Effective February 1, 2026: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Gemcitabine Intravesical System (Inlexzo) (CP.PHAR.753)

Medicaid and CHIP

Policy includes

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

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

·         Initial Approval Criteria

o   Non-Muscle Invasive Bladder Cancer (NMIBC) (must meet all):

§  Diagnosis of NMIBC with carcinoma in-situ;

§  Prescribed by or in consultation with an oncologist or urologist;

§  Age at least 18 years;

§  Member is refractory to  bacillus Calmette-Guerin (BCG)* treatment; *Prior authorization may be required for BCG immunotherapy

§  Member is not a candidate for cystectomy;

§  Member has previously undergone transurethral resection of bladder tumor (TURBT);

§  Request meets one of the following:

·         Dose does not exceed 225 mg once every 3 weeks for 8 instillations, followed by once every 12 weeks for 6 instillations;

·         Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

§  Approval duration: 12 months

·         Continued Therapy

o   Non-Muscle Invasive Bladder Cancer (must meet all):

§  Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Inlexzo for a covered indication and has received this medication for at least 30 days;

§  Member is responding positively to therapy as evidenced by lack of disease recurrence or progression;

§  Member has not received at least 14 instillations;

§  If request is for a dose increase, request meets one of the following:

·         If member has received < 8 instillations: New dose does not exceed 225 mg once every 3 weeks for up to 8 total instillations, followed by once every 12 weeks for 6 instillations;

·         If member has received at least 8 instillations: New dose does not exceed 225 mg once every 12 weeks for up to 6 total instillations;

·         New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

§  Approval duration: 12 months

Immune Globulins (CP.PHAR.103)

Medicaid and CHIP

Policy updates include:

·         For continued therapy, added language “(or health plan-preferred* immune globulin product)” to continue its usage, unless medical justification supports necessity for immune globulin product switch

Aflibercept (Eylea, Eylea HD, Ahzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, Yesafili) (CP.PHAR.184)

Medicaid and CHIP

Policy updates include:

·         Added new Eylea biosimilar Eydenzelt

Factor VIII-von Willebrand (Alphanate, Humate-P, Vonvendi, Wilate) (CP.PHAR.216)

Medicaid and CHIP

Policy updates include:

·         For Vonvendi, updated with pediatric extension for on-demand treatment of bleeding episodes, control of bleeding episodes, and perioperative management of bleeding, as well as with expansion to types 1 and 2 von Willebrand disease for routine prophylaxis

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

Medicaid and CHIP

Policy updates include:

·         Added new subcutaneous formulation Keytruda Qlex to policy

·         For Keytruda, converted Food and Drug Administration (FDA) approved indication for 400 mg every 6 week dosing regimen in adults with classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma to full approval

Bortezomib (Boruzu, Velcade) (CP.PHAR.410)

Medicaid and CHIP

Policy updates include:

·         Added new formulation Boruzu

·         Removed “if available” from generic bortezomib redirection as it is currently available

Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)

Medicaid and CHIP

Policy updates include:

·         Corrected follicular lymphoma and mantle cell lymphoma maximum dose from 100 to 110 x 106 chimeric antigen receptor (CAR)-positive viable T cells

Human Growth Hormone (Somapacitan, Somatrogon, Somatropin, Lonapegsomatropin-tcgd) (CP.PHAR.517)

Medicaid and CHIP

Policy updates include:

·         For Skytrofa, added new indication for replacement of endogenous growth hormone in adults with growth hormone deficiency and added new cartridge strengths (0.7 mg, 1.4 mg, 1.8 mg, 2.1 mg, 2.5 mg)

Beremagene Geperpavec (Vyjuvek) (CP.PHAR.592)

Medicaid and CHIP

Policy updates include:

·         Removed lower age limit of 6 months and modified maximum dose from 1.6 and 3.2 x 109 PFU per week to 2 and 4 x 109 PFU per week per updated labeling

·         Added administration information allowing application by patient or caregiver per updated instructions for use

Risperidone LA inj (Risperdal Consta, Perseris, Rykindo, Uzedy) (CP.PHAR.293)

Medicaid and CHIP

Policy updates include:

·         Added new indication of bipolar 1 disorder for Uzedy

Pemetrexed (Alimta, Pemfexy, Axtle) (CP.PHAR.368)

Medicaid and CHIP

Policy updates include:

·         Updated indication for Axtle to include combination with Keytruda and a platinum for non-small cell lung cancer

·         added off-label indication of thyroid carcinoma per National Comprehensive Cancer Network (NCCN) Compendium

·         updated HCPCS code description for J9292

Lenacapavir (Sunlenca, Yeztugo) (CP.PHAR.622)

Medicaid and CHIP

Policy updates include:

·         Removed failure of Fuzeon per manufacturer discontinuation