Blue Cross Blue Shield MA specialty drug Prior Auth

Medical Necessity and Coverage Criteria

Alpha-1 antitrypsin replacement therapy — medical necessity

Covered when ALL of the following are met

Alpha-1 antitrypsin criteria: Diagnosis of emphysema with CT scan showing significant emphysema; AND age >= 18 years; AND documented alpha-1 antitrypsin deficiency demonstrated by blood levels < 80 mg/dL (11 umol/L); AND plasma levels less than 80 mg/dL (11 umol/L); AND FEV1/FVC < 70%; AND current non-smoker.

Amvuttra for hATTR polyneuropathy

Covered when ALL of the following are met

hATTR polyneuropathy criteria: Confirmed diagnosis of polyneuropathy of hereditary transthyretin-mediated amyloidosis with documentation of a mutation in the TTR gene; AND baseline polyneuropathy disability (PND) score < III; AND prescribed by a board-certified or board-eligible geneticist or neurologist; AND no dual therapy with another TTR‑lowering agent such as patisiran (Onpattro) or inotersen (Tegsedi).

Amvuttra for ATTR cardiomyopathy

Covered when ALL of the following are met

ATTR-CM criteria: Age >= 18 years; AND confirmed diagnosis of cardiomyopathy of wild‑type or hereditary transthyretin‑mediated amyloidosis confirmed by endomyocardial biopsy or appropriate bone scintigraphy; AND prescribed by a board‑certified or board‑eligible geneticist or cardiologist.

Aphexda for hematopoietic stem cell mobilization

Covered when ALL of the following are met

Aphexda criteria: Age >= 18 years; AND confirmed diagnosis of multiple myeloma; AND medication is used to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation; AND used in combination with filgrastim (G‑CSF).

Teriparatide therapy — medical necessity and treatment duration

Covered when ALL of the following are met

Teriparatide criteria: Diagnosis of osteoporosis (post‑menopausal women OR primary/hypogonadal osteoporosis in men OR glucocorticoid‑induced osteoporosis); AND considered at high risk for fracture (multiple risk factors or history of fractures); AND age >= 18 years; AND for certain products prior use of specified teriparatide formulations where noted.

Authorization approved for 24 months; continuation may allow up to one additional year if continuation criteria are met.

Briumvi for relapsing multiple sclerosis

Covered when ALL of the following are met

Briumvi criteria: Diagnosis of relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) in adults; AND prescribed by a board‑certified or board‑eligible neurologist; AND age >= 18 years.

Enzyme replacement for Gaucher disease

Covered when the following is met

Gaucher disease criteria: Documented diagnosis of Type Gaucher disease.

Briumvi (ublituximab) — Initial coverage criteria

Briumvi (ublituximab) coverage

Briumvi (ublituximab)

diagnosis: Diagnosis of relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing‑remitting disease, active secondary progressive disease) in adults
prescriber: Prescribed by a board‑certified or board‑eligible Neurologist
age: Age 18 years or older>=18

Gaucher disease — Enzyme replacement

Cerezyme, Elelyso, VPRIV coverage

Gaucher enzyme replacement therapies

diagnosis: Diagnosis of Type Gaucher disease

Dupixent (dupilumab) — Multiple indications

Dupixent (dupilumab) — indication-specific criteria

Moderate-to-Severe Asthma

use: Add‑on maintenance treatment of patients with moderate‑to‑severe asthma
age: Patient is > 6 years old>6
phenotype_or_oral_steroids: Patient is diagnosed with an eosinophilic phenotype OR has oral corticosteroid dependent asthma
prescriber: Prescribed by a board‑certified or board‑eligible Allergist or Pulmonologist

Ebglyss / Lebrikizumab — Atopic dermatitis

Ebglyss / lebrikizumab — Atopic dermatitis criteria

Moderate-to-Severe Atopic Dermatitis (Ebglyss)

disease: Patient has moderate‑to‑severe atopic dermatitis
prior_systemic_or_topical: Inadequate response to at least ONE other systemic immunosuppressant OR contraindication to other systemic drugs OR claim history of one topical pimecrolimus/tacrolimus within prior 90 days
age: Patient is >= 12 years of age>=12
topical_steroid_failure:

Enjaymo — incomplete criteria in this fragment

Enjaymo (sutimlimab)

Enjaymo: Coverage criteria section present but incomplete in this segment; no specific criteria listed in this chunk.

Evenity — Osteoporosis

Evenity (romosozumab)

diagnosis: Diagnosis of osteoporosis
high_risk_or_failed_other: Considered high risk for fracture (history of osteoporotic fracture or multiple risk factors) OR patients who have failed or are intolerant to other available osteoporosis therapy
Treatment duration limited to 12 monthly doses due to reduced anabolic effect

Filsuvez — DEB/JEB

Covered when ALL of the following are met

Filsuvez: Diagnosis of Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB) confirmed by genetic testing; AND age > 6 months; AND prescribed by a board‑certified or board‑eligible Dermatologist; AND cannot be used concurrently with Vyjuvek (beremagene geperpavec‑svdt); AND will not be mixed with other topical skin products or applied concurrently with such products; AND patient is receiving treatment under a single benefit (Pharmacy or Medical).

Galafold — Fabry disease

Galafold (migalastat) — Fabry disease

Galafold (migalastat): Confirmed diagnosis of Fabry disease; AND age > 18 years; AND laboratory testing demonstrating an amenable galactosidase alpha gene (GLA) variant; AND prescribed by a board‑certified or board‑eligible Geneticist or a clinician specializing in Fabry disease.

