October Policy Updates

Policy

Policy Name

Revision

Effective Date

CP.PHAR.130

vatrombopag (Doptelet, Doptelet Sprinkle)

Per August SDC, added redirection to eltrombopag (generic Promacta) for ITP. Per September SDC, removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid. 

1/1/2026

CP.PHAR.165

Ferumoxytol (Feraheme)

Modified to redirect from brand Venofer to generic per SDC request.

1/1/2026

CP.PHAR.179

Romiplostim (Nplate)

Per August SDC, added redirection to eltrombopag (generic Promacta) for ITP and MDS. Per September SDC, for ITP removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid. For ITP and NCCN supported uses, revised initial approval duration from 6 to 12 months.

1/1/2026

CP.PHAR.180

Eltrombopag (Alvaiz, Promacta)

Per August SDC, added redirection to eltrombopag (generic Promacta). Per September SDC, for ITP removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid. For all indications other than hepatitis C-associated thrombocytopenia, revised initial approval duration from 6 to 12 months.
*For Health Insurance Marketplace (HIM), if request is through pharmacy benefit, Alvaiz is non-formulary and should not be approved using these criteria; refer to the formulary exception policy, HIM.PA.103. 

1/1/2026

CP.PHAR.234

Ferric Carboxymaltose (Injectafer)

Modified to redirect from brand Venofer to generic per SDC request.

1/1/2026

CP.PHAR.24

Fostamatinib (Tavalisse)

Per August SDC, added redirection to eltrombopag (generic Promacta). Per September SDC, removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid. Revised initial approval duration from 6 to 12 months.

1/1/2026

CP.PHAR.340

Valbenazine (ingrezza, Ingrezza Sprinkle)

Per SDC request, added HIM line of business (removed from CP.PCH.48 which is being retired).

1/1/2026

CP.PHAR.480

Ferric Derisomaltose (Monoferric)

Modified to redirect from brand Venofer to generic per SDC request; added step therapy bypass for IL HIM per IL HB 5395.

1/1/2026

CP.PHAR.625

Concizumab-mtci (Alhemo)

RT4: added new indication for hemophilia A and B without inhibitors; added step therapy bypass for IL HIM per IL HB 5395; added continued therapy criterion for provider confirmation that member has discontinued any use of Hemlibra, bypassing agents, FVIII, or FIX products as prophylactic therapy while on Alhemo. HCPCS code added [J7173], HCPCS codes removed [C9399, J3590].

1/1/2026

CP.PHAR.717

Donidalorsen (Dawnzera)

Per September SDC, added redirection to one of the following: Haegarda, Takhzyro, or Orladeyo.

1/1/2026

CP.PHAR.725

Tiopronin Delayed-Release (Thiola EC)

Per SDC request, added requirement for Thiola EC requests that member must use tiopronin delayed-release (generic Thiola EC).

1/1/2026

CP.PMN.156

Perampanel (Fycompa)

Per August SDC, revised policy/criteria to also include generic parampanel and added required use of generic perampanel for brand Fycompa requests. 

1/1/2026

CP.PMN.33

Pregabalin (Lyrica, Lyrica CR)

Per September SDC, added clarification for Commercial and Health Insurance Marketplace (HIM), requests for immediate-release pregabalin (Lyrica) should be reviewed using step therapy criteria CP.CPA.83 for Commercial, and HIM.PA.109 for Health Insurance Marketplace.
*For Commercial and Health Insurance Marketplace (HIM), requests for immediate-release pregabalin (Lyrica) should be reviewed using step therapy criteria CP.CPA.83 for Commercial, and HIM.PA.109 for Health Insurance Marketplace.

1/1/2026

HIM.PA.09

Insulin glargine (Basaglar, Lantus, Rezvoglar, Toujeo) 

Per August SDC, removed redirection to branded Semglee and unbranded Tresiba from policy; added redirection to insulin glargine-yfgn (unbranded Semglee) and branded Tresiba.

