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Home , Asfotase alfa, Carglumic acid, Sebelipase alfa, Uridine triacetate

The following list of abbreviated criteria is a tool used to ensure drug benefits are administered as designed and that plan members receive therapy that is safe, effective for their condition, and provides the greatest value. These policies promote the use of evidence-based drug therapy and can minimize overall medical costs and improve member access to more affordable care.

Carbaglu® () Formulary 1, 2, Date of Origin: 4/11 Last Reviewed: 3/21 Updated: 5/21 3/Exclusive, Coverage Criteria: Coverage is provided when ALL of the following criteria are met: 4/AON • Medication has been prescribed by or in consultation with a physician experienced in treating metabolic disorders • ONE of the following: o Medication has been requested for the treatment of acute or chronic due to documented N- acetylglutamate synthase (NAGS) deficiency o Medication has been requested for adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)

Initial Coverage Duration: NAGS: 6 months, PA/MMA: 1 month (up to a 7 day course) Renewal Criteria: NAGS: May be renewed in 24-month intervals in presence of sustained benefit of therapy. PA/MMA: may be renewed for additional treatment courses (up to a 7 day course at a time) if the initial criteria is met

Dificid™ (fidaxomicin) Formulary 1, 2, Date of Origin: 6/12 Last Reviewed: 9/20 Updated: 1/21 3/Exclusive, Coverage Criteria: Coverage for quantities greater than 10 day supply of medication (20 4/AON tablets or one 150 ml glass bottle containing granules for oral suspension) requires clinical rationale and proof of medical necessity. Coverage Duration/Renewal Criteria: Reviewed on a case-by-case basis

Drug Therapy Guidelines Abbreviated Criteria for Drug Coverage

Gralise® (gabapentin ER) Formulary 1, 2, Date of Origin: 9/11 Last Reviewed: 9/20 Updated: 1/21 3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of adult postherpetic neuralgia 4/AON Coverage Duration/Renewal Criteria: Indefinite

Hetlioz® (tasimelteon) Formulary 1, 2, Date of Origin: 6/14 Last Reviewed: 9/20 Updated: 1/21 3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of adult Non-24-Hour Sleep-Wake 4/AON Disorder (Non-24) Coverage Duration/Renewal Criteria: Indefinite

Jetrea® (ocriplasmin) – J7316 Medical Date of Origin: 9/13 Last Reviewed: 6/21 Updated: 08/21 Coverage Criteria: Coverage is provided for the one-time treatment of vitreomacular adhesion (H43.821, H43.822, H43.823, H43.829). Coverage Duration/Renewal Criteria: 1 month for one-time treatment. May not be renewed for treatment of same vitreomacular adhesion.

Kanuma® () – J2840 Medical Date of Origin: 6/16 Last Reviewed: 6/21 Updated: 08/21 Coverage Criteria: Coverage is provided when ALL of the following criteria are met: • Prescribed by, or in consultation with, a provider with expertise in lysosomal storage diseases • Member has a diagnosis of lysosomal acid lipase (LAL) deficiency (including Wolman disease and cholesterol ester storage disease) (R74.8, E75.5, E75.6) • Diagnosis has been confirmed by laboratory tests, imaging studies, genetic testing, or highly specific dried blood spot (clinical documentation required). Coverage Duration/Renewal Criteria: 12 months. May be renewed in presence of sustained benefit of therapy.

Keveyis® (dichlorphenamide) Formulary 1, 2, Date of Origin: 12/15 Last Reviewed: 3/21 Updated: 5/21 3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of primary hyperkalemic periodic 4/AON paralysis, primary hypokalemic periodic paralysis, and related variants Drug Therapy Guidelines Abbreviated Criteria for Drug Coverage

Coverage Duration/Renewal Criteria: Indefinite

Mulpleta® (lusutrombopag) Formulary 1, 2, Date of Origin: 9/18 Last Reviewed: 6/21 Updated: 08/21 3/Exclusive, Coverage Criteria: Coverage is provided when ALL of the following criteria are met: 4/AON • Medication has been prescribed by a hepatologist or hematologist • Diagnosis of chronic liver disease with thrombocytopenia (platelet count < 50 x 109/L) has been documented • Patient will undergo a procedure and the medication will be administered in accordance with FDA-approved dosing and timing (based on date of procedure) Coverage Duration/Renewal Criteria: 7-day treatment prior to scheduled procedure

