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Pharmacy Policy Changes - June 2025
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Medical Policy Number
| Medical Policy Name | Effective Date of Change | Description of Changes |
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CP.PHAR.121 |
Nivolumab (Opdivo), Nivolumab/Hyaluronidase-nvhy (Opdivo Qvantig)
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09/01/2025 |
Per March SDC, for SCCHN, added redirection for nasopharyngeal carcinoma to Loqtorzi; added Appendix F to include states with regulations against redirections in cancer.
RT4: for CRC: updated FDA Approved Indication(s) section to include combination use with Yervoy for unresectable or metastatic MSI-H or dMMR CRC and to reflect conversion from accelerated approval to full approval for MSI-H or dMMR CRC that has progressed following treatment with fluropyrimidine, oxaliplatin, and irinotecan per PI, clarified criteria for Opdivo Qvantig requests is prescribed as subsequent-line systemic therapy per PI, updated Section V for adult and pediatric patients weighing ≥ 40 kg from "3 mg/kg” to “240 mg” IV followed by ipilimumab on the same day and added option for 6 mg/kg every 4 weeks after combination with ipilimumab for pediatric patients weighing < 40 kg per PI; for HCC: updated FDA Approved Indication(s) section with addition of first-line treatment in combination with ipilimumab and conversion from accelerated approval to full approval for those who has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan per PI and updated criteria with the following: added disease is unresectable or metastatic, added criteria for usage in first-line systemic therapy setting and additional criteria for subsequent-line systemic therapy setting per NCCN. |
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CP.PHAR.319 |
Ipilimumab (Yervoy)
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09/01/2025 |
2Q 2025 annual review: updated FDA indication for RCC and HCC to mirror PI; for melanoma, clarified combination use with Keytruda is off-label use per NCCN and revised adjuvant treatment maximum dosage per PI; for NSCLC per NCCN, added criteria for NRG1 gene fusion positive; removed criteria for the following mutations: RET rearrangement, EGFR exon 19 deletion, exon 21 L858R, ALK rearrangement, ROS1 rearrangement; for ESCC per NCCN, added off-label indication for prescribed as induction systemic therapy; for off-label NCCN compendium indications, consolidated MSI-H/dMMR cancers, revised biliary tract cancer criteria to allow primary treatment; in Appendix B, removed entries that are not redirections (Opdivo and Keytruda); in Appendix D, added no longer recommended indications; in Section V, clarified dosing regimen wording per PI; references reviewed and updated.
RT4: for CRC, updated FDA Approved Indication(s) section to earlier line of therapy with removal of language “that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan” and conversion from accelerated approval to full approval per PI and updated dosing in Section V to reflect a maximum of 4 doses per PI; for HCC, updated FDA Approved Indication(s) section with addition of first-line treatment in combination with nivolumab and conversion from accelerated approval to full approval for those who have been previously treated with sorafenib per PI, and updated criteria with the following: added disease is unresectable, metastatic or advanced; removed documentation of Child-Pugh Class A status and member has previously received Nexavar, Lenvima, or Tecentriq + bevacizumab; added criteria for usage in first-line and subsequent-line systemic therapy setting per NCCN. |
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CP.PHAR.322 |
Pembrolizumab (Keytruda)
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09/01/2025 |
Per March SDC, for HNSCC, added redirection for nasopharyngeal carcinoma to Loqtorzi; added Appendix G to include states with regulations against redirections in cancer.
RT4: updated FDA Approved Indication(s) section for first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (CPS ≥ 1) from accelerated approval to full approval per PI; for gastric cancer, esophageal cancer, or GEJ cancer, added option to bypass disease is unresectable, locally advanced, recurrent, or metastatic if member is planned for esophagectomy per NCCN.
Added step therapy bypass for IL HIM per IL HB 5395. |
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CP.PHAR.339 |
Durvalumab (Imfinzi)
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09/01/2025 |
2Q 2025 annual review: per NCCN – for NSCLC, added that Imfinzi must be prescribed as a single agent and that disease does not have EGFR exon 19 deletion or exon 21 L858R mutation if stage II-III; added use as first-line therapy for NRG1 gene fusion positive tumors; removed use as subsequent therapy for EGFR exon 19 deletion, exon 21 deletion, exon 21 L858R tumors, ALK1 rearrangement, and ROS1 rearrangement positive tumors; for HCC; added additional qualifier of extrahepatic; for endometrial cancer, added additional qualifiers of metastatic, stage III, and stage IV; for cervical cancer, added that Imfinzi can be used as a single agent for maintenance therapy following combination use; for ampullary adenocarcinoma, removed qualifiers of unresectable localized and stage IV resected; for BTC, added “with curative intent” for recurrent definition to align with NCCN compendium wording; RT4: updated FDA approved indication for dMMR endometrial cancer to include FDA approved testing language; references reviewed and updated.
RT4: added criteria for newly FDA-approved indication of MIBC; under continued approval duration, revised maximum number of cycles for resectable NSCLC from 12 to 16 to include neoadjuvant treatment. |
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CP.PHAR.596 |
Lecanemab-irmb (Leqembi)
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09/01/2025 |
In the Continued Therapy section, removed the word “baseline” in reference to the required cognitive and functional tests to ensure that Leqembi therapy is not continued in those who have progressed to the moderate stage of disease severity. |
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HIM.PA.SP60 |
Biologic and Non-biologic DMARDs
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09/01/2025 |
RT4: for Rinvoq, added newly approved GCA indication to criteria. Added HCPCS codes [Q5098, Q5099, and Q5100]. |
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CP.PHAR.259 |
Natalizumab (Tysabri, Tyruko)
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09/01/2025 |
Per April SDC: for CD, added criteria requiring use of one preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, and Steqeyma are preferred). |
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CP.PHAR.93 |
Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev)
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09/01/2025 |
RT4: added newly FDA-approved biosimilar Jobevne to criteria; for cervical cancer, added Tecentriq as an option to combination therapy for paclitaxel/cisplatin and paclitaxel/carboplatin, and clarified topotecan is used with paclitaxel per NCCN; for HCC, removed option for use as adjuvant therapy following resection or ablation and member is at high risk for recurrence and added option for use as subsequent-line systemic therapy if progression on or after systemic therapy per NCCN. |
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CP.PHAR.619 |
Nedosiran (Rivfloza)
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09/01/2025 |
RT4: revised age and dosing criteria for updated pediatric extension to include children aged ≥ 2 years and added requirement that request must be for a prefilled syringe unless the monthly dose is < 128 mg. |
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For questions about QualChoice Medical Coverage Policies, please contact your Provider Relations Representative at 800.235.7111 or 501.228.7111, Monday through Friday, 8:00 a.m. to 5:00 p.m.
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