Abatacept (Orencia) (CP.PHAR.241)

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

Policy updates include:

• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Adalimumab (Humira), Adalimumab-atto (Amjevita), Adalimumab-adbm (Cyltezo), Adalimumab-bwwd (Hadlima), Adalimumab-adaz (Hyrimoz) (CP.PHAR.242)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity
• Updated criteria to reflect pediatric extension for UC to include patients 5 years of age and older

Agalsidase Beta (Fabrazyme)

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

Policy updates include:

• Added a requirement for a clinical geneticist specialist and no concomitant use with Galafold

Anakinra (Kineret) (CP.PHAR.244)

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

Policy updates include:

• Added criteria for new indication of DIRA
• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Apalutamide (Erleada) (CP.PHAR.376)

Ambetter

Policy updates include:

• Added that PSADT ≤ 10 months for non-metastatic CRPC
• Added that member continues to use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy
• Added generic redirection language to “must use” since oral oncology product

Baricitinib (Olumiant) (CP.PHAR.135)

Ambetter

Policy updates include:

• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity
• Updated dosage form to include 1 mg

Bevacizumab (Avastin, Mvasi, Zirabev) (CP.PHAR.93)

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

Policy updates include:

• Applied redirection of Avastin to preferred biosimilars to other diagnoses/indications

Binimetinib (Mektovi) (CP.PHAR.50)

Ambetter

Policy updates include:

• Removed colorectal cancer off-label use as it is no longer included in the NCCN Compendium
• Oral oncology generic redirection language added

Biologic DMARDs (HIM.PA.SP60)

Ambetter

Policy updates include:

• Added criteria for new indication of DIRA for Kineret
• Added additional criteria related to diagnosis of PsO per 2019 AAD/NPF guidelines specifying involvement of areas that severely impact daily function OR at least 3% BSA involvement for moderate-to-severe, at least 10% BSA involvement for chronic-severe
• Updated CDAI table with “>” to prevent overlap in classification of severity

Bosutinib (Bosulif) (CP.PHAR.105)

Ambetter

Policy updates include:

• Added that member does not have any of the following mutations: T315I, V299L, G250E, or F317L per NCCN
• Added generic redirection language to “must use” since oral oncology produc
• Added approval criteria for myeloid/lymphoid neoplasm with eosinophilia and tyrosine kinase fusion genes
• Added that member has contraindication, intolerance, or disease progression on imatinib

Brodalumab (Siliq) (CP.PHAR.375)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III

Cabazitaxel (Jevtana) (CP.PHAR.316)

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

Policy updates include:

• Allowed bypassing prior docetaxel if not a candidate for or are intolerant of docetaxel per NCCN
• Added that Jevtana continues to be prescribed with steroids

Cabozantinib (Cabometyx, Cometriq) (CP.PHAR.111)

Ambetter

Policy updates include:

• Delineated maximum dose based on drug interactions per prescribing information

Canakinumab (Ilaris) (CP.PHAR.246)

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

Policy updates include:

• Added requirements to confirm diagnosis/severity for periodic fever syndromes
• Added combination of bDMARDs under Section III

Certolizumab (Cimzia) (CP.PHAR.247)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Dabrafenib (Tafinlar) (CP.PHAR.239)

Ambetter

Policy updates include:

• Removed colorectal cancer off-label use as it is no longer included in the NCCN Compendium
• Oral oncology generic redirection language added

Darbepoetin Alfa (Aranesp) (CP.PHAR.236)

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

Policy updates include:

• For MDS and MF associated anemia added for continued therapy hemoglobin or transfusion response criteria per NCCN

Doxycycline Hyclate (Acticlate, Doryx), Doxycycline (Oracea) (CP.PMN.79)

Ambetter

Policy updates include:

• Updated IR doxycycline prior trial requirement to “must use” language
• Adjusted max dose of Acticlate and Doryx to match labeling for these two products

