Effective October 2nd, 2023: Pharmacy and Biopharmacy Policies

Peginterferon Alfa-2a (Pegasys) (CP.PHAR.89)

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

Policy updates include:

• Removed PegIntron brand from policy Removed minimum age of 5 years criterion from NCCN off-label oncology indications as Pegasys is indicated for peds as young as 3 years
• Removed osteopenia/osteoporosis off-label indication as this is a complication of systemic mastocytosis
• Clarified that myelofibrosis, polycythemia vera, and essential thrombocythemia are myeloproliferative neoplasms
• Added off-label NCCN-supported criterion for use in combination with zidovudine in adult T-cell leukemia or lymphoma
• Removed hairy cell leukemia criterion for use following initial treatment with cladribine or pentostatin per NCCN

Deferasirox (Exjade, Jadenu) (CP.PHAR.145)

Ambetter

Policy updates include:

• Added clarification that concurrent therapy with other iron chelators is allowable if member has excess cardiac iron as evidence by cardiac T2* < 20 millisecond or iron-induced cardiomyopathy
• Added requirement for generic use for continuation of therapy

Deferoxamine (Desferal) (CP.PHAR.146)

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

Policy updates include:

• Updated FDA approved indications per prescribing information
  Added requirement that member is responding positively to therapy as evidenced by a decrease in serum ferritin levels as compared to pretreatment baseline
  for chronic iron overload
• Added requirement that therapy does not include concurrent use of other iron chelators, unless member has excess cardiac iron as evidence by cardiac T2* < 20 millisecond or iron-induced cardiomyopathy
  
  

C1 Esterase Inhibitors (Berinert Cinryze Haegarda Ruconest) (CP.PHAR.202)

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

Policy updates include:

• Revised Cinryze maximum dose to 2,000 units (4 vials)
• Removed pharmacy benefit disclaimer language for Ambetter Berinert requests per Ambetter formulary status
  
  

Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-pbbk (Fylnetra), Pegfilgrastim-apgf (Nyvepria), Eflapegrastim-xnst (Rolvedon), Pegfilgrastim-fpgk (Stimufend), Pegfilgrastim-cbqv (Udenyca), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)

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

Policy updates include:

• Added HCPCS codes Q5127 for Stimufend, Q5130 for Fylnetra, and J1449 for Rolvedon
• Removed HCPCS code J3590
  for bone marrow transplantation removed off-label use in supportive care post autologous hematopoietic cell transplantation as this is no longer NCCN Compendium supported
• Updated Appendix D for consistency
  for mobilization of peripheral-blood progenitor cells prior to autologous transplantation added requirement for being prescribed in combination with Mozobil per NCCN Compendium
  
  

Ixazomib (Ninlaro) (CP.PHAR.302)

Ambetter

Policy updates include:

• Per NCCN for multiple myeloma removed option for use in combination with dexamethasone alone (without lenalidomide or cyclophosphamide)
• For systemic light chain amyloidosis removed option for use as a single-agent
  
  
  

Brentuximab Vedotin (Adcetris) (CP.PHAR.303)

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

Policy updates include:

• For adult classical Hodgkin lymphoma, added specific regimens for use per both FDA and NCCN
• For pediatric classical Hodgkin lymphoma, moved specific staging requirements for high risk disease to Appendix D to also allow for NCCN high risk definition
• Updated criteria Per NCCN, including requirements for use in combination with chemotherapy as well as allowance for use as subsequent therapy
• For T-cell lymphomas, Clarified that CD30-positive disease requirement does not apply to ALCL
• Added requirement for use as a single agent or in combination with CHP per NCCN
  for cutaneous ALCL,
• Added pathway for disease multifocal lesions per NCCN for mycosis fungoides/ Sezary syndrome,
• Removed requirement for CD30-positive disease per NCCN for B-cell lymphomas, Removed specific subtypes of diffuse large B-Cell lymphoma to simplify criteria,
• Revised “AIDS-related” to “HIV-related”, Added B-cell type monomorphic PTLD,
• Added pathway for pediatric primary mediastinal large B-cell lymphoma,
• Added that member is not a transplant candidate for all requests except T-cell type monomorphic post-transplant lymphoproliferative disorder per NCCN
  
  

Daratumumab (Darzalex), Daratumumab/Hyaluronidase-fihj (Darzalex Faspro) (CP.PHAR.310)

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

Policy updates include:

• Per NCCN added off-label use for maintenance therapy for symptomatic multiple myeloma as a single agent for transplant candidates clarified for systemic light chain amyloidosis use is as a single agent for relapsed or refractory disease
  
  

Pembrolizumab (Keytruda) (CP.PHAR.322)

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

Policy updates include:

• Classical Hodgkin lymphoma, Primary mediastinal large B-cell lymphoma, Microsatellite instability-high or mismatch repair deficient, Merkel cell carcinoma,  Tumor mutational burden-high: adjusted pediatric age from 2 years to 6 months per PI/KEYNOTE-051
• For Melanoma added option to be prescribed in combination with Mekinist and Trafinlar for disease with BRAF V600 activating mutation per NCCN
• Added endemic or classic Kaposi Sarcoma for adult off-label use and hypermutant tumor diffuse high-grade glioma for pediatric off-label use per NCNN
• Added criterion prescribed as single agent for Merkel cell carcinoma per NCCN
• For Hepatocellular carcinoma, added option for Stivarga
  For pediatric Primary mediastinal large B-cell lymphoma added option to be prescribed in combination with Adcetris
• For endometrial carcinoma added option for combination with carboplatin and paclitaxel if disease is recurrent or stage III-IV tumor
  
  

Cerliponase alfa (Brineura) (CP.PHAR.338)

Ambetter

Policy updates include:

• Revised and added to continuation of therapy to ensure member does not have acute intraventricular access device-related complications (e.g., leakage, device failure, or device-related infection) or ventriculoperitoneal shunts
  
  

Tezacaftor-Ivacaftor (Symdeko) (CP.PHAR.377)

Ambetter

Policy updates include:

• Updated criteria to include maximum dosing stratified by age and weight
  
  

Mechlorethamine (Valchlor) (CP.PHAR.381)

Ambetter

Policy updates include:

• Updated Sezary Syndrome staging from “IV” to “IVA” per NCCN compendium
• Added “topical carmustine” as an alternative skin-therapy agent in Appendix B
  
  

Erdafitinib (Balversa) (CP.PHAR.423)

Ambetter

Policy updates include:

• Added monotherapy requirement per NCCN and New Century Health
  
  

Selinexor (Xpovio) (CP.PHAR.431)

Ambetter

Policy updates include:

• For Diffuse Large B-Cell, removed follicular lymphoma, added high-grade B-cell lymphoma, and revised “AIDS-related” to “HIV-related” per NCCN
• Consolidated legacy WCG initial approval duration to standard Medicaid initial approval duration
  
  

Tafamidis (Vyndaqel, Vyndamax) (CP.PHAR.432)

Ambetter

Policy updates include:

• Added the following requirements - member has heart failure of NHYA Class I, II, or III and member has at least 1 prior hospitalization for heart failure or current (within the last 30 days) clinical evidence of heart failure
  
  

Polatuzumab Vedotin-piiq (Polivy) (CP.PHAR.433)

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

Policy updates include:

• Added criteria for new indication as first-line treatment for Diffuse Large B-Cell Lymphoma and high-grade B-cell lymphoma,
• Updated FDA approved indications section to reflect full approval of the third-line Diffuse Large B-Cell Lymphoma indication
  for off-label uses,
• Removed mantle cell lymphoma
• Revised nodal marginal zone lymphoma to indolent lymphoma, and revised “AIDs-related” to “HIV-related” per NCCN
  
  
  

Mitomycin for Pyelocalyceal Solution (Jelmyto) (CP.PHAR.495)

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

Policy updates include:

• Added criteria that LG-UTUC be non-Metastatic
• Added requirement for endoscopic resection or ablation if member is a candidate per NCCN and New Century Health

Tucatinib (Tukysa) (CP.PHAR.497)

Ambetter

Policy updates include:

• Per NCCN recommendations added a requirement for checkpoint inhibitor immunotherapy for deficient mismatch repair/microsatellite instability-high colorectal cancer
  
  

Lurbinectedin (Zepzelca) (CP.PHAR.500)

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

Policy updates include:

• Added monotherapy requirement per NCCN
  

Ripretinib (Qinlock) (CP.PHAR.502)

Ambetter

Policy updates include:

• Per NCCN – added off-label criteria for cutaneous melanoma for Gastrointestinal Stromal Tumor
• Removed Sprycel as a prior treatment option for fourth-line use
• Added pathway for second-line use following imatinib if Sutent-intolerant, removed specific criteria for non-D842V PDGFRA exon 18
• Added requirement for use as a single agent
  
  

Loncastuximab tesirine-lpyl (Zynlonta) (CP.PHAR.539)

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

Policy updates include:

• Added Zynlonta prescribed as a single agent per NCCN
  
  

Infigratinib (Truseltiq) (CP.PHAR.547)

Ambetter

Policy updates include:

• Initial approval criteria changed to “new patient initiation is not permitted as manufacturer has voluntarily withdrawn indication for Cholangiocarcinoma and discontinued distribution of Truseltiq”
  
