cognitive impairments without caregiver, or medical instability — include descriptions
For continuation: document clinical response or intolerable adverse events on current VPRIV therapy
Provide VPRIV dose and directions for use

Denial Risk

Documentation triggers denial

Failure to provide required clinical documentation will result in denial of the request. This includes not providing confirmation of Gaucher disease by enzyme assay or genetic testing, incomplete precertification form fields (e.g., missing start/continuation dates, product dose, infusion setting justification), or absent documentation regarding prior enzyme replacement therapy when applicable.

Missing confirmation of diagnosis by enzyme assay or genetic testing
Incomplete precertification form (missing dates, dose, directions, or requester contact)
Absent documentation about prior Elelyso (imiglucerase) response/contraindication/intolerance for initiation requests
Lack of justification for outpatient hospital infusion when indicated

Site of Administration

Billing Rule

Specify site of care and justify outpatient hospital infusion when required

Indicate the intended site of administration (home, physician’s office, outpatient infusion center, or outpatient hospital). If the request is for an outpatient hospital infusion, provide justification such as severe adverse events not manageable elsewhere, severe venous access issues requiring special interventions, medical instability, or significant behavioral/functional impairments without available caregiver support.

Select place of administration on the form (Home, Physician's Office, Outpatient Infusion Center, Outpatient Hospital).
If outpatient hospital is selected, provide detailed justification: severe infusion-related adverse events, need for special venous access interventions, medical instability (cardiopulmonary/respiratory/renal), or behavioral/functional issues without caregiver.

Key Definitions

Confirmed Gaucher disease

DefinitionDiagnosis demonstrated by enzyme assay showing deficiency of beta-glucocerebrosidase (glucosidase) activity or by genetic testing.

Confirmation fieldPrecertification form asks: 'Was the diagnosis of Gaucher disease confirmed by an enzyme assay demonstrating a deficiency of beta-glucocerebrosidase (glucosidase) enzyme activity or by genetic testing?' with Yes/No selection.

Applies toRequired clinical information for ALL precertification requests (initiation and continuation).

Impact of missing confirmationLack of confirmed diagnosis would preclude medical necessity determination and may lead to denial of the request.

Background

Gaucher disease is diagnosed by demonstration of deficient beta-glucocerebrosidase activity on an enzyme assay or by genetic testing; the precertification form explicitly asks whether the diagnosis was confirmed by one of these methods. VPRIV (velaglucerase alfa) is an enzyme replacement therapy option for patients with Gaucher disease and the form gathers disease-specific details such as the type of Gaucher disease (Type 1, 2, 3, or other).

The form also collects safety and administration-related information relevant to VPRIV: whether the infusion will occur in an outpatient hospital setting, a history of infusion-related adverse events or severe reactions not responsive to conventional interventions, severe venous access issues, significant behavioral or cognitive impairments without caregiver support, and medical instability (cardiopulmonary, respiratory, renal, or other) that may affect tolerance of infusion therapy.

Step Therapy / Prior Treatment

Step	Requirement	Notes
1	Documentation that the patient had an ineffective response, contraindication, or intolerance to Elelyso (imiglucerase)	Requested for initiation requests — form includes checkbox asking whether patient had ineffective response, contraindication, or intolerance to Elelyso