POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Talazoparib (Talzenna) (CP.PHAR.409)
| Ambetter
| Policy updates include:
- Added new soft gelatin capsule formulation
- For continued therapy, changed maximum dosing criteria from “does not exceed both of the following” to “does not exceed any of the following” to allow variability in maximum daily dose reduction per prescriber information
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Amivantamab-vmjw (Rybrevant) (CP.PHAR.544)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added criteria for new indication of first-line treatment of adults with non-small cell lung cancer
- Added monotherapy criterion for non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy per Prescribing Information and National Comprehensive Cancer Network
- Removed “locally” as qualifying advanced non-small cell lung cancer per National Comprehensive Cancer Network
- For Rybrevant prescribed as a single agent corrected initial dosing to be weekly for 5 weeks instead of 4 weeks
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Iloperidone (Fanapt) (CP.PMN.32)
| Ambetter
| Policy updates include:
- Criteria added for newly approved indication of bipolar disorder
- Corrected maintenance dosing for schizophrenia in Section V Dosing and Administration per package insert
|
Berdazimer (Zelsuvmi) (CP.PMN.293)
| Ambetter
| Policy includes:
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria: Molluscum Contagiosum (MC) (must meet all):
- Diagnosis of MC
- Age ≥ 1 year
- Member meets at least one of the following:
- Lesion is located in a sensitive area, such as facial and anogenital areas
- Member has atopic dermatitis
- Member has a weakened immune system
- Lesion did not resolve within six months since diagnosis
- Member experiences bleeds or discomfort from the lesion, such as itchiness and pain
- Zelsuvmi is not prescribed concurrently with any other pharmacologic treatments for
- Dose does not exceed one kit per 14 days.
- Approval duration: 3 months
- Continued Therapy: Molluscum Contagiosum
- Re-authorization is not permitted. Members must meet the initial approval criteria
- Approval duration: Not applicable
|
Garadacimab (CSL312) (CP.PHAR.673)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy includes:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
- Initial Approval Criteria: Hereditary Angioedema (HAE) (must meet all):
- Diagnosis of HAE confirmed by both of the following:
- History of recurrent angioedema
- Low C4 level and low C1-INH antigenic or functional level (see Appendix D)
- Prescribed by or in consultation with a hematologist, allergist, or immunologist
- Age ≥ 12 years
- Prescribed for long-term prophylaxis of HAE attacks, and request meets one of the following
- Member experiences more than one severe event per month
- Member is disabled more than five days per month
- Member has a history of previous airway compromise
- Member is not using CSL312 in combination with another FDA-approved product for long-term prophylaxis of HAE attacks (e.g., Cinryze®, Haegarda®, Takhzyro™, Orladeyo®)
- Dose does not exceed both of the following:
- Loading dose: 400 mg
- Maintenance dose: 200 mg every month.
- Approval duration: 6 months
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Marstacimab (PF-06741086) (CP.PHAR.674)
| Ambetter
| Policy includes:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria: Congenital Hemophilia A or B (must meet all):
- Prescribed for routine prophylaxis of bleeding episodes in members with one of the following:
- Congenital hemophilia A (FVIII deficiency)
- Congenital hemophilia B (FIX deficiency)
- Prescribed by or in consultation with a hematologist
- Age ≥ 12 years
- Weight ≥ 35 kg
- Member meets one of the following:
- For hemophilia A: Member has severe hemophilia, defined as FVIII level of <1%
- For hemophilia B: Member has moderate to severe hemophilia, defined as FIX level of ≤ 2%
- Member meets one of the following:
- Failure of a FVIII or FIX product used for routine prophylaxis as assessed and documented by prescriber (see Appendix D)
- Member had ≥ 6 acute bleeding episodes in the previous 6 months that were treated with a FVIII or FIX product
- No documented history of inhibitors
- Provider confirms that member will discontinue any use of FVIII or FIX products as prophylactic therapy while on PF-06741086 (on-demand usage may be continued)
- Dose does not exceed one loading dose of 300 mg followed by a maintenance dose of 150 mg per week thereafter.
- Approval duration: 6 months (12 months for HIM Texas)
- Continued Therapy: Congenital Hemophilia A or B (must meet all):
- Member meets one of the following:
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
- Member is responding positively to therapy (e.g., reduction in the number of all bleeds, joint bleeds, and/or target joint bleeds over time)
- Provider confirms that member has discontinued any use of FVIII products or FIX products as prophylactic therapy while on PF-06741086 (on-demand usage may be continued)
- If request is for a dose increase, new dose does not exceed 150 mg per week.
