AbobotulinumtoxinA (Dysport) (CP.PHAR.230)

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

Policy updates include:

• Treatment plan requirement detailing number of Units per site and treatment session is changed to per indication and treatment session
• Treatment of multiple indications restriction removed and replaced with total treatment dose limitation (Section III)
• Off-label uses added as follows per previously approved clinical guidance: adults (OAB/urinary incontinence, migraine, AH, blepharospasm, strabismus, sialorrhea, LD, OMD, UE dystonia, UE essential tremor; EA, HD, IAS achalasia, CAF

Ado-Trastuzumab Emtansine (Kadcyla) (CP.PHAR.229)

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

Policy updates include:

• Combined NSCLC and new off-label salivary gland tumor indications supported by NCCN into one off-label section

Bedaquiline (Sirturo) (CP.PMN.212)

Ambetter

Policy updates include:

• Clarified expert in the treatment of tuberculosis to include state or county public health department, specialists affiliated with any of the four TB Centers of Excellence as designated by the CDC, or ID specialists managing TB clinics

Belimumab (Benlysta) (CP.PHAR.88)

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

Policy updates include:

• Added criteria to reflect new indication for lupus nephritis in adults and aligned with Lupkynis (voclosporin)

Bexarotene (Targretin Capsules, Gel) (CP.PHAR.75)

Ambetter

Policy updates include:

• Added off-label indication for Mycosis Fungoides/Sezary Syndrome

Brigatinib (Alunbrig) (CP.PHAR.342)

Ambetter

Policy updates include:

• Added NCCN supported use in ALK positive IMT

Brimonidine Tartrate (Mirvaso) (CP.PMN.192)

Ambetter

Policy updates include:

• Added ivermectin 1% cream as an option for failure

Buprenorphine-naloxone (Bunavail, Cassipa, Suboxone, Zubsolv) (CP.PMN.81)

Ambetter

Policy updates include:

• Modified redirection to also allow use of generic buprenorphine/naloxone sublingual film

Capecitabeine (Xeloda) (CP.PHAR.60)

Ambetter

Policy updates include:

• Removed the criteria for prescribing as single agent or in combination with temozolomide for the indication of neuroendocrine tumor of the pancreas as capecitabine can be prescribed as part of other regimens per NCCN
• Removed the differentiation of neuroendocrine tumor of the gastrointestinal tract, lung, or thymus as there are several different supported indications per NCCN
• Added NCCN-supported indication of squamous cell skin cancer

Carglumic Acid (Carbaglu) (CP.PHAR.206)

Ambetter

Policy updates include:

• Added new indication as adjunctive therapy for acute hyperammonemia due to PA or MMA

Casimersen (Amondys 45) (CP.PHAR.470)

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

Policy updates include:

• Drug is now FDA approved
• Added option for continuation of therapy for patients who have been receiving the medication through another healthcare insurer and/or has been responding positively to therapy with stable disease
• Modified time frame for positive response parameters from within the last 30 days to within the last 6 months
• Added requirement for neurologist assessment within the last 6 months
• LVEF requirement revised from > to ≥ 40%

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

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

Policy updates include:

• Added new indications for BCC and NSCLC

Crizanlizumab-tmca (Adakveo) (CP.PHAR.449)

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

Policy updates include:

• Corrected optional criteria that required at least 2 VOC to requiring at least 1 VOC within the past 6 months while on hydroxyurea

Crizotinib (Xalkori) (CP.PHAR.90)

Ambetter

Policy updates include:

• Updated with FDA-approved indication for ALCL (previously included as an NCCN supported off-label use) with age 1 year or older and dosing limits per label

Cysteamine ophthalmic (Cystaran, Cystadrops) (CP.PMN.130)

Ambetter

Policy updates include:

• Revised Cystadrops dosing in approval criteria from a maximum of 3 bottles/month to a maximum of 1 bottle/week to align with the prescribing information

Dasatinib (Sprycel) (CP.PHAR.72)

Ambetter

Policy updates include:

• Added off-label indication myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement in chronic phase

Daunorubicin-cytarabine (Vyxeos) (CP.PHAR.352)

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

• Updated AML criteria from adults only to pediatric extension of 1 year old and older

Deutetrabenazine (Austedo) (CP.PCH.42)

Ambetter

Policy updates include:

• Removed redirection to tetrabenazine for chorea

Evinacumab-dgnb (Evkeeza) (CP.PHAR.511)

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

Policy updates include:

• Drug is now FDA approved
• Criteria updated per FDA labeling
• Revised age limit from ≥ 18 years to ≥ 12 years
• Added requirement for documentation of body weight
• Added re-direction to Repatha
• Added requirement for adherence to statin therapy on re-auth

Hydroxyurea (Siklos) (CP.PMN.193)

Ambetter

Policy updates include:

• Myelodysplastic syndromes added as option for off-label oncology indication per NCCN-supported category 2A recommendation

Imatinib (Gleevec) (CP.PHAR.65)

Ambetter

Policy updates include:

• Added off-label indication for myeloid/lymphoid neoplasm with eosinophilia and tyrosine kinase fusion genes

IncobotulinumtoxinA (Xeomin) (CP.PHAR.231)

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

Policy updates include:

• Chronic sialorrhea age updated to include pediatrics per FDA label
• Treatment plan requirement detailing number of Units per site and treatment session is changed to per indication and treatment session
• Treatment of multiple indications restriction removed and replaced with total treatment dose limitation (Section III)
• Off-label uses added as follows per previously approved clinical guidance: adults (lower limb spasticity, OAB/urinary incontinence, migraine, AH, OMD, UE dystonia, UE essential tremor

Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)

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

Policy updates include:

• Drug is now FDA approved
• Criteria updated per FDA labeling
• Removed minimum absolute lymphocyte count requirement

Lorlatinib (Lorbrena) (CP.PHAR.406)

Ambetter

Policy updates include:

• Per NCCN Compendium which supports Lorbrena as first-line therapy in ALK positive NSCLC, removed requirement for use of prior therapies

Midostaurin (Rydapt) (CP.PHAR.344)

Ambetter

Policy updates include:

• Added off-label indication for myeloid/lymphoid neoplasm with eosinophilia and FGFR1 or FLT3 rearrangements in blast phase

Osimertinib (Tagrisso) (CP.PHAR.294)

Ambetter

Policy updates include:

• Added new indication for use in the adjuvant setting

Oxymetazoline (Rhofade, Upneeq) (CP.PMN.86)

Ambetter

Policy updates include:

• Added ivermectin 1% cream as an option for failure

Pretomanid (CP.PMN.222)

Ambetter

Policy updates include:

• Clarified expert in the treatment of tuberculosis to include state or county public health department, specialists affiliated with any of the four TB Centers of Excellence as designated by the CDC, or ID specialists managing TB clinics

Regorafenib (Stivarga) (CP.PHAR.107)

Ambetter

Policy updates include:

• Added NCCN-supported uses to indications, such as regorafenib use as a single agent for most indications, advanced or metastatic disease distinction for CRC
• Expanded past treatment options for HCC in Appendix B, Child-Pugh class A disease for HCC, and off-label soft-tissue sarcoma additions

Relugolix (Orgovyx) (CP.PHAR.529)

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

Prostate Cancer (must meet all):

1. Diagnosis of advanced prostate cancer defined as one of the following (a, b, or c):

a. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent

b. Newly diagnosed castration-sensitive metastatic disease;

c. Advanced localized disease unlikely to be cured by local primary intervention with curative intent;

2. Prescribed by or in consultation with an oncologist or urologist;

3. Age ≥ 18 years;

4. Request meets one of the following (a, b, or c):*

a.Initial dose does not exceed 360 mg (3 tablets) given on the first day of treatment as a loading dose

b. Maintenance dose does not exceed (i or ii):

i.120 mg (1 tablet) per day;

ii.240 mg (2 tablets) per day if combined with rifampin and combination use is unavoidable;

c. 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 criteria:

Prostate Cancer (must meet all):

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Orgovyx for prostate cancer and has received this medication for at least 30 days;
2. Member is responding positively to therapy;
3. If request is for a dose increase, request meets one of the following (a, b, or c):*

a. New dose does not exceed 120 mg (1 tablet) per day;

b. New dose does not exceed 240 mg (2 tablets) per day if combined with rifampin and combination use is unavoidable;

c. 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 month

RimabotulinumtoxinB (Myobloc) (CP.PHAR.233) (PDF) 

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

Policy updates include:

• Treatment plan requirement detailing number of Units per site and treatment session is changed to per indication and treatment session

Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) (HIM.PA.SP63)

Ambetter

Policy updates include:

• Updated criteria to include pibrentasvir as an acceptable option for previous treatment with an HCV regimen containing an NS5A inhibitor to align with appendix D table

Tepotinib (Tepmetko) (CP.PHAR.530)

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):

1. Diagnosis of advanced or metastatic NSCLC;
2. Prescribed by or in consultation with an oncologist;
3. Age ≥ 18 years;
4. Disease is positive for a mutation causing MET exon 14 skipping;
5. Disease is epidermal growth factor receptor (EGFR) wild-type and anaplastic lymphoma kinase (ALK) negative;
6. Member does not have symptomatic CNS metastases;
7. Request meets one of the following (a or b):*

a.Dose does not exceed 450 mg (2 tablets) per day;

b.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 criteria:

Non-Small Cell Lung Cancer (must meet all):

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tepmetko for a covered indication and has received this medication for at least 30 days;
2. Member is responding positively to therapy;
3. If request is for a dose increase, request meets one of the following (a or b):*

a. New dose does not exceed 450 mg (2 tablets) per day;

b. 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

Tetrabenazine (Xenazine) (CP.PHAR.92)

Ambetter

Policy updates include:

• Added off-label indication of TD supported by APA 2020 Practice Guideline

Thalidomide (Thalomid) (CP.PHAR.78)

Ambetter

Policy updates include:

• Added hematology specialist option to MM and myeloproliferative neoplasm indications
• Removed “hyaline vascular histology” requirement from MCD to align with NCCN removal
• Added criteria for corticosteroid-refractory immune reconstitution inflammatory syndrome in Kaposi sarcoma per NCCN

Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase (CP.PHAR.228)

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

Policy updates include:

• Added choice of oxaliplatin, in addition to cisplatin, for combination treatment of gastric cancers per NCCN
• Updated product availability for Herceptin and Kanjinti

Umbralisib (Ukoniq) (CP.PHAR.531)

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:

Marginal Zone Lymphoma (must meet all):

1. Diagnosis of MZL;
2. Prescribed by or in consultation with an oncologist or hematologist;
3. Age ≥ 18 years;
4. Relapsed or refractory disease after  ≥ 1 anti-CD20-based regimen* (see Appendix B for examples); *Prior authorization may be required
5. Request meets one of the following (a or b):*

a.Dose does not exceed 800 mg(4 tablets) per day;

b.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

Follicular Lymphoma (must meet all):

1. Diagnosis of FL;
2. Prescribed by or in consultation with an oncologist or hematologist;
3. Age ≥ 18 years;
4. Relapsed or refractory disease after ≥ 3 lines of systemic therapy* (see Appendix B for examples); *Prior authorization may be required
5. Request meets one of the following (a or b):

a.      Dose does not exceed 800 mg(4 tablets) per day;

b.      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 criteria:

1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ukoniq for a covered indication and has received this medication for at least 30 days;
2. Member is responding positively to therapy;
3. If request is for a dose increase, request meets one of the following (a or b):*

a. New dose does not exceed 800 mg(4 tablets) per day;

b. 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

Voclosporin (Lupkynis) (CP.PHAR.504)

Ambetter

• Drug is now FDA approved
• Criteria updated per FDA labeling
• eGFR requirement removed
• Cyclophosphamide as an option for concurrent immunosuppressive therapy w/Lupkynis removed as this is not recommended per the labeling
• Concurrently prescribed with “non-biologic” immunosuppressive therapy was changed to “background” immunosuppressive therapy
• Rheumatology specialist added
• Criterion for diagnosis of SLE added
• Clarification of maximum dose as 6 capsules/day added

Zanubrutinib (Brukinsa) (CP.PHAR.467)

Ambetter

Policy updates include:

• Added off-label indication for CLL/SLL per NCCN guidelines.