Medicare Part B Drugs Requiring Step Therapy
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Defines step therapy requirements for Medicare Advantage (HealthPartners) Part B medications, including preferred step agents and criteria for exceptions; applies to HealthPartners Medicare products noted. Affects providers requesting coverage/authorization for Part B drugs for Medicare Advantage members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Exceptions to step therapy
Coverage for a non-preferred product may be authorized when ALL of the following are met:
Items 2 and 3 are OR-linked as alternative paths to exception
Provider Actions and Prior Authorization
Prior authorization required for step therapy
Patients new-to-therapy must use the preferred step agent; prior authorization may be granted for a non-preferred product only when medical necessity is shown and the exception criteria are met.
Step therapy requirement and preferred agents
For patients new-to-therapy, use of the preferred medication (the listed step agent) is required. Preferred step agents are specified by drug/group (examples: Inflectra or Renflexis for infliximab; Kanjinti, Ogivri, or Trazimera for trastuzumab; Ruxience or Truxima for rituximab; Mvasi or Zirabev for bevacizumab; Neulasta/Onpro, Fulphila, or Ziextenzo for long-acting G-CSF; Ocular Avastin for many ocular anti‑VEGF products).
Exception documentation requirements
To authorize a non-preferred product, documentation must demonstrate medical necessity and either that the patient is stable on the non-preferred medication or that the patient has tried and failed, or has medical contraindications to, the preferred products.
- Documentation must show medical necessity per applicable Medicare NCD/LCD or Benefit Policy Manual criteria.
- Show stability on the non-preferred product OR trial-and-failure/contraindication to preferred agents.
Step therapy enforcement for new-to-therapy patients
Coverage for new-to-therapy patients requires use of the preferred step agent unless the exception criteria are met; failure to document step therapy or meet exception criteria may result in denial of coverage.
Background
Step therapy is a utilization management approach applied to Medicare Advantage Part B drugs that requires patients who are new-to-therapy to begin treatment with a preferred step agent. This policy applies to HealthPartners Medicare Advantage plans only and references applicable Medicare NCDs/LCDs or the Medicare Benefit Policy Manual for full medical necessity criteria. When medical necessity is met, use of the preferred medication is required for patients who have not previously taken the requested drug; patients already stable on a non-preferred product may continue that therapy if medical necessity criteria are satisfied.
Coverage for a non-preferred product may be authorized only when ALL of the following are met: 1) medical necessity has been demonstrated based on medical necessity criteria; and 2) the patient is stable on a non-preferred medication, OR 3) the patient has tried and failed or has medical contraindications to preferred products. The policy list of step agents and preferred medications is subject to change; refer to the plan-specific documents for scope and contact Member Services for questions.
Definitions
Initial Therapy / Step Agent Requirement
Initial therapy / Step agent requirement
For patients new-to-therapy the preferred medication (step agent) must be used unless exception criteria are met.
Preferred agents are listed per drug group in the policy text (see step agent list).
Continuation Therapy
Continuation therapy
Patients stable on a non-preferred medication will have continued coverage of the non-preferred medication if other requirements of medical necessity are met.
Documentation of ongoing stability and medical necessity should be provided.
Step Therapy Table — Preferred Agents by Drug Group
| Drug / Drug Group | Preferred Step Agent (new-to-therapy patients) |
|---|---|
| {"text":"Remicade and other infliximab products","status":""},{"text":"Inflectra or Renflexis","status":""} | |
| {"text":"Herceptin, Herceptin Hylecta, and single‑agent trastuzumab products","status":""},{"text":"Kanjinti, Ogivri, or Trazimera","status":""} | |
| {"text":"Rituxan and other rituximab products; Enjaymo","status":""},{"text":"Ruxience or Truxima","status":""} | |
| {"text":"Avastin and other bevacizumab products","status":""},{"text":"Mvasi or Zirabev","status":""} | |
| {"text":"Long‑acting G‑CSF products (e.g., Udenyca, Nyvepria, Rolvedon, etc.)","status":""},{"text":"Neulasta, Neulasta Onpro, Fulphila, or Ziextenzo","status":""} | |
| {"text":"IV iron products (e.g., Injectafer, Monoferric, Triferic)","status":""},{"text":"Feraheme, Ferrlecit, Infed, or Venofer","status":""} | |
| {"text":"Ocular anti‑VEGF agents (e.g., Eylea, Beovu, Lucentis, Susvimo, Vabysmo, etc.)","status":""},{"text":"Ocular Avastin","status":""} | |
| {"text":"Intra‑articular hyaluronan products (e.g., Durolane, Genvisc, Hyalgan, Supartz, etc.)","status":""},{"text":"Euflexxa, Synvisc, or Synvisc One","status":""} | |
| {"text":"Lanreotide (Somatuline Depot)","status":""},{"text":"Sandostatin or Sandostatin LAR","status":""} | |
| {"text":"Pemetrexed products (Pemfexy, Pemrydi RTU, Axtle, etc.)","status":""},{"text":"Generic pemetrexed or Alimta","status":""} | |
| {"text":"Docivyx and docetaxel products","status":""},{"text":"Generic docetaxel","status":""} | |
| {"text":"Vectibix","status":""},{"text":"Erbitux","status":""} | |
| {"text":"Entyvio IV","status":""},{"text":"Inflectra or Renflexis","status":""} | |
| {"text":"Tepezza","status":""},{"text":"IV steroids (e.g., methylprednisolone)","status":""} |
Biosimilar Preferred Agents
Preferred step agents for infliximab products
Inflectra or Renflexis are the designated preferred step agents for Remicade and other infliximab products not otherwise listed.
- Use Inflectra or Renflexis as the step agent for infliximab products unless exception criteria are met.
Preferred step agents for trastuzumab products
Kanjinti, Ogivri, or Trazimera are the preferred step agents for Herceptin, Herceptin Hylecta, and other single-agent trastuzumab products not otherwise listed.
- Use Kanjinti, Ogivri, or Trazimera as the step agent for trastuzumab products unless exception criteria are met.
Preferred step agents for rituximab products and Enjaymo
Ruxience or Truxima are the preferred step agents for Rituxan and other rituximab products and for Enjaymo when not otherwise listed.
- Use Ruxience or Truxima as the step agent for rituximab products and Enjaymo unless exception criteria are met.
Preferred step agents for bevacizumab products
Mvasi or Zirabev are the preferred step agents for Avastin and other bevacizumab products not otherwise listed.
- Use Mvasi or Zirabev as the step agent for bevacizumab products unless exception criteria are met.
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