1/1/2026

HIM.PA.109

Step Therapy Criteria

Per April SDC, removed Azelex from policy. Per August SDC, for Aptiom added redirection to eslicarbazepine (generic Aptiom). Per September SDC, added pregabalin immediate-release (Lyrica) requiring step through gabapentin and one of the following: antidepressant, anticonvulsant, buspirone, or cyclobenzaprine.
*For Eucrisa requests, this policy applies only to Fidelis Health Plan members, for all other Eucrisa requests refer to CP.PMN.110
^For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB 5395.

1/1/2026

HIM.PA.153

Inhaled asthma and COPD agents

Per August SDC, for LABA/LAMA and Ohtuvayre requests revised redirection from brand Anoro Ellipta to umeclidinium/vilanterol (Anoro Ellipta authorized generic), added brand Anoro Ellipta to criteria requiring prior authorization as agent is non-formulary and applied redirection to authorized generic. 

1/1/2026

HIM.PA.171

Insulin detemir (Levemir)

Per August SDC, removed redirection to branded Semglee and unbranded Tresiba from policy; added redirection to insulin glargine-yfgn (unbranded Semglee) and branded Tresiba.

1/1/2026

HIM.PA.175

Mepolizumab (Nucala)

Revised initial approval durations from 6 to 12 months. Per SDC request, the following revisions we made: for asthma increased required exacerbations from 1 to 2 in the last 12 months, added redirection to Dupixent and Fasenra; for EGPA added redirection to Fasenra; for HES added redirection to corticosteroid and removed criteria requiring member has tried at least one other HES treatment for a minimum of 4 weeks; for CRSwNP increased required intranasal corticosteroids from 1 to 2, added redirection to Dupixent for initial and continuation requests; for COPD added redirection to Dupixent.

1/1/2026

HIM.PA.176

Tezepelumab (Tezspire)

Per SDC request, removed redirection to Nucala.

1/1/2026

HIM.PA.177

Age Limit Override

Policy created.
* All requests for non-formulary drugs should be reviewed against HIM.PA.103 Brand Name Override and Non-Formulary Medications

1/1/2026

HIM.PA.91

SGLT2 inhibitors

Per August SDC: removed reference to branded Farxiga where redirection is stated for dapagliflozin. 

1/1/2026

HIM.PA.SP60

Biologic and Non-biologic DMARDs

Per August SDC: for PsO, PsA, CD, and UC initial approval criteria, added redirection to additional preferred ustekinumab products (Pyzchiva, Steqeyma, and Yesintek) and applied to continuation of therapy requests, and for members initiating therapy with Stelara added a single step through preferred agents; for RA, pJIA, PsA, AS, CD, UC, PsO, HS, UV initial therapy, added redirection to preferred adalimumab products (adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, Simlandi) and removed redirection to Cyltezo; for members initiating therapy with Humira initial approval criteria, added single step through preferred agents. 

1/1/2026

HIM.PA.178

Immune Globulins

Policy created (adapted from CP.PHAR.103) per SDC request to remove step through Gammagard, Gammaked and Gamunex for HyQqvia.

1/1/2026

CP.PHAR.116

Pomalidomide (Pomalyst)

Per August SDC, removed redirection to generic.

3/1/2026

CP.PHAR.129

Venetoclax (Venclexta)

4Q 2025 annual review: revised Medicaid and HIM initial approval durations to 12 months for all indications; for CLL/SLL, removed the requirement for “relapse if previously used as first-line therapy” when used in combination with Gazyva per NCCN, removed requirement for “for relapsed/refractory disease” when used as subsequent therapy per NCCN, added combination therapies recommended per NCCN; for AML, removed the age ≥ 60 years pathway and added the FDA-labeled option for age ≥ 75 years, replaced “disease is newly diagnosed” with “induction, post-induction, or consolidation therapy” per NCCN, and simplified criteria for relapsed/refractory disease; for MM, added option for central nervous system per NCCN; for additional NCCN recommended uses section, added adult ALL supported uses and MDS use per NCCN; references reviewed and updated.

3/1/2026

CP.PHAR.130

Avatrombopag (Doptelet)

4Q 2025 annual review: RT4: updated pediatric extension for ITP and added new formulation Doptelet Sprinkle (oral granules) to policy; for ITP diagnosis criterion, added option that ITP could be persistent; approval duration for ITP revised from 6 months to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.131

Infertility and Fertility Preservation

4Q 2025 annual review: evidence of coverage for infertility/fertility preservation language added for HIM line of business (DE, GA, IN, KS, KY, MI, MO, NE, NY, NH, OH, OK, PA, SC, TN, TX); references reviewed and updated.

3/1/2026

CP.PHAR.134

Methotrexate (Otrexup, Rasuvo, Xatmep, Reditrex, Jylamvo)

4Q 2025 annual review: for MF, clarified disease is stage IA-III per NCCN; for Jylamvo, added off-label indication for Sezary syndrome stage IV, primary cutaneous CD30+ T-cell lymphoproliferative disorders – subtype ACLC and LyP, subcutaneous panniculitis-like T-cell lymphoma and management of immunotherapy-related toxicities as supported by NCCN 2A; updated initial approval duration for all indications from 6 to 12 months for Medicaid/HIM lines of business; Added HCPCS code [C9399, J3490]; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PHAR.137

Ivosidenib (Tibsovo)

4Q 2025 annual review: revised Medicaid and HIM initial approval durations to 12 months; for AML, removed the age ≥ 60 years pathway, removed requirement that disease is newly diagnosed, added requirement for monotherapy use in relapsed/refractory disease, and replaced medical justification requirement for inability to use intensive induction chemotherapy with option to either be unsuitable candidate or decline per NCCN; for MDS, added option for higher-risk disease per NCCN; for glioma indication, added requirement for lack of Voranigo tolerability per NCCN; references reviewed and updated.

3/1/2026

CP.PHAR.138

Lenvatinib (Lenvima)

4Q 2025 annual review: for all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; for DTC, added Lenvima use in oncocytic carcinoma that is not RAI-refractory per NCCN and added off-label use in combination with pembrolizumab per NCCN; for MTC, added Retevmo as an option for treatment failure; for EC, clarified that EC should be advanced or recurrent and added option for off label use as a single agent per NCCN; references reviewed and updated.

3/1/2026

CP.PHAR.140

Pegvaliase-pqpz (Palynziq)

4Q 2025 annual review: added Sephience (newly FDA-approved for PKU) as an agent that should not be used concomitantly with Palynziq; references reviewed and updated.

3/1/2026

CP.PHAR.149

Baclofen (Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax/Ozobax DS)

4Q 2025 annual review: added member must use generic baclofen vial or ampule language for Gablofen vial or Lioresal requests; for Gablofen and Lioresal updated approval duration for initial and continued therapy to 12 months; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PHAR.171

Goserelin Acetate (Zoladex)

4Q 2025 annual review: added NCCN compendium supported off-label uses in ovarian cancer, salivary gland tumors, and uterine sarcoma; references reviewed and updated. Added step therapy bypass for IL HIM per IL HB 5395.

3/1/2026

CP.PHAR.175

Triptorelin Pamoate (Trelstar, Triptodur)

4Q 2025 annual review: for Trelstar added NCCN compendium supported off-label uses in breast cancer, salivary gland tumors, and uterine sarcoma; references reviewed and updated.

3/1/2026

CP.PHAR.246

Canakinumab (Ilaris)

For sJIA, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy.

3/1/2026

CP.PHAR.259

Natalizumab (Tysabri), Natalizumab-sztn (Tyruko)

For CD, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy.

3/1/2026

CP.PHAR.260

ituximab (Rituxan), Rituximab-arrx (Riabni), Rituximab-pvvr (Ruxience), Rituximab-abbs (Truxima), Rituximab/Hyaluronidase (Rituxan Hycela)

Per SDC, added off-label criteria for bullous pemphigoid. For RA, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy.

