Effective November 15, 2024 Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Nogapendekin alfa inbakicept-pmln (Anktiva) (CP.PHAR.684)

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: Non-muscle Invasive Bladder Cancer (must meet all):

o    Diagnosis of NIMBC characterized as one of the following:

§  carcinoma in situ (CIS) only;

§  Ta/T1 high-grade disease with concomitant CIS;

o    Prescribed by or in consultation with an oncologist;

o    Age ≥ 18 years;

o    Member is refractory to Bacillus Calmette-Guérin (BCG) treatment;

o    Anktiva is prescribed in combination with BCG;

o    Request meets one of the following:

o    Dose does not exceed 400 mcg (1 vial) administered per week for up to 12 doses;

o    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 6 months (up to 12 doses)

·         Continued Therapy: Non-muscle Invasive Bladder Cancer must meet all):

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

o    Member is responding positively to therapy as evidenced by lack of disease recurrence or progression;

o    Total treatment duration does not exceed 37 months;

o    If request is for a dose increase, request meets one of the following:

o    New dose does not exceed 400 mcg (1 vial) per week for up to 24 doses;

o    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 12 months (up to 24 doses)

Tarlatamab-dlle (Imdelltra) (CP.PHAR.685)

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: Small Cell Lung Cancer (must meet all):

o    Diagnosis of extensive stage small cell lung cancer (ES-SCLC);

o    Prescribed by or in consultation with an oncologist;

o    Age ≥ 18 years;

o    Disease has progressed on or after receiving platinum based therapy;

o    Request meets one of the following:

§  Dose does not exceed:

·         Cycle 1, step-up dose: 1 mg on Day 1, and 10 mg on Day 8 and Day 15;

·         Cycle 2 and beyond: 10 mg on Day 1 and Day 15 of each cycle;

§  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 6 months

·         Continued Therapy: Small Cell Lung Cancer (must meet all):

o    Currently receiving medication via Centene benefit, or documentation supports that

o    member is currently receiving Imdelltra for a covered indication and has received this

o    medication for at least 30 days;

o    Member is responding positively to therapy;

o    If request is for a dose increase, request meets one of the following:*

§  New dose does not exceed 10 mg on Days 1 and 15 of each cycle;

§  New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 12 months

Tislelizumab-jsgr (Tevimbra) (CP.PHAR.686)

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: Esophageal Cancer (must meet all):

o    Diagnosis of unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell

o    Carcinoma (ESCC);

o    Prescribed by or in consultation with an oncologist;

o    Age ≥18 years;

o    For ESCC, both of the following:

§  Member has had previous treatment with a fluoropyrimidine-based (e.g., 5-fluorouracil, capecitabine) and platinum-based (e.g., carboplatin, cisplatin, oxaliplatin) chemotherapy;

§  Prior systemic chemotherapy did NOT include a PD-1 or PD-(L)1 inhibitor (e.g.,nivolumab, ipilimumab, pembrolizumab);

o    Tevimbra is used as a single-agent;

o    Request meets one of the following:

o    Dose does not exceed 200 mg IV every 3 weeks;

o    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 6 months

·         Continued Therapy Esophageal cancer (must meet all):

·         Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tevimbra 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:

o    New dose does not exceed 200 mg IV every 3 weeks;

o    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

·         Approval duration: 12 months

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

Medicaid

Policy updates include:

·         Per National Comprehensive Cancer Network (NCCN) Compendium for systemic light chain amyloidosis added off-label use as a single agent for newly diagnosed disease if member has significant neuropathy or has Mayo stage IIIb disease

·         Added off-label use for T-cell acute lymphoblastic leukemia

·         For multiple myeloma as subsequent therapy added combination use with dexamethasone and Venclexta

·         For multiple myeloma maintenance therapy added combination use with lenalidomide

Lutetium Lu 177 Dotatate (Lutathera) (CP.PHAR.384)

Medicaid

Policy updates include:

·         Updated neuroendocrine tumor criteria to reflect newly approved pediatric expansion

Atidarsagene autotemcel (Lenmeldy) (CP.PHAR.602)

Medicaid

Policy updates include:

·         Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified diagnostic criteria to only require 24-hour urine collection if novel alleles are identified, added coverage for children between 7 to 17 years of age as long as onset of symptoms began before age 7, revised metachromatic leukodystrophy forms to align with terminology used in the package insert, clarified that walking independently means without support and modified intelligence quotient (IQ) requirement from 70 to 85, updated dosing to include minimum and maximum recommendations

·         Added physician specialized in bone marrow transplantation as a prescriber option per specialist feedback

·         Added allowance for prior receipt of allogeneic hematopoietic stem cell transplant in alignment with study protocol

Anakinra (Kineret) (CP.PHAR.244)

Medicaid

Policy updates include:

·         For Rheumatoid arthritis, added Simlandi to listed examples of preferred adalimumab products

·         For Rheumatoid arthritis, added unbranded adalimumab-aaty to listed examples of preferred adalimumab products

Ustekinumab (Stelara, Wezlana, Selarsdi) (CP.PHAR.264)

Medicaid

Policy updates include:

·         Added Simlandi to listed examples of preferred adalimumab products

·         Added newly approved biosimilar Pyzchiva to criteria

·         Added unbranded adalimumab-aaty to listed examples of preferred adalimumab products

Eculizumab (Soliris), Eculizumab-aeeb (Bkemv)  (CP.PHAR.97)

Medicaid

Policy updates include:

·         Added newly approved biosimilar, Bkemv

·         Updated the list of therapies that Soliris/Bkemv should not be prescribed concurrently with to include Rystiggo, Vyvgart Hytrulo, and Zilbrysq for generalized myasthenia gravis, Fabhalta for paroxysmal nocturnal hemoglobinuria, and Ultomiris for neuromyelitis optica spectrum disorder

·         Revised contraindications in Appendix C per updated Soliris prescribing information

·         Added newly approved biosimilar, Epysqli

Pegfilgrastim (Neulasta and biosimilars) (CP.PHAR.296)

Medicaid

Policy updates include:

·         For bone marrow transplantation consolidated required drug redirections into a single sub-bullet for added clarity

·         For all indications, removed redirection to Zarxio and Ziextenzo, added redirection to Nyvepria to co-prefer Udenyca and Nyvepria.

Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko) (CP.PHAR.297)

Medicaid

Policy updates include:

·         Per National Comprehensive Cancer Network (NCCN) Compendium for MDS added requirement that member previously has no response to either an erythropoiesis-stimulating agent (e.g., epoetin alfa, darbepoetin) or Reblozyl

·         For bone marrow transplantation removed subcutaneous route of administration per prescribing information

·         To confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)

·         Added Nypozi to policy

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

Medicaid

Policy updates include:

·         Per National Comprehensive Cancer Network (NCCN) – for classical Hodgkin lymphoma, added pathway for use as a component of BrECADD for stage III-IV disease for members aged 18-61 years

·         For T-cell lymphomas, removed requirement for 2 prior therapies for hepatosplenic T-cell lymphoma and added pathway for combination use with bendamustine for peripheral T-cell lymphoma, breast implant-associated anaplastic large cell lymphoma, and hepatosplenic T-cell lymphoma

·         For mycosis fungoides and Sezary syndrome, added that Adcetris must be prescribed as a single agent, in combination with skin-directed therapy, or in combination with bendamustine

·         For B-cell lymphomas, removed T-cell type monomorphic post-transplant lymphoproliferative disorder (PTLD)

Plerixafor (Mozobil) (CP.PHAR.323)

Medicaid

Policy updates include:

·         To confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)

Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)

Medicaid

Policy updates include:

·         For paroxysmal nocturnal hemoglobinuria, added Fabhalta, Voydeya, and Bkemv to the list of therapies that Empaveli should not be prescribed concurrently with

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

·         Revised Empaveli contraindications in Appendix C per updated prescribing information

Betibeglogene Autotemcel (Zynteglo) (CP.PHAR.545)

Medicaid

Policy updates include:

·         Revised lower age limit to age ≥ 4 years and removed accompanying age < 5 criteria

·         Removed age qualifier of ≥ 12 years for receipt of ≥ 8 transfusions of packed red blood cells per year

·         Added clarification for time component and documentation within the last 6 months for negative human immunodeficiency virus (HIV) test

·         Approval duration extended from 3 months to 6 months to allow for member preparation and adequate time for gene therapy manufacture

·         Added clarification of a one-time dose only for continued authorization

·         Corrected template language for continued therapy

Fidanacogene Elaparvovec-dzkt (Beqvez) (CP.PHAR.643)

Medicaid

Policy updates include:

·         Drug is now Food and Drug Administration (FDA) approved – criteria updated per Food and Drug Administration (FDA) labeling: clarified documentation of negative test for neutralizing antibodies to AAVRh74var

·         Added medical director review

·         Removed criterion for subsequent negative factor IX inhibitor test if member has an initial positive test result

·         Added criteria for documentation of HIV test with minimum CD4+ cell count or maximum viral load for positive HIV test

·         Added criterion that member does not have current liver-related conditions

·         Added criterion for hepatologist attestation of Beqvez eligibility if sustained liver enzymes or radiological liver abnormalities present

·         Added criterion for documentation of member’s body weight to allow verification of weight based dose

·         Added information in Appendix E on dose calculation for weight based doses

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

Medicaid

Policy updates include:

·         Updated the list of therapies that Ultomiris should not be prescribed concurrently with to include Bkemv for all indications, Fabhalta for paroxysmal nocturnal hemoglobinuria, and Rystiggo, Vyvgart Hytrulo, and Zilbrysq for generalized myasthenia gravis

Infliximab (Avsola, Inflectra, Remicade, Renflexis, Zymfentra) (CP.PHAR.254)

Medicaid

Policy updates include:

·         Modified Remicade redirection by adding if member has failed Avsola, Inflectra, and Renflexis, member must use unbranded Remicade

·         For unbranded Remicade, added redirection to Avsola, Inflectra, and Renflexis

·         For Crohn’s disease and ulcerative colitis, added additional requirement for Zymfentra requests requiring provider attestation that “member is unable to receive continued therapy with intravenous infliximab due to lack of caregiver or support system for assistance with administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility.”

Blinatumomab (Blincyto) (CP.PHAR.312)

Medicaid

Policy updates include:

·         Specified that infant acute lymphoblastic leukemia must have KMT2A status (11q23 rearranged) and added pathway for use as frontline consolidation therapy per National Comprehensive Cancer Network (NCCN)

·         Revised boxed warning in Appendix C per updated prescribing information

·         Added new Food and Drug Administration (FDA) approved indication for Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (B-ALL) as consolidation therapy and added age restriction of at least 1 month per updated prescribing information

·         Rearranged criteria into Philadelphia chromosome-positive (Ph+) vs Ph- disease, added pathway for use as induction therapy for Ph+ disease, removed requirement that relapsed or refractory Ph+ disease must be refractory to tyrosine kinase inhibitor (TKI), added pathway for use as maintenance therapy for Ph- disease, added pathway for use after consolidation therapy and for Ph-like disease for pediatric members, and specified how Blincyto should be prescribed for all uses per National Comprehensive Cancer Network (NCCN)

Pembrolizumab (Keytruda) (CP.PHAR.322)

Medicaid

Policy updates include:

·         For classical Hodgkin lymphoma, added option to be prescribed with ICE and added pathway for palliative therapy (previously had after hematopoietic stem cell transplant, which falls under palliative therapy) per National Comprehensive Cancer Network (NCCN)

·         For urothelial carcinoma, added pathway to be prescribed as single agent and member has previously received other chemotherapy (previously only allowed post-platinum chemotherapy)

·         For hepatocellular carcinoma, removed disease is classified as Child-Pugh Class A

·         For biliary tract cancer, added option for resected gross residual (R2) disease and removed combination with Lenvima per National Comprehensive Cancer Network (NCCN)

·         For endometrial carcinoma, clarified continued as a single agent for maintenance therapy when prescribed in combination with carboplatin and paclitaxel

·         For National Comprehensive Cancer Network (NCCN) recommended uses (off-label): expanded to stage IB for mycosis fungoides, for prescribed as first-line or subsequent therapy - added metastatic anaplastic carcinoma, anaplastic sarcoma, and vaginal cancer, for prescribed as single-agent subsequent therapy – added soft tissue sarcoma subtypes, added option for Keytruda to be prescribed in combination with cyclophosphamide and bevacizumab for platinum-resistant persistent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer per National Comprehensive Cancer Network (NCCN)

·         For continuation requests, added criterion for maximum duration of therapy (previously was included within requests for dose increase criterion)

·         Updated appendix E

·         Added new Food and Drug Administration (FDA) approved indication for endometrial cancer in combination with carboplatin and paclitaxel followed by Keytruda as a single agent

Imetelstat (Rytelo) (CP.PHAR.690)

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: Myelodysplastic Syndromes (MDS) (must meet all):

o    Diagnosis of MDS with transfusion-dependent anemia;

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

o    Age ≥ 18 years;

o    Member has low risk or intermediate-1 risk MDS disease as classified by International Prognostic Scoring System (IPSS);

o    Documentation of at least 4 red blood cell (RBC) units transfused over 8 weeks;

o    Member does not have del(5q) cytogenetic abnormality;

o    Member meets one of the following :

§  Inadequate response to or ineligible for ESA therapy;

§  One of the following:

·         Failure of Retacrit™, unless contraindicated or clinically significant adverse effects are experienced;

·         *Prior authorization may be required for Retacrit

·         If Retacrit is unavailable due to shortage, member must use Epogen®, unless contraindicated or clinically significant adverse effects are experienced;

·         *Prior authorization may be required for Epogen

o    Rytelo is not prescribed concurrently with Reblozyl®;

o    Request meets one of the following :*

§  Dose does not exceed 7.1 mg/kg every 4 weeks;

§  Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 6 months

·         Continued Therapy: Myelodysplastic Syndromes (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 as evidence by decrease of red blood cell (RBC) transfusions requirement;

o    Rytelo is not prescribed concurrently with Reblozyl;

o    If request is for a dose increase, request meets one of the following :

o    Dose does not exceed 7.1 mg/kg every 4 weeks;

o    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)

o    Approval duration: 6 months

Sarilumab (Kevzara) (CP.PHAR.346)

Medicaid

Policy update includes:

·         For rheumatoid arthritis, added Simlandi to listed examples of preferred adalimumab products.

·         Added newly approved polyarticular juvenile idiopathic arthritis indication

·         For rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, added unbranded adalimumab-aaty to listed examples of preferred adalimumab products

Immune Globulins (CP.PHAR.103)

Medicaid

Policy Updates include:

·         Added Yimmugo to policy

Afilbercept (Eylea, Eylea HD, Opuviz, Yesafili, Ahzantive) (CP.PHAR.184)

Medicaid

Policy Updates include:

·         Added Eylea biosimilars Opuviz, Yesafili, and Ahzantive

·         Separated macular edema following retinal vein occlusion into new section with specification that request is for Eylea, Opuviz, Yesafili, or Ahzantive

Durvalumab (Imfinzi) (CP.PHAR.339)

Medicaid

Policy Updates include:

·         Added criteria for newly Food and Drug Administration (FDA)-approved indication of mismatch repair deficient (dMMR) endometrial cancer

Tesamorelin (Egrifta SV) (CP.PHAR.109)

Medicaid

Policy updates include:

·         Revised clinical indicators for abdominal lipodystrophy criteria to require waist circumference and waist-hip ratio thresholds that reflect efficacy studies

·         Revised Food and Drug Administration (FDA) Approved Indications and contraindications, removed criteria allowing pediatric use in members with closed epiphyses

Mecasermin (Increlex) (CP.PHAR.150)

Medicaid

Policy updates include:

·         Revised verbiage that Increlex is not prescribed concurrently with growth hormone (previously only Somatropin was included)

Risperidone Long-Acting Injection (Perseris, Risperdal Consta, Rykindo, Uzedy) (CP.PHAR.293)

Medicaid

Policy updates include:

·         Added generic redirection to brand Risperdal Consta requests

·         Revised approval duration for whichever is longer

·         Added HCPCs code [J3590, C9399] for Risvan

Sargramostim (Leukine) (CP.PHAR.295)

Medicaid

Policy updates include:

·         Per National Comprehensive Cancer Network (NCCN) Compendium for high-risk neuroblastoma added additional supported combination therapies

·         Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in the treatment of chemotherapy-induced febrile neutropenia

·         Revised dosing requirements to allow guideline or National Comprehensive Cancer Network (NCCN) supported off-label dosing

·         For acute radiation syndrome to confirm weight-based dosing added requirement for documentation of member’s current weight (in kg)

Burosumab-twza (Crysvita) (CP.PHAR.11)

Medicaid

Policy updates include:

·         For all indications, added requirement to Continued Therapy section that Crysvita not be used concomitantly with oral phosphate or vitamin D replacement therapy

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

Medicaid

Policy updates include:

·         Updated definition of significant fibrosis from stage 3-4 to stage 2-4 per 2024 World Health Organization (WHO) chronic hepatitis B guidelines

Aztreonam (Cayston) (CP.PHAR.209)

Medicaid

Policy updates include:

·         For initial criteria, added Kitabis Pak to list of preferred tobramycin inhalation agents

Polatuzumab Vedotin-piiq (Polivy) (CP.PHAR.433)

Medicaid

Policy updates include:

·         Consolidated Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) recommended uses into one criteria set under the umbrella diagnosis of B-cell lymphoma

·         For first-line use, added stage modified International Prognostic Index (IPI) score as an alternate pathway per National Comprehensive Cancer Network (NCCN)

·         Allowed first-line use in histologic transformation of indolent lymphoma to diffuse large B-cell lymphoma per National Comprehensive Cancer Network (NCCN)

·         Removed follicular lymphoma as a coverable off-label use as it is no longer supported by National Comprehensive Cancer Network (NCCN)

Talimogene laherepvec (Imlygic) (CP.PHAR.542)

Medicaid

Policy updates include:

·         Added criteria for metastatic melanoma and off label criteria for combination use with Yervoy per National Comprehensive Cancer Network (NCCN) compendium

·         In continued therapy, clarified criteria to require documentation of the type, quantity, and size of new or remaining lesions

Ferumoxytol (Feraheme) (CP.PHAR.165)

Medicaid

Policy Updates include:

·         Added criteria for National Comprehensive Cancer Network (NCCN)-supported indication of cancer- and chemotherapy-induced anemia with redirection to preferred iron products

Crovalimab (PiaSky) (CP.PHAR.664)

Medicaid

Policy updates include:

·         Drug is now FDA approved - criteria updated per FDA labeling: modified criteria to require age ≥ 13 years and body weight ≥ 40 kg, added documentation of member’s current body weight, added criterion that members switching therapy from another C5 must administer dose at the time of next scheduled C5 inhibitor dose, clarified dose maximum to include only SC maintenance doses in the continued therapy section; references reviewed and updated.

Deferoxamine (Desferal) (CP.PHAR.146)

Medicaid

Policy updates include:

·         Clarified policy is medically necessary for all deferoxamine products not only Desferal; references reviewed and updated.

Apomorphine (Apokyn) (CP.PHAR.488)

Medicaid

Policy updates include:

·         Removed Kynmobi formulation from policy due to market withdrawal by manufacturer due to low utilization.