Step Therapy Requirements — Part 1 (select drugs; Step 2 prior-therapy rules)
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Defines step therapy (prior trial) requirements for specific drugs and formulations for Denver-Health-Medical-Plan Elevate Medicare Choice (HMO D-SNP) and Elevate Medicare Select (HMO). Affects providers submitting pharmacy claims or prior auth for listed products.
No material clinical or coverage changes in this revision.
Coverage Criteria — Step Therapy Details
Febuxostat initial therapy
Covered when ALL of the following are met for febuxostat (Step 2):
Applies to febuxostat 40 mg and 80 mg tablets
Esomeprazole granules initial therapy
Covered when ALL of the following are met for esomeprazole magnesium granules (Step 2):
Applies to esomeprazole magnesium DR granules 10 mg, 20 mg, 40 mg
Antipsychotic products criteria
Covered when specified trials of formulary oral antipsychotics are documented:
Applies to certain disintegrating tablets and films
Applies to some patches, dose packs, and other products requiring two-agent trial
AUVELITY initial therapy
Covered when ALL of the following are met for AUVELITY ER:
Applies to AUVELITY 45 mg–105 mg ER tablet
Dihydroergotamine initial therapy
Covered when ALL of the following are met for dihydroergotamine nasal spray:
Applies to dihydroergotamine 0.5 mg/pump nasal spray
ELEPSIA XR initial therapy
Covered when ALL of the following are met for ELEPSIA XR:
Applies to ELEPSIA XR 1000 mg and 1500 mg ER tablets
Eslicarbazepine (200 mg, 400 mg) initial Step requirement
Coverage of eslicarbazepine 200 mg and 400 mg tablets (Step 2) when the following is met:
Applies to eslicarbazepine 200 mg and 400 mg tablets
Eslicarbazepine (600 mg, 800 mg) Step requirement
Coverage of eslicarbazepine 600 mg and 800 mg tablets (Step 2) when the following is met:
Applies to eslicarbazepine 600 mg and 800 mg tablets
Omega-3 acid ethyl esters Step requirement
Coverage of omega-3 acid ethyl esters 1 g capsule (Step 2) when the following is met:
Applies to omega‑3 acid ethyl esters 1 g capsule
PCSK9 / LDL-lowering agents Step listing
Coverage of listed PCSK9 inhibitor presentations and LDL‑lowering agents (Step 2) when the following is met:
Chunks 23–24
FANAPT (iloperidone) Step requirement
Coverage of FANAPT products (Step 2) when the following is met:
Applies to FANAPT tablets and titration packs
Medical supplies and consumables Step 2 listing
Coverage of listed medical supply items (pen needles, syringes, alcohol pads, gauze, etc.) as Step 2 items:
No explicit prior-therapy criteria stated in these chunks for supplies; coverage contingent on the listed product being assigned Step 2
Injectable insulin prior-claim criterion
Criteria related to injectable insulin Part D payment
Used to assist Part D payment determination
Trintellix + generic antidepressant prior-claim
Criteria for Trintellix step requirement
Required to meet step criteria for related products
CAPLYTA step therapy
Step therapy requirements for CAPLYTA products
Applies to CAPLYTA 10.5 mg, 21 mg, and 42 mg per listing
Memantine prior-claim requirement
Memantine extended‑release products
Applies to listed memantine ER sprinkle capsule strengths
Methotrexate injector step/requirement
Methotrexate injector coverage
Applies to listed methotrexate injector products
Loteprednol prior-claim requirement
Topical ophthalmic steroid (loteprednol) requirement
Applies to ALREX / loteprednol etabonate 0.2%
Perampanel/Fycompa step therapy
Step 2 epilepsy products
Applies to perampanel oral suspension and tablets as listed
Prior claim requirement (levocetirizine/cromolyn/epinastine)
Coverage for the product(s) referenced under this Details entry is conditioned on ALL of the following:
Supports step‑therapy for the associated product grouping
Perampanel tablet Step 2 prior-therapy
Perampanel higher‑strength tablets Step 2 criteria:
Applies to perampanel 10 mg and 12 mg tablets grouping
Rufinamide prior-therapy
Rufinamide product grouping criteria:
Applies to certain rufinamide strengths
EMSAM prior-therapy
EMSAM (selegiline patch) step criteria:
Supports coverage of EMSAM patch formulations
Antipsychotic prior-therapy
Antipsychotic-related step requirements:
Applies to COBENFY/grouped entries and related products
For certain oral alkylating agents and other immunomodulators, the policy requires documentation to support a Medicare Part B versus Part D payment determination. Specifically, a prior claim for a rheumatoid arthritis, psoriasis, or active polyarticular juvenile idiopathic arthritis drug within the past 120 days will qualify the drug for Part D payment; all other indications will be adjudicated through the formulary exception process prior to approval.
