POLICY
| APPLICABLE PRODulcerative colitisTS
| New policy overview or updated policy revisions
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Immune Globulins (CP.PHAR.103)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:- For chronic inflammatory demyelinating polyneuropathy (CIDP), revised diagnostic criteria from “atypical CIDP” to “CIPD variants” aligning with 2021 EAN/PNS CIDP guidelines
- Applied redirection language to other diagnoses/indications section
- For Section III, clarified usage for “maintenance or chronic” treatment of secondary immunodeficiencies induced by biologic therapies
- For Arkansas, added reference to state-specific PANS/PANDAS AR.CP.PHAR.103 policy;
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Omacetaxine (Synribo) (CP.PHAR.108)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Removed off-label use in T315I mutation as this is no longer supported by National Comprehensive Cancer Network Guidelines (NCCN) Compendium;
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Nivolumab, Nivolumab Hyaluronidase-nvhy (Opdivo, Opdivo Qvantig) (CP.PHAR.121)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For squamous cell carcinoma of the head and neck, added redirection for nasopharyngeal carcinoma to Loqtorzi
- Added Appendix F to include states with regulations against redirections in cancer
- For colorectal cancer: updated Food and Drug Administration (FDA) Approved Indication(s) section to include combination use with Yervoy for unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and to reflect conversion from accelerated approval to full approval for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with fluropyrimidine, oxaliplatin, and irinotecan, clarified criteria for Opdivo Qvantig requests is prescribed as subsequent-line systemic therapy, updated Section V for adult and pediatric patients weighing at least 40 kg from "3 mg/kg” to “240 mg” IV followed by ipilimumab on the same day and added option for 6 mg/kg every 4 weeks after combination with ipilimumab for pediatric patients weighing less than 40 kg
- For hepatocellular carcinoma: updated Food and Drug Administration (FDA) Approved Indication(s) section with addition of first-line treatment in combination with ipilimumab and conversion from accelerated approval to full approval for those who has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan and updated criteria with the following: added disease is unresectable or metastatic, added criteria for usage in first-line systemic therapy setting and additional criteria for subsequent-line systemic therapy setting per National Comprehensive Cancer Network (NCCN)
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Evolocumab (Repatha) (CP.PHAR.123)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- For all indications, reduced statin adherence duration from 4 months to 8 weeks, simplified statin trial and failure criteria for moderate- and low-intensity statin regimens to require insufficient therapeutic response to one high intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin, removed ezetimibe trial criteria
- In Appendix D, removed atherosclerotic cardiovascular disease risk information for heterozygous familial hypercholesterolemia diagnosis.
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Cysteamine oral (Cystagon, Procysbi) (CP.PHAR.155)
| Ambetter
| Policy update includes:
- Added prescriber requirement for nephrologist or a metabolic disease specialist experienced in management of nephropathic cystinosis (e.g., endocrinologist or urologist)
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Agalsidase Beta (Fabrazyme) (CP.PHAR.158)
| Ambetter
| Policy update includes:
- Added requirement for documentation of member’s weight for dose calculation purposes;
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Miglustat (Zavesca) (CP.PHAR.164)
| Ambetter
| Policy update includes:
- Added generic redirection
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Pertuzumab (Perjeta) (CP.PHAR.227)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For continued therapy, added criterion for maximum duration for neoadjuvant or adjuvant breast cancer treatment, does not exceed a total of 1 year treatment (up to 18 cycles)
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Darbepoetin Alfa (Aranesp) (CP.PHAR.236)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter for anemia due to chronic kidney disease
- Removed 300 mg vial from product availability per updated prescribing information
- For all indications, revised Retacrit and Epogen redirection language from “failure of” to “member must use” and revised criteria from “member meets one of the following” to “member must meet both of the following”, clarified members must use Epogen if member is unable to use Retacrit.
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Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) (CP.PHAR.238)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter
- For all indications, revised Retacrit and Epogen redirection language from “failure of” to “member must use” and revised criteria from “member meets one of the following” to “member must meet both of the following”, clarified members must use Epogen if member is unable to use Retacrit.
