POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Deflazacort (Emflaza) (CP.PHAR.331)
| Ambetter
| Policy updates include:
- Revised policy/criteria section to include generic deflazacort and added redirection to generic deflazacort for brand Emflaza requests
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Inotuzumab Ozogamicin (Besponsa) (CP.PHAR.359)
| Ambetter
| Policy updates include:
- Updated criteria to include pediatric aged pediatric expansion for 1 year and older
- For disease that is not replased or refractory and Philadelphia chromosome-negative, updated age to > 15 years to reflect “adolescent and young adult” population per NCCN compendium
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Danicopan (Voydeya) (CP.PHAR.665)
| Ambetter
| Policy updates include:
- Drug is now FDA approved – criteria updated per FDA labeling: revised C5 inhibitor requirements to specifically state ravulizumab or eculizumab
- Added quantity limit of 6 tablets per day
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Step Therapy Criteria (HIM.PA.109)
| Ambetter
| Policy updates include:
- Added adapalene cream 0.1% and gel 0.1% to criteria with existing adapalene step requirements
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Cinacalcet (Sensipar) (CP.PHAR.61)
| Ambetter
| Policy updates include:
- For all indications, added criteria to use generic cinacalcet over brand Sensipar
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Eculizumab (Soliris), Eculizumab-aeeb (Bkemv) (CP.PHAR.97)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added newly approved biosimilar, Bkemv
- Updated the list of therapies that Soliris/Bkemv should not be prescribed concurrently with to include Rystiggo, Vyvgart Hytrulo, and Zilbrysq for generalized myasthenia gravis, Fabhalta for paroxysmal nocturnal hemoglobinuria, and Ultomiris for neuromyelitis optica spectrum disorder
- Revised contraindications in Appendix C per updated Soliris prescribing information
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Tesamorelin (Egrifta SV) (CP.PHAR.109)
| Ambetter
| Policy updates include:
- Revised clinical indicators for abdominal lipodystrophy criteria to require waist circumference and waist-hip ratio thresholds that reflect efficacy studies
- Revised Food and Drug Administration (FDA) Approved Indications and contraindications, removed criteria allowing pediatric use in members with closed epiphyses
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Mecasermin (Increlex) (CP.PHAR.150)
| Ambetter
| Policy updates include:
- Revised verbiage that Increlex is not prescribed concurrently with growth hormone (previously only Somatropin was included)
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Risperidone Long-Acting Injection (Perseris, Risperdal Consta, Rykindo, Uzedy) (CP.PHAR.293)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added generic redirection to brand Risperdal Consta requests
- Revised approval duration for whichever is longer
- Added HCPCs code [J3590, C9399] for Risvan
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Sargramostim (Leukine) (CP.PHAR.295)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) Compendium for high-risk neuroblastoma added additional supported combination therapies
- Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in the treatment of chemotherapy-induced febrile neutropenia
- Revised dosing requirements to allow guideline or National Comprehensive Cancer Network (NCCN) supported off-label dosing
- For acute radiation syndrome to confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)
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Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko) (CP.PHAR.297)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) Compendium for MDS added requirement that member previously has no response to either an erythropoiesis-stimulating agent (e.g., epoetin alfa, darbepoetin) or Reblozyl
- For bone marrow transplantation removed subcutaneous route of administration per prescribing information
- To confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)
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Brentuximab Vedotin (Adcetris) (CP.PHAR.303)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) – for classical Hodgkin lymphoma, added pathway for use as a component of BrECADD for stage III-IV disease for members aged 18-61 years
- For T-cell lymphomas, removed requirement for 2 prior therapies for hepatosplenic T-cell lymphoma and added pathway for combination use with bendamustine for peripheral T-cell lymphoma, breast implant-associated anaplastic large cell lymphoma, and hepatosplenic T-cell lymphoma
- For mycosis fungoides and Sezary syndrome, added that Adcetris must be prescribed as a single agent, in combination with skin-directed therapy, or in combination with bendamustine