Hematologic agents — Gamifant; Granix/Zarxio

Gamifant (emapalumab) and G‑CSF biosimilars — hematologic criteria

Gamifant — HLH/MAS: Diagnosis of primary HLH with refractory/recurrent/progressive disease OR HLH/MAS in Still's disease (including systemic JIA) with inadequate response/intolerance to glucocorticoids or recurrent MAS; AND HLH diagnosis confirmed by molecular diagnosis OR fulfillment of five out of eight conventional criteria (examples: low/absent NK cell function; splenomegaly; elevated sCD25 >= 2,400 U/mL; triglycerides >= 265 mg/dL or fibrinogen < 1.5 g/L; hemophagocytosis; cytopenias affecting >=2 lineages); AND receiving prophylaxis for Herpes Zoster, Pneumocystis jirovecii, and fungal infections.

Granix/Zarxio — congenital/cyclic/idiopathic neutropenia: Diagnosis of symptomatic congenital neutropenia OR cyclic neutropenia OR idiopathic neutropenia; AND used to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers); AND previous treatment failure with filgrastim biosimilars Zarxio AND Granix as specified for some Neupogen indications.

Gamifant - Initial coverage criteria

Gamifant (emapalumab) is covered when ALL of the following are met:

Diagnosis of ONE of: (a) Primary HLH with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy; OR (b) HLH/macrophage activation syndrome (MAS) in known or suspected Still's disease including systemic JIA with inadequate response or intolerance to glucocorticoids or recurrent MAS

HLH confirmation: HLH diagnosis confirmed by molecular diagnosis OR five out of eight conventional criteria (including low/absent NK cell function; splenomegaly; elevated sCD25 ≥2,400 U/mL; triglycerides ≥265 mg/dL or fibrinogen <1.5 g/L; hemophagocytosis; cytopenias affecting ≥2 lineages)

Infection prophylaxis: Receiving prophylaxis for Herpes Zoster; Pneumocystis jirovecii; and fungal infections

Filgrastim products - Covered indications

Filgrastim products (Granix, Zarxio, Neupogen and others) covered when ALL corresponding criteria for each indication are met:

Symptomatic congenital/cyclic/idiopathic neutropenia: Diagnosis of symptomatic congenital neutropenia OR cyclic neutropenia OR idiopathic neutropenia; AND used to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers);

For some Neupogen indications previous treatment failure with filgrastim biosimilars Zarxio and Granix is required.

Autologous hematopoietic progenitor cell mobilization: Used for mobilization of autologous hematopoietic progenitor cells into peripheral blood for collection by leukapheresis;

Coverage notes include prior treatment failure with biosimilars for some products.

Radiation exposure: Use to increase survival in patients acutely exposed to myelosuppressive doses of radiation;

Neulasta may require prior use of Udenyca or Udenyca Onbody; Neupogen indications list prior biosimilar failure for some uses.

Lamzede - Initial and continuation

Lamzede (velmanase alfa) coverage:

Diagnosis confirmation: Diagnosis of alpha‑mannosidosis confirmed by enzyme assay demonstrating alpha‑mannosidase activity < 10% of normal activity; AND provider attests signs/symptoms consistent with mild/moderate disease; AND prescribed by a specialist familiar with lysosomal storage disorders.

Continuation: For continuation, requires documentation of clinical response to therapy (improvement or stabilization in motor function, FVC, reduction in infections).

Lemtrada - Coverage criteria

Lemtrada (alemtuzumab) coverage:

Diagnosis of relapsing forms of multiple sclerosis or active secondary progressive disease.

Prior treatment failure: Inadequate response to two or more drugs indicated for treatment of MS (see related policy for examples).

Myalept - Coverage criteria

Myalept (metreleptin) coverage:

Myalept criteria: Diagnosis of congenital or acquired generalized lipodystrophy; AND HIV negative; AND documented leptin deficiency; AND enrollment in and compliance with REMS/prescription authorization requirements.

Nemlivo - Coverage criteria

Nemlivo (nemolizumab) coverage for dermatitis and prurigo nodularis:

Moderate-to-severe atopic dermatitis: Patient has moderate‑to‑severe atopic dermatitis; AND inadequate response to at least one other systemic immunosuppressant OR contraindication to other systemic drugs OR claim history of topical calcineurin (pimecrolimus/tacrolimus) within prior 90 days; AND patient is >= 12 years old; AND documented failure of a 14‑day trial of a prescription topical corticosteroid in claims history or prior treatment; AND prescribed by a board‑certified or board‑eligible Allergist or Dermatologist; AND documented dose and frequency within FDA‑approved dosing.

Prurigo nodularis: Patient >= 18 years old with diagnosis of prurigo nodularis; AND documented dose and frequency within FDA‑approved dosing.

Initial Therapy - Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab‑csfr) — Covered when ALL of the following are met

Niktimvo criteria: 1) Patient is either >= 18 years OR < 18 years and >= 40 kg; AND 2) Diagnosis of chronic graft‑versus‑host disease (cGVHD); AND 3) Prior treatment with at least two lines of systemic therapies.

Initial Therapy - Nivestym (filgrastim-aafi)

Nivestym (filgrastim‑aafi) — Covered when ALL of the following are met

Nivestym criteria: 1) Diagnosis of severe chronic neutropenia; AND 2) Previous treatment failure with filgrastim biosimilars Zarxio AND Granix where specified.

