Policy
| Applicable Products
| New Policy Overview or Updated Policy Revisions
|
Epinephrine (Epipen, Epipen Jr, Neffy, Auvi-Q) (CP.PCH.55)
| Ambetter
| Policy updates include:
- Updated Auvi-Q indication and added weight minimum in initial criteria per Food and Drug Administration (Food and Drug Administration (FDA) labeled indication
- Updated criteria from “for Neffy requests only, has manual dexterity limitations that preclude use of an auto-injector” to “for Neffy requests only, has limitations (e.g., manual dexterity, needle phobia) that preclude use of an auto-injector”
- For section VI, updated Auvi-Q dose from 0.15 mg/0.3 ml to 0.15 mg/0.15 ml
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Burosumab-twza (Crysvita) (CP.PHAR.11)
| Ambetter
| Policy updates include:
- For X-linked hypophosphatemia, modified to allow diagnostic confirmation of PHEX gene in member or first-degree relative per competitor analysis, added requirement for documentation of member’s current weight, for dose calculation purposes
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Nivolumab (Opdivo), Nivolumab/Hyaluronidase-nvhy (Opdivo Qvantig) (CP.PHAR.121)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma adenocarcinoma, added redirection to Tevimbra
|
Deferasirox (Exjade, Jadenu) (CP.PHAR.145)
| Ambetter
| Policy updates include:
- For chronic iron overload, revised concurrent iron chelator bypass threshold from cardiact2* < 20 ms to mt2* ≤ 10 ms per Thalassaemia International Federation (TIF) guidelines
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Deferoxamine (Desferal) (CP.PHAR.146)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For chronic iron overload, revised concurrent iron chelator bypass threshold from cardiac T2* < 20 ms to mt2* ≤ 10 ms per Thalassaemia International Federation (TIF) guidelines
|
Deferiprone (Ferriprox) (CP.PHAR.147)
| Ambetter
| Policy updates include:
- For chronic iron overload, revised concurrent iron chelator bypass threshold from cardiac T2* < 20 ms to mt2* ≤ 10 ms per Thalassaemia International Federation (TIF) guidelines
|
Vigabatrin (Sabril, Vigafyde) (CP.PHAR.169)
| Ambetter
| Policy updates include:
- Added a generic redirection for brand Sabril
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Ivacaftor (Kalydeco) (CP.PHAR.210)
| Ambetter
| Policy updates include:
- Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria
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Lumacaftor/Ivacaftor (Orkambi) (CP.PHAR.213)
| Ambetter
| Policy updates include:
- Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria
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Tolvaptan (Jynarque, Samsca) (CP.PHAR.27)
| Ambetter
| Policy updates include:
- For autosomal dominant polycystic kidney disease, added requirements for minimum egfr and high risk for rapidly progressive disease per 2025 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and in alignment with pivotal study design and Food and Drug Administration (FDA) labeling, respectively
- For Jynarque, added redirection to generic tolvaptan
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Sargramostim (Leukine) (CP.PHAR.295)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) Compendium for neuroblastoma removed requirement for relapse or refractory disease, clarified combination with Danyelza should also include temozolomide and irinotecan
- Updated Appendix E with revised language and exception for Tennessee
|
Ixazomib (Ninlaro) (CP.PHAR.302)
| Ambetter
| Policy updates include:
- Added National Comprehensive Cancer Network (NCCN) Compendium supported use as primary treatment as a substitute for bortezomib or carfilzomib
- Clarified for combination with dexamethasone and Pomalyst, member is lenalidomide- or anti-CD-38-refractory
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Brentuximab Vedotin (Adcetris) (CP.PHAR.303)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) – for classical Hodgkin lymphoma, added option for use with CHP (cyclophosphamide, doxorubicin, prednisone) as alternative to with AVD (doxorubicin, vinblastine, and dacarbazine) if vinblastine is unavailable due to shortage, added option for use with nivolumab for age > 60 years, revised requirements around use as component of BrECADD (brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone) (removed requirement for stage III-IV disease, added option for use with Deauville score 4-5, added requirement for use with granulocyte colony-stimulating factor)
