POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Acalabrutinib (Calquence) (CP.PHAR.366)

Ambetter

Policy updates include:

· Updated the conditions under which Calquence can be used as first-line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma

Aflibercept (Eylea, Eylea HD), Eylea Biosimilars (CP.PHAR.184)

Ambetter

Policy updates include:

· For Enzeevu, updated Food and Drug Administration (FDA)-approved indications to include diabetic macular edema, diabetic retinopathy, and retinal vein occlusion

Amivantamab-vmjw, Amivantamab-Hyaluronidase-lpuj (Rybrevant, Rybrevant Faspro) (CP.PHAR.544)

Ambetter

Policy updates include:

· Added two new Rybrevant Faspro dosage strengths of 2,400 mg amivantamab and 30,000 units hyaluronidase/15 mL and 3,520 mg amivantamab and 44,000 units hyaluronidase/22 mL

Antithymocyte Globulin (Atgam, Thymoglobulin) (CP.PHAR.506)

Ambetter

Policy updates include:

· Updated Thymoglobulin indication to include pediatric and adult patients

· Per National Comprehensive Cancer Network (NCCN): Updated “immunotherapy-related” to “immune checkpoint inhibitor-related” toxicity, specified cardiovascular toxicity as myocarditis, added indications of immune checkpoint inhibitor-related hepatobiliary toxicity and aplastic anemia, specified that myelodysplastic syndrome and acute graft-versus-host disease are specific to Atgam requests, specified that acute graft-versus-host disease is steroid-refractory, specified that myelodysplastic syndrome is lower-risk, added conditioning regimen as an option for Atgam use, and clarified that chimeric antigen receptor T-cell-related toxicity is specific to grade 4 cytokine release syndrome

Axicabtagene ciloleucel (Yescarta) (CP.PHAR.362)

Ambetter

Policy updates include:

· Removed limitation of use in primary central nervous system lymphoma

· Removed exclusion for those with history of current central nervous system disease

Daratumumab, Daratumumab-Hyaluronidase-fihj (Darzalex, Darzalex Faspro) (CP.PHAR.310)

Ambetter

Policy updates include:

· For Darzalex Faspro added to Food and Drug Administration (FDA) approved indications new use for multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant

Filgrastim (Neupogen, Zarxio, Granix, Nivestym, Releuko, Nypozi, Filkri) (CP.PHAR.297)

Ambetter

Policy updates include:

· Added Filkri to policy

· Revised peripheral blood progenitor cell collection initial approval duration for Medicaid/Ambetter to 12 months

· For continued therapy of peripheral blood progenitor cell collection, added exclusion for re-authorization and that member must meet the initial approval criteria

· Revised continued therapy approval duration for all other indications for Medicaid/Ambetter to 12 months

Iloperidone (Fanapt) and Milsaperidone (Bysanti) (CP.PMN.32)

Ambetter

Policy updates include:

· Added Bysanti to policy and requirement against concurrent use of Fanapt and Bysanti (duplicate therapy)

Inclisiran (Leqvio) (CP.PHAR.568)

Ambetter

Policy updates include:

· Added criteria for new indication of homozygous familial hypercholesterolemia

· Added pediatric expansion for heterozygous familial hypercholesterolemia

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

Ambetter

Policy updates include:

· Added new indication for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (previously off-label, now Food and Drug Administration (FDA)-labeled)

Zongertinib (Hernexeos) (CP.PHAR.750)

Ambetter

Policy updates include:

· Removed prior systemic therapy in Food and Drug Administration (FDA) approved indications section and “failure of a prior systemic therapy” requirement in initial approval criteria to reflect expanded indication