CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Roctavian™ (valoctocogene roxaparvovec-rvox) Criteria

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New Hampshire Medicaid Fee-for-Service prior authorization and coverage criteria for a single lifetime dose of Roctavian in adults with severe congenital hemophilia A.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyRoctavian™ (valoctocogene roxaparvovec-rvox) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJanuary 22, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document that every approval criterion, including eligibility, safety screening, laboratory testing, and post-treatment monitoring, is satisfied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18 yearsMinimum patient age

<1 IU/dLSevere hemophilia A threshold

1 dose

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Roctavian™ (valoctocogene roxaparvovec-rvox) Criteria

Customize your policy alerts

Sign up for all New Hampshire Department of Health and Human Services policy alerts

Know when New Hampshire Department of Health and Human Services releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

New Hampshire Medicaid Fee-for-Service prior authorization and coverage criteria for a single lifetime dose of Roctavian in adults with severe congenital hemophilia A.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyRoctavian™ (valoctocogene roxaparvovec-rvox) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJanuary 22, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document that every approval criterion, including eligibility, safety screening, laboratory testing, and post-treatment monitoring, is satisfied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18 yearsMinimum patient age

<1 IU/dLSevere hemophilia A threshold

1 dose

Lifetime treatment limit

<0.6 BUMaximum inhibitor result

NegativeAAV5 antibody status

ALT, liver, factor VIIIPost-treatment monitoring

Roctavian Coverage Criteria

Initial Roctavian approval criteria

Covered when ALL of the following are met:

Roctavian approval criteria

Eligibility and safety: Patient is at least 18 years of age; has severe hemophilia A (congenital factor VIII deficiency) with factor VIII activity below 1 IU/dL in the absence of exogenous factor VIII; evidence of any bleeding disorder not related to hemophilia A has been ruled out; patient is receiving a stable dose of regularly administered exogenous factor VIII for prevention and control of bleeding episodes; patient does not have an active acute or uncontrolled chronic infection; Roctavian will not be administered concurrently with live vaccines while the patient is receiving immunosuppressive therapy; patient does not have significant hepatic fibrosis stage 3 or 4 or cirrhosis; patient has no known hypersensitivity to mannitol; and patient has not received prior hemophilia AAV-vector-based gene therapy.Age ≥18 years; factor VIII activity <1 IU/dL
All eligibility and safety conditions are required.
Laboratory eligibility: Patient is negative for AAV serotype 5 antibodies as determined by an FDA-approved or CLIA-compliant test; has tested negative for active factor VIII inhibitors; and is not receiving a bypass agent such as Feiba.Factor VIII inhibitor result <0.6 BU on 2 consecutive occasions ≥1 week apart within the past 12 months
Inhibitor testing may use a Bethesda assay or a Nijmegen-modified Bethesda assay.
Required monitoring plan
- Factor VIII response management: When factor VIII activity exceeds 5 IU/dL, routine prophylactic exogenous factor VIII should be discontinued; OR, if factor VIII activity decreases and/or bleeding is not controlled, assess for factor VIII inhibitors and the need for hemostatic prophylaxis.>5 IU/dL for discontinuing routine prophylaxis

Coverage excludes patients with active acute or uncontrolled chronic infection, significant hepatic fibrosis (stage 3 or 4), or cirrhosis. Patients with known hypersensitivity to mannitol, prior hemophilia A AAV-vector gene therapy, positive AAV5 antibody testing, active factor VIII inhibitors, or current use of a bypass agent such as Feiba are also not eligible.

Roctavian must not be administered concurrently with live vaccines while the patient is receiving immunosuppressive therapy.

Clinical Thresholds and Eligibility Values

Severe hemophilia A factor VIII activity

ConditionSevere hemophilia A

Required factor VIII activity< 1 IU/dL

Testing contextMeasured in the absence of exogenous factor VIII

Factor VIII inhibitor testing

Maximum inhibitor result< 0.6 BU

Testing frequency2 consecutive occasions

Minimum interval≥ 1 week apart

Authorization and Documentation Requirements

Prior Authorization

All Approval Criteria Required

Prior authorization requires satisfaction of every approval criterion listed in the policy. Document that all required clinical, testing, treatment, safety, and monitoring conditions are met before requesting coverage.

Documentation Required

Baseline Eligibility Documentation

Submit baseline documentation establishing eligibility and documenting the required exclusions before treatment.

Patient is 18 years of age or older.
Severe hemophilia A is confirmed by factor VIII activity < 1 IU/dL in the absence of exogenous factor VIII.
Other bleeding disorders not related to hemophilia A have been ruled out.
The patient is receiving a stable dose of regularly administered exogenous factor VIII for prevention and control of bleeding episodes.

Therapy Overview

Roctavian is a gene therapy indicated for adults with severe hemophilia A, defined as congenital factor VIII deficiency with factor VIII activity below 1 IU/dL in the absence of exogenous factor VIII. New Hampshire Medicaid Fee-for-Service coverage requires prior authorization and satisfaction of the policy’s clinical eligibility, safety screening, laboratory testing, and post-administration monitoring requirements.

