CP.PCH.06 Valganciclovir (Valcyte)

Ambetter

Policy updates include:

• For off-label use in post-transplant cytomegalovirus infection, added requirement that Valcyte is not prescribed concurrently with Livtencity
  him

CP.PHAR.114 Teduglutide (Gattex)

Ambetter

Policy updates include:

• Added criteria, “documentation requirement of current body weight in kg”

CP.PHAR.121 Nivolumab (Opdivo)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Hepatocellular carcinoma, added option for Child-Pugh Class B and prescribed as a single agent per National Comprehensive Cancer Network 2A recommendation

CP.PHAR.179 Romiplostim (Nplate)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For chronic immune thrombocytopenia added spleen tyrosine kinase inhibitor (e.g., Tavalisse™) to list of drugs in which concurrent use is excluded

CP.PHAR.188 Teriparatide (Forteo, Bonsity)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added Bonsity and revised Food and Drug Administration Approved Indication(s) section to align with current labeling language for both Forteo and Bonsit
• Added generic Forteo (620 mcg/2.4 mL formulation)
• Added generic Bonsity (620 mcg/2.48 mL formulation)
• Added redirection to generic Forteo for all brand requests
• Clarified dosage regimen in Appendix B
• Added HCPC codes [C9399, J3490]

CP.PHAR.189 Ibandronate injection (Boniva)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria that member must use generic ibandronate injection; clarified failure of “generic” alendronate is preferred
• Clarified dosage regimens in Appendix B

CP.PHAR.235 Atezolizumab (Tecentriq)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For non-small cell lung cancer, added option for stage IIIB non-small cell lung cancer; for hepatocellular carcinoma, added option for Child-Pugh Class B per National Comprehensive Cancer Network
• For melanoma, added option for usage as re-induction therapy per National Comprehensive Cancer Network
• For alveolar soft part sarcoma, added prescribed as single-agent therapy per National Comprehensive Cancer Network
• Added criterion for cervical cancer per National Comprehensive Cancer Network
• Updated generic availability for Tarceva and Iressa in Appendix B

CP.PHAR.323 Plerixafor (Mozobil)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For brand requests, added redirection to generic plerixafor.

CP.PHAR.40 Octreotide Acetate (Sandostatin, Sandostatin LAR, Mycapssa)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Removed Sandostatin LAR Depot from non-formulary list which references usage of the formulary exception policy (HIM.PA.103)
• For thymoma and thymic carcinoma, removed criterion, “prescribed as second-line therapy” and added octreotide scan or dotatate PET/CT is positive per National Comprehensive Cancer Network
• Removed references to Bynfezia from policy due to product discontinuation

CP.PHAR.428 Romosozumab-aqqg (Evenity)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria to ensure the member has not received ≥ 12 months cumulative Evenity therapy before approval
• Clarified failure of “generic” alendronate is preferred
• Clarified dosage regimen in Appendix B

CP.PHAR.457 Givosiran (Givlaari)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added criteria “documentation of member’s current body weight (in kg);”

CP.PHAR.568 Inclisiran (Leqvio)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• For redirection to a preferred PCSK9 inhibitor added requirement for 8 week trial duration
• Added the following requirement from initial approval criteria to also require for continuation of therapy “Treatment plan does not include coadministration with Juxtapid, Repatha, or Praluent”
• Divided criteria with multiple elements into separate bullets for added clarity
• Appendix I clarified smoking is specific to tobacco

CP.PHAR.606 Spesolimab-sbzo (Spevigo)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• no significant changes
• Added Tofidence to section III.B
• Removed expired HCPCS codes for Spevigo [C9399, J3590]

CP.PHAR.655 Motixafortide (Aphexda)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added redirection to plerixafor

CP.PHAR.123 Evolocumab (Repatha)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added Leqvio to list of drugs where coadministration is not allowed; added the following requirement from initial approval criteria to also require for continuation of therapy “Treatment plan does not include coadministration with Leqvio, Juxtapid or Praluent”
• Divided criteria with multiple elements into separate bullets for added clarity
• Appendix I clarified smoking is specific to tobacco

CP.PHAR.124 Alirocumab (Praluent)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added Leqvio to list of drugs where coadministration is not allowed
• Added the following requirement from initial approval criteria to also require for continuation of therapy “Treatment plan does not include coadministration with Juxtapid, Leqvio, or Repatha”
• Appendix I clarified that smoking is specific to tobacco and revised heterozygous familial hypercholesterolemia to familial hypercholesterolemia

CP.PHAR.254 Infliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:  

• Added newly approved Zymfentra to criteria
  for ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, Kawasaki Disease, added “request is for Avsola, Inflectra, Remicade, or Renflexis” to initial approval criteria
• Added Tofidence and Zymfentra to section III.B.

CP.PHAR.346 Sarilumab (Kevzara)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For rheumatoid arthritis added redirection to Actemra and one TNF antagonist.

CP.PHAR.511 Evinacumab-dgnb (Evkeeza)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• For redirection to Praluent added requirement for 8 week trial duration
• Added Leqvio to list of potential co-administered drugs along with Juxtapid, Praluent, and Repatha
• Divided criteria with multiple elements into separate bullets for added clarity
• Appendix H clarified smoking is specific to tobacco

CP.PHAR.100 Axitinib (Inlyta)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network: for thyroid carcinomas, revised “Hurthle cell” to “oncocytic” per updated terminology, added criterion that disease is progressive and/or symptomatic, replaced criterion for failure of Lenvima or Nexavar with requirement that clinical trials or other systemic therapies are not available or appropriate

CP.PHAR.106 Enzalutamide (Xtandi)

Ambetter

Policy updates include:

• Added requirement per National Comprehensive Cancer Network if prescribed concurrently with Talzenna, request is for metastatic castration-resistant prostate cancer
  removed abiraterone from Appendix B as redirection is not required

CP.PHAR.111 Cabozantinib (Cabometyx, Cometriq)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network: for thyroid carcinomas, revised “Hurthle cell” to “oncocytic” per updated terminology and clarified that DTC is locally advanced, unresectable, or metastatic
• For hepatocellular carcinoma clarified that disease is unresectable, inoperable, or metastatic

CP.PHAR.180 Eltrombopag (Promacta)

Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network Compendium-supported indication of prolonged thrombocytopenia post-hematopoietic cell transplant
  added exclusion of concurrent thrombopoietin receptor agonist with Promacta to aplastic anemia, chronic hepatitis C-associated thrombocytopenia, and National Comprehensive Cancer Network Compendium indications
• For all Food and Drug Administration-labeled indications added exclusion of concurrent spleen tyrosine kinase inhibitor (e.g., Tavalisse™)

CP.PHAR.196 Selexipag (Uptravi)

Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP

Policy updates include:

• Added intravenous Uptravi 1800 mcg/10 mL formulation and criteria for use
• Clarified concomitant administration with CYP2C8 inducers require higher doses
• Updated contraindications
• Removed commercially unavailable branded products from Appendix B

CP.PHAR.24 Fostamatinib (Tavalisse)

Ambetter

Policy updates include:

• Added Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists

CP.PHAR.288 Eteplirsen (Exondys 51)

Ambetter

Policy updates include:

• Added criteria, member has not previously received gene replacement therapy for DMD (e.g., Elevidys)
• Added Agamree to list of corticosteroids in Appendix B

CP.PHAR.331 Deflazacort (Emflaza)

Ambetter

Policy updates include:

• Asded criterion “documentation of member’s current weight in kg” to initial and continued approval criteria

CP.PHAR.361 Tisagenlecleucel (Kymriah)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network for Ph+ acute lymphoblastic leukemia, revised requirement to include relapse or refractory disease and modified verbiage from “failure of” to “member has received 2 lines of chemotherapy that included 2 tyrosine kinase inhibitors,”
• Revised reference from AIDS to human immunodeficiency virus consistent with National Comprehensive Cancer Network
• Added Carvykti as an additional example of CAR T-cell immunotherapy that Kymriah should not be prescribed concurrently with or that member has previously received

CP.PHAR.402 Emapalumab-lzsg (Gamifant)

Ambetter

Policy updates include:

• Added examples of possible hemophagocytic lymphohistiocytosis related genetic mutations added immunologist as an additional specialist prescriber added requirement for concurrent use with dexamethasone to continuation of therapy

CP.PHAR.407 Lusutrombopag (Mulpleta)

Ambetter

Policy updates include:

• Added spleen tyrosine kinase inhibitor (e.g., Tavalisse™) concurrent use exclusion

CP.PHAR.409 Talazoparib (Talzenna)

Ambetter

Policy updates include:

• For prostate cancer, added “member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy” per National Comprehensive Cancer Network compendium for breast cancer, added “prescribed as a single agent” to align with Food and Drug Administration indication and National Comprehensive Cancer Network compendium
  updated Appendix D to align with current National Comprehensive Cancer Network compendium

CP.PHAR.411 Amifampridine (Firdapse)

Ambetter

Policy updates include:

• Added additional option for prescribing by a neuromuscular specialist
• Applied exclusion for history of seizures to continued therapy requests

CP.PHAR.453 Golodirsen (Vyondys 53)

Ambetter

Policy updates include:

• Added criteria, member has not previously received gene replacement therapy for DMD (e.g., Elevidys)
• Added Agamree to list of corticosteroids in Appendix B
  references updated and reviewed.

