Acalabrutinib (Calquence) (CP.PHAR.366)

Ambetter

Policy updates include:

• Removed the following for MCL, CLL, and SLL indications: “If refractory to Imbruvica (member previously used Imbruvica and remission was not achieved or disease stopped responding), member does not have a BTK C481S mutation”
• For WM, LPL, and MZL added requirement that Calquence is not prescribed concurrently with Imbruvica or Brukinsa
• For MZL, clarified non-gastric MALT is noncutaneous and added Nodal MZL per NCCN.

Alpelisib (Piqray, Vijoice) (CP.PHAR.430)

Ambetter

Policy updates include:

• For PROS, for initiation of therapy added option for diagnosis of PROS if PIK3CA gene mutation is not identified
• For continuation of therapy added option to demonstrate positive response that includes improvement in PROS related signs, symptoms or complications and functional status
• For imaging requirement added must be obtained within the last 6 months

Belinostat (Beleodaq) (CP.PHAR.311)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated NCCN-recommended off-label uses
• Removed mycosis fungoides, cutaneous CD30+ T-cell lymphoma, and Sézary syndrome
• Added breast implant ALCL (Category 2A recommendation)

Belumosudil (Rezurock) (CP.PHAR.552)

Ambetter

Policy updates include:

• Added exclusion for concomitant use with Imbruvica or Jakafi into the Continued Therapy section

Bendamustine (Belrapzo, Bendeka, Treanda) (CP.PHAR.307)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added SLCA and hematopoietic cell transplantation under NCCN recommended use given category 2A recommendation
• Removed primary cutaneous lymphomas as use is no longer supported by NCCN primary cutaneous lymphoma guideline

Bevacizumab (Alymsys, Avastin, Mvasi, Zirabev) (CP.PHAR.93)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added additional NCCN-supported indications of ampullary adenocarcinoma cancer, malignant peritoneal mesothelioma, and pediatric diffuse high-grade glioma
• Re-classified anaplastic gliomas to astrocytoma and oligodendroglioma per updated NCCN classification
• Removed breast cancer indication, WHO grade 2 glioma indication, and single-agent therapy option for cervical cancer per NCCN
• Removed “radiographic and/or clinical relapse”, “recurrent”, and “carcinosarcoma with… BRCA 1/2 mutation” disease qualifiers for ovarian cancer as there are other clinical scenarios per NCCN
• Added new regimens for cervical and colorectal cancers per NCCN

Biologic and Non-biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• Modified Remicade redirection to be stepwise, first requiring Inflectra and Renflexis, then if member has failed Inflectra and Renflexis member must use Avsola
• For Avsola added redirection to Inflectra and Renflexis

Cetuximab (Erbitux) (CP.PHAR.317)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For HNSCC, removed required 5-FU combination per NCCN
• Added “advanced, unresectable, or metastatic” for CRC setting and “after prior therapy” if BRAF V600E positive for CRC per NCCN
• For NSCLC, removed requirement that tumor be T790M negative and added T790M positive option per NCCN
• For skin cancer, added criterion that for use as a single agent and removed basal cell carcinoma indication per NCCN

Continuous Glucose Monitors (CP.PMN.214)

Ambetter

Policy updates include:

• Revised to align with InterQual medical criteria as follows: initial criteria – removed requirements for a prescribing physician who has seen the member in person in the last 6 months, blood glucose testing 4 or more times per day, and in person visits every 6 months
• Added additional pathway to approval for members not receiving intensive insulin therapy (adults with type 2 diabetes)
• Added requirement for participation in a physician-directed comprehensive diabetes management program; continued criteria – added additional pathways to receive replacement devices based on the age/lifetime of the current device
• Added requirement for ongoing monitoring from a physician/clinical specialist

Duvelisib (Copiktra) (CP.PHAR.400)

Ambetter

Policy updates include:

• Removed off-label criteria for FL and MZL as these indications are no longer supported by NCCN
• Added off-label criteria for T-cell lymphomas supported by NCCN

Eculizumab (Soliris) (CP.PHAR.97)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For NMOSD, removed redirection to Enspryng
• For gMG modified from two to one immunosuppressive therapy required, added requirement that Soliris is not prescribed concurrently with Ultomiris or Vyvgart.

