Effective January 2, 2024: Pharmacy and Biopharmacy Policies

Nivolumab (Opdivo) (CP.PHAR.121)

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

Policy updates include:

• Updated indication and criteria for the treatment of melanoma in the adjuvant setting.

Etanercept (Enbrel) (CP.PHAR.250)

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

• Added newly approved juvenile psoriatic arthritis indication
• Added Tofidence to section III.B.

Secukinumab (Cosentyx) (CP.PHAR.261)

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

Policy updates include:

• Added new dosage form single-dose vial 125 mg/ 5 mL for intravenous infusion
• Added intravenous specific dosing for ankylosing spondylitis, non-radiographic axial spondyloarthritis and psoriatic arthritis
• Added Tofidence to section III.B.

Tocilizumab (Actemra, Tofidence) (CP.PHAR.263)

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

Policy updates include:

• Added newly approved biosimilar Tofidence to polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, systemic juvenile idiopathic arthritis criteria and added “request is for Actemra” for indications not approved for Tofidence use
• For polyarticular juvenile idiopathic arthritis for Tofidence requests, added redirection to preferred agents Actemra, adalimumab product, and Xeljanz
• For rheumatoid arthritis for Tofidence requests, added redirection to preferred agents Actemra, adalimumab product, Kevzara, and Xeljanz/Xeljanz XR or Olumiant
• Added Tofidence dosing to section V
• Updated Appendix B with relevant therapeutic alternatives
• Added Tofidence to section III.B
• Removed HCPCS code Q0249 as code only applies to Actemra EUA use.

Vedolizumab (Entyvio) (CP.PHAR.265)

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

Policy updates include:

• Added new dosage forms (prefilled syringe and Entyvio Pen) for subcutaneous injection to sections V and VI;
• For section VI, revised “single-use vial” to “lyophilized powder in a single-dose vial for reconstitution for intravenous infusion: 300 mg”
• For ulcerative colitis, updated to include subcutaneous maximum dose option in initial approval and continued therapy sections; for Crohn’s disease, added “request is for intravenous formulation” in initial approval and continued therapy sections
• Added Tofidence to section III.B

Sargramostim (Leukine) (CP.PHAR.295)

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

Policy updates include:

• Added off-label indication for relapsed or refractory high-risk neuroblastoma in combination with Danyelza

Respiratory Syncytial Virus Vaccine (Abrysvo) (CP.PHAR.658)

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: Request for Immunization (must meet all):
  • Member meets one of the following:
    • Member is pregnant at 32 through 36 weeks gestational age;
    • Age ≥ 60 years;
  • Dose does not exceed one injection (0.5 mL) given one time.
  • Approval duration: 1 month
• Continued Therapy: Not applicable

• Insulin glargine (Rezvoglar, Semglee, Toujeo) (HIM.PA.09)

• Ambetter

Policy updates include:

• Removed Levemir redirection and clarified redirection to unbranded Tresiba with references to preferred insulin degludec NDCs.

Step Therapy Criteria (HIM.PA.109)

Ambetter

Policy updates include:

• Removed Ilevro from policy
• Added Eucrisa to policy for Fidelis health plan requiring step through one generic topical corticostetoid or topical calcineurin inhibitor

Evolocumab (Repatha) (HIM.PA.156)

Ambetter

Policy updates include:

• For all indications, reduced statin adherence duration from 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

Insulin detemir (Levemir) (HIM.PA.171)

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: Diabetes Mellitus (must meet all):
  • Diagnosis of type 1 or type 2 diabetes mellitus
  • Failure of Basaglar® and unbranded Tresiba® (insulin degludec, NDC 73070-0403-15, 73070-0503-15, or 73070-0400-11), unless clinically significant adverse effects are experienced or both are contraindicated
• Approval duration: 12 months

Lanadelumab-fylo (Takhzyro) (HIM.PA.172)

Ambetter

Policy updates include:

• Policy created and adapted from CP.PHAR.396
• Removed criteria point:  For members age ≥ 6 years: Failure of Haegarda®, unless contraindicated or clinically significant adverse effects are experienced

GLP-1 receptor agonists (HIM.PA.53)

Ambetter

Policy updates include:

• Added separate initial approval criteria for preferred agents [Trulicity, Victoza, Xultophy, Soliqua, Ozempic, Rybelsus] with diagnosis, age, "not prescribed concurrently with another GLP-1 receptor agonist” criteria, and maximum dose limit requirements
• For initial approval criteria, applied existing Type 2 Diabetes Mellitus criteria set to non-preferred agents [Bydureon, Bydureon BCise, Byetta, Adlyxin, Mounjaro], added redirection to Rybelsus, and removed redirection requirements for Soliqua
• For continued therapy, updated “Type 2 Diabetes Mellitus” header to “All Indications in Section I.”

Sofosbuvir-Velpatasvir (Epclusa) (HIM.PA.SP1)

Ambetter

Policy updates include:

• Applied Epclusa authorized generic redirection to all requests.

Dabrafenib (Tafinlar) (CP.PHAR.239)

Ambetter

Policy updates include:

• For V600E mutation positive unresectable or metastatic solid tumors indication, updated FDA approved indication section and criteria to reflect pediatric expansion from patients aged 6 years of age and older to patients aged 1 year of age and older

Trametinib (Mekinist) (CP.PHAR.240)

Ambetter

Policy updates include:

• For V600E mutation positive unresectable or metastatic solid tumors indication, updated FDA approved indication section and criteria to reflect pediatric expansion from patients aged 6 years of age and older to patients aged 1 year of age and older

Lanreotide (Somatuline Depot) (CP.PHAR.391)

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

Policy updates include:

• For carcinoid syndrome and neuroendocrine tumor added redirection bypass if request is for treatment associated cancer for a State with regulations against step therapy in certain oncology settings, added Appendix E for details on states with regulations against redirections in cancer

Inhaled asthma and COPD agents (HIM.PA.153)

Ambetter

Policy updates include:

• Redirection from brand Flovent HFA/Flovent Diskus to instead redirect to fluticasone proprionate HFA (Flovent HFA authorized generic)
• Added Flovent HFA and Advair HFA to policy requiring redirection to authorized generic
• Revised redirection to brand Advair HFA to instead redirect to authorized generic
• For long acting beta-2 agonist / long acting muscarinic antagonist revised redirection to Bevespi Aerosphere to instead redirect to Stiolto Respimat
• Added Bevespi Aerosphere to policy with redirection to Anoro Ellipta and Stiolto Respimat
• For AirDuo Digihaler, AirDuo RespiClick, Dulera, updated redirection to include both Breo Ellipta authorized generic and brand Breo Ellipta
• Added dose/quantity limit bypass for Georgia members with asthma or other life-threatening bronchial ailments for inhalants prescribed by the treating physician

Glecaprevir-Pibrentasvir (Mavyret) (HIM.PA.SP36)

Ambetter

Policy updates include:

• Removed redirection to Vosevi and applied Epclusa authorized generic redirection to all requests