Effective March 1, 2021: Pharmacy and Biopharmacy Policies

Alirocumab (Praluent) (CP.PHAR.124)

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

Policy updates include:

• Removed HoFH from diagnoses not covered based on positive results from ODYSSEY HoFH study

Amantadine ER (Gocovri,Osmolex ER) (CP.PMN.89)

Ambetter

Policy includes:

I. Initial Approval Criteria

A. Dyskinesia in Patients with Parkinson’s Disease (must meet all):

1. Diagnosis of dyskinesia in patients with Parkinson’s disease;

2. Member is receiving levodopa-based therapy;

3. Meets one of the following (a or b):

a. Failure of a 2-week trial of immediate-release amantadine unless contraindicated or clinically significant adverse effects are experienced;

b. Medical justification supports inability to continue use of immediate-release amantadine (e.g., contraindications to excipients);

4. Dose does not exceed 274 mg (2 capsules) per day for Gocovri or 322 mg (2 tablets) per day for Osmolex ER.

Approval duration:

Medicaid/HIM – 12 months

Commercial – Length of Benefit

B. Drug Induced Extrapyramidal Reactions (must meet all):

1. Diagnosis of a drug induced extrapyramidal reaction;

2. Request is for Osmolex ER;

3. Meets one of the following (a or b):

a. Failure of a 2-week trial of immediate-release amantadine unless contraindicated or clinically significant adverse effects are experienced;

b. Medical justification supports inability to continue use of immediate-release amantadine (e.g., contraindications to excipients);

4. Dose does not exceed 322 mg (2 tablets) per day.

Approval duration:

Medicaid/HIM – 12 months

Commercial – Length of Benefit

II. Continued Therapy

A. All Indications in Section I (must meet all):

1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;

2. Member is responding positively to therapy (e.g., reductions in OFF time, improvement in dyskinesia symptoms);

3. If request is for a dose increase, new dose does not exceed 274 mg (2 capsules) per day for Gocovri or 322 mg (2 tablets) per day for Osmolex ER.

Approval duration:

Medicaid/HIM – 12 months

Commercial – Length of Benefit

Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PA.154 for Ambetter

Anakinra (Kineret) (CP.PHAR.244)

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

Policy updates include:

• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Atezolizumab (Tecentriq) (CP.PHAR.235)

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

Policy updates include:

• For HCC, unresectable or metastatic removed to accommodate local disease per NCCN

Avapritinib (Ayvakit) (CP.PHAR.454)

Ambetter

Policy updates include:

• NCCN recommended use for myeloid/lymphoid neoplasm added

Axitinib (Inlyta) (CP.PHAR.100)

Ambetter

Policy updates include:

• For RCC, relapsed, stage IV, or metastatic disease added, clear
  cell histology restriction limited to combination therapy with Keytruda
  and Bacencio, single-agent first-line therapy added per NCCN

·         For thyroid carcinoma, persistent disease added per NCCN

Baricitinib (Olumiant) (CP.PHAR.135)

Ambetter

Policy updates include:

• Added criteria for Coronavirus-19 Infection (FDA Emergency Use Authorization); Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic 

Bedaquiline (Sirturo) (CP.PMN.212)

Ambetter

Policy updates include:

• For requests in combination with Pretomanid revised prescriber requirement from infectious disease specialist to an expert in the treatment of tuberculosis

Biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• Added newly FDA-approved indication for Simponi Aria: pJIA and Xeljanz: pcJIA
• Updated Xeljanz new dosage form: oral solution
• Updated Simponi for PsA given age extension to pediatrics
• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Bortezomib (Velcade) (CP.PHAR.410)

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

Policy updates include:

• AIDS-related Kaposi sarcoma pediatric HL NCCN recommended uses added

Cabozantinib (Cabometyx, Cometriq) (CP.PHAR.111)

Ambetter

Updates include:

• For Cometriq, boxed warning removed
• GIST added per NCCN

Certolizumab (Cimzia) (CP.PHAR.247)

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

Policy updates include:

• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

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

Ambetter

Policy update includes:

• Removed criteria for combination DPP4/SGLT2 products and directed requests to the SGLT2 policy instead

Eltrombopag (Promacta) (CP.PHAR.180)

Ambetter

Policy updates include:

• For aplastic anemia clarified use either as first-line combination therapy or second-line as monotherapy
• Removed upper age limit for combination therapy per clinical trial baseline characteristics of study population

Enfortumab Vedotin-ejfv (Padcev) (CP.PHAR.455)

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

Policy updates include:

• Recurrent UC added and trial settings (e.g.,neoadjuvant) removed to encompass NCCN recommended uses

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

Ambetter

Policy updates include:

• For HL, WM//LPL, thymoma, or thymic carcinoma, unresectable or disease not responding to previous therapy added

Factor IX (Human, Recombinant) (CP.PHAR.218)

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

Policy updates include:

• Added newly approved indication for Ixinity for routine prophylaxis.

