POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
|
Dupilumab (Dupixent) (HIM.PA.SP69)
| Ambetter
| Policy updates include:
- Policy created (adapted from CP.PHAR.336 with the following revisions: for atopic dermatitis initial approval criteria, modified requirement from failure of two to only one topical corticosteroid
- For Asthma initial approval criteria, modified criteria to require history of two exacerbations to require one exacerbation, added allowance for emergency room visit, removed intubation option, modified requirement of “leukotriene modifier” to “one additional asthma controller medication”)
|
Lisocabtagene Maraleucel (Breyanzi) (CP.PHAR.483)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Added pre-emptive criteria sets for follicular lymphoma and mantel cell lymphoma
|
Bupropion/Naltrexone (Contrave) (CP.PCH.12)
| Ambetter
| Policy updates include:
- For indicators of increased cardiovascular risk, clarified hypertension should be “controlled” due to contraindication for uncontrolled hypertension
- For documentation of weight loss program, added members has been actively enrolled for at least 6 months to initial criteria and added a weight loss program that also involves behavioral modification as supported by American College of Cardiology/American Heart Association guidelines
|
Phentermine (Adipex-P, Lomaira) (CP.PCH.13)
| Ambetter
| Policy updates include:
- For indicators of increased cardiovascular risk, removed coronary artery/heart disease and clarified hypertension should be “controlled” due to package insert contraindications
- For documentation of weight loss program, added members has been actively enrolled for at least 6 months to initial criteria and added a weight loss program that also involves behavioral modification as supported by American College of Cardiology/American Heart Association guidelines
|
Phendimetrazine (CP.PCH.47)
| Ambetter
| Policy updates include:
- For documentation of weight loss program, added members has been actively enrolled for at least 6 months to initial criteria and added a weight loss program that also involves behavioral modification as supported by American College of Cardiology/American Heart Association guidelines
|
Sapropterin Dihydrochloride (Kuvan) (CP.PHAR.43)
| Ambetter
| Policy updates include:
- Increased initial auth duration to align with those of other drugs for rare diseases
- For Continued Therapy added exclusion for concomitant use with Palynziq to match with the Initial Approval Criteria
|
Binimetinib (Mektovi) (CP.PHAR.50)
| Ambetter
| Policy updates include:
- For melanoma, added criteria for neoadjuvant therapy and re-induction therapy for disease progression/relapse
- For non-small cell lung cancer, removed redundant criteria for treatment naïve or subsequent therapy, removed criteria for prior B-Raf proto-oncogene, serine/threonine kinase (BRAF) therapy, revised capsules to tablets
|
Topotecan (Hycamtin) (CP.PHAR.64)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For ovarian cancer, revised mucinous carcinoma to mucinous neoplasms per National Comprehensive Cancer Network guideline revisions
- For off-label National Comprehensive Cancer Network recommendations, added neuroblastoma indication per National Comprehensive Cancer Network, revised merkel cell carcinoma to include progression of disease on checkpoint immunotherapy per National Comprehensive Cancer Network
- For all indications, added redirection to generic topotecan if available
|
Sorafenib (Nexavar) (CP.PHAR.69)
| Ambetter
| Policy updates include:
- For differentiated thyroid carcinoma clarified reference to oncocytic (formerly known as Hürthle cell) carcinoma per National Comprehensive Cancer Network
- For medullary thyroid carcinoma clarified disease progression on preferred systemic therapy and included Gavreto and Retevmo as additional examples
- For acute myeloid leukemia added option for FLT3 mutation-positive disease and use for induction or consolidation per National Comprehensive Cancer Network Compendium
- For gastrointestinal stromal tumors added requirement for use as single-agent therapy and removed Sprycel from the list of required prior therapies
|
Lenalidomide (Revlimid) (CP.PHAR.71)
| Ambetter
| Policy updates include:
- For multiple myeloma, updated relapse or progressive disease criteria to include “ in combination with dexamethasone and one of the following: bortezomib, carfilzomib, daratumumab, ixazomib, cyclophosphamide, elotuzumab, or bendamustine” and maintenance therapy to include “combination with one of the following: carfilzomib, bortezomib, daratumumab” per National Comprehensive Cancer Network compendium
- For myelodysplastic syndrome, added Reblozyl option for serum erythropoietin ≤ 500 mU/mL per National Comprehensive Cancer Network compendium
- For marginal zone lymphomas and follicular lymphoma, removed criteria “histologic transformation after multiple lines of chemoimmunotherapy for indolent or transformed disease” as not supported on National Comprehensive Cancer Network compendium
- For off-label indications, updated myelofibrosis-associated anemia to “in combination with prednisone taper and presence of del(5q) and removed serum erythropoietin requirement
