CurrentFidelis CarePolicy N/A

2026 Medicare Part B Step Therapy Criteria

Defines the Medicare Part B drugs subject to the payer's step therapy requirement and the general rule that step therapy applies if the drug has not been used in the past 365 days. Explains that exceptions may be requested per Evidence of Coverage.

Policy Summary

PayerFidelis Care

Policy2026 Medicare Part B Step Therapy Criteria

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionProvider must ensure an appropriate first-line (different or less expensive) drug has been tried if the requested drug is on the step therapy list and has not been used in the past 365 days; coverage will be conditioned on meeting step therapy or granted exception.

SourceLink

POLICY UPDATE CHANGES

Document lists drugs that require step therapy and defines step therapy and the 365-day application rule.

~140Drugs listed

365Lookback days for prior use

Summary & Scope

This bulletin enumerates Medicare Part B drugs subject to the plan's step therapy program. Step therapy requires that a member try an initial agent (typically a different or less expensive drug) before a subsequent agent will be covered. The list includes biologics, oncology agents, injectables, immune globulins, and other specialty therapies. Exceptions to step therapy may be requested as described in the member's Evidence of Coverage.

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Drugs Subject to Step Therapy (listed by name)

The following drugs are listed as subject to step therapy: (see full drug list). This bulletin does not provide specific per-drug step sequences or alternative agents; it identifies drugs that require step therapy. An exception may be requested by the member, prescriber, or authorized representative as described in the Evidence of Coverage.

