Effective February 1, 2025: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Afamitresgene Autoleucel (Tecelra) (CP.PHAR.678)

Medicaid

Policy includes:

·         Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the non-FDA approved use policy MS.PMN.53 for Medicaid.

·         Initial Approval Criteria: Synovial Sarcoma* (must meet all):

o   Diagnosis of unresectable or metastatic synovial sarcoma;

o   Prescribed by or in consultation with an oncologist;

o   Age ≥ 18 years;

o   Member is positive for one of the following (a, b, c, or d; see Appendix D):

§  HLA-A*02:01P;

§  HLA-A*02:02P;

§  HLA-A*02:03P;

§  HLA-A*02:06P,

o   Member is not heterozygous or homozygous for HLA-A*02:05P ;

o   Documentation of MAGE-A4 antigen expression as determined by FDA-approved or cleared companion diagnostic device;

o   Member has received ≥ 1 prior systemic chemotherapy (see Appendix B);

o   Member has not received prior allogenic hematopoietic stem cell transplant;

o   Member has not received prior gene therapy;

o   Dose does not exceed a single dose of 10 x 109 MAGE-A4 T cell receptor (TCR) positive T-cells.

o   Approval duration: 3 months (one time infusion per lifetime)

·         Continued Therapy: Synovial Sarcoma

o   Continued therapy will not be authorized as Tecelra is indicated to be dosed one time only.

Axatilimab-csfr (Niktimvo) (CP.PHAR.691)

Medicaid

Policy includes:

·         Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the non-FDA approved use policy MS.PMN.53 for Medicaid.

·         Initial Approval Criteria: Graft-Versus-Host Disease (must meet all):

o   Diagnosis of chronic graft-versus-host disease (cGVHD) post hematopoietic cell transplantation;

o   Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist;

o   Age at least 6 years;

o   Weight at least 40 kg;

o   Failure of a systemic corticosteroid at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

o   Failure of a systemic immunosuppressant at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

§  Prior authorization may be required

o   Niktimvo is not prescribed concurrently with Jakafi^®, Imbruvica^®, or Rezurock^®;

o   Request meets one of the following:

§  Dose does not exceed 0.3 mg/kg (up to maximum of 35 mg) every 2 weeks;

§  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.

o   Approval duration: 6 months

·         Continued Therapy: Graft-Versus-Host Disease (must meet all):

o   Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Niktimvo for a covered indication and has received this medication for at least 30 days;

•  
  • Member is responding positively to therapy;
  • Niktimvo is not prescribed concurrently with Jakafi, Imbruvica, or Rezurock;
  • If request is for a dose increase, request meets one of the following:

§  New dose does not exceed 0.3 mg/kg (up to maximum of 35 mg) every 2 weeks;

§  New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.

o   Approval duration: 12 months

Denileukin Diftitox-cxdl (Lymphir) (CP.PHAR.693)

Medicaid

Policy includes:

·         Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the non-FDA approved use policy MS.PMN.53 for Medicaid.

·         Initial Approval Criteria: Cutaneous T-Cell Lymphoma (CTCL) (must meet all):

o   Diagnosis of CTCL

o   Prescribed by or in consultation with an oncologist or hematologist;

o   Age at least 18 years;

o   For CTCL subtypes that are not mycosis fungoides (MF) or Sezary syndrome, all of the following:

§  Disease is relapsed or refractory;

§  Disease is stage I, III, or III;

§  Failure of at least one prior systemic therapy;

o   Request meets one of the following:

§  Dose does not exceed 9 mcg/kg per day on days 1 to 5 of a 21-day cycle;

§  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use. 

• • Approval duration: 6 months

·         Continued Therapy: Cutaneous T-Cell Lymphoma (must meet all):

o   Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lymphir for a covered indication and has received this medication for at least 30 days;

•  
  • Member is responding positively to therapy;
  • If request is for a dose increase, request meets one of the following:

§  New dose does not exceed 9 mcg/kg per day on days 1 to 5 of a 21-day cycle;

§  New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.

o   Approval duration: 6 months

Palopegteriparatide (Yorvipath) (CP.PHAR.696)

Medicaid

Policy includes:

·         Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the non-FDA approved use policy MS.PMN.53 for Medicaid.

