New pharmacy policies
Effective November 1, 2018
BRAF and MEK Inhibitors, 5.01.589
BRAF and MEK inhibitors are considered medically necessary for treating unresectable or metastatic melanoma with a BRAF V600E or V600K variant. Indications are updated based on FDA labeling. Content is transferred from policy 5.01.534 into this policy. Criteria for Braftovi™ (encorafenib) and Mektovi® (binimetinib) are added.
Bruton’s Kinase Inhibitors, 5.01.590
Criteria for Imbruvica® (ibrutinib) and Calquence® (acalabrutinib) are transferred from policy 5.01.534 into this policy. Indications are updated based on FDA labeling.
Gene Therapy for Inherited Retinal Dystrophy, 2.04.144
Voretigene neparvovec-rzyl adeno-associated virus vector-based gene therapy (Luxturna™) subretinal injection is considered medically necessary for patients with vision loss due to biallelic RPE65 variant-associated retinal dystrophy meeting criteria. This policy replaces 8.01.536.
Immune Checkpoint Inhibitors, 5.01.591
Criteria for Imfinzi® (durvalumab), Keytruda® (pembrolizumab), Opdivo® (nivolumab), Tecentriq® (atezolizumab), and Yervoy® (ipilimumab), and are transferred from policy 5.01.540 into this policy. Criteria are added for Libtayo® (cemiplimab).
Revised pharmacy policies
November 1, 2018
CGRP Inhibitors for Migraine Prophylaxis, 5.01.584
Medical necessity criteria are added for Emgality™ (galcanezumab).
Epidermal Growth Factor Receptor (EGFR) Inhibitors, 5.01.603
Criteria are added for Visimpro® (dacomitinib), and all indications are updated based on FDA labeling.
Hemlibra® (emicizumab‐kxwh), 5.01.581
The criteria are updated to reflect the FDA expanded indication for hemophilia A with or without anti‐factor VIII.
Kalydeco® (ivacaftor), Orkambi® (lumacaftor/ivacaftor), and Symdeko™ (tezacaftor/ivacaftor), 5.01.539
This policy updates the age criterion for Orkambi® (lumacaftor/ivacaftor) to 2 years old, instead of 6 years old.
Medical Necessity Criteria and Dispensing Quantity Limits for Exchange Formulary Benefits, 5.01.547
This policy is revised to include HIV drug quantity limits.
Medical Necessity Criteria for Pharmacy Edits, 5.01.605
This policy now includes criteria for Epidiolex® (cannabidiol), Orilissa® (elagolix), Jynarque™ (tolvaptan), Qbrexza™ (glycopyrronium cloth), Plixda™ (adapalene), and all branded single-source oral NSAIDs. Criteria are also added for the purpose of establishing statin intolerance.
Miscellaneous Oncology Drugs, 5.01.540
This policy is revised as follows:
- Added medical necessity criteria for Tibsovo® (ivosidenib)
- Updated indications for all agents per FDA labeling
- Organized the drugs listed in the policy by pharmacology
- Moved immunotherapy drugs to new policy 5.01.591
Multiple Receptor Tyrosine Kinase Inhibitors, 5.01.534
This policy is revised as follows:
- Added new label indication for Lenvima® (lenvatinib) for hepatocellular carcinoma
- Added Braftovi™ (encorafenib) and Mektovi® (binimetinib) for BRAF V600 mutated melanoma
- Moved all BRAF and MEK inhibitors to new policy 5.01.589
- Moved Bruton’s Kinase Inhibitors, Imbruvica™ (ibrutinib) and Calquence® (acalabrutinib), to new policy 5.01.590
- Reorganized policy and updated indications per FDA labeling
Pharmacotherapy of Multiple Sclerosis, 5.01.565
Medical necessity criteria are added for Ocrevus™ (ocrelizumab) as first-line therapy for relapsing-remitting multiple sclerosis. For Copaxone 40 mg, the criterion is added that a generic equivalent must be tried first.
Use of Vascular Endothelial Growth Factor Receptor (VEGF) Inhibitors and Other Angiogenesis Inhibitors in Oncology Patients, 5.01.517
The policy updates Avastin® (bevacizumab) criteria for ovarian cancer based on FDA labeling.