Policy
| Applicable Products
| New Policy Overview or Updated Policy Revisions
|
Pirfenidone (Esbriet) (CP.PHAR.286)
| Ambetter
| Policy updates include:
- For other indications/diagnoses, revised generic redirection to allow either tablet or capsule by removing specific formulations
|
Aripiprazole Long-Acting Injections (Abilify Maintena, Abilify Asimtufii, Aristada, Aristada Initio) (CP.PHAR.290)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Abilify Maintena added criterion option for 800 mg once-time dose followed by 400 mg per month for new dosing regimen for 1-day initiation regimen
- Updated Section V for Abilify Maintena and Abilify Asimtufii
|
Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-pbbk (Fylnetra), Pegfilgrastim-apgf (Nyvepria), Eflapegrastim-xnst (Rolvedon), Efbemalenograstim alfa-vuxw (Ryzneuta), Pegfilgrastim-fpgk (Stimufend), Pegfilgrastim-cbqv (Udenyca, Udenyca Autoinjector, Udenyca Onbody), Pegfilgrastim-bmez (Ziextenzo) (CP.PHAR.296)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added Fylnetra to indication for acute exposure to myelosuppressive doses of radiation per updated prescribing information
|
Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko), Filgrastim-txid (Nypozi) (CP.PHAR.297)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Per updated prescribing information, added Releuko to indications for mobilizing autologous hematopoietic progenitor cells for collection by leukapheresis and to increase survival in patients acutely exposed to myelosuppressive doses of radiation
|
Daratumumab (Darzalex), Daratumumab/Hyaluronidase-fihj (Darzalex Faspro) (CP.PHAR.310)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For systemic light chain amyloidosis added National Comprehensive Cancer Network (NCCN) Compendium supported use in combination with lenalidomide and dexamethasone
- For multiple myeloma added National Comprehensive Cancer Network (NCCN) Compendium supported use as subsequent therapy in combination with carfilzomib, pomalidomide, and dexamethasone
|
Abaloparatide (Tymlos) (CP.PHAR.345)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Revised initial approval duration to 12 months for Medicaid/Ambetter
|
Mechlorethamine Gel (Valchlor) (CP.PHAR.381)
| Ambetter
| Policy updates include:
- For National Comprehensive Cancer Network (NCCN) recommended uses (off-label), removed “failure of at least one skin-directed therapy” as National Comprehensive Cancer Network (NCCN) compendium allows for primary treatment
- For Appendix B, added UVA1 as phototherapy option per National Comprehensive Cancer Network (NCCN) guideline
|
Lutetium Lu 177 Dotatate (Lutathera) (CP.PHAR.384)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added option for first-line use in gastrointestinal or pancreas neuroendocrine tumor with Ki-67 at least 10% and clinically significant tumor burden per National Comprehensive Cancer Network (NCCN)
|
Corticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq) (CP.PHAR.385)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For allergic conjunctivitis, added bypass of redirection for members unable to manage regular eye drop use
- For macular edema following retinal vein occlusion and diabetic macular edema clarified failure of a single intravitreal anti- vascular endothelial growth factor (VEGF) agent
- For non-infectious uveitis, added examples of trial and failure agents and clarified non-biologic “systemic” immunosuppressive therapy
- For Dextenza, removed age requirement for ocular inflammation per Food and Drug Administration (FDA) pediatric expansion and updated age requirement for allergic conjunctivitis from at least 18 years to at least 2 years per Food and Drug Administration (FDA) pediatric expansion
- In Appendix B, consolidated non-biologic systemic immunosuppressive therapies
- Updated HCPCS code description for Xipere
- In Section V, updated Ozurdex and Iluvien indications and updated Ozurdex maximum dose from every 6 months to every 3 months
|
Erdafitinib (Balversa) (CP.PHAR.423)
| Ambetter
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) Compendium, added off-label indications of pancreatic adenocarcinoma, cholangiocarcinoma, and non-small cell lung cancer
|
Osilodrostat (Isturisa) (CP.PHAR.487)
| Ambetter
| Policy updates include:
- Revised Food and Drug Administration (FDA) Approved Indication(s) to reflect expanded approval in Cushing’s syndrome (previously only Cushing’s disease) and modified criteria to reflect updated labeling language
- Removed 10 mg tablet strength as it is no longer on market
|
Capmatinib (Tabrecta) (CP.PHAR.494)
| Ambetter
| Policy updates include:
