Does J2508 require prior authorization?

Yes, J2508 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J2508?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J2508`, Injection, pegunigalsidase alfa-iwxj, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Objective laboratory confirmation of diagnosis for each therapy: as specified per drug — typically one of: (a) deficiency/absence of specific enzyme activity measured in fibroblasts, leukocytes, dried blood spots, lymphocytes, serum, or muscle (policy specifies thresholds where applicable: e.g., Aldurazyme alpha‑L‑iduronidase; Elfabrio/Fabrazyme α‑Gal A <5% of mean; Lamzede alpha‑Mannosidase <10% of mean; Lumizyme infantile <1% fibroblasts; Lumizyme/Nexviazyme/Pombiliti late‑onset <40% lab mean), OR (b) molecular genetic testing confirming pathogenic mutations in the disease‑specific gene (examples: IDUA for MPS I, IDS for MPS II, GLA for Fabry, LIPA for LAL‑D, MAN2B1 for alpha‑mannosidosis, GAA for Pompe, GUSB for MPS VII, ASB for MPS VI, MOCS1 for MoCD type A, ADA1 for ADA‑SCID, GALNS for MPS IVA, SMPD1 for ASMD).
Presence of clinical signs and symptoms consistent with the disease at time of request (policy lists disease‑specific examples: e.g., hepatosplenomegaly, cardiac abnormalities, corneal clouding, dysostosis multiplex for MPS I; hepatosplenomegaly and skeletal deformities for MPS II; acroparesthesias, angiokeratomas, renal disease for Fabry; abdominal distention, hepatosplenomegaly, liver fibrosis for LAL‑D; cardiomyopathy, respiratory distress, skeletal muscle weakness for Pompe; seizures, exaggerated startle, feeding difficulties and specific biochemical markers within first 28 days for MoCD type A; etc.).
For continuation/reauthorization: documentation that patient previously received the specified therapy and has experienced a positive clinical response (examples provided in policy: improved endurance, improved functional capacity, improved respiratory/cardiac function, reduced urine GAG/dermatan sulfate/heparan sulfate, reduced spleen or liver volume, reduced urine keratan sulfate or SSC, reduced plasma GL‑3, improved lab values such as LFTs/cholesterol/triglycerides, normalization or improvement in ADA activity/dATP levels for ADA‑SCID, etc.).
For Pombiliti: provider attestation that patient is not improving on current ERT and that current ERT will be stopped; documentation of patient weight (≥ 40 kg); prescription for combination therapy with Opfolda (miglustat).
For Revcovi: documentation of ADA deficiency by one of the listed laboratory methods (ADA levels in plasma/erythrocytes/fibroblasts, increased dATP in erythrocytes, decreased ATP concentration in erythrocytes), molecular confirmation of biallelic ADA1 mutations, or positive TREC screen; and documentation of HCT candidacy status (not suitable for HCT, failed HCT, or awaiting HCT).
For Nulibry: documentation of MoCD Type A diagnostic confirmation (sulfite oxidase activity deficiency in fibroblasts or MOCS1 mutation) and clinical signs/symptoms within first 28 days of life and biochemical evidence (elevated urinary sulfite and/or SSC, elevated xanthine, low/absent uric acid) when available.

