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    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsNew Hampshire DHHS Lenmeldy Coverage | OpenPayer
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    CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

    Lenmeldy (atidarsagene autotemcel) Coverage Criteria

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    This policy governs prior authorization and medical necessity requirements for Lenmeldy gene therapy under the New Hampshire Medicaid Fee-for-Service Program for children with specified presymptomatic or early symptomatic forms of metachromatic leukodystrophy.

    Policy Summary
    PayerNew Hampshire Department of Health and Human Services
    PolicyLenmeldy (atidarsagene autotemcel) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing that all listed clinical, diagnostic, transplant-history, infection-screening, treatment-preparation, monitoring, vaccination, donor-availability, and pregnancy-testing criteria are satisfied.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    <18Maximum patient age
    18Approval criteria
    3Covered disease presentations
    7Negative infection screens

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    Not metDenial basis

    Lenmeldy Coverage Criteria

    Initial Lenmeldy approval

    Lenmeldy is approved when all applicable criteria are met.

    All approval criteria

    • Age and confirmed diagnosis

      • Biochemical evidence

        • Low ARSA activity: Arylsulfatase A (ARSA) enzyme activity is below the normal range in peripheral blood mononuclear cells, leukocytes, or fibroblasts.Below normal range
        • Elevated urinary sulfatides: Urinary excretion of sulfatides is increased.Above normal range
      • Molecular evidence: Biallelic ARSA pathogenic mutations of known polymorphisms are present. For novel mutations, a 24-hour urine collection must show elevated sulfatide levels.Biallelic ARSA pathogenic mutations

        Novel mutations require elevated sulfatides on a 24-hour urine collection.

    • Covered disease presentation

      • PSLI: Presymptomatic late infantile disease.
      • PSEJ: Presymptomatic early juvenile disease.
      • ESEJ: Early symptomatic early juvenile disease.
    • Therapy and transplant eligibility: Lenmeldy will be used as single-agent therapy, excluding the busulfan conditioning regimen; the patient is a candidate for autologous stem cell transplantation, such as with adequate renal and hepatic function; and the patient has not received other gene therapy for MLD.

    • Prior allogeneic transplant status

      • No prior transplant: Patient has not received prior allogeneic stem cell transplantation.
      • No residual donor cells: Patient previously received allogeneic stem cell transplantation but has no evidence of residual donor cells.
    • Infection screening: Before collection of cells for manufacturing, the patient tests negative for hepatitis B virus (HBV), hepatitis C virus (HCV), human T-lymphotropic virus 1 and 2 (HTLV-1/HTLV-2), human immunodeficiency virus 1 and 2 (HIV-1/HIV-2), cytomegalovirus (CMV), and mycoplasma infection.Negative for all listed infections
    • Mobilization and conditioning: Stem cells will be mobilized using granulocyte-colony stimulating factor (G-CSF) with or without plerixafor, and myeloablative conditioning such as busulfan will be administered at least 24 hours before Lenmeldy infusion.Conditioning at least 24 hours before infusion
    • Risk evaluation and prophylaxis: Risk factors for thrombosis and veno-occlusive disease are evaluated before administration, and infection prophylaxis follows standard institutional guidelines.
    • Post-treatment monitoring: The patient will be monitored periodically for hematological malignancies after treatment.Periodic monitoring
    • Antiretroviral restriction: The patient will not receive prophylactic HIV antiretroviral therapy for at least 1 month before mobilization because antiretrovirals may interfere with manufacturing.No prophylactic HIV ARV therapy for at least 1 month before mobilization
    • Related donor availability: The patient does not have a known willing 10/10 HLA-matched related donor for allogeneic hematopoietic stem cell transplantation.No known willing 10/10 HLA-matched related donor
    • Vaccination timing: The patient will not receive vaccinations during the 6 weeks before the start of myeloablative conditioning and until hematological recovery after treatment. Where feasible, childhood vaccinations should be administered before myeloablative conditioning.No vaccination from 6 weeks before conditioning through hematological recovery
    • Pregnancy testing: Females of childbearing potential have a confirmed negative pregnancy test before mobilization, reconfirmed before conditioning procedures and before Lenmeldy administration.Negative testing at all required time points

    Requests for children with the late juvenile form of metachromatic leukodystrophy (MLD) are not automatically included within the listed covered disease presentations. These requests are reviewed on a case-by-case basis.