• Initial Approval Criteria: Hypoparathyroidism (must meet all):
  • Diagnosis of hypoparathyroidism;
  • Prescribed by or in consultation with an endocrinologist;
  • Age at least 18 years;
  • At therapy initiation, Yorvipath is prescribed as an adjunct to calcium supplements and active forms of vitamin D (e.g., calcitriol), unless contraindicated or clinically significant adverse effects are experienced;
  • Recent (dated within the last 30 days) albumin-corrected serum calcium level is at least 7.8 mg/dL;
  • Recent (dated within the last 30 days) lab result shows serum 25-hydroxyvitamin D (25(OH)D) is within the laboratory defined normal range (e.g., 30-100 ng/mL, 75-250 nmol/L);
  • Failure of a 12-week trial of calcium supplements and active forms of vitamin D (e.g., calcitriol) at up to maximally indicated doses, unless contraindicated or clinically significant adverse events are experienced;

§  Prescriber must indicate that the hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D.

•  
  • Dose does not exceed both of the following:
    • 30 mcg per day, administered as a single injection;
    • 2 pens per 28 days.

o   Approval duration: 6 months

·         Continued Therapy: Hypoparathyroidism (must meet all):

o   Member meets one of the following:

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

§  Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;

•  
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Albumin-corrected serum calcium in the normal range (e.g., 8.3 to 10.6 mg/dL);
    • Independence from conventional therapy (e.g., no active vitamin D and elemental calcium supplementation ≤ 600 mg/day);

o   If request is for a dose increase, new dose does not exceed both of the following.

§  30 mcg per day, administered as a single injection;

§  2 pens per 28 days.

o   Approval duration: 6 months

Naltrexone (Vivitrol) (CP.PHAR.96)

Medicaid

Policy updates include:

·         For alcohol dependence, removed requirement for alcohol screening test and revised to “member has abstained from drinking prior to Vivitrol therapy”

Irinotecan Liposome (Onivyde) (CP.PHAR.304)

Medicaid

Policy updates include:

·         Updated Food and Drug Administration (FDA)  approved indications section to align with prescriber information

·         Updated continued therapy section from “pancreatic adenocarcinoma” to “all indications in Section I”

·         Added ampullary adenocarcinoma off-label criteria as supported by National Comprehensive Cancer Network (NCCN) compendium and guideline

Obinutuzumab (Gazyva) (CP.PHAR.305)

Medicaid

Policy updates include:

·         Added Commercial line of business for use in medical coverage determinations

·         For chronic lymphocytic leukemia/small lymphocytic lymphoma removed requirement for del(17p)/TP53-negative status per National Comprehensive Cancer Network (NCCN) Compendium

·         For B-cell lymphomas, added option for Gazyva monotherapy prior to Columvi administration for specific lymphomas and for follicular lymphoma removed requirement for combination chemotherapy in second line and subsequent therapy per National Comprehensive Cancer Network (NCCN)

·         For hairy cell leukemia, clarified that member must be unable to tolerate purine analogs per National Comprehensive Cancer Network (NCCN) and removed active infection as an option for criteria consolidation

Temsirolimus (Torisel) (CP.PHAR.324)

Medicaid

Policy updates include:

·         Updated “Endometrial Carcinoma” indication to “Uterine Neoplasms” per National Comprehensive Cancer Network (NCCN) compendium as Uterine Neoplasms include both endometrial carcinoma and uterine sarcoma

Pasireotide (Signifor, Signifor LAR) (CP.PHAR.332)

Medicaid

Policy updates include:

·         For acromegaly, revised initial criteria from “(growth hormone) level at least 1 μg/ml” to “(growth hormone) level at least 1 μg/L” per PS/ES practice guidelines and Acromegaly Consensus Group

Gemtuzumab Ozogamicin (Mylotarg) (CP.PHAR.358)

Medicaid

Policy updates include:

·         For acute myeloid leukemia, collapsed combination therapy options for newly diagnosed disease to “combination with chemotherapy” as there are various recommended combinations per National Comprehensive Cancer Network (NCCN)

·         Revised Commercial approval duration to “6 months or to the member’s renewal date, whichever is longer” for this injectable drug

Pegvisomant (Somavert) (CP.PHAR.389)

Medicaid

Policy updates include:

·         For acromegaly, revised initial criteria from “(growth hormone) level at least 1 µg/ml” to “(growth hormone) level at least 1 µg/L” per PS/ES practice guidelines and Acromegaly Consensus Group

·         Removed inactive HCPCS code C9399 and updated J3590 HCPCS code description to “unclassified biologics”

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

Medicaid

Policy updates include:

·         For acromegaly, revised initial criteria from “(growth hormone) level at least 1 µg/ml” to “(growth hormone) level at least 1 µg/L” per PS/ES practice guidelines and Acromegaly Consensus Group

·         For neuroendocrine tumors, added to initial criteria “diagnosis of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia” and revised “bronchopulmonary neuroendocrine tumor (NET)” to “lung neuroendocrine tumor (NET)” per National Comprehensive Cancer Network (NCCN) compendium and guideline

·         Updated Appendix D “National Comprehensive Cancer Network (NCCN) guidelines - Neuroendocrine and Adrenal Tumors” supplemental information

Cemiplimab-rwlc (Libtayo) (CP.PHAR.397)

Medicaid

Policy updates include:

·         For cutaneous squamous cell carcinoma, added option for disease is recurrent and prescribed in neoadjuvant setting

·         non-small cell lung cancer, added option for disease is recurrent

·         For basal cell carcinoma, removed criterion requiring previous treatment with a hedgehog pathway inhibitor per National Comprehensive Cancer Network (NCCN)

·         Added National Comprehensive Cancer Network (NCCN) supported recommended uses (off-label) section to include: cervical cancer, vaginal, vulvar cancer

Antithymocyte Globulin (Atgam, Thymoglobulin) (CP.PHAR.506)

Medicaid

Policy updates include:

·         Added National Comprehensive Cancer Network (NCCN) supported recommended uses (off-label) section to include immunotherapy-related cardiovascular toxicity, CAR t-cell-related toxicity,

graft-verus-host disease, and myelodysplastic syndrome

Efgartigimod alfa, efgartigimod-hyaluronidase (Vyvgart, Vyvgart Hytrulo) (CP.PHAR.555)

Medicaid

Policy updates include:

·         Added new indication of chronic inflammatory demyelinating polyneuropathy for Vyvgart Hytrulo

·         Updated Commercial approval durations from 6/12 months to “6 months or to the member’s renewal date, whichever is longer” since this is an injectable agent.

Asfotase Alfa (Strensiq) (CP.PHAR.328)

Medicaid

Policy updates include:

Added elevated inorganic pyrophosphate (PPi) level as an additional biochemical marker of decreased alkaline phosphatase (ALP) activity based on the pathophysiology of hypophosphatasia

·         Added information regarding the need to stop pyridoxine supplementation one week prior to measuring plasma pyridoxal 5’-phosphate (PLP) to ensure accurate assessments of endogenous PLP levels

·         Added new Boxed Warning from a recent label update

Bevacizumab (Alymsys, Avastin, Avzivi, Mvasi, Vegzelma, Zirabev) (CP.PHAR.93)

Medicaid

Policy update includes:

·         Re-organized Food and Drug Administration (FDA)-approved indications for improved clarity

·         For the following oncology indications, revised the following per National Comprehensive Cancer Network (NCCN): for non-small cell lung cancer, added qualifier of unresectable, specified sensitizing EGFR mutation for combination use with erlotinib, added additional agents with which pemetrexed and Tecentriq can be prescribed, removed requirement that the combination of carboplatin and paclitaxel is reserved for first-line treatment

·         For renal cell carcinoma, added qualifier of relapsed

·         For ovarian cancer, removed requirement that use with platinum agent + chemotherapy followed by single agent bevacizumab be limited to Stage IB-IV disease, added that combination with Zejula may be used for maintenance therapy if intolerant to Lynparza, added additional combination regimens for platinum-resistant disease (cyclophosphamide and Keytruda, Ixempra, Elahere), added combination with Elhere for platinum-sensitive disease

·         For hepatocellular carcinoma, removed requirement that disease is Child-Pugh class A or B and added pathway for adjuvant therapy in members at high risk of recurrence following resection or ablation

·         Added additional off-label uses (pleomorphic xanthroastrocytoma, gliosarcoma, H3-mutated high-grade glioma, high-grade astrocytoma with piloid features, neurofibromatosis type 2 vestibular schwannomas with hearing loss, vaginal cancer)

·         Added requirement for combination use for ampullary adenocarcinoma, peritoneal mesothelioma, pleural mesothelioma, small bowel adenocarcinoma, or vulvar cancer

·         For ophthalmology uses: revised choroidal neovascularization to allow any cause and added additional examples, added radiation retinopathy and retinopathy of prematurity as supported by literature, added requirement for ophthalmologist prescriber, removed age restriction as some covered diagnoses may affect pediatric populations

Erenumab-aooe (Aimovig) (CP.PHAR.128)

Medicaid

Policy update includes:

·         Added Zavzpret to list of calcitonin gene-related peptide (CGRP) inhibitors that should not be prescribed concurrently with Aimovig, removed references to “injectable or oral calcitonin gene-related peptide (CGRP)” as Zavzpret is a nasal product

·         Updated HCPCS code J3490 to J3590 for unclassified biologics

Bendamustine (Belrapzo, Bendeka, Treanda, Vivimusta) (CP.PHAR.307)

Medicaid

Policy update includes:

·         Clarified that policy applies to generic bendamustine

·         For all indications, revised commercial approval duration to “6 months or to the member’s renewal date, whichever is longer”

·         For non-Hodgkin lymphoma per National Comprehensive Cancer Network (NCCN), clarified follicular lymphoma is classic, updated formatting for Marginal zone lymphoma to clarify types

·         Specified DLBL is with no intention to preceed to transplant, revised high-grade B-cell lymphoma criteria to lymphoma with no intention to proceed to transplant, added requirements for combination use for classic follicular lymphoma, Marginal zone lymphoma, indolent non-Hodgkin lymphoma, diffuse large B-cell lymphoma, human immunodeficiency virus (HIV)-related B-cell lymphoma, post-transplant lymphoproliferative disorder not otherwise specified, and high-grade B-cell lymphoma per National Comprehensive Cancer Network (NCCN)

·         For off-label National Comprehensive Cancer Network (NCCN) uses per National Comprehensive Cancer Network (NCCN), added relapsed or refractory requirements to Hodgkin lymphoma, multiple myeloma, and systemic light chain amyloidosis, added as subsequent therapy requirement to multiple myeloma and Pthymic carcinomaL, added initial therapy requirement to peripheral T-cell lymphoma

·         Added off-label indications of mycosis fungoides / Sezary syndrome, enteropathy-associated T-cell lymphoma, and anaplastic large cell lymphoma, clarified peripheral T-cell lymphoma subtypes, clarified Waldenstrom’s macroglobulinemia includes Bing-Neel syndrome, added requirements for combination use for T-cell lymphomas, mycosis fungoides / Sezary syndrome, and Waldenstrom’s macroglobulinemia

·         Updated Appendix B per National Comprehensive Cancer Network (NCCN)

·         Removed bendamustine 45mg and 180mg vials per product discontinuation

Elotuzumab (Empliciti) (CP.PHAR.308)

Medicaid

Policy update includes:

·         Added hematologist as prescriber option

·         Added criterion disease is relapsed or refractory per National Comprehensive Cancer Network (NCCN)

·         Added International Myeloma Working Group (IMWG) criterion defining progressive multiple myeloma disease as multiple myeloma class alignment

·         For Commercial line of business, revised approval duration to standard language of “6 months or to the member’s renewal date, whichever is longer”

Carfilzomib (Kyprolis) (CP.PHAR.309)

Medicaid

Policy update includes:

·         For relapse or refractory multiple myeloma prescribing regimens: added hematologist as prescriber option, added International Myeloma Working Group (IMWG) criterion defining progressive multiple myeloma disease as multiple myeloma class alignment, revised verbiage from “one or three lines of therapy” to “one to three lines of therapy”, added verbiage “in patients who have received one to three lines of therapy” when used in combination with Xpovio, cyclophosphamide, or pomalidomide

·         Added regimen option in combination with venetoclax and dexamethasone in patients with t(11:14) translocations

·         For systemic light chain amyloidosis, added option for treatment for newly diagnosed disease or relapsed/refractory disease as a repeat of initial therapy if relapse-free for several years per National Comprehensive Cancer Network (NCCN)

·         For Commercial line of business, revised approval duration to standard language of “6 months or to the member’s renewal date, whichever is longer”

Belinostat (Beleodaq) (CP.PHAR.311)

Medicaid

Policy update includes:

·         Per National Comprehensive Cancer Network (NCCN), added that Beleodaq must be prescribed as a single agent and added requirements regarding prior therapies (with bypass allowed if prescribed as palliative therapy for peripheral T-cell lymphoma)

·         Removed primary cutaneous anaplastic large cell lymphoma as a coverable off-label use as it is no longer recommended by National Comprehensive Cancer Network (NCCN)

·         Removed “gamma delta” qualifier from hepatosplenic T-cell lymphoma as National Comprehensive Cancer Network (NCCN) does not specify this

Pralatrexate (Folotyn) (CP.PHAR.313)

Medicaid

Policy update includes:

·         Revised policy/criteria section to also include generic pralatrexate

·         For non-cutaneous T-cell lymphomas, added requirement that Folotyn be prescribed as a single agent per National Comprehensive Cancer Network (NCCN)

·         Removed “gamma delta” qualifier from hepatosplenic T-cell lymphoma as National Comprehensive Cancer Network (NCCN) does not specify this

Cetuximab (Erbitux) (CP.PHAR.317)

Medicaid

Policy update includes:

·         Per National Comprehensive Cancer Network (NCCN) – for HNSCC, added qualifier of unresectable disease and added alternative combinations with Keytruda, paclitaxel, or docetaxel

·         For colorectal cancer, added pathways for Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) G12C, deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H), and polymerase epsilon/delta (POLE/POLD1) mutations with corresponding requirements related to combination use and/or prior therapy, limited combination use with irinotecan for after prior therapy only, and modified requirement for left-sided colon cancer to only apply to unresectable synchronous liver/lung metastases

·         For non-small cell lung cancer, specified sensitizing EGFR mutations (EGFR exon 19 deletion or exon 21 L858R, EGFR S768I, L861Q, and/or G719X mutation positive)

·         For penile cancer, added qualifier of recurrent disease

·         For squamous cell skin cancer, added qualifiers of unresectable and recurrent disease, removed qualifier of very high risk, and added pathway for combination use with carboplatin and paclitaxel

Panitumumab (Vectibix) (CP.PHAR.321)

Medicaid

Policy update includes:

·         Per National Comprehensive Cancer Network (NCCN) – added pathways for Kirsten rat sarcoma 2 viral oncogene homologue (KRAS) G12C, deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H), and polymerase epsilon/delta (POLE/POLD1) mutations with corresponding requirements related to combination use and/or prior therapy

·         Removed prior therapy requirement when requested for use as a single agent

·         Modified requirement for left-sided colon cancer to only apply to unresectable synchronous metastases

Pegaspargase (Oncaspar), Calaspargase Pegol-mknl (Asparlas) (CP.PHAR.353)

Medicaid

Policy update includes:

·         For T-cell lymphoma removed hepatosplenic T-cell lymphoma indication and added GELAD (gemcitabine, etoposide, pegaspargase, dexamethasone)

·         regimen option per National Comprehensive Cancer Network (NCCN)

·         Revised Commercial approval durations to “6 months or to the member’s renewal date, whichever is longer;” references reviewed and updated.

Azacitidine (Onureg, Vidaza) (CP.PHAR.387)

Medicaid

Policy update includes:

·         Revised policy/criteria section to also include generic azacitidine

·         For all indications where applicable, updated generic redirection to include Vidaza

·         For acute myelogenous leukemia, removed requirement for Onureg that member is not able to or declines to complete intensive consolidation therapy and added requirements regarding usage of Vidaza (single agent and combination) per National Comprehensive Cancer Network (NCCN)

·         Updated off-label criteria for “myelofibrosis” to instead refer to “myeloproliferative neoplasms” and added specific requirements around recommended uses (bridging therapy prior to transplant and use as a single agent or in various combinations) per National Comprehensive Cancer Network (NCCN)

·         Added off-label criteria for peripheral T-cell lymphomas per National Comprehensive Cancer Network (NCCN)

Fremanezumab-vfrm (Ajovy) (CP.PHAR.403)

Medicaid

Policy update includes:

·         Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Ajovy, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product

Galcanezumab-gnlm (Emgality) (CP.PHAR.404)

Medicaid

Policy update includes:

·         Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Emgality, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product

·         Updated HCPCS code J3490 to J3590 for unclassified biologics

Valrubicin (Valstar) (CP.PHAR.439)

Medicaid

Policy update includes:

·         Clarified that policy applies to generic valrubicin

·         Added criterion for brand Valstar requests, that member must use generic valrubicin

Eptinezumab-jjmr (Vyepti) (CP.PHAR.489)

Medicaid

Policy update includes:

·         Added Zavzpret to list of calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP)) inhibitors that should not be prescribed concurrently with Vyepti, removed references to “injectable or oral calcitonin gene-related peptide (calcitonin gene-related peptide (CGRP))” as Zavzpret is a nasal product

Tafasitamab-cxix (Monjuvi) (CP.PHAR.508)

Medicaid

Policy update includes:

·         For additional National Comprehensive Cancer Network (NCCN) recommended uses (off-label) criteria, removed follicular lymphoma (grade 1-2) as not currently supported by National Comprehensive Cancer Network (NCCN) compendium

·         For Appendix B, updated first-line therapy options for B-cell lymphoma subtypes

Avacincaptad pegol (Izervay) (CP.PHAR.641)

Medicaid

Policy update includes:

·         Clarified that diagnostic characteristics must be confirmed on fundus autofluorescence imaging per health plan request in alignment with Syfovre geographic atrophy criteria and per pivotal study design

·         Added exclusions for geographic atrophy that is secondary to a condition other than AMD and for combination use with other intravitreal complement inhibitor therapies per competitor analysis

Rozanolixizumab-noli (Rystiggo) (CP.PHAR.648)

Medicaid

Policy update includes:

·         Added new 420 mg/3 ml, 560 mg/4 ml, and 840/6 ml volume formulations and updated all quantity limits to 1 vial

·         Added Bkemv, Epysqli, and Zilbrysq to the list of therapies that Rystiggo should not be prescribed concurrently with

Talquetamab-tgvs (Talvey) (CP.PHAR.649)

Medicaid

Policy update includes:

·         Added International Myeloma Working Group (IMWG) criterion defining progressive multiple myeloma disease as multiple myeloma class alignment

Bimekizumab-bkzx (Bimzelx) (CP.PHAR.660)

Medicaid

Policy updates include:

·         Added criteria for newly approved indications for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis

·         For plaque psoriasis and continued therapy section, added criteria “member does not have combination use with biological disease-modifying antirheumatic drugs or janus kinase inhibitors”

·         Added new strength [320 mg/2 ml] for single-dose prefilled syringe and single-dose prefilled autoinjector

Nemolizumab-ito (Nemluvio) (CP.PHAR.703)

Medicaid

Policy includes:

·         Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy MS.PMN.53 for Medicaid

·         Initial Approval Criteria: Prurigo Nodularis (PN) (must meet all):

o   Diagnosis of PN with documentation of both of the following:

§  Numeric rating scale ≥ 7 on a scale of 0 (“no itch”) to 10 (“worst imaginable itch”) (e.g., Peak Pruritus Numeric Rating Scale, Worst Itch-Numeric Rating Scale);

§  ≥ 20 nodular lesions total on both legs, and/or both arms and/or trunk;

o   Prescribed by or in consultation with a dermatologist;

o   Age ≥ 18 years;

•  
  • Failure of a ≥ 2-week course of a medium to very high potency topical corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Nemluvio is not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent®) or JAK inhibitor (e.g., Olumiant®, Rinvoq®, Cinbinqo®, Opzelura®);

o   Dose does not exceed one of the following:

§  Weight < 90 kg: 60 mg once, followed by 30 mg every 4 weeks;

§  Weight ≥ 90 kg: 60 mg once, followed by 60 mg every 4 weeks.

o   Approval duration: 6 months

·         Continued Therapy: Prurigo Nodularis (must meet all):

o   Member meets one of the following:

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

§  Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;

o   Member is responding positively to therapy (examples may include but are not limited to: improvement in itching or skin pain, reduction in number of nodules);

•  
  • Nemluvio is not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent) or JAK inhibitor (e.g., Olumiant, Rinvoq, Cinbinqo, Opzelura);

o   If request is for a dose increase, new dose does not exceed one of the following:

§  Weight < 90 kg: 30 mg every 4 weeks;

§  Weight ≥ 90 kg: 60 mg every 4 weeks.

o   Approval duration: 12 months

Mepolizumab (Nucala)  (CP.PHAR.200)

Medicaid

Policy updates include:

·         For eosinophilic granulomatosis with polyangiitis: revised eosinophilia requirement from “blood eosinophil count at least 150 cells/mcL” to “eosinophils > 1 x 109/L and/or > 10% of leukocytes” in alignment with pivotal study design and American College of Rheumatology (ACR) eosinophilic granulomatosis with polyangiitis classification criteria and management guidelines

·         Replaced requirements for asthma and 2 additional characteristics of eosinophilic granulomatosis with polyangiitis with requirement for active, non-severe disease

·         Removed requirements for refractory or relapsed disease

Certolizumab (Cimzia)  (CP.PHAR.247)

Medicaid

Policy updates include:

·         Added criteria for newly approved indication for polyarticular juvenile idiopathic arthritis

·         Added Appendix H with 10-joint clinical juvenile

·         arthritis disease activity score (cJADAS-10) scores

Ustekinumab (Stelara and biosimilars)  (CP.PHAR.264)

Medicaid

Policy updates include:

·         Added newly approved biosimilar Otulfi to criteria

Guselkumab (Tremfya)  (CP.PHAR.364)

Medicaid

Policy updates include:

·         Added criteria for newly approved indication for ulcerative colitis

·         Added appendix E with Mayo Score supplemental information

·         Added new subcutaneous formulations [single-dose prefilled syringe 200 mg/2 ml

·         Single-dose prefilled pen (Tremfya Pen) 200 mg/2 ml] and intravenous formulation [single-dose vial 200 mg/20 ml]

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

Medicaid

Policy updates include:

·         For acromegaly, revised initial criteria from “(growth hormone [GH]) level ≥ 1 µg/ml” to “(growth hormone  [GH]) level ≥ 1 µg/L” per Pituitary Society (PS) and Endocrine society (ES) practice guidelines and ACG

·         For neuroendocrine tumors, added to initial criteria “diagnosis of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia” and revised “bronchopulmonary neuroendocrine tumor” to “lung neuroendocrine tumor” per National Comprehensive Cancer Network (NCCN) compendium and guideline

·         Updated Appendix D “National Comprehensive Cancer Network (NCCN) guidelines - Neuroendocrine and Adrenal Tumors” supplemental information

·         For unbranded lanreotide, added newly approved carcinoid syndrome indication to FDA Approved Indication(s) section

Nivolumab (Opdivo) (CP.PHAR.121)

Medicaid

Policy updates include:

·         Added new Food and Drug Administration (FDA)-approved indication for neoadjuvant treatment followed by single-agent Opdivo as adjuvant treatment after surgery for non-small cell lung cancer

·         Increased maximum duration allowed for neoadjuvant therapy from 3 cycles/9 weeks to 4 cycles/12 weeks

·         For continued therapy: added criterion for maximum duration of therapy limit of 13 cycles for adjuvant non-small cell lung cancer, up to 1 year for all other adjuvant treatment, and up to 2 years for metastatic or recurrent non-small cell lung cancer, malignant pleural mesothelioma, advanced renal cell carcinoma in combination with cabozatinib, unresectable or metastatic urothelial carcinoma, esophageal squamous cell carcinoma, gastric cancer, esophagogastric junction, and esophageal adenocarcinoma

·         Revised dose limit for non-small cell lung cancer in combination with Yervoy to 360 mg every 3 weeks

·         Added additional dose limit option of 240 mg every 2 weeks for gastric cancer, esophagogastric junction cancer, and esophageal adenocarcinoma