Provider Quick Alert

July 17, 2026

Review all Medical Coverage Policies at QualChoice.com.

QualChoice is amending or implementing new policies. Please see the table below for a list of these policies and their effective dates.

Medical Policy Number

Medical Policy Name

Effective Date of Change

Description of Changes

CP.PHAR.109

Tesamorelin (Egrifta SV, Egrifta WR)

3Q 2026 annual review: added ICHRA line of business; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.146

Deferoxamine (Desferal)

3Q 2026 annual review: added ICHRA line of business; revised approval continued therapy duration for Commercial from 12 months to standard injectable authorization of “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated.

9/1/2026

CP.PHAR.177

Ecallantide (Kalbitor)

3Q 2026 annual review: added ICHRA line of business; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.178

Icatibant (Firazyr)

3Q 2026 annual review: added ICHRA line of business; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.27

Tolvaptan (Jynarque, Samsca)

3Q 2026 annual review: for hyponatremia, added option for acute care physician prescriber since Samsca is initiated in a hospital setting; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.285

Nintedanib (Ofev)

"3Q 2026 annual review: revised policy/criteria section to also include generic nintedanib; for all indications, added redirection to generic nintedanib for brand Ofev requests and extended initial approval durations from 6 to 12 months for this maintenance medication for a chronic condition; for chronic fibrosing ILDs, added rheumatologist as a prescriber option; references reviewed and updated. Per June SDC, added Commercial and HIM/ICHRA line of business (retire CP.PCH.54).

9/1/2026

CP.PHAR.286

Pirfenidone (Esbriet)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.297

Filgrastim (Neupogen), Filgrastim-sndz (Zarxio), Tbo-filgrastim (Granix), Filgrastim-aafi (Nivestym), Filgrastim-ayow (Releuko), Filgrastim-txid (Nypozi)

3Q 2026 annual review: added NCCN Compendium supported use for neutropenia following CAR T-cell therapy or lymphocyte engager-therapy; references reviewed and updated.

9/1/2026

CP.PHAR.303

Brentuximab Vedotin (Adcetris)

3Q 2026 annual review: per NCCN – for cHL in adults, removed option for Deauville score 4-5 and revised age 18-61 to age 18-60 for use as a component of BrECADD and added option that member is unfit for intensive therapy for use in combination with dacarbazine or nivolumab; for T-cell lymphomas, added option for use in combination with CHEP for PTCL; for B-cell lymphomas, added that DLBCL includes histologic transformation of indolent lymphomas to DLBCL and removed requirement that disease is CD30-positive; added ICHRA line of business; for all indications, extended initial approval durations for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated.

9/1/2026

CP.PHAR.310

Daratumumab (Darzalex), Daratumumab/Hyaluronidase-fihj (Darzalex Faspro)

3Q 2026 annual review: added NCCN Compendium supported use for MM in combination with Tecvayli; added additional use for systemic light chain amyloidosis in combination with Venclexta, clarified use in combination with lenalidomide and dexamethasone should be for relapsed/refractory previously treated disease, and for use as single agent therapy in newly diagnosed disease corrected to require no significant neuropathy; added criteria set for HIV-related plasmablastic lymphoma; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.312

Blinatumomab (Blincyto)

3Q 2026 annual review: revised option for adult consolidation therapy for Ph+ disease to specify disease must be refractory to TKIs per NCCN; added ICHRA line of business; extended initial approval duration for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated

9/1/2026

CP.PHAR.322

Pembrolizumab, Pembrolizumab/Berahyaluronidase Alfa-pmph (Keytruda, Keytruda Qlex)

"3Q 2026 annual review: added ICHRA line of business; for urothelial carcinoma and MPM, removed requirement for locally advanced, relapsed, or metastatic disease; for NSCLC, added option to be prescribed as single-agent for those who have received previous adjuvant chemotherapy or neoadjuvant chemotherapy with pembrolizumab; for MSI-H/dMMR, added option for neoadjuvant systemic therapy for gallbladder cancer, gastric cancer, adenocarcinoma GEJ, and small bowel adenocarcinoma; for off-label anal carcinoma and vulvar cancer, added option to be prescribed in combination with paclitaxel and cisplatin/carboplatin; for off-label soft tissue sarcoma subtypes, added option to be prescribed as single-agent for cutaneous angiosarcoma or dedifferentiated liposarcoma and as neoadjuvant or adjuvant therapy for UPS related sarcomas; for off-label vaginal cancer, added requirement for unresectable, metastatic or recurrent PD-L1-positive (CPS ≥ 1) disease; added the following off-label indications per NCCN: appendiceal neoplasms and cancers, recurrent conventional chordoma (including chondroid), dedifferentiated chondrosarcoma; CLL/SLL with histologic (Richter) transformation, and malignant histiocytic neoplasm; references reviewed and updated.