Key Coverage Criteria

Aldurazyme (laronidase) for treatment of mucopolysaccharidosis I (MPS I): Hurler variant (MPS IH), Hurler-Scheie variant (MPS IHS), or Scheie variant (MPS IS) when diagnosis is confirmed by deficiency/absence of alpha-L-iduronidase enzyme activity in fibroblasts or leukocytes or by molecular genetic confirmation of mutations in the alpha-L-iduronidase gene, plus presence of clinical signs/symptoms.
Elaprase (idursulfase) for treatment of mucopolysaccharidosis II (MPS II, Hunter syndrome) when diagnosis is confirmed by deficiency in iduronate 2-sulfatase activity in fibroblasts or leukocytes (with normal activity of another sulfatase) or by molecular genetic testing for iduronate 2-sulfatase gene mutations, plus presence of clinical signs/symptoms.
Elfabrio (pegunigalsidase alfa-iwxj) for treatment of adults with confirmed Fabry disease when diagnosis is confirmed by absence/deficiency (<5% of mean) of alpha-galactosidase A activity in leukocytes, dried blood spots, or serum analysis, or by molecular genetic testing for GLA (galactosidase alpha) gene mutations, plus presence of clinical signs/symptoms, and when not given in combination with another disease-modifying Fabry therapy.
Fabrazyme (agalsidase beta) for treatment of Fabry disease when diagnosis is confirmed by absence/deficiency (<5% of mean) of alpha-galactosidase A activity in leukocytes, dried blood spots, or serum analysis, or by molecular genetic testing for GLA gene mutations, plus presence of clinical signs/symptoms, and when not given in combination with another disease-modifying Fabry therapy.
Kanuma (sebelipase alfa) for treatment of lysosomal acid lipase deficiency (LAL-D; including Wolman disease and cholesteryl ester storage disease) when diagnosis is confirmed by absence/deficiency of LAL activity by dried blood spot test or by molecular genetic testing for LIPA gene mutations, plus presence of clinical signs/symptoms.
Lamzede (velmanase alfa-tycv) for treatment of alpha-mannosidosis when diagnosis is confirmed by absence/deficiency (<10% of lab-specific normal mean) of alpha-mannosidase enzyme activity or by molecular genetic testing for MAN2B1 gene mutations, plus presence of clinical signs/symptoms, and only for non–central nervous system (non‑CNS) manifestations.

20 Active Policies

ARKBLUE-ENZYME-REPLACEMENT-THERAPY-ERT-FOR-FABRY-DISEASE-21A5216485, Enzyme Replacement Therapy (ERT) for Fabry Disease: Agalsidase Beta (e.g., Fabrazyme) and Pegunigalsidase alfa (e.g., Elfabrio)

HEALTHPARTNERS-CC-ENTRY-186765, Fabry disease enzyme replacement therapy: agalsidase beta (Fabrazyme) and pegunigalsidase alfa-iwxj (Elfabrio)

MULTI

HEALTHPARTNERS-CC-ENTRY-187817, Fabry disease enzyme replacement therapy: agalsidase agalsidase beta (Fabrazyme) and pegunigalsidase alfa-iwxj (Elfabrio) – Minnesota Health Care Programs

MULTI

HEALTHNET_OR-HNOR-PEGUNIGALSIDASE-ALFA-IWXJ-ELFABRIO-CP-PHAR-512-23C7A7D8E9, Pegunigalsidase alfa-iwxj (Elfabrio); CP.PHAR.512

MODA-ELFABRIO-DE62BB3B86, Elfabrio (pegunigalsidase alfa-iwxj)

IBX-COMMERCIAL-08-00-69D-5193E18AE1, Agalsidase beta (Fabrazyme) and pegunigalsidase alfa-iwxj (Elfabrio)

IBX-MEDICARE-ADVANTAGE-MA08-033D-CE268E1F37, Agalsidase beta (Fabrazyme) and pegunigalsidase alfa-iwxj (Elfabrio)

BCBSNM-ADM1001.034, Specialty Medication Administration Site of Care

BCBSOK-RX501.067, Enzyme-Replacement Therapy for Lysosomal Storage Disorders

BCBSOK-ADM1001.034, Specialty Medication Administration Site of Care

UMR-POL-UMR-enzyme-replacement-therapy, Medical Therapies for Enzyme Deficiencies

UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

UHC-POL-enzyme-replacement-therapy, Medical Therapies for Enzyme Deficiencies

AMERIHEALTH-COMMERCIAL-08-00-69D-56F0A60026, Agalsidase beta (Fabrazyme) and pegunigalsidase alfa-iwxj (Elfabrio)

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-033D-555E82C8ED, Agalsidase beta (Fabrazyme) and pegunigalsidase alfa-iwxj (Elfabrio)

BCBSTN-fb9deb86e9, Pegunigalsidase Alfa-iwxj (Elfabrio)

EVICORE-MEDICAL_DRUG-C8A707AB103D, Elfabrio (pegunigalsidase alfa)

SUREST-POL-SUREST-enzyme-replacement-therapy, Medical Therapies for Enzyme Deficiencies

UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

BCBSIL-RX501.067, Enzyme-Replacement Therapy for Lysosomal Storage Disorders

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J2508, Injection, pegunigalsidase alfa-iwxj, 1 mg