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Antiulcer agents — formulary step edits and prior-claim requirements (coverage criteria)

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Rules governing formulary step edits and prior-claim requirements for various oral antiulcer and related products; affects providers prescribing or dispensing the listed products to San Francisco Health Plan members.

Policy Summary

Payersanfranciscohealthplan

PolicyAntiulcer agents — formulary step edits and prior-claim requirements (coverage criteria)

Policy CodePolicy N/A

Change TypeTechnical review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument prior pharmacy claims for the specified formulary generic alternatives within the stated lookback periods (e.g., generic PPI within 120 days or two generic triptans within 365 days) when requesting coverage for Step 2 products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Step 2formulary step referenced

120 / 365lookback windows

~20+product entries

includes

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CurrentsanfranciscohealthplanPolicy N/A

Antiulcer agents — formulary step edits and prior-claim requirements (coverage criteria)

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Policy Summary

Payersanfranciscohealthplan

PolicyAntiulcer agents — formulary step edits and prior-claim requirements (coverage criteria)

Policy CodePolicy N/A

Change TypeTechnical review — no material changes

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Step 2formulary step referenced

120 / 365lookback windows

~20+product entries

includes

Coverage Criteria and Step Therapy Rules

Step therapy and prior-claim criteria (excerpt)

Coverage for listed Step 2 products is subject to prior-claim or trial requirements as specified per product.

Step 2 esomeprazole magnesium granules: Prior claim for a formulary generic oral proton pump inhibitor (lansoprazole capsule, esomeprazole capsule, rabeprazole, omeprazole, or pantoprazole) within the past 120 days.120 days

Applies to esomeprazole magnesium DR granules 10 mg, 20 mg, 40 mg listed as Step 2.

Dihydroergotamine nasal spray: Prior claim for two formulary generic triptans (e.g., sumatriptan and rizatriptan) within the past 365 days.365 days

Applies to dihydroergotamine 0.5 mg/pump nasal spray listed as Step 2.

Selected antipsychotics (examples): Prior claim(s) for specified formulary oral antipsychotic(s) within the past 120 or 365 days as noted per product (examples include risperidone, clozapine tablet, olanzapine, immediate‑release quetiapine, ziprasidone, aripiprazole, asenapine, paliperidone, lurasidone).120 or 365 days depending on product

Specific per‑product criteria appear in the policy (see product lines for exact lookback).

Step 2 prior-claim criteria

Covered at Step 2 when ALL of the following product-specific prior-claim requirements are met:

Drizalma (Drizalma Sprinkle) - triptan requirement: Prior claim for 2 formulary generic triptans (for example, sumatriptan and rizatriptan) within the past 365 days is required for Step 2 Drizalma sprinkle products.2 claims within 365 days

Supports Step 2 placement for DRIZALMA sprinkle formulations.

Topiramate oral solution: Prior claim for generic topiramate (tablets or capsules) within the past 120 days is required for the Step 2 topiramate oral solution listing.1 claim within 120 days

See topiramate 25 mg/mL oral solution Step 2 entry.

Eslicarbazepine acetate: Prior claim for two generic anticonvulsant agents from the specified list (e.g., carbamazepine, divalproex sodium, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, zonisamide, lacosamide) within the past 365 days is required.

For administrative Part B vs Part D payment determination, a prior pharmacy claim for a drug used to treat rheumatoid arthritis, psoriasis, or active polyarticular juvenile idiopathic arthritis within the past 120 days will qualify the drug for Part D payment. All other indications must undergo a Part B vs D payment determination via the formulary exception process before the drug can be approved.

Certain Step 2 products in the high-intensity statin pathway require evidence of a prior trial of a formulary generic high-intensity statin. Specifically, a prior 25-day trial of a formulary generic high-intensity statin (atorvastatin 40 mg or 80 mg OR rosuvastatin 20 mg or 40 mg) within the past 120 days is required; if that trial is not documented, a step exception request is required.

The provided document fragments in this section primarily list product names and SKU variants (pen needles, insulin syringes, gauze, bandages). There are no explicit clinical coverage or exclusion criteria

Coverage is scoped to the items enumerated under the payer's 'Products Affected' inventory. Products not appearing in the listed entries (for example, specific insulin syringe or pen needle SKUs shown here) are effectively outside the scope of this affected-products list and may not be considered for coverage under these listings.