    Authorization and Documentation Requirements

    Prior Authorization

    All Approval Criteria Required

    Prior authorization requires that every approval criterion be satisfied. Submit documentation supporting all applicable clinical, diagnostic, disease-stage, treatment, transplant-candidacy, infection-screening, mobilization, conditioning, monitoring, vaccination, and pregnancy-testing requirements below.

    Documentation Required

    Diagnosis and Molecular Evidence

    Document that the patient is younger than 18 years of age and has confirmed metachromatic leukodystrophy (MLD), also known as arylsulfatase A deficiency. Confirmation requires the specified biochemical and molecular evidence.

    • Arylsulfatase A (ARSA) enzyme activity is below the normal range in peripheral blood mononuclear cells, leukocytes, or fibroblasts; or urinary sulfatide excretion is increased.
    • A biallelic ARSA pathogenic mutation of known polymorphisms is present.
    • For a patient with novel ARSA mutations, a 24-hour urine collection must demonstrate elevated sulfatide levels.

    Therapy Overview

    Lenmeldy (atidarsagene autotemcel) is a gene therapy for children with metachromatic leukodystrophy (MLD), also known as arylsulfatase A deficiency. Under this policy, treatment is covered for presymptomatic late infantile, presymptomatic early juvenile, and early symptomatic early juvenile forms of MLD when the applicable coverage criteria are met.

    MLD Disease Presentations

    Metachromatic leukodystrophy (MLD)
    DefinitionA lysosomal storage disorder also known as arylsulfatase A deficiency.
    Biochemical confirmationARSA enzyme activity is below the normal range in peripheral blood mononuclear cells, leukocytes, or fibroblasts, or urinary sulfatide excretion is increased.
    Molecular confirmationBiallelic ARSA pathogenic mutations are present; for novel mutations, a 24-hour urine collection must show elevated sulfatide levels.
    PSLI
    AbbreviationPSLI
    Expanded termPresymptomatic late infantile metachromatic leukodystrophy.

    Initial Lenmeldy Authorization

    Initial Lenmeldy authorization

    Initial Lenmeldy therapy requires all applicable approval criteria to be met.

    Initial therapy requirements: Patient meets all applicable age, confirmed MLD diagnosis, covered disease presentation, single-agent therapy, transplant history, autologous transplant candidacy, prior gene-therapy, infection-screening, mobilization, conditioning, risk-evaluation, prophylaxis, monitoring, antiretroviral, donor-availability, vaccination, and pregnancy-testing requirements specified by the policy.

    The complete nested logic and alternatives are set out in the initial Lenmeldy approval criteria.

    Policy Summary
    PayerNew Hampshire Department of Health and Human Services
    PolicyLenmeldy (atidarsagene autotemcel) Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation showing that all listed clinical, diagnostic, transplant-history, infection-screening, treatment-preparation, monitoring, vaccination, donor-availability, and pregnancy-testing criteria are satisfied.
    SourceLink
    On This Page
    Lenmeldy Coverage CriteriaAuthorization and Documentation RequirementsTherapy OverviewMLD Disease PresentationsInitial Lenmeldy Authorization
    Documentation Required

    Treatment Eligibility and Preparation

    Document the eligible disease presentation and completion of all treatment-preparation requirements before Lenmeldy administration.