- Approval duration: 6 months (12 months for HIM Texas)
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Obecabtagene autoleucel (AUTO1) (CP.PHAR.675)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy includes:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
- Initial Approval Criteria: Acute Lymphoblastic Leukemia (ALL) (must meet all):
- Diagnosis of B-cell precursor ALL
- Prescribed by or in consultation with an oncologist or hematologist
- Age ≥ 18 years
- Request meets one of the following:
- Member has relapsed or refractory disease defined as one of the following:
- Primary refractory disease
- First relapse if first remission ≤ 12 months
- Relapsed or refractory disease after 2 or more lines of systemic therapy
- Relapsed or refractory disease following allogeneic stem cell transplantation
- Disease is Philadelphia chromosome positive (Ph+), relapsed or refractory, and one of the following:
- Member has failed 2 tyrosine kinase inhibitors (e.g., imatinib, Sprycel®, Tasigna®, Bosulif®, Iclusig®)
- Member has failed one second-generation tyrosine kinase inhibitor (e.g., Bosulif, Sprycel, Tasigna)
- Member has a contraindication to all tyrosine kinase inhibitors
- If previously treated with Blincyto®, documentation of CD19 tumor expression on blasts obtained from bone marrow or peripheral blood after completion of the most recent prior line of therapy
- Member does not have central nervous system (CNS)-3 disease or have a history or presence of any CNS disorder (e.g., seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema * CNS-3 disease is defined as detectable cerebrospinal blast cells in a sample of cerebrospinal fluid with ≥ 5 white blood cells (WBCs) per mm3
- If member has CNS-2 disease, documentation of no clinically evident neurological changes * CNS-2 disease is defined as cerebrospinal fluid blast cells with < 5 WBC/mm3
- Member has not previously received treatment with chimeric antigen receptor (CAR) T-cell immunotherapy (e.g., Abecma®, Breyanzi™, Carvykti™, Kymriah™, Tecartus®, Yescarta™)
- AUTO1 is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta)
- Dose does not exceed a total of 410 x 106 CAR-positive viable T cells administered as a split dose.
- Approval duration: 3 months (2 doses only, with 4 doses of tocilizumab (Actemra) if requested at up to 800 mg per dose
- Continued Therapy: Acute Lymphoblastic Leukemia
- Continued therapy will not be authorized as AUTO1 is indicated as a single treatment course.
- Approval duration: Not applicable
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Capecitabine (Xeloda) (CP.PHAR.60)
| Ambetter
| Policy updates include:
- Added National Comprehensive Cancer Network-supported indication of endometrial carcinoma and vulvar cancer into off-label criteria set
|
Crizotinib (Xalkori) (CP.PHAR.90)
| Ambetter
| Policy updates include:
- Added palliative treatment option for anaplastic large cell lymphoma per National Comprehensive Cancer Network
- Condensed uterine sarcoma inflammatory myofibroblastic tumor-specific criteria
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Immune Globulins (CP.PHAR.103)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed Rasmussen’s syndrome from Section
- For HyQvia and Gammagard Liquid, added chronic inflammatory demyelinating polyneuropathy indication
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Encorafenib (Braftovi) (CP.PHAR.127)
| Ambetter
| Policy updates include:
- Removed appendiceal adenocarcinoma per National Comprehensive Cancer Network compendium removal
- Removed redundant criteria for treatment naïve or subsequent therapy, removed criteria for prior BRAF therapy
|
Pertuzumab (Perjeta) (CP.PHAR.227)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Ror gallbladder cancer and cholangiocarcinoma, added option for treatment with resected gross residual (R2) disease
- Residual (R) tumor classification added to Appendix D
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AbobotulinumtoxinA (Dysport) (CP.PHAR.230)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For blepharospasm, clarified that it is 120 units “per eye” per treatment session
- Revised max dose for oromandibular dystonia from “100 units” to standard language “Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use and member age (prescriber must submit supporting evidence
- Units per treatment session does not exceed the lower of 16 Units/kg body weight or 640 Units for pediatrics, or 1,000 Units for adults”
- Added upper extremity dystonia, upper extremity essential tremor maximum dosing regimen to all other indications (off-label) in continued therapy
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OnabotulinumtoxinA (Botox) (CP.PHAR.232)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For chronic sialorrhea changed age from ≥ 18 years to ≥ 21 months
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Sonidegib (Odomzo) (CP.PHAR.272)
| Ambetter
| Policy updates include:
- Added indication for nodal disease and surgery is not feasible per National Comprehensive Cancer Network
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Osimertinib (Tagrisso) (CP.PHAR.294)
| Ambetter
| Policy updates include:
- Removed single agent therapy requirement
- Updated criteria to include combination chemotherapy for specific non-small cell lung cancer indication