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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 update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- For Appendix F, added supplemental information on modified Mayo Score
- For polyarticular juvenile idiopathic arthritis: removed criteria for minimum clinical juvenile arthritis disease activity score (cJADAS)-10 score greater than 8.5 for documentation of high disease activity and “baseline 10-joint clinical juvenile arthritis disease activity score” in initial criteria to align with competitor analysis
- Removed criteria for “member is responding positively to therapy as evidence by decrease in clinical juvenile arthritis disease activity score (cJADAS)-10 from baseline” in continued therapy
- For Appendix J, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology guidelines
- For Simlandi, added new single-dose autoinjector strength [80 mg/0.8 ml]
- For continued therapy section, removed “if new dosing regimen, approve for 6 months” for approval duration
- Updated section III.B with Spevigo and biosimilar verbiage;
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Anakinra (Kineret) (CP.PHAR.244)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- Updated section III.B with Spevigo and biosimilar verbiage;
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Canakinumab (Ilaris) (CP.PHAR.246)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For systemic juvenile idiopathic arthritis, added redirection to nonsteroidal anti-inflammatory drugs (NSAID) as an option per clinical practice guidelines and competitor analysis
- Updated section III.B with Spevigo and biosimilar verbiage;
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Certolizumab (Cimzia) (CP.PHAR.247)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- For polyarticular juvenile idiopathic arthritis: removed criteria for minimum clinical juvenile arthritis disease activity score (cJADAS)-10 score greater than 8.5 for documentation of high disease activity and “baseline 10-joint clinical juvenile arthritis disease activity score” in initial criteria to align with competitor analysis
- Removed criteria for “member is responding positively to therapy as evidence by decrease in clinical juvenile arthritis disease activity score (cJADAS)-10 from baseline” in continued therapy
- For Appendix H, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology guidelines
- Updated section III.B with Spevigo and biosimilar verbiage;
- For plaque psoriasis, psoriatic arthritis, and Crohn’s disease, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
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Etanercept (Enbrel) (CP.PHAR.250)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For polyarticular juvenile idiopathic arthritis: removed criteria for minimum clinical juvenile arthritis disease activity score (cJADAS)-10 score greater than 8.5 for documentation of high disease activity and “baseline 10-joint clinical juvenile arthritis disease activity score” in initial criteria to align with competitor analysis
- Removed criteria for “member is responding positively to therapy as evidence by decrease in clinical juvenile arthritis disease activity score (cJADAS)-10 from baseline” in continued therapy
- For Appendix I, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology guidelines
- Updated section III.B with Spevigo and biosimilar verbiage;
- For plaque psoriasis and psoriatic arthritis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
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Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association guidelines
- Revised redirection to Zeposia with bypass allowance stating member must use Zeposia unless member has had history of failure of biological disease-modifying antirheumatic drug or Janus kinase inhibitor as supported by 2024 American Gastroenterological Association guidelines
- For Appendix E, added supplemental information on modified Mayo Score
- For polyarticular juvenile idiopathic arthritis: removed criteria for minimum clinical juvenile arthritis disease activity score (cJADAS)-10 score greater than 8.5 for documentation of high disease activity and “baseline 10-joint clinical juvenile arthritis disease activity score” in initial criteria to align with competitor analysis
- Removed criteria for “member is responding positively to therapy as evidence by decrease in clinical juvenile arthritis disease activity score (cJADAS)-10 from baseline” in continued therapy
- For Appendix J, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology guidelines
- Updated section III.B with Spevigo and biosimilar verbiage;
- For psoriatic arthritis and ulcerative colitis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
- For ulcerative colitis, removed criteria requiring use of preferred agent Zeposia
- For ulcerative colitis, revised requirement to include option for step through preferred adalimumab product or preferred ustekinumab product
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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 update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- For Appendix F, added supplemental information on modified Mayo Score
- For Kawasaki disease, updated maximum dose from 5 mg/kg given over 2 hours to 10 mg/kg given over 2 hours
- For continued therapy section, removed “if new dosing regimen, approve for 6 months” for approval duration
- Updated section III.B with Spevigo and biosimilar verbiage
- Added off-label criteria for steroid-refractory acute graft-versus-host disease as supported by National Comprehensive Cancer Network Guidelines (NCCN) compendium