- For initial criteria: added option for “used as a single-agent for brain metastases” per National Comprehensive Cancer Network (NCCN)
- Updated epidermal growth factor receptor mutant with high-level mesenchymal-epithelial transition amplifications criteria from “Tabrecta is used with Tagrisso” to “Tabrecta can be administered with continuation of Tagrisso” per National Comprehensive Cancer Network (NCCN) guideline
|
Talimogene laherepvec (Imlygic) (CP.PHAR.542)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added off-label criteria for Merkel cell carcinoma per National Comprehensive Cancer Network (NCCN)
|
Amivantamab-vmjw (Rybrevant) (CP.PHAR.544)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For initial criteria, removed “for disease that is positive for epidermal growth factor receptor mutation in exon 18 (G719X), exon 20 (S768I), or exon 21 (L861Q): Presence of symptomatic systemic disease with multiple lesions” as not supported in National Comprehensive Cancer Network (NCCN) compendium and guideline update
|
Epcoritamab-bysp (Epkinly) (CP.PHAR.634)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Per National Comprehensive Cancer Network (NCCN) Compendium – added use in second-line and subsequent therapy in combination with gemcitabine and oxaliplatin
- Removed specific criteria requirements for histologic transformation of indolent lymphoma to diffuse large B-cell lymphoma
- Added Appendix D to specify diffuse large B-cell lymphoma subtypes per National Comprehensive Cancer Network (NCCN)
|
Glofitamab-gxbm (Columvi) (CP.PHAR.636)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in human immunodeficiency virus-related B-cell lymphomas, and post-transplant lymphoproliferative disorders
- Added option for use as second-line therapy in combination with GemOx (gemcitabine, oxaliplatin)
|
Tislelizumab-jsgr (Tevimbra) (CP.PHAR.687)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For hepatocellular carcinoma, clarified criterion as first-line systemic therapy and added option to be prescribed as subsequent-line systemic therapy
- Updated Appendix B
|
Avutometinib, Defactinib (Avmapki Fakzynja Co-Pack) (CP.PHAR.731)
| Ambetter
| Policy includes:
- Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria: Ovarian Cancer (must meet all):
- Diagnosis of low-grade serous ovarian cancer (LGSOC);
- Prescribed by or in consultation with an oncologist;
- Age at least 18 years;
- Disease is recurrent;
- Disease is positive for KRAS mutation;
- Avmapki Fakzynja Copack is not prescribed concurrently with any other agents for LGSOC;
- Member has received prior systemic therapy;
- For Avmapki Fakzynja Co-Pack requests, member must use avutometinib and defactinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following:
- Dose does not exceed the following for the first 3 weeks of every 4-week cycle:
- Avmapki: 6.4 mg (8 capsules) per week;
- Fakzynja: 400 mg (2 tablets) per day; 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: 6 months
- Continued Therapy Ovarian Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Avmapki Fakzynja Co-Pack for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- Avmapki Fakzynja Copack is not prescribed concurrently with any other agents for LGSOC;
- For Avmapki Fakzynja Co-Pack requests, member must use avutometinib and defactinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- If request is for a dose increase, request meets one of the following:
- New dose does not exceed the following for the first 3 weeks of every 4-week cycle:
- Avmapki: 6.4 mg (8 capsules) per week;
- Fakzynja: 400 mg (2 tablets) per day;
- 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)
- 6. Approval duration: 12 months
|
Penpulimab-kcqx (CP.PHAR.732)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
- Initial Approval Criteria: Non-Keratinizing Nasopharyngeal Carcinoma (NPC) (must meet all):
- Diagnosis of non-keratinizing NPC;
- Prescribed by or in consultation with an oncologist;
- Age at least 18 years;
- Disease is recurrent or metastatic;
- Penpulimab-kcqx is prescribed in one of the following ways:
- In combination with cisplatin or carboplatin and gemcitabine;
- As a single agent for disease that has progressed on or after both of the following:
- Platinum-containing chemotherapy;
- At least one other prior line of therapy;
- Member has not received prior treatment with an anti-PD-(L)1 antibody;
- Request meets one of the following:
- In combination with cisplatin or carboplatin and gemcitabine: Dose does not exceed 200 mg every three weeks;
- As a single agent: Dose does not exceed 200 mg every two 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).
- Approval duration: 6 months
- Continued Therapy: Non-Keratinizing Nasopharyngeal Carcinoma (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving penpulimab-kcqx 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:
- In combination with cisplatin or carboplatin and gemcitabine: New dose does not exceed 200 mg every three weeks for up to total maximum of 24 months;
- As a single agent: New dose does not exceed 200 mg every two weeks for up to total maximum of 24 months;
- 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
|
Telisotuzumab Vedotin-tllv (Emrelis) (CP.PHAR.733)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
- Initial Approval Criteria: Non-Small Cell Lung Cancer (NSCLC)(must meet all):
- Diagnosis of NSCLC;
- Disease is recurrent, locally advanced, or metastatic;
- Disease has all of the following characteristics:
- Non-squamous;
- High c-Met/MET protein overexpression, defined as at least 50% of tumor cells;
- Strong (3+) immunohistochemistry staining (IHC 3+);
- Epidermal growth factor receptor (EGFR) wild-type;
- Prescribed by or in consultation with an oncologist;
- Age at least 18 years;
- Member has received prior systemic therapy for NSCLC;
- Request is for single agent therapy;
- Request meets one of the following:
- Dose does not exceed 1.9 mg/kg, up to a maximum of 190 mg, every 2 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)
- Approval duration: 6 months
- Continued Therapy: Non-Small Cell Lung Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Emrelis 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 1.9 mg/kg, up to a maximum of 190 mg, every 2 weeks;
- 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
|
Acoltremon (Tryptyr) (CP.PHAR.739)
| Ambetter
| Policy includes:
- Requests for indications not approved by the Food and Drug Administration (FDA) are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
- Initial Approval Criteria: Dry Eye Disease (DED) (must meet all):
- Diagnosis of DED;
- Age at least 18 years;
- Failure of an artificial tears, unless clinically significant adverse effects are experienced or all are contraindicated;
- Failure of at least one ophthalmic anti-inflammatory agent at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
- Failure of generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis®), unless contraindicated or clinically significant adverse effects are experienced;
- Request does not exceed 60 vials (1 carton) per 30 days.
- Approval duration: 12 months
- Continued Therapy: Dry Eye Disease (must meet all):
- 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;
- If request is for a dose increase, request does not exceed 60 vials (1 carton) per 30 days.
- Approval duration: 12 months
|
Vorinostat (Zolinza) (CP.PHAR.83)
| Ambetter
| Policy updates include:
- Added off-label criteria for use in Hodgkin lymphoma per National Comprehensive Cancer Network (NCCN)
|
Progesterone (Crinone, Endometrin) (CP.PMN.243)
| Ambetter
| Policy updates include:
- For prevention of preterm birth, removed criterion regarding concurrent usage with Makena due to product discontinuation
- Evidence of coverage for infertility/fertility preservation language added for Ambetter line of business (AZ, DE, GA, IN, KS, KY, MI, MO, NE, NY, NH, OH, OK, PA, SC, TN, TX)
|
Mavacamten (Camzyos) (CP.PMN.272)
| Ambetter
| Policy updates include:
- Per labeling updates, revised Appendix C (removed contraindication with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors) and Section V (for maintenance dosing, revised frequency of required echo monitoring from once every 12 weeks to every 6 months for left ventricular ejection fraction (LVEF) at least 55% and a Valsalva left ventricular outflow tract (LVOT) gradient less than 30 mmhg)
|
Roflumilast (Daliresp, Zoryve) (CP.PMN.46)
| Ambetter
| Policy updates include:
- Added newly Food and Drug Administration (FDA)-approved indication of plaque psoriasis for Zoryve foam
- Removed econazole, luliconazole, oxiconazole, and sulconazole from Appendix B as there is insufficient evidence for the use of these agents in seborrheic dermatitis
|
Tedizolid (Sivextro) (CP.PMN.62)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added pediatric extension to include use in members at least 26 weeks gestational age and weight at least 1 kg
- Updated to include pediatric specific weight-based dosing
|
Galcanezumab-gnlm (Emgality) (HIM.PA.SP67)
| Ambetter
| Policy updates include:
- For episodic cluster headaches, changed approval duration from 3 months to 12 months for initial approval criteria and continued therapy, removed the following verbiage from continued therapy approval duration: “up to a total of 12 months per cluster period”
|
Nitisinone (Orfadin, Nityr, Harliku) (CP.PHAR.132)
| Ambetter
| Policy updates include:
- Added Harliku to criteria along with new criteria set for alkaptonuria.