3/1/2026

CP.PHAR.304

Irinotecan Liposome (Onivyde)

4Q 2025 annual review: for ampullary adenocarcinoma, added option for prescribed in combination with NALIRIFOX regimen as first-line therapy for metastatic disease per NCCN; for initial approval criteria, extended approval duration from 6 months to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.305

Obinutuzumab (Gazyva)

4Q 2025 annual review: for CLL/SLL indication and combination therapy with Venclexta, removed requirement for previous combination use as first-line therapy per NCCN; for section header “Follicular and Other B-Cell Lymphomas,” revised to “B-Cell Lymphomas and Tumors with B-Cell Predominance” to capture indication for Castleman disease; for indication of histologic transformation of marginal zone lymphoma to DLBCL, revised indication language from marginal zone lymphoma to indolent lymphomas per NCCN; for certain B-cell neoplasms where Gazyva is prescribed prior to Columvi administration, removed monotherapy requirement, revised third-line to for second-line therapy, and added mantle cell lymphoma indication per NCCN; for FL and marginal zone lymphomas, add combination therapy with Revlimid option per NCCN; for mantle cell lymphoma, added option for in combination with Venclexta and Brukinsa per NCCN; added monotherapy option for hairy cell leukemia per NCCN; revised all initial approval durations for Medicaid and HIM lines of business to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.307

Bendamustine (Belrapzo, Bendeka, Treanda, Vivimusta)

4Q 2025 annual review: for all indications, extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; for off-label NCCN uses per NCCN, added off-label indications of T-PLL and TFH lymphoma and removed mycosis fungidoes/Sezary syndrome; references reviewed and updated.

3/1/2026

CP.PHAR.309

Carfilzomib (Kyprolis)

4Q 2025 annual review: for MM primary treatment, added option to be prescribed in combination with Sarclisa per NCCN; initial approval durations changed from 6 to 12 months for Medicaid/HIM; references reviewed and updated.

3/1/2026

CP.PHAR.313

Pralatrexate (Folotyn)

4Q 2025 annual review: added NCCN off-label use for subcutaneous panniculitis-like T-cell lymphoma; for brand requests, added redirection to generic; extended initial approval duration for HIM/Medicaid from 6 to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.317

Cetuximab (Erbitux)

4Q 2025 annual review: per NCCN – for HNSCC, added option for use if member is receiving reirradiation with concurrent radiotherapy; for CRC, replaced “unresectable” with “recurrent”, specified that orLE/orLD1 mutation positive disease must have ultra-hypermutated phenotype, removed prior therapy requirement when prescribed for BRAF V600E mutation positive in combination with Braftovi and added clarification that regimen may be “with or without FOLFOX”, and modified requirement for left-sided colon cancer to also apply to unresectable metachronous metastases; for NSCLC, simplified criterion requiring disease progression on prior therapy to no longer call out T790M positive disease; extended initial approval duration for HIM/Medicaid from 6 to 12 months; revised approval durations for Commercial from 6/12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated

3/1/2026

CP.PHAR.318

Eribulin Mesylate (Halaven)

4Q 2025 annual review: for STS, added liposarcoma and epithelioid hemangioendothelioma subtypes per NCCN compendium and guidelines; for initial approval criteria, extended approval duration from 6 months to 12 months for HIM and Medicaid; references reviewed and updated.

3/1/2026

CP.PHAR.321

Panitumumab (Vectibix)

4Q 2025 annual review: specified that orLE/orLD1 mutation positive disease must have ultra-hypermutated phenotype and specified that unresectable synchronous metastases are in the liver and/or lung per NCCN; extended initial approval duration for HIM/Medicaid from 6 to 12 months; revised approval durations for Commercial from 6/12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated.

3/1/2026

CP.PHAR.352

Daunorubicin/Cytarabine (Vyxeos)

4Q 2025 annual review: added diagnosis option of AML that is poor risk without TP53 mutation or del(17)p abnormality per NCCN; updated NCCN nomenclature for AML-MRC; revised Medicaid and HIM initial and continued approval durations to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.355

Abemaciclib (Verzenio)

4Q 2025 annual review: added criteria for soft tissue sarcoma as off-label indication is supported by NCCN compendium and guidelines; for initial approval criteria, extended approval duration from 6 months to 12 months for HIM and Medicaid; for endometrial carcinoma initial therapy, added “12 months or duration of request, whichever is less” for commercial; references reviewed and updated

3/1/2026

CP.PHAR.359

Inotuzumab Ozogamicin (Besponsa)

4Q 2025 annual review: removed criteria option for age ≥ 15 years for Philadelphia chromosome-negative per NCCN Compendium; added criteria option to relapsed or refractory disease when prescribed as frontline therapy and age ≥ 18 years per NCCN Compendium; references reviewed and updated.

3/1/2026

CP.PHAR.365

Neratinib (Nerlynx)

4Q 2025 annual review: for breast cancer, added prescribed in combination with Kadcyla for central nervous system brain metastases per NCCN; extended approval duration from 6 months to 12 months for HIM and Medicaid; added criteria for cervical cancer as off-label indication is supported by NCCN compendium and guidelines; references reviewed and updated.

3/1/2026

CP.PHAR.387

Azacitidine (Onureg, Vidaza)

4Q 2025 annual review: for AML, added that use with Nexavar must be for relapsed or refractory disease per NCCN; added step therapy bypass for IL HIM per IL HB 5395; extended initial approval durations from 6 to 12 months for HIM/Medicaid and for Onureg requests for Commercial; updated Appendix E with revised language and exception for Tennessee; references reviewed and updated.

3/1/2026

CP.PHAR.393

Leucovorin Injection

4Q 2025 annual review: revised initial approval durations for high-dose MTX therapy rescue and combination chemotherapy with 5-FU to 12 months for Medicaid line of business; for continued therapy section, added continuation of care pathway for high-dose MTX rescue as part of chemotherapy or combination chemotherapy with 5-FU; references reviewed and updated.

3/1/2026

CP.PHAR.397

Cemiplimab-rwlc (Libtayo)

4Q 2025 annual review: for CSCC, added option for disease that is satellitosis/in-transit metastasis that is unresectable or incompletely resected per NCCN; for cervical, vaginal cancer and vulvar cancer, clarified usage as second-line or subsequent therapy per NCCN; added off-label indications for anal carcinoma and dMMR/MSI-H or orLE/orLD1 mutation with tumor cancers for: small bowel adenocarcinoma, and rectal and colon cancer per NCCN; initial approval durations changed from 6 to 12 months for Medicaid/HIM; references reviewed and updated.

3/1/2026

CP.PHAR.399

Dacomitinib (Vizimpro)

4Q 2025 annual review: added criterion for use as single-agent
therapy for NSCLC; extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

3/1/2026

CP.PHAR.400

Duvelisib (Copiktra)

4Q 2025 annual review: for all indications, extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; for off-label T-cell lymphomas, added option for use in combination with romidepsin per NCCN; references reviewed and updated.

3/1/2026

CP.PHAR.43

Sapropterin Dihydrochloride (Kuvan, Javygtor)

Added Sephience (newly FDA-approved for PKU) as an agent that should not be used concomitantly with sapropterin; extended initial approval duration to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.437

Thioguanine (Tabloid)

4Q 2025 annual review: removed hematologist specialty from glioma indication; references reviewed and updated.

3/1/2026

CP.PHAR.438

Trientine (Cuvrior, Syprine)

4Q 2025 annual review: added trientine hydrocholoride to medically necessary statement as generic trientine hydrocholoride also requires prior authorization; for initial therapy, extended approval duration from 6 months to 12 months for Medicaid and HIM; revised step therapy to require generic trientine hydrocholoride for brand Syprine requests for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PHAR.439

Valrubicin (Valstar)

4Q 2025 annual review: added option of urologist to fulfill specialist requirement; removed specification of recurrent or persistent disease and added option for use as initial intravesical chemotherapy for NMIBC per NCCN; clarified failure of BCG to member is refractory to BCG treatment and added criterion that member is not a candidate for cystectomy per FDA labeling; references reviewed and updated.

3/1/2026

CP.PHAR.441

Entrectinib (Rozlytrek)

4Q 2025 annual review: revised NTRK fusion-positive solid tumor section to NTRK fusion-positive cancer to include off-label non-solid tumor indications; for NTRK fusion-positive cancer, added criteria for histiocytic neoplasms per NCCN 2A recommendation with allowance for hematology specialty, added option for advanced disease for solid tumors, and revised maximum capsules for pediatrics per PI; for all indications, extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

3/1/2026

CP.PHAR.442

Fedratinib (Inrebic)

4Q 2025 annual review: added off-label criteria for MPN per NCCN category 2A; added step therapy bypass for IL HIM per IL HB 5395; initial approval durations changed from 6 to 12 months for Medicaid/HIM; references reviewed and updated.

3/1/2026

CP.PHAR.462

Ozanimod (Zeposia)

For UC, added option for Mayo Endoscopic Score > 2 to define moderate-to-severe UC; for UC, added bypass of conventional therapies if a member has failed a biologic agent to clarify intention of not stepping back from biologic agent to conventional therapy.

3/1/2026

CP.PHAR.510

Arimoclomol (Miplyffa)

4Q 2025 annual review: Per August SDC added requirement that for members weighing ≥ 15 kg, failure of a ≥ 3-month trial of Aqneursa; added step therapy bypass for IL HIM per IL HB 5395; revised initial approval duration from 6 months to 12 months; for continued therapy, added positive response option of slowed disease progression in a domain affected by NPC; references reviewed and updated.

3/1/2026

CP.PHAR.552

Belumosudil (Rezurock)

4Q 2025 annual review: added exclusion for concomitant use with Niktimvo; references reviewed and updated.

3/1/2026

CP.PHAR.554

Chlorambucil (Leukeran)

4Q 2025 annual review: added use in Hodgkin’s disease per PI (removed from Section III); for all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

3/1/2026

CP.PHAR.556

Elivaldogene Autotemcel (Skysona)

4Q 2025 annual review: RT4: updated FDA-approved indication to include lack of an available HLA-matched donor for allogeneic HSCT; removed criterion option for having an HLA-matched donor and its accompanying criteria per PI; references reviewed and updated.

3/1/2026

CP.PHAR.561

Tisotumab Vedotin-tftv (Tivdak)

4Q 2025 annual review: added allowance for combination use with Keytruda for PD-L1 positive cervical cancer per NCCN; extended initial approval duration for HIM/Medicaid from 6 to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.58

Denosumab (Prolia, Xgeva and biosimilars)

Per August SDC: for multiple myeloma or solid tumor, giant cell tumor of bone, hypercalcemia of malignancy, systemic mastocytosis, added redirection to Osenvelt and Wyost for if request is for a product other than Osenvelt and WyostXgeva requests for initial and continuation of therapy requests. 
RT4: added new biosimilars Bildyos and Bilprevda to criteria. Added new HCPCS codes Q5157, Q5158, Q5159.
Added step therapy bypass for IL HIM per IL HB 5395

3/1/2026

CP.PHAR.591

Tofersen (Qalsody)

4Q 2025 annual review: for continued therapy, added requirement for no tracheostomy or permanent ventilation and a positive response example of slowing of ALSFRS-R slope decline compared to baseline; references reviewed and updated.

3/1/2026

CP.PHAR.594

Donanemab (Kisunla)

4Q 2025 annual review: updated recommended dosing regimen per the Prescribing Information; for Continued Therapy criteria, clarified that the neurocognitive testing results used for coverage redetermination should be “recent (within the last month)” to ensure that Kisunla continues to be used only for those who remain in the mild stage of disease; updated the requirement for follow-up pre-infusion MRIs to be done within the prior week instead of within the prior month, to align with the approach for Leqembi; references reviewed and updated.

3/1/2026

CP.PHAR.596

Lecanemab-irmb (Leqembi)

4Q 2025 annual review: for Continued Therapy criteria, clarified that the neurocognitive testing results used for coverage redetermination should be “recent (within the last month)” to ensure that Leqembi continues to be used only for those who remain in the mild stage of disease; updated the requirement for follow-up pre-infusion MRIs to be done within the prior week instead of within the prior month per the updated Leqembi Prescribing Information; added dosing and auth limits for newly FDA-approved SC Leqembi Iqlik to the criteria; references reviewed and updated.

3/1/2026

CP.PHAR.646

Quizartinib (Vanflyta)

4Q 2025 annual review: revised AML initial approval duration to 12 months; for AML added option for relapsed/refractory disease treatment and for maintenance therapy as a single agent, added options of post-allogeneic hematopoietic cell transplantation and previous receipt a FLT3 inhibitor per NCCN; added off-label criteria for lymphoid, myeloid or mixed phenotype neoplasms with eosinophilia per NCCN; references reviewed and updated.