The excerpt at hand is a catalog-style listing of affected supply SKUs (insulin syringes, pen needles and related items) and contains no explicit statements excluding coverage for any clinical indications; it functions as an inventory rather than a coverage-exclusion section.

This fragment continues the 'Products Affected' inventory with additional insulin syringe and pen needle variants. It lists item names, gauges, lengths and volumes but does not include explicit coverage exclusions or clinical criteria in these chunks.

The material here repeats product SKU listings (Healthy Accents, Healthwise, U-100 syringes, pen needles) and does not contain clinical exclusion language; it is limited to enumerating product names and variants without coverage decisions.

The document excerpts in this area list additional insulin syringe and pen needle SKUs and their gauge/length permutations. No explicit coverage exclusions or clinical denial rules are presented in these product-listing chunks.

Within the provided excerpts there are no 'not medically necessary' statements. The text segments function as product inventories and do not declare any items as not medically necessary in these chunks.

Across the product-listing fragments included here, no items are labeled or described as not medically necessary; the content consists of SKU and item enumerations without NMN determinations.

Coding and Lookback Windows

Prior-claim lookback windows

Primary lookback window120 days

Secondary lookback window365 days

Used for esomeprazole Step 2 prior-claim requirementPrior claim for a formulary oral PPI within the past 120 days (see product entries).

Used for triptan/ergot criteriaTwo formulary generic triptan claims within the past 365 days required for dihydroergotamine nasal spray (Step 2).

Provider Actions, Documentation, and Prior-Claim Requirements

Prior Authorization
Prior claim required for Step 2 esomeprazole products
Certain esomeprazole magnesium delayed‑release granule products are designated Step 2 and require documentation of a prior pharmacy claim for a formulary generic oral proton pump inhibitor (lansoprazole capsule, esomeprazole capsule, rabeprazole, omeprazole, or pantoprazole) within the past 120 days before the Step 2 product will be approved.
Lookback window: 120 days
Required prior claim examples: lansoprazole capsule; esomeprazole capsule; rabeprazole; omeprazole; pantoprazole

Prior Authorization
Prior claim required for dihydroergotamine nasal spray
Dihydroergotamine 0.5 mg/pump nasal spray is placed at Step 2 and requires prior pharmacy claims showing trials of two formulary generic triptans (for example, sumatriptan and rizatriptan) within the past 365 days to meet the Step 2 requirement.
Lookback window: 365 days
Required prior claims: two formulary generic triptans (e.g., sumatriptan and rizatriptan)

Initial Therapy and Trial Requirements

Initial therapy prior-claim requirements

Initial coverage requires prior trials or prior claims of formulary preferred generics before Step 2 drugs are authorized.

Esomeprazole magnesium granules initial requirement: Prior claim for a formulary generic oral proton pump inhibitor (lansoprazole capsule, esomeprazole capsule, rabeprazole, omeprazole, or pantoprazole) within the past 120 days is required prior to initial coverage of Step 2 esomeprazole magnesium granules.120 days

Applies to esomeprazole magnesium DR granules 10 mg, 20 mg, 40 mg.

Dihydroergotamine nasal spray initial requirement: Prior claims for two formulary generic triptans within the past 365 days are required prior to initial coverage of dihydroergotamine 0.5 mg/pump nasal spray.365 days

Applies to the listed nasal spray product.