Key Clinical Definitions

Severe hemophilia A

DefinitionCongenital factor VIII deficiency

Factor VIII activity< 1 IU/dL

Measurement contextIn the absence of exogenous factor VIII

AAV5 antibody negative

Antibody targetAntibodies to adeno-associated virus serotype 5 (AAV5)

Required resultNegative

Acceptable testing methodFDA-approved or CLIA-compliant test

Initial Therapy Requirements

Initial therapy criteria

Initial treatment is approved only when ALL policy criteria are satisfied:

Initial Roctavian eligibility: Patient is at least 18 years of age; has severe hemophilia A (congenital factor VIII deficiency) with factor VIII activity below 1 IU/dL in the absence of exogenous factor VIII; evidence of any bleeding disorder not related to hemophilia A has been ruled out; patient is receiving a stable dose of regularly administered exogenous factor VIII for prevention and control of bleeding episodes; patient has no active acute or uncontrolled chronic infection; Roctavian will not be administered concurrently with live vaccines while the patient is receiving immunosuppressive therapy; patient has no significant hepatic fibrosis stage 3 or 4 or cirrhosis; patient has no known hypersensitivity to mannitol; patient has not received prior hemophilia AAV-vector-based gene therapy; patient is AAV5 antibody negative by an FDA-approved or CLIA-compliant test; patient has negative active factor VIII inhibitor testing on 2 consecutive occasions at least 1 week apart within the past 12 months; patient is not receiving a bypass agent such as Feiba; and the required post-administration ALT, liver, and factor VIII monitoring plan is in place.Age ≥18 years; factor VIII activity <1 IU/dL; inhibitor result <0.6 BU on 2 consecutive occasions ≥1 week apart within the past 12 months

A single dose is permitted per lifetime.

Post-Administration Monitoring

Post-administration monitoring

Following administration, ongoing monitoring is required:

Post-treatment monitoring

Factor VIII response management: If factor VIII activity exceeds 5 IU/dL, discontinue routine prophylactic exogenous factor VIII; OR, if factor VIII activity decreases and/or bleeding is not controlled, assess for factor VIII inhibitors and the need for hemostatic prophylaxis.>5 IU/dL for discontinuing routine prophylaxis

Lifetime Dose Limit

Quantity limit

MedicationRoctavian (valoctocogene roxaparvovec-rovx)

Quantity limitA single dose

Lifetime limitationOne dose per lifetime

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyRoctavian™ (valoctocogene roxaparvovec-rvox) Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJanuary 22, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document that every approval criterion, including eligibility, safety screening, laboratory testing, and post-treatment monitoring, is satisfied.

SourceLink

On This Page

Lookback periodWithin the past 12 months

Patient age

Minimum age≥ 18 years

Eligibility categoryAdult patient

Approval requirementPatient must be at least 18 years of age

Factor VIII activity for discontinuing routine prophylaxis

Monitoring requirementFactor VIII activity monitored periodically

Discontinuation threshold> 5 IU/dL

Required actionDiscontinue routine prophylactic exogenous factor VIII when factor VIII activity exceeds 5 IU/dL

The patient is AAV5-antibody negative based on an FDA-approved or CLIA-compliant test.

The patient has not previously received hemophilia AAV-vector-based gene therapy.

Documentation Required

Inhibitor and Bypass-Agent Assessment

Document negative inhibitor testing and confirm that the patient is not receiving a bypass agent before administration.

Active factor VIII inhibitors must be ruled out, such as Bethesda or Nijmegen-modified Bethesda assay results of < 0.6 BU on 2 consecutive occasions at least 1 week apart within the past 12 months.
Document that the patient is not receiving a bypass agent, such as FEIBA.

Documentation Required

Post-Treatment Monitoring Plan

The treatment plan must include post-administration monitoring and the required responses to laboratory or clinical changes.

Monitor serum ALT according to the product-labeling schedule and document administration of corticosteroids or other immunosuppressive therapy in response to ALT elevations.
For patients with hepatocellular carcinoma risk factors, including hepatitis B or C, NAFLD, NASH, chronic alcohol consumption, or advanced age, perform regular liver ultrasounds (for example, annually) and test for AFP elevations after administration.
Monitor factor VIII activity periodically. Discontinue routine prophylactic exogenous factor VIII when activity is > 5 IU/dL; if activity decreases or bleeding is not controlled, assess for factor VIII inhibitors and the need for hemostatic prophylaxis.

Denial Risk

Failure to Meet Approval Criteria

Coverage is subject to denial when the patient does not meet all approval criteria, including required eligibility, testing, treatment, safety, and monitoring requirements.

Failure to satisfy any one approval criterion results in denial.

Denial Risk

Lifetime Dose Exceeded

The policy permits a single dose per lifetime. Coverage may be denied if the permitted lifetime dose has already been administered.

Confirm the patient has not previously received the covered treatment dose.

Denial Risk

Clinical Ineligibility or Safety Exclusion

Clinical ineligibility or a safety exclusion may result in denial, including age, diagnostic, infection, hepatic, hypersensitivity, vaccination, or prior-gene-therapy concerns.

Patient is younger than 18 years of age.
Severe hemophilia A is not confirmed, or another bleeding disorder has not been ruled out.
Active acute or uncontrolled chronic infection is present, including acute hepatitis or chronic active hepatitis B.
The patient has significant hepatic fibrosis (stage 3 or 4) or cirrhosis.
The patient has a known hypersensitivity to mannitol.
The patient is receiving immunosuppressive therapy and would receive a live vaccine concurrently.
The patient has previously received hemophilia AAV-vector-based gene therapy.
The patient is not AAV5-antibody negative or the result was not obtained using an FDA-approved or CLIA-compliant test.

Negative active factor VIII inhibitor test

Maximum inhibitor result< 0.6 BU

Consecutive testing2 consecutive occasions

Testing interval≥ 1 week apart

Lookback periodWithin the prior 12 months

Acceptable assaysBethesda assay or Bethesda assay with Nijmegen modification