REPATHA presentations are listed with an administrative status note: the ST Criteria: Pending CMS Approval designation applies to REPATHA SURECLICK 140 mg/mL pen and REPATHA syringe 140 mg/mL. This indicates a pending CMS decision rather than a defined prior‑therapy requirement at this time; providers should expect special administrative handling until CMS approval is resolved.
Coverage for RASUVO subcutaneous auto‑injector products is conditioned on prior use of or a documented contraindication to generic oral methotrexate tablets. In other words, a trial of generic oral methotrexate or documentation of contraindication is required before RASUVO will be approved.
SPRITAM (levetiracetam oral suspension/tablet for suspension) appears in the Step 2 product listings without any explicit exclusion language in this excerpt. The listing shows SPRITAM as Products Affected Step 2 but no separate exclusion clause is stated here.
This portion of the document functions as an index only and does not list explicit coverage exclusions for the indexed items. Entries such as delayed‑release capsules, injectable supplies, and other products are shown for reference rather than presenting standalone coverage criteria or exclusions.
Coding and Look-back Windows
| No codes listed |
What Providers Must Do / Denial Risks
Esomeprazole granules prior‑claim requirement
Esomeprazole granules (delayed‑release oral suspension granules) are subject to a Step 2 prior‑claim requirement. Providers must document a prior pharmacy claim within the past 120 days for a generic formulary oral proton‑pump inhibitor (examples listed in the policy: lansoprazole capsules, esomeprazole capsules, rabeprazole, omeprazole, or pantoprazole). Absence of such a prior claim may result in denial of the Step 2 product.
- Products listed: esomeprazole magnesium DR 10 mg granules; esomeprazole magnesium DR 20 mg granules; esomeprazole magnesium DR 40 mg granules
- Required lookback: 120 days
- Acceptable prior agents: generic lansoprazole capsules, esomeprazole capsules, rabeprazole, omeprazole, pantoprazole
Antipsychotic products prior‑claim requirement
Many oral and transdermal antipsychotic products in the Step 2 group require evidence of prior use of formulary oral antipsychotics. Providers must show prior pharmacy claims within the specified lookback periods (typically 120 or 365 days depending on product) documenting trials of listed generic/formulary oral antipsychotics before Step 2 agents will be approved.
- Examples of Step 2 antipsychotics: aripiprazole ODT, aripiprazole film, aripiprazole disintegrating tablets, cariprazine (Vraylar), Caplyta, Fanapt, Secuado (asenapine patch)
- Common required prior agents: risperidone, clozapine tablet, olanzapine, immediate‑release quetiapine fumarate, ziprasidone, aripiprazole (tablets/film/solution), asenapine, paliperidone, lurasidone
- Lookback windows: 120 days for many products; some require evidence of 2 different formulary oral generics within past 365 days
Step 2 prior‑therapy verification
For all Step 2 products, providers must verify prior‑therapy criteria exactly as stated for the specific product. This commonly requires one or more prior claims for listed generic or formulary agents within the stated lookback window (examples below). Failure to submit prior‑therapy documentation matching the policy criteria risks denial.