Initial therapy prior-claim requirements

Step Assignments and Examples

Step	Requirement summary	Lookback / threshold
Step 2	Designation requires prior claim for a formulary generic oral proton pump inhibitor (lansoprazole, esomeprazole capsule, rabeprazole, omeprazole, or pantoprazole) for listed esomeprazole magnesium DR granules	Prior claim within the past 120 days
Step 2	Designation requires prior claims for two formulary generic triptans for dihydroergotamine nasal spray (0.5 mg/pump)	Two claims within the past 365 days
Step 2	Several antipsychotic and anticonvulsant products listed as Step 2 require prior claims/trials of specified formulary oral alternatives per product details	Product-specific: 120 or 365 days as noted per product

Product / group	Prior-claim requirement (Step 2)	Lookback / threshold
Drizalma sprinkle products (20, 30, 40, 60 mg)	Prior claim for 2 formulary generic triptans (e.g., sumatriptan and rizatriptan)	2 claims within the past 365 days
Topiramate 25 mg/mL oral solution	Prior claim for generic topiramate (tablets or capsules)	Claim within the past 120 days
Eslicarbazepine acetate (200, 400, 600, 800 mg)	Prior claim for 2 generic anticonvulsant agents from specified list (e.g., carbamazepine, divalproex, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, zonisamide, lacosamide)	2 claims within the past 365 days
Omega-3 acid ethyl esters (1 g)	Prior claim for generic fenofibrate	Claim within the last 120 days
High-intensity statin pathway (e.g., Nexletol/Nexlizet/Repatha listed among Step 2)	Prior 25-day trial of a formulary generic high-intensity statin (atorvastatin 40 or 80 mg OR rosuvastatin 20 or 40 mg) is required before Step 2 products or a step exception is needed	25-day trial within the past 120 days
Iloperidone (Fanapt) and other listed antipsychotics	Claim for 2 formulary oral generic antipsychotics from specified list required for Step 2 Fanapt products	2 claims within the past 365 days

Definitions and Products Affected

Part B vs Part D payment determination

DefinitionAdministrative determination whether a drug is payable under Medicare Part B or Part D; a prior claim for a rheumatoid arthritis, psoriasis, or active polyarticular juvenile idiopathic arthritis drug within the past 120 days will qualify for Part D payment; other indications require a formulary exception for Part B vs D determination.

Provider action for Part B vs DDocument prior pharmacy claim for the disease-specific agent within lookback period when requesting payment determination.

Context in policyApplied when determining coverage/payment pathway for certain disease-specific drugs referenced in the formulary step rules.

Products Affected — categories

Device and supply categoriesInsulin pen needles, insulin syringes, alcohol prep pads, gauze pads and bandages, topical pads.

Examples of pen needles

Background

This policy excerpt documents multiple products designated at Step 2 that require prior pharmacy claims or trials of specified formulary generics before coverage. Common lookback windows referenced are 120 days and 365 days, and examples include: prior claim for a formulary generic oral PPI within 120 days for certain esomeprazole magnesium granule products, and two formulary generic triptan claims within 365 days for dihydroergotamine nasal spray.

Policy Summary

Payersanfranciscohealthplan

PolicyAntiulcer agents — formulary step edits and prior-claim requirements (coverage criteria)

Policy CodePolicy N/A

Change TypeTechnical review — no material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

2 claims within 365 days

Applies to Step 2 eslicarbazepine products.

Omega‑3 / fibrate pathway: Prior claim for generic fenofibrate within the last 120 days is required for the Step 2 omega‑3 acid ethyl esters listing.1 claim within 120 days

Applies to omega‑3 acid ethyl esters 1 gram capsule Step 2 entry.

High‑intensity statin pathway for specified products: Prior 25‑day trial of a formulary generic high‑intensity statin (atorvastatin 40 mg or 80 mg OR rosuvastatin 20 mg or 40 mg) within the past 120 days is required; otherwise a step exception request is necessary.25 day trial within 120 days

Applies to Step 2 high‑intensity statin pathway (e.g., Nexletol, Nexlizet, Repatha entries).

Iloperidone (Fanapt) and related antipsychotics: Claim for 2 formulary oral generic antipsychotics from the specified list within the past 365 days is required for Step 2 Fanapt products.2 claims within 365 days

Applies to Fanapt (iloperidone) Step 2 entries and similar antipsychotic Step 2 placements.