- For B-cell lymphomas, removed T-cell type monomorphic post-transplant lymphoproliferative disorder (PTLD)
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Blinatumomab (Blincyto) (CP.PHAR.312)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Specified that infant acute lymphoblastic leukemia must have KMT2A status (11q23 rearranged) and added pathway for use as frontline consolidation therapy per National Comprehensive Cancer Network (NCCN)
- Revised boxed warning in Appendix C per updated prescribing information
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Pembrolizumab (Keytruda) (CP.PHAR.322)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For classical Hodgkin lymphoma, added option to be prescribed with ICE and added pathway for palliative therapy (previously had after hematopoietic stem cell transplant, which falls under palliative therapy) per National Comprehensive Cancer Network (NCCN)
- For urothelial carcinoma, added pathway to be prescribed as single agent and member has previously received other chemotherapy (previously only allowed post-platinum chemotherapy)
- For hepatocellular carcinoma, removed disease is classified as Child-Pugh Class A
- For biliary tract cancer, added option for resected gross residual (R2) disease and removed combination with Lenvima per National Comprehensive Cancer Network (NCCN)
- For endometrial carcinoma, clarified continued as a single agent for maintenance therapy when prescribed in combination with carboplatin and paclitaxel
- For National Comprehensive Cancer Network (NCCN) recommended uses (off-label): expanded to stage IB for mycosis fungoides, for prescribed as first-line or subsequent therapy - added metastatic anaplastic carcinoma, anaplastic sarcoma, and vaginal cancer, for prescribed as single-agent subsequent therapy – added soft tissue sarcoma subtypes, added option for Keytruda to be prescribed in combination with cyclophosphamide and bevacizumab for platinum-resistant persistent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer per National Comprehensive Cancer Network (NCCN)
- For continuation requests, added criterion for maximum duration of therapy (previously was included within requests for dose increase criterion)
- Updated appendix E
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Plerixafor (Mozobil) (CP.PHAR.323)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- To confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)
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Fulvestrant (Faslodex Injection) (CP.PHAR.424)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Revised policy/criteria section to also include generic fulvestrant
- Added redirection to generic fulvestrant for all indications
- Removed stage II and IIIA disease references from endometrial carcinoma criteria per National Comprehensive Cancer Network (NCCN)
- Removed adjuvant therapy for stage IV disease from endometrial carcinoma criteria for consolidation as this may be captured by metastatic disease option
- Added additional criteria options for recurrent and extrauterine disease for uterine carcinoma criteria per National Comprehensive Cancer Network (NCCN)
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Tucatinib (Tukysa) (CP.PHAR.497)
| Ambetter
| Policy updates include:
- Added POLE/POLD1 mutation option if member is ineligible for, or disease has progressed on, checkpoint inhibitor immunotherapy in colorectal cancers
- Added off-label criteria for National Comprehensive Cancer Network (NCCN)-supported biliary tract cancers
- Added note that prior authorization may be required for combination therapy for all indications
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Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For paroxysmal nocturnal hemoglobinuria, added Fabhalta, Voydeya, and Bkemv to the list of therapies that Empaveli should not be prescribed concurrently with
- For geographic atrophy, clarified that diagnostic characteristics must be confirmed on fundus autofluorescence imaging per health plan request and in alignment with pivotal study design
- Revised Empaveli contraindications in Appendix C per updated prescribing information
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Maralixibat (Livmarli) (CP.PHAR.543)
| Ambetter
| Policy updates include:
- For initial criteria, added exclusions for portal hypertension and history of a hepatic decompensation event for both progressive familial intrahepatic
- Cholestasis and Alagille syndrome per competitor analysis and to align with other progressive familial intrahepatic
- Cholestasis and Alagille syndrome criteria
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Betibeglogene Autotemcel (Zynteglo) (CP.PHAR.545)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Revised lower age limit to age ≥ 4 years and removed accompanying age < 5 criteria
- Removed age qualifier of ≥ 12 years for receipt of ≥ 8 transfusions of packed red blood cells per year
- Added clarification for time component and documentation within the last 6 months for negative human immunodeficiency virus (HIV) test
- Approval duration extended from 3 months to 6 months to allow for member preparation and adequate time for gene therapy manufacture
- Added clarification of a one-time dose only for continued authorization
- Corrected template language for continued therapy
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Fidanacogene Elaparvovec-dzkt (Beqvez) (CP.PHAR.643)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified documentation of negative test for neutralizing antibodies to AAVRh74var
- Added medical director review
- Removed criterion for subsequent negative factor IX inhibitor test if member has an initial positive test result
- Added criteria for documentation of HIV test with minimum CD4+ cell count or maximum viral load for positive HIV test
- Added criterion that member does not have current liver-related conditions
- Added criterion for hepatologist attestation of Beqvez eligibility if sustained liver enzymes or radiological liver abnormalities present
- Added criterion for documentation of member’s body weight to allow verification of weight based dose
- Added information in Appendix E on dose calculation for weight based doses
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Givinostat (Duvyzat) (CP.PHAR.644)
| Ambetter
| Policy updates include:
- Duvyzat is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: added option for positive muscle biopsy for diagnosis of duchenne muscular dystrophy (DMD) if genetic studies negative per DMD Care Considerations Working Group
- Removed age restriction of < 18 years at therapy initiation
- Revised ambulatory criteria with removal of 4SC ≤ 8 seconds requirement
- Removed Corrected QT Interval (QTcF), triglycerides and Left ventricular ejection fraction (LVEF) contraindications from criteria
- Added documentation of member’s baseline ambulatory function as evidenced by motor function tests
- For continued therapy, added improvement or stabilization in member’s ambulatory function from baseline as example of responding positively to therapy
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Lidocaine Transdermal (Lidoderm, ZTlido) (CP.PMN.08)
| Ambetter
| Policy updates include:
- For diabetic neuropathy, added desvenlafaxine as an example serotonin-norepinephrine reuptake inhibitor (SNRI) per American Academy of Neurology (AAN) and American Diabetes Association (ADA) guidelines
- Revised Lidoderm/ZTlido to generic transdermal lidocaine in Policy/Criteria
- For continued therapy, added requirement of a trial of generic lidocaine patches
- In Appendix B, removed commercially unavailable brand alternatives
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Linezolid (Zyvox) (CP.PMN.27)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added requirement if request is for orally administered brand Zyvox, member must use generic linezolid
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Quetiapine Extended-Release (Seroquel XR) (CP.PMN.64)
| Ambetter
| Policy updates include:
- Revised continued therapy criteria to allow continuity of care for all indications
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Vortioxetine (Trintellix) (CP.PMN.65)
| Ambetter
| Policy updates include:
- Revised continued therapy to allow continuity of care for antidepressants
- In Appendix B, added Wellbutrin SR to therapeutic alternatives and clarified that fluvoxamine used in depression is off-label
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Milnacipran (Savella) (CP.PMN.125)
| Ambetter
| Policy updates include:
- Revised continued therapy criteria to allow continuity of care in antidepressants for all indications
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Esketamine (Spravato) (CP.PMN.199)
| Ambetter
| Policy updates include:
- Revised continued therapy section to allow continuity of care for treatment-resistant depression
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Amisulpride (Barhemsys) (CP.PMN.236)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added age requirement per prescribing information
- Revised approval duration from one time “approval” to “dose”
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Ivermectin (Stromectol, Sklice) (CP.PMN.269)
| Ambetter
| Policy updates include:
- For Appendix C, updated contraindications section for Stromectol to align with prescriber information
- For Appendix D, updated supplemental information for ivermectin’s use in COVID-19
- For table V, updated dosing regimen for Sklice
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Dextromethorphan-bupropion (Auvelity) (CP.PMN.284)
| Ambetter
| Policy updates include:
- Revised continued therapy section to allow continuity of care.
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Gepirone (Exxua) (CP.PMN.292)
| Ambetter
| Policy updates include:
- Revised continued therapy to allow continuity of care for antidepressants
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Levomilnacipran (Fetzima) (HIM.PA.125)
| Ambetter
| Policy updates include:
- Revised continued therapy to allow continuity of care for antidepressants
- In Appendix B, added Wellbutrin SR to therapeutic alternatives and clarified that fluvoxamine used in depression is off-label
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Tolvaptan (Jynarque, Samsca) (CP.PHAR.27)
| Ambetter
| Policy updates include:
- Revised policy/ criteria section to also include generic tolvaptan
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Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated the list of therapies that Ultomiris should not be prescribed concurrently with to include Bkemv for all indications, Fabhalta for paroxysmal nocturnal hemoglobinuria, and Rystiggo, Vyvgart Hytrulo, and Zilbrysq for generalized myasthenia gravis
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Inebilizumab-cdon (Uplizna) (CP.PHAR.458)
| Ambetter
| Policy updates include:
- Added Bkemv and Ultomiris to the list of therapies that Uplizna should not be prescribed concurrently with
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Satralizumab-mwge (Enspryng) (CP.PHAR.463)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Bkemv and Ultomiris to the list of therapies that Enspryng should not be prescribed concurrently with
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Iptacopan (Fabhalta) (CP.PHAR.656)
| Ambetter
| Policy updates include:
- Added Voydeya and Bkemv to the list of therapies that Fabhalta should not be prescribed concurrently with
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Cariprazine (Vraylar) (CP.PMN.91)
| Ambetter
| Policy updates include:
- Revised continued therapy criteria to allow continuity of care for all indications
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Topiramate Extended-Release (Qudexy XR, Trokendi XR) (CP.PMN.281)
| Ambetter
| Policy updates include:
- Revised “Failure of a trial” language to template “Member must use” language
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Mometasone (Nasonex) (HIM.PA.93)
| Ambetter
| Policy updates include:
- Revised policy/criteria section to also include generic mometasone
- Added redirection to generic mometasone for brand Nasonex requests
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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 updates include:
- Added Simlandi with specific NDCs [51759-0402-17 and 51759-0402-02] to Appendix K to list of preferred adalimumab products
- Added adalimumab-ryvk [NDC 82009-0156-22] to list of requested products where redirection would apply.
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Infliximab (Avsola, Inflectra, Remicade, Renflexis, Zymfentra) (CP.PHAR.254)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Modified Remicade redirection by adding if member has failed Avsola, Inflectra, and Renflexis, member must use unbranded Remicade
- For unbranded Remicade, added redirection to Avsola, Inflectra, and Renflexis
- For Crohn’s disease and ulcerative colitis, added additional requirement for Zymfentra requests requiring provider attestation that “member is unable to receive continued therapy with intravenous infliximab due to lack of caregiver or support system for assistance with administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility.”
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Pegfilgrastim (Neulasta and biosimilars) (CP.PHAR.296)
| Ambetter
| Policy updates include:
- For bone marrow transplantation consolidated required drug redirections into a single sub-bullet for added clarity
- For all indications, removed redirection to Zarxio and Ziextenzo, added redirection to Nyvepria to co-prefer Udenyca and Nyvepria.
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Biologic and Non-biologic DMARDs (HIM.PA.SP60)
| Ambetter
| Policy updates include:
- Modified Remicade stepwise redirection by adding if member has failed Inflectra, Renflexis, and Avsola, member must use unbranded Remicade
- For unbranded Remicade, member must use Inflectra and Renflexis, then if member has failed Inflectra and Renflexis, member must use Avsola
- For Crohn’s disease and ulcerative colitis, added additional requirement for Zymfentra requests requiring provider attestation that “member is unable to receive continued therapy with intravenous infliximab due to lack of caregiver or support system for assistance with administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility.”
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