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Ixekizumab (Taltz) (CP.PHAR.257)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- Updated section III.B with Spevigo and biosimilar verbiage;
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Natalizumab (Tysabri, Tyruko) (CP.PHAR.259)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Crohn’s disease, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
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Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For B-cell lymphomas initial criteria, added extranodal marginal zone (stomach or nongastric sites), histologic transformation of indolent lymphomas to diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and removed low-grade B-cell lymphoma for non-Hodgkin’s lymphoma subtypes per National Comprehensive Cancer Network Guidelines (NCCN) compendium
- For National Comprehensive Cancer Network Guidelines (NCCN) compendium indications, removed “in patients who are CD20 positive” for acute lymphoblastic leukemia per National Comprehensive Cancer Network Guidelines (NCCN) compendium
- For neuromyelitis optica spectrum disorder initial criteria, added Bkemv, Epysqli, and Ultomiris to list of drugs not prescribed concurrently with Rituxan/Riabni/Ruxience/Truxima
- For granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis, updated age to allow option for Riabni, Ruxience, Truxima: age at least 18 years
- For continued therapy section, updated approval duration from 6 months to 12 months
- Updated section III.B with Spevigo and biosimilar verbiage;
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Secukinumab (Cosentyx) (CP.PHAR.261)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For enthesitis-related arthritis initial criteria, added statement disclaimer that prior authorization may be required for Actemra
- For continued therapy section, removed “if new dosing regimen, approve for 6 months” for approval duration
- Updated section III.B with Spevigo and biosimilar verbiage;
- For plaque psoriasis and psoriatic arthritis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
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Tocilizumab (Actemra), Tocilizumab-bavi (Tofidence), Tocilizumab-aazg (Tyenne) (CP.PHAR.263)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For systemic juvenile idiopathic arthritis, added redirection to nonsteroidal anti-inflammatory drugs (NSAID) as an option per clinical practice guidelines and competitor analysis
- Added newly approved biosimilar Avtozma to criteria
- For cytokine release syndrome, revised criteria from “member has developed refractory cytokine release syndrome related to blinatumomab therapy” to “used as supportive care in severe cytokine release syndrome related to blinatumomab therapy” and added criteria “used as prophylaxis to reduce the risk of cytokine release syndrome when administering teclistamab-cqyv” per National Comprehensive Cancer Network Guidelines (NCCN) compendium
- Updated section III.B with Spevigo and biosimilar verbiage
- For Tyenne, added newly approved cytokine release syndrome and COVID-19 indications to criteria.
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Ustekinumab (Stelara), Ustekinumab-aauz, Ustekinumab-srlf (Imuldosa), (Otulfi), Ustekinumab-ttwe (Pyzchiva), Ustekinumab-aekn (Selarsdi), Ustekinumab-stba (Steqeyma), Ustekinumab-auub (Wezlana), Ustekinumab-kfce (Yesintek) (CP.PHAR.264)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association (AGA) guidelines
- Revised redirection to Zeposia with bypass allowance stating member must use Zeposia unless member has had history of failure of biological disease-modifying antirheumatic drug or Janus kinase inhibitor as supported by 2024 American Gastroenterological Association (AGA) guidelines
- For Appendix F, added supplemental information on modified Mayo Score
- Added HCPCS codes [Q9999, C9399, J3590]
- Updated section III.B with Spevigo and biosimilar verbiage
- For Otulfi, added new dosage formulation [single-dose vial for subcutaneous injection: 45 mg/0.5 ml]
- For psoriatic arthritis and plaque psoriasis, added Otulfi to “weight less than 60 kg: 0.75 mg/kg per dose” pediatric dosing criteria.
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Vedolizumab (Entyvio) (CP.PHAR.265)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association guidelines
- Revised redirection to Zeposia with bypass allowance stating member must use Zeposia unless member has had history of failure of biological disease-modifying antirheumatic drug or Janus kinase inhibitor as supported by 2024 American Gastroenterological Association guidelines
- For Appendix F, added supplemental information on modified Mayo Score
- Updated section III.B with Spevigo and biosimilar verbiage;
- Added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
- For ulcerative colitis, removed criteria requiring use of preferred agent Zeposia
- For ulcerative colitis, revised requirement to include option for step through preferred adalimumab product or preferred ustekinumab product
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Rilonacept (Arcalyst) (CP.PHAR.266)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Updated section III.B with Spevigo and biosimilar verbiage;
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Ofatumumab (Arzerra, Kesimpta) (CP.PHAR.306)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For Arzerra, removed Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma criteria as this off-label use is no longer supported by National Comprehensive Cancer Network Guidelines (NCCN) and removed primary therapeutic examples for Appendix B
- For Kesimpta (multiple sclerosis), removed requirements for documentation of baseline relapses/ expanded disability status score and specific measures of positive response per competitor analysis and removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business as it is no longer available on market
- Updated Appendix C to include Kesimpta’s new hypersensitivity contraindication
- For multiple sclerosis continued therapy, modified Ambetter and Medicaid approval duration from “if member has received < 1 year of total treatment – up to a total of 12 months of treatment and if member has received greater than 1 year of total treatment – 12 months” to “12 months”;
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Ipilimumab (Yervoy) (CP.PHAR.319)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Updated Food and Drug Administration (Food and Drug Administration (FDA)) indication for renal cell carcinoma and hepatocellular carcinoma
- For melanoma, clarified combination use with Keytruda is off-label use per National Comprehensive Cancer Network Guidelines (NCCN) and revised adjuvant treatment maximum dosage
- For non-small cell lung cancer (NSCLC) per National Comprehensive Cancer Network Guidelines (NCCN), added criteria for NRG1 gene fusion positive
- Removed criteria for the following mutations: RET rearrangement, epidermal growth factor receptor (EGFR) exon 19 deletion, exon 21 L858R, ALK rearrangement, ROS1 rearrangement
- For ESCC per National Comprehensive Cancer Network Guidelines (NCCN), added off-label indication for prescribed as induction systemic therapy
- For off-label National Comprehensive Cancer Network Guidelines (NCCN) compendium indications, consolidated microsatellite instability-high mut/Mb: mutations/megabase (MSI-H)/mismatch repair deficient (dMMR) cancers, revised biliary tract cancer criteria to allow primary treatment
- In Appendix B, removed entries that are not redirections (Opdivo and Keytruda)
- In Appendix D, added no longer recommended indications
- In Section V, clarified dosing regimen wording
- For colorectal cancer, updated Food and Drug Administration (FDA) Approved Indication(s) section to earlier line of therapy with removal of language “that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan” and conversion from accelerated approval to full approval and updated dosing in Section V to reflect a maximum of 4 doses
- For hepatocellular carcinoma, updated Food and Drug Administration (FDA) Approved Indication(s) section with addition of first-line treatment in combination with nivolumab and conversion from accelerated approval to full approval for those who have been previously treated with sorafenib, and updated criteria with the following: added disease is unresectable, metastatic or advanced
- Removed documentation of Child-Pugh Class A status and member has previously received Nexavar, Lenvima, or Tecentriq + bevacizumab
- Added criteria for usage in first-line and subsequent-line systemic therapy setting per National Comprehensive Cancer Network (NCCN).
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For head and neck squamous cell carcinoma (HNSCC), added redirection for nasopharyngeal carcinoma to Loqtorzi
- Added Appendix G to include states with regulations against redirections in cancer
- Updated Food and Drug Administration (FDA) Approved Indication(s) section for first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (CPS at least 1) from accelerated approval to full approval
- For gastric cancer, esophageal cancer, or gastroesophageal junction cancer, added option to bypass disease is unresectable, locally advanced, recurrent, or metastatic if member is planned for esophagectomy per National Comprehensive Cancer Network (NCCN)
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Durvalumab (Imfinzi) (CP.PHAR.339)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Per National Comprehensive Cancer Network Guidelines (NCCN) – for non-small cell lung cancer (NSCLC), added that Imfinzi must be prescribed as a single agent and that disease does not have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation if stage II-III
- Added use as first-line therapy for NRG1 gene fusion positive tumors
- Removed use as subsequent therapy for epidermal growth factor receptor (EGFR) exon 19 deletion, exon 21 deletion, exon 21 L858R tumors, ALK1 rearrangement, and ROS1 rearrangement positive tumors
- For hepatocellular carcinoma, added additional qualifier of extrahepatic
- For endometrial cancer, added additional qualifiers of metastatic, stage III, and stage IV
- For cervical cancer, added that Imfinzi can be used as a single agent for maintenance therapy following combination use
- For ampullary adenocarcinoma, removed qualifiers of unresectable localized and stage IV resected
- For biliary tract cancer, added “with curative intent” for recurrent definition to align with National Comprehensive Cancer Network Guidelines (NCCN) compendium wording
- Updated Food and Drug Administration (FDA) approved indication for mismatch repair deficient (dMMR) endometrial cancer to include Food and Drug Administration (FDA) approved testing language
- Added criteria for newly Food and Drug Administration (Food and Drug Administration (FDA))-approved indication of muscle invasive bladder cancer
- Under continued approval duration, revised maximum number of cycles for resectable non-small cell lung cancer from 12 to 16 to include neoadjuvant treatment
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Edaravone (Radicava, Radivaca ORS) (CP.PHAR.343)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Added edaravone to the Policy/Criteria applicability section
- Added generic redirection for intravenous Radicava request to initial and continued criteria
- In initial criteria and Appendix D, clarified that “El Escorial” refers to revised El Escorial or Airlie House;
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Sarilumab (Kevzara) (CP.PHAR.346)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For polyarticular juvenile idiopathic arthritis: removed criteria for minimum clinical juvenile arthritis disease activity score (cJADAS)-10 score greater than 8.5 for documentation of high disease activity and “baseline 10-joint clinical juvenile arthritis disease activity score” in initial criteria to align with competitor analysis
- Removed criteria for “member is responding positively to therapy as evidence by decrease in clinical juvenile arthritis disease activity score (cJADAS)-10 from baseline” in continued therapy
- For Appendix I, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology guidelines
- Updated section III.B with Spevigo and biosimilar verbiage;
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Ceritinib (Zykadia) (CP.PHAR.349)
| Ambetter
| Policy update includes:
- Removed criteria option for ROS1-positive non-small cell lung cancer (NSCLC) per National Comprehensive Cancer Network Guidelines (NCCN) update;
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Guselkumab (Tremfya) (CP.PHAR.364)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association guidelines
- Revised redirection to Zeposia with bypass allowance stating member must use Zeposia unless member has had history of failure of biological disease-modifying antirheumatic drug or Janus kinase inhibitor as supported by 2024 American Gastroenterological Association guidelines
- For Appendix E, added supplemental information on modified Mayo Score
- Updated section III.B with Spevigo and biosimilar verbiage;
- Added criteria for newly approved indication for Crohn’s disease, including Appendix F with immunomodulator medical justification
- Added new strength [100 mg/ml] for single-dose prefilled pen (Tremfya Pen)
- For plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
- For ulcerative colitis, removed criteria requiring use of preferred agent Zeposia
- For ulcerative colitis, revised requirement to include option for step through preferred adalimumab product or preferred ustekinumab product
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Brodalumab (Siliq) (CP.PHAR.375)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For contraindication section, added hypersensitivity to brodalumab or to any of the excipients per prescriber information
- Updated section III.B with Spevigo and biosimilar verbiage;
- For plaque psoriasis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
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Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- Updated section III.B with Spevigo and biosimilar verbiage;
- Added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
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Lorlatinib (Lorbrena) (CP.PHAR.406)
| Ambetter
| Policy update includes:
- Removed Zykadia from list of ROS1-positive non-small cell lung cancer (NSCLC) failure agents per National Comprehensive Cancer Network Guidelines (NCCN) update
- Added pediatric diffuse high-grade glioma to National Comprehensive Cancer Network Guidelines (NCCN)-supported off-label indications;
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Dexrazoxane (Totect) (CP.PHAR.418)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Removed brand Totect from criteria as product has been discontinued and obsolete
- For doxorubicin-induced cardiomyopathy, clarified anthracycline-induced extravasation is an off-label use now that Totect has been discontinued
- Removed Hodgkin lymphoma in adults age greater than 60 years per National Comprehensive Cancer Network Guidelines (NCCN)
- Removed redirections to generic dexrazoxane now that product is only available as generic;
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Risankizumab-rzaa (Skyrizi) (CP.PHAR.426)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association guidelines
- Revised redirection to Zeposia with bypass allowance stating member must use Zeposia unless member has had history of failure of biological disease-modifying antirheumatic drug or Janus kinase inhibitor as supported by 2024 American Gastroenterological Association guidelines
- For Appendix F, added supplemental information on modified Mayo Score
- Updated section III.B with Spevigo and biosimilar verbiage;
- For plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
- For ulcerative colitis, removed criteria requiring use of preferred agent Zeposia
- For ulcerative colitis, revised requirement to include option for step through preferred adalimumab product or preferred ustekinumab product
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Sapropterin Dihydrochloride (Kuvan, Javygtor) (CP.PHAR.43)
| Ambetter
| Policy update includes:
- Added requirement for a redirection from Javygtor (branded generic) to unbranded generic sapropterin per an SDC recommendation
- Added a requirement for documentation of member’s current weight for dose calculation purposes;
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Ozanimod (Zeposia) (CP.PHAR.462)
| Ambetter
| Policy updates include:
- For ulcerative colitis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred) or one preferred adalimumab product
|