9/1/2026

CP.PHAR.381

Mechlorethamine Gel (Valchlor)

3Q 2026 annual review: added stage IVA1 or IVA2 for Sezary syndrome diagnosis criteria per NCCN compendium; for Medicaid and HIM, updated approval durations from 6 months to 12 months for chronic therapy; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.383

Trifluridine/Tipiracil (Lonsurf)

3Q 2026 annual review: added ICHRA line of business; for appendiceal carcinoma, moved out of CRC criteria to its own criteria set to reflect additional disease-specific recommendations for use; revised initial approval duration from 6 months to 12 months for Medicaid, HIM, and ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.41

Enfuvirtide (Fuzeon)

3Q 2026 annual review: added ICHRA line of business; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.415

Ravulizumab-cwvz (Ultomiris)

3Q 2026 annual review: for gMG, added Imaavy and Uplizna to the list of therapies that Ultomiris should not be prescribed concurrently with; added ICHRA line of business; for all indications, extended initial approval durations for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer” for this maintenance medication for a chronic condition; removed 300 mg/30 mL IV vial and SC injection dosage form per prescribing information and updated dosing requirements accordingly in criteria; references reviewed and updated.

9/1/2026

CP.PHAR.424

Fulvestrant (Faslodex Injection)

3Q 2026 annual review: for ovarian, fallopian tube, and primary peritoneal cancers, expanded cancer stage range from just low-grade serous carcinoma to IC-IV per NCCN; for endometrial carcinoma, added option for combination therapy with Verzenio for ER-positive tumors per NCCN; for uterine sarcoma, clarified disease must be HR-positive and removed criteria that fulvestrant must be prescribed in specific scenarios per NCCN; revised initial and continued approval durations for all non-Commercial lines of business from 6 months to 12 months; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.425

Metreleptin (Myalept)

3Q 2026 annual review: added ICHRA line of business; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.431

Selinexor (Xpovio)

3Q 2026 annual review: RT4: removed DLBCL as an FDA approved indication (retained criteria as this use is still supported by NCCN at this time); for MM, added options for treatment of POEMS, MIDD, MGRS, and MM with CNS system disease per NCCN; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.432

Tafamidis (Vyndaqel, Vyndamax)

3Q 2026 annual review: for diagnosis by cardiac uptake, specified radionucleotide scan should be SPECT per updated 2025 ACC Clinical Guidance; in initial approval criteria, added examples of heart failure from Appendix D; revised initial approval duration from 6 to 12 months; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.433

Polatuzumab Vedotin-piiq (Polivy)

3Q 2026 annual review: added off-label coverage for mantle cell lymphoma and Burkitt lymphoma per NCCN; for other lymphomas, added option for combination use with Columvi or with GemOx and rituximab for non-transplant/CAR T-cell candidates per NCCN; incorporated existing cycle limitations from approval duration into criteria; added ICHRA line of business; for Medicaid/HIM, revised initial approval duration from 6 to 12 months; for Commercial, revised initial/continued approval durations from 6/12 months to “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated

9/1/2026

CP.PHAR.440

Elexacaftor/Ivacaftor/Tezacaftor; Ivacaftor (Trikafta)

3Q 2026 annual review: RT4: updated FDA approved indication to patients who have at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein; updated Appendix E with list of CFTR gene variants that are responsive to Trikafta per prescribing information; added ICHRA line of business; for initial therapy, updated duration from 6 months to 12 months for chronic therapy; references reviewed and updated.

9/1/2026

CP.PHAR.463

Satralizumab-mwge (Enspryng)

3Q 2026 annual review: added ICHRA line of business; extended initial approval durations for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer” for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.485

Berotralstat (Orladeyo)

3Q 2026 annual review: extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.487

Osilodrostat (Isturisa)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.491

Setmelanotide (Imcivree)

RT4: drug is now FDA-approved for acquired HO – acquired HO criteria updated per FDA labeling: modified requirement for diagnosis of acquired HO to allow option of assessment by MRI or documented history of hypothalamic injury for brain tumors affecting the hypothalamic region; added requirement for rapid, persistent weight gain occurring during the first 12 months following onset of hypothalamic damage per expert guidance; added additional prescriber options of neurologist or metabolic disease specialist; revised initial approval duration from 12 to 6 months to assess for positive response after 6 months rather than 12 months; for all indications, corrected creatinine clearance to eGFR; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.495

Mitomycin Instillation Solution (Jelmyto, Zusduri)

3Q 2026 annual review: for NMIBC, removed requirement for low-grade disease and TURBT and added option for high risk disease per NCCN; added off-label indication of MIBC per NCCN; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.496

Pemigatinib (Pemazyre)

3Q 2026 annual review: for cholangiocarcinoma, add option for gross residual disease (R2 resection) per NCCN; added ICHRA line of business; revised initial approval duration from 6 months to 12 months for Medicaid, HIM and ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.497