Nuedexta™ (dextromethorphan-quinidine) Formulary 1, 2, Date of Origin: 6/11 Last Reviewed: 9/20 Updated: 1/21 3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of pseudobulbar affect (PBA) 4/AON Coverage Duration/Renewal Criteria: Indefinite

Nuplazid™ (pimavanserin) Formulary 1, 2, Date of Origin: 8/16 Last Reviewed: 9/20 Updated: 1/21 3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of hallucinations and delusions 4/AON associated with Parkinson’s disease psychosis (PA will not be required for those with a recent pharmacy claim for an anti-Parkinson’s medication). Coverage Duration/Renewal Criteria: Indefinite

Panretin® (altretinoin) Formulary 1, 2, Date of Origin: 3/21 Last Reviewed: 3/21 Updated: 5/21 3/Exclusive, Coverage Criteria: Coverage is provided for members at least 18 years of age for the 4/AON treatment of cutaneous lesions associated with AIDS-related Kaposi’s sarcoma

Coverage for the treatment Duration/Renewal of hallucinations Criteria: and Indefinite delusions associated with Parkinson’s disease psychosis (PA will not be required for those with a recent pharmacy claim for an anti- Parkinson’s medication).

Drug Therapy Guidelines Abbreviated Criteria for Drug Coverage

Strensiq® () Formulary 1, 2, Date of Origin: 3/16 Last Reviewed: 6/21 Updated: 08/21 3/Exclusive, Coverage Criteria: Coverage is provided when ALL of the following criteria are met: 4/AON • Prescribed by or in consultation with an endocrinologist or a provider who specializes in the treatment of perinatal, infantile-onset or juvenile-onset hypophosphatasia (HPP) AND • Age at disease onset is less than 18 years AND • The member has a documented diagnosis of perinatal/infantile- or juvenile-onset HPP supported by all of the following: o Serum (ALP) level below the age-adjusted normal range AND o Plasma pyridoxal-5’- (PLP) above the upper limit of normal AND o Documentation of tissue nonspecific alkaline phosphatase (TNSALP) gene mutation(s) Coverage Duration/Renewal Criteria: 12 months. May be renewed upon submission of chart notes documenting response to therapy.

Sylvant® (siltuximab) – J2860 Medical Date of Origin: 9/14 Last Reviewed: 3/21 Updated: 5/21 Coverage Criteria: Coverage is provided for the treatment of members with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Coverage Duration/Renewal Criteria: 12 months. May be renewed upon submission of chart notes documenting response to therapy.

Trientine (Clovique™, Syprine®, trientine) Formulary 1, 2, Date of Origin: 1/16 Last Reviewed: 12/20 Updated: 2/21 3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of Wilson’s disease when 4/AON continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Coverage Duration/Renewal Criteria: 12 months. May be renewed upon submission of chart notes documenting response to therapy.

Xatmep™ (methotrexate oral solution) Formulary 1, 2, Date of Origin: 7/17 Last Reviewed: 12/20 Updated: 2/21 Drug Therapy Guidelines Abbreviated Criteria for Drug Coverage

3/Exclusive, Coverage Criteria: Coverage is provided for the treatment of pediatric patients with acute 4/AON lymphoblastic leukemia (ALL) as a component of a combination maintenance regimen OR pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy, when appropriate dosing is requested. Coverage Duration/Renewal Criteria: 6 months. May be renewed in presence of sustained benefit of therapy.

Xuriden® ( triacetate) Formulary 1, 2, Date of Origin: 6/16 Last Reviewed: 6/21 Updated: 08/21 3/Exclusive, Coverage Criteria: Coverage is provided when a diagnosis of hereditary orotic aciduria is 4/AON confirmed. Coverage Duration/Renewal Criteria: Indefinite

The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post- payment reviews to assess the medical appropriateness of the above-referenced therapies.

The preceding policy applies only to members for whom the above named pharmacy benefit are included on their covered formulary. Members with closed formulary benefits are subject to trying all appropriate formulary alternatives before a coverage exception for a non-formulary medication will be considered.

The preceding policy is a guideline to allow for coverage of the pertinent medication/product, and is not meant to serve as a clinical practice guideline.

08/03/21