Policy created per SDC (adapted from CP.PHAR.373 with the following revisions: for initial approval criteria, modified criteria requiring history of two exacerbations to instead require one exacerbation, added allowance for ER visit, removed intubation option, modified requirement of “LTRA” to “one additional asthma controller medication”). RT4: added criteria for newly approved indication of EGPA.
4Q 2024 annual review: in initial approval criteria, clarified that combination products may require prior authorization, removed redirection to specific concentrations for benzoyl peroxide and tretinoin, removed redirection to trimethoprim-sulfamethoxazole per acne guideline; updated Appendix B per Clinical Pharmacology; references reviewed and updated.
CP.PHAR.121
Nivolumab (Opdivo)
03/01/25
RT4: added new FDA-approved indication for neoadjuvant treatment followed by single-agent Opdivo as adjuvant treatment after surgery for NSCLC; increased maximum duration allowed for neoadjuvant therapy from 3 cycles/9 weeks to 4 cycles/12 weeks.
Ad hoc: for continued therapy: added criterion for maximum duration of therapy limit of 13 cycles for adjuvant NSCLC, up to 1 year for all other adjuvant treatment, and up to 2 years for metastatic or recurrent NSCLC, malignant pleural mesothelioma, advanced RCC in combination with cabozatinib, unresectable or metastatic UC, ESCC, gastric cancer, EGJ, and esophageal adenocarcinoma; revised dose limit for NSCLC in combination with Yervoy to 360 mg every 3 weeks; added additional dose limit option of 240 mg every 2 weeks for gastric cancer, EGJ cancer, and esophageal adenocarcinoma.
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