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Ipilimumab (Yervoy) (CP.PHAR.319)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For melanoma, added criteria for resectable and limited resectable per National Comprehensive Cancer Network 2A recommendations, removed specification to use combination Opdivo/Yervoy for only unresectable or metastatic melanoma
- For colorectal cancer, added indication of POLE/POLD1 mutation per National Comprehensive Cancer Network
- For non-small cell lung cancer ROS1 rearrangement, added reprotrectinib and lorlatinib as prior use option per National Comprehensive Cancer Network
- For malignant pleural mesothelioma, revised criteria to allow both unresectable and resectable disease per National Comprehensive Cancer Network
- For off-label National Comprehensive Cancer Network compendium indication, added the following indications: MSI-H or dMMR gastric cancer, MSI-H or dMMR esophageal adenocarcinoma, biliary tract cancers, merkel cell carcinoma, and soft tissue sarcoma
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Ceritinib (Zykadia) (CP.PHAR.349)
| Ambetter
| Policy updates include:
- Added off-label National Comprehensive Cancer Network-supported indication of anaplastic large cell lymphoma
- Condensed uterine sarcoma inflammatory myofibroblastic tumor-specific criteria
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Alectinib (Alecensa) (CP.PHAR.369)
| Ambetter
| Policy updates include:
- Added inflammatory myofibroblastic tumor indication per National Comprehensive Cancer Network and condensed uterine sarcoma inflammatory myofibroblastic tumor-specific criteria
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Cobimetinib (Cotellic) (CP.PHAR.380)
| Ambetter
| Policy updates include:
- For melanoma, added indication for re-induction therapy for disease progression or relapse per National Comprehensive Cancer Network, specified unacceptable toxicities to Tafinlar/Mekinist for only stage III or limited resectable melanoma
- For central nervous system cancers, added pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, and recurrent/progressive circumscribed glioma and removed adult-low grade glioma, IDH-mutant 1p19q codeleted oligodendroglioma, and recurrent IDH-mutant astrocytoma per National Comprehensive Cancer Network
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Lorlatinib (Lorbrena) (CP.PHAR.406)
| Ambetter
| Policy updates include:
- Added Augtyro as a failure option for ROS1-positive disease and added anaplastic large cell lymphoma indication per National Comprehensive Cancer Network
- Condensed uterine sarcoma inflammatory myofibroblastic tumor-specific criteria
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Sacituzumab Govitecan-hziy (Trodelvy) (CP.PHAR.475)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For triple-negative breast cancer, revised failure of prior regimens from “two or more” to “one or more” per National Comprehensive Cancer Network
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Ferric Derisomaltose (Monoferric) (CP.PHAR.480)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added criteria for National Comprehensive Cancer Network-supported indication of cancer- and chemotherapy-induced anemia
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Idecabtagene Vicleucel (Abecma) (CP.PHAR.481)
| Ambetter
| Policy updates include:
- Updated criteria to reflect indication expansion for earlier use after two or more prior lines of therapy
- Added secondary hematological malignancies to boxed warnings
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Isatuximab-irfc (Sarclisa) (CP.PHAR.482)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added indication in transplant candidates for primary therapy in combination with bortezomib, lenalidomide, and dexamethasone per National Comprehensive Cancer Network 2A recommendation
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Lisocabtagene Maraleucel (Breyanzi) (CP.PHAR.483)
| Ambetter
| Policy updates include:
- For T-cell/histiocyte-rich large B-cell lymphoma removed requirement for use as second line therapy
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Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) (CP.PHAR.582)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added F-18 flotufolastat as an additional option to confirm prostate- specific membrane antigen (PSMA)-positive disease
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Pacritinib (Vonjo) (CP.PHAR.583)
| Ambetter
| Policy updates include:
- for myelofibrosis, removed failure of therapeutic alternative drugs for lower-risk myelofibrosis per National Comprehensive Cancer Network 2A recommendation revised criteria to approve lower-risk myelofibrosis with platelet count of <50 x 109/L, revised criteria to approve high-risk myelofibrosis of any platelet count, and removed redundant intermediate risk stratification
- Added off-label criteria for myelofibrosis-associated anemia per National Comprehensive Cancer Network 2A recommendation
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Delandistrogene moxeparvovec-rokl (Elevidys) (CP.PHAR.593)
| Ambetter
| Policy updates include:
- Removed the following functional assessments: North Star Ambulatory Assessment (NSAA), 100-meter timed test, time to ascend 4 steps, time to rise from the floor, and 10-meter timed test.