3/1/2026

CP.PHAR.647

Resmetirom (Rezdiffra)

4Q 2025 annual review: revised biopsy lookback period from 6 months to 3 years per AASLD guidance; for imaging-based biomarker examples, replaced FibroScan with VCTE as FibroScan is an example of VCTE; moved MAST, FAST, and MEFIB examples of non-invasive diagnostic scores to Appendix E; for diet and exercise criterion, removed the BMI ≥ 25 kg/m2 , revised “lifestyle modification” to “physician-directed weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification,” and clarified that member continues these strategies with Rezdiffra use per the PI; revised initial approval duration to 12 months; for continued therapy, added requirements for prescriber attestation of continued standard of care management and documentation of adherence to physician-directed weight loss program; references reviewed and updated.
Per SDC: added redirection to Wegovy and exclusion for concurrent Wegovy use.

3/1/2026

CP.PHAR.648

Rozanolixizumab-noli (Rystiggo)

4Q 2025 annual review: for gMG, clarified that the required immunosuppressive therapy should be non-steroidal; for Medicaid and HIM, extended approval durations from 6 to 12 months as gMG is a chronic condition; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PHAR.649

Talquetamab-tgvs (Talvey)

4Q 2025 annual review: added option to be prescribed in combination with Tecvayli with ≥ 3 prior lines of therapy per NCCN; initial approval duration changed from 6 to 12 months for Medicaid/HIM; references reviewed and updated.

3/1/2026

CP.PHAR.652

Elranatamab-bcmm (Elrexfio)

4Q 2025 annual review: added new 4-week dosing regimen to criteria; initial approval duration changed from 6 to 12 months for Medicaid/HIM; references reviewed and updated.

3/1/2026

CP.PHAR.655

Motixafortide (Aphexda)

4Q 2025 annual review: added transplant specialist as a prescriber option; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PHAR.673

Garadacimab (Andembry)

Per August SDC, added redirection to one of the following: Haegarda, Takhzyro, or Orladeyo.

3/1/2026

CP.PHAR.682

Levacetylleucine (Aqneursa)

4Q 2025 annual review: revised initial approval duration from 6 months to 12 months; for continued therapy, added positive response option of slowed disease progression in a domain affected by NPC; references reviewed and updated.

3/1/2026

CP.PHAR.691

Axatilimab-csfr (Niktimvo)

4Q 2025 annual review: clarified systemic immunosuppressant as non-steroidal; added step therapy bypass for IL HIM per IL HB 5395; extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

3/1/2026

CP.PHAR.699

Vorasidenib (Voranigo)

4Q 2025 annual review: added indication of other high-grade glioma per NCCN; for WHO grade 3 and 4 disease, removed criterion for poor KPS and added option for use as adjuvant therapy per NCCN; revised initial approval duration to 12 months; references reviewed and updated.

3/1/2026

CP.PHAR.702

Inavolisib (Itovebi)

4Q 2025 annual review: added option for regionally advanced disease or recurrent disease per NCCN; clarified ovarian ablation or ovarian suppression is required if members are premenopausal or perimenopausal; added requirement to be prescribed in combination with an agent that suppresses testicular steroidogenesis if members are male; extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

3/1/2026

CP.PHAR.705

Zolbetuximab-clzb (Vyloy)

4Q 2025 annual review: added options for use in recurrent disease and as palliative therapy in members who are not surgical candidates per NCCN; extended initial approval duration for HIM/Medicaid from 6 to 12 months; revised approval durations for Commercial from 6/12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated.

3/1/2026

CP.PHAR.730

Zopapogene Imadenovec (Papzimeos)

RT1: drug is now FDA-approved; added option to be prescribed by or in consultation with a pulmonologist; for HPV vaccination requirement, clarified the vaccination serious must be completed; references reviewed and updated.

3/1/2026

CP.PHAR.79

Lapatinib (Tykerb)

4Q 2025 annual review: for breast cancer, removed extensive from brain metastases as NCCN supports use in limited and extensive brain metastases; added “perimenopausal” to member is a premenopausal female to align with other breast cancer criteria; for initial approval criteria, extended approval duration from 6 months to 12 months for HIM and Medicaid; for colorectal cancer, removed criteria for “no previous use of a HER2 inhibitor therapy (e.g., trastuzumab, Kadcyla, Tykerb, Perjeta)” as NCCN supports use for Tykerb without this requirement, updated HER2-positive to HER2-amplified per NCCN; references reviewed and updated.