Initial Therapy - Nulibry (fosdenopterin)

Nulibry (fosdenopterin) — Covered when ALL of the following are met

Nulibry criteria: 1) Confirmed diagnosis of Molybdenum cofactor deficiency Type A (MoCD Type A); AND 2) Confirmed MOCS1 mutation; AND 3) Prescribed by a board‑certified or board‑eligible Geneticist or Neonatologist.

Initial Therapy - Ocrevus (ocrelizumab) and Ocrevus Zunovo

Ocrevus and Ocrevus Zunovo — Covered when ALL of the following are met

Diagnosis options: Relapsing forms of MS (including CIS, RRMS, active SPMS) in adults OR Primary progressive MS in adults.

Prescriber and age: Age >= 18 years; AND prescribed by a board‑certified or board‑eligible Neurologist.

Initial Therapy - Onpattro (patisiran)

Onpattro (patisiran) — Covered when ALL of the following are met

Onpattro criteria: 1) Age >= 2 years; AND 2) Confirmed diagnosis of hereditary transthyretin‑mediated amyloidosis (hATTR); AND 3) Polyneuropathy characterized by baseline PND IIb or lower OR baseline FAP Stage 1 or 2; AND 4) Tissue biopsy showing amyloid deposition OR genetic test confirming hATTR mutation; AND 5) Prescribed by a board‑certified or board‑eligible Neurologist, Geneticist, or specialist in amyloidosis.

Initial Therapy - Oxlumo (lumasiran)

Oxlumo (lumasiran) — Covered when ALL of the following are met

Oxlumo criteria: 1) Confirmed diagnosis of Primary Hyperoxaluria type 1 (PH1); AND 2) Confirmed AGXT mutation; AND 3) No history of kidney or liver transplant; AND 4) No clinical evidence of systemic oxalosis; AND 5) Concurrent use of pyridoxine OR prior trial of pyridoxine >= 3 months without significant improvement (e.g., <30% reduction in urine oxalate); AND 6) Documentation of efforts to increase fluid intake as specified.

Initial Therapy - Denosumab (Prolia, Jubbonti, Stobclo)

Prolia (denosumab) and biosimilars — Covered when ALL of the following are met

Denosumab criteria: 1) Diagnosis of osteoporosis OR glucocorticoid‑induced osteoporosis; AND 2) Documented dose and frequency within FDA‑approved dosing; AND 3) Previous treatment failure with one or more oral bisphosphonates resulting in intolerance OR inability to swallow or remain upright during administration; OR 4) Other listed indications such as androgen‑deprivation or aromatase inhibitor‑induced bone loss in cancer patients as specified.

Initial Therapy - Zoledronic acid / Ibandronate

Reclast (zoledronic acid) / Ibandronate — Covered when corresponding criteria are met

Osteoporosis with reclast/ibandronate: Diagnosis of osteoporosis; AND previous treatment failure with one or more oral bisphosphonates resulting in intolerability or inability to swallow/remain upright; AND for Reclast a contraindication to zoledronic acid noted where applicable.

Paget's disease / prevention: Diagnosis of Paget's disease of bone; OR being used for prevention of osteoporosis/osteopenia; AND for Reclast may be covered after treatment failure or contraindication to zoledronic acid.

Initial Therapy - Regranex (becaplermin)

Regranex (becaplermin) — Covered when ALL of the following are met

Diabetic ulcers: Confirmed lower extremity neuropathic diabetic ulcer(s); AND full‑thickness ulcer(s) (Stage III or IV) extending through dermis into subcutaneous tissue; AND adequate tissue oxygenation (transcutaneous partial pressure of oxygen >= 30 mm Hg at foot dorsum or ulcer margin); AND participation in a wound‑management program including sharp debridement, pressure relief, and infection control.

Pressure ulcers: Confirmed pressure ulcer(s); AND full‑thickness ulcer(s) (Stage III or IV); AND ulcer location that can be off‑loaded for duration of treatment; AND albumin > 2.5 g/dL; AND total lymphocyte count > 1,000; AND normal vitamins A and C.

Initial Therapy - Rivfloza (nedosiran)

Rivfloza (nedosiran) — Covered when ALL of the following are met

Rivfloza initial criteria: 1) Documented diagnosis of Primary Hyperoxaluria type 1 (PH1) with confirmed AGXT mutation via genetic testing or liver enzyme analysis; AND 2) estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m2; AND 3) age >= 2 years; AND 4) prescribed by a board‑certified or board‑eligible Nephrologist or Urologist; AND 5) 24‑hour urinary oxalate excretion >= 0.7 mmol normalized to 1.73 m2 BSA; AND 6) member is not taking Oxlumo concurrently; AND 7) patient is receiving the treatment under only one benefit (Pharmacy or Medical).

Rivfloza (nedosiran) — Initial Therapy

Rivfloza initial criteria: 1) Documented diagnosis of Primary Hyperoxaluria type 1 (PH1) with confirmed AGXT mutation via genetic testing or liver enzyme analysis; AND 2) eGFR >= 30 mL/min/1.73 m2; AND 3) age >= 2 years; AND 4) prescribed by a board‑certified or board‑eligible Nephrologist or Urologist; AND 5) 24‑hour urinary oxalate excretion >= 0.7 mmol normalized to 1.73 m2 BSA; AND 6) member is not taking Oxlumo concurrently; AND 7) patient is only receiving treatment under one benefit (Pharmacy or Medical).