Prior Authorization
Prior claim requirements for listed psychiatric agents
Several antipsychotic products listed at Step 2 require prior pharmacy claims for one or two formulary oral antipsychotics within specified lookback periods (examples include a single prior claim within 120 days or two prior claims within 365 days depending on the product).
Example 120‑day requirement: prior claim for one formulary oral antipsychotic (risperidone, clozapine tablet, olanzapine, IR quetiapine, ziprasidone, aripiprazole, asenapine, paliperidone, lurasidone) within past 120 days (chunk 5).
Example 365‑day requirement: claim for two formulary oral generic antipsychotics (lurasidone, risperidone, olanzapine, IR quetiapine, ziprasidone, aripiprazole, asenapine) within past 365 days (chunks 10, 30).

Step Therapy
Step 2 prior authorization requirement
Multiple products are designated Step 2 and require prior evidence of trials or pharmacy claims for specified formulary generic alternatives as described per product; providers must supply the product‑specific prior‑claim documentation listed in the criteria for approval.
Topiramate oral solution: prior claim for generic topiramate (tablets or capsules) within past 120 days (chunk 22).
Eslicarbazepine: prior claim for two generic anticonvulsant agents within past 365 days (chunk 23).
Omega‑3 listing: prior claim for generic fenofibrate within past 120 days (chunk 27).
High‑intensity statin pathway: prior 25‑day trial of a formulary generic high‑intensity statin (atorvastatin 40/80 mg or rosuvastatin 20/40 mg) within past 120 days, otherwise a step exception request is required (chunk 28).

Note
Prior authorization not specified in fragment
The provided product list fragments do not contain explicit prior authorization procedures, authorization criteria, or denial rules; they primarily enumerate products affected. When requesting coverage, follow the product‑specific Step 2 criteria above because no separate PA process is specified in these fragments.
No separate prior authorization statement or billing codes are specified in these chunks (chunk 36).
Product‑specific Step 2 criteria are the actionable requirements for approval; reference exact product descriptions when submitting requests (chunk 126).
Products not listed in the 'Products Affected' sections may not be authorized under these listings (chunk 126).

Note
Prior authorization not described in this segment
These document segments are product inventories and do not describe a formal prior authorization workflow or affected billing codes; providers must rely on the product‑specific Step 2 criteria when preparing submissions.
No prior authorization statements or billing codes are present in these product list chunks (chunk 54).
Reference exact product model/description from the 'Products Affected' list when submitting a request (chunk 126).

Note
Prior authorization (not specified)
No prior authorization requirements are specified in many of the product listing chunks; providers should document the product name exactly as listed and include required prior‑claim evidence because no separate PA criteria are provided in these excerpts.
Chunks with product listings do not state PA requirements (chunk 72).
Product descriptions must match payer list entries when requesting coverage (chunk 126/144).

Documentation Required
Product-specific PA guidance
When seeking coverage for products listed in these fragments, reference the exact product descriptions from the 'Products Affected' inventory in your submission; the document does not provide separate PA criteria but requires product‑specific prior‑claim evidence where noted.
Document product model/description exactly (e.g., 'HEALTHWISE INSULIN SYRINGE 0.3 ML 31 GAUGE X 5/16"') to match the payer's listed items (chunk 126).
If a product is listed as Step 2, include the product‑specific prior‑claim documentation described in the criteria nodes (chunk 23).

Note
Prior authorization not specified in this section
The fragments include no explicit prior authorization statements; for any prior‑claim Step 2 requests, include the required prior pharmacy claim documentation because no alternate authorization/denial triggers are specified here.
No PA requirements are stated in these chunks; the Step 2 prior‑claim rules are the operative criteria (chunk 144).
If prior generic trial requirements are not met, a step exception may be required where noted (chunk 28).

Denial Risk
Products Affected
The document lists many products under 'Products Affected' without explicit authorization criteria in these sections; be aware that requests for products not listed may be denied, and include matching product descriptions and any required prior‑claim evidence.
Coverage/authorization could be denied if the request is for products not listed in the payer's 'Products Affected' list (chunk 126).
Supply and syringe SKUs are inventories only; include matching descriptions and any Step 2 prior claims when applicable (chunks 180, 126).

Step Therapy
Step therapy: Step 2 prior-claim/trial requirements
Multiple Step 2 placements require specific prior‑claim/trial evidence before coverage: providers must document the prior claims or trials as listed for each product (examples below) because the excerpts do not provide separate step exception submission details.
Esomeprazole magnesium granules: