Effective May 3, 2021: Pharmacy and Biopharmacy Policies

Date: 03/02/21

Superior HealthPlan has created a new policy and revised existing pharmacy and biopharmacy policies to ensure medical necessity review criteria is current and appropriate for members and the scope of services provided. As a result the following policies have been created, revised or retired:

Policy

Applicable Products

New Policy Overview or Updated Policy Revisions

Abatacept (Orencia) (CP.PHAR.241)

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

Updates include:

Updated pJIA criteria to require diagnosis as evidenced by ≥ 5 joints, cJADAS assessment, and rediretion to Enbrel and Xeljanz per SDC.
Additionally, updated criteria to allow tiered redirection or bypass of MTX in the event of sacroiliitis or high disease activity
Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Adalimumab (Humira), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-adaz (Hyrimoz) (CP.PHAR.242)

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

Updates include:

Updated pJIA criteria to require diagnosis as evidenced by ≥ 5 joints, cJADAS assessment, and rediretion to Enbrel and Xeljanz per SDC.
Additionally, updated criteria to allow tiered redirection or bypass of MTX in the event of sacroiliitis or high disease activity
Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Amifampridine (Firdapse, Ruzurgi) (CP.PHAR.411)

Ambetter

Updates include:

Added requirement for diagnostic testing to confirm diagnosis

Aspirin/Dipyridamole (Aggrenox)

Ambetter

Updates include:

Added requirement for documentation of member’s current body weight for calculation of appropriate dosage .

Avacopan (CCX168, pending FDA Approval) (CP.PHAR.515)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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.PA.154 for Ambetter and CP.PMN.53 for Medicaid
Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
Initial Approval Criteria*
- **Criteria will mirror the clinical information from the prescribing information once FDA-approved**
- ANCA-Associated Vasculitis (must meet all):
- Diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, or renal limited vasculitis;*
- Prescribed by or in consultation with a rheumatologist;
- Age ≥ 18 years;*
- Must meet one of the following (a, b, or c):*
  - Positive indirect immunofluorescence test for P-ANCA or C-ANCA;
  - Positive ELISA test for anti-proteinase-3;
  - Positive ELISA test for anti-myeloperoxidase;
- Documentation of baseline Birmingham vasculitis activity score (BVAS, see Appendix D), with at least one of the following (a, b, or c):*
  - At least 1 major item;
  - At least 3 non-major items;
  - At least the 2 renal items of proteinuria and hematuria;
- Recent (within the last 30 days) failure of ≥ 3 month trial of glucocorticoid therapy at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;*
- CCX168 is prescribed in combination with cyclophosphamide or rituximab, unless clinically significant adverse effects are experienced or both are contraindicated;^{^}* ^{*^}Prior authorization may be required**
- Dose does not exceed 60 mg (2 tablets) per day.*
- Approval duration: 6 months
Continued Therapy*
- **Criteria will mirror the clinical information from the prescribing information once FDA-approved**
- ANCA-Associated Vasculitis (must meet all):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is responding positively to therapy as evidenced by at least a 50% reduction in BVAS from baseline or remission (BVAS of zero);*
- If request is for a dose increase, new dose does not exceed 60 mg (2 tablets) per day.*
- Approval duration: 6 months

Avelumab (Bavencio) (CP.PHAR.333)

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

Updates include:

For UC, recurrent disease added per NCCN, and platinum-based chemotherapy history added per label and NCCN
Gestational trophoblastic neoplasia off-label use added per NCCN

Aztreonam (Cayston) (CP.PHAR.209)

Ambetter

Updates include:

Added prescriber restriction of pulmonologist or infection disease specialist to initial criteria
Added positive response to therapy examples: reduction in respiratory symptoms (e.g., cough, wheezing, sputum production, or pulmonary exacerbations due to Pseudomonas aeruginosa) in continuation criteria

Brand Name Override and Non-Formulary Medications (HIM.PA.103)

Ambetter

Updates include:

Added language to require use of preferred biosimilars if available

Buprenorphine-naloxone (Bunavail, Cassipa, Suboxone, Zubsolv) (CP.PMN.81)

Ambetter

Policy Includes:

Initial Approval Criteria
- Opioid Dependence (must meet all):
- Diagnosis of opioid dependence;
- Documentation supports inability to use generic buprenorphine/naloxone sublingual tablets;
- Dose does not exceed:
- Bunavail: 12.6 mg/2.1 mg per day;
- Cassipa: 16 mg/4 mg per day;
- Suboxone film: 24 mg/6 mg per day;
- Zubsolv: 17.1 mg/4.2 mg per day.
- Approval duration: 12 months
Continued Therapy
- Opioid Dependence (must meet all):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is responding positively to therapy;
- One of the following conditions is met (a or b):
- Member has NOT received an opioid analgesic since last approval;
- Prescriber submits documentation acknowledging that the use of opioid during the last approval period was due to a diagnosis of acute pain;
- If request is for a dose increase, new dose does not exceed:
- Bunavail: 12.6 mg/2.1 mg per day;
- Cassipa: 16 mg/4 mg per day;
- Suboxone film 24 mg/6 mg per day;
- Zubsolv: 17.1 mg/4.2 mg per day.
- Approval duration: 12 months
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

Carglumic acid (Carbaglu) (CP.PHAR.206)

Ambetter

Policy updates include:

Added maximum initial and maintenance dose requirement

Ciclopirox (Penlac) (CP.PMN.24)

Ambetter

Updates include:

Added requirement for use of generic Penlac;
Clarified redirection applies to age 18 or older similar to Jublia and Kerydin

Dornase Alfa (Pulmozyme) (CP.PHAR.212)

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

Updates include:

Added age restriction of 5 years and older

Eculizumab (Soliris) (CP.PHAR.97)

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

Updates include:

For PNH and aHUS, added requirement against concurrent use with Ultomiris;
For NMOSD, specified that Ruxience is the preferred rituximab product

Emapalumab-lzsg (Gamifant) (CP.PHAR.402)

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

Updates include:

Added criteria for diagnosis confirmation per clinical trial inclusion criteria

Enoxaparin (Lovenox) (CP.PHAR.224)

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

Updates include:

Added generic redirection language to initial and continuation criteria

Etanercept (Enbrel) (CP.PHAR.250)

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

Updates include:

Updated pJIA criteria to require diagnosis as evidenced by ≥ 5 joints and cJADAS assessment
Additionally, updated criteria to allow tiered redirection or bypass of MTX in the event of sacroiliitis or high disease activity
Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Factor VIII/von Willebrand Factor Complex (Human – Alphanate, Humate-P, Wilate); von Willebrand Factor (Recombinant – Vonvendi) (CP.PHAR.216)

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

Updates include:

For VWD type 1 or 2 (except 2B), added requirement for a prior trial of desmopressin

Ferric Gluconate (Ferrlecit) (CP.PHAR.166)

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

Updates include:

Added off-label dosing limits per label or practice guidelines for iron deficiency anemia without CKD

Fondaparinux (Arixtra) (CP.PHAR.226)

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

Updates include:

Added criteria if request is for Arixtra, medical justification supports inability to use generic fondaparinux to initial and continuation criteria

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (CP.PMN.183)

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

Policy updates include:

Required redirection to SGLT2-containing product for ALL GLP-1 requests, not just Rybelsus

Ibrutinib (Imbruvica) (CP.PHAR.126)

Ambetter

Updates include:

Oral oncology generic redirection language added
For MCL, NCCN directed language inserted to clarify combination therapy with rituximab
For CLL/SCC, histologic transformation combination therapy added per NCCN
For MZL, subtypes delineated for clarity, therapy trials broadened beyond rituximab per NCCN
For cGVHD, trial requirement edited to require a systemic corticosteroid and an immunosuppressant agent per NCCN and the Imbruvica pivotal trial

Icosapent ethyl (Vascepa) (CP.PMN.187)

Ambetter

Policy updates include:

Added redirection to generic icosapent ethyl for brand Vascepa requests

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

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.PA.154 for Ambetter
Initial Approval Criteria:
Requests for Xopenex HFA/ Inhalation Solution (must meet all):
- Member meets one of the following:
  - Presence of cardiac disease;
  - Member experienced clinically significant adverse effects from albuterol use within the last 90 days;
- Member does NOT have history of allergy or hypersensitivity to albuterol or levalbuterol;
- Request does not exceed:
  - Xopenex HFA: 2 inhalers per 30 days;
  - Xopenex inhalation solution: 4 vials per day (12 mL per day).
- Approval duration: 6 months
- Requests for All Other Inhaled Agents for Asthma or Chronic Obstructive Pulmonary Disease (must meet all):
- Diagnosis of asthma or COPD as FDA-approved for the requested agent (see FDA Approved Indications section);
- Age is one of the following:
  - Asthma: Appropriate per the prescribing information for the requested agent (see FDA Approved Indications section);
  - COPD: ≥ 18 years;
- Failure of the following formulary agent(s) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated:

Requested Agent	Required Step Through Agent(s)
ProAir Digihaler	Two generic albuterol sulfate HFA products, each from a different manufacturer
Pulmicort Respules	Age is between 1 to 8 years or documentation supports inability to use inhaler devices AND if request is for brand Pulmicort Respules, medical justification supports inability to use generic Pulmicort Respules (e.g., contraindications to excipients)
All other ICS: Alvesco, Armonair Digihaler, Asmanex HFA, Asmanex Twisthaler	Qvar^® RediHaler^™ AND Pulmicort Flexhaler^™ AND Arnuity^® Ellipta^® AND Flovent^® Diskus^®/HFA^®
LABA: Brovana, Perforomist	Arcapta^® Neohaler^®AND Serevent^® Diskus^® AND Striverdi^® Respimat^®, unless request is for a nebulized LABA and documentation supports inability to use inhaler devices
LAMA: Lonhala Magnair, Seebri Neohaler, Tudorza Pressair, Yupelri	Incruse^® Ellipta^® AND Spiriva^® Handihaler^®/ Respimat^®, unless request is for a nebulized LAMA and documentation supports inability to use inhaler devices
Brand Advair Diskus	Medical justification supports inability to use fluticasone/salmeterol (generic Advair Diskus and Wixhela^™ Inhub^™) (e.g., contraindications to excipients)
All other ICS/LABA: AirDuo Digihaler, AirDuo RespiClick, Dulera	Advair HFA^® AND Breo Ellipta^® AND Symbicort (brand or generic budesonide/formoterol) AND fluticasone/salmeterol (generic Advair Diskus or Wixhela Inhub)
LABA/LAMA: Duaklir Pressair, Stiolto Respimat, Utibron Neohaler	Anoro^® Ellipta^®AND Bevespi Aerosphere^™
ICS/LABA/LAMA: Breztri Aerosphere	Trelegy^™ Ellipta^®

For requests for an agent with a digital component (e.g., Digihaler products): Medical justification supports necessity of the digital component (i.e., rationale why inhaler usage cannot be tracked manually);
Dose does not exceed the FDA-approved maximum dose for the relevant indication (see Section V).
Approval duration: 12 months
Continued Therapy
- All Requests in Section I (must meet all):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Member is responding positively to therapy;
- If request is for Xopenex HFA/inhalation solution, albuterol has not been used within the past 3 months as evidenced by pharmacy claims history;
- If request is for a dose increase, new dose does not exceed the FDA-approved maximum dose for the relevant indication (see Section V).
- Approval duration: 12 months

Iron Sucrose (Venofer) (CP.PHAR.167)

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

Updates include:

Added off-label dosing limits per label or practice guidelines for iron deficiency anemia

Larotrectinib (Vitrakvi) (CP.PHAR.414)

Ambetter

Updates include:

Oral oncology generic redirection language added
Tumor subtype and subsequent therapy restrictions removed per NCCN
Kinase resistance mutation confirmation added/ if known, exclusion added (Section III)

Latanoprostene Bunod (Vyzulta) (CP.PMN.108)

Ambetter

Policy Includes:

Initial Approval Criteria
- Open-Angle Glaucoma, Ocular Hypertension (must meet all):
  - Diagnosis of open-angle glaucoma or ocular hypertension;
  - Age ≥ 17 years;
  - Failure of two of the following, unless clinically significant adverse events are experienced or all are contraindicated: a generic ophthalmic prostaglandin analog (e.g., latanoprost), ophthalmic beta-blocker (e.g., timolol), ophthalmic alpha-2 adrenergic agonist (e.g., brimonidine);
  - Dose does not exceed one bottle every 30 days.
- Approval duration: 12 months
Continued Therapy
- Open-Angle Glaucoma, Ocular Hypertension (must meet all):
  - Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
  - Member is responding positively to therapy;
  - If request is for a dose increase, new dose does not exceed one bottle every 30 days.
- Approval duration: 12 months
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

Lusutrombopag (Mulpleta) (CP.PHAR.407)

Ambetter

Updates include:

Added requirement that Mulpleta is not prescribed concurrently with other thrombopoietin receptor agonists

Natalizumab (Tysabri) (CP.PHAR.259)

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

Policy updates include:

Revised redirection for relapsing-remitting MS to require two of the following: Aubagio, generic dimethyl fumarate, and Gilenya, interferon-beta, or glatiramer, unless member has highly active MS, in which Gilenya redirection is maintained

Nivolumab (Opdivo) (CP.PHAR.121)

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

Updates include:

FDA approved malignant pleural mesothelioma added
Per FDA/NCCN as follows: for melanoma, unresectable, metastatic, or lymph node positive disease added
For NSCLC, single-agent therapy for TMB positive tumor added, combination therapy for RET rearrangement added, combination therapy changed from Yervoy and platinum doublet therapy toYervoy plus/minus a platinum based regimen
For cHL, relapsed, refractory or progressive disease added, post HSCT replaced with prescribed as subsequent therapy
For HCC, Lenvima added as a prior therapy option; off-label pediatric Hodgkin lymphoma and vulvar cancer added

Olaratumab (Lartruvo) (CP.PHAR.326)

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

Updates include:

Removed initial approval criteria for soft tissue sarcoma
Added criteria to continuation approval for soft tissue sarcoma requiring patient has not had disease progression on Lartruvo

Omega-3-Acid Ethyl Esters (Lovaza) (CP.PMN.52)

Ambetter

Policy includes:

Initial Approval Criteria
- Hypertriglyceridemia (must meet all):
  - Diagnosis of hypertriglyceridemia;
  - Age ≥ 18 years;
  - Fasting triglycerides ≥ 500 mg/dL (lab must be dated within 90 days);
  - Failure of a ≥ 3 consecutive month trial of fibrate therapy in the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
  - If request is for brand Lovaza, medical justification supports inability to use generic omega-3-acid ethyl esters (e.g., contraindication to excipients);
  - Dose does not exceed 4 g (4 capsules) per day.
- Approval duration: 6 mos

Continued Therapy
- Hypertriglyceridemia (must meet all):
  - Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
  - Member is responding positively to therapy;
  - If request is for brand Lovaza, medical justification supports inability to use generic omega-3-acid ethyl esters (e.g., contraindication to excipients);
  - If request is for a dose increase, new dose does not exceed 4 g (4 capsules) per day.
- Approval duration: 12 months
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

Pegfilgrastim (Neulasta), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-cbqv (Udenyca), Pegfilgrastim-bmez (Ziextenzo), Pegfilgrastim-apgf (Nyvepria) (CP.PHAR.296)

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

Updates include:

Add requirement for confirmation that there is at least 12 days between pegfilgrastim dose and the next cycle of chemotherapy

