FLASH: P&T Changes at February Meeting

February 18, 2025

Oncology / Hematology

New Drug Reviews / Policies

Beqvez (fidanacogene elaparvovec)—Treatment of moderate to severe hemophilia B (congenital factor IX deficiency) in adults who currently use factor IX prophylaxis therapy or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid
- Formulary placement recommendations
  - Commercial—Non-Preferred Specialty Medical with PA
  - Medicare—Part B with PA
- Hympavzi (marstacimab)— Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII [FVIII] deficiency) without FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) without FIX inhibitors
  - Formulary placement recommendations
    - Commercial—Non-Preferred Specialty Pharmacy/Medical with PA and MDL (#4/28 days)
    - Medicare—Non-Formulary
  - Alhemo (concizumab)— Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors
    - Formulary placement recommendations
      - Commercial—Non-Preferred Specialty Pharmacy with PA
      - Medicare—Non-Formulary
    - Piasky (crovalimab)—Treatment of paroxysmal nocturnal hemoglobinuria in patients ≥13 years of age and ≥40 kg
      - Formulary placement recommendations
        
        Commercial—Non-Formulary
        
        Medicare—Non-Formulary
      - Note: Medicare Piasky placement and criteria are pending CMS review
    - Voydeya (danicopan)—Treatment of extravascular hemolysis, as add-on therapy to ravulizumab or eculizumab, in adults with paroxysmal nocturnal hemoglobinuria
      - Formulary placement recommendations
        
        Commercial—Non-Preferred Specialty Pharmacy with PA and MDL (#180/30)
        
        Medicare—Non-Formulary
      - Vafseo (vadadustat)—Treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least 3 months
        