|
Emapalumab-lzsg (Gamifant) (CP.PHAR.402)
| Ambetter
| Policy updates include:
- Added new indication for hemophagocytic lymphohistiocytosis / macrophage activation syndrome per updated prescribing information.
|
Clesrovimab-cfor (Enflonsia) (CP.PHAR.740)
| Ambetter
| Policy include:
- 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
- Preterm, Late Preterm or Term Infant (must meet all):
- Age at onset of respiratory syncytial virus (RSV) season at most 12 months;
- Request is for RSV prophylaxis;
- Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
-
- Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
- If member previously received Synagis® for the current RSV season, less than 5 Synagis doses were administered;* *Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.
- Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
- Dose does not exceed a 105 mg single dose.
- Approval duration: 4 weeks (1 dose per lifetime)
- Chronic Lung Disease of Prematurity (must meet all):
- Diagnosis of chronic lung disease (CLD) of prematurity (i.e., bronchopulmonary dysplasia [BPD]) defined as both of the following:
- Gestational age less than 32 weeks;
- Requirement for greater than 21% oxygen for at least 28 days after birth;
- Medical management (i.e., supplemental oxygen, bronchodilators, diuretics, or chronic corticosteroid therapy) of CLD was required within the previous 6 months;
- Age at onset of respiratory syncytial virus (RSV) season at most 12 months;
- Request is for RSV prophylaxis;
- Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
- Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
- If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;* *Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.
- Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
- Dose does not exceed a 105 mg single dose.
- Approval duration: 4 weeks (1 dose per lifetime)
- Congenital Heart Disease (must meet all):
- Diagnosis of hemodynamically significant congenital heart disease (CHD) and one of the following:
- CHD is unoperated or partially corrected;
- Presence of acyanotic cardiac lesions and one of the following:
- Pulmonary hypertension with at least 40 mmHg measured pressure in the pulmonary artery;
- Requirement of daily medication therapy to manage CHD;
- Age at onset of respiratory syncytial virus (RSV) season at most 12 months;
- Request is for RSV prophylaxis;
- Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
- Member has not previously received another RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
- If member is undergoing cardiac surgery with cardiopulmonary bypass, member has not previously received at least 2 doses of Enflonsia;
- If member previously received Synagis, one of the following:
- Request for Enflonsia is not within the same RSV season in which Synagis was administered;
- Less than 5 Synagis doses were administered for the current RSV season; *Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.
- Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
- Dose does not exceed one of the following:
- 105 mg single dose;
- Member is undergoing cardiac surgery with cardiopulmonary bypass: an additional 105 mg dose (2 doses total).
- Approval duration:
- Cardiac surgery with cardiopulmonary bypass – 12 months (2 doses total per lifetime)
- All other requests – 4 weeks (1 dose per lifetime)
- Anatomic Pulmonary Abnormalities, Neuromuscular Disorders, Infants Profoundly Immunocompromised (off-label) (must meet all):
- Member has anatomic pulmonary abnormalities, neuromuscular disorders, or is profoundly immunocompromised;
- Age and diagnosis at onset of respiratory syncytial virus (RSV) season at most 12 months;
- Request is for RSV prophylaxis;
- Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
- Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
- If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;* *Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.
- Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
- Dose does not exceed a 105 mg single dose.