- Confirm the exact prior agents and number required (e.g., one formulary oral antipsychotic vs. two distinct generic anticonvulsants)
- Confirm the lookback period (commonly 120 days or 365 days as specified)
- Attach prior pharmacy claim details to the authorization request (dates, NDC or drug name, and days supply)
Product list only (supplies/index entries)
This portion of the document also contains product and supplies index listings only. These index entries list product names, packaging, and page references — they are informational and do not by themselves state prior‑authorization or step‑therapy approval criteria.
- Index entries include numerous pen needles, syringes, alcohol pads, gauze and other supplies
- Index listings show page references for each product (useful for locating full policy text)
Prior‑claim evidence required
Several Step 2 entries require submission of prior‑claim evidence to meet criteria. Providers must include prior pharmacy claim records showing the agent(s) used, date(s) of dispensing within the policy lookback window, and sufficient detail to identify the formulary product (drug name and strength, NDC if available, and days supply).
- Common lookback windows: 120 days or 365 days depending on product
- Required details: drug name, strength, date of fill, and indication where relevant (e.g., insulin or rheumatologic agents for Part B vs Part D determination)
- Examples: Trintellix + one generic antidepressant within past 365 days; generic topiramate within past 120 days; injectable insulin prior claim within past 120 days
Prior authorization conditioned on prior trials
Prior authorization approvals for many Step 2 drugs are conditioned on prior trials of specified agents. Examples: trials of two distinct generic anticonvulsants within 365 days for certain anticonvulsant Step 2 products; trial of Trintellix plus one generic antidepressant in past 365 days for labeled antidepressant Step 2 products.
- Anticonvulsant requirement examples: two generic agents from list (carbamazepine, divalproex, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, zonisamide, lacosamide) within past 365 days
- Antidepressant example: prior claim for Trintellix and one generic antidepressant within 365 days
Prior authorization (none stated)
Some index portions and product listings do not specify a prior authorization requirement in the excerpted text. For those entries, no specific prior‑auth criteria are stated on the index page; providers should consult the full policy text at the referenced page for any action requirements.
- Index-only entries (supplies and some drug names) show no explicit prior authorization criteria in this section
- If an authorization is needed, the detailed criteria will appear in the product detail pages referenced by the index
No explicit authorization or denial criteria in index entries
Several entries in the provided pages contain no explicit authorization or denial criteria (index or supply listings). These are informational; providers should not infer step‑therapy rules from index lines alone and must review the detailed product sections for coverage rules.
- Examples: supply index lines and simple product name listings without adjacent 'Details' criteria
- These entries are not actionable for prior authorization without the product detail page
Lack of a prior claim for Trintellix plus a generic antidepressant may cause denial
For Trintellix‑related Step 2 criteria, providers must document a prior claim for Trintellix plus one generic antidepressant within the past 365 days. Lack of documented prior use of Trintellix plus a qualifying generic antidepressant will not meet the Step 2 requirement and may result in denial.
- Required prior agents: Trintellix plus one generic antidepressant (examples: citalopram, escitalopram, fluoxetine, paroxetine, sertraline, desvenlafaxine, duloxetine, venlafaxine, mirtazapine, bupropion IR/SR/XL, vilazodone)
- Lookback window: 365 days
Prior claim required (120 days) for certain ocular/allergy agents
Certain ocular and allergy agents (e.g., ALREX, loteprednol etabonate) require documentation of a prior pharmacy claim for specified agents (levocetirizine, cromolyn sodium, or epinastine) within the past 120 days. Providers should include these prior claims when requesting Step 2 products to avoid denial.
- Examples: ALREX 0.2% eye drops; loteprednol etabonate 0.2% eye drops
- Required prior agents: levocetirizine, cromolyn sodium, or epinastine
- Lookback: 120 days
Prior trial of two generic anticonvulsants (365 days)
Some anticonvulsant Step 2 approvals require documented trials of two different generic anticonvulsants within the past 365 days (example agents listed in policy). Providers must present claims for two distinct qualifying agents with dates within the 365‑day lookback to satisfy these criteria.