        Formulary placement recommendations
        
        Commercial—Non-Formulary
        
        Medicare— Non-Formulary

Oncology New Drug Chart Below are the new medications approved in the last year indicated for oncology conditions. Please note, eviCore completes reviews for commercial oncology requests as well as Medicare part B medications. Any new drug covered on Medicare part D would be reviewed by us internally.
Drug	Indication	Coverage Recommendation
Amtagvi (lifileucel); intravenous suspension	Melanoma, unresectable or metastatic: Treatment of unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor in adults.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Anktiva (nogapendekin alfa inbakicept); intravesical solution	Bladder cancer, high-risk, BCG-unresponsive non–muscle invasive: Treatment of Bacillus Calmette-Guérin (BCG)-unresponsive non–muscle invasive bladder cancer, in combination with BCG, with carcinoma in situ (CIS) with or without papillary tumors in adults.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Aucatzyl (obecabtagene autoleucel); intravenous suspension	Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory: Treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Bizengri (zenocutuzumab); intravenous suspension	Non-small cell lung cancer, advanced unresectable or metastatic, NRG1 fusion-positive: Treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Datroway (datopotamab); intravenous solution	Breast cancer, unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative: Treatment of unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in adults who have received prior endocrine-based therapy and chemotherapy.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Ensacove (ensartinib); oral capsule	Non–small cell lung cancer, anaplastic lymphoma kinase positive, locally advanced or metastatic: Treatment of anaplastic lymphoma kinase (ALK)-positive (as detected by an approved test) locally advanced or metastatic non–small cell lung cancer in adults who have not previously received an ALK-inhibitor.	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#30/30) Medicare: Tier 5 with PA
Imdelltra (tarlatamab); intravenous solution	Small cell lung cancer, extensive stage: Treatment of extensive stage small cell lung cancer in adults with disease progression on or after platinum-based chemotherapy.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Itovebi (inavolisib); oral tablet	Breast cancer, locally advanced or metastatic, endocrine-resistant, HR-positive, HER2-negative, PIK3CA-mutated: Treatment (in combination with palbociclib and fulvestrant) of endocrine-resistant, hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated (as detected by an approved test), locally advanced or metastatic breast cancer in adults following recurrence on or after completing adjuvant endocrine therapy.	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#30/30) Medicare: Tier 5 with PA
Lazcluze (lazertinib); oral tablet	Non–small cell lung cancer, locally advanced or metastatic: First-line treatment (in combination with amivantamab) of locally advanced or metastatic non–small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations (as detected by an approved test)	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#30/30 or #60/30) Medicare: Tier 5 with PA
Lymphir (denileukin diftitox-cxdl); intravenous solution	Cutaneous T-cell lymphoma, stage I-III, relapsed or refractory: Treatment of relapsed or refractory stage I-III cutaneous T-cell lymphoma in adults after at least one prior systemic therapy.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Ojemda (tovorafenib); oral tablet and suspension	Glioma, low-grade, relapsed or refractory: Treatment of relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, in patients ≥6 months of age.	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#24T/28, 96mL/28) Medicare: Tier 5 with PA
Revuforj (revumenib); oral tablet and solution	Acute leukemia, relapsed or refractory: Treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients ≥1 year of age	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#60T/30) Medicare: Tier 5 with PA
Rytelo (imetelstat); intravenous solution	Myelodysplastic syndromes, low- to intermediate-1 risk: Treatment of low- to intermediate-1 risk myelodysplastic syndromes in adults with transfusion-dependent anemia requiring ≥4 RBC units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Tecelra (afamitresgene autoleucel); intravenous solution	Synovial sarcoma, unresectable or metastatic: Treatment of unresectable or metastatic synovial sarcoma in adults who have received prior chemotherapy, are HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by an approved or cleared companion diagnostic device.	Commercial: Non-Preferred Specialty Medical with PA Medicare: Medicare part B
Tepmetko (tepotinib); oral tablet	Non–small cell lung cancer, metastatic: Treatment of metastatic non–small cell lung cancer in adults harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#60/30) Medicare: Tier 5 with PA
Tevimbra (tislelizumab); intravenous solution	Esophageal squamous cell carcinoma (ESCC): treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a programmed death-ligand 1 (PD-L1) inhibitor.	Commercial: Non- Preferred Specialty Medical with PA Medicare: Medicare part B
Unloxcyt (cosibelimab); intravenous solution	Cutaneous squamous cell carcinoma, metastatic or locally advanced: Treatment of metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC in adults who are not candidates for curative surgery or curative radiation.	Commercial: Non- Preferred Specialty Medical with PA Medicare: Medicare part B
Voranigo (vorasidenib); oral tablets	Astrocytoma or oligodendroglioma, grade 2, IDH1 or IDH2 mutated: Treatment of grade 2 astrocytoma or oligodendroglioma in patients ≥12 years of age with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation following surgery, including biopsy, subtotal resection, or gross total resection.	Commercial: Non- Preferred Specialty Pharmacy with PA and MDL (#30/30) Medicare: Tier 5 with PA
Vyloy (zolbetuximab); intravenous solution	Gastric cancer: indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 (CLDN18.2) positive as determined by an FDA-approved test	Commercial: Non- Preferred Specialty Medical with PA Medicare: Medicare part B
Ziihera (zanidatamab); intravenous solution	Biliary tract cancer, HER2-positive, unresectable or metastatic: Treatment of previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer in adults	Commercial: Non- Preferred Specialty Medical with PA Medicare: Medicare part B

Commercial

Oncology / Hematology

Criteria Changes

Ultomiris
- Added criteria for NMOSD, added vaccination criteria per package insert

Miscellaneous Policy Changes

Fabhalta
- Added exclusion for IgAN indication, updated reauthorization criteria
Filspari
- Drug was previously excluded from formulary
- Created coverage criteria because FDA approval changed from Accelerated to Traditional Approval
Ivermectin
- Retiring policy and removing PA since no longer seeing large quantity of inappropriate usage
Spravato
- Removed augmentation requirement and removed conjunction antidepressant requirement due to updated indication approval
Wegovy
- Added Virta requirement for SOIL members
Zepbound
- Policy was created given the new FDA indication for obstructive sleep apnea (OSA)
Medicare Part B Policy for Qalsody
- Policy was created after CMS ruled that drug cannot be excluded from Medicare coverage due to Accelerated Approval status

The P&T Committee meets bimonthly, and formulary changes and criteria changes can occur during the meetings. Negative formulary changes are generally made effective on 1/1 and 7/1, while positive formulary changes are effective immediately to better serve our members and providers. Upcoming negative formulary and criteria changes can be found online at the following website: HealthAlliance.org/Documents/960/2022. Drug coverage and policies in the following categories will be reviewed during the remainder of 2025 and changes may be made:

April Meeting: Rheumatology, Gastroenterology, Dermatology.
June Meeting: Cardiology, Endocrinology, Pulmonology.
August Meeting: Neurology, Psychiatry, Pain.
October Meeting: Ophthalmology, Urology, Rare Diseases.
December Meeting: Specialty and Medicare