Pegunigalsidase alfa-iwxj (Elfabrio) (CP.PHAR.512)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Added concomitant use exclusion to the Continued Therapy section to echo the exclusion which currently exists in the Initial Approval Criteria
- Added requirement for documentation of member’s weight for dose calculation purposes;
|
Odevixibat (Bylvay) (CP.PHAR.528)
| Ambetter
| Policy update includes:
- For initial and continued therapy, added exclusion for concurrent use with other ileal bile acid transporter inhibitors
- For exclusion of pathologic variations of the ABCB11 gene that predict complete absence of the BSEP protein, clarified this is specific to progressive familial intrahepatic cholestasis type 2;
|
Lecanemab-irmb (Leqembi) (CP.PHAR.596)
| Ambetter
| Policy updates include:
- In the Continued Therapy section, removed the word “baseline” in reference to the required cognitive and functional tests to ensure that Leqembi therapy is not continued in those who have progressed to the moderate stage of disease severity
|
Spesolimab-sbzo (Spevigo) (CP.PHAR.606)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Updated section III.B with Spevigo and biosimilar verbiage;
|
Elacestrant (Orserdu) (CP.PHAR.623)
| Ambetter
| Policy update includes:
- In continued therapy, added minimum dose of 172 mg per prescribing information
- In Appendix B, updated therapeutic alternative dosing regimens per Clinical Pharmacology;
|
Concizumab-tci (Alhemo) (CP.PHAR.625)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Added Hemlibra redirection for hemophilia A with inhibitors indication
- Moved Appendix D examples of positive response to therapy into continued therapy criteria section;
|
Pozelimab-bbfg (Veopoz) (CP.PHAR.626)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Added criterion to prevent duplicative therapy with other complement inhibitors;
|
Sparsentan (Filspari) (CP.PHAR.631)
| Ambetter
| Policy update includes:
- Added to continuation of therapy requirement that Filspari is not prescribed concurrently with renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), or aliskiren;
|
Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For hidradenitis suppurativa, added “contraindicated or clinically significant adverse effects are experienced” bypass for preferred adalimumab product redirection
- Updated section III.B with Spevigo and biosimilar verbiage;
- For plaque psoriasis added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
|
Mirikizumab-mrkz (Omvoh) (CP.PHAR.662)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy update includes:
- For initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association guidelines
- Revised redirection to Zeposia with bypass allowance stating member must use Zeposia unless member has had history of failure of biological disease-modifying antirheumatic drug or Janus kinase inhibitor as supported by 2024 American Gastroenterological Association guidelines
- For Appendix E, added supplemental information on modified Mayo Score
- Added newly approved Crohn’s disease indication to criteria
- Added new dosage forms [single-dose prefilled pen 200 mg/2 ml and single-dose syringe 200 mg/2 ml]
- Updated section III.B with Spevigo and biosimilar verbiage;
- For Crohn’s disease and ulcerative colitis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
- For ulcerative colitis, removed criteria requiring use of preferred agent Zeposia
- For ulcerative colitis, revised requirement to include option for step through preferred adalimumab product or preferred ustekinumab product
|
Vadadustat (Vafseo) (CP.PHAR.677)
| Ambetter
| Policy update includes:
- Added requirement that Vafseo is not prescribed concurrently with Jesduvroq
- Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter
- Modified to require redirection to both Retacrit and Epogen (if member is unable to use Retacrit).
|
Sorafenib (Nexavar) (CP.PHAR.69)
| Ambetter
| Policy update includes:
- Revised policy/criteria section to also include generic sorafenib
- Revised the following per National Comprehensive Cancer Network Guidelines (NCCN) – for hepatocellular carcinoma, removed requirement for confirmation of Child-Pugh class A or B7 status and added requirement for use as a single agent
- For renal cell carcinoma, removed qualifiers of “relapsed” and “stage IV”
- For differentiated thyroid carcinoma, added coverage for symptomatic disease
- For medullary thyroid carcinoma, specified that disease must be metastatic
- For acute myeloid leukemia, restricted combination use to relapsed/refractory disease and removed allowance for single agent use for induction/consolidation therapy;
|
Lenalidomide (Revlimid) (CP.PHAR.71)
| Ambetter
| Policy update includes:
- Revised policy/criteria section to also include generic lenalidomide
- Per National Comprehensive Cancer Network Guidelines (NCCN) – for multiple myeloma, added use as primary therapy for high-risk smoldering multiple myeloma and symptomatic multiple myeloma
- For myelodysplastic syndrome, clarified recommended uses for no deletion 5q abnormality depending on ring sideroblasts (including addition of trial of Reblozyl or Rytelo for ring sideroblasts at least 15% [or at least 5% if SF3B1 mutation]), added that member has poor probability to respond to immunosuppressive therapy for serum erythropoietin greater than 500 mu/ml, and removed allowance for myelodysplastic syndrome/myeloproliferative overlap neoplasms that are wild-type for SF3B1 mutation
- For marginal zone lymphomas, added use as first-line therapy in combination with rituximab and removed use in combination with Monjuvi
