POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
|
Evolocumab (Repatha) (CP.PHAR.123)
| Medicaid
| 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.
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Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase (CP.PHAR.228)
| Medicaid
| Policy updates include:
· For gallbladder cancer or cholangiocarcinoma, added option to be prescribed with tucatinib per National Comprehensive Cancer Network (NCCN)
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Ado-Trastuzumab Emtansine (Kadcyla) (CP.PHAR.229)
| Medicaid
| Policy updates include:
· Added bypass of prior use of trastuzumab-based therapy and a taxane if prescribed in the adjuvant setting per National Comprehensive Cancer Network (NCCN)
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AbobotulinumtoxinA (Dysport) (CP.PHAR.230)
| Medicaid
| Policy updates include:
· For upper and lower limb spasticity, removed verbiage “staying within per limb dosing guidelines”
· For focal dystonia and essential tremor, added prescriber option for orofacial pain specialist
· Updated Appendix B with additional agents for overactive bladder
|
IncobotulinumtoxinA (Xeomin) (CP.PHAR.231)
| Medicaid
| Policy updates include:
· For focal dystonia and essential tremor, added prescriber option for orofacial pain specialist
· Updated Appendix B with additional agents for overactive bladder
|
OnabotulinumtoxinA (Botox) (CP.PHAR.232)
| Medicaid
| Policy updates include:
· For focal dystonia and essential tremor, added prescriber option for orofacial pain specialist
· Updated Appendix B with additional agents for overactive bladder
|
Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx (Retacrit) (CP.PHAR.237)
| Medicaid
| Policy updates include:
· Extended continuation of therapy approval duration from 6 to 12 months for Medicaid/Ambetter for anemia due to chronic kidney disease and zidovudine in human immunodeficiency virus (HIV)-infected patients
· For all indications, separated redirection criteria for Epogen and Procrit
· Revised Procrit redirection language to also require use of Epogen if member is unable to use Retacrit.
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Abatacept (Orencia) (CP.PHAR.241)
| Medicaid
| 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 J, added polyarticular juvenile idiopathic arthritis disease activity information per 2019 American College of Rheumatology/Arthritis guidelines
· Updated section III.B with Spevigo and biosimilar verbiage
· For psoriatic arthritis, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred)
|
Alemtuzumab (Lemtrada) (CP.PHAR.243)
| Medicaid
| Policy updates include:
· Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
· 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
|
Glatiramer Acetate (Copaxone, Glatopa) (CP.PHAR.252)
| Medicaid
| Policy updates include:
· Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
· Updated Appendix C with new boxed warning for anaphylactic reactions
· For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 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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Interferon Beta-1a (Avonex, Rebif) (CP.PHAR.255)
| Medicaid
| Policy updates include:
· Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
· For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 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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Interferon Beta-1b (Betaseron, Extavia) (CP.PHAR.256)
| Medicaid
| Policy updates include:
· Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
· For continued therapy, modified approval duration from “if member has received less than 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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Mitoxantrone (CP.PHAR.258)
| Medicaid
| Policy updates include:
· For multiple sclerosis, removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response 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
· And increased the Medicaid/Ambetter continued approval duration from 6 to 12 months for this chronic condition
· For pediatric acute lymphoblastic leukemia, revised “Ph” to “BCR::ABL1” per National Comprehensive Cancer Network (NCCN)
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Natalizumab (Tysabri), Natalizumab-sztn (Tyruko) (CP.PHAR.259)
| Medicaid
| Policy updates include:
· For multiple sclerosis, removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response 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
· For multiple sclerosis continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 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”
· 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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Peginterferon Beta-1a (Plegridy) (CP.PHAR.271)
| Medicaid
| Policy updates include:
· Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
· For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 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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Cabazitaxel (Jevtana) (CP.PHAR.316)
| Medicaid
| Policy updates include:
· Added an additional bypass to required prior use of docetaxel-containing treatment regimen for members with small cell/neuroendocrine prostate cancer per National Comprehensive Cancer Network (NCCN) Compendium
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Ocrelizumab (Ocrevus) (CP.PHAR.335)
| Medicaid
| Policy updates include:
· Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response
· 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 Ocrevus Zunovo’s hypersensitivity contraindication
· For continued therapy, modified Ambetter and Medicaid approval duration from “if member has received less than 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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Inotersen (Tegsedi) (CP.PHAR.405)
| Medicaid
| Policy updates include:
· Removed criteria “member has not received prior treatment with Amvuttra, Onpattro, or Wainua”
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Elapegademase-lvlr (Revcovi) (CP.PHAR.419)
| Medicaid
| Policy updates include:
· Added an additional diagnostic option to genetic testing of both deficient adenosine deaminase (ADA) catalytic activity and increase in adenosine or deoxyadenosine nucleotide levels
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Remestemcel-L (Ryoncil) (CP.PHAR.474)
| Medicaid
| Policy updates include:
· Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: for continued therapy, added pathway for use in cases of graft-versus-host disease recurrence following complete response and revised total number of doses allowed from 12 to 16
· For both initial and continued therapy, added requirement for documentation of member’s current weight
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Isatuximab-irfc (Sarclisa) (CP.PHAR.482)
| Medicaid
| Policy updates include:
· Added off-label indication for primary therapy in combination with Kryprolis, lenalidomide, and dexamethasone per National Comprehensive Cancer Network (NCCN) Compendium
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Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)
| Medicaid
| Policy updates include:
· Added criteria for small bowel adenocarcinoma, colon cancer, and rectal cancer per National Comprehensive Cancer Network (NCCN) 2A recommendation
· For anal carcinoma, added option to be prescribed in combination with carboplatin and paclitaxel
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Eplontersen (Wainua) (CP.PHAR.633)
| Medicaid
| Policy updates include:
· Removed criteria “member has not received prior treatment with, Onpattro or Amvuttra”
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Topotecan (Hycamtin) (CP.PHAR.64)
| Medicaid
| Policy updates include:
· For off-label National Comprehensive Cancer Network (NCCN) recommendations, added pediatric medulloblastoma and vaginal cancer criteria
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Datopotamab Deruxtecan-dlnk (Datroway) (CP.PHAR.715)
| Medicaid
| Policy includes:
· Criteria is only applicable for Medicaid when the drug is added to the formulary for coverage
· Requests for indications not approved by the FDA are reviewed with the off-label use policy MS.PMN.53 for Medicaid
· Initial Approval Criteria: Breast Cancer (must meet all):
o Diagnosis of unresectable or metastatic breast cancer;
o Prescribed by or in consultation with an oncologist;
o Age at least 18 years;
o Documentation of hormone receptor (HR)-positive disease;
o Documentation of HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) disease;
o Member received prior endocrine based therapy (see Appendix B);
o Member received prior chemotherapy for unresectable or metastatic disease;
o Prescribed as a single agent;
o Request meets one of the following:*
§ Dose does not exceed both of the following once every 3 weeks (21-day cycle):
· 6 mg/kg;
· 540 mg;
§ Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
*Prescribed regimen must be FDA-approved or recommended by NCCN
o Approval duration: 6 months
· Continued Therapy: Breast Cancer (must meet all):
o Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Datroway for a covered indication and has received this medication for at least 30 days;
-
- Member is responding positively to therapy;
o If request is for a dose increase, request meets one of the following:*
o New dose does not exceed both of the following once every 3 weeks (21-day cycle):
· 6 mg/kg;
· 540 mg;
o New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
*Prescribed regimen must be FDA-approved or recommended by NCCN
o Approval duration: 12 months
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Immune Globulins (CP.PHAR.103)
| Medicaid
| 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
| 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
| 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
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Pertuzumab (Perjeta) (CP.PHAR.227)
| Medicaid
| 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
| 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
| 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
| 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
| Policy update includes:
· Updated section III.B with Spevigo and biosimilar verbiage;
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Canakinumab (Ilaris) (CP.PHAR.246)
| Medicaid
| 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
| 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 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
| 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)
|
Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)
| Medicaid
| 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
|
Infliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis) (CP.PHAR.254)
| Medicaid
| 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
|
Ixekizumab (Taltz) (CP.PHAR.257)
| Medicaid
| Policy update includes:
· Updated section III.B with Spevigo and biosimilar verbiage;
|
Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)
| Medicaid
| 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;
|
Secukinumab (Cosentyx) (CP.PHAR.261)
| Medicaid
| 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)
|
Tocilizumab (Actemra), Tocilizumab-bavi (Tofidence), Tocilizumab-aazg (Tyenne) (CP.PHAR.263)
| Medicaid
| 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
|
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
| 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 preferred Stelara biosimilars Otulfi, Pyzchiva (branded), Selarsdi (or unbranded ustekinumab-aekn), Steqeyma, Yesintek
· Removed redirection criteria for requests that are above the labeled maximum dose
· For Crohn’s disease, removed criteria requiring use of preferred adalimumab products
· For plaque psoriasis, removed criteria requiring use of preferred adalimumab products and Taltz
· For psoriatic arthritis, removed criteria requiring use of preferred adalimumab products, Otezla, Taltz, Xeljanz/Xeljanz XR
· For ulcerative colitis, removed criteria requiring use of Zeposia
· Added HCPCS codes [Q5098, Q5099, and Q5100]
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Vedolizumab (Entyvio) (CP.PHAR.265)
| Medicaid
| 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
|
Rilonacept (Arcalyst) (CP.PHAR.266)
| Medicaid
| Policy update includes:
· Updated section III.B with Spevigo and biosimilar verbiage;
|
Ofatumumab (Arzerra, Kesimpta) (CP.PHAR.306)
| Medicaid
| 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
| 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 ;
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Medicaid
| 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.
|
Durvalumab (Imfinzi) (CP.PHAR.339)
| Medicaid
| 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;
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Edaravone (Radicava, Radivaca ORS) (CP.PHAR.343)
| Medicaid
| 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
| 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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Guselkumab (Tremfya) (CP.PHAR.364)
| Medicaid
| 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
|
Brodalumab (Siliq) (CP.PHAR.375)
| Medicaid
| 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)
|
Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)
| Medicaid
| 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)
|
Dexrazoxane (Totect) (CP.PHAR.418)
| Medicaid
| 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
| 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
|
Pegunigalsidase alfa-iwxj (Elfabrio) (CP.PHAR.512)
| Medicaid
| 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;
|
Concizumab-tci (Alhemo) (CP.PHAR.625)
| Medicaid
| 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;
|
Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)
| Medicaid
| 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
| 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
|
Temozolomide (Temodar) (CP.PHAR.77)
| Medicaid
| 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;
|
Agalsidase Beta (Fabrazyme) (CP.PHAR.158)
| Medicaid
| Policy update includes:
· Added requirement for documentation of member’s weight for dose calculation purposes;
|
Palivizumab (Synagis) (CP.PHAR.16)
| Medicaid
| Policy updates include:
· For preterm infants added clarification regarding maternal vaccine exclusion if administered at least 14 days prior to delivery per American Academy of Pediatrics (AAP) / Advisory Committee on Immunization Practices (ACIP) recommendations
· Removed statement regarding redirection to Beyfortus “For the 2023-2024 RSV season, supply issues are anticipated” as the American Academy of Pediatrics (AAP) states shortage of Beyfortus is not expected this coming season
· Removed statements referencing elevated interseasonal activity as per the Centers for Disease Control and Prevention (CDC) regular seasonal patterns are now expected
|
Dabrafenib (Tafinlar) (CP.PHAR.239)
| Medicaid
| Policy updates include:
· For B-Raf proto-oncogene, serine/ threonine kinase (BRAF) V600E mutation-positive solid tumor per National Comprehensive Cancer Network (NCCN), consolidated types of biliary tract cancers, added neuroglioma and glioneuronal tumor, added recurrent or progressive adult high-grade gliomas, clarified listed types of ovarian cancer are acceptable diagnoses in addition to ovarian cancer, fallopian tube cancer, and peritoneal cancer
· Consolidated criterion for recurrent ovarian cancer, fallopian tube cancer, and peritoneal cancer
· Consolidated gastric, esophageal, or esophagogastric cancers for anaplastic thyroid cancer, updated Food and Drug Administration (Food and Drug Administration (FDA))-approved indication to include detection by an Food and Drug Administration (Food and Drug Administration (FDA)) approved test.