- Approval duration: 4 weeks (1 dose per lifetime)
- Cystic Fibrosis (off-label) (must meet all):
- Diagnosis of cystic fibrosis and one of the following:
- Clinical evidence of nutritional compromise;
- Diagnosis of chronic lung disease (CLD) of prematurity defined as both of the following:
- Gestational age less than 32 weeks;
- Requirement for greater than 21% oxygen for at least 28 days after birth;
- Age at onset of respiratory syncytial virus (RSV) season at most 12 months;
- Request is for RSV prophylaxis;
- Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
- Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
- If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;* *Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.
- Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
- Dose does not exceed a 105 mg single dose.
- Approval duration: 4 weeks (1 dose per lifetime)
- Alaska Native and Other American Indian Infants (off-label) (must meet all):
- Medical director consultation is required for requests relating to Alaska native and other American Indian infants that fall outside the criteria outlined above;
- Alaska native infants: Eligibility for prophylaxis may differ from the remainder of the U.S. on the basis of epidemiology of respiratory syncytial virus (RSV) in Alaska, particularly in remote regions where the burden of RSV disease is significantly greater than in the general U.S. population;
- Other American Indian infants: Limited information is available concerning the burden of RSV disease among American Indian populations. However, special consideration may be prudent for Navajo and White Mountain Apache infants.
- Age at onset of RSV season at most 12 months;
- Request is for RSV prophylaxis;
- Medical justification supports requests for RSV prophylaxis outside the identified season* duration for the specific region;
- Member has not previously received Enflonsia or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination (unless infant is born less than 14 days after maternal RSV vaccination);
- If member previously received Synagis for the current RSV season, less than 5 Synagis doses were administered;* *Synagis should no longer be administered following Enflonsia. Existing Synagis authorizations should be termed.
- Member has not been hospitalized or previously infected with RSV disease during the current RSV season;
- Dose does not exceed a 105 mg single dose.
- Approval duration: 4 weeks (1 dose per lifetime)
- Continued Therapy: All Indications in Section I
- Continued therapy will not be authorized as Enflonsia is indicated to be dosed once, unless member is undergoing cardiac surgery with cardiopulmonary bypass, in which case an additional dose may be administered (2 doses total per lifetime).
- Approval duration: Not applicable
|
Taletrectinib (Ibtrozi) (CP.PHAR.741)
| 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: Non-Small Cell Lung Cancer (NSCLC) (must meet all):
- Diagnosis of NSCLC;
- Prescribed by or in consultation with an oncologist;
- Age at least 18 years;
- Disease has both of the following characteristics:
- Recurrent, locally advanced, or metastatic;
- ROS1-positive;
- For Ibtrozi requests, member must use taletrectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following:*
- Both of the following:
- Dose does not exceed 600 mg (3 capsules) per day;
- Dose is at least 200 mg per day;
- 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 FDA-approved or recommended by NCCN
- Approval duration: 6 months
- Continued Therapy: Non-Small Cell Lung Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ibtrozi for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- For Ibtrozi requests, member must use taletrectinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- If request is for a dose increase, request meets one of the following:*
- Both of the following:
- New dose does not exceed 600 mg (3 capsules) per day;
- New dose is at least 200 mg per day;
- 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 FDA-approved or recommended by NCCN
- Approval duration: 12 months
|
Sunvozertinib (Zegfrovy) (CP.PHAR.742)
| 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: Non-small Cell Lung Cancer (must meet all):
- Diagnosis of recurrent, advanced, or metastatic NSCLC;
- Prescribed by or in consultation with an oncologist;
- Age at least 18 years;
- Disease is positive for EGFR exon 20 insertion mutations;
- Zegrovy is prescribed as subsequent therapy;
- Zegfrovy is prescribed as a single agent;
- For Zegfrovy requests, member must use sunvozertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Request meets one of the following (a, b, or c):*
- Dose does not exceed:
- 200 mg per day;
- 1 tablet per day;
- Both of the following:
- Dose does not exceed both of the following (1 and 2):