- Qualifying generic anticonvulsants include: carbamazepine, divalproex sodium, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, zonisamide, lacosamide
- Lookback window: 365 days
- Applies to products like eslicarbazepine and perampanel/Fycompa Step 2 listings
No denial criteria are present in these index listings
Multiple index pages contain no denial criteria or authorization triggers visible in the index excerpts; these are purely navigational product lists. Providers should reference the corresponding detailed product pages for any required documentation or prior authorization steps.
- Index lists of pen needles, syringes, supplies and many product names show no authorization language in the index
- Use page references in the index to find the detailed criteria
Part B vs Part D payment determination documentation
The document includes notes to assist with Part B vs Part D payment determinations. For certain agents (e.g., cyclophosphamide, methotrexate), providers should include documentation of the indication (rheumatoid arthritis, psoriasis, active polyarticular juvenile idiopathic arthritis) and prior pharmacy claims within the stated lookback to qualify for Part D payment. Otherwise a Part B vs D determination will be made via the formulary exception process.
- Example: Cyclophosphamide entries include a Part B vs D payment determination note
- Required supporting info: prior claim for a rheumatologic agent within past 120 days; indication documentation may be needed
Documentation must show prior pharmacy claims meeting lookback criteria
Documentation submitted for prior‑therapy verification must show prior pharmacy claims within the exact lookback periods specified in the policy. Include drug name, dispensing date, NDC if available, days supply, and, when relevant, the clinical indication to support Part B vs Part D determinations.
- Required elements: drug name, strength, date of fill, NDC (if available), days supply
- Match the lookback window specified (e.g., 120 days or 365 days)
- For Part B vs D issues, include diagnosis/indication documentation
The document provides product names and page references (index)
Several sections explicitly state that the page is an index of supplies or injectables and that product names and page references are provided for navigation. These listings are operational aids; they do not replace the detailed product criteria in the policy.
- Index lists injectable product names and page numbers (e.g., Rasuvo injectors, Repatha injectors)
- Index also lists many supply items (pen needles, syringes, alcohol pads)
This section is an index of supply and drug names (no actionable criteria)
This section contains many index entries only (supply and drug name indexes). There are no step‑therapy actions or requirements stated on those index lines — providers must consult the referenced product detail pages for any coverage rules or prior authorization instructions.
- Index entries are for navigation; they do not show 'Details' criteria on the index page
- Locate the detailed criteria by page reference when an authorization is required
Cyclophosphamide Step 2 and Part B/D note
Cyclophosphamide Step 2 entries include both Step 2 placement and a Part B vs D note — providers should submit prior therapy evidence for indicated rheumatologic agents within the past 120 days to support Part D payment; otherwise a Part B vs D determination will be performed.
- Cyclophosphamide products listed as Step 2: 25 mg and 50 mg tablets/capsules
- Part B vs D qualifier: prior claim for rheumatoid arthritis, psoriasis, or active polyarticular juvenile idiopathic arthritis drug within past 120 days will qualify for Part D payment
Background and Policy Scope
Background: This section defines the policy’s step therapy (Step 2) approach. Step assignments require documentation of prior pharmacy claims or trials of specified formulary or generic alternatives within defined look‑back windows (commonly 120 days or 365 days, depending on the product). Certain entries include administrative notes affecting payment pathway or CMS approval status (for example, Part B vs D determinations for immunomodulators and a pending CMS approval status for specific REPATHA presentations). Indexed pages list supply and injectable product names but do not, by themselves, define authorization criteria.