Efgartigimod Alfa-fcab (Vyvgart) (CP.PHAR.555)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Updated requirement for no concurrent use to include Ultomiris
• Added to continuation of therapy requirement for no concurrent use with Soliris or Ultomiri.

Elagolix (Orilissa), elagolix-estradiol-norethindrone (Oriahnn) (CP.PHAR.136)

Ambetter

Policy updates include:

• Added reproductive endocrinologist as a prescriber option
• Added requirement that member has not previously received 24 or more months of cumulative elagolix therapy

Enasidenib (Idhifa) (CP.PHAR.363)

Ambetter

Policy updates include:

• In patients age ≥ 60 years, added Idhifa must be used as a single agent and option to decline intensive therapy per NCCN

Eribulin Mesylate (Halaven) (CP.PHAR.318)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Removed coverage for angiosarcoma and solitary fibrous tumor as use is no longer supported by the NCCN Soft Tissue Sarcoma guidelines

Finerenone (Kerendia) (CP.PMN.266)

Ambetter

Policy updates include:

• Added redirection to SGLT inhibitor per American Diabetes Association guideline

Flibanserin (Addyi) (CP.PHAR.446)

Ambetter

Policy updates include:

• Added to initial criteria that HSDD is not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance per PI

Gabapentin ER (Gralise, Horizant) (CP.PMN.240

Ambetter

Policy updates include:

• Added additional redirection requirements to generic pregabalin immediate and controlled-release and TCA

GLP-1 receptor agonists (HIM.PA.53)

Ambetter

Policy updates include:

• For Rybelsus added additional requirement for redirection to Victoza, Trulicity, and Ozempic

Inhaled Agents for Asthma and COPD (HIM.PA.153)

Ambetter

Policy updates include:

• Added Flovent HFA to policy requiring step through fluticasone propionate HFA (Flovent HFA authorized generic)
• Added maximum age limit of 12 years for Flovent HFA

Inotersen (Tegsedi) (CP.PHAR.405)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added requirement that member has not received prior treatment with Amvuttra or Onpattro as a result of the recent Amvuttra FDA approval and for consistency across this therapeutic area
• Applied to continued therapy requirement that member has not had a prior liver transplant; added Amvuttra should not be prescribed concurrently with Tegsedi

Irinotecan Liposome (Onivyde) (CP.PHAR.304)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per NCCN and FDA label, added that disease must be locally advanced, metastatic, or recurrent and added requirement for disease progression following gemcitabine-based therapy or FOLFIRINOX

Lanreotide (Somatuline Depot) (CP.PHAR.391)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For acromegaly, added confirmatory diagnostic requirements (IGF-I or GH) per PS/ES practice guidelines
• Per NCCN, specified that thymic/ bronchopulmonary NETs and insulinomas must be SSTR-positive or have hormonal symptoms and added that any grade 3 NETs with favorable biology are also coverable

Lapatinib (Tykerb) (CP.PHAR.79)

Ambetter

Policy updates include:

• Per NCCN, for breast cancer, added requirement for prior therapy if prescribed in combination with capecitabine or trastuzumab (with bypass for brain metastases for capecitabine) and for colorectal cancer, added additional disease qualifier of unresectable

Lenvatinib (Lenvima) (CP.PHAR.138)

Ambetter

Policy updates include:

• Added off-label criteria for TC per NCCN category 2A recommendation
• Removed off-label criteria for ATC as use is no longer supported by NCCN
• For EC, revised dMMR to pMMR per updated FDA approved indication

Mavacamten (Camzyos) (CP.PMN.272)

Ambetter

Policy updates include:

• Added requirement for maximal left ventricular wall thickness

Migalastat (Galafold) (CP.PHAR.394)

Ambetter

Policy updates include:

• Added requirement on continuation of therapy to document improvement on patient-specific clinical manifestations of Fabry disease

Montelukast Oral Granules (Singulair) (HIM.PA.129)

Ambetter

Policy updates include:

• Added redirection to generic

Moxetumomab Pasudotox-tdfk (Lumoxiti) (CP.PHAR.398)

Ambetter

Policy updates include:

• Changed approval duration to 6 months for initial and continued therapy
• Added maximum of 6 cycles per PI

Octreotide Acetate (Sandostatin, Sandostatin LAR Depot, Bynfezia, Mycapssa) (CP.PHAR.40)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For acromegaly, added confirmatory diagnostic requirements (IGF-I or GH) per PS/ES practice guidelines.

Olaparib (Lynparza) (CP.PHAR.360)

Ambetter

Policy updates include:

• Due to withdrawal of the previously FDA-approved indication, added prescriber attestation requirement for use in gBRCAm ovarian cancer after ≥ 3 lines of chemotherapy

Panitumumab (Vectibix) (CP.PHAR.321)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added qualifiers that CRC is advanced, recurrent, or metastatic per NCCN
• Added BRAF V600E mutation positive criterion option to wild-type options as this mutation also allows for Vectibix administration per NCCN category 2A rating

Pasireotide (Signifor, Signifor LAR) (CP.PHAR.332)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For acromegaly, added confirmatory diagnostic requirements (IGF-I or GH) per PS/ES practice guidelines

Patisiran (Onpattro) (CP.PHAR.395)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added criterion for no prior treatment with Amvuttra or Tegsedi in initial approval criteria due to lack of supportive evidence
• Updated concurrent use exclusion with recently approved TTR-directed small interfering ribonucleic acid Amvuttra for both initial and continued approval criteria
• Included criterion for no prior liver transplant for continued approval criteria (already exists in initial approval criteria)

Pegvisomant (Somavert) (CP.PHAR.389)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added confirmatory diagnostic requirements (IGF-I or GH) per PS/ES practice guidelines

Pertuzumab (Perjeta) (CP.PHAR.227)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Revised criteria to clarify pertuzumab must be prescribed with trastuzumab and docetaxel or chemotherapy

Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For gMG modified from two to one immunosuppressive therapy required, clarified MG-ADL total score should be assessed on continuation of therapy requests
• Added Vyvgart should not be prescribed concurrently with Ultomiris.

Rifaximin (Xifaxan) (CP.PMN.47)

Ambetter

Policy updates include:

• Added requirement for concurrent lactulose and rifaximin to initial criteria for HE per guidelines

Romidepsin (Istodax) (CP.PHAR.314)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per NCCN, clarified CTCL vs other coverable T-cell lymphomas
• Per NCCN and PI, added requirement for failure of at least one prior systemic therapy, unless member has mycosis fungoides or Sezary syndrome

Ruxolitinib (Jakafi, Opzelura) (CP.PHAR.98)

Ambetter

Policy updates include:

• Criteria added for new Opzelura indication of NSV
• For myelofibrosis, added criterion for recent documentation of a platelet count of ≥ 50 × 109/L per PI and to align with other myelofibrosis policies

Temsirolimus (Torisel) (CP.PHAR.324)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per NCCN, added disease qualifiers for PEComa
• Added non-pleomorphic rhabdomyosarcoma as a coverable off-label diagnosis

Zanubrutinib (Brukinsa) (CP.PHAR.467)

Ambetter

Policy updates include:

• Per NCCN Compendium added off label use in LPL
• For WM, LPL, MZL added requirement that Brukinsa is not prescribed concurrently with Calquence

Ziv-aflibercept (Zaltrap) (CP.PHAR.325)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added diagnosis qualifier that CRC is advanced, unresectable, or metastatic per NCCN