Tegsedi (inotersen) — Initial Therapy

Tegsedi (inotersen) — Covered when ALL of the following are met

Tegsedi initial criteria: 1) Diagnosis of hereditary transthyretin‑mediated amyloidosis (hATTR); AND 2) age > 18 years; AND 3) documented polyneuropathy characterized by tissue biopsy showing amyloid deposition OR baseline PND IIb or lower OR baseline FAP Stage 1 or 2; AND 4) prescribed by a board‑certified or board‑eligible Neurologist, Geneticist, or amyloidosis specialist; AND 5) previous treatment failure with, or contraindication to, Onpattro (patisiran).

Biopsy and staging are acceptable documentation for polyneuropathy.

Tepezza (teprotumumab) — Initial Therapy

Tepezza (teprotumumab) — Covered when ALL of the following are met

Tepezza initial criteria: Confirmed diagnosis of Thyroid Eye Disease (TED) with documentation of active moderate to severe disease; AND age >= 18 years; AND prescribed by a board‑certified or board‑eligible ophthalmologist; AND laboratory results demonstrating patient is euthyroid prior to starting therapy; AND documented dose and frequency within FDA‑approved dosing; AND documentation of one or more of: lid retraction >2 mm, moderate/severe soft‑tissue involvement, proptosis >3 mm above normal for race/sex, or periodic/constant diplopia; AND therapy limited to one course of 8 doses.

Criteria for retreatment pending trial results.

Tymlos (abaloparatide) — Initial Therapy

Tymlos (abaloparatide) — Covered when ALL of the following are met

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Tysabri (natalizumab) — Multiple Indications

Tysabri (natalizumab) — Covered for specified indications when ALL the corresponding criteria are met

Tysabri for Multiple Sclerosis: Diagnosis of relapsing forms of MS (including CIS, RRMS, active SPMS); AND age > 18 years; AND treatment failure with, or contraindication to, one of Avonex, Betaseron, Copaxone, or Rebif within the past 6 months; AND prescribed by a board‑certified or board‑eligible neurologist.

Tysabri for Crohn's Disease: Diagnosis of moderately to severely active Crohn's disease; AND age >= 18 years; AND treatment failure with, or contraindication to, one TNF blocker; AND prescribed by a board‑certified or board‑eligible gastroenterologist; AND not used in combination with other integrin inhibitors (e.g., vedolizumab).

Tzield (teplizumab) — Initial Therapy

Tzield (teplizumab) — Covered when ALL of the following are met

Tzield initial criteria: Diagnosis of stage 2 type 1 diabetes characterized by laboratory evidence of dysglycemia AND presence of >= 2 positive pancreatic autoantibodies; AND age >= 8 years; AND prescribed by or in consultation with a board‑certified or board‑eligible endocrinologist.

Authorization is a one‑time, one‑month lifetime allowance.

Veopoz (pozelimab) — Initial Therapy

Veopoz (pozelimab) — Covered when ALL of the following are met

Veopoz initial criteria: Diagnosis of CHAPLE disease with confirmed CD55 loss‑of‑function mutation; AND age >= 1 year; AND not receiving Soliris concurrently with Veopoz; AND prescribed by a board‑certified or board‑eligible hematologist, gastroenterologist, or rare‑disease specialist.

Authorization valid for a one‑time, one‑month per lifetime when approved.

Vyjuvek (beremagene geperpavec-svdt) — Initial Therapy

Vyjuvek (beremagene geperpavec‑svdt) — Covered when ALL of the following are met

Vyjuvek initial criteria: Diagnosis of dystrophic epidermolysis bullosa (DEB); AND documented COL7A1 mutation(s); AND age > 6 months; AND dosing within weekly maximum per age (0.8 mL/week for <3 years; 1.6 mL/week for >=3 years) as specified; AND patient receives treatment under a single benefit (Pharmacy or Medical).

Wainua (eplontersen) — Initial Therapy

Wainua (eplontersen) — Covered when ALL of the following are met

Wainua initial criteria: Diagnosis of hereditary transthyretin‑mediated amyloidosis (hATTR); AND tissue biopsy showing amyloid deposition OR genetic test confirming hATTR mutation; AND age > 18 years; AND documented polyneuropathy characterized by baseline PND IIb or lower OR FAP Stage 1 or 2; AND no prior or planned liver transplant, NYHA class >2 heart failure, or concomitant use of another TTR silencer (e.g., Amvuttra, Tegsedi, Onpattro); AND prescribed by a board‑certified or board‑eligible specialist (Neurologist/Geneticist/amyloidosis specialist).

Winrevair (sotatercept) — Initial Therapy

Winrevair (sotatercept) — Covered when ALL of the following are met

Winrevair initial criteria: Documented diagnosis of pulmonary arterial hypertension (WHO Group 1); AND WHO Functional Class II or III; AND age >= 18 years; AND prescribed by a board‑certified or board‑eligible cardiologist or pulmonologist; AND concurrent therapy with two or more classes among PDE‑5 inhibitor, endothelin receptor antagonist, sGC stimulator, or prostacyclin agents;

Xenpozyme (olipudase alfa) — Initial Therapy

Xenpozyme (olipudase alfa) — Covered when ALL of the following are met

Xenpozyme initial criteria: Diagnosis of acid sphingomyelinase deficiency (ASMD) confirmed via enzyme assay and judged to be ASMD type B or A/B; AND no central nervous system manifestations; AND prescribed by a specialist familiar with lysosomal storage disorders; AND for adults DLco < 70% predicted normal.

Osenvelt/Xgeva/Wyost (denosumab products) — Indications

Covered when criterion 1 and a single other corresponding criterion is met

Denosumab products criteria: 1) Documented dose and frequency submitted and within FDA‑approved dosing; AND 2) one of: prevention of skeletal related events in bone metastases from solid tumors; OR prevention of skeletal related events in multiple myeloma; OR treatment of unresectable giant cell tumor of bone in adults/skeletally mature adolescents; OR treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Xiaflex (clostridial collagenase) — Dupuytren's Contracture

Xiaflex for Dupuytren's contracture: Documented diagnosis of Dupuytren's contracture; AND age >= 18 years; AND presence of a palpable cord; AND functional impairment; AND fixed‑flexion contracture of MCP or PIP joint >= 20 degrees (excluding thumb); AND injection administered by a physician credentialed in hand surgery or by a board‑certified rheumatologist experienced in hand injections.

Authorization granted for up to 3 injections at 4‑week intervals per lesion.

Pressure Ulcers — Medical Necessity

Covered when ALL of the following are met

Pressure ulcers criteria: Confirmed pressure ulcer(s); AND documentation of full‑thickness ulcer(s) (Stage III or IV) extending through dermis into subcutaneous tissue; AND ulcer(s) are in an anatomic location that can be off‑loaded or completely relieved for duration of treatment; AND albumin level > 2.5 g/dL; AND total lymphocyte count > 1,000; AND normal values of vitamins A and C.

Dupuytren's Contracture

Covered when ALL of the following are met

Dupuytren's contracture criteria: Documented diagnosis of Dupuytren's contracture; AND age >= 18 years; AND palpable cord present; AND functional impairment; AND fixed‑flexion contracture of MCP or PIP >= 20 degrees (excluding thumb); AND injection administered only by a physician credentialed in hand surgery or by a board‑certified rheumatologist experienced in hand injections.

Authorization up to 3 injections at 4‑week intervals per lesion.

Peyronie's Disease

Covered when ALL of the following are met

Peyronie's disease criteria: Documented diagnosis of Peyronie's disease; AND age >= 18 years; AND palpable plaque causing curvature; AND curvature deformity >= 30 degrees at start of therapy; AND injection administered only by a physician board certified or board eligible in urology.

Authorization up to 8 injections at 6‑week intervals per lesion.

Zometa (zoledronic acid) / Zoledronic Acid

Zoledronic acid is considered medically necessary for any of the following

Zometa/zoledronic acid indications: Hypercalcemia of malignancy; OR multiple myeloma; OR documented bone metastases from solid tumors; OR for Zometa (brand) prior treatment failure with or contraindication to zoledronic acid.

Medical Necessity for Acthar (J0800)

Covered when ALL of the following are met

Submission requirements: The listed CPT and HCPCS codes (including J0800) must be submitted with one of the specified ICD‑10 diagnosis codes and meet the policy's medical necessity criteria for Commercial Members (HMO, POS, PPO, Indemnity).

Medical necessity mapping for HCPCS → ICD-10

Covered when ALL of the following are met

Submission and necessity: The listed HCPCS code is submitted with one of the specified ICD‑10 diagnosis codes and the policy medical necessity criteria (as referenced) are met; applies to Commercial Members (HMO, POS, PPO, Indemnity).

Coverage condition for listed HCPCS codes

Covered when ALL of the following are met

Linkage and criteria: HCPCS code is submitted with an ICD‑10 diagnosis code listed in this section AND applicable medical necessity clinical criteria are met (clinical criteria referenced but not included in this excerpt).

General medical necessity linkage

Coverage of the listed HCPCS codes is subject to the medical necessity criteria in the policy and requires submission of one of the specified diagnosis codes for Commercial Members (HMO/POS, PPO, Indemnity).

General requirement: HCPCS code submitted with an associated ICD‑10 diagnosis code listed in this section AND the medical necessity criteria in the policy are met (applies to codes listed in related HCPCS lists).

Teriparatide products (Bonsity, Forteo, Teriparatide) are approved only when the policy's medical necessity criteria for osteoporosis are met and when the authorization limits are observed. Authorization is for 24 months when initial criteria are satisfied; continuation may allow up to one additional year. These products are not covered for other indications, including Paget's disease, use for prevention of osteoporosis, pediatric patients with open epiphyses, patients with bone metastases or prior skeletal malignancy, prior radiation involving the skeleton, or for patients with hypercalcemia.

Teriparatide therapies must be billed with the appropriate HCPCS/ICD-10 linkage described elsewhere in the policy and meet documentation and age requirements to avoid denial.

Filsuvez (birch triterpenes) coverage explicitly prohibits concurrent use with Vyjuvek (beremagene geperpavec‑svdt). When requesting authorization, providers must attest that the patient is not receiving Vyjuvek concurrently and that Filsuvez will be administered under a single benefit (Pharmacy or Medical) as required by the policy.

Several agents in this policy (including filgrastim/pegfilgrastim products and related supportive-care therapies) are not covered for indications that are not listed in this policy or in related policy #105 (Supportive Care Treatments for Patients with Cancer). Requests for uses outside the specified indications referenced here or in policy #105 will be denied as not covered.

Providers should consult the related policy #105 for the full list of supportive‑care indications; absence of an allowed indication in either policy is a basis for noncoverage.

Neupogen and Nivestym are limited to the indications enumerated in this policy (and where applicable, to indications cross‑referenced to policy #105). Use of Neupogen or Nivestym for conditions not listed in this policy or in policy #105 is not covered and may be denied.

For certain Neupogen indications the policy also requires prior treatment failure with specific filgrastim biosimilars (e.g., Zarxio, Granix) as part of step‑therapy and documentation expectations.

The policy requires that a patient receive a specialty therapy under one benefit only (Pharmacy OR Medical). Concurrent billing or dual coverage of the same treatment under both the pharmacy and medical benefits is not allowed and may result in denial. Examples in this policy (Vyjuvek, Rivfloza) reinforce the single‑benefit requirement and the need to indicate on requests and claims which benefit will cover the therapy.

Medications designated as specialty and obtained through the Pharmacy benefit (except as noted for some Medicare plans) must be dispensed through a provider in the payer's retail specialty pharmacy network. Providers should confirm specialty‑pharmacy network requirements prior to filling prescriptions to ensure benefit compliance and avoid claim issues.

HCPCS and other procedure codes listed in this policy are covered only when the associated medical necessity criteria are met. Submission of the HCPCS code alone without meeting the policy clinical requirements does not establish coverage.

Claims for listed HCPCS codes (examples and code groups are provided in the coding section) must therefore be supported by the clinical documentation required by the relevant drug or indication criteria.

When billing HCPCS codes that appear in this section, providers must submit an appropriate ICD‑10 diagnosis code from the lists in this policy. The policy requires that the HCPCS code be submitted with one of the listed ICD‑10 diagnosis codes to be considered medically necessary.

Failure to include a matching ICD‑10 diagnosis on the claim or prior authorization request may result in denial or claim rejection.

Coverage for many of the HCPCS codes in this policy is contingent on submission of a specified ICD‑10 diagnosis code that supports the medical necessity criteria. If an HCPCS code is submitted without an associated listed ICD‑10 diagnosis, coverage will generally not be allowed.

Providers should include the applicable ICD‑10 code(s) from the policy's diagnosis lists with any HCPCS/CPT submission to satisfy the linkage requirement.

Any request or claim that does not meet the medical necessity criteria in this policy (including missing or inappropriate diagnosis codes) will be considered not medically necessary and may be denied. This includes HCPCS/CPT claims submitted without the required listed ICD‑10 diagnosis or without satisfying the indication‑specific clinical criteria.

Providers should ensure that documentation (clinical notes, tests, genetic results where required) accompanies prior authorization requests and claims to demonstrate that the policy criteria are met.

The Enjaymo (sutimlimab) section appears in the policy text but is incomplete in this fragment of the document and does not provide full coverage or not‑medically‑necessary statements in the available excerpt. Providers should refer to the complete policy text or contact the payer for the full medical necessity criteria and any exclusion language for Enjaymo before submitting an authorization request.

Filgrastim products (e.g., Granix, Zarxio, Neupogen and related agents) are covered only for the specified indications listed in this policy (such as symptomatic congenital/cyclic/idiopathic neutropenia, autologous stem cell mobilization, and radiation exposure). Use for any other condition not listed here or in related policy #105 is not covered and may be denied.

Some Neupogen indications additionally require prior treatment failure with specific filgrastim biosimilars; check the indication‑specific criteria for step‑therapy requirements.

Neupogen is explicitly referenced as not covered for conditions that are not listed in this policy or in related policy #105. Requests for Neupogen outside the enumerated indications will be considered non‑covered and may be denied.

Providers must document the indication and, where required, prior biosimilar trials or reasons preventing such trials to support coverage.

Any submission that does not meet the policy's medical necessity criteria — including failure to provide a required ICD‑10 diagnosis code with submitted CPT/HCPCS codes — will be considered not medically necessary. Providers should verify that the clinical scenario, documentation, and coding correspond to the policy's listed criteria before submitting an authorization or claim to avoid denial.

The policy reiterates that medical necessity must be demonstrated for CPT/HCPCS codes to be covered for Commercial members.

Use of HCPCS codes without an appropriate listed ICD‑10 diagnosis code or without meeting the policy's medical necessity criteria is specifically excluded from coverage. The policy treats HCPCS submissions lacking the required diagnosis linkage as insufficient to establish medical necessity.

To support adjudication, include the specific ICD‑10 code(s) named in the policy when submitting HCPCS claims or prior authorization requests.

Claims submitted with HCPCS codes that do not meet the policy's medical necessity criteria or that lack one of the specified ICD‑10 diagnosis codes may be denied. The document explicitly states that absence of the required criteria or diagnosis linkage will lead to noncoverage for Commercial members.

Providers should ensure completeness of clinical documentation and correct ICD‑10 coding on claims to reduce the risk of denial.

Claims that do not meet the stated criteria will be denied. The policy makes clear that HCPCS/CPT codes, drugs, or services listed in the policy are covered only when the corresponding medical necessity criteria and required ICD‑10 diagnosis codes are submitted; otherwise the claim will be adjudicated as not medically necessary or not covered.

Review the policy's indication‑specific sections and the ICD‑10 lists when preparing prior authorization requests or claims to ensure all requirements are met.

Initial Authorization Requirements

inv-210: Initial therapy requirements (drug-specific)

Initial authorization criteria for specific agents

Initial therapy entries: See individual drug‑specific criteria sets for required diagnostic confirmation, prescriber specialty, age limits, and concomitant therapy prohibitions (e.g., no dual TTR‑lowering therapy for Amvuttra; Aphexda must be used with filgrastim).

inv-211: Evenity — Initial therapy limitation

Evenity treatment limitation

treatment_limit: Treatment duration of Evenity is limited to 12 monthly doses due to reduced anabolic effect.

inv-212: Initial therapy criteria

Initial coverage nodes for selected agents:

Continuation and Retreatment Criteria

inv-218: Teriparatide continuation

Duration and continuation rules when initial criteria met

Teriparatide continuation: If initial teriparatide criteria are met, authorization will be approved for 24 months. If continuation is approved, up to one additional year may be granted.

inv-219: Continuation requirements

Continuation requirements where specified:

Lamzede continuation: Documentation of clinical response to therapy (improvement or stabilization in motor function, FVC, reduction in frequency of infections) attested by provider is required for continuation.

inv-220: Tepezza continuation/retreatment

Tepezza retreatment

CPT / HCPCS / ICD-10 Codes

Covered HCPCS CodesHCPCSCovered

J9038	Injection, axatilimab-csfr, 0.1 mg (Niktimvo)
J0256	Injection, alpha 1-proteinase inhibitor (human), 10 mg (examples: Aralast, Prolastin-C, Zemaira)
J0257	Injection, alpha proteinase inhibitor (human) (GLASSIA) 10 mg
J0775	HCPCS unspecified - example entry
J0800	Example covered HCPCS (placeholder)
J3110	Injection, teriparatide; 10 mcg
J1726	Injection, hydroxyprogesterone caproate, 10 mg (Makena)
J1729	Injection, hydroxyprogesterone caproate NOS, 10 mg
J2323	Injection, natalizumab
J1786	Injection, imiglucerase 10 units (Cerezyme)

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Covered CPT CodesCPTCovered

20527	Injection, enzyme (eg, collagenase) Dupuytren's contracture
26341	Manipulation, palmar fascial cord (post enzyme injection), single cord

Covered CPT Codes (additional)CPTCovered

26341

Manipulation, palmar fascial cord (i.e., Dupuytren's cord), post enzyme injection (e.g., collagenase) single cord

Covered ICD-10 CodesICD-10Covered

D89.811	Chronic graft-versus-host disease
E88.01	Alpha-1-antitrypsin deficiency
J43.1	Panlobular emphysema
J43.2	Centrilobular emphysema
J43.8	Other emphysema
J43.9	Emphysema, unspecified
N48.6	Induration penis plastica
M72.0	Palmar fascial fibromatosis [Dupuytren]
M75.00	Adhesive capsulitis of unspecified shoulder
M75.01	Adhesive capsulitis of right shoulder

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Authorization, Documentation, and Denial Risk — What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization required. Providers must submit a Massachusetts Standard Form for Medication Prior Authorization Requests (eForm #434) or the BCBSMA prior authorization form; clinical documentation should be faxed to Pharmacy Operations at 1-800-583-6289 or submitted via phone 1-800-366-7778. Length of approval is generally 12 months unless otherwise specified in individual drug criteria.

Use prescription claims history to document prior trials when available; if claims do not establish prior use, submit supporting medical records.
Individual consideration (exception) requests require detailed clinical documentation including names/strengths of formulary alternatives tried, dates, and reasons for failure.

Documentation Required

Medical Necessity and Diagnosis Coding Required

Many specialty drugs in this policy are covered only when medical necessity criteria are met and appropriate documentation is provided. Submitting the correct ICD-10 diagnosis code that matches the HCPCS/CPT code and the medical necessity criteria is required for claim adjudication; missing or non-matching diagnosis codes are a frequent denial trigger.

Step Therapy and Prior-Use Requirements

Requirement	Details
Provider documentation of trials and reasons for failure or contraindication required
Documentation must include name and strength of alternatives tried and failed (including dates if available) and specifics regarding treatment failure or clinical reasons preventing trial; prescription claims may be used to establish prior use; additional information may be requested if claims are unavailable or do not establish step therapy

Requirement	Atopic dermatitis specifics
Required before approval for atopic dermatitis indications
Inadequate response to at least one other systemic immunosuppressant OR contraindication to systemic agents OR claim history of topical pimecrolimus/tacrolimus within prior 90 days; demonstrated failure of a 14-day trial of a prescription topical corticosteroid; drug prescribed by board-certified/eligible Allergist or Dermatologist; documented dose and frequency within FDA‑approved dosing must be submitted

Requirement

Atopic dermatitis specifics

Required before approval for atopic dermatitis indications

Inadequate response to at least one other systemic immunosuppressant OR contraindication to systemic agents OR claim history of topical pimecrolimus/tacrolimus within prior 90 days; demonstrated failure of a 14-day trial of a prescription topical corticosteroid; drug prescribed by board-certified/eligible Allergist or Dermatologist; documented dose and frequency within FDA‑approved dosing must be submitted

Requirement	Examples / Notes
Prior therapy required before coverage of next-line agent
Examples include inadequate response to two or more MS drugs before Lemtrada; treatment failure with listed first-line agents (e.g., interferons, glatiramer) prior to escalation to agents like Tysabri; for Crohn's, failure/contraindication to a TNF blocker is required before certain next-line biologics

Requirement	Denosumab / Zoledronic acid specifics
Prior trial or intolerance required before denosumab or zoledronic acid coverage
Coverage requires previous treatment failure with one or more oral bisphosphonates resulting in intolerance OR documented inability to swallow or remain upright for oral bisphosphonates; documented dose and frequency within FDA‑approved dosing must be submitted

Requirement	Filgrastim biosimilar requirement
Prior filgrastim biosimilar trials required
Some indications require previous treatment failure with filgrastim biosimilars Zarxio and Granix (e.g., Nivestym and certain Neupogen indications) prior to coverage of alternative filgrastim products

Requirement	Details / Examples
Failure or contraindication to listed therapies required before coverage
For several agents, coverage is contingent on documented failure of or contraindication to specified alternative therapies (examples: Tysabri requires failure/contraindication to interferons/glatiramer for MS; Crohn's indications require failure/contraindication to a TNF blocker). Providers must document trials or clinical rationale preventing trial.