- For systemic light chain amyloidosis off-label indication, removed “bortezomib” requirement as not supported by National Comprehensive Cancer Network compendium
- For Kaposi sarcoma off-label indication, added “subsequent therapy following treatment of first-line systemic therapy for relapsed, refractory, or advanced disease”, removed failure of liposomal doxorubicin and paclitaxel, added prescribed as a single agent, and revised “AIDS-related Kaposi sarcoma” to “HIV-related Kaposi sarcoma”
- Updated Appendix B with relevant therapeutic alternatives
- For Appendix D, revised current drug therapies for MCL per National Comprehensive Cancer Network B-Cell Lymphomas guideline
- Updated generic lenalidomide shortage criteria to “unavailable until sometime in 2026”
|
Sunitinib (Sutent) (CP.PHAR.73)
| Ambetter
| Policy updates include:
- For myeloid/lymphoid neoplasms added requirement for use in the chronic or blast phase per National Comprehensive Cancer Network Compendium
- For gastrointestinal stromal tumors modified reference from ‘SDH mutation positive’ to ‘SDH-deficient’ per National Comprehensive Cancer Network
- For differentiated thyroid carcinoma clarified reference to oncocytic (formerly known as Hürthle cell) carcinoma per National Comprehensive Cancer Network
|
Nilotinib (Tasigna) (CP.PHAR.76)
| Ambetter
| Policy updates include:
- For gastrointestinal stromal tumors removed Sprycel from list of prior therapy options
- For Appendix D, added state OH and updated state OH notes to include Commercial line of business
|
Temozolomide (Temodar) (CP.PHAR.77)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added generic temozolomide to policy/criteria section given formulary and prior authorization status
- For off-label National Comprehensive Cancer Network Compendium, added unresectable uveal melanoma, added neuroblastoma in combination with irinotecan, dinutuzimab, and sargramostim, revised recurrent or progressive low-grade glioma to circumscribed glioma
|
Thalidomide (Thalomid) (CP.PHAR.78)
| Ambetter
| Policy updates include:
- Removed myeloproliferative neoplasms criteria set as this indication is no longer supported by National Comprehensive Cancer Network compendium
- Revised Revlimid to generic lenalidomide
|
Belimumab (Benlysta) (CP.PHAR.88)
| Ambetter
| Policy updates include:
- Added exclusion for concurrent treatment with Lupkynis or a biologic for all indications
|
Regorafenib (Stivarga) (CP.PHAR.107)
| Ambetter
| Policy updates include:
- For colorectal cancer, added that appendiceal carcinoma is a coverable diagnosis and specified the prior therapies required based on disease characteristics (proficient mismatch repair/microsatellite-stable (pMMR/MSS), deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H),
polymerase epsilon/delta (POLE/POLD1)) per National Comprehensive Cancer Network recommendations
- For gastrointestinal stromal tumors, added additional disease qualifiers, added that Qinlock should be used if intolerant to Sutent when requested for single agent therapy, and revised from SDH mutation-positive to SDH-deficient per National Comprehensive Cancer Network
- For soft tissue sarcoma, added that Stivarga should be used as subsequent therapy for pleomorphic rhabdomyosarcoma per National Comprehensive Cancer Network
- For bone cancers, added Ewing sarcoma, mesenchymal chondrosarcoma, dedifferentiated chondrosarcoma, and high-grade undifferentiated pleomorphic sarcoma as coverable cancer types and added an additional disease qualifier of progressive per National Comprehensive Cancer Network
- Revised glioblastoma to central nervous system cancer and added additional coverable cancers (gliosarcoma, H3-mutated high-grade glioma) and disease qualifier of progressive per National Comprehensive Cancer Network
|
Ponatinib (Iclusig) (CP.PHAR.112)
| Ambetter
| Policy updates include:
- Added criteria set for off-label use in gastrointestinal stromal tumor per National Comprehensive Cancer Network Compendium
- Added quantity limit of one tablet per day
- For Appendix B, removed Iclusig
- For Appendix D, added state OK and updated state OH notes to include Commercial line of business
- Added new indication and dosing for newly diagnosed Ph+ acute lymphoblastic leukemia
- Revised Appendix D to E
- In Appendix D added general information regarding the number of recommended cycles for combination therapy in newly diagnosed acute lymphoblastic leukemia
|
Cysteamine oral (Cystagon, Procysbi) (CP.PHAR.155)
| Ambetter
| Policy updates include:
- Added requirement that request is not for combination use of Procysbi and Cystagon for initial criteria
- For diagnostic confirmation by leukocyte cystine concentration, clarified this must be above the upper limit of the normal reference range for the reporting laboratory
|
Histrelin Acetate (Vantas, Supprelin LA) (CP.PHAR.172)
| Ambetter-Medical Benefit, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For prostate cancer, added requirement that request is for palliative treatment to align with the FDA-approved indication
- Corrected units for basal luteinizing hormone level to mIU/mL
|
Nafarelin Acetate (Synarel) (CP.PHAR.174)
| Ambetter
| Policy updates include:
- For endometriosis reduced total treatment duration from 12 to 6 months per prescribing information
