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Medical Policy Number
| Medical Policy Name | Effective Date of Change | Description of Changes |
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CP.PHAR.478
| Selpercatinib (Retevmo) | 11/01/24 | RT4: updated to reflect pediatric expanded use down to 2 years of age (previously 12 years of age) for thyroid cancers and new pediatric use in solid tumors; added age restriction for histiocytic neoplasms per NCCN; converted FDA approved indication for thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) from accelerated approval to full approval per PI. |
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CP.PHAR.480
| Derisomaltose (Monoferric) | 11/01/24 | For cancer- and chemotherapy-induced anemia, added redirection to preferred iron products. |
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CP.PHAR.534
| Insulin Delivery Systems (V-Go, Omnipod, InPen) | 11/01/24 | For Omnipod DASH and Omnipod 5, moved device limit (1 per 4 years) from approval duration to criteria and revised approval duration to 30 days due to operational limitations for benefit programming. Added NDC for Omnipod DASH PDM Kit per request. |
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CP.PHAR.577
| Tralokinumab-ldrm (Adbry) | 11/01/24 | RT4: added new autoinjector 300 mg/2 mL dosage formulation and added maximum numbers of injections to approval criteria. |
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CP.PMN.42
| Sodium Oxybate (Xyrem, Lumryz) and Calcium Magnesium Potassium Sodium Oxybate (Xywav) | 11/01/24 | Per SDC: for narcolepsy with cataplexy and narcolepsy with EDS, added redirection to generic Xyrem for brand Xyrem requests and “for Xywav or Lumryz requests” modified failure of “Xyrem” to failure of “sodium oxybate (Xyrem)”; added generic Xyrem to criteria and Xyrem to REMS program information in Appendix C. |
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CP.PHAR.593
| Delandistrogene Moxeparvovec-rokl (Elevidys) | 11/01/24 | RT4: updated FDA approved indications with conversion from accelerated approval to full approval for patients with DMD ≥ 4 years of age and ambulatory plus expansion to non-ambulatory patients (accelerated approval); revised age restrictions to ≥ 4 years (previously ≥ 4 and ≤ 5 years); added treatment of non-ambulatory DMD patients to Section III Diagnosis/Indications not covered based on current available evidence. |
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CP.PHAR.594
| Donanemab-azbt (Kisunla) | 11/01/24 | 4Q 2024 annual review: drug is now FDA-approved – criteria updated per FDA labeling: clarified that the initial 3 month auth duration covers the first 3 monthly infusions instead of the first 4 monthly infusions; for Continued Therapy updated the required follow-up MRI schedule, treatment discontinuation thresholds, and MRI-contingent reauth durations to reflect the Kisunla PI; references reviewed and updated. |
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HIM.PA.SP60
| Biologic and Non-biologic DMARDs | 11/01/24 | Per June SDC: modified Remicade stepwise redirection by adding if member has failed Inflectra, Renflexis, and Avsola, member must use unbranded Remicade; for unbranded Remicade, member must use Inflectra and Renflexis, then if member has failed Inflectra and Renflexis, member must use Avsola; for CD and UC, added additional requirement for Zymfentra requests requiring provider attestation that “member is unable to receive continued therapy with IV infliximab due to lack of caregiver or support system for assistance with administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility.” RT4: for Kevzara, added newly approved polyarticular juvenile idiopathic arthritis indication to criteria; RT4: for Skyrizi, added newly approved Ulcerative Colitis indication to criteria; RT4: for CD, UC, PsO, PsA: added newly approved biosimilar Pyzchiva to criteria.For PsA: added Rinvoq to list of agents for ages > 2 years and older; for Orencia requests for ages 2 to 17 years and Selarsdi/Wezlana requests for ages 6 to 17 years, added Rinvoq to list of redirected agents. |
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CP.PHAR.322
| Pembrolizumab (Keytruda) | 11/01/24 | 3Q 2024 annual review: for cHL, added option to be prescribed with ICE and added pathway for palliative therapy (previously had after hematopoietic stem cell transplant, which falls under palliative therapy) per NCCN; for UC, added pathway to be prescribed as single agent and member has previously received other chemotherapy (previously only allowed post-platinum chemotherapy); for HCC, removed disease is classified as Child-Pugh Class A; for BTC, added option for resected gross residual (R2) disease and removed combination with Lenvima per NCCN; for endometrial carcinoma, clarified continued as a single agent for maintenance therapy when prescribed in combination with carboplatin and paclitaxel; for NCCN recommended uses (off-label): expanded to stage IB for mycosis fungoides, for prescribed as first-line or subsequent therapy - added metastatic anaplastic carcinoma, anaplastic sarcoma, and vaginal cancer, for prescribed as single-agent subsequent therapy – added soft tissue sarcoma subtypes, added option for Keytruda to be prescribed in combination with cyclophosphamide and bevacizumab for platinum-resistant persistent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer per NCCN; for continuation requests, added criterion for maximum duration of therapy (previously was included within requests for dose increase criterion); updated appendix E; references reviewed and updated. RT4: added new FDA approved indication for endometrial cancer in combination with carboplatin and paclitaxel followed by Keytruda as a single agent per PI. |
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CP.PHAR.312
| Blinatumomab (Blincyto) | 11/01/24 | 3Q 2024 annual review: specified that infant ALL must have KMT2A status (11q23 rearranged) and added pathway for use as frontline consolidation therapy per NCCN; revised boxed warning in Appendix C per updated prescribing information; references reviewed and updated.RT4: added new FDA approved indication for Ph- B-ALL as consolidation therapy and added age restriction of at least 1 month per updated prescribing information; rearranged criteria into Ph+ vs Ph- disease, added pathway for use as induction therapy for Ph+ disease, removed requirement that relapsed or refractory Ph+ disease must be refractory to TKIs, added pathway for use as maintenance therapy for Ph- disease, added pathway for use after consolidation therapy and for Ph-like disease for pediatric members, and specified how Blincyto should be prescribed for all uses per NCCN. |