- For follicular lymphoma, added use as first-line in combination with Gazyva, specified use as a single agent or combination therapy for second-line or subsequent therapy, and removed specific requirements surrounding combination use with Monjuvi in non-transplant candidates
- For classic Hodgkin lymphoma, removed requirement for use as fourth-line or later therapy and added use as single agent palliative subsequent therapy
- For adult T-cell leukemia/lymphoma and hepatosplenic gamma-delta T-cell lymphoma, specified use must be as a single agent
- For chronic lymphocytic leukemia/small lymphocytic lymphoma, specified use must be as a single agent or in combination with rituximab and specified prior therapies that must be tried
- For B-cell lymphomas, clarified that Monjuvi can also be used in non-CAR T-cell therapy candidates and added additional pathways for use;
|
Sunitinib (Sutent) (CP.PHAR.73)
| Ambetter
| Policy update includes:
- Revised policy/criteria section to also include generic sunitinib
- Per National Comprehensive Cancer Network Guidelines (NCCN), revised the following – for gastrointestinal stromal tumor, added tumor rupture as an acceptable qualifier
- For pancreatic neuroendocrine tumor, added that tumor must be well-differentiated and removed requirement for use as a single agent
- For off-label indications, added extraskeletal myxoid chondrosarcoma as a covered use and updated myeloid/lymphoid neoplasms to include mixed phenotype
- Modified Medicaid/Ambetter continued approval duration from 6 months to 12 months per standard oncology approach;
|
Temozolomide (Temodar) (CP.PHAR.77)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- For off-label National Comprehensive Cancer Network Guidelines (NCCN) Compendium, added criteria for well-differentiated grade 3 neuroendocrine tumors, added criteria for pediatric medulloblastoma, revised the following off-label indications to align with National Comprehensive Cancer Network Guidelines (NCCN) recommended category 1 or 2A ratings: cutaneous melanoma, pediatric diffuse high-grade gliomas, intracranial and spinal ependymoma, and medulloblastoma;
|
Thalidomide (Thalomid) (CP.PHAR.78)
| Ambetter
| Policy update includes:
- Consolidated criteria for multicentric Castleman’s disease, Kaposi sarcoma, and histiocytic neoplasms into one section of off-label National Comprehensive Cancer Network Guidelines (NCCN) Compendium Indications
- In off-label National Comprehensive Cancer Network Guidelines (NCCN) compendium indications, added criteria for pediatric medulloblastoma per National Comprehensive Cancer Network Guidelines (NCCN) 2A recommendation
- In continued therapy, clarified continuity of care does not apply to erythema nodosum leprosum, aphthous stomatitis, or aphthous ulcers and only applies to oncological indications
- Updated Appendix B per Clinical Pharmacology;
|
Milnacipran (Savella) (CP.PMN.125)
| Ambetter
| Policy update includes:
- Added gabapentin redirection option to fibromyalgia criteria;
|
Overactive Bladder Agents (CP.PMN.198)
| Ambetter
| Policy update includes:
- For brand Myrbetriq, added redirection to generic mirabegron
- Added fesoterodine and solifenacin to list of examples of formulary generic overactive bladder agents
|
Solriamfetol (Sunosi) (CP.PMN.209)
| Ambetter
| Policy update includes:
- For narcolepsy, updated indication in initial approval criteria to Food and Drug Administration (FDA)-approved indication of “Narcolepsy with excessive daytime sleepiness” to align with prescriber information and competitor analysis
- Added criteria for documentation of multiple sleep latency test (MSLT) with mean sleep latency ≤ 8 minutes with evidence of two or more soremps or at least one sleep-onset rapid eye movement period (SOREMP) on MSLT and a SOREMP (less than 15 minutes) on the preceding overnight PSG and daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months to align with other narcolepsy with excessive daytime sleepiness criteria;
|
Tenapanor (Ibsrela, Xphozah) (CP.PMN.224)
| Ambetter
| Policy update includes:
- Removed Commercial and added HIM line of business
- For irritable bowel syndrome with constipation added redirection to Linzess and Trulance (adapted from HIM.PA.174 that will be retired to align Medicaid with the existing Ambetter strategy), applied similar redirections from initial to continuation of therapy requests.
|
Ulcer Therapy Products (CP.PMN.277)
| Ambetter
| Policy update includes:
- For H. Pylori infection, removed required redirection to generic Prevpac for all agents except for Omeclamox-Pak
- For Talicia, added redirection to bismuth quadruple therapy
- For Voquezna and Voquezna Triple/Dual Pak if request is for a clarithromycin-containing regimens, added requirement that H. Pylori is clarithromycin-sensitive
- For Voquezna, added requirement that it is prescribed in combination with amoxicillin or amoxicillin and clarithromycin;
|
Tirzepatide (Zepbound) (CP.PMN.298)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy update includes:
- Added Rybelsus as option for step therapy
- For documentation of weight loss program, added member has been actively enrolled for at least 6 months and continues to be actively enrolled while concomitantly prescribed Zepbound
- For continued therapy, modified approval duration for first reauthorization as 6 months and subsequent reauthorization as 12 months;
- Added requirement for recent polysomnography or home sleep apnea test to be within 12 months
|
Prucalopride (Motegrity) (HIM.PA.159)
| Ambetter
| Policy update includes:
- Added redirection to generic prucalopride for initial approval criteria and continued therapy.