- For central precocious puberty clarified for bone age the requirement is that the difference between bone age and chronological age was > 1 year (bone age-chronological age)
- Corrected units for basal luteinizing hormone level to mIU/mL
|
Paclitaxel, Protein-Bound (Abraxane) (CP.PHAR.176)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Clarified language from “Abraxane” to “paclitaxel, protein-bound” where applicable to reduce confusion that policy also applies to generic paclitaxel
- For adenocarcinoma of the pancreas, removed criteria that disease is metastatic, unresectable or borderline resectable per National Comprehensive Cancer Network
- Separated cutaneous melanoma from uveal melanoma as it can be used as a single agent or in combination per National Comprehensive Cancer Network
- For cervical cancer, added prescribed as a single agent per National Comprehensive Cancer Network
- For gallbladder cancer or cholangiocarcinoma, added option for treatment with resected gross residual (R2) disease per National Comprehensive Cancer Network
- Residual tumor classification added to Appendix D
- Removed no longer valid therapeutic alternatives [anthracyclines, gemcitabine] from Appendix B
|
Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase (CP.PHAR.228)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For adjuvant breast cancer continued therapy, added member has received ≤ 52 weeks of therapy
- For gastric, esophageal, or esophagogastric junction, added option for unresectable disease, revised prescribed combination therapy to “systemic chemotherapy” as additional regimens options available per National Comprehensive Cancer Network
- For endometrial carcinoma added option to be prescribed as single agent for maintenance therapy per National Comprehensive Cancer Network
- For colorectal cancer, removed requirement for no previous use of HER2 inhibitor therapy and added tucatinib as option to be prescribed in combination with
- For gallbladder cancer or cholangiocarcinoma, added option for treatment with resected gross residual (R2) disease per National Comprehensive Cancer Network
- Residual (R) tumor classification added to Appendix F
- For Ogivri, updated product availability of 420 mg multi-dose vial supplied with or without diluent
|
IncobotulinumtoxinA (Xeomin) (CP.PHAR.231)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added max dose for laryngeal dystonia (off-label)
- Revised max dose for oromandibular dystonia from “25 units” to standard language “Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use and member age (prescriber must submit supporting evidence number of Units per treatment session does not exceed 400 Units IM per treatment session every 12 weeks)”
|
Darbepoetin Alfa (Aranesp) (CP.PHAR.236)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For anemia associated with myelofibrosis, added requirement that pretreatment hemoglobin < 10 g/dL for initial requests and current hemoglobin ≤ 12 g/dL for continuation requests
- For anemia due to chronic kidney disease, added requirement for continuation requests that current hemoglobin ≤ 12 g/dL
|
Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx (Retacrit) (CP.PHAR.237)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For anemia associated with myelofibrosis, added requirement that pretreatment hemoglobin < 10 g/dL for initial requests and current hemoglobin ≤ 12 g/dL for continuation requests
- For anemia due to chronic kidney disease, added requirement for continuation requests that current hemoglobin ≤ 12 g/dL
|
Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) (CP.PHAR.238)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added requirement for continuation requests that current hemoglobin ≤ 12 g/dL
- Updated dosing in Section V to include 1.2 mcg/kg once monthly dosing option for adult patients with chronic kidney disease not on dialysis
|
Dabrafenib (Tafinlar) (CP.PHAR.239)
| Ambetter
| Policy updates include:
- For thyroid cancer, revised section to specify only anaplastic thyroid cancer (other thyroid carcinomas are covered in solid tumor section)
- For BRAF V600E mutation-positive solid tumor per National Comprehensive Cancer Network, revised criteria to include off-label indications for resectable disease, removed “as subsequent treatment” from thyroid carcinomas to allow first-line treatment, specified adult low-grade glioma to adult pilocytic astrocytoma, ganglioglioma, and pleomorphic xanthoastrocytoma (grade 2), removed recurrent adult isocitrate dehydrogenase (IDH)-mutant oligodendroglioma and IDH-mutant astrocytoma, added that thyroid carcinoma must not be amenable to radioactive iodine therapy, added the following indications: off-label resected gross residual hepatobiliary cancer, recurrent or progressive circumscribed glioma, progressive adult glioblastoma, poorly differentiated mixed neuroendocrine carcinomas, gastrointestinal stromal tumors, gastric and esophageal adenocarcinoma, esophageal and esophagogastric squamous cell carcinoma, and small bowel adenocarcinoma
- For off-label National Comprehensive Cancer Network compendium recommendations added indication of hairy cell leukemia
|
Trametinib (Mekinist) (CP.PHAR.240)
| Ambetter