3/1/2026

CP.PHAR.93

Bevacizumab (Alymsys, Avastin, Avzivi, Jobevne, Mvasi, Vegzelma, Zirabev)

4Q 2025 annual review: for all indications, added step therapy bypass for IL HIM per IL HB 5395, extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition; for the following oncology indications, revised the following per NCCN: for epithelial ovarian, fallopian tube, and primary peritoneal cancer, added option for combination use in platinum-resistant persistent disease with carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin; added additional off-label use in primary spinal cord tumors; for ophthalmology uses, revised diabetic retinopathy to allow any cause and stage; references reviewed and updated.

3/1/2026

CP.PMN.142

Lubiprostone (Amitiza)

4Q 2025 annual review: for OIC, updated initial approval duration from 6 to 12 months; for continued therapy, added criterion for OIC, member continues to receive opioid therapy; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated

3/1/2026

CP.PMN.214

Continuous Glucose Monitors

4Q 2025 annual review: per August SDC, removed option for management with oral agents for type 2 diabetes; per GA regulation and August SDC, added options for gestational diabetes and history of problematic hypoglycemia; updated FreeStyle Libre redirection to apply to age ≥ 2 years; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PMN.249

Ciprofloxacin/Fluocinolone (Otovel)

4Q 2025 annual review: for otitis media with tympanostomy tubes, revised systemic antibiotic requirement to otic antibiotic; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PMN.266

Finerenone (Kerendia)

4Q 2025 annual review: RT4: added new heart failure indication and accompanying 40 mg dosage strength; for CKD, added criterion requiring serum potassium ≤ 5.0 mEq/L per PI; references reviewed and updated.

3/1/2026

CP.PMN.267

Levodopa Inhalation Powder (Inbrija)

4Q 2025 annual review: removed the exclusion qualifier of “early morning” from “off” time requirement; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

3/1/2026

CP.PMN.270

Pilocarpine (Qlosi, Vuity)

4Q 2025 annual review: removed requirement that member does not have glaucoma or ocular hypertension per PI and current literature; extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; added step therapy bypass for IL HIM per IL HB 5395; added requirement that pilocarpine is not prescribed concurrently with Vizz; references reviewed and updated.

3/1/2026

CP.PMN.291

Lotilaner (Xdemvy)

4Q 2025 annual review: added optometrist or ophthalmologist prescriber requirement; references reviewed and updated.

3/1/2026

CP.PMN.295

Semaglutide (Wegovy)

RT4: Wegovy is now FDA approved for MASH – criteria updated per FDA labeling: revised biopsy lookback period from 6 months to 3 years per AASLD guidance; for imaging-based biomarker examples, replaced Fibroscan with VCTE as FibroScan is an example of VCTE; moved MAST, FAST, and MEFIB examples of non-invasive diagnostic tests to Appendix E; for members with concurrent T2DM, added trial of Rybelsus, Trulicity and Victoza; for diet and exercise criterion, clarified that member continues diet and exercise with concomitant Wegovy; for continued therapy, moved location of criterion regarding tolerance to maintenance dose of ≥ 1.7 mg once weekly after at least 17 weeks of Wegovy therapy; revised language from “if this is a second or subsequent renewal request” to “after at least 12 months of therapy” to determine positive response; references reviewed and updated.

3/1/2026

CP.PMN.298

Tirzepatide (Zepbound)

For OSA, updated PAP criterion to require continued symptoms of OSA despite adherence to PAP therapy, unless a member is not a candidate for PAP therapy.

3/1/2026

CP.PMN.59

Quantity Limit Override and Dose Optimization

4Q 2025 annual review: added quantity limit exception criteria specific to acute therapies, with requirements for epinephrine (adopted from CP.PMN.144 that will be retired) and other acute therapies; removed criteria set for opioid QL exceptions as section I.A. will be applied; references reviewed and updated.

3/1/2026