- For pediatric classical Hodgkin lymphoma, added option for use as a component of brecadd and Bv-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine) for stage III-IV disease, specified that only use following high-dose therapy and autologous stem cell rescue has to be in high-risk disease, and modified requirement for high risk disease for nearly all requests to instead require risk factors only for stage I-II disease
- For mycosis fungoides/Sezary syndrome, removed option for combination use with bendamustine
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Blinatumomab (Blincyto) (CP.PHAR.312)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) – clarified that Philadelphia chromosome (Ph) refers to adult disease and added the term BCR::ABL1 for pediatric disease
- For pediatrics, removed pathways for use after consolidation therapy and added combination therapy option for BCR::ABL1-negative/like disease
- For infant acute lymphoblastic leukemia, removed requirement for KMT2A status (11q23 rearranged)
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For non-small cell lung cancer, updated targeted therapies for epidermal growth factor receptor (EGFR) exon 19 deletion, L858R, and ROS proto-oncogene 1 (ROS1) rearrangement positive disease
- For head and neck squamous cell carcinoma added option to be prescribed in combination with Erbitux as first-line therapy or subsequent-line therapy
- For classical Hodgkin lymphoma, added option to be prescribed in combination with decitabine and vorinostat, for post-allogenic hematopoietic cell transplant or post autologous stem cell rescue, and members not candidate for anthracycline therapy and revised for relapsed disease for both adults and pediatrics after at least 1 line of systemic therapy (previously at least 2 lines of systemic therapy for pediatrics)
- For urothelial carcinoma, added option to be prescribed in combination with Inlyta or Lenvima, usage for relapsed disease, and prescribed as a single agent for adjuvant therapy
- For cervical cancer, added International Federation of Gynecology and Obstetrics (FIGO) 2018 stage III-IVA in combination with chemoradiotherapy and added option to be prescribed in combination with Tivdak for tumors expressing PD-L1 and has not received prior immune-oncology therapy, recurrent or metastatic disease, and disease as progressed on or after at least 1 line of systemic therapy
- For hepatocellular carcinoma, removed specific treatment regimens member has had disease progression following from and revise to prescribed as subsequent line therapy
- For biliary tract cancer, added option for disease is resectable locoregionally advanced and prescribed as neoadjuvant therapy for gallbladder cancer
- For triple-negative breast cancer, added option to be prescribed as preoperative systemic therapy in combination with carboplatin and docetaxel
- Added off-label usage for central nervous (CNS) cancer, thyroid carcinoma, peritoneal mesothelioma, penile cancer
- For mycosis fungoides, revised stage to Stage IA – III
- For thymic carcinoma, removed metastatic or unresectable requirement
- Updated Food and Drug Administration (FDA) Approved Indication(s) section and criteria to reflect revised indication that limits use to tumors expressing PD-L1 (combined positive score (CPS) at least 1) for esophageal or gastroesophageal junction carcinoma in combination with chemotherapy and HER2-negative gastric or gastroesophageal junction adenocarcinoma as first-line therapy in combination with chemotherapy (previously approved regardless of PD-L1 status)
- Updated Food and Drug Administration (FDA) Approved Indications(s) section for cervical cancer to clarify International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA per updated PI
- Updated Appendix E with addition of soft tissue sarcoma as an example for microsatellite instability-high mut/Mb: mutations/megabase (MSI-H) solid tumors and small bowel adenocarcinoma for tumor mutational burden-high solid tumors
- Updated Appendix G with revised language and exception for Tennessee
- Added redirection to Tevimbra for HER2-negative gastric or gastroesophageal junction adenocarcinoma and esophageal carcinoma or gastroesophageal junction squamous cell carcinoma
- Added new Food and Drug Administration (FDA) approved indication for usage in the neoadjuvant/adjuvant setting for locally advanced head and neck squamous cell cancer
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Tezacaftor/Ivacaftor; Ivacaftor (Symdeko) (CP.PHAR.377)
| Ambetter
| Policy updates include:
- Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria
|
Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated the list of therapies that Ultomiris should not be prescribed concurrently with to include Epysqli for all indications and Piasky for paroxysmal nocturnal hemoglobinuria
- For generalized myasthenia gravis, clarified that the required immunosuppressive therapy should be non-steroidal
- Revised continued approval duration from 6 to 12 months for all indications as they are chronic conditions
|
Fulvestrant (Faslodex Injection) (CP.PHAR.424)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For breast cancer, added triple negative disease option per National Comprehensive Cancer Network (NCCN)
- For ovarian, fallopian tube, and primary peritoneal cancer, endometrial carcinoma, and uterine cancer, added requirement for monotherapy per National Comprehensive Cancer Network (NCCN)
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Romosozumab-aqqg (Evenity) (CP.PHAR.428)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Revised initial approval duration to 12 months for Medicaid/Ambetter
- Revised continuation of therapy to state member must meet the initial approval criteria
|
Alpelisib (Piqray, Vijoice) (CP.PHAR.430)
| Ambetter
| Policy updates include:
- For breast cancer, removed requirement for “locally” in “locally recurrent” and added for premenopausal female member to be treated with ovarian ablation/suppression per National Comprehensive Cancer Network (NCCN)
|
Polatuzumab Vedotin-piiq (Polivy) (CP.PHAR.433)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) – for post-transplant lymphoproliferative disorder, removed specification that disease must be monomorphic and added option for use in combination with rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for disease with International Prognostic Index (IPI) score at least 2
- For second-line use, added that member is either not a candidate for chimeric antigen receptor (CAR) T-cell therapy or Polivy is prescribed as bridging therapy until chimeric antigen receptor (CAR) T-cell therapy becomes available and added option for use in combination with Lunsumio for non-transplant/chimeric antigen receptor (CAR) T-cell therapy candidates
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Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta) (CP.PHAR.440)
| Ambetter
| Policy updates include:
- Added Alyftrek to list of cystic fibrosis transmembrane conductance regulator (CFTR) modulator concurrent exclusion criteria
|
Crizanlizumab-tmca (Adakveo) (CP.PHAR.449)
| Ambetter
| Policy updates include:
- For hydroxyurea trial, added that documentation supports adherence to hydroxyurea for at least the past 6 months, examples of hydroxyurea contraindications and intolerances, and a bypass option requiring provider attestation of past adherence to hydroxyurea for at least 6 months at the maximum tolerated dose and at least 1 vasoocclusive crises while on the maximum tolerated dose
- Removed ICD-10-CM Codes section
|
Inebilizumab-cdon (Uplizna) (CP.PHAR.458)
| Ambetter
| Policy updates include:
- For neuromyelitis optica spectrum disorder, added Epysqli to the list of therapies that Uplizna should not be prescribed concurrently with, and revised continued approval duration from 6 to 12 months as neuromyelitis optica spectrum disorder is a chronic condition
- Added criteria for the newly approved indication of immunoglobulin G4-related disease
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Satralizumab-mwge (Enspryng) (CP.PHAR.463)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Epysqli to the list of therapies that Enspryng should not be prescribed concurrently with
- Revised continued approval duration from 6 to 12 months as neuromyelitis optica spectrum disorder is a chronic condition
|
Mitomycin Instillation Solution (Jelmyto, Zusduri) (CP.PHAR.495)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed requirement for cancer location above the ureteropelvic junction per National Comprehensive Cancer Network (NCCN)
- Removed exclusion for “recent history of carcinoma in situ in the urinary tract, invasive urothelial carcinoma, or high-grade papillary urothelial carcinoma” as this is not excluded per National Comprehensive Cancer Network (NCCN) or the Food and Drug Administration (FDA) indication
- Added requirement for use as monotherapy per National Comprehensive Cancer Network (NCCN)
- Added criteria for newly approved Zusduri