| Policy updates include:
- For BRAF V600E mutation-positive solid tumor per National Comprehensive Cancer Network, moved metastatic uveal melanoma to off-label compendium indications section, revised criteria to include off-label indications for resectable disease, removed “as subsequent treatment” from thyroid carcinomas to allow first-line treatment, specified adult low-grade glioma to adult pilocytic astrocytoma, ganglioglioma, and pleomorphic xanthoastrocytoma (grade 2), removed recurrent adult IDH-mutant oligodendroglioma and isocitrate dehydrogenase (IDH)-mutant astrocytoma, added that thyroid carcinoma must not be amenable to radioactive iodine therapy, added the following indications: off-label resected gross residual hepatobiliary cancer, recurrent or progressive circumscribed glioma, progressive adult glioblastoma, poorly differentiated mixed neuroendocrine carcinomas, gastrointestinal stromal tumor, gastric and esophageal adenocarcinoma, esophageal and esophagogastric squamous cell carcinoma, and small bowel adenocarcinoma
- For off-label National Comprehensive Cancer Network compendium recommendations, added the following indications: hairy cell leukemia, and metastatic uveal melanoma
|
Abatacept (Orencia) (CP.PHAR.241)
| Ambetter
| Policy updates include:
- Updated Appendix D with removal of psoriatic arthritis guideline supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, and Velsipity to section III.B
|
Adalimumab (Humira), Adalimumab-afzb (Abrilada), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-fkjp (Hulio), Adalimumab-adaz (Hyrimoz), Adalimumab-aacf (Idacio), Adalimumab-ryvk (Simlandi), Adalimumab-aaty (Yuflyma), Adalimumab-aqvh (Yusimry) (CP.PHAR.242)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Yuflyma, added newly approved uveitis indication to criteria
- Added HCPCS codes [C9399] and [J3590]
- Added Bimzelx, Zymfentra, Omvoh, Sotyktu, and Velsipity to section III.B
- Added newly approved biosimilar Simlandi to criteria.
|
Anakinra (Kineret) (CP.PHAR.244)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Appendix I, added Actemra information as an FDA-approved alternative for COVID-19
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, and Velsipity to section III.B
|
Canakinumab (Ilaris) (CP.PHAR.246)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For adult-onset Still’s disease, removed redirection to methotrexate per guideline update and competitor analysis and added redirection to NSAID
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Tofidence, and Velsipity to section III.B
|
Certolizumab (Cimzia) (CP.PHAR.247)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Appendix D with removal of CRADLE trial supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, and Velsipity to section III.B
|
Etanercept (Enbrel) (CP.PHAR.250)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Appendix D with removal of Hidradenitis Suppurativa guideline supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Sotyktu, Wezlana, and Velsipity to section III.B
|
Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Appendix D with removal of ankylosing spondylitis and non-radiographic axial spondyloarthritis guideline supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, and Velsipity to section III.B
|
Infliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis) (CP.PHAR.254)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Renflexis, removed “re-administration to patients who have experienced severe hypersensitivity reaction to infliximab products” in contraindications section
- Added Bimzelx, Omvoh, Sotyktu, Wezlana, and Velsipity to section III.B
|
Ixekizumab (Taltz) (CP.PHAR.257)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Appendix D with removal of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis guideline supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, Wezlana, and Velsipity to section III.B
- Updated HCPCS code description for [C9399] and [J3590]
|
Mitoxantrone (CP.PHAR.258)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For acute lymphoblastic leukemia (ALL), rearranged existing criteria to clarify that disease must be relapsed/refractory, added additional allowable regimen for adult T-ALL, and specified the allowable regimens for pediatric Ph-positive B-ALL per National Comprehensive Cancer Network
- Removed Hodgkin lymphoma/follicular lymphoma as coverable diagnoses as National Comprehensive Cancer Network no longer recommends these uses
|
Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For B-Cell Lymphomas initial criteria, updated “AIDS-related B-cell lymphomas” to “HIV-related B-cell lymphomas” per National Comprehensive Cancer Network compendium
- For Appendix E, updated state OH description to include commercial line of business
- Added Bimzelx, Zymfentra, Omvoh, Sotyktu, Tofidence, Wezlana, and Velsipity to section III.B
|
Secukinumab (Cosentyx) (CP.PHAR.261)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Appendix D with removal of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis guideline supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, and Velsipity to section III.B
|
Tocilizumab (Actemra), Tocilizumab-bavi (Tofidence), Tocilizumab-aazg
(Tyenne) (CP.PHAR.263)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Castleman’s disease, added member has either unicentric disease with Human Immunodeficiency Virus (HIV)-negative and Human Herpes Virus 8 (HHV-8)-negative or multicentric disease as supported by National Comprehensive Cancer Network compendium
- For Cytokine Release Syndrome (CRS), added “Carvykti™” to list of CAR T cell examples
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, and Velsipity to section III.B
- Added newly approved biosimilar Tyenne to rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis criteria
- Updated criteria to reflect expanded indication for use after at least one prior line of therapy
|
Ustekinumab (Stelara), Ustekinumab-auub (Wezlana) (CP.PHAR.264)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated Appendix D with removal of psoriatic arthritis guideline and pediatric pharmacokinetic studies supplemental information
- Added Bimzelx, Zymfentra, Omvoh, Tofidence, Sotyktu, and Velsipity to section III.B
|
Vedolizumab (Entyvio) (CP.PHAR.265)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, and Velsipity to section III.B
|
Rilonacept (Arcalyst) (CP.PHAR.266)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed supplemental information on concomitant use of Arcalyst and other biologics in Appendix D
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Tofidence, and Velsipity to section III.B
|
Vismodegib (Erivedge) (CP.PHAR.273)
| Ambetter
| Policy updates include:
- For basal cell carcinoma, specified locally advanced basal cell carcinoma, added indication of nodal basal cell carcinoma if surgery is not feasible per National Comprehensive Cancer Network 2A recommendation
|
Durvalumab (Imfinzi) (CP.PHAR.339)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network – for non-small cell lung cancer, added recommended uses when actionable molecular biomarkers are present
- For biliary tract cancer, added resected gross residual (R2) disease
- added off-label uses for gastric, esophageal, esophagogastric junction, and ampullary adenocarcinoma
- For all indications, added redirection to generic if available
|
Brigatinib (Alunbrig) (CP.PHAR.342)
| Ambetter
| Policy updates include:
- Added off-label National Comprehensive Cancer Network-supported indication of anaplastic large cell lymphoma
- added maximum daily tablet quantity
- Condensed uterine sarcoma Inflammatory myofibroblastic tumor-specific criteria
|
Midostaurin (Rydapt) (CP.PHAR.344)
| Ambetter
| Policy updates include:
- Per National Comprehensive Cancer Network – for acute myeloid leukemia, added that Rydapt may also be prescribed with idarubicin for induction therapy and added off-label use for maintenance therapy
- For systemic mastocytosis, added that Rydapt must be prescribed as a single agent
|
Sarilumab (Kevzara) (CP.PHAR.346)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Tofidence, and Velsipity to section III.B
|
Guselkumab (Tremfya) (CP.PHAR.364)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Tofidence, and Velsipity to section III.B
|
Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Todifence, and Velsipity to section III.B
|
Patisiran (Onpattro) (CP.PHAR.395)
| Ambetter-Medical Benefit
| Policy updates include:
- Added Wainua to list of drugs that should not have been previously received or prescribed concurrently
|
Inotersen (Tegsedi) (CP.PHAR.405)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Wainua to list of drugs that should not have been previously received or prescribed concurrently
- Added active HCPCS codes [C9399] and [J3490]
- Added disclaimer regarding manufacturer discontinuing commercial avilaiblity of Tegsedi and added Appendix D
|
Dexrazoxane (Totect) (CP.PHAR.418)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For doxorubicin-induced cardiomyopathy, added redirection to generic dexrazoxane, added the following National Comprehensive Cancer Network 2A indications: relapsed/refractory Ph-positive acute lymphoblastic leukemia (ALL), Hodgkin lymphoma in adults age > 60 years, and neuroblastoma
|
Risankizumab-rzaa (Skyrizi) (CP.PHAR.426)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Tofidence, and Velsipity to section III.B
- Added HCPCS codes [C9399] and [J3590]
|
Lumasiran (Oxlumo) (CP.PHAR.473)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added exclusion for concomitant use of Oxlumo with Rivfloza
- Clarified the intent of the dialysis criteria to reflect that the member should not be on peritoneal dialysis and if they are on hemodialysis then they have been on a stable hemodialysis regimen for at least 4 weeks, per the ILLUMINATE-C trial inclusion criteria
- Updated Commercial authorization duration language to match current standard language
|
Selpercatinib (Retevmo) (CP.PHAR.478)
| Ambetter
| Policy updates include:
- Clarified that Hurthle cell carcinoma is now known as oncocytic carcinoma per National Comprehensive Cancer Network
- For rearranged during transfection (RET) fusion-positive solid tumors added qualifier that tumors can be recurrent and added option for Retevmo use as first-line therapy in pancreatic adenocarcinoma, soft tissue sarcoma, or ampullary adenocarcinoma per National Comprehensive Cancer Network
- For rearranged during transfection (RET) fusion-positive solid tumors, added criterion that member age ≥ 18 years per FDA-labeling
- Revised maximum capsules corresponding to 240 mg per day dose to 6 capsules per day
- Added new tablet formulation
|
Voclosporin (Lupkynis) (CP.PHAR.504)
| Ambetter
| Policy updates include:
- Added exclusion for concurrent treatment with cyclophosphamide or a biologic
- Revised continued approval duration to 12 months and removed treatment response criterion for requests exceeding 12 months of Lupkynis based on updated 2024 Kidney Disease: Improving Global Outcomes (KDIGO) lupus nephritis management guideline
|
Odevixibat (Bylvay) (CP.PHAR.528)
| Ambetter
| Policy updates include:
- Added exclusions for portal hypertension and history of a hepatic decompensation event for both progressive familial intrahepatic and Alagille syndrome per competitor analysis
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Vutrisiran (Amvuttra) (CP.PHAR.550)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Wainua to list of drugs that should not have been previously received or prescribed concurrently
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Ropeginterferon alfa-2b-njft (Besremi) (CP.PHAR.570)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed peginterferon alfa-2a as therapeutic alternative as no longer a preferred cytoreductive therapy for high-risk polycythemia vera per National Comprehensive Cancer Network
- Added option for usage in low-risk polycythemia vera with indications for cytoreductive therapy per National Comprehensive Cancer Network
- for Appendix D, added definition for low-risk and high-risk polycythemia vera, removed peginterferon alfa-2a from preferred regimen for cytoreductive therapy for high-risk polycythemia vera, added examples of symptoms of disease progression per National Comprehensive Cancer Network.
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Beremagene Geperpavec (Vyjuvek) (CP.PHAR.592)
| Ambetter
| Policy updates include:
- Added exclusion of concomitant use with Filsuvez.
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Exagamglogene autotemcel (Casgevy) (CP.PHAR.603)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Criteria updated with newly approved indication for transfusion dependent β-thalassemia per FDA labeling and pivotal trial: added additional option for meeting transfusion dependence with receipt of ≥ 8 transfusions of packed red blood cells per year for the previous two years to align with Zynteglo
- Added associated α-thalassemia and > 1 alpha chain deletion, alpha multiplications, and associated sickle cell β-thalassemia as exclusions per specialist feedback
- Added criteria that member is negative for active HIV, hepatitis B virus, hepatitis C virus, advanced liver disease, current malignancy, and current immunodeficiency disorder
- Clarified minimum Casgevy dose required
- Revised initial approval duration to 6 months to allow adequate time for gene therapy manufacture
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Spesolimab-sbzo (Spevigo) (CP.PHAR.606)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, and Velsipity to section III.B
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Nedosiran (Rivfloza) (CP.PHAR.619)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Commercial line of business changed approval duration to “6 months or to the member’s renewal date, whichever is longer”
- Added exclusion for concomitant use of Rivfloza with Oxlumo
- For Continued Therapy clarified that one of the listed criteria would need to be met, to align with Oxlumo criteria
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Pirtobrutinib (Jaypirca) (CP.PHAR.620)
| Ambetter
| Policy updates include:
- For all indications, added maximum dose criteria for concomitant use with CYP3A inducers
- Updated Appendix B for therapeutic alternatives per National Comprehensive Cancer Network
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Daprodustat (Jesduvroq) (CP.PHAR.628)
| Ambetter
| Policy updates include:
- Added requirement for continuation requests that hemoglobin ≤ 12 g/dL
- Added Oklahoma to Appendix D
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Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Merkel cell carcinoma, added pathways for primary locally advanced disease and recurrent regional disease per National Comprehensive Cancer Network 2A recommendation and added requirement that Zynyz be prescribed as a single agent
- Added criteria for anal carcinoma per National Comprehensive Cancer Network 2A recommendation
- Added Zynyz HCPCS code and removed inactive codes
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Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Wezlana, Sotyktu, and Velsipity to section III.B
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Mirikizumab-mrkz (Omvoh) (CP.PHAR.662)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Zymfentra, Wezlana, Sotyktu, and Velsipity to section III.B
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Birch Triterpenes (Filsuvez) (CP.PHAR.669)
| Ambetter
| Policy updates include:
- Added exclusion of concomitant use with Vyjuvek in dystropic epidermolysis bullosa (Vyjuvek is not FDA-approved for use in junctional epidermolysis bullosa).
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Pregabalin (Lyrica, Lyrica CR) (CP.PMN.33)
| Ambetter
| Policy updates include:
- For partial onset seizures, revised maximum dose from 420 mg to 14 mg/kg/day for members weighing < 30 kg
- For neuropathic pain associated-with spinal cord injury, clarified usage of pregabalin immediate release only
- Added generalized anxiety disorder products and dosing regimen to Appendix B
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Naproxen/Esomeprazole (Vimovo) (CP.PMN.117)
| Ambetter
| Policy updates include:
- For commercial line of business, updated approval duration from length of benefit to “12 months”
- Request for generic formation added to continued therapy
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Ibuprofen/Famotidine (Duexis) (CP.PMN.120)
| Ambetter
| Policy updates include:
- Added redirection to generic product in continued therapy
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Rifamycin (Aemcolo) (CP.PMN.196)
| Ambetter
| Policy updates include:
- Added requirement that member must use Xifaxan
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Quinine Sulfate (Qualaquin) (CP.PMN.262)
| Ambetter
| Policy updates include:
- Revised policy/criteria section to also include generic quinine
- For malaria, added Plasmodium ovale, Plasmodium malariae, and Plasmodium knowlesi as additional off-label coverable infections per CDC guidelines
- For babesiosis, added redirection to generic
- Updated malaria dosing recommendations in Section V per Clinical Pharmacology
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Ganaxolone (Ztalmy) (CP.PMN.278)
| Ambetter
| Policy updates include:
- Revised language from “member is experiencing” to “documentation” of baseline monthly seizure frequency to help determine positive response with example added for continued therapy
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Repository Corticotropin Injection (H.P. Acthar Gel, Purified Cortrophin Gel) (HIM.PA.168)
| Ambetter
| Policy updates include:
- For infantile spasm reduced approval durations from 3 to 1 month
- For Purified Cortrophin Gel added 1 mL multiple dose vial formulation to Section VI
- Revised references to “H.P. Acthar Gel” to instead reference “Acthar Gel” per prescribing information
- For Acthar Gel updated product availability to include pre-filled injector.
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Apalutamide (Erleada) (CP.PCH.45)
| Ambetter
| Policy updates include:
- Added clarification for daily quantity of 1 tablet per day
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Valbenazine (Ingrezza) (CP.PCH.48)
| Ambetter
| Policy updates include:
- Added Austedo XR formulation as additional concurrent treatment exclusion
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Dasatinib (Sprycel, Phyrago) (CP.PHAR.72)
| Ambetter
| Policy updates include:
- For dosing limits added clarification that dose optimization is required in each criteria set
- Added Appendix D to define dose optimization
- For Appendix E, updated state OH description to include Commercial line of business
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Bexarotene (Targretin Capsules, Gel) (CP.PHAR.75)
| Ambetter
| Policy updates include:
- Revised policy/criteria section to also include generic bexarotene
- Added redirection to generic bexarotene gel for Targretin gel requests
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Agalsidase Beta (Fabrazyme) (CP.PHAR.158)
| Ambetter
| Policy updates include:
- Added exclusion for concomitant use with Elfabrio to align with the Elfabrio criteria
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Alglucosidase Alfa (Lumizyme) (CP.PHAR.160)
| Ambetter
| Policy updates include:
- Added exclusion for concomitant use with Pombiliti+Opfolda to align with the Pombiliti criteria
|
Vestronidase Alfa-vjbk (Mepsevii) (CP.PHAR.374)
| Ambetter
| Policy updates include:
- Added requirement for documentation of member’s weight to determine appropriate dosing for initial approval and for reauthorization
- Updated auth durations to reflect LOB-specific differences
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Avalglucosidase Alfa-ngpt (Nexviazyme) (CP.PHAR.521)
| Ambetter
| Policy updates include:
- Added exclusion for concomitant use with Pombiliti+Opfolda to align with the Pombiliti criteria
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Itraconazole (Sporanox, Tolsura) (CP.PMN.124)
| Ambetter
| Policy updates include:
- Revised policy/criteria section to also include generic itraconazole
- Revised criteria to specify capsule or solution formulation for respective FDA-approved indications
- Updated drug interaction contraindications per PI
- Clarified contraindication in patients with CHF for treatment of onychomycosis or non-threatening infections only
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Age Limit Override (Codeine, Tramadol, Hydrocodone) (CP.PMN.138)
| Ambetter
| Policy updates include:
- Limitations of use added to FDA approved indications section
|
Viloxazine (Qelbree) (CP.PMN.264)
| Ambetter
| Policy updates include:
- Added criteria for maximum capsule quantities based on maximum dosing
|
Nitisinone (Orfadin, Nityr) (CP.PHAR.132)
| Ambetter
| Policy updates include:
- For Orfadin revised generic redirection to apply generally to the capsule formulation (to now include the 20 mg strength).
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Dupilumab (Dupixent) (CP.PHAR.336)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Ambetter line of business removed as separate criteria is required
- for asthma and atopic dermatitis added reference to “Refer to HIM.PA.SP69 for California Exchange Plans and refer to NY.HIM.SP69 for NY CHIP Plans”
- For Asthma initial approval criteria, added allowance for emergency room visit and removed intubation option.
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Brodalumab (Siliq) (CP.PHAR.375)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bimzelx, Zymfentra, Omvoh, Wezlana, Sotyktu, Tofidence, and Velsipity to section III.B
- Added criteria requiring use of Taltz and preferred adalimumab products (Hadlima, Yusimry, adalimumab-adaz, adalimumab-adbm, and adalimumab-fkjp)
- Added therapeutic alternatives Taltz and adalimumab products to Appendix B
- Updated Appendix D with examples of tumor necrosis factor blockers.
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SGLT2 inhibitors (HIM.PA.91)
| Ambetter
| Policy updates include:
- Added reference to generic dapagliflozin where redirection is stated for Farxiga
- For continued therapy, added redirection to preferred agents for all indications
- Removed Glyxambi and Trijardy XR as prior authorization is not required.
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Inhaled agents for asthma and COPD (HIM.PA.153)
| Ambetter
| Policy updates include:
- For “All other inhaled corticosteroid” requests added additional redirection to fluticasone propionate diskus (Flovent Diskus authorized generic)
- Revised Flovent Diskus redirection requirements to fluticasone propionate diskus (Flovent Diskus authorized generic) in a new row
- For “All other inhaled corticosteroid / long acting beta-2 agonist” requests added additional redirection to Dulera.
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Biologic and Non-biologic DMARDs (HIM.PA.SP60)
| Ambetter
| Policy updates include:
- For uveitis, added Yuflyma to criteria
- For Castleman’s disease, added member has either unicentric disease with HIV-negative and Human Herpesvirus 8 (HHV-8)-negative or multicentric disease as supported by National Comprehensive Cancer Network compendium and updated duration from “6 months or to member’s renewal date, whichever is longer” to “6 months”
- For cytokine release syndrome, added “i.e., inadequate response to steroids, vasopressors” as examples for refractory CRS
- For Appendix D, removed ankylosing spondylitis and non-radiographic axial spondyloarthritis guideline, CRADLE trial for Cimzia, and pediatric pharmacokinetic studies for Stelara
- For Appendix M, added Actemra information as an FDA-approved alternative for Coronavirus disease 2019 (COVID-19)
- For Renflexis, removed “re-administration to patients who have experienced severe hypersensitivity reaction to infliximab products” in contraindications section
- For Cosentyx, Rinvoq, Avsola, Inflectra, Remicade, and Renflexis, added “maximum dose escalation allowed per prescriber information with documentation of inadequate response” in criteria and section V
- Added Bimzelx, Zymfentra, Omvoh, Sotyktu, Tofidence, and Velsipity to section III.B
- For Rinvoq in Atopic Dermatitis, modified requirement of two topical corticosteroids to require only one, removed requirement for use of one systemic agent
- Added newly approved Humira biosimilar Simlandi to criteria
- Added newly approved Actemra biosimilar Tyenne to rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis criteria
- Added Sotyktu to description section and “medically necessary” section
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