Effective November 1, 2022: Pharmacy and Biopharmacy Policies

Amisulpride (Barhemsys) (CP.PMN.236)

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

Policy updates include:

• Revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy

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

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

Policy updates include:

• Per NCCN Compendium clarified extranodal NK/T-cell lymphoma should be in the relapsed or refractory setting and removed requirement for nasal type
• Clarified hepatosplenic T-cell lymphoma should be after two first-line therapy regimens

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

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

Policy updates include:

• Per NCCN added additional combination regimens for MM primary therapy in those eligible for ASCT
• For MM subsequent therapy added combination use with Xpovio and clarified use as monotherapy is allowable only after at least 3 prior lines of therapy or if double-refractory to PI and immunomodulatory agent

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

Ambetter

Policy updates include:

• Clarified initial auth duration is “up to a total of” 12 weeks
• Added omeprazole coadministration as unacceptable rationale for not using preferred Epclusa

Dostarlimab-gxly (Jemperli) (CP.PHAR.540)

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

Policy updates include:

• Per NCCN – for all indications, added that cancer can also be MSI-H
• For solid tumors, added that cancer can also be metastatic, added additional examples of solid tumors that are eligible for coverage, and added requirement for use as a single agent

Dupilumab (Dupixent) (CP.PHAR.336)

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

Policy updates include:

• Criteria added for new FDA indication of EoE;
• For all indications, added Tezspire as an agent with which Dupixent should not be used concurrently.

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

Ambetter

Policy updates include:

• Added omeprazole coadministration as unacceptable rationale for not using preferred Epclusa 

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), CHIP, and Ambetter

Policy updates include:

• Added Releuko to criteria
  
• Removed general description of “stage IV or metastatic” cancer for states with regulations against redirections
• Applied redirection bypass for State with regulations against step therapy to all indications
• Added requirement that requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., pegfilgrastim, Leukine) within any chemotherapy cycle
• Clarified non-myeloid malignancy refers to solid tumor and lymphoid malignancies

Gabapentin ER (Gralise, Horizant) (CP.PMN.240)

Ambetter

Policy updates include:

• Updated RLS approval criteria – removed trial of ropinirole and pramipexole, added trial of gabapentin IR and generic pregabalin to align with RLS Foundation clinical guidelines

Immune Globulins (CP.PHAR.103)

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

Policy updates include:

• Removed “Systemic vasculitides” and “Wegener’s granulomatosis” from Section III, based on 2021 ACR guidelines and 2016 EULAR guidelines providing some support use of IG products for patients with refractory GPA/MPA
• Added requirement for use of Gammunex-C or Gammaked if Gammagard (or health plan-preferred immune globulin product) is unavailable due to shortage

Infigratinib (Truseltiq) (CP.PHAR.547)

Ambetter

Policy updates include:

• Added requirement for use as a single agent per NCCN
• Modified max dose requirement to specify treatment is for 21 days per every 28-day cycle per PI

Ixazomib (Ninlaro) (CP.PHAR.302)

Ambetter

Policy updates include:

• For MM removed use as a single agent for subsequent therapy in transplant candidates as this has been downgraded to a NCCN category 2B recommendation
• Clarified combination use with dexamethasone and Pomalyst requires two prior therapies per NCCN
• Added limitations of use for maintenance therapy and newly diagnosed MM per updated prescribing information
• For MM added requirement that member has received at least one prior therapy
• Removed maintenance use as a single agent after prior autologous stem cell transplant
• For systemic light chain amyloidosis added requirements for use as a single agent or in combination per NCCN

Lurbinectedin (Zepzelca) (CP.PHAR.500)

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

Policy updates include:

• Removed option to bypass platinum containing regimen if contraindicated or clinically significant adverse effects are experienced per prescribing information

Metreleptin (Myalept) (CP.PHAR.425)

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

Policy updates include:

• Added prescriber requirement; clarified that leptin deficiency should be confirmed by laboratory testing per clinical study design
• Clarified that congenital generalized lipodystrophy should be confirmed by gene mutation

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

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

Policy updates include:

• Updated initial approval criteria to include “member is not candidate for or seeking nephroureterectomy as definitive treatment” to mirror NCCN bladder cancer guidelines

Obeticholic Aacid (Ocaliva) (CP.PHAR.287)

Ambetter

Policy updates include:

• Added “without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension” to indication and initial criteria per PI
• Removal of Child Pugh B/C dosing as it is contraindicated per PI

Panobinostat (Farydak) (CP.PHAR.382)

Ambetter

Policy updates include:

• Revised to limit approved MM uses to FDA-labeled indication as NCCN no longer includes recommendations for regimens including panobinostat due to recent market withdrawal

Pazopanib (Votrient) (CP.PHAR.81)

Ambetter

Policy updates include:

• For RCC added additional option for von Hippel-Lindau (VHL)-associated disease per NCCN
• For STS added additional option for “member is ineligible for IV chemotherapy or is not a candidate for anthracycline-based regimens”
• Per NCCN and added Qinlock and Sprycel as additional options for prior therapies in GIST
• Removed ovarian cancer as an off-label use as this is a NCCN Category 2B recommendation

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

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

Policy updates include:

• Removed general description of “stage IV or metastatic” cancer for states with regulations against redirections
• Applied redirection bypass for State with regulations against step therapy to all indications
• Added requirement that Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle

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

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

Policy updates include:

• Removed Sylatron brand and corresponding melanoma criteria from policy as it has been discontinued with a Medispan obsolete date of 09/28/2021
• Per NCCN added chronic myeloid leukemia off-label indication and updated Erdheim-Chester disease, essential thrombocythemia, polycythemia vera, and systemic mastocytosis off-label indications

Pembrolizumab (Keytruda) (CP.PHAR.322)

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

Policy updates include:

• Updated FDA Approved Indication(s) section to include newly approved indication for use as monotherapy for MSI-H or dMMR endometrial
• Per NCCN – melanoma: added requirement for use as a single agent or in combination with Lenvima or Yervoy
• NSCLC: added requirement for no contraindications to PD-1/PD-L1 inhibitors, clarified criteria regarding disease mutation status (disease should be negative for actionable biomarkers and prior targeted therapy is now required only for ROS1 and EGFR S768I, L861Q, and/or G719X mutations), added pathway for use as single-agent continuation maintenance therapy if previously given first line as part of a chemotherapy regimen
• HNSCC: added pathway for combination use with docetaxel or gemcitabine
• cHL: added pathway for combination use with GVD in adults
• cSCC, HCC, PMBCL: added requirement for use as a single agent; urothelial carcinoma: added requirement for use as a single agent for locally advanced or metastatic disease in members who are ineligible for or have previously received platinum-containing chemotherapy
• MSI-H/dMMR cancers: added additional cancers for which Keytruda may be used first line (ampullary adenocarcinoma, non-nasopharyngeal head and neck cancer, pancreatic adenocarcinoma), removed requirement for oxaliplatin contraindication for small bowel adenocarcinoma, added requirement for use as a single agent
• RCC: added requirement for use as a single agent for adjuvant treatment
• TMB-H cancer: added pathway for use as first-line for ampullary adenocarcinoma or pancreatic adenocarcinoma, added requirement for use as a single agent
• Off-label uses: added additional coverable cancers (adrenocortical carcinoma, alveolar soft part sarcoma, anaplastic large cell lymphoma, small cell lung cancer), added pathway for use as first line for thymic carcinoma, removed use for malignant pleural mesothelioma, updated mycosis fungoides to allow stage IIB, updated anal carcinoma to require no prior treatment with Keytruda or Opdivo, updated cancers where Keytruda is to be used only as subsequent therapy to require use as a single agent, updated extranodal NK/T-cell lymphoma to remove nasal type specification

Pemigatinib (Pemazyre) (CP.PHAR.496)

Ambetter

Policy updates include:

• Added requirement for use as a single agent for cholangiocarcinoma per NCCN
• Modified max dose requirement to specify treatment is for 14 days per every 21-day cycle per PI

Sargramostim (Leukine)(CP.PHAR.295)

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

Policy updates include:

• Removed general description of “stage IV or metastatic” cancer for states with regulations against redirections
• Applied redirection bypass for State with regulations against step therapy to all indications
• Added requirement that Leukine will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, pegfilgrastim) within any chemotherapy cycle

Sofosbuvir (Sovaldi) (HIM.PA.SP2)

Ambetter

Policy updates include:

• Added omeprazole coadministration as unacceptable rationale for not using preferred Epclusa

Sotorasib (Lumakras) (CP.PHAR.549)

Ambetter

Policy updates include:

• Added option for recurrent disease per NCCN
• Removed option to bypass failure of at least one systemic therapy if contraindicated or clinically significant adverse effects are experienced per prescribing information

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

Ambetter

Policy updates include:

• Added requirement that Vyndaqel/Vyndamax is not prescribed concurrently with Onpattro and Tegsedi

Trifluridine-tipiracil (Lonsurf) (CP.PHAR.383)

Ambetter

Policy updates include:

• Per NCCN, added appendiceal adenocarcinoma as a type of colon cancer that is eligible for coverage, added requirement for use as a single agent (CRC, GC/GEJ) or in combination with bevacizumab (CRC), and added pathway for approval if member is not a surgical candidate for GC/GEJ
• Per PI, revised max dosing criterion to include body-weight dosing and allow therapy only on Days 1-5 and 8-12 of every 28-day cycle
• Added requirement for documentation of body surface area for dose calculation purposes

Valbenazine (Ingrezza)(CP.PCH.48)

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: Tardive Dyskinesia (must meet all):
  • Diagnosis of TD secondary to a centrally acting dopamine receptor blocking agent (DRBA)
  • Prescribed by or in consultation with a psychiatrist or neurologist
  • Age ≥ 18 years
  • Ingrezza is not prescribed concurrently with Austedo or tetrabenazine
  • Dose does not exceed 80 mg (1 capsule) per day
  • Approval duration: 6 months
• Continuation Approval Criteria: Tardive Dyskinesia (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 a reduction since baseline in any one of Abnormal Involuntary Movement Scale (AIMS) items 1 through 9
  • Ingrezza is not prescribed concurrently with Austedo or tetrabenazine
  • If request is for a dose increase, new dose does not exceed 80 mg (1 capsule) per day
  • Approval duration: 12 months