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Elacestrant (Orserdu) (CP.PHAR.623)
| Ambetter
| Policy updates include:
- Clarified diagnosis of postmenopausal women
- Revised quantity limit from 1 tablet per day to 3 tablets per day dosage modifications for adverse reactions
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Zuranolone (Zurzuvae) (CP.PHAR.650)
| Ambetter
| Policy updates include:
- Added obstetrician-gynecologist as an additional prescriber specialty and specialist that can perform a clinical interview to confirm severe depression
- Added Beck Depression Inventory (BDI) and Edinburgh Postnatal Depression Scale (EPDS) scales as additional methods to identify severe depression
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Sodium Oxybate (Xyrem, Lumryz) and Calcium, Magnesium, Potassium, and Sodium Oxybate (Xywav) (CP.PMN.42)
| Ambetter
| Policy updates include:
- For Narcolepsy with Cataplexy, revised antidepressant redirection criteria by adding “unless member’s age is ≥ 65” to align with Wakix criteria
- For boxed warnings, updated central nervous system depression description to “respiratory depression can occur” and added “available only through a restricted Risk evaluation and mitigation strategy (REMS) program”
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Hydroxyurea (Siklos) (CP.PMN.193)
| Ambetter
| Policy updates include:
- Revised age criterion to age ≥ 9 months given guideline support and lack of availability and/or access to age-appropriate hydroxyurea formulation
- Clarified that generic hydroxyurea trial applies to members age ≥ 2 years
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Colonoscopy Preparation Products (CP.PCH.43)
| Ambetter
| Policy updates include:
- Added generic Suprep as a redirect option for members ≥ 12 years old.
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Factor VIII (Human, Recombinant) (CP.PHAR.215)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added pathway for off-label use as immune tolerance induction (ITI) if regimen is supported by practice guidelines or peer-reviewed literature
- Removed criteria for routine prophylaxis regarding severity of hemophilia, prior use of factor VIII, and Appendix D
- Removed desmopressin redirection.
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Factor IX (Human, Recombinant) (CP.PHAR.218)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed criteria for routine prophylaxis regarding severity of hemophilia, prior use of factor IX, and Appendix D.
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Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-pbbk (Fylnetra), Pegfilgrastim-apgf (Nyvepria), Eflapegrastim-xnst (Rolvedon), Efbemalenograstim alfa-vuxw (Ryzneuta), Pegfilgrastim-fpgk (Stimufend), Pegfilgrastim-cbqv (Udenyca, Udenyca Autoinjector, Udenyca Onbody), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added clarification that redirection to Udenyca refers to all formulations (prefilled syringe, autoinjector, and on-body injector)
- For Ziextenzo, added new indication for hematopoietic subsyndrome of acute radiation syndrome
|
Amikacin (Arikayce) (CP.PHAR.401)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Extended initial authorization approval duration from 6 months to 12 months
- Revised continued therapy criteria language for negative monthly sputum cultures requirement from “documentation” to “confirmation” (which can be determined by documentation or attestation)
- Removed description of policy/criteria that stated “Provider must submit documentation…”
|
Factor VIII (Human, Recombinant) (CP.PHAR.215)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added pathway for off-label use as ITI if regimen is supported by practice guidelines or peer-reviewed literature
- For continued therapy clarified that member’s current weight is only needed if a higher dose is being requested. removed criteria for routine prophylaxis regarding severity of hemophilia, prior use of factor VIII, and Appendix D
- Removed desmopressin redirection.