|
Nusinersen (Spinraza) (CP.PHAR.327)
| Medicaid
| Policy updates include:
· For initial criteria stating four copies of SMN2 gene, removed “documentation indicates presence of spinal muscular atrophy symptoms” as four copies of SMN2 gene without symptoms is supported by practice guidelines
|
Patisiran (Onpattro) (CP.PHAR.395)
| Medicaid
| Policy updates include:
· Removed criteria “member has not received prior treatment with Amvuttra, Tegsedi, or Wainua” and to allow alternative therapy as a result of Tegsedi market withdrawal
|
Lisocabtagene Maraleucel (Breyanzi) (CP.PHAR.483)
| Medicaid
| Policy updates include:
· Added bypass for age requirement for primary mediastinal large B-cell lymphoma per National Comprehensive Cancer Network (NCCN) Guidelines in Pediatric Aggressive Mature B-Cell Lymphomas
· Added National Comprehensive Cancer Network (NCCN) Compendium supported use in human immunodeficiency virus (HIV)-related plasmablastic lymphoma
|
Lecanemab-irmb (Leqembi) (CP.PHAR.596)
| Medicaid
| Policy updates include:
· Updated the maintenance dosing regimen to include the option for every 4 week dosing after the initial 18 months of therapy
|
Revakinagene Taroretcel-lwey (Encelto) (CP.PHAR.697)
| Medicaid
| Policy includes:
· Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
· Requests for indications not approved by the FDA are reviewed with the off-label use policy MS.PMN.53 for Medicaid
· Initial Approval Criteria: Idiopathic Macular Telangiectasia Type 2 (must meet all):
o Diagnosis of MacTel confirmed by both of the following:
§ Fluorescein angiographic leakage of the retinal vessels;
§ One of the following:
· Retinal opacification;
· Crystalline deposits;
· Right angle vessels;
· Inner/outer lamellar cavities;
· Hyperpigmentation not involving the foveal center;
o Prescribed by or in consultation with a retina specialist;
o Age at least 18 years;
o Ellipsoid zone (EZ) disruption between 0.16 mm2 and 2.00 mm2 as measured by optical coherence tomography (OCT);
o Best corrected visual acuity (BCVA) of 54 letters or better on Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/80 Snellen equivalent);
o Member does not have intraretinal or subretinal neovascularization;
o Member has not previously received an ocular implant containing Encelto in the affected eye(s);
o Dose does not exceed 1 ocular implant per eye.
o Approval duration: 3 months (one implant per eye per lifetime)
· Continued Therapy: Idiopathic Macular Telangiectasia Type 2
-
- Re-authorization is not permitted for previously treated eyes. If request is for treatment of an eye that has not previously received an ocular implant, members must meet the initial approval criteria.
- Approval duration: Not applicable
|
Cabozantinib (Cabometyx, Cometriq) (CP.PHAR.111)
| Medicaid
| Policy updates include:
· Added new neuroendocrine tumors indication and updated differentiated thyroid carcinoma dosing for Cabometyx
|
Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev) (CP.PHAR.93)
| 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)
|
Nedosiran (Rivfloza) (CP.PHAR.619)
| Medicaid
| 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
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