Effective August 1, 2026: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Marnetegragene autotemcel (Kresladi) (CP.PHAR.599)

Medicaid and CHIP

Policy updates include:

·         Criteria updated per FDA labeling: removed minimum age requirement, removed option for those with an HLA-matched sibling donor, and updated dose requirement

Navepegritide (Yuviwel) (CP.PHAR.746)

Medicaid and CHIP

Policy updates include:

·         Criteria updated per prescribing information to include weight-based dosing and quantity limits

·         Added to continued therapy requirement that Yuviwel is not prescribed concurrently with Voxzogo and any human growth hormone products

Pembrolizumab, Pembrolizumab Berahyaluronidase alfa-pmph (Keytruda, Keytruda Qlex) (CP.PHAR.322)

Medicaid and CHIP

Policy updates include:

·         Updated Food and Drug Administration (FDA) Approved Indication section with addition of Food and Drug Administration (FDA)-approved test for esophageal or GEJ cancer whose tumors express PD-L1 (combined positive score (CPS) at least 1)

·         For Keytruda Qlex, added indication for usage in the neoadjuvant/adjuvant setting for locally advanced head and neck squamous cell carcinoma

Teplizumab-mzwv (Tzield) (CP.PHAR.492)

Medicaid and CHIP

Policy updates include:

·         Revised age requirement from at least 8 years to at least 1 year to reflect pediatric extension and added new boxed warning (viral reactivation)

Anifrolumab-fnia (Saphnelo) (CP.PHAR.551)

Medicaid and CHIP

Policy updates include:

·         Added new subcutaneous formulations of prefilled syringe and autoinjector

Tividenofusp Alfa (Avlayah) (CP.PHAR.748)

Medicaid and CHIP

Policy includes:

·         Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage

·         Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business MS.PMN.53 for Medicaid and CHIP

·         Initial Approval Criteria: Mucopolysaccharidosis (MPS) II: Hunter Syndrome (must meet all):

o   Diagnosis of MPS II (Hunter syndrome) confirmed by one of the following:

§  Enzyme assay demonstrating a deficiency of iduronate 2-sulfatase (IDS) activity;

§  Genetic confirmation of pathogenic or likely pathogenic mutation(s) in the IDS gene;

o   Age less than 18 years at initiation of Avlayah;

o   Member’s weight meets both of the following:

§  Documentation of current weight in kg;

§  Current weight ≥ 5 kg;

o   Member does not have advanced neurological impairment (e.g., severe cognitive decline, profound functional dependence);

o   Avlayah is not prescribed concurrently with Elaprase^®;

o   Dose does not exceed 15 mg/kg per week.

o   Approval duration: 12 months

·         Continued Therapy: Mucopolysaccharidosis II: Hunter Syndrome (must meet all):

o   Member meets one of the following:

§  Currently receiving medication via Centene benefit or member has previously met initial approval criteria;

§  Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;

o   Member is responding positively to therapy as evidenced by improvement or stabilization in the individual member’s MPS II manifestation profile;

o   Member does not have advanced neurological impairment (e.g., severe cognitive decline, profound functional dependence);

o   Avlayah is not prescribed concurrently with Elaprase;

o   Documentation of member’s current weight in kg;

o   If request is for a dose increase, new dose does not exceed 15 mg/kg per week.

o   Approval duration: 12 months

Lunsotogene parvec-cwha (Otarmeni) (CP.PHAR.757)

Medicaid and CHIP

Policy includes:

·         Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage

·         Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: MS.PMN.53 for Medicaid and CHIP

·         Initial Approval Criteria: Sensorineural Hearing Loss (must meet all):

o   Diagnosis of severe-to-profound sensorineural hearing loss as evidenced by both of the following:

§  Genetic testing confirms biallelic pathogenic or likely pathogenic OTOF variants;

§  Member meets all of the following in the requested treatment ear(s):

·         Severe-to-profound hearing loss defined by an average audiometric threshold of greater than 90 dB HL;

·         Absent auditory brainstem response (ABR);

·         Intact outer hair cell function as evidenced by one of the following:

o   Presence of otoacoustic emissions (OAE);

o   Presence of a cochlear microphonic;

o   Prescribed by or in consultation with an otolaryngologist;

o   Member does not have a history of a cochlear implant in the requested treatment ear(s);

o   Member has not previously been treated with Otarmeni in the requested treatment ear(s);

o   Member has not received prior gene therapy;

o   Dose does not exceed a single intracochlear infusion of 7.2 x 10¹² vector genomes (vg) per ear.

o   Approval duration: 3 months (one lifetime intracochlear infusion per ear)

·         Continued Therapy: Sensorineural Hearing Loss  

o   Re-authorization is not permitted. Members must meet the initial approval criteria.

o   Approval duration: Not applicable