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Factor VIII/von Willebrand Factor Complex (Human – Alphanate, Humate-P, Wilate); von Willebrand Factor (Recombinant – Vonvendi) (CP.PHAR.216)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For continued therapy clarified that member’s current weight is only needed if a higher dose is being requested.
|
Factor IX_Human Recombinant (CP.PHAR.218)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed criteria for routine prophylaxis regarding severity of hemophilia, prior use of factor IX, and Appendix D.For continued therapy clarified that member’s current weight is only needed if a higher dose is being requested. RT4: updated new Ixinity pediatric age expansion to include children < 12 years of age.
|
Factor IX Complex, Human (Profilnine) (CP.PHAR.219)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For continued therapy clarified that member’s current weight is only needed if a higher dose is being requested.
|
Emicizumab-kxwh (Hemlibra) (CP.PHAR.370)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For continued therapy clarified that member’s current weight is only needed if a higher dose is being requested.
|
Brexanolone (Zulresso) (CP.PHAR.417)
| Ambetter
| Policy updates include:
- Added obstetrician-gynecologist as an additional prescriber specialty and specialist that can perform a clinical interview to confirm severe depression
- Added Beck Depression Inventory (BDI) and Edinburgh Postnatal Depression Scale (EPDS) scales as additional methods to identify severe depression
|
Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)
| Ambetter
| Policy updates include:
- For T-cell/histiocyte-richlarge B-cell lymphoma removed requirement for use as second line therapy
- References reviewed and updated.
- Added new indication for chronic lymphocytic leukemia/small lymphocytic lymphoma
- Updated boxed warnings to include secondary hematological malignancies per updated prescribing information.
|
Lifileucel (Amtagvi) (CP.PHAR.598)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Drug is now FDA approved - criteria updated per FDA labeling: added requirement for Amtagvi to be prescribed in combination with IL-2 therapy
- Added documentation of at least one resectable lesion
- Added documentation that the member’s melanoma is not of known uveal/ocular origin, added restriction in prior organ allograft, prior tumor infiltrating lymphocytes therapy, or prior chimeric antigen receptor-T therapy
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Zuranolone (Zurzuvae) (CP.PHAR.650)
| Ambetter
| Policy updates include:
- Added obstetrician-gynecologist as an additional prescriber specialty and specialist that can perform a clinical interview to confirm severe depression
- Added Beck Depression Inventory (BDI) and Edinburgh Postnatal Depression Scale (EPDS) scales as additional methods to identify severe depression
|
Repotrectinib (Augtyro) (CP.PHAR.667)
| Ambetter
| Policy updates include:
- Added Ambetter non-formulary status note with reference to review all Ambetter requests under formulary exception policy, Ambetter.PA.103.
|
Aprocitentan (Tryvio) (CP.PHAR.676)
| Ambetter
| Policy includes:
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria: Hypertension (must meet all):
- Diagnosis of hypertension;
- Age ≥ 18 years;
- Documentation of recent (within the last 30 days) blood pressure ≥ 140/90 mmHg, and both of the following:
- Tryvio is prescribed concurrently with an antihypertensive regimen containing THREE or more drug classes, unless clinically significant adverse effects are experienced or all are contraindicated;
- Member has been adherent for at least the last 4 weeks at up to maximally tolerated doses of an antihypertensive drug regimen containing at least three different antihypertensive drug classes;
- Tryvio is not prescribed concurrently with endothelin receptor antagonists (e.g., ambrisentan [Letairis®], bosentan [Tracleer®], Opsumit®, Filspari™);
- Dose does not exceed 12.5 mg (1 tablet) per day.
- Approval duration: 6 months
- Continued Therapy: Hypertension (must meet all):
- Member meets one of the following (a or b):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy;
- Tryvio is not prescribed concurrently with endothelin receptor antagonists (e.g., ambrisentan [Letaris], bosentan [Tracleer], Opsumit, Filspari);
- If request is for a dose increase, new dose does not exceed 12.5 mg (1 tablet) per day
- Approval duration: 12 months
|
Vadadustat (Vafseo) (CP.PHAR.677)
| Ambetter
| Policy includes:
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria: Anemia due to Chronic Kidney Disease (CKD) (must meet all):
- Diagnosis of anemia of CKD;
- Age ≥ 18 years;
- Prescribed by or in consultation with a hematologist or nephrologist;
- Member has received dialysis for ≥ 3 months;
- Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;
- Pretreatment hemoglobin level of 8 to 11 g/dL;
- Member meets one of the following:
- Failure of Retacrit®, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization may be required for Retacrit
- If Retacrit is unavailable due to shortage, failure of Epogen®, unless contraindicated or clinically significant adverse effects are experienced. *Prior authorization may be required for Epogen
- Approval duration: 6 months
- Continued Therapy: Anemia due to Chronic Kidney Disease (must meet all):
- Member meets one of the following (a or b):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy;
- Current hemoglobin ≤ 11 g/dL;
- Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%.