Definitions and Reference Lists
Initial Therapy Examples and Required Trials
Initial therapy examples
Initial therapy step rules included in this part:
Example initial therapy rule: febuxostat 40 mg and 80 mg
Initial Step 2 therapy requirements
See Details chunks 18–26 for specific agent lists and lookback windows
Step Therapy Assignments and Lookup
| Product (Step Level) | Prior-therapy / Look-back Requirement | Notes |
|---|---|---|
| febuxostat 40 mg tablet | ||
| Prior claim for formulary version of allopurinol tablets within the past 120 days | ||
| Designated Step 2; applies to febuxostat 40 mg and 80 mg listings |
| Example Prior-claim Scenario | Required prior pharmacy claim(s) | Look-back window (days) |
|---|---|---|
| Eslicarbazepine 200 mg / 400 mg (example) | ||
| Prior claim for generic topiramate (tablets or capsules) | ||
| 120 | ||
| Eslicarbazepine 600 mg / 800 mg (example) | ||
| Prior claims for two generic anticonvulsant agents (listed agents) | ||
| 365 | ||
| Omega-3 acid ethyl esters 1 g capsule (example) | ||
| Prior claim for generic fenofibrate | ||
| 120 |
| Product (Step Level) | Prior-therapy Requirement | Look-back (days) |
|---|---|---|
| CAPLYTA 10.5 mg capsule | ||
| Claim for 2 formulary oral generic antipsychotics (lurasidone, risperidone, olanzapine, immediate‑release quetiapine fumarate, ziprasidone, aripiprazole, asenapine) | ||
| 365 | ||
| CAPLYTA 21 mg capsule | ||
| Claim for 2 formulary oral generic antipsychotics (same agent list) | ||
| 365 | ||
| CAPLYTA 42 mg capsule | ||
| Claim for 2 formulary oral generic antipsychotics (same agent list) | ||
| 365 |
| Product (Step Level) | Required prior claim | Look-back (days) |
|---|---|---|
| memantine 7 mg / 14 mg / 21 mg / 28 mg capsule (extended‑release sprinkle strengths) | ||
| Prior claim for formulary version of memantine immediate‑release | ||
| 120 |
| Product (Step Level) | Prior-therapy requirement | Look-back (days) |
|---|---|---|
| ALREX / loteprednol etabonate 0.2% (eye drops) | ||
| Prior claim for federal legend levocetirizine, cromolyn sodium, or epinastine | ||
| 120 |
| Product (Step Level) | Prior-therapy requirement | Look-back (days) |
|---|---|---|
| FYCOMPA 0.5 mg/mL oral suspension | ||
| Per listing: assigned Step 2 (prior‑therapy details for higher strengths noted separately) | ||
| See perampanel table | ||
| Perampanel 10 mg tablet / 12 mg tablet | ||
| Prior claim for 2 generic anticonvulsant agents (listed agents) for higher‑strength tablets | ||
| 365 |
| Product grouping | Required prior pharmacy claim(s) | Look-back (days) |
|---|---|---|
| Perampanel (10 mg, 12 mg tablets) and FYCOMPA suspension | ||
| Prior claim for 2 generic anticonvulsant agents (carbamazepine, divalproex sodium, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, zonisamide, lacosamide) | ||
| 365 | ||
| Rufinamide (200 mg, 40 mg/mL suspension; 400 mg tablet) | ||
| Prior claim for a generic anticonvulsant agent (listed agents) | ||
| 120 | ||
| Products referencing topiramate criterion (e.g., eslicarbazepine 200/400 mg) | ||
| Prior claim for generic topiramate (tablets or capsules) | ||
| 120 |
| Index segment | Step therapy rules present | Notes |
|---|---|---|
| Index entries (supplies and miscellaneous) — page index excerpt | ||
| No step therapy rules present in this index segment | ||
| Content is an item index (e.g., gauze, syringes); use index references for locating product listings |
| Index fragment | Step therapy requirements | Notes |
|---|---|---|
| Index fragment showing dose‑pack capsule entries (VRAYLAR dose pack example) | ||
| No step therapy requirements specified in this index fragment | ||
| Fragment is an index listing only; no coverage criteria included in these lines |
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