inv-01: Alpha-1 antitrypsin replacement — medical necessity — Covered when ALL of the following are met
Aralast/NP, Glassia, Prolastin C, or Zemaira (alpha-1 antitrypsin) may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:
ALL of the following
Diagnosis of emphysema (must have CT scan showing significant emphysema disease).
Documented alpha-1 antitrypsin deficiency, as demonstrated by blood levels less than 80 mg/dL (11 µmol/L).
Plasma levels less than 80 mg/dL (11 µmol/L).
inv-02: Aphexda — medical necessity
Aphexda (motixafortide) may be considered MEDICALLY NECESSARY and covered when ALL the following criteria are met:
ALL of the following
Confirmed diagnosis of multiple myeloma.
The medication is being used to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation.
Will be used in combination with filgrastim (G-CSF).
inv-03: Denosumab (oncologic indications)
Bilprevda (denosumab-nxxp), Bomyntra (denosumab-bnht), Osenvelt (denosumab-bmwo), Xgeva (denosumab), Wyost (denosumab-bbdz) may be considered MEDICALLY NECESSARY and covered for the below indications when criterion 1 and a single other corresponding criterion is met:
ALL of the following
Documented Dose and Frequency must be submitted and must be within the FDA approved Dosing and Frequency.
ANY of the following
Prevention of skeletal related events in bone metastases from solid tumors.
Prevention of skeletal related events in Multiple Myeloma.
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
inv-04: Denosumab/Prolia — osteoporosis indications
Ospomyv, Bildyos, Conexxence, Prolia, Jubbonti, or Stobclo (denosumab products) may be considered MEDICALLY NECESSARY and covered for osteoporosis indications when ALL the following criteria are met:
ALL of the following
Diagnosis of osteoporosis OR glucocorticoid-induced osteoporosis.
Documented Dose and Frequency must be submitted and must be within the FDA approved Dosing and Frequency.
Previous treatment failure with one (1) or more oral bisphosphonates (e.g., alendronate, risedronate) resulting in intolerability to the oral product OR one of the following: a) Inability to swallow; b) Inability to remain upright during post oral bisphosphonate administration; c) Being used to increase bone mass in adults at high risk for fracture; d) Initiating or continuing systemic glucocorticoids ≥ 7.5 mg prednisone daily and expected to remain on glucocorticoids for ≥ 6 months.
For Bildyos, Ospomyv, and Prolia: previous use of TWO (2) preferred drugs and failure or clinical rationale for not using the preferred medication.
inv-05: Teriparatide — medical necessity and limits
Bonsity (Teriparatide), Forteo (Teriparatide), or Teriparatide may be considered MEDICALLY NECESSARY and covered when ALL the following criteria are met:
ALL of the following
Diagnosis of osteoporosis in post-menopausal women OR primary or hypogonadal osteoporosis in men OR glucocorticoid-induced osteoporosis.
Considered high risk of fractures, determined by having multiple risk factors or having a history of fractures.
For Bonsity and Forteo requests: Previous use teriparatide.
inv-06: Briumvi — relapsing MS
Briumvi (ublituximab) may be considered MEDICALLY NECESSARY and covered when ALL the following criteria are met:
ALL of the following
Diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Prescribed by a board-certified or board-eligible Neurologist.
inv-07: Gaucher disease — enzyme replacement
Cerezyme (imiglucerase), Elelyso (taliglucerase), or VPRIV (velaglucerase) may be considered MEDICALLY NECESSARY and covered when the following criteria are met:
ALL of the following
Diagnosis of Type 1 Gaucher disease.
inv-08: Dupixent — asthma and atopic dermatitis
Dupixent (dupilumab) may be considered MEDICALLY NECESSARY and covered when ALL the following criteria are met for the specific indications below:
ANY of the following
Moderate to Severe Asthma
ALL of the following
Add-on maintenance treatment of patients with moderate-to-severe asthma.
Patient is ≥ 6 years old.
Patient is diagnosed with an eosinophilic phenotype OR has oral corticosteroid dependent asthma.
Documented Dose and Frequency must be submitted and must be within the FDA approved Dosing and Frequency.
inv-16: Ebglyss (lebrikizumab) - Moderate to Severe Atopic Dermatitis
Ebglyss (lebrikizumab) may be considered MEDICALLY NECESSARY and covered when ALL the following criteria are met:
ALL of the following
The patient has moderate-to-severe atopic dermatitis (eczema).
The patient is ≥ 12 years of age.
The patient demonstrated treatment failure with a 14-day trial of a prescription topical corticosteroid OR topical calcineurin inhibitors in claims history or previous treatment.
The drug is prescribed by a board-certified or board-eligible Allergist or Dermatologist.
Documented Dose and Frequency must be submitted and must be within the FDA approved Dosing and Frequency.