  
  

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

Policy updates include:

• Added standard oral oncology generic redirection language
  
  

Calcifediol (Rayaldee) (CP.PMN.76)

Ambetter

Policy updates include:

• Added specialist prescriber requirement
• Added requirement for no concomitant use with other vitamin D derivatives/analogs
• Shortened initial approval duration to 6 months instead of 12 months
  

Lacosamide (Vimpat, Motpoly XR) (CP.PMN.155)

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

Policy updates include:

• Added a requirement for documentation that the oral formulation is temporarily not feasible
• Specified that the existing 12 month approval duration applies to only the oral formulation Revised to allow only 1 month for the intravenous formulation
• For continuation criteria for brand Vimpat added a requirement for prior trial of generic lacosamide
• Added Motpoly XR to the policy as a newly FDA-approved dose formulation

Netupitant and Palonosetron (Akynzeo), Fosnetupitant and Palonosetron (Akynzeo IV) (CP.PMN.158)

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

Policy updates include:

• Added requirement for continuation of therapy that member continues to receive moderately to highly emetogenic cancer chemotherapy
  
  

Progesterone (Crinone, Endometrin, Milprosa) (CP.PMN.243)

Ambetter

Policy updates include:

• For section I.C. removed “singleton pregnancy and history of spontaneous preterm birth”
• Added short cervix defined as a cervical length ≤ 25 mm per updated 2023 ACOG practice bulletin
  
  

Sofosbuvir (Sovaldi) (Ambetter.PA.SP2)

Ambetter

Policy updates include:

• Eliminated adherence program participation criterion
• Added redirections to other diagnoses initial criteria section
  
  

Ledipasvir/Sofosbuvir (Harvoni) (Ambetter.PA.SP3)

Ambetter

Policy updates include:

• Removed criteria redirections to Vosevi
• Eliminated adherence program participation criterion
• Added preferred redirections to other diagnoses/indications initial approval section
  
  

Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir (Viekira Pak) (Ambetter.PA.SP61)

Ambetter

Policy updates include:

• Eliminated adherence program participation criterion
• Added preferred redirections to other diagnoses/indications initial criteria section
  
  

Elbasvir/Grazoprevir (Zepatier) (Ambetter.PA.SP62)

Ambetter

Policy updates include:

• Eliminated adherence program participation criterion
• Added asterisk to Epclusa redirection in initial criteria
• Added redirections to other diagnoses initial criteria section
  
  

Brivaracetam (Briviact) (CP.PCH.26)

Ambetter

Policy updates include:

• For continuation of therapy of IV Briviact, added requirement for documentation that the oral formulation is temporarily not feasible

Pertuzumab/Trastuzumab/Hyaluronidase-zzxf (Phesgo) (CP.PHAR.501)

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

Policy updates include:

• For Continued Therapy added criteria to document whether Phesgo is being used as neoadjuvant or adjuvant therapy in order to determine the appropriate total treatment duration
  
  

Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko) (CP.PHAR.297)

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

Policy updates include:

• For Myelodysplastic Syndrome added requirement per NCCN to be prescribed in combination with an erythropoiesis-stimulating agent
• Removed inactive HCPCS codes C9096, C9399, J3590
• If member is unable to use Zarxio, added stepwise redirection to use Nivestym
  
  

Patiromer (Veltassa) (CP.PMN.205)

Ambetter

Policy updates include:

• Added redirection to Lokelma
  
  

Human Growth Hormone (Somapacitan, Somatropin) (HIM.PA.161)

Ambetter

Policy updates include:

• Added pediatric extension for growth failure due to growth hormone deficiency and new 15 mg/1.5 mL strength
• For pediatric growth hormone deficiency criteria set added Sogroya specific age limit and dosing
• Updated Appendix C with Sogroya pediatric contraindications

Inhaled Agents for Asthma and COPD (HIM.PA.153)

Ambetter

Policy updates include:

• Added newly approved dosage form Symbicort Aerosphere to policy with redirection to generic Symbicort
• Updated dosing for Breo Ellipta in Appendix B per prescribing information for pediatric extension down to 5 years of age and older
• Corrected maximum dose for Bevespi Aerosphere from 2 inhalations/day to 4 inhalations/day per dosing regimen (2 inhalations twice a day)
• Added redirection to generic Symbicort for brand Symbicort

Niraparib (Zejula) (CP.PHAR.408)

Ambetter

Policy updates include:

• Added BRCA-mutation must be confirmed on a CLIA approved diagnostic test

Added new tablet formulation

Teriflunomide (Aubagio) (CP.PCH.40)

Ambetter

Policy updates include:

• Added redirection to generic teriflunomide for brand Aubagio requests