|
Medical Policy Number
| Medical Policy Name | Effective Date of Change | Description of Changes |
|---|
|
CP.PHAR.11 |
Burosumab-twza (Crysvita)
|
12/01/2025 |
3Q 2025 annual review: for XLH, modified to allow diagnostic confirmation of PHEX gene in member or first-degree relative per competitor analysis, added requirement for documentation of member’s current weight, for dose calculation purposes; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PHAR.147 |
Deferiprone (Ferriprox)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; for chronic iron overload, revised concurrent iron chelator bypass threshold from cardiac T2* < 20 ms to mT2* ≤ 10 ms per TIF guidelines; references reviewed and updated. |
|
CP.PHAR.322 |
Pembrolizumab (Keytruda)
|
12/01/2025 |
3Q 2025 annual review: for NSCLC, updated targeted therapies for EGFR exon 19 deletion, L858R, and ROS1 rearrangement positive disease; for HNSCC added option to be prescribed in combination with Erbitux as first-line therapy or subsequent-line therapy; for cHL, added option to be prescribed in combination with decitabine and vorinostat, for post-allogenic hematopoietic cell transplant or post autologous stem cell rescue, and members not candidate for anthracycline therapy and revised for relapsed disease for both adults and pediatrics after ≥ 1 line of systemic therapy (previously ≥ 2 lines of systemic therapy for pediatrics); for UC, added option to be prescribed in combination with Inlyta or Lenvima, usage for relapsed disease, and prescribed as a single agent for adjuvant therapy; for cervical cancer, added FIGO 2018 stage III-IVA in combination with CRT and added option to be prescribed in combination with Tivdak for tumors expressing PD-L1 and has not received prior immune-oncology therapy, recurrent or metastatic disease, and disease as progressed on or after ≥ 1 line of systemic therapy; for HCC, removed specific treatment regimens member has had disease progression following from and revise to prescribed as subsequent line therapy; for BTC, added option for disease is resectable locoregionally advanced and prescribed as neoadjuvant therapy for gallbladder cancer; for TNBC, added option to be prescribed as preoperative systemic therapy in combination with carboplatin and docetaxel; added off-label usage for central nervous (CNS) cancer, thyroid carcinoma, peritoneal mesothelioma, penile cancer; for mycosis fungoides, revised stage to Stage IA – III; for thymic carcinoma, removed metastatic or unresectable requirement; RT4: updated FDA Approved Indication(s) section and criteria to reflect revised indication that limits use to tumors expressing PD-L1 (CPS ≥ 1) for esophageal or GEJ carcinoma in combination with chemotherapy and HER2-negative gastric or GEJ adenocarcinoma as first-line therapy in combination with chemotherapy per updated PI (previously approved regardless of PD-L1 status); RT4: updated FDA Approved Indications(s) section for cervical cancer to clarify FIGO 2014 Stage III-IVA per updated PI; updated Appendix E with addition of soft tissue sarcoma as an example for MSI-H solid tumors and small bowel adenocarcinoma for TMB-H solid tumors; updated Appendix G with revised language and exception for Tennessee; references reviewed and updated.
Per June SDC: added redirection to Tevimbra for HER2-negative gastric or GEJ adenocarcinoma and esophageal carcinoma or GEJ squamous cell carcinoma.
RT4: added new FDA approved indication for usage in the neoadjuvant/adjuvant setting for locally advanced HNSCC. |
|
CP.PHAR.408 |
Niraparib (Zejula)
|
12/01/2025 |
RT4: updated indication for maintenance treatment of adult patients with advanced ovarian cancer in the first-line setting with restriction to those with HRD-positive tumors only per updated PI; for ovarian cancer, added criteria for members with platinum-sensitive persistent or recurrent disease per NCCN and revised tablet quantity limit from 3 tablets to 1 tablet. |
|
CP.PHAR.415 |
Ravulizumab-cwvz (Ultomiris)
|
12/01/2025 |
3Q 2025 annual review: updated the list of therapies that Ultomiris should not be prescribed concurrently with to include Epysqli for all indications and PiaSky for PNH; for gMG, clarified that the required immunosuppressive therapy should be non-steroidal; revised continued approval duration from 6 to 12 months for all indications as they are chronic conditions; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PHAR.447 |
Mercaptopurine (Purixan)
|
12/01/2025 |
Added redirection to generic oral suspension; for redirection to mercaptopurine tablets revised verbiage from “member must use” to “failure of.” |
|
CP.PHAR.458 |
Inebilizumab-cdon (Uplizna)
|
12/01/2025 |
3Q 2025 annual review: for NMOSD, added Epysqli to the list of therapies that Uplizna should not be prescribed concurrently with, and revised continued approval duration from 6 to 12 months as NMOSD is a chronic condition; RT4: added criteria for the newly approved indication of IgG4-RD; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PHAR.495 |
Mitomycin Instillation Solution (Jelmyto, Zusduri)
|
12/01/2025 |
3Q 2025 annual review: removed requirement for cancer location above the ureteropelvic junction per NCCN; removed exclusion for “recent history of carcinoma in situ in the urinary tract, invasive urothelial carcinoma, or high-grade papillary urothelial carcinoma” as this is not excluded per NCCN or the FDA indication; added requirement for use as monotherapy per NCCN; references reviewed and updated.