Durvalumab (Imfinzi) (CP.PHAR.339)

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

Policy updates include:

• Removed criteria for bladder cancer as the FDA labeled indication was withdrawn by the manufacturer based on confirmatory trial results
• Added coverage for stage II NSCLC per NCCN 2A recommendation
• Revised dosing for all indications per updated FDA label

Elapegademase-lvlr (Revcovi) (CP.PHAR.419)

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

Policy updates include:

• Added a requirement for a prior failure or non-candidacy for BMT

Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx (Retacrit) (CP.PHAR.237)

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

Policy updates include:

• For MDS and MF associated anemia added for continued therapy hemoglobin or transfusion response criteria per NCCN

Esketamine (Spravato) (CP.PMN.199)

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

Policy updates include:

• Corrected upper age limit to less than 65 years

Etanercept (Enbrel) (CP.PHAR.250)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Evinacumab (CP.PHAR.511)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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

 A. Homozygous Familial Hypercholesterolemia (must meet all):

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

a. Genetic mutation indicating HoFH (e.g., mutations in low density lipoprotein receptor [LDLR] gene, proprotein convertase subtilisin kexin 9 (PCSK9) gene, apo B gene, low density lipoprotein receptor adaptor protein 1 [LDLRAP1] gene);

b. Treated LDL-C ≥ 300 mg/dL or non-HDL-C ≥ 330 mg/dL;

c. Untreated LDL-C ≥ 500 mg/dL, and one of the following (i or ii):

i. Tendinous or cutaneous xanthoma prior to age 10 years;

ii. Evidence of heterozygous familial hypercholesterolemia (HeFH) in both parents (e.g., documented history of elevated LDL-C ≥ 190 mg/dL prior to lipid-lowering therapy);

2. Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist;

3. Age ≥ 18 years;

4. Documentation of recent (within the last 60 days) LDL-C ≥ 70 mg/dL;

5. For members on statin therapy, both of the following (a and b):

a. Evinacumab is prescribed in conjunction with a statin at the maximally tolerated dose;

b. Member has been adherent for at least the last 4 months to maximally tolerated doses of one of the following statin regimens (i, ii, or iii):

i. A high intensity statin (see Appendix D);

ii. A moderate intensity statin (see Appendix D) and member has one of the following (a or b):

a) Intolerance to two high intensity statins;

b) A statin risk factor (see Appendix F);

iii. A low intensity statin and member has one of the following (a or b):

a) Intolerance to one high and one moderate intensity statins;

b) A statin risk factor (see Appendix F) and history of intolerance to two moderate intensity statins;

6. For members not on statin therapy, member meets one of the following (a or b):

a. Statin therapy is contraindicated per Appendix E;

b. For members who are statin intolerant, member has tried at least two statins, 1 of which must be hydrophilic statins (pravastatin, fluvastatin, or rosuvastatin), and member meets one of the following (i or ii):

i.  Member has documented statin risk factors (see Appendix F);

ii. Member is statin intolerant due to statin-associated muscle symptoms (SAMS) and meets both of the following (a and b):

a) Documentation of intolerable SAMS persisting at least two weeks, which disappeared with discontinuing the statin therapy and recurred with a statin re-challenge;

b) Documentation of re-challenge with titration from lowest possible dose and/or intermittent dosing frequency (e.g., 1 to 3 times weekly);

7. Member has been adherent to ezetimibe therapy used concomitantly with a statin at the maximally tolerated dose for at least the last 4 months, unless contraindicated per Appendix E or member has a history of ezetimibe intolerance (e.g., associated diarrhea or upper respiratory tract infection);

8. If request is for coadministration with Juxtapid^®, Praluent^®, Kynamro^®, or Repatha^®, member has tried the prior therapy for at least 3 consecutive months with inadequate response defined as failure to achieve LDL-C ≤ 250 mg/dL or a 20% reduction in LDL-C from baseline;