Tucatinib (Tukysa)

3Q 2026 annual review: for breast cancer, removed “confirmation of” from HER2 positive disease requirement and added HER2 negative disease option per NCCN; for colorectal cancer and appendiceal carcinoma, added requirement for BRAF wild-type disease per NCCN; added small bowel adenocarcinoma indication per NCCN; moved appendiceal carcinoma from colorectal cancer section to Additional NCCN Recommended Uses (off-label) section; revised initial approval durations for non-Commercial lines of business from 6 months to 12 months; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.500

Lurbinectedin (Zepzelca)

3Q 2026 annual review: for continued therapy, removed single-agent requirement; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.502

Ripretinib (Qinlock)

3Q 2026 annual review: for GIST, specified that disease should be imatinib-sensitive KIT or PDGFRA mutant for requests for use as a third-line therapy per NCCN; added ICHRA line of business; for all indications, extended initial approval durations for Medicaid and HIM from 6 to 12 months; references reviewed and updated.

9/1/2026

CP.PHAR.518

Mannitol (Bronchitol)

3Q 2026 annual review: for initial approval criteria, added prescribed by or in consultation with an expert in treatment of cystic fibrosis; for initial therapy, updated approval duration from 6 months to 12 months for chronic therapy; references reviewed and updated.

9/1/2026

CP.PHAR.524

Pegcetacoplan (Empaveli, Syfovre)

3Q 2026 annual review: added ICHRA line of business; for PNH and C3G/primary IC-MPGN, revised all approval durations to “6 months or to the member’s renewal date, whichever is longer” for Commercial and initial approval durations from 6 to 12 months for Medicaid and HIM; references reviewed and updated.

9/1/2026

CP.PHAR.525

Vosoritide (Voxzogo)

Per June SDC, added requirement that member will not have limb-lengthening surgery during treatment; added ICHRA line of business.

9/1/2026

CP.PHAR.540

Dostarlimab-gxly (Jemperli)

3Q 2026 annual review: per NCCN – for solid tumors, revised to require use as subsequent therapy for pancreatic adenocarcinoma, added option for use as neoadjuvant therapy for gastric, colon, rectal, or small bowel adenocarcinoma, esophageal, esophagogastric junction, appendiceal cancers, and added option for use as induction systemic therapy for esophageal and esophagogastric junction cancers; for anal carcinoma, added options for use in combination with paclitaxel and carboplatin; added ICHRA line of business; for all indications, extended initial approval durations for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer”; references reviewed and updated.

9/1/2026

CP.PHAR.542

Talimogene laherepvec (Imlygic)

3Q 2026 annual review: added ICHRA line of business; for all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; for MCC, added requirement for disease progression following treatment with anti-PD-1/PD-L1 therapy unless contraindication per NCCN compendium; references reviewed and updated.

9/1/2026

CP.PHAR.544

Amivantamab-vmjw (Rybrevant), Amivantamab/Hyaluronidase-lpuj (Rybrevant Faspro)

Q 2026 annual review: for initial approval criteria, added Rybrevant/Rybrevant Faspro is prescribed in combination with Lazcluze for leptomeningeal metastases per NCCN; added ICHRA line of business; added HCPCS code J9062 and removed codes C9399 and J9999; references reviewed and updated.

9/1/2026

CP.PHAR.549

Sotorasib (Lumakras)

3Q 2026 annual review: for colorectal cancer, added “or as a less intensive agent” for monotherapy per NCCN; for NCCN recommended uses (off-label), added appendiceal neoplasms and cancers as an option per NCCN and removed “prescribed as monotherapy” as sotorasib can be used as combination therapy; for continued therapy, added For Lumakras requests, member must use generic sotorasib; added ICHRA line of business; revised initial approval duration for HIM/Medicaid from 6 months to 12 months; references reviewed and updated.

9/1/2026

CP.PHAR.555

Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart, Vyvgart Hytrulo)

For CIDP, added ≥ 3 months duration to immune globulin therapy criterion to ensure adequate trial prior to advancing treatment; added ICHRA line of business.

9/1/2026

CP.PHAR.568

Inclisiran (Leqvio)

Per 2026 guideline updates: added ICHRA line of business; for all indications, modified moderate or low intensity statin requirement therapy from requiring previous use of one high intensity statin and LDL remained ≥ 70 mg/dL to LDL goal was not achieved to reflect differing LDL goals based on specific indication; modified recent LDL requirements to ≥ 55 mg/dL for history of ASCVD regardless of very high risk status; for HeFH, simplified baseline LDL to at least 160 mg/dL for all ages, revised recent LDL requirement to ≥ 70 mg/dL; for primary hypercholesterolemia, added recent LDL requirement of ≥ 70 mg/dL for severe primary hypercholesterolemia with ASCVD risk factors with corresponding Appendix H, clarified recent LDL requirement of ≥ 100 mg/dL is for without ASCVD risk factors, added requirement that treatment plan does not include coadministration with Lerochol to prevent duplicate therapy; for HoFH, revised LDL requirements to ≥ 100 mg/dL.

9/1/2026

CP.PHAR.572

Budesonide (Tarpeyo)

3Q 2026 annual review: added ICHRA line of business; for initial approval criteria, clarified ACEi/ARB for 90 days to RAS inhibitor for 12 weeks, clarified confirmation requirement to documentation; for continued therapy, added reduction of proteinuria by lower total urine protein per day from baseline as evidence of positive response to therapy; references reviewed and updated.

9/1/2026

CP.PHAR.588

Nivolumab and Relatlimab-rmbw (Opdualag)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.589

Bulevirtide (Hepcludex)

3Q 2026 annual review: RT4: drug is now FDA approved – criteria updated per FDA labeling: revised requirement for detectable HDV RNA levels to be recent (within the last 60 days); revised elevated ALT requirement from ≥ 70 IU/L for men and ≥ 50 IU/L for women to > 35 IU/L for men and > 25 IU/L for women per clinical trial eligibility and guidelines; clarified Child-Pugh Class A status for those with cirrhosis present; added provider attestation that member is receiving appropriate HBV infection therapy; revised positive response criterion from “both” to “one” of the following: reduction in HDV RNA or ALT normalization; added ICHRA line of business; for Medicaid and HIM, revised initial approval duration from 6 months to 12 months for this chronic disease; references reviewed and updated.

9/1/2026

CP.PHAR.599

Marnetegragene Autotemcel (Kresladi)

RT1: clarified that ITGB2 gene mutation should be biallelic and added age requirement < 18 years per prescribing information; added additional options for severe disease (genetic testing, delayed umbilical cord separation, omphalitis, LAD-I-related clinical events) per 2026 international Delphi consensus; references reviewed and updated.

9/1/2026

CP.PHAR.614

Nirsevimab (Beyfortus)

3Q 2026 annual review: for all indications other than preterm, late preterm or term infant, clarified exclusion for prior use of other RSV monoclonal antibody (e.g., Enflonsia); removed references to prior Synagis use as product is discontinued; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.631

Sparsentan (Filspari)

3Q 2026 annual review: added redirection to SGLT2i per KDIGO guideline; extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; RT4: added criteria for newly approved FSGS indication; references reviewed and updated.

9/1/2026

CP.PHAR.636

Glofitamab-gxbm (Columvi)

3Q 2026 annual review: added criteria sets for NCCN Compendium supported uses in mantle cell lymphoma and Burkitt lymphoma; clarified prior therapy requirements for DLBCL arising from CLL (Richter transformation); added option for DLBCL combination use with Polivy; modified initial approval duration for Medicaid/HIM from 6 to 12 months; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.644

Givinostat (Duvyzat)

3Q 2026 annual review: added ICHRA line of business; revised initial approval duration from 6 months to 12 months for this chronic disease; references reviewed and updated.

9/1/2026

CP.PHAR.656

Iptacopan (Fabhalta)

3Q 2026 annual review: for IgAN, revised criterion for proteinuria from ≥ 1 g/day to ≥ 0.5 g/day and added redirection to SGLT2 inhibitor per 2025 KDIGO IgAN guidelines; for C3G, added requirement that disease has not recurred after kidney transplant per prescribing information and added requirement against concurrent use with Empaveli; added ICHRA line of business; extended all initial approval durations from 6 to 12 months; references reviewed and updated.

9/1/2026

CP.PHAR.664

Crovalimab-akkz (PiaSky)

3Q 2026 annual review: per SDC, revised redirection from Soliris or Ultomiris to only Ultomiris; added ICHRA line of business; extended initial approval duration for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer” for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.665

Danicopan (Voydeya)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PHAR.680

Elamipretide (Forzinity)

3Q 2026 annual review: added alternative tests for documentation of impaired muscle strength; references reviewed and updated.

9/1/2026

CP.PHAR.683

Acoramidis (Attruby)

3Q26 annual review: for diagnosis by cardiac uptake, specified radionucleotide scan should be SPECT per updated 2025 ACC Clinical Guidance; added “Nutrition (e.g., body mass index)” as an option for positive response parameters to align with vutrisiran and tafamidis ATTR-CM continued therapy criteria; in initial approval criteria, added examples of heart failure from Appendix D; revised initial approval duration from 6 to 12 months; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.684

Nogapendekin Alfa Inbakicept-pmln (Anktiva)

"3Q 2026 annual review: added ICHRA line of business; added off-label indication for Ta/T1 high-grade disease without CIS per NCCN; added option to be prescribed by or in consultation with an urologist; added requirement that member is not a candidate for cystectomy per NCCN; references reviewed and updated. Per June SDC, added requirement for provider attestation that Adstiladrin therapy has been considered and not recommended with clinical rationale supporting Anktiva over Adstiladrin."