RT4: added criteria for newly approved Zusduri; policy renamed to “Mitomycin Instillation Solution.” |
|
CP.PHAR.543 |
Maralixibat (Livmarli)
|
12/01/2025 |
3Q 2025 annual review: for ALGS initial and continued therapy and PFIC continued therapy, added exclusion for concurrent use with other IBAT inhibitors; RT4: added new tablet formulation [10 mg, 15 mg, 20 mg, 30 mg] for ALGS and PFIC; for ALGS, updated criteria from “request is for oral solution 9.5 mg/mL” to “if request is for oral solution, request is for 9.5 mg/mL strength”; for PFIC, updated criteria from “request is for oral solution 19 mg/mL” to “request is for oral solution, request is for 19 mg/mL strength”; for both indications, added criteria “if request is for tablets, documentation of member’s current body weight ≥ 25 kg”; for section V, updated ALGS and PFIC sections with tablet dosage by weight; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PHAR.656 |
Iptacopan (Fabhalta)
|
12/01/2025 |
3Q 2025 annual review: for PNH, added Epysqli and PiaSky to the list of therapies that Fabhalta should not be prescribed concurrently with, and revised continued approval duration from 6 to 12 months as PNH is a chronic condition; references reviewed and updated.
Per June SDC: for IgAN, added redirection to Filspari or Vanrafia in initial approval criteria.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PHAR.665 |
Danicopan (Voydeya)
|
12/01/2025 |
3Q 2025 annual review: added Epysqli (Soliris biosimilar) as another C5 inhibitor option; added requirement for no concurrent use with Empaveli, Fabhalta, or PiaSky; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PHAR.97 |
Eculizumab (Soliris, Bkemv, Epysqli)
|
12/01/2025 |
3Q 2025 annual review: RT4: updated FDA approved indication for Bkemv to include adult patients with gMG who are AChR antibody positive; for PNH, added PiaSky to the list of therapies that Soliris/Bkemv/Epysqli should not be prescribed concurrently with; for gMG, clarified that the required immunosuppressive therapy should be non-steroidal; revised continued approval duration from 6 to 12 months for all indications as they are chronic conditions; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PMN.157 |
Rufinamide (Banzel)
|
12/01/2025 |
3Q 2025 annual review: no significant changes; generic redirection added to Continued Therapy section; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated. |
|
CP.PMN.239 |
Chenodiol (Chenodal, Ctexli)
|
12/01/2025 |
3Q 2025 annual review: for CTX, added that diagnosis must be confirmed by genetic testing and added specialist prescriber requirement for this rare genetic disease; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. |
|
CP.PMN.240 |
Gabapentin ER (Gralise, Horizant)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; for PHN, added member must use generic Gralise if available; in Appendix B, updated dosing regimens and clarified listed therapeutics alternatives have evidence supporting their use in the indications covered by this policy; references reviewed and updated. |
|
HIM.PA.SP1 |
Sofosbuvir-Velpatasvir (Epclusa)
|
12/01/2025 |
3Q 2025 annual review: for continued therapy criteria, added “Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen”; references reviewed and updated.
For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days. |
|
HIM.PA.SP2 |
Sofosbuvir (Sovaldi)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; for continued therapy criteria, added “Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen”; references reviewed and updated.
For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype. |
|
HIM.PA.SP3 |
Ledipasvir-Sofosbuvir (Harvoni)
|
12/01/2025 |
3Q 2025 annual review: for continued therapy criteria, added “Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen”; references reviewed and updated.
Added step therapy bypass for IL HIM per IL HB 5395. For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype. |
|
HIM.PA.SP36 |
Glecaprevir-Pibrentasvir (Mavyret)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; for continued therapy criteria, added “Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen”; references reviewed and updated.
RT4: updated indication to include acute HCV. For continued therapy criteria, revised option for treatment duration minimum from 40 days to 28 days and removed requirement for specific confirmed genotype. |
|
HIM.PA.SP62 |
Elbasvir-Grazoprevir (Zepatier)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; for continued therapy criteria, added “Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen”; references reviewed and updated.
For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype. |
|
HIM.PA.SP63 |
Sofosbuvir-Vepatasvir-Voxilaprevir (Vosevi)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; for continued therapy criteria, added “Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen”; references reviewed and updated.
For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype with treatment status. |
|
CP.PCH.55 |
Epinephrine (Epipen, Epipen Jr, Neffy, Auvi-Q)
|
12/01/2025 |
3Q 2025 annual review: updated Auvi-Q indication and added weight minimum in initial criteria per FDA labeled indication; updated criteria from “for Neffy requests only, has manual dexterity limitations that preclude use of an auto-injector” to “for Neffy requests only, has limitations (e.g., manual dexterity, needle phobia) that preclude use of an auto-injector”; for section VI, updated Auvi-Q dose from 0.15 mg/0.3 mL to 0.15 mg/0.15 mL per prescribing information; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated |
|
CP.PHAR.121 |
Nivolumab, Nivolumab Hyaluronidase-nvhy
|
12/01/2025 |
Per June SDC: for ESCC and gastric/GEJ adenocarcinoma, added redirection to Tevimbra. |
|
CP.PHAR.145 |
Deferasirox (Exjade, Jadenu)
|
12/01/2025 |
3Q 2025 annual review: for chronic iron overload, revised concurrent iron chelator bypass threshold from cardiacT2* < 20 ms to mT2* ≤ 10 ms per TIF guidelines; references reviewed and updated. |
|
CP.PHAR.146 |
Deferoxamine (Desferal)
|
12/01/2025 |
3Q 2025 annual review: for chronic iron overload, revised concurrent iron chelator bypass threshold from cardiac T2* < 20 ms to mT2* ≤ 10 ms per TIF guidelines; references reviewed and updated |
|
CP.PHAR.169 |
Vigabatrin (Sabril, Vigafyde)
|
12/01/2025 |
3Q 2025 annual review: no significant changes; added a generic redirection for brand Sabril; references reviewed and updated. |
|
CP.PHAR.210 |
Ivacaftor (Kalydeco)
|
12/01/2025 |
3Q 2025 annual review: added Alyftrek to list of CFTR modulator concurrent exclusion criteria; references reviewed and updated. |
|
CP.PHAR.213 |
Lumacaftor/Ivacaftor (Orkambi)
|
12/01/2025 |
3Q 2025 annual review: added Alyftrek to list of CFTR modulator concurrent exclusion criteria; references reviewed and updated. |
|
CP.PHAR.27 |
Tolvaptan (Jynarque, Samsca)
|
12/01/2025 |
3Q 2025 annual review: for ADPKD, added requirements for minimum eGFR and high risk for rapidly progressive disease per 2025 KDIGO guidelines and in alignment with pivotal study design and FDA labeling, respectively; for Jynarque, added redirection to generic tolvaptan; references reviewed and updated. |
|
CP.PHAR.295 |
Sargramostim (Leukine)
|
12/01/2025 |
3Q 2025 annual review: per NCCN Compendium for neuroblastoma removed requirement for relapse or refractory disease, clarified combination with Danyelza should also include temozolomide and irinotecan; added step therapy bypass for IL HIM per IL HB 5395; updated Appendix E with revised language and exception for Tennessee; references reviewed and updated. |
|
CP.PHAR.302 |
Ixazomib (Ninlaro)
|
12/01/2025 |
3Q 2025 annual review: added NCCN Compendium supported use as primary treatment as a substitute for bortezomib or carfilzomib; clarified for combination with dexamethasone and Pomalyst, member is lenalidomide- or anti-CD-38-refractory; references reviewed and updated. |
|
CP.PHAR.303 |
Brentuximab Vedotin (Adcetris)
|
12/01/2025 |