Factor VIIa, Recombinant (NovoSeven RT, SevenFact) (CP.PHAR.220)

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

Policy updates include:

• Clarified covered indications for SevenFact to align with FDA label

Fam-Trastuzumab Deruxtecan-nxki (Enhertu) (CP.PHAR.456)

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

Policy updates include:

• Recurrent breast cancer added per NCCN

Gilteritinib (Xospata) (CP.PHAR.412)

Ambetter

Updates include:

• TKI trials removed from AML given increased Xospata NCCN rating from 2A to 1
• AML continuing therapy duration increased to 12 months
• MLNE NCCN recommended use added

Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)

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

Policy updates include:

• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Hyaluronate Derivatives (CP.PHAR.05)

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

Policy updates include:

• Revised requirement for diagnosis confirmation by radiologic imaging – generalized to imaging beyond just radiologic type (i.e.,to include MRIs); imaging reference added.

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

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

Policy updates include:

• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Ipilimumab (Yervoy) (CP.PHAR.319)

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

Policy updates include:

• FDA approved malignant pleural mesothelioma added.
• For HCC, Lenvima added as a prior therapy option per NCCN
• For NSCLC, single agent therapy for TMB positive tumor added and combination therapy for RET rearrangement added per NCCN, therapy changed from Yervoy and platinum doublet therapy to Yervoy plus/minus a platinum based regimen to accommodate NCCN recommended uses

Mepolizumab (Nucala) (CP.PHAR.200)

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

Policy updates include:

• Criteria added for new FDA indication: hypereosinophilic syndrome indication (HES)

Mometasone Furoate (Sinuva) (CP.PHAR.448)

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

Policy updates include:

• Added re-authorization criteria based on results of a repeat administration study in patients with ethmoid sinus polyps grade ≥ 1 per PI

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

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

Policy updates include:

• Advanced adrenal pheochromocytoma /paraganglioma added per NCCN

Ofatumumab (Arzerra, Kesimpta) (CP.PHAR.306)

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

Policy updates include:

• Added new subcutaneous dosage form Kesimpta to the policy for the treatment of multiple sclerosis;

Pitolisant (Wakix) (CP.PMN.221)

Ambetter

Policy updates include:

• Updated criteria to reflect expansion of FDA indication to include cataplexy

Prasterone (Intrarosa) (CP.PMN.99)

Ambetter

Policy includes:

I. Initial Approval Criteria

A. Dyspareunia (must meet all):

1. Diagnosis of dyspareunia due to menopause;

2. Age ≥ 18 years;

3. Failure of two vaginal lubricants or vaginal moisturizers, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B);

4. Failure of ≥ 4 week trial of one vaginal estrogen (e.g., estradiol vaginal cream (Estrace®), estradiol vaginal insert (Vagifem®), Premarin® vaginal cream)), unless contraindicated or clinically significant adverse effects are experienced (see Appendix B);

5. Dose does not exceed one vaginal insert daily.

Approval duration:

Medicaid/HIM – 12 months

Commercial - Length of Benefit

II. Continued Therapy

A. Dyspareunia (must meet all):

1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;

2. Member is responding positively to therapy (e.g., dyspareunia symptom reduction);

3. If request is for a dose increase, new dose does not exceed one vaginal insert daily.

Approval duration:

Medicaid/HIM – 12 months

Commercial - Length of Benefit

Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PA.154 for Ambetter

Rituximab (Rituxan), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)

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

Policy updates include:

• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Safinamide (Xadago) (CP.PMN.113)

Ambetter

Policy updates include:

• Monotherapy limitation of use removed per FDA label update

Sarilumab (Kevzara) (CP.PHAR.346)

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

Policy updates include:

• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Talazoparib (Talzenna) (CP.PHAR.409)

Ambetter

Policy updates include:

• Updated dose limits given renal impairment adjustments would exceed 1 capsule per day;

Tavaborole (Kerydin) (CP.PMN.105)

Ambetter

Policy updates include:

• Clarified redirection applies to age 18 or older similar to Jublia

Teriparatide (Forteo) (CP.PHAR.188)

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

Policy updates include:

• Removal of osteosarcoma black box warning per package insert update

Tisagenlecleucel (Kymriah) (CP.PHAR.361)

Ambetter

Policy updates include:

• Clarified acceptable types of LBCL diagnoses per FDA indication and NCCN compendium
• For ALL; removed exclusion for active CNS disease per NCCN support for use in extramedullary disease

Tofacitinib (Xeljanz, Xeljanz XR) (CP.PHAR.267)

Ambetter

Policy updates include:

• Added criteria for newly FDA-approved indication for Xeljanz: pcJIA
• Updated Xeljanz new dosage form: oral solution
• Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Zoledronic Acid (Reclast, Zometa) (CP.PHAR.59)

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

Policy updates includes:

• The MM/solid tumor common criteria line item, at risk for skeletal related event, is removed for solid tumor and for MM is replaced with receiving or initiating therapy for symptomatic disease per pivotal trials/NCCN