Cobimetinib (Cotellic) (CP.PHAR.380)

Ambetter

Policy updates include:

• For Melanoma criteria, added stage III melanoma as adjuvant therapy, limited resectable melanoma, and requirements for trial of Tafinlar/Mekinist,
• Updated off-label criteria for CNS cancers to include WHO grade 2, or 3 adult oligodendroglioma and WHO grade 2, 3, or 4 adult IDH-mutant astrocytoma, per NCCN-supported 2A recommendation
• Removed anaplastic glioma and grade 2 glioma as terminology is no longer used in NCCN compendium

Dabrafenib (Tafinlar) (CP.PHAR.239)

Ambetter

Policy updates include:

• Moved the following indications: hepatobiliary cancers, CNS cancers, ovarian, fallopian and peritoneal cancers from off-label criteria and added ampullary adenocarcinoma, pancreatic adenocarcinoma, salivary gland tumor, thyroid carcinoma (papillary, follicular, Hürthle) to solid tumor criteria (per NCCN 2A recommendation), as they are classified as solid tumors

Darbepoetin Alfa (Aranesp) (CP.PHAR.236)

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

Policy updates include:

• Per NCCN for MDS continuation of therapy modified treatment response assessment to occur after at least 8 weeks of therapy (previously this was 12 weeks)
• Per NCCN Compendium for MDS added approval pathway for lower risk (IPSS low/intermediate-1) disease associated with symptomatic anemia with del(5q)

Deferasirox (Exjade, Jadenu) (CP.PHAR.145)

Ambetter

Policy updates include:

• Added Parkinson disease to section III Diagnoses / Indications for which coverage is NOT authorized with rationale in Appendix E

Deferoxamine (Desferal) (CP.PHAR.146)

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

Policy updates include:

• Added Parkinson disease to section III Diagnoses / Indications for which coverage is NOT authorized with rationale in Appendix D

Dexrazoxane (Totect) (CP.PHAR.418)

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

Policy updates include:

• Updated FDA approved indication to mirror PI
• Clarified that use is limited to the pediatric population for Ph-negative ALL and Hodgkin lymphoma
• Added off-label use for soft tissue sarcoma to criteria under doxorubicin-induced cardiomyopathy per NCCN 2A recommendation

Dostarlimab-gxly (Jemperli) (CP.PHAR.540)

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

Policy updates include:

• Updated previously accelerated approved indication that was converted to full approval for dMMR EC with additional wording stating “not candidates for curative surgery or radiation.”

Entecavir (Baraclude) (HIM.PA.08)

Ambetter

Policy updates include:

• Removed HIM pharmacy benefit non- formulary exception language as prior authorization for both brand and generic Baraclude tabs is required for several state HIM formularies
• Added entecavir oral tablet criteria with template generic redirection verbiage
• Added maximum oral tablet dosing criteria

Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx (Retacrit) (CP.PHAR.237)

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

Policy updates include:

• Per NCCN for MDS continuation of therapy modified treatment response assessment to occur after at least 8 weeks of therapy (previously this was 12 weeks)
• Per NCCN Compendium for MDS added approval pathway for lower risk (IPSS low/intermediate-1) disease associated with symptomatic anemia with del(5q)
• For cancer indications and other indications sections clarified redirection requirements to include an option for Retacrit requests where no redirection is required
• For zidovudine induced anemia continuation of therapy added requirement to confirm member continues to receive zidovudine therapy

Esketamine (Spravato) (CP.PMN.199)

Ambetter

Policy updates include:

• For TRD added clarification that Spravato be used in combination with oral antidepressant

Ferric Carboxymaltose (Injectafer) (CP.PHAR.234)

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

Policy updates include:

• Updated initial criteria to require failure of the following with associated age considerations: for IDA and CKD Ferrlecit and Venofer; for IDA without CKD two of Ferrlecit, Infed, or Venofer;
• Additionally, added redirection to Feraheme in a step-wise fashion if member has intolerance or contraindication to all preferred injectable agents

Ferric Derisomaltose (Monoferric) (CP.PHAR.480)

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

Policy updates include:

• Per February SDC, updated initial criteria to require failure of the following: for IDA and CKD Ferrlecit and Venofer; for IDA without CKD two of Ferrlecit, Infed, or Venofer
• Additionally, added redirection to Feraheme in a step-wise fashion if member has intolerance or contraindication to all preferred injectable agents

Ferumoxytol (Feraheme) (CP.PHAR.165)

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

Policy updates include:

• Added Commercial line of business
• Updated initial criteria to require failure of the following: for IDA and CKD Ferrlecit and Venofer; for IDA without CKD two of Ferrlecit, Infed, or Venofer

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

Ambetter

Policy updates include:

• Per January SDC and prior clinical guidance, applied SGLT2 inhibitor redirection to all non-preferred GLP-1 agonists

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (CP.PMN.183)

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

Policy updates include:

• Per February SDC, added Soliqua requiring use of either basal insulin or GLP-1 receptor agonist within the past 180 days

IncobotulinumtoxinA (Xeomin) (CP.PHAR.231)

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

Policy updates include:

• Per February SDC and prior clinical guidance, added redirection requirement to co-prefer Botox and Dysport for all indications except chronic sialorrhea

Ipilimumab (Yervoy) (CP.PHAR.319)

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

Policy updates include:

• Updated FDA indication for RCC to mirror PI;
• Revised NSCLC criteria to include additional requirements related to mutation status
• Added off-label use for MSI-H/dMMR ampullary adenocarcinoma, bone cancer, brain metastases, and Kaposi sarcoma per NCCN compendium

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

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

Policy updates include:

• Per February SDC and prior clinical guidance added redirection to Sandostatin LAR depot.

Lecanemab-irmb (Leqembi) (CP.PHAR.596)

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

Policy updates include:

• Added specialist requirement
• Added attestation that the prescriber has discussed the potentially increased risk of ARIA in ApoE4 homozygotes and with concomitant anticoagulants/antithrombotics

Lenalidomide (Revlimid) (CP.PHAR.71)

Ambetter

Policy updates include:

• Per NCCN Compendium updated MM criteria updated maintenance therapy following autologous hematopoietic stem cell transplantation to include option for carfilzomib or bortezomib with dexamethasone
• For myelodysplastic syndrome added SF3B1 mutation status
• For myelofibrosis-associated anemia, added “in combination with prednisone taper”
• Updated off-label criteria for systemic light chain amyloidosis to include combination therapy
• For classic Hodgkin lymphoma changed “as third-line” to “as fourth-line” to align with NCCN Hodgkin Lymphoma guideline
• For HIV related B-cell lymphoma, post-transplant lymphoproliferative disorder of B-cell lymphomas and high grade B-cell diffuse lymphoma added “in combination with Monjuvi for non-transplant candidates”
• Added off-label criteria for POEMS syndrome per NCCN 2A recommendation  

Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) (CP.PHAR.582)

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

Policy updates include:

• Added clarification to approval duration is for up to a total of 6 doses
• Revised continued therapy approval duration from 12 to 6 months; for continued therapy added requirement that member has not received ≥ 6 doses (infusions) of Pluvicto
• Added piflufolastat F-18 as an additional radioactive diagnostic agent for identification of PSMA-positive disease

Mavacamten (Camzyos) (CP.PMN.272)

Ambetter

Policy updates include:

• ·For familial hypertrophic cardiomyopathy, updated maximal left ventricular wall thickness range to ≥ 13 mm to < 15 mm and added option for positive genetic test per AHA/ACC hypertrophic cardiomyopathy guidelines
• Clarified disopyramide’s place in therapy as add-on therapy to beta blocker or calcium channel blockers

Naldemedine (Symproic) (CP.PMN.112)

Ambetter

Policy updates include:

• Added redirection to Movantik

Naproxen/Esomeprazole (Vimovo) (CP.PMN.117)

Ambetter

Policy updates include:

• Added quantity limit for adolescents with weight 38 kg to < 50 kg

Ofatumumab (Arzerra, Kesimpta) (CP.PHAR.306)

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

Policy updates include:

• For Arzerra, removed B-cell lymphoma criteria, SLL criteria, and off-label CLL uses per updated NCCN guidelines and limited commercial availability
• For Kesimpta, applied template changes to continued therapy section, and for MS, to be inclusive of members continuing therapy from a different benefit
• Revised Medicaid/HIM continued approval duration to reference the duration of total treatment received rather than the number of re-authorizations

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

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

Policy updates include:

• For chronic anal fissure, revised maximum dosing allowance up to 25 units for initial therapy and 100 units for continued therapy per treatment session
• Added chronic sialorrhea off-label indication
• Per February SDC: removed Dysport and/or Xeomin redirection requirement for upper and lower limp spasticity, cervical dystonia, blepharospasm, overactive bladder, chronic migraine, and axillary hyperhidrosis
• For Overactive Bladder, updated criteria for adults to require use of two anticholinergic agents or one oral beta-3 agonist medication (previously both were required)
• Changed all approval durations to 12 months for Medicaid, HIM, and Commercial.

Opioid Analgesics (HIM.PA.139)

Ambetter

Policy updates include:

• For long acting agents or request exceeding 14-day supply within 28 days or 28-day supply within 90 days section
• For section II.C.2 changed day supply requirement from “7-day supply of opioid in last 90 days” to “14-day supply of opioid within 28 days or 28-day supply within 90 days”
• For section II.C II.D, added additional options to allow “documentation of recent (within the last 6 months) office visit or office chart notes demonstrating follow-up with the member” and “attestation that the provider has reviewed the treatment plan with the member and assessed the risks and benefits of the opioid dose and duration” to support need of opioid analgesics for member.

Overactive Bladder Agents (CP.PMN.198)

Ambetter

Policy updates include:

• For Toviaz requests added generic redirection

Paclitaxel, Protein-Bound (Abraxane) (CP.PHAR.176)

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

Policy updates include:

• Removed criterion for prior anthracycline therapy for non-triple negative breast cancer per NCCN
• Added ampullary adenocarcinoma and cervical cancer as additional NCCN supported indications (off-label)

Pembrolizumab (Keytruda) (CP.PHAR.322)

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

Policy updates include:

• Added criteria for newly FDA approved indication of single-agent adjuvant therapy for NSCLC
• Added “as determined by an FDA-approved test” for MSI-H/dMMR cancer and microsatellite instability-high or mismatch repair deficient CRC
• Revised “adult indications: additional dosing regimen” to apply only to adult cHL and PMBCL per updated PI
• Revised NSCLC criteria to include additional requirements related to mutation status per NCCN compendium

Phendimetrazine (CP.PCH.47)

Ambetter

Policy updates include:

• Clarified phendimetrazine ER is non-formulary for California and Florida LOB
• Added obesity definition for age < 18 years to initial criteria; removed continued therapy criterion of BMI ≥ 25 kg/m2 

Pomalidomide (Pomalyst) (CP.PHAR.116)

Ambetter

Policy updates include:

• For MM, added requirement that Pomalyst must be prescribed in combination with dexamethasone per PI and NCCN
• Added off-label criteria for POEMS and added requirement for Pomalyst to be prescribed as a single agent for primary CNS lymphomas per NCCN 2A compendium recommendation

Ponatinib (Iclusig) (CP.PHAR.112)

Ambetter

Policy updates include:

• For ALL added age requirement of 18 years or older

Regorafenib (Stivarga) (CP.PHAR.107)

Ambetter

Policy updates include:

• For GIST per prescribing information and NCCN clarified previous treatment requiring imatinib and Sutent
• Added per NCCN Compendium off label uses in combination with everolimus and SDH mutation positive disease
• For soft tissue sarcoma removed solitary fibrous tumor as this off-label use is no longer NCCN Compendium supported
• For pleomorphic rhabdomyosarcoma clarified disease is advanced or metastatic
• For non-adipocytic sarcoma clarified use is for subsequent therapy for advanced, metastatic, recurrent unresectable or recurrent stage IV disease

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

Policy updates include:

• Added requirement that member has not received prior treatment with Krazati per NCCN
• Revised Commercial approval durations from length of benefit to “12 months or duration of request, whichever is less.”

Step Therapy (HIM.PA.109)

Ambetter

Policy updates include:

• Removed Symtuza, dihydroergotamine, lovastatin SR as EST is no longer required
• Added clobetasol gel with similar requirements as Olux
• Clarified age limit is not required for Cimduo/Temixys

Temozolomide (Temodar) (CP.PHAR.77)

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

Policy updates include:

• For astrocytoma, replaced term anaplastic (no longer used in compendium) with IDH mutant per NCCN
• Added WHO grading per NCCN
• Added “disease is refractory and progressive despite treatment with procarbazine and nitrosourea” and added Appendix B per FDA label
• Per NCCN, removed criteria for mucosal melanoma (downgraded to 2B recommendation) and angiosarcoma as use is no longer recommended
• Updated off label-use criteria for solitary fibrous tumor to require use with bevacizumab
• Added off-label criteria for extrapulmonary poorly differentiated neuroendocrine carcinoma, large or small cell carcinoma, mixed neuroendocrine-non-neuroendocrine neoplasms, pediatric diffuse high-grade gliomas
• Updated off-label criteria for astrocytoma, oligodendroglioma and uterine sarcoma to align with NCCN

Tepotinib (Tepmetko) (CP.PHAR.530)

Ambetter

Policy updates include:

• For NSCLC that is MET exon 14 skipping-positive
• Added exclusion for previous progression with a MET exon 14 skipping mutation-targeted regimen per NCCN Compendium and New Century Health criteria
• Added monotherapy criterion per NCCN and New Century Health criteria

Thalidomide (Thalomid) (CP.PHAR.78)

Ambetter

Policy updates include:

• For myeloproliferative neoplasms added prescribed in combination with prednisone per NCCN 2A recommendation
• For aphthous stomatitis/ulcers, updated dose from 100 to 400 mg per day in initial criteria per Clinical Pharmacology and referenced trial (Jacobson et al)
• Clarified MM dosing in continued therapy criteria
• Revised oral oncology generic (if available) redirection language to align with template

Tivozanib (Fotivda) (CP.PHAR.538)

Ambetter

Policy updates include:

• Clarified requirement that RCC is of clear cell histology per NCCN and pivotal clinical trial inclusion criteria

Topotecan (Hycamtin) (CP.PHAR.64)

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

Policy updates include:

• Updated off-label criteria for endometrial carcinoma to include “as second line or subsequent therapy” per NCCN compendium

Tralokinumab-ldrm (Adbry) (CP.PHAR.577)

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

Policy updates include:

• Modified list of agents for which concurrent use is not allowed to include non-asthma biologic immunomodulators
• Clarified that topical corticosteroids requirement is for corticosteroids of different molecular identities and expanded examples of medium to very high potency topical corticosteroids, and removed low potency topical corticosteroids from Appendix B

Trametinib (Mekinist) (CP.PHAR.240)

Ambetter

Policy updates include:

• Moved the following indications: hepatobiliary cancers, CNS cancer, ovarian, fallopian, and peritoneal cancers, and metastatic uveal melanoma from off-label criteria and added ampullary adenocarcinoma, pancreatic adenocarcinoma, salivary gland tumor, thyroid carcinoma (papillary, follicular, Hürthle) to solid tumor criteria (per NCCN 2A recommendation), as they are classified as solid tumors
• For NSCLC updated oral oncology generic redirection language to align with other indications in policy

Umbralisib (Ukoniq) (CP.PHAR.531)

Ambetter

Policy updates include:

• Removed initial approval criteria for marginal zone lymphoma and follicular lymphoma as use is not supported by the FDA and NCCN

Velaglucerase alfa (VPRIV) (CP.PHAR.163)

Ambetter

Policy updates include:

• Added weight requirement and max dose limits
• Added redirections to Cerdelga and Cerezyme