- Approval duration: Medicaid/HIM – 6 months
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Budesonide (Eohilia, Uceris) (CP.PMN.294)
| Ambetter
| Policy updates include:
- Policy created (adapted from CP.PCH.11, which is to be retired): added budesonide extended-release tablet and budesonide rectal foam to Policy/Criteria section
- Added Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP line of business
- For Commercial, revised approval duration from “12 months or duration of request, whichever is less” to the standard 12 months
- Added new dosage form Eohilia and corresponding criteria for eosinophilic esophagitis
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Semaglutide (Wegovy) (CP.PMN.295)
| Ambetter
| Policy created:
- Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria:
- Cardiovascular Event Prevention (must meet all):
- Member has at least one of the following established cardiovascular disease:
- History of myocardial infarction;
- History of stroke;
- Symptomatic peripheral arterial disease (PAD) (see Appendix D);
- Age ≥ 18 years;
- body mass index (BMI) ≥27 kg/m2;
- Prescriber attestation that member is currently receiving cardiovascular standard of care management;
- For members with concurrent type 2 diabetes mellitus, both of the following:
- Failure of ≥ 3 consecutive months of Ozempic®, Trulicity®, and Victoza®, unless clinically significant adverse effects are experienced or all are contraindicated;*
*Prior authorization may be required - If member is currently receiving a glucagon-like peptide-1 (GLP-1) receptor agonist and is requesting to switch to Wegovy therapy, medical justification* supports necessity for Wegovy; *Intolerance due to common adverse effects of the GLP-1 receptor agonists class such as gastrointestinal symptoms is not considered acceptable medical justification
- Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s);
- Documentation supports member's participation in a physician-directed weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification that meets both of the following:
- Been actively enrolled in a physician-directed weight loss program for at least 6 months;
- Will continue to be enrolled in a physician-directed weight loss program while concomitantly prescribed Wegovy;
- Documentation of member’s baseline body weight in kg;
- Dose does not exceed the following:
- Week 1 through 4: 0.25 mg once weekly;
- Week 5 through 8: 0.5 mg once weekly;
- Week 9 through 12: 1 mg once weekly;
- Week 13 through 16: 1.7 mg once weekly;
- Week 17 and onward: 2.4 mg once weekly.
- Approval duration: 6 months
- Weight Management
- Use of Wegovy for the treatment of weight management is a benefit exclusion and will not be authorized
- Approval duration: Not applicable
- Continued Therapy:
- Cardiovascular Event Prevention (must meet all):
- Member meets one of the following:
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy as evidenced by one of the following:
- If this is the first request renewal, member has lost ≥ 5% of baseline body weight;
- If this is a second or subsequent renewal request, member has lost weight and/or maintained weight loss on therapy;
- Documentation of member’s current body weight in kilograms;
- Prescriber attestation that member is currently receiving cardiovascular standard of care management:
- Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s);
- Documentation that member is actively enrolled in a physician-directed program that involves a reduced calorie diet, increased physical activity, and behavioral modification adjunct to therapy;
- Request meets both of the following (a and b):
- Dose does not exceed 2.4 mg once weekly;
- After the initial dose escalation period, maintenance dose is ≥ 1.7 mg once weekly
- Approval duration: 12 months
- Weight Management
- Use of Wegovy for the treatment of weight management is a benefit exclusion and will not be authorized
- Approval duration: Not applicable
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Step Therapy (HIM.PA.109)
| Ambetter
| Policy updates include:
- Removed venlafaxine SR as electronic step therapy is no longer required
- Removed references to Temixys, Axert, Zomig-ZMT, Requip XL, and Requip IR as products are discontinued
- Revised Ubrelvy step-through agent requirement from two to one 5HT1B/1D-agonist medication
- Removed celecoxib as electronic step therapy is no longer required
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