    • Disease is presymptomatic late infantile (PSLI), presymptomatic early juvenile (PSEJ), or early symptomatic early juvenile (ESEJ). Requests for late juvenile disease are reviewed case by case.
    • Lenmeldy will be used as single-agent therapy; this does not include the busulfan conditioning regimen.
    • The patient has not received a prior allogeneic stem cell transplant, or received one but has no evidence of residual donor cells.
    • The patient is a candidate for autologous stem cell transplantation, including adequate renal and hepatic function, and has not received other gene therapy for MLD.
    • Before cell collection for manufacturing, testing is negative for HBV, HCV, HTLV-1/HTLV-2, HIV-1/HIV-2, CMV, and mycoplasma infection.
    • Stem-cell mobilization will use granulocyte-colony stimulating factor (G-CSF), with or without plerixafor.
    • Myeloablative conditioning, such as busulfan, will be administered at least 24 hours before Lenmeldy infusion.
    • Thrombosis and veno-occlusive disease risk factors will be evaluated before administration; infection prophylaxis will follow standard institutional guidelines; and the patient will be monitored periodically for hematological malignancies after treatment.
    • The patient will not receive prophylactic HIV antiretroviral therapy for at least 1 month before mobilization because antiretrovirals may interfere with manufacturing.
    • The patient does not have a willing 10/10 human leukocyte antigen-matched related donor for allogeneic HSCT.
    • Vaccinations will not be administered during the 6 weeks before myeloablative conditioning or until hematological recovery after treatment; when feasible, childhood vaccinations should be given before conditioning.
    Documentation Required

    Pregnancy Testing Required

    For females of childbearing potential, document a confirmed negative pregnancy test before mobilization, with a negative test reconfirmed before conditioning procedures and again before Lenmeldy administration.

    Denial Risk

    Failure to Meet Approval Criteria

    Denial applies when the approval criteria are not met. The provider must submit sufficient documentation to establish every required criterion before prior authorization can be approved.

    Denial Risk

    Patient or Diagnosis Requirements Not Met

    Denial risk applies when the patient is not younger than 18 years of age, does not have confirmed MLD, lacks the required ARSA biochemical findings or qualifying urinary sulfatide evidence, or lacks the required biallelic ARSA pathogenic mutation. For novel mutations, denial risk applies when the required elevated sulfatide result from a 24-hour urine collection is not documented.

    • The eligible disease presentation must be PSLI, PSEJ, or ESEJ; late juvenile disease is subject to case-by-case review.
    Denial Risk

    Treatment Eligibility or Preparation Requirements Not Met

    Denial risk applies when any treatment eligibility or preparation requirement is not met or documented, including prior gene therapy, residual donor cells after allogeneic transplant, lack of autologous-transplant candidacy, required infection screening, mobilization or conditioning plans, donor assessment, medication or vaccination restrictions, monitoring, prophylaxis, or pregnancy testing.

    • Lenmeldy must be single-agent therapy, apart from the conditioning regimen, and the patient must not have received other gene therapy for MLD.
    • The patient must have no residual donor cells if previously treated with allogeneic stem cell transplantation and must be a candidate for autologous transplantation.
    • Required negative HBV, HCV, HTLV-1/HTLV-2, HIV-1/HIV-2, CMV, and mycoplasma screening must be documented before cell collection.
    • Required G-CSF-based mobilization, myeloablative conditioning at least 24 hours before infusion, thrombosis and veno-occlusive disease risk evaluation, infection prophylaxis, post-treatment malignancy monitoring, and vaccination restrictions must be documented.
    • The patient must not receive prophylactic HIV antiretroviral therapy for at least 1 month before mobilization and must not have a willing 10/10 HLA-matched related donor for allogeneic HSCT.
    • Females of childbearing potential must have negative pregnancy testing before mobilization, before conditioning, and before Lenmeldy administration.
    Coverage relevance
    PSLI is one of the metachromatic leukodystrophy presentations listed for Lenmeldy treatment in children.
    PSEJ
    AbbreviationPSEJ
    Expanded termPresymptomatic early juvenile metachromatic leukodystrophy.
    Coverage relevancePSEJ is one of the metachromatic leukodystrophy presentations listed for Lenmeldy treatment in children.
    ESEJ
    AbbreviationESEJ
    Expanded termEarly symptomatic early juvenile metachromatic leukodystrophy.
    Coverage relevanceESEJ is one of the metachromatic leukodystrophy presentations listed for Lenmeldy treatment in children.