|
Repository Corticotropin Injection (H.P. Acthar Gel, Purified Cortrophin Gel) (HIM.PA.168)
| Ambetter
| Policy update includes:
- For infantile spasm added requirement for documentation of member’s current body surface area (BSA) in m2;
|
Biologic and Non-biologic DMARDs (HIM.PA.SP60)
| Ambetter
| Policy update includes:
- For ulcerative colitis initial criteria, added option for documentation of modified Mayo Score at least 5
- Removed redirection to preferred adalimumab products as adalimumab is not recommended due to low efficacy per 2024 American Gastroenterological Association guidelines
- For Appendix F, added supplemental information on modified Mayo Score
- For Omvoh, added criteria for newly approved indication for Crohn’s disease and added new dosage forms [single-dose prefilled pen 200 mg/2 ml and single-dose syringe 200 mg/2 ml]
- Added newly approved biosimilar Avtozma to criteria
- For Simlandi, added new single-dose autoinjector strength [80 mg/0.8 ml]
- For systemic juvenile idiopathic arthritis, added redirection to nonsteroidal anti-inflammatory drugs (NSAID) as an option per clinical practice guidelines and competitor analysis
- For Crohn’s disease, allowed redirection to preferred agent Rinvoq after tumor necrosis factor (TNF) blocker per Food and Drug Administration (Food and Drug Administration (FDA)) labeling
- For cytokine release syndrome, revised criteria from “member has developed refractory cytokine release syndrome related to blinatumomab therapy” to “used as supportive care in severe cytokine release syndrome related to blinatumomab therapy” and added criteria “used as prophylaxis to reduce the risk of cytokine release syndrome when administering teclistamab-cqyv” per National Comprehensive Cancer Network Guidelines (NCCN) compendium
- For Appendix D, removed supplemental information on Enbrel in hidradenitis suppurativa,
- Updated section III.B with Spevigo and biosimilar verbiage
- For Kawasaki disease, updated dose in section V from 5 mg/kg given over 2 hours to 10 mg/kg given over 2 hours
- For Appendix M, removed supplemental information on COVID-19 therapeutic alternatives;
- For Tyenne, added newly approved cytokine release syndrome and COVID-19 indications to criteria
- For Appendix D, removed psoriatic arthritis and plaque psoriasis supplemental information on Otezla
- For Tremfya, added criteria for newly approved indication for Crohn’s disease
- For Tremfya, added new strength [100 mg/ml] for single-dose prefilled pen (Tremfya Pen)
- For Otulfi, added new dosage formulation [single-dose vial for subcutaneous injection: 45 mg/0.5 ml]
- Added Otulfi to “weight less than 60 kg: 0.75 mg/kg per dose” pediatric dosing in section V for psoriatic arthritis and plaque psoriasis
- For ulcerative colitis, revised redirection to include adalimumab product in criteria for “three of the following: Stelara, Skyrizi, Tremfya, adalimumab product [Humira/Cyltezo/Yuflyma]”
- For Rinvoq, added newly approved giant cell arteritis indication to criteria.
- Added HCPCS codes [Q5098, Q5099, and Q5100]
|
Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) (CP.PHAR.93)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added newly Food and Drug Administration (FDA)-approved biosimilar Jobevne to criteria
- For cervical cancer, added Tecentriq as an option to combination therapy for paclitaxel/cisplatin and paclitaxel/carboplatin, and clarified topotecan is used with paclitaxel per National Comprehensive Cancer Network (NCCN)
- For hepatocellular carcinoma, removed option for use as adjuvant therapy following resection or ablation and member is at high risk for recurrence and added option for use as subsequent-line systemic therapy if progression on or after systemic therapy per National Comprehensive Cancer Network (NCCN)
|
Belzutifan (Welireg) (CP.PHAR.553)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For renal cell carcinoma, revised indication and criteria to specify clear cell histology per updated Food and Drug Administration (FDA) labeling and National Comprehensive Cancer Network (NCCN), and added bypass of prior PD-1 or PD-L1 inhibitor therapy per National Comprehensive Cancer Network (NCCN)
|
Nedosiran (Rivfloza) (CP.PHAR.619)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Revised age and dosing criteria for updated pediatric extension to include children aged at least 2 years and added requirement that request must be for a prefilled syringe unless the monthly dose is less than 128 mg
|
Non-Calcium Phosphate Binders (CP.PMN.04)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For brand Auryxia requests added redirection to generic
- Added references to generic product names for Auryxia, Fosrenol, Renagel, Renvela
|
