Effective October 1, 2021: Pharmacy and Biopharmacy Policies

Berotralstat (Orladeyo) (CP.PHAR.485)

Ambetter

Policy updates include:

• Added redirection to Haegarda

C1 Esterase Inhibitors (Berinert Cinryze Haegarda Ruconest) (CP.PHAR.202)

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

Policy updates include:

• Added redirection to generic Firazyr for treatment of acute HAE attacks
• Added redirection to Haegarda for HAE prophylaxis

CNS Stimulants (CP.PMN.92)

Ambetter

Policy updates include:

• Revised redirection from failure of 1 methylphenidate and 1 amphetamine product to failure of 2 from the same therapeutic class
• For Evekeo ODT added pediatric extension to 3 years of age and 2.5 mg strength per updated prescribing information
• For Mydayis added age requirement for 13 years or older per label

Ecallantide (Kalbitor) (CP.PHAR.177)

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

Policy updates include:

• Added redirection to generic Firazyr

Icatibant (Firazyr) (CP.PHAR.178)

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

Policy updates include:

• Added requirement for use of generic Firazyr for continuation of therapy requests

Immune Globulins (CP.PHAR.103)

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

Policy updates include:

• For myasthenia gravis/LEMS, revised requirement for steroid or alternative immunosuppressant to a requirement for both
• For multiple myeloma infection prevention, updated IgG level to < 400 mg/dL per NCCN guidelines
• Added guidance language re: optimal dose calculations for adults based on ideal or total body weight, whichever is less, and re: using adjusted body weight for dosing for obese members
• For AIDP/GBS/CIDP: separated existing criteria to clearly delineate which apply to AIDP/GBS and which apply to CIDP
• Added criteria for confirmation of CIDP diagnosis, per 2010 EFNS/PNS guidelines; added requirement for a prior trial of corticosteroid therapy

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 Avsola to list of biosimilar infliximab products that must be used prior to Remicade

Lanadelumab-fylo (Takhzyro) (CP.PHAR.396)

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

Policy updates include:

• Added redirection to Haegarda

Leuprolide Acetate (Eligard, Fensolvi, Lupaneta Pack, Lupron Depot, Lupron Depot-Ped) (CP.PHAR.173)

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

Policy updates include:

• For endometriosis and uterine fibroid indications added requirements for total duration of therapy per prescribing information
• For uterine fibroids continuation of therapy revised to restrict re-authorization and require use of initial approval criteria as each preoperative treatment course would be evaluated individually
• Revised salivary gland tumor to allow continuity of care and revised initial approval duration from duration of request or through the end of contract year to 12 months to align with other oncology approval durations
• For gender dysphoria continuation of therapy added requirement that request is not for Lupaneta Pack to align with initial approval criteria
• For ovarian cancer added Lupron Depot 7.5 mg and 22.5 mg strengths per NCCN

Linaclotide (Linzess) (CP.PMN.71)

Ambetter

Policy updates include:

• Added requirement for use of generic lubiprostone

Memantine (Namenda XR, Namzaric) (CP.PCH.30)

Ambetter

Policy updates include:

• Revised medical justification language for not using memantine and donepezil separately to “must use” language
• Added criterion that generic memantine extended release is used if Namenda XR is requested

Natalizumab (Tysabri) (CP.PHAR.259)

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

Policy updates include:

• Modified Avsola to parity status with Inflectra and Renflexis

Nintedanib (Ofev) (CP.PHAR.285)

Ambetter

Policy updates include:

• For SSc-ILD added redirection to cyclophosphamide or mycophenolate mofetil

Paricalcitol Injection (Zemplar) (CP.PHAR.270)

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

Policy updates include:

• Added redirection for brand Zemplar requests to generic paricalcitol to both initial and continued therapy sections

Pemigatinib (Pemazyre)(CP.PHAR.496)

Ambetter

Policy updates include:

• Added NCCN compendium supported off-label use in myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes
• For cholangiocarcinoma remove language allowing for first-line use if other alternatives are not suitable, as Pemazyre is only indicated as second-line therapy

Pyrimethamine (Daraprim) (CP.PMN.44)

Ambetter

Policy updates include:

• Added initial approval duration of 12 months for treatment of congenital toxoplasmosis in newborns per CDC guidelines
• Added requirement for use of generic to continued criteria

Rituximab (Rituxan), 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:

• Modified Avsola to parity status with Inflectra and Renflexis
• Clarified age threshold for redirection to Ruxience for NHL and continued therapy for all other indications in section I.

Step Therapy (HIM.PA.109)

Ambetter

Policy updates include:

• Modified Complera, Delstrigo, and Symtuza to require preferred single-tablet complete regimen if member is treatment naïve

Teriparatide (Forteo) (CP.PHAR.188)

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

Policy updates include:

• Added Prolia in addition to Tymlos as redirect options for PMO

Trifluridine-tipiracil (Lonsurf) (CP.PHAR.383)

Ambetter

Policy updates include:

• For GC/GEJ adenocarcinoma clarified two prior lines of chemotherapy required per label and NCCN compendium
• For CRC clarified per label and NCCN compendium that member has progressed through all available regimens
• For CRC removed coverage for unresectable disease per NCCN compendium