|
Pemigatinib (Pemazyre) (CP.PHAR.496)
| Ambetter
| Policy updates include:
- Updated regimens in Appendix B
|
Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For paroxysmal nocturnal hemoglobinuria, added Epysqli and Piasky to the list of therapies that Empaveli should not be prescribed concurrently with, added improvement of extravascular hemolysis as an example of positive response to therapy, and revised continued approval duration from 6 to 12 months as paroxysmal nocturnal hemoglobinuria is a chronic condition
- Updated Syfovre contraindications in Appendix C to include hypersensitivity per updated prescribing information
|
Dostarlimab-gxly (Jemperli) (CP.PHAR.540)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For endometrial carcinoma, added that combination use with carboplatin/paclitaxel for advanced/recurrent disease may be followed by single agent use per Food and Drug Administration (FDA) labeling and National Comprehensive Cancer Network (NCCN)
- For solid tumors, removed option for early-stage gastric cancer, added option for locally unresectable, medically inoperable, or polymerase epsilon/delta (POLE/POLD1) mutated small bowel adenocarcinoma, and clarified that polymerase epsilon/delta (POLE/POLD1) mutation should have ultra-hypermutated phenotype per National Comprehensive Cancer Network (NCCN)
- Added off-label criteria for anal carcinoma per National Comprehensive Cancer Network (NCCN)
|
Maralixibat (Livmarli) (CP.PHAR.543)
| Ambetter
| Policy updates include:
- For Alagille syndrome initial and continued therapy and progressive familial intrahepatic cholestasis continued therapy, added exclusion for concurrent use with other IBAT inhibitors
- Added new tablet formulation [10 mg, 15 mg, 20 mg, 30 mg] for Alagille syndrome and progressive familial intrahepatic cholestasis
- For Alagille syndrome, updated criteria from “request is for oral solution 9.5 mg/ml” to “if request is for oral solution, request is for 9.5 mg/ml strength”
- For progressive familial intrahepatic cholestasis, updated criteria from “request is for oral solution 19 mg/ml” to “request is for oral solution, request is for 19 mg/ml strength”
- For both indications, added criteria “if request is for tablets, documentation of member’s current body weight at least 25 kg”
- For section V, updated Alagille syndrome and progressive familial intrahepatic cholestasis sections with tablet dosage by weight
|
Betibeglogene Autotemcel (Zynteglo) (CP.PHAR.545)
| Ambetter
| Policy updates include:
- Added template statement requiring medical director review
- Added criterion for documentation of member’s body weight for verification of weight-based dose
|
Beremagene geperpavec-svdt (Vyjuvek) (CP.PHAR.592)
| Ambetter
| Policy updates include:
- Added exclusion of concomitant use with Zevaskyn
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Cinacalcet (Sensipar) (CP.PHAR.61)
| Ambetter
| Policy updates include:
- For primary hyperparathyroidism, added requirement that member has failed or is unable to undergo a parathyroidectomy per Food and Drug Administration (FDA)-labeled indication
- Included Parsabiv as an example of a calcimimetic that should not be prescribed concurrently with cinacalcet
|
Iptacopan (Fabhalta) (CP.PHAR.656)
| Ambetter
| Policy updates include:
- For paroxysmal nocturnal hemoglobinuria, added Epysqli and Piasky to the list of therapies that Fabhalta should not be prescribed concurrently with, and revised continued approval duration from 6 to 12 months as paroxysmal nocturnal hemoglobinuria is a chronic condition
- For immunoglobulin A nephropathy, added redirection to Filspari or Vanrafia in initial approval criteria
|
Danicopan (Voydeya) (CP.PHAR.665)
| Ambetter
| Policy updates include:
- Added Epysqli (Soliris biosimilar) as another C5 inhibitor option
- Added requirement for no concurrent use with Empaveli, Fabhalta, or Piasky
|
Pazopanib (Votrient) (CP.PHAR.81)
| Ambetter
| Policy updates include:
- For thyroid carcinoma, removed requirement for iodine-refractory disease for oncocytic carcinoma, added requirement for progressive or symptomatic disease for medullary carcinoma, and updated trial options for medullary carcinoma to include Retevmo per National Comprehensive Cancer Network (NCCN)
- Added off-label criteria for Merkel cell carcinoma per National Comprehensive Cancer Network (NCCN)
|
Peginterferon Alfa-2a (Pegasys) (CP.PHAR.89)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For primary cutaneous CD30+ T-cell lymphoproliferative disorder, clarified diagnosis as primary cutaneous anaplastic large cell lymphoma and added requirement for monotherapy use per National Comprehensive Cancer Network (NCCN)
|
Eculizumab (Soliris), Eculizumab-aeeb (Bkemv), Eculizumab-aagh (Epysqli) (CP.PHAR.97)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Food and Drug Administration (FDA) approved indication for Bkemv to include adult patients with generalized myasthenia gravis who are acetylcholine receptor (AchR) antibody positive
- For paroxysmal nocturnal hemoglobinuria, added Piasky to the list of therapies that Soliris/Bkemv/Epysqli should not be prescribed concurrently with
- For generalized myasthenia gravis, clarified that the required immunosuppressive therapy should be non-steroidal
- Revised continued approval duration from 6 to 12 months for all indications as they are chronic conditions
|
Rufinamide (Banzel) (CP.PMN.157)
| Ambetter
| Policy updates include:
- Generic redirection added to Continued Therapy section
|
Chenodiol (Chenodal) (CP.PMN.239)
| Ambetter
| Policy updates include:
- For cerebrotendinous xanthomatosis, added that diagnosis must be confirmed by genetic testing and added specialist prescriber requirement for this rare genetic disease
|
Gabapentin ER (Gralise, Horizant) (CP.PMN.240)
| Ambetter
| Policy updates include:
- For postherpetic neuralgia, added member must use generic Gralise if available
- In Appendix B, updated dosing regimens and clarified listed therapeutics alternatives have evidence supporting their use in the indications covered by this policy
|
Compounded Medications (CP.PMN.280)
| Ambetter
| Policy updates include:
- Added route of administration, in addition to the indication, for requirement that acceptable compendium supports efficacy and safety
|
Topiramate Extended-Release (Qudexy XR, Trokendi XR) (CP.PMN.281)
| Ambetter
| Policy updates include:
- Extended the generic redirection requirement to the Continued Therapy section for seizures
|
Pyrimethamine (Daraprim) (CP.PMN.44)
| Ambetter
| Policy updates include:
- For initial therapy for toxoplasmosis active disease, for toxoplasmosis prophylaxis, clarified member must use trimethoprim/sulfamethoxazole unless contraindicated or clinically significant adverse effects are experienced
- In continued therapy for chronic maintenance following initial therapy for active disease, increased duration of approval from 6 months to 12 months
- In Appendix B, clarified dosing regimen per guideline
- Updated Section V per guidelines
|
Vortioxetine (Trintellix) (CP.PMN.65)
| Ambetter
| Policy updates include:
- Clarified failure of two antidepressants from at least two different drug classes
- In Appendix B, updated therapeutic alternative per Clinical Pharmacology
|
Levomilnacipran (Fetzima) (HIM.PA.125)
| Ambetter
| Policy updates include:
- Clarified failure of two antidepressants from at least two different drug classes
- In Appendix B, updated therapeutic alternatives per Clinical Pharmacology
|
Sofosbuvir/Velpatasvir (Epclusa) (HIM.PA.SP1)
| Ambetter
| Policy updates include:
- For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
- For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days
|
Sofosbuvir (Sovaldi) (HIM.PA.SP2)
| Ambetter
| Policy updates include:
- For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
- For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype
|
Ledipasvir/Sofosbuvir (Harvoni) (HIM.PA.SP3)
| Ambetter
| Policy updates include:
- For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
- For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype
|
Glecaprevir/Pibrentasvir (Mavyret) (HIM.PA.SP36)
| Ambetter
| Policy updates include:
- For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
- Updated indication to include acute hepatitis C virus
- For continued therapy criteria, revised option for treatment duration minimum from 40 days to 28 days and removed requirement for specific confirmed genotype
|
Elbasvir/Grazoprevir (Zepatier) (HIM.PA.SP62)
| Ambetter
| Policy updates include:
- Added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
- For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype
|
Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) (HIM.PA.SP63)
| Ambetter
| Policy updates include:
- For continued therapy criteria, added “Prescribed regimen is consistent with an Food and Drug Administration (FDA) or American Association for the Study of Liver Diseases - Infectious Diseases Society of America (AASLD-IDSA) recommended regimen”
|