- 400 mg per day;
- 2 tablets per day;
- Prescriber attestation of member’s inability to avoid concomitant use of CYP3A inducer (e.g., carbamazepine, rifampin, ritonavir, St. John’s wort);
- 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 FDA-approved or recommended by NCCN
- Approval duration: 12 months
- Continued Therapy: Non-small Cell Lung Cancer (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Zegfrovy for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- For Zegfrovy requests, member must use sunvozertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
- Zegfrovy is prescribed as a single agent;
- If request is for a dose increase, request meets one of the following (a, b, or c):*
- New dose does not exceed:
- 200 mg per day;
- 1 tablet per day;
- Both of the following
- New dose does not exceed both of the following (1 and 2):
- 400 mg per day;
- 2 tablets per day;
- Prescriber attestation of member’s inability to avoid concomitant use of CYP3A inducer (e.g., carbamazepine, rifampin, ritonavir, St. John’s wort);
- 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 FDA-approved or recommended by NCCN
- Approval duration: 12 months
|
Linvoseltamab-gcpt (Lynozyfic) (CP.PHAR.743)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary for coverage
- 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, and CP.PMN.53 for Medicaid and CHIP
- Initial Approval Criteria: Multiple Myeloma (must meet all):
- Diagnosis of MM;
- Prescribed by or in consultation with an oncologist or hematologist;
- Age at least 18 years;
- Disease is relapsed or refractory;
- One of the following:
- Member has measurable disease as evidenced by one of the following assessed within the last 28 days (i, ii, or iii):
- Serum M-protein at least 0.5 g/dL;
- Urine M-protein at least 200 mg/24 h;
- Serum free light chain (FLC) assay: involved FLC level at least 10 mg/dL (100 mg/L) provided serum kappa lambda FLC ratio is abnormal;
- Member has progressive disease, as defined by the International Myeloma Working Group (IMWG) response criteria (see Appendix D), assessed within 60 days following the last dose of the last anti-myeloma drug regimen received;
- Member has received or has documented intolerance to at least 4 prior lines of therapy (see Appendix B for examples) that include all of the following (a, b, and c):
- One proteasome inhibitor (e.g., bortezomib, Kyprolis®, Ninlaro®);
- One immunomodulatory agent (e.g., Revlimid®, Pomalyst®, Thalomid®);
- One anti-CD38 monoclonal antibody (e.g., Darzalex®/Darzalex Faspro™, Sarclisa®);
- *Prior authorization may be required
- Member does not have known multiple myeloma brain lesions or meningeal involvement;
- Request meets one of the following:*
- Dose does not exceed all of the following (i – v):
- Day 1: 5 mg;
- Day 8: 25 mg;
- Day 15: 200 mg;
- One week after Day 15 treatment dose and once weekly from week 4 to week 13 for 10 treatment doses: 200 mg per week;
- Week 14 and every 2 weeks thereafter: 200 mg every 2 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 FDA-approved or recommended by NCCN
- Approval duration: 6 months
- Continued Therapy: Multiple Myeloma (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lynozyfic 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 one of the following:
- 200 mg every 2 weeks;
- For members that have achieved and maintained very good partial response (VGPR) or better at or after week 24 and received at least 17 doses of 200 mg: 200 mg every 4 weeks;
- 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 FDA-approved or recommended by NCCN
- Approval duration: 12 months
|
Dasatinib (Sprycel, Phyrago) (CP.PHAR.72)
| Ambetter
| Policy updates include:
- Added brand Phyrago for pediatric use to all indications per pediatric extension in positive Philadelphia chromosome (Ph+) chronic myelogenous leukemia and acute lymphoblastic leukemia
|
Inclisiran (Leqvio) (CP.PHAR.568)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated indication to reflect revised use as an adjunct to exercise (rather than statin therapy) for hypercholesterolemia
- Revised hyperlipidemia to hypercholesterolemia throughout the criteria
|
Cyclosporine ophthalmic emulsion (Cequa, Klarity-C, Restasis, Verkazia, Vevye) (CP.PMN.48)
| Ambetter
| Policy updates include:
- Removed “at up to maximally indicated doses” for failure of artificial tears
- In Appendix B per Clinical Pharmacology, clarified ophthalmic anti-inflammatory agents and artificial tears examples
|
Mepolizumab (Nucala) (HIM.PA.175)
| Ambetter
| Policy updates include:
- For chronic obstructive pulmonary disease, revised blood eosinophil count requirement from “at least 300 cells/µl” to “at least 150 cells/µl at time of request or at least 300 cells/µl in the past 12 months”
|