3Q 2025 annual review: per NCCN – for cHL, added option for use with CHP as alternative to AVD if vinblastine is unavailable due to shortage, added option for use with nivolumab for age > 60 years, revised requirements around use as component of BrECADD (removed requirement for stage III-IV disease, added option for use with Deauville score 4-5, added requirement for use with granulocyte colony-stimulating factor); for pediatric cHL, added option for use as a component of BrECADD and Bv-AVD for stage III-IV disease, specified that only use following high-dose therapy and autologous stem cell rescue has to be in high-risk disease, and modified requirement for high risk disease for nearly all requests to instead require risk factors only for stage I-II disease; for MF/Sezary syndrome, removed option for combination use with bendamustine; references reviewed and updated. |
|
CP.PHAR.312 |
Blinatumomab (Blincyto)
|
12/01/2025 |
3Q 2025 annual review: per NCCN – clarified that Ph refers to adult disease and added the term BCR::ABL1 for pediatric disease; for pediatrics, removed pathways for use after consolidation therapy and added combination therapy option for BCR::ABL1-negative/like disease; for infant ALL, removed requirement for KMT2A status (11q23 rearranged); references reviewed and updated. |
|
CP.PHAR.377 |
Tezacaftor/Ivacaftor; Ivacaftor (Symdeko)
|
12/01/2025 |
3Q 2025 annual review: added Alyftrek to list of CFTR modulator concurrent exclusion criteria; references reviewed and updated. |
|
CP.PHAR.424 |
Fulvestrant (Faslodex Injection)
|
12/01/2025 |
3Q 2025 annual review: for breast cancer, added triple negative disease option per NCCN; for ovarian, fallopian tube, and primary peritoneal cancer, endometrial carcinoma, and uterine cancer, added requirement for monotherapy per NCCN; references reviewed and updated. |
|
CP.PHAR.428 |
Romosozumab-aqqg (Evenity)
|
12/01/2025 |
Revised initial approval duration to 12 months for Medicaid/HIM; added Commercial approval duration of 6 months or to the member’s renewal date, whichever is longer; revised continuation of therapy to state member must meet the initial approval criteria. |
|
CP.PHAR.430 |
Alpelisib (Piqray, Vijoice)
|
12/01/2025 |
3Q 2025 annual review: for breast cancer, removed requirement for “locally” in “locally recurrent” and added for premenopausal female member to be treated with ovarian ablation/suppression per NCCN; references reviewed and updated. |
|
CP.PHAR.433 |
Polatuzumab Vedotin-piiq (Polivy)
|
12/01/2025 |
3Q 2025 annual review: per NCCN – for PTLD, removed specification that disease must be monomorphic and added option for use in combination with R-CHP for disease with IPI score ≥ 2; for second-line use, added that member is either not a candidate for CAR T-cell therapy or Polivy is prescribed as bridging therapy until CAR T-cell therapy becomes available and added option for use in combination with Lunsumio for non-transplant/CAR T-cell therapy candidates; references reviewed and updated. |
|
CP.PHAR.440 |
Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta)
|
12/01/2025 |
3Q 2025 annual review: added Alyftrek to list of CFTR modulator concurrent exclusion criteria; references reviewed and updated. |
|
CP.PHAR.449 |
Crizanlizumab-tmca (Adakveo)
|
12/01/2025 |
For hydroxyurea trial, added that documentation supports adherence to hydroxyurea for at least the past 6 months, examples of hydroxyurea contraindications and intolerances, and a bypass option requiring provider attestation of past adherence to hydroxyurea for ≥ 6 months at the maximum tolerated dose and ≥ 1 VOC while on the maximum tolerated dose; removed ICD-10-CM Codes section. |
|
CP.PHAR.463 |
Satralizumab-mwge (Enspryng)
|
12/01/2025 |
3Q 2025 annual review: added step therapy bypass for IL HIM per IL HB 5395; added Epysqli to the list of therapies that Enspryng
should not be prescribed concurrently with; revised continued approval duration from 6 to 12 months as NMOSD is a chronic condition; references reviewed and updated. |
|
CP.PHAR.496 |
Pemigatinib (Pemazyre)
|
12/01/2025 |
3Q 2025 annual review: updated regimens in Appendix B; references reviewed and updated. |
|
CP.PHAR.524 |
Pegcetacoplan (Empaveli, Syfovre)
|
12/01/2025 |
3Q 2025 annual review: for PNH, added Epysqli and PiaSky to the list of therapies that Empaveli should not be prescribed concurrently with, added improvement of extravascular hemolysis as an example of positive response to therapy, and revised continued approval duration from 6 to 12 months as PNH is a chronic condition; updated Syfovre contraindications in Appendix C to include hypersensitivity per updated prescribing information; references reviewed and updated. |
|
CP.PHAR.540 |
Dostarlimab-gxly (Jemperli)
|
12/01/2025 |
3Q 2025 annual review: for EC, added that combination use with carboplatin/paclitaxel for advanced/recurrent disease may be followed by single agent use per FDA labeling and NCCN; for solid tumors, removed option for early-stage gastric cancer, added option for locally unresectable, medically inoperable, or POLE/POLD1 mutated small bowel adenocarcinoma, and clarified that POLE/POLD1 mutation should have ultra-hypermutated phenotype per NCCN; added off-label criteria for anal carcinoma per NCCN; references reviewed and updated. |
|
CP.PHAR.545 |
Betibeglogene Autotemcel (Zynteglo)
|
12/01/2025 |
3Q 2025 annual review: no significant changes; added template statement requiring medical director review; added criterion for documentation of member’s body weight for verification of weight-based dose; references reviewed and updated. |
|
CP.PHAR.592 |
Beremagene geperpavec-svdt (Vyjuvek)
|
12/01/2025 |
3Q 2025 annual review: added exclusion of concomitant use with Zevaskyn; references reviewed and updated. |
|
CP.PHAR.61 |
Cinacalcet (Sensipar)
|
12/01/2025 |
3Q 2025 annual review: for primary HPT, added requirement that member has failed or is unable to undergo a parathyroidectomy per FDA-labeled indication; included Parsabiv as an example of a calcimimetic that should not be prescribed concurrently with cinacalcet; for secondary HPT, added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated. |
|
CP.PHAR.81 |
Pazopanib (Votrient)
|
12/01/2025 |
3Q 2025 annual review: for thyroid carcinoma, removed requirement for iodine-refractory disease for oncocytic carcinoma, added requirement for progressive or symptomatic disease for medullary carcinoma, and updated trial options for medullary carcinoma to include Retevmo per NCCN; added off-label criteria for Merkel cell carcinoma per NCCN; references reviewed and updated. |
|
CP.PHAR.89 |
Peginterferon Alfa-2a (Pegasys)
|
12/01/2025 |
3Q 2025 annual review: for primary cutaneous CD30+ T-cell lymphoproliferative disorder, clarified diagnosis as primary cutaneous anaplastic large cell lymphoma and added requirement for monotherapy use per NCCN; references reviewed and updated. |
|
CP.PMN.280 |
Compounded Medications
|
12/01/2025 |
3Q 2025 annual review: added route of administration, in addition to the indication, for requirement that acceptable compendium supports efficacy and safety. |
|
CP.PMN.281 |
Topiramate Extended-Release (Qudexy XR, Trokendi XR)
|
12/01/2025 |
3Q 2025 annual review: no significant changes; extended the generic redirection requirement to the Continued Therapy section for seizures; references reviewed and updated. |
|
CP.PMN.44 |
Pyrimethamine (Daraprim)
|
12/01/2025 |
3Q 2025 annual review: for initial therapy for toxoplasmosis active disease, added step therapy bypass for IL HIM per IL HB 5395; for toxoplasmosis prophylaxis, clarified member must use TMP-SMX unless contraindicated or clinically significant adverse effects are experienced; in continued therapy for chronic maintenance following initial therapy for active disease, increased duration of approval from 6 months to 12 months; in Appendix B, clarified dosing regimen per guideline; updated Section V per guidelines; references reviewed and updated. |
|
CP.PMN.65 |
Vortioxetine (Trintellix)
|
12/01/2025 |
3Q 2025 annual review: clarified failure of two antidepressants from at least two different drug classes; added step therapy bypass for IL HIM per IL HB 5395; in Appendix B, updated therapeutic alternative per Clinical Pharmacology; references reviewed and updated. |
|
HIM.PA.125 |
Levomilnacipran (Fetzima)
|
12/01/2025 |
3Q 2025 annual review: clarified failure of two antidepressants from at least two different drug classes; added step therapy bypass for IL HIM per IL HB 5395; in Appendix B, updated therapeutic alternatives per Clinical Pharmacology; references reviewed and updated. |
|
HIM.PA.SP61 |
Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir (Viekira Pak)
|
10/01/2025 |
Retired |
