POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
|
Denosumab (Prolia, Xgeva, and biosimilars) (CP.PHAR.58)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added new biosimilars Jubbonti and Wyost to policy
- Added Appendix F to provide clarity on the interpretation of bone mineral density T-scores
|
Risperidone LA inj (Risperdal Consta, Perseris, Risvan, Rykindo, Uzedy) (CP.PHAR.293)
| Ambetter
| Policy updates include:
- Added newly approved dosage form Risvan to criteria.
|
Benralizumab (Fasenra) (CP.PHAR.373)
| Ambetter
| Policy updates include:
- Expanded age to 6+ years old and added new 10 mg prefilled syringe formulation
|
Mirvetuximab soravtansine-gynx (Elahere) (CP.PHAR.617)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Removed limitation of use language due to accelerated approval per updated labeling
|
Nirogacestat (Ogsiveo) (CP.PHAR.671)
| Ambetter
| Policy updates include:
- Added new dosage strengths (100 mg and 150 mg tablets) and removed specification of 6 tablets for 300 mg daily dose
|
Fluticasone propionate (Xhance) (CP.PMN.95)
| Ambetter
| Policy updates include:
- Added new indication for chronic rhinosinusitis without nasal polyps
|
Diazepam (Libervant, Valtoco) (CP.PMN.216)
| Ambetter
| Policy updates include:
- Added newly approved Libervant buccal film
|
Tenofovir Alafenamide Fumarate (CP.PMN.268)
| Ambetter
| Policy updates include:
- Added pediatric extension to at least 6 years and weight at least 25kg
|
Evolocumab (Repatha) (HIM.PA.156)
| Ambetter
| Policy updates include:
- For pediatric homozygous familial hypercholesterolemia, removed ezetimibe trial criteria
|
Mavorixafor (Xolremdi) (CP.PHAR.679)
| 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: warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) Syndrome (must meet all):
- Diagnosis of WHIM syndrome confirmed by genetic confirmation of a CXCR4 variant;
- Prescribed by or in consultation with a geneticist, hematologist, immunologist, or infectious disease specialist;
- Age ≥ 12 years;
- Baseline absolute neutrophil count (ANC) is ≤ 400 cells/µL;
- Documentation of member’s baseline absolute lymphocyte count (ALC) and number of infections experienced within the last year;
- Xolremdi is not prescribed concurrently with plerixafor (Mozobil®);
- Documentation of member’s current weight (in kg);
- Dose does not exceed any of the following:
- Weight > 50 kg: 400 mg (4 capsules) per day;
- Weight ≤ 50 kg: 300 mg (3 capsules) per day
- Approval duration: 6 months
- Continued Therapy: warts, hypogammaglobulinemia, infections and myelokathexis (WHIM) Syndrome (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 (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
- Member is responding positively to therapy as evidenced by both of the following:
- At least two instances of an ANC ≥ 500 cells/µL, on two separate days within the last six months;
- One of the following (i or ii):
- At least two instances of an ALC ≥ 1,000 cells/µL, on two separate days within the last six months;
- Reduction from baseline in infections;
- Xolremdi is not prescribed concurrently with plerixafor (Mozobil®);
- Documentation of member’s current weight (in kg);
- If request is for a dose increase, new dose does not exceed any of the following:
- Weight > 50 kg: 400 mg (4 capsules) per day;
- Weight ≤ 50 kg: 300 mg (3 capsules) per day
- Approval duration: 12 months
|
Onasemnogene Abeparvovec (Zolgensma) (CP.PHAR.421)
| Ambetter
| Policy updates include:
- Removed requirement of symptoms due to masking of symptoms with standard of care bridging therapy
- Allowed bridging therapy prior to Zolgensma administration
|
Colchicine (Colcrys, Lodoco) (CP.PMN.123)
| Ambetter
| Policy updates include:
- Removed generic redirection to colchicine 0.6 mg tablet for cardiovascular prophylaxis
- Updated Appendix B with indications for respective therapeutic alternatives
|
OnabotulinumtoxinA (Botox) (CP.PHAR.232)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For overactive bladder, revised criteria for adults to require use of one anticholinergic agent (previously two anticholinergics were required)
|
Brand Name Override and Non-Formulary Medications (HIM.PA.103)
| Ambetter
| Policy updates include:
- Added non-formulary weight loss drugs as an example of a benefit excluded use
|
Valbenazine (Ingrezza, Ingrezza Sprinkle) (CP.PCH.48)
| Ambetter
| Policy updates include:
- Added newly approved Ingrezza Sprinkle formulation
|
Trastuzumab Biosimilars Trastuzumab-Hyaluronidase (CP.PHAR.228)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added Hercessi to policy as non-preferred biosimilar
|
Methoxy polyethylene glycol-epoetin beta (Mircera) (CP.PHAR.238)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Updated to reflect expanded uses down to 3 months of age for pediatric patients on dialysis and added new use in pediatric patients not on dialysis
- Added option for subcutaneous route of administration in pediatrics
|
Adalimumab (Humira) Humira Biosimilars (CP.PHAR.242)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For Cyltezo, added new 40 mg/04 mL dosage strengths for single-dose pen and single-dose prefilled syringe
- Added unbranded adalimumab-adbm 40 mg/04 mL specific NDCs [0597-0575-40, 0597-0575-50, 0597-0575-60, 0597-0565-20] to Appendix K to list of preferred adalimumab products
|
Ustekinumab (Stelara, Wezlana, Selarsdi) (CP.PHAR.264)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added newly approved biosimilar Selarsdi to criteria
|
Vedolizumab (Entyvio) (CP.PHAR.265)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- For CD initial and continued therapy sections, added new dosage form (subcutaneous injection) to dosing regimen and removed request is for intravenous formulation
|
Alectinib (Alecensa) (CP.PHAR.369)
| Ambetter
| Policy updates include:
- Added new indication for the adjuvant treatment of non-small cell lung cancer
|
Fam-trastuzumab deruxtecan-nxki (Enhertu) (CP.PHAR.456)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added newly approved indication for IHC 3+ solid tumors
|
Tisotumab vedotin-tftv (Tivdak) (CP.PHAR.561)
| Ambetter, Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Converted FDA approved indication for cervical cancer from accelerated approval to full approval
- Added off-label vaginal cancer indication
|
Mirikizumab-mrkz (Omvoh) (CP.PHAR.662)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), and CHIP
| Policy updates include:
- Added new dosage form [single-dose prefilled syringe 100 mg/mL]
|
Fentanyl IR (Actiq, Fentora, Lazanda, Subsys) (CP.PMN.127)
| Ambetter
| Policy updates include:
- Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix E
|
Hydroxyurea (Siklos, Xromi) (CP.PMN.193)
| Ambetter
| Policy updates include:
- Added newly approved Xromi formulation
- Added clarification that for off-label oncology use request is for Siklos and template language that prescribed regimen is Food and Drug Administration (FDA)-approved or recommended by National Comprehensive Cancer Network (NCCN)
|
Sacubitril-Valsartan (Entresto) (CP.PMN.67)
| Ambetter
| Policy updates include:
- Added film-coated oral pellets contained in a hard capsule dosage form
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