CP.PHAR.461 Nadofaragene firadenovec-vncg (Adstiladrin)

Ambetter

Policy updates include:

• Removed initial criteria requirement for clinically significant elevated liver or renal function tests per prescribing information
• Added oncology dosing criteria to allow doses supported by practice guidelines or literature ;removed category 2B National Comprehensive Cancer Network recommendation: NMIBC characterized by Ta/T1 high-grade without concomitant CIS per National Comprehensive Cancer Network
• Removed HCPCS code J3590 and C9399

CP.PHAR.464 Selumetinib (Koselugo)

Ambetter

Policy updates include:

• For glioma, removed restriction to WHO grade 1 as supported by National Comprehensive Cancer Network added criteria for failure of Mekinist or Cotellic for Langerhans cell histiocytosis per National Comprehensive Cancer Network and updated Appendix B
• Added approval duration of 6 months and 12 months respectively for initial and continuation criteria to off-label National Comprehensive Cancer Network compendium recommended indications (Section I.B and II.B)
• Updated Appendix D

CP.PHAR.466 Valoctocogene Roxaparvovec (Roctavian)

Ambetter

Policy updates include:

• Added exclusion for prior gene therapy per competitor analysis and pivotal trial exclusion criteria

CP.PHAR.472 Brexucabtagene autoleucel (Tecartus)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network for Ph+ acute lymphoblastic leukemia, revised requirement to include relapse or refractory disease and modified verbiage from “failure of” to “member has received 2 tyrosine kinase inhibitors”

CP.PHAR.484 Viltolarsen (Viltepso)

Ambetter

Policy updates include:

• Added criteria, member has not previously received gene replacement therapy for DMD (e.g., Elevidys)
• Added Agamree to list of corticosteroids in Appendix B

CP.PHAR.565 Asciminib (Scemblix)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network recommendations added coverage for BCR::ABL1-mutated disease (off-label), excluded coverage for those with F359V/I/C mutations (contraindicated per National Comprehensive Cancer Network), and added coverage criteria for myeloid/lymphoid neoplasm with eosinophilia (off-label)

CP.PHAR.590 Omaveloxolone (Skyclarys)

Ambetter

Policy updates include:

• For genetic testing, added that it shows a GAA triplet-repeat expansion in the FXN gene
• Modified baseline mFARs score by removing 20 to 80 score requirement
• Removed member does not have history of clinically significant left sided heart disease or cardiac disease
  removed exclusion for pes cavus as not excluded in PI or Moxie trial
• Removed requirement that member has ability to swallow capsules
• For continued therapy, revised language from “improvement in any of the following parameters” to “improvement or stabilization in any of the following parameters” and changed approval duration from 6 months to 12 months.

CP.PHAR.605 Adagrasib (Krazati)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network: for non-small cell lung cancer added monotherapy criterion and added brain metastases as exception to having received ≥ 1 prior therapy
• Added off-label criteria for pancreatic adenocarcinoma and colorectal cancer

CP.PHAR.63 Everolimus (Afinitor, Afinitor Disperz, Zortress)

Ambetter

Policy updates include:

• Clarified oral oncology redirection language to “generic” everolimus
• For differentiated thyroid cancer, removed requirement of prior therapy per National Comprehensive Cancer Network
  for Hodgkin lymphoma, Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma, thymoma, thymic carcinoma, histiocytic neoplasms, perivascular epithelioid cell tumor, recurrent angiomyolipoma, and lymphangioleiomyomatosis, added prescribed as single agent per National Comprehensive Cancer Network

CP.PHAR.84 Abiraterone (Zytiga, Yonsa)

Ambetter

Policy updates include:  

• Added requirement per National Comprehensive Cancer Network if prescribed concurrently with Lynparza or Zejula, request is for metastatic castration-resistant prostate cancer
• Removed abiraterone from Appendix B as dosing information is already included in Section V

CP.PHAR.98 Ruxolitinib (Jakafi, Opzelura)

Ambetter

Policy updates include:

• For atopic dermatitis , added criterion member has ≤ 20% body surface area involvement per guidelines
• For nonsegmental vitiligo, clarified affected body surface area is “≤.”
• For both atopic dermatitis  and nonsegmental vitiligo, added bypass of medium-to-very high potency topical corticosteroids if use is for face or intertriginous areas

CP.PMN.100 Risedronate (Actonel, Atelvia)

Ambetter

Policy updates include:
in approval criteria, clarified Actonel dose limit per week and per month
added redirection to generic risedronate
added criteria to ensure Atelvia is prescribed for PMO
clarified failure of “generic” alendronate is preferred

CP.PMN.104 Tasimelteon (Hetlioz)

Ambetter

Policy updates include:

• Applied generic tasimelteon capsule redirection for brand Hetlioz capsule requests to SMS indication
• Added the following examples for positive response to therapy: increase in nighttime sleep, decrease in daytime nap time, improvement in sleep quality
• For criteria specific to Hetlioz capsules, clarified this also applies to the generic tasimelteon capsules
• For redirection to ramelteon added clarification that generic is preferred when referencing brand Rozerem product

CP.PMN.218 Lasmiditan (Reyvow)

Ambetter

Policy updates include:

• Added pain specialist prescriber option
• Clarified redirection should be to generic 5HT1B/1D-agonist migraine medications
• Add to continuation of therapy similar requirement for dose increase requests for quantities greater than two doses per month as required currently for initial requests

CP.PMN.223 Rifabutin (Mycobutin)

Ambetter

Policy updates include:

• Added specific requirement that "request is for MAC prophylaxis in member with human immunodeficiency virus” to support labeled indication
• For off-label use in tuberculosis, added to continuation of therapy the following to support existing approval duration: “member has not received more than 12 months of therapy”
• For added clarity with requests for H.pylori added the following note “for Talicia requests, see CP.PMN.277 Ulcer Therapy Combinations”

CP.PMN.237 Bempedoic acid (Nexletol), bempedoic acid-ezetimibe (Nexlizet)

Ambetter

Policy updates include:

• Added the following requirement from initial approval criteria to also require for continuation of therapy “Treatment plan does not include coadministration with Repatha or Praluent;”
• Appendix I clarified that smoking is specific to tobacco and revised heterozygous familial hypercholesterolemia to familial hypercholesterolemia

CP.PMN.257 Clascoterone (Winlevi)

Ambetter

Policy updates include:

• For initial approval criteria, updated “failure of ≥ 2 of the following topical preparations” to “failure of ≥ 2 of the following generic formulary topical preparations”
• Updated dosing for benzoyl peroxide in Appendix B

CP.PMN.271 Maribavir (Livtencity)

Ambetter

Policy updates include:

• Added requirement that Livtencity is not prescribed concurrently with ganciclovir or valganciclovir

HIM.PA.156 Evolocumab (Repatha)

Ambetter

Policy updates include:

• Added Leqvio to list of drugs where coadministration is not allowed
• Added the following requirement from initial approval criteria to also require for continuation of therapy “Treatment plan does not include coadministration with Leqvio, Juxtapid or Praluent”
• Divided criteria with multiple elements into separate bullets for added clarity
• Appendix I clarified smoking is specific to tobacco

HIM.PA.166 Evinacumab-dgnb (Evkeeza)

Ambetter

Policy updates include:

• For redirection to Repatha added requirement for 8 week trial duration
• Added Leqvio to list of potential co-administered drugs along with Juxtapid, Praluent, and Repatha
• Divided criteria with multiple elements into separate bullets for added clarity
• Appendix H clarified smoking is specific to tobacco

HIM.PA.58 Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

Ambetter

Policy updates include:

• Added newly approved Zituvimet to criteria
• For Onglyza, Kombiglyze XR, Nesina, Kazano, and Oseni, added requirement that member must use generic products

CP.PMN.57 Febuxostat (Uloric)

Ambetter

Policy updates include:

• Added redirection to generic febuxostat
• Updated boxed warning with “cardiovascular death” to align with prescriber information

CP.PMN.67 Sacubitril-Valsartan (Entresto)

Ambetter

Policy updates include:

• Updated contraindications to include concomitant use with aliskiren
  
  

CP.PHAR.470 Casimersen (Amondys 45)

Ambetter

Policy updates include:

• Added criteria, member has not previously received gene replacement therapy for duchenne muscular dystrophy (e.g., Elevidys)
• added Agamree to list of corticosteroids in Appendix B

CP.PMN.87 Plecanatide (Trulance)

Ambetter

Policy updates include:

• Added HIM line of business (retire HIM.PA.158)
• Added redirection to generic lubiprostone and Linzess.