Requirement	Provider actions when claims unavailable
Provider must document prior use via claims or supply additional clinical information if claims are unavailable
Prescription claims may be used to verify prior medication trials; when claims data are not available or insufficient, provider must submit supporting clinical documentation (e.g., notes listing medication name/strength/dates, reasons for discontinuation or intolerance) to demonstrate step therapy or formulary alternative trials

Requirement	Details
Submit HCPCS with an approved ICD-10 diagnosis and meet medical necessity criteria
The listed HCPCS codes must be submitted with one of the specified ICD‑10 diagnosis codes in the policy and the applicable medical necessity criteria must be met for coverage (applies to Commercial members). Absence of an appropriate ICD‑10 or failure to meet medical necessity may result in denial or be considered not medically necessary.

Quantity and Dosing Limits

inv-230: Vyjuvek (beremagene geperpavec-svdt) — maximum weekly volume by age

Maximum weekly volume (<3 years)0.8 mL per week (maximum weekly volume after mixing Vyjuvek suspension with excipient gel for patients 6 months to <3 years)

Maximum weekly volume (>=3 years)1.6 mL per week (maximum weekly volume after mixing Vyjuvek suspension with excipient gel for patients >=3 years)

Dose units reportedPolicy expresses maximum dose both as plaque forming units (PFU) and milliliters after mixing (PFU values listed in policy for age bands)

inv-120: Abaloparatide/teriparatide cumulative duration <= 24 months

Cumulative duration limitAbaloparatide and teriparatide combined lifetime aggregate treatment duration must not exceed 24 months

Initial authorization period

Benefit Channel and Administration Site Guidance

Note

Infusion center / buy‑and‑bill may apply

Some medications may be covered under the medical benefit (Buy‑and‑Bill) rather than the pharmacy benefit; providers should confirm site‑of‑care billing requirements.

Billing Rule

Single benefit billing requirement

Treatments must be billed under a single benefit (Pharmacy or Medical); members receiving the treatment are not to be concurrently billed under multiple benefits.

Documentation Required

Office administration credentialing for Xiaflex

For Xiaflex injections, the policy requires injections be administered only by physicians credentialed in hand surgery (orthopedics or plastic surgery) or by a board‑certified rheumatologist experienced in hand injections.

Biosimilar Substitution and Prior-Therapy Notes

Step Therapy

Neupogen / filgrastim biosimilar prior‑failure requirement

For some Neupogen indications, prior failure with filgrastim biosimilars (Zarxio and Granix) is required before coverage of the requested product will be authorized.

Document prior treatment failure with Zarxio AND Granix

Billing Rule

Denosumab biosimilar (Q5136) — same criteria and ICD‑10 required

Denosumab biosimilar Q5136 is listed alongside J0897; when billed the biosimilar requires meeting the same medical necessity criteria and submission of an appropriate ICD‑10 diagnosis for coverage.

Q5136 is treated equivalently to J0897 for medical necessity and ICD‑10 submission

Key Definitions and Clinical Thresholds

inv-188: Alpha-1 antitrypsin deficiency definition & thresholds

Defining laboratory thresholdAlpha-1 antitrypsin blood level < 80 mg/dL (11 µmol/L)

Required imagingCT scan demonstrating significant emphysema

Pulmonary function thresholdFEV1/FVC < 70%

Age and smoking statusPatient age ≥ 18 years and current non-smoker

inv-189: hATTR polyneuropathy and ATTR cardiomyopathy definitions

hATTR polyneuropathy confirmationConfirmed diagnosis with documented TTR gene mutation and baseline PND score < III

ATTR cardiomyopathy confirmation

Policy Background and Scope

This policy provides medical necessity criteria for a broad range of specialty therapies — including enzyme replacement therapies, biologics, gene‑modulating therapies, colony‑stimulating factors, anabolic osteoporosis agents, and topical growth factors. It includes condition‑specific criteria (for example: alpha‑1 antitrypsin deficiency/emphysema, hereditary transthyretin‑mediated amyloidosis, Gaucher disease, osteoporosis, multiple sclerosis) and maps certain HCPCS codes to required ICD‑10 diagnosis codes.

Providers seeking coverage for the therapies listed in this policy must follow the policy's prior authorization, documentation, and coding requirements to demonstrate that the medical necessity criteria are met.

Policy Revision History

2025-09-15revisionLatest

Moved multiple HAE agents to Medical Policy #058; added new indication for Gamifant; updated various drug indications and added products (e.g., Niktimvo).

2025-08-01revision

Updated indications for Dupixent (added Chronic Spontaneous Urticaria and Chronic Rhinosinusitis) and added ATTR-CM indication for Amvuttra; added several denosumab products and Niktimvo; removed discontinued products and updated references.

2025-07-01

OpenPayer

Prior authorization and medical necessity criteria for specialty and pharmacy drugs

Medical Necessity and Coverage Criteria

Initial Authorization Requirements

Continuation and Retreatment Criteria

CPT / HCPCS / ICD-10 Codes

Authorization, Documentation, and Denial Risk — What Providers Must Do

Step Therapy and Prior-Use Requirements

Quantity and Dosing Limits

Benefit Channel and Administration Site Guidance

Biosimilar Substitution and Prior-Therapy Notes

Key Definitions and Clinical Thresholds

Policy Background and Scope

Policy Revision History