Pegloticase (Krystexxa) (CP.PHAR.115)

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

Policy updates include:

Added requirement in continued therapy that member is not concurrently taking other oral urate-lowering therapy to for initial approval

Pemetrexed (Alimta, Pemfexy) (CP.PHAR.368)

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

Updates include:

Induction therapy offered for primary CNS lymphoma per NCCN
Urothelial carcinoma off-label use removed per NCCN

Potassium Chloride for Oral Solution (Klor-Con Powder) (HIM.PA.143)

Ambetter

Updates include:

Amended medical justification criteria to require for both oral capsules and tablets

Ramucirumab (Cyramza) (CP.PHAR.119)

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

Updates include:

NSCLC - EGRF mutation requirement added if therapy in combination with erlotinib

Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)

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

Updates include:

Added requirement against concurrent use with Soliris

Rifabutin (Mycobutin), Rifabutin/Omeprazole/Amoxicillin (Talicia) (CP.PMN.223)

Ambetter

Updates include:

Added “off-label” for Mycobutin for H. pylori infection
Added redirection to generic rifabutin in initial and continuation criteria

Rucaparib (Rubraca) (CP.PHAR.350)

Ambetter

Updates include:

mCRPC label update to require FDA-approved diagnostic test -no change to mCRPC indication
Oral oncology generic redirection language added
For ovarian cancer, single-agent therapy clarification added

Ruxolitinib (Jakafi) (CP.PHAR.98)

Ambetter

Updates include:

Oral oncology generic redirection language added
For pediatric ALL, consolidation therapy and additional mutations added per NCCN
New myeloid/lymphoid and essential thrombocytopenia indications added per NCCN

Siponimod (Mayzent) (CP.PHAR.427)

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

Policy updates include:

Added redirection to preferred MS products for CIS and RRMS

Tasimelteon (Hetlioz, Hetlioz LQ) (CP.PMN.104)

Ambetter

Updates include:

Modified initial approval duration from 6 to 12 months
Added new dosage form Hetlioz LQ and new indication for nighttime sleep disturbances in SMS
For non-24 added age 18 or older and requirement that request is for Hetlioz per updated prescribing information.

Tazemetostat (Tazverik) (CP.PHAR.452)

Ambetter

Updates include:

Oral oncology generic redirection language added
For FL, EZH2 wild type mutation status clarified as negative, and unknown mutation status added for completeness

Tobramycin (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler) (CP.PHAR.211)

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

Updates include:

Added prescriber restrictions of pulmonologist or infection disease specialist references reviewed and updated.

Tocilizumab (Actemra) (CP.PHAR.263)

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

Updates include:

Updated pJIA criteria to require diagnosis as evidenced by ≥ 5 joints, cJADAS assessment, and rediretion to Enbrel and Xeljanz per SDC
Additionally, updated criteria to allow tiered redirection or bypass of MTX in the event of sacroiliitis or high diseas MTX in the event of sacroiliitis or high disease activity
Added criteria for RAPID3 assessment for RA given limited in-person visits during COVID-19 pandemic

Vandetanib (Caprelsa) (CP.PHAR.80)

Ambetter

Updates include:

Oral oncology generic redirection language added
For lung cancer, recurrent, advanced, or metastatic disease added

Vemurafenib (Zelboraf) (CP.PHAR.91)

Ambetter

Updates include:

Oral oncology generic redirection language added
Recurrent/ lymph node positive added to melanoma per NCCN
Progressive/symptomatic added to thyroid carcinoma per NCCN
Astrocytoma/oligodendroglioma use added per NCCN
CRC removed per NCCN

To review all Clinical policies, please visit Superior’s Clinical, Payment & Pharmacy Policies webpage.

Prior to updates, pharmacy and biopharmacy clinical policies are reviewed and approved by the Pharmacy and Therapeutics (P&T) Committee.

For questions or additional information, please contact Superior’s Pharmacy Department at 1-800-218-7453, ext. 22272.