9/1/2026

CP.PHAR.685

Tarlatamab-dlle (Imdelltra)

3Q 2026 annual review: added ICHRA line of business; in continued therapy, added criteria for “Other diagnoses/indications” per template; references reviewed and updated.

9/1/2026

CP.PHAR.686

Tovorafenib (Ojemda)

3Q 2026 annual review: added off-label criteria for adult glioma and adult Langerhans cell histiocytosis as supported by NCCN; added oral oncology generic redirection for brand Ojemda requests; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.687

Tislelizumab-jsgr (Tevimbra)

3Q 2026 annual review: added ICHRA line of business; revised the following off-label indications per NCCN: for anal carcinoma, added option to be prescribed in combination with paclitaxel and carboplatin, added uterine neoplasms, appendiceal neoplasms, and Hodgkin lymphoma, removed criterion requirements for CLL or SLL; revised initial approval duration from 6 months to 12 months for Medicaid, HIM, and ICHRA line of business; added standard approval duration of “6 months or to the member’s renewal date, whichever is longer” for Commercial line of business; references reviewed and updated.

9/1/2026

CP.PHAR.688

Elafibranor (Iqirvo)

3Q 2026 annual review: added ICHRA line of business; added requirement to initial therapy that member does not have decompensated cirrhosis; added requirement to initial and continued therapy that Iqirvo is not prescribed concurrently with Livdelzi to prevent duplicate therapy; references reviewed and updated.

9/1/2026

CP.PHAR.689

Olezarsen (Tryngolza)

3Q 2026 annual review: Per 2026 guideline updates: revised fasting triglyceride requirement to ≥ 1000 mg/dL; revised clinically suggestive FCS requirement to inconclusive genetic test results and NAFCS score > 45; added trial and failure of fibrate therapy or omega-3 fatty acids; references reviewed and updated.

9/1/2026

CP.PHAR.700

Vanzacaftor/Tezacaftor/Deutivacaftor (Alyftrek)

3Q 2026 annual review: RT4: updated FDA approved indication to patients who have at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in the production of CFTR protein; updated Appendix E with list of CFTR gene variants that are responsive to Alyftrek per prescribing information; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.717

Donidalorsen (Dawnzera)

3Q 2026 annual review: no significant changes; references reviewed and updated.

9/1/2026

CP.PHAR.721

Plozasiran (Redemplo)

Per 2026 guideline updates: revised fasting triglyceride requirement to ≥ 1000 mg/dL; revised clinically suggestive FCS requirement to inconclusive genetic test results and NAFCS score > 45; added trial and failure of fibrate therapy or omega-3 fatty acids.

9/1/2026

CP.PHAR.723

Sebetralstat (Ekterly)

3Q 2026 annual review: added quantity limit; references reviewed and updated.

9/1/2026

CP.PHAR.727

Atrasentan (Vanrafia)

3Q 2026 annual review: added redirection to SGLT2i per updated 2025 KDIGO guidelines; references reviewed and updated.

9/1/2026

CP.PHAR.732

Penpulimab-kcqx

3Q 2026 annual review: modified initial approval duration for Medicaid/HIM from 6 to 12 months; added criteria for NCCN Compendium supported uses in anal carcinoma, appendiceal cancer, small bowel adenocarcinoma, colon cancer, and rectal cancer; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.740

Taletrectinib (Ibtrozi)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 to 12 months; references reviewed and updated.

9/1/2026

CP.PHAR.746

Navepegritide (Yuviwel)

Per June SDC, added requirement that member will not have limb-lengthening surgery during treatment and added redirection to Voxzogo.

9/1/2026

CP.PHAR.753

Gemcitabine Intravesical System (Inlexzo)

Per June SDC, added requirement for provider attestation that Adstiladrin therapy has been considered and not recommended with clinical rationale supporting Inlexzo over Adstiladrin. Added ICHRA line of business.

9/1/2026

CP.PHAR.759

Nerandomilast (Jascayd)

3Q 2026 annual review: per SDC, revised “Ofev” redirection to “generic nintendanib”; for PPF, added rheumatologist as a prescriber option; removed health plan-approved quantity limit criterion; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PHAR.768

Lerodalcibep-liga (Lerochol)

3Q26 annual review: Per 2026 guideline update: added ICHRA line of business; for all indications, modified moderate or low intensity statin requirement therapy from requiring previous use of one high intensity statin and LDL remained ≥ 70 mg/dL to LDL goal was not achieved to reflect differing LDL goals based on specific indication; modified recent LDL requirements to ≥ 55 mg/dL for history of ASCVD regardless of very high risk status; for increased risk for CV events, added diabetes, 10-year estimated risk for ASCVD ≥ 10%, and CAC score ≥ 100 to 299 AU as examples of increased risk for CV events, added CAC score ≥ 300 AU as example of history of ASCVD, added recent LDL requirement ≥ 70 mg/dL separate from history of ASCVD; for HeFH, simplified baseline LDL to at least 160 mg/dL for all ages, revised recent LDL requirement to ≥ 70 mg/dL; for primary hypercholesterolemia, added recent LDL requirement of ≥ 70 mg/dL for severe primary hypercholesterolemia with ASCVD risk factors with corresponding Appendix H, clarified recent LDL requirement of ≥ 100 mg/dL is for without ASCVD risk factors.

9/1/2026

CP.PHAR.775

Sibeprenlimab-szsi (Voyxact)

3Q 2026 annual review: added ICHRA line of business; revised proteinuria criterion from 1 g/day to 0.5g/day per 2025 KDIGO guidelines; added 12 week trial requirement to SGLT2 inhibitor trial and failure requirement; references reviewed and updated.

9/1/2026

CP.PHAR.781_PEPP

Denecimig (Mim8)_PEPP

Policy created preemptively.

9/1/2026

CP.PHAR.782_PEPP

Molgramostim (Molbreevi)_PEPP

Policy created preemptively.

9/1/2026

CP.PHAR.783_PEPP

Relutrigine (PRAX-562)_PEPP

Policy created preemptively.

9/1/2026

CP.PHAR.784

Linerixibat (Lynavoy)

Policy created

9/1/2026

CP.PHAR.785

Pivekimab Sunirine-pvzy (Decnupaz)

Policy created

9/1/2026

CP.PHAR.786

Sonrotoclax (Beqalzi)

Policy created

9/1/2026

CP.PHAR.787

Vepdegestrant (Veppanu)

Policy created

9/1/2026

CP.PHAR.789_PEPP

Lonvoguran Ziclumeran (Lonvo-z)_PEPP

Policy created preemptively.

9/1/2026

CP.PHAR.790_PEPP

Tiratricol (Emcitate)_ PEPP

Policy created preemptively.

9/1/2026

CP.PHAR.791_PEPP

Bepirovirsen (GSK3228836)_PEPP

Policy created preemptively.

9/1/2026

CP.PHAR.792

Baxdrostat (Baxfendy)

Policy created.

9/1/2026

CP.PHAR.81

Pazopanib (Votrient)

3Q 2026 annual review: per NCCN – for STS, added coverage of pediatric rhabdomyosarcoma, added bypass of ineligibility or prior therapy requirements for dedifferentiated liposarcoma with or without concurrent well-differentiated liposarcoma, specified tumor should be imatinib-sensitive KIT or PDGFRA mutant if not SDH-deficient, and added additional qualifiers or gross residual (R2 resection) or preoperative/intraoperative tumor rupture for adult disease; for chondrosarcoma, added option for dedifferentiated disease; for Merkel cell carcinoma, added option for in-transit regional node-positive disease; added ICHRA line of business; for all indications, extended initial approval duration for Medicaid and HIM from 6 to 12 months; references reviewed and updated.

9/1/2026

CP.PHAR.83

Vorinostat (Zolinza)

3Q 2026 annual review: added ICHRA line of business; for all indications, extended initial approval duration for Medicaid and HIM from 6 to 12 months; references reviewed and updated.

9/1/2026

CP.PHAR.97

Eculizumab (Soliris), Eculizumab-aeeb (Bkemv), Eculizumab-aagh (Epysqli)

3Q 2026 annual review: for gMG, added Imaavy and Uplizna to the list of therapies that Soliris/Bkemv/Epysqli should not be prescribed concurrently with; added ICHRA line of business; for all indications, extended initial approval durations for Medicaid/HIM from 6 to 12 months and revised all approval durations for Commercial to “6 months or to the member’s renewal date, whichever is longer” for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PMN.08

Lidocaine Transdermal (Lidoderm, ZTlido)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PMN.143

sotretinoin (Absorica, Absorica LD, Amnesteem, Claravis, Zenatane)

Added ICHRA line of business; added off-label criteria for acne fulminans per local market request.

9/1/2026

CP.PMN.15

Asenapine (Saphris, Secuado)

3Q 2026 annual review: added ICHRA line of business; removed all line of business-specific distinctions from Appendix D; references reviewed and updated.

9/1/2026

CP.PMN.187

Icosapent Ethyl (Vascepa)

Per 2026 guideline updates: for hypertriglyceridemia without ASCVD, added 3 consecutive month trial for failure of omega-3-acid ethyl esters; for reduction of cardiovascular disease risk, modified moderate or low intensity statin requirement therapy from requiring previous use of one high intensity statin and LDL remained ≥ 70 mg/dL to LDL goal was not achieved to reflect differing LDL goals based on specific indication.

9/1/2026

CP.PMN.220

Peanut Allergen Powder-dnfp (Palforzia)

3Q 2026 annual review: added ICHRA line of business; extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PMN.237

Bempedoic Acid (Nexletol), Bempedoic Acid/Ezetimibe (Nexlizet)

Per 2026 guideline updates: added ICHRA line of business; added off-label HoFH indication; for all indications, modified moderate or low intensity statin requirement therapy from requiring previous use of one high intensity statin and LDL remained ≥ 70 mg/dL to LDL goal was not achieved to reflect differing LDL goals based on specific indication; modified recent LDL requirements to ≥ 55 mg/dL for history of ASCVD regardless of very high risk status; for increased risk for CV events, revised definition of high risk for a CVD event to diabetes or 10-year estimated risk for ASCVD ≥ 10%, added CAC score ≥ 300 AU as example of history of ASCVD, added recent LDL requirement ≥ 70 mg/dL separate from history of ASCVD; for HeFH, simplified baseline LDL to at least 160 mg/dL for all ages, revised recent LDL requirement to ≥ 70 mg/dL; for primary hypercholesterolemia, added recent LDL requirement of ≥ 70 mg/dL for severe primary hypercholesterolemia with ASCVD risk factors with corresponding Appendix H, clarified recent LDL requirement of ≥ 100 mg/dL is for without ASCVD risk factors.

9/1/2026

CP.PMN.238

Carbidopa/Levodopa ER Capsules (Rytary), Enteral Suspension (Duopa), IR Tablets (Dhivy)

3Q 2026 annual review: added generic carbidopa-levodopa extended release to list of drugs criteria is applicable to; added to both initial and continued therapy criteria, member must use generic carbidopa-levodopa extended release (generic Rytary) and generic carbidopa-levodopa for Rytary and Dhivy requests, respectively; added ICHRA line of business; references reviewed and updated.

9/1/2026

CP.PMN.240

Gabapentin ER (Gralise, Horizant)

3Q 2026 annual review: added ICHRA line of business; removed “if available” from “member must use generic Gralise”; references reviewed and updated.

9/1/2026

CP.PMN.265

Olanzapine/Samidorphan (Lybalvi)

3Q 2026 annual review: added ICHRA line of business; removed all line of business-specific distinctions” from Appendix D; references reviewed and updated.

9/1/2026

CP.PMN.272

Mavacamten (Camzyos)

3Q 2026 annual review: for initial and continued therapy, added requirement against concurrent use with Myqorzo; for continued therapy, added requirement for LVEF ≥ 50% per prescribing information and as supported by practice guidelines; added ICHRA line of business; extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

CP.PMN.278

Ganaxolone (Ztalmy)

Added trial and failure of two preferred anticonvulsants.

9/1/2026

CP.PMN.298

Tirzepatide (Zepbound)

Per June SDC: for initial and continued therapy, added requirement if request is for Zepbound Pre-filled Single-Use Pen formulation, member must use Zepbound KwikPen formulation.

9/1/2026

CP.PMN.310_PEPP

Potassium citrate-potassium bicarbonate (ADV7013)_PEPP

Policy created preemptively.

9/1/2026

CP.PMN.32

Iloperidone (Fanapt)

3Q 2026 annual review: added ICHRA line of business; removed all line of business-specific distinctions from Appendix D; references reviewed and updated.

9/1/2026

CP.PMN.65

Vortioxetine (Trintellix)

3Q 2026 annual review: added ICHRA line of business; removed “applies to HIM request only” from Appendix D for TX; references reviewed and updated.

9/1/2026

CP.PMN.68

Brexpiprazole (Rexulti)

3Q 2026 annual review: added ICHRA line of business; removed all line of business-specific distinctions from Appendix D; references reviewed and updated.

9/1/2026

CP.PMN.91

Cariprazine (Vraylar)

3Q 2026 annual review: added ICHRA line of business; removed all line of business-specific distinctions from Appendix D; references reviewed and updated.

9/1/2026

CP.PCH.63

Denosumab (Prolia, Xgeva and biosimilars)

Policy created (adapted from CP.PHAR.58) per June SDC and prior clinical guidance; for osteoporosis and prostate/breast cancer fracture prevention, revised redirections to oral or IV bisphosphonate therapy and added Bildyos, Enoby, and Stoboclo as preferred biosimilars; for all other indications, added Xtrenbo as an additional preferred biosimilar; removed HIM IL bypass language as all preferred biosimilars are interchangeable.

9/1/2026

HIM.PA.109

Step Therapy

Per June SDC: added Corlanor requiring step through two beta-blockers recommended for heart failure.

9/1/2026

HIM.PA.175

Mepolizumab (Nucala)

Per June SDC, added redirection to Fasenra for HES. Added ICHRA line of business.

9/1/2026

CP.PCH.30

Memantine ER (Namenda XR), Memantine/Donepezil ER (Namzaric)

3Q 2026 annual review: added ICHRA line of business; added step therapy bypass for IL HIM per IL HB 5395; references reviewed and updated.

9/1/2026

CP.PCH.53

Leuprolide Acetate, Leuprolide Mesylate

Added off-label use for female infertility per plan request.

9/1/2026

CP.PCH.56

Delandistrogene moxeparvovec-rokl (Elevidys)

"3Q 2026 annual review: updated FDA approved indication with removal of non-ambulatory indication per updated PI; added ICHRA line of business; references reviewed and updated."

9/1/2026

HIM.PA.125

Levomilnacipran (Fetzima)

3Q 2026 annual review: added ICHRA line of business; removed “applies to HIM request only” from Appendix D for TX; references reviewed and updated.

9/1/2026

HIM.PA.156

Evolocumab (Repatha)

Per 2026 guideline updates: for all indications, modified moderate or low intensity statin requirement therapy from requiring previous use of one high intensity statin and LDL remained ≥ 70 mg/dL to LDL goal was not achieved to reflect differing LDL goals based on specific indication; modified recent LDL requirements to ≥ 55 mg/dL for history of ASCVD regardless of very high risk status; for increased risk for CV events, added diabetes, 10-year estimated risk for ASCVD ≥ 10%, and CAC score ≥ 100 to 299 AU as examples of increased risk for CV events, added CAC score ≥ 300 AU as example of history of ASCVD, added recent LDL requirement ≥ 70 mg/dL separate from history of ASCVD; for HeFH, simplified baseline LDL to at least 160 mg/dL for all ages, revised recent LDL requirement to ≥ 70 mg/dL; for primary hypercholesterolemia, added recent LDL requirement of ≥ 70 mg/dL for severe primary hypercholesterolemia with ASCVD risk factors with corresponding Appendix H, clarified recent LDL requirement of ≥ 100 mg/dL is for without ASCVD risk factors, added requirement that treatment plan does not include coadministration with Lerochol to prevent duplicate therapy; for HoFH, revised LDL requirements to ≥ 100 mg/dL for pediatric population; removed ‘very high risk’ qualifier from adult LDL requirement.

9/1/2026

HIM.PA.166

Evinacumab-dgnb (Evkeeza)

Per 2026 guideline updates: revised ezetimibe requirements to ages ≥ 10 years; revised statin requirement to ages ≥ 7 years; revised LDL requirements to ≥ 100 mg/dL for pediatric population ≥ 7 years; removed ‘very high risk’ qualifier from adult LDL requirement; modified moderate or low intensity statin requirement therapy from requiring previous use of one high intensity statin and LDL remained ≥ 70 mg/dL to LDL goal was not achieved to reflect differing LDL goals based on specific indication

9/1/2026

HIM.PA.169

Berotralstat (Orladeyo)

3Q 2026 annual review: extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

HIM.PA.172

Lanadelumab-fylo (Takhzyro)

3Q 2026 annual review: extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

9/1/2026

HIM.PA.174

Tenapanor (Ibsrela, Xphozah)

Policy recreated as HIM and Medicaid line of business strategy no longer align due to regulations (HIM line of business removed from CP.PMN.224) added ICHRA line of business; added step therapy bypass for IL HIM per IL HB 5395.

9/1/2026

HIM.PA.SP60

Biologic and Non-biologic DMARDs

RT4: added newly FDA-approved Icotyde for PsO; for PsO: for Taltz and Icotyde pediatric redirection; updated criteria from “failure of TWO” to “failure of THREE” to align with redirection to Enbrel and Otezla as alternative option with “or” instead of “and” rationale; RT4: for Cosentyx, updated AS criteria with pediatric extension for ages 12 years and older per prescribing information; RT4: for Stelara/ustekinumab, updated CD criteria with pediatric extension for ages 2 to 17 years per prescribing information; RT4: for Hadlima, applied pediatric age extensions for HS and UV and added new single-dose autoinjector PushTouch dosage strength [80 mg/0.8 mL]; for HS, UC, UV, and continued therapy “All Other Indications In Section I”, added bypass of “FDA-approved age limit does not overlap” for preferred adalimumab biosimilar requirement; RT4: added FDA approved biosimilars Immgolis and Immgolis Intri to criteria; for RA for Simponi, Simponi Aria, Immgolis, and Immgolis Intri, added requirement for concomitant use with MTX or another DMARD; added HCPCS code Q5164.

9/1/2026

CP.PCH.54

Nintedanib (Ofev)

Retire, combined with CP.PHAR.285 Nintedanib (Ofev) for all lines of business per June SDC

9/1/2026

CP.PHAR.587_PEPP

Pegzilarginase (AEB1102)_PEPP

Retire, drug is now FDA approved, refer to CP.PHAR.587

9/1/2026

CP.PHAR.589_PEPP

Bulevirtide (Hepcludex)_PEPP

Retire, drug is now FDA approved, refer to CP.PHAR.589

9/1/2026

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.

 pr@qualchoice.com | Provider Relations Representatives

QCA26-AR-H-188