Drug name (listed)
Abatacept (Orencia ® )
Ado-trastuzumab emtansine (Kadcyla ® )
Afamitresgene autoleucel (Tecelra ® )
Aflibercept (Eylea ® , Eylea ® HD, Ahzantive ™ , Enzeevu ™ , Opuviz ™ , Pavblu ™ , Yesafili ™ )
Atezolizumab (Tecentriq ® )
Atezolizumab/hyaluronidase-tqjs (Tecentriq Hybreza)
Axicabtagene ciloleucel (Yescarta ® )
Bevacizumab (Avastin ® , Alymsys ® , Mvasi ® , Vegzelma ™ , Zirabev ™ )
Brentuximab vedotin (Adcetris ® )
Brexucabtagene autoleucel (Tecartus ™ )
Brolucizumab-dbll (Beovu ® )
Cemiplimab-rwlc (Libtayo ® )
Certolizumab (Cimzia ® )
Ciltacabtagene autoleucel (Carvykti ™ )
Corticosteroid intravitreal implants: dexamethasone (Ozurdex ® ), fluocinolone acetonide (Iluvien ® )
Corticotropin (H.P. Acthar ® , Purified Cortrophin ™ Gel)
Daratumumab (Darzalex ® ), daratumumab/hyaluronidase-fihj (Darzalex Faspro)
Darbepoetin alfa (Aranesp ® )
Denosumab (Prolia ® , Xgeva ® )
Efbemalenograstim alfa-vuxw (Ryzneuta ® )
Eflapegrastim-xnst (Rolvedon ™ )
Elranatamab-bcmm (Elrexfio ™ )
Elotuzumab (Empliciti ® )
Emapalumab-lzsg (Gamifant ™ )
Epoetin alfa (Epogen ® , Procrit ® )
Faricimab-svoa (Vabysmo ® )
Ferric carboxymaltose (Injectafer ® )
Ferric derisomaltose (Monoferric ® )
Ferumoxytol (Feraheme ® )
Fidanacogene elaparvovec-dzkt (Beqvez ™ )
Filgrastim (Neupogen ® , Zarxio ® , Nivestym ™ , Granix ® , Releuko ® , Nypozi ™ )
Golimumab (Simponi ® , Simponi Aria ® )
Hyaluronate derivatives: sodium hyaluronate (Euflexxa ® , Gelsyn-3 ™ , GenVisc ® 850, Hyalgan ® , Supartz FX ™ , Synojoynt ™ , Triluron ™ , TriVisc ™ , VISCO-3 ™ ), hyaluronic acid (Durolane ® ), cross-linked hyaluronate (Gel-One ® ), hyaluronan (Hymovis ® , Orthovisc ® , Monovisc ® ), hylan polymers A and B (Synvisc ® , Synvisc One ® )
Idecabtagene vicleucel (Abecma ™ )
Imetelstat (Rytelo ™ )
Immune globulins (Alyglo ™ , Asceniv ™ , Bivigam ® , Cutaquig ® , Cuvitru ™ , Flebogamma ® DIF, GamaSTAN ® , GamaSTAN ® S/D, Gammagard ® liquid, Gammagard ® S/D, Gammaked ™ , Gammaplex ® , Gamunex ® -C, Hizentra ® , HyQvia ® , Octagam ® , Panzyga ® , Privigen ® , Xembify ® )
IncobotulinumtoxinA (Xeomin ® )
Infliximab-ayyb (Zymfentra ® )
Lanreotide (Somatuline ® Depot)
Lisocabtagene maraleucel (Breyanzi ® )
Lurbinectedin (Zepzelca ™ )
Luspatercept-aamt (Reblozyl ® )
Lutetium Lu 177 dotatate (Lutathera ® )
Mirikizumab-mrkz (Omvoh ™ )
Motixafortide (Aphexda ® )
Nadofaragene firadenovec-vncg (Adstiladrin ® )
Natalizumab (Tysabri ® , Tyruko ® )
Nivolumab (Opdivo ® ), nivolumab/hyaluronidase-nvhy (Opdivo Qvantig ™ )
Obecabtagene autoleucel (Aucatzyl ® )
Pasireotide (Signifor ® LAR)
Pegfilgrastim (Neulasta ® , Fulphila ™ , Fylnetra ® , Nyvepria ™ , Stimufend ® , Udenyca ™ , Ziextenzo ™ )
Pembrolizumab (Keytruda ® )
Polatuzumab vedotin-piiq (Polivy ™ )
Ramucirumab (Cyramza ® )
Ranibizumab (Lucentis ® , Byooviz ® , Cimerli ™ , Susvimo ™ )
Remestemcel-L-rknd (Ryoncil ® )
RimabotulinumtoxinB (Myobloc ® )
Rituximab (Rituxan ® , Riabni ™ , Ruxience ™ , Truxima ® ), rituximab/hyaluronidase (Rituxan Hycela ™ )
Romiplostim (Nplate ® )
Romosozumab-aqqg (Evenity ™ )
Sargramostim (Leukine ® )
Sipuleucel-T (Provenge ® )
Talquetamab-tgvs (Talvey ™ )
Teclistamab-cqyv (Tecvayli ® )
Teprotumumab-trbw (Tepezza ™ )
Tisagenlecleucel (Kymriah ® )
Tocilizumab (Actemra ® , Avtozma ® , Tofidence ™ , Tyenne ® )
Trastuzumab (Herceptin ® , Ontruzant ® , Herzuma ® , Ogivri ™ , Trazimera ™ , Kanjinti , Hercessi ™ ), trastuzumab/hyaluronidase (Herceptin Hylecta ™ )
Triamcinolone ER injection (Zilretta ® )
Vedolizumab (Entyvio ® )
Verteporfin (Visudyne ® )

What Providers Must Do

Step Therapy

Step therapy requirement prior to coverage

Ensure an appropriate first-line (different or less expensive) drug has been tried when the requested drug appears on the step therapy list and has not been used in the past 365 days. Coverage for the requested drug is conditioned on meeting the step therapy requirement or on a granted exception.

Lookback period: 365 days
See member Evidence of Coverage for exception rules

Documentation Required

Exception request process

An exception may be requested per the member's Evidence of Coverage. The member, their prescriber, or an authorized representative may request an exception; supporting documentation to show medical necessity should be submitted as described in the Evidence of Coverage.

Who may request: provider, member, or authorized representative
Submit supporting documentation per Evidence of Coverage instructions

OpenPayer

2026 Medicare Part B Step Therapy Criteria

Summary & Scope

Step Therapy Coverage Criteria

Drugs Subject to Step Therapy (listed by name)

What Providers Must Do

Definitions

Policy Update Changes