9. Dose does not exceed 15 mg/kg every 4 weeks.

Approval duration: 6 months

Continued Therapy

A. Homozygous Familial Hypercholesterolemia (must meet all):

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

2. Member is responding positively to therapy as evidenced by lab results within the last 3 months showing an LDL-C reduction since initiation of evinacumab therapy;

3. If request is for a dose increase, new dose does not exceed 15 mg/kg every 4 weeks.

Approval duration: 12 months

  Ferric Derisomaltose (Monoferric) (CP.PHAR.480)

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

Policy updates include:

• Updated max dosing per PI

Fibrinogen concentrate (human) (Fibryga, RiaSTAP) (CP.PHAR.526)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and 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, and CP.PMN.53 for Medicaid and CHIP
• Initial approval criteria:

Congenital Fibrinogen Deficiency (must meet all):

1. Diagnosis of congenital fibrinogen deficiency, including afibrinogenemia or hypofibrinogenemia;

2. Confirmation that the member does not have dysfibrinogenemia;

3. Prescribed by or in consultation with a hematologist;

4. Request is for treatment of acute bleeding episodes;

5. Documentation of both of the following (a and b):

a. Plasma functional and immunoreactive fibrinogen levels are < 150 mg/dL;

b. Prolonged prothrombin time and activated partial thromboplastin time as determined by laboratory-specific reference values;

6. Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication.

Approval duration: 3 months

• Continuation criteria:

Congenital Fibrinogen Deficiency (must meet all):

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

2. Member is responding positively to therapy;

3. If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose for the relevant indication.

Approval duration: 3 months

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

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

Policy updates include:

• Applied redirection language to preferred products to other diagnoses/indications

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (CP.PMN.183)

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

Policy updates include:

• Removed Victoza as a preferred agent

Golimumab (Simponi, Simponi Aria) (CP.PHAR.253)

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

Policy updates include:

• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Guselkumab (Tremfya) (CP.PHAR.364)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III

Ibuprofen/Famotidine (Duexis) (CP.PMN.120)

Ambetter

Policy updates include:

• Revised requirement of medical justification for inability to use individual components to “must use” language
• Added risk factors for developing NSAID-induced gastric ulcers
• Revised initial and continued approval durations from 12 months

Infliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra), and Infliximab-abda (Renflexis) (CP.PHAR.254)

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

Policy updates include:

• Added additional criteria related to diagnosis of chronic severe PsO per 2019 AAD/NPF guidelines specifying at least 10% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Ipilimumab (Yervoy) (CP.PHAR.319)

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

Policy updates include:

• Clarified RCC as “advanced or metastatic” per NCCN and prescribing information
• Removed SCLC from off-label indications as this is no longer supported by NCCN

Ixekizumab (Taltz) (CP.PHAR.257)

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

Policy updates include:

• Added additional criteria related to diagnosis of chronic severe PsO per 2019 AAD/NPF guidelines specifying at least 10% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III
• Updated dose limits to reflect pediatric limits

Laronidase (Aldurazyme) (CP.PHAR.152)

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

Policy updates include:

• Clarified the covered subtypes of MPS I, to align with the FDA-approved indication

Lenalidomide (Revlimid) (CP.PHAR.71)

Ambetter

Policy updates include:

• For MCL removed optional use as second-line therapy as a single agent
• Consolidated off-label use for primary CNS lymphoma and expanded use to members unsuitable or intolerant to high-dose methotrexate
• For classic Hodgkin lymphoma clarified use is for third-line or subsequent therapy and removed optional use as palliative therapy
• Oral oncology generic redirection language added

Mitoxantrone (Novantrone) (CP.PHAR.258)

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

Policy updates include:

• For lymphoma: updated use in Hodgkin lymphoma and T-cell prolymphocytic leukemia per NCCN

Naproxen/Esomeprazole (Vimovo) (CP.PMN.117)

Ambetter

Policy updates include:

• Added weight requirement per PI
• Revised medical justification to member “must use” individual components
• Added that request is for generic formulation

Narsoplimab (OMS721) (CP.PHAR.527)

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

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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:

Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (must meet all):

1. Diagnosis of HSCT-TMA;

2. Prescribed by or in consultation with a hematologist or transplant specialist;

3. Age ≥ 18 years;

4. Member has signs of persistent TMA as evidenced by presence of all of the following for at least 2 weeks after modification or discontinuation of calcineurin inhibitor therapy (e.g., cyclosporine, tacrolimus) (a, b, and c):

a. Platelet count ≤ 150 x 10⁹/L;

b. Hemolysis such as an elevation in serum lactate dehydrogenase (LDH);

c. Serum creatinine above the upper limits of normal or member requires dialysis;

5. Documentation that member does not have any of the following:

a. A disintegrin and metalloproteinase with thrombospondin type 1 motif, member 13 (ADAMTS13) deficiency;

b. Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS);

c. Atypical hemolytic uremic syndrome (aHUS);

6. MS721 is not prescribed concurrently with Soliris^® or Ultomiris^®;

7. Dose does not exceed 4 mg/kg once weekly.

Approval duration: 8 weeks

• Continuation criteria:

Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (must meet all):

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

2. Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:*

a. Improved measures of intravascular hemolysis (e.g., normalization of LDH);

b. Increased or stabilized platelet counts;

c. Improved or stabilized serum creatinine or estimated glomerular filtration rate (eGFR);

d. Reduced need for dialysis;

3. Member has not received OMS721 for > 12 weeks;

4. OMS721 is not prescribed concurrently with Soliris or Ultomiris;

5. If request is for a dose increase, new dose does not exceed 4 mg/kg once weekly.

Approval duration: Up to 12 weeks total

Odevixibat (A4250) (CP.PHAR.528)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• 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:

Progressive Familial Intrahepatic Cholestasis (must meet all):

1. Diagnosis of genetically confirmed PFIC type 1 or 2 (formerly known as Byler disease or syndrome) with presence of both of the following (a and b):

a. Pruritus requiring at least medium scratching (e.g., ≥ 2 on 0-4 scale);

b. Serum bile acids ≥ 100 µmol/L;

2. Prescribed by or in consultation with a hepatologist or gastroenterologist;

3. Age ≥ 6 months and ≤ 18 years at therapy initiation;

4. Body weight ≥ 5 kg;

5. Member does not have pathologic variations of the ABCB11 gene that predict complete absence of the bile salt export pump (BSEP) protein;

6. Failure of ursodeoxycholic acid, unless clinically significant adverse effects are experienced or contraindicated;

7. Failure of an agent used for symptomatic relief of pruritus (e.g., antihistamine, rifampicin, cholestyramine), unless clinically significant adverse effects are experienced or all are contraindicated;

8. Dose does not exceed 120 mcg/kg per day.

Approval duration: 6 months

•  Continuation Criteria:

Progressive Familial Intrahepatic Cholestasis (must meet all):

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

2. Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:

a. Improvement in pruritus;

b. Reduction of serum bile acids from baseline;

3. If request is for a dose increase, new dose does not exceed 120 mcg/kg per day.

Approval duration: 12 months

Ofatumumab (Arzerra, Kesimpta) (CP.PHAR.306)

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

Policy updates include:

• CLL/SLL- added specific requirements if request is for use as first-line therapy per NCCN and FDA

Off-Label Drug Use (HIM.PA.154)

Ambetter

Policy updates include:

• Added redirection to generic/biosimilar products, with bypass allowed for states with regulations against redirections in stage IV or metastatic cancer

Off-Label Use (CP.PMN.53)

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

Policy updates include:

• Added bypass to biosimilar redirection for states with regulations against redirections in stage IV or metastatic cancer
• Added redirection to preferred biosimilar products for continued therapy

Omacetaxine (Synribo) (CP.PHAR.108)

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

Policy updates include:

• Added Member has experienced resistance, toxicity, or intolerance to prior therapy with two or more TKIs (e.g., imatinib, bosutinib, dasatinib, nilotinib, ponatinib)

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

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

Policy updates include:

• Spasticity step therapy criteria updated
• 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
• Added newly FDA-approved diagnosis of pediatric detrusor overactivity

Paclitaxel, Protein-Bound (Abraxane) (CP.PHAR.176)

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

Policy updates include:

• Clarified NSCLC to be recurrent, advanced or metastatic per NCCN
• Revised requirement of medical justification for inability to use paclitaxel to “must use” language
• Clarified hepatic cholangiocarcinoma as “cholangiocarcinoma,” unresectable or metastatic and Abraxane prescribed in combination with gemcitabine per NCCN

Palivizumab (Synagis) (CP.PHAR.16)

Ambetter

Policy updates include:

• Added requirement for continued therapy that member will not reach 24 months of age at the start of RSV season

Pegfilgrastim (Neulasta, Neulasta Onpro), Pegfilgrastim-jmdb (Fulphila), Pegfilgrastim-cbqv (Udenyca), Pegfilgrastim-bmez (Ziextenzo), Pegfilgrastim-apgf (Nyvepria) (CP.PHAR.296)

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

Policy updates include:

• Applied redirection language to preferred products to other diagnoses/indications

Pertuzumab (Perjeta) (CP.PHAR.227)

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

Policy updates include:

• Added requirement for BRAF wild-type disease for off-label indication of colorectal cancer per NCCN
• Added NCCN compendium-supported indication of salivary gland tumors and combined with colorectal cancer criteria

Phendimetrazine (Bontril PDM) (HIM.PA.114)

Ambetter

Policy updates include:

• Age limitation updated from ≥ 16 to ≥ 18 years

Pitolisant (Wakix) (CP.PMN.221)

Ambetter

Policy updates include:

• Added diagnostic criteria for narcolepsy with cataplexy and narcolepsy associated with excessive daytime sleepiness

Pomalidomide (Pomalyst) (CP.PHAR.116)

Ambetter

Policy updates include:

• Added hematology specialist option to MM and amyloidosis indications
• For systemic light chain amyloidosis, added requirement for combination with dexamethasone per NCCN

Ponatinib (Iclusig) (CP.PHAR.112)

Ambetter

Policy updates include:

• Added Member has experienced resistance, toxicity, or intolerance to prior therapy with two or more TKIs (e.g., imatinib, bosutinib, dasatinib, nilotinib, ponatinib) for CML and ALL
• Allowed option for T315I mutation to bypass prior TKIs for CML

Quinine Sulfate (Qualaquin) (CP.PMN.262)

Ambetter

Policy updates include:

• Added that request is for generic formulation

Rilonacept (Arcalyst) (CP.PHAR.266)

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

Policy updates include:

• Added combination of bDMARDs under Section III
• Added criteria for new indication of DIRA
• Added requirements to confirm diagnosis/severity for CAPS

Risankizumab-rzaa (Skyrizi) (CP.PHAR.426)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III

Rituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab-Hyaluronidase (Rituxan Hycela) (CP.PHAR.260)

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

Policy updates include:

• Added GVHD (2A) to NCCN Compendium (off-label) section
• Ensured alignment of biosimilars with Rituxan throughout policy
• Added recently FDA-approved biosimilar Riabni to all policy criteria applicable to Rituxan
• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Sapropterin (Kuvan) (CP.PHAR.43)

Ambetter

Policy updates include:

• Added requirements for a Phe-restricted diet
• Excluded coverage of concurrent use of Kuvan and Palynziq

Sarilumab (Kevzara) (CP.PHAR.346)

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

Policy updates include:

• Added combination of bDMARDs under Section III; updated CDAI table with “>” to prevent overlap in classification of severity

Secukinumab (Cosentyx) (CP.PHAR.261)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function
• Added combination of bDMARDs under Section III

Sipuleucel-T (Provenge) (CP.PHAR.120)

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

Policy updates include:

• Added that member has no or minimal symptoms without visceral metastases with greater than 6 months of life expectancy and an ECOG status of 0 to 1 per NCCN
• Removed Ambetter line of business per formulary status as alternatives exist for CRPC indication

Sodium Oxybate (Xyrem) and Calcium, Magnesium, Potassium, Sodium Oxybate (Xywav) (CP.PMN.42)

Ambetter

Policy updates include:

• Added diagnostic criteria for narcolepsy with cataplexy and narcolepsy associated with excessive daytime sleepiness
• Added prescriber requirements for neurologist or sleep medicine specialist for all indications

Sonidegib (Odomzo) (CP.PHAR.272)

Ambetter

Policy updates include:

• Added BCC criteria for diagnosis of locally advanced BCC, previous surgery or radiation therapy if eligible, and use as a single agent, as these criteria are supported by the FDA label and/or NCCN

Sorafenib (Nexavar) (CP.PHAR.69)

Ambetter

Policy updates include:

• Clarified RCC criteria to be advanced RCC
• Added requirement for Child-Pugh class A or B7 for HCC
• Added requirement for disease progression to include Qinlock for GIST as 4th line therapy per off-label recommendation of NCCN category 2A

Sunitinib (Sutent) (CP.PHAR.73)

Ambetter

Policy updates include:

• Clarified Sutent use in PNET be as a single agent per NCCN
• Added NCCN-supported indications of myeloid/lymphoid neoplasms with eosinophilia and alveolar soft part sarcoma
• Removed “second line therapy” from off-label thymic carcinoma indication per NCCN

Temozolomide (Temodar) (CP.PHAR.77)

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

Policy updates include:

• Added anaplastic glioma as an off-label NCCN-supported category 2A indication
• Modified the following off-label indications to align with NCCN recommended category 1 or 2A ratings: brain metastases, small cell lung cancer, pleomorphic rhabdomyosarcoma, solitary fibrous tumor, uterine sarcoma, and uveal melanoma
• Removed off-label indication of primary cutaneous anaplastic large cell lymphoma as this is no longer supported by NCCN
• Revised requirement of medical justification for inability to use generic temozolomide to “must use” language and added it to continued therapy criteria

Tildrakizumab-asmn (Ilumya) (CP.PHAR.386)

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

Policy updates include:

• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function

·        Added combination of bDMARDs under Section III

Tocilizumab (Actemra) (CP.PHAR.263)

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

Policy updates include:

• Added combination of bDMARDs under Section III
• Updated CDAI table with “>” to prevent overlap in classification of severity

Trametinib (Mekinist) (CP.PHAR.240)

Ambetter

Policy updates include:

• Removed colorectal cancer off-label use as it is no longer included in the NCCN Compendium
• Oral oncology generic redirection language added

Ustekinumab (Stelara) (CP.PHAR.264)

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

Policy updates include:

• Added combination of bDMARDs under Section III
• Added additional criteria related to diagnosis of moderate-to-severe PsO per 2019 AAD/NPF guidelines specifying at least 3% BSA involvement or involvement of areas that severely impact daily function

Vedolizumab (Entyvio) (CP.PHAR.265)

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

Policy updates include:

• Added combination of bDMARDs under Section III

Vismodegib (Erivedge) (CP.PHAR.273)

Ambetter

Policy updates include:

• Added BCC criteria for diagnosis of advanced, recurrent or metastatic BCC, previous surgery or radiation therapy if eligible, and use as a single agent for both BCC and medulloblastoma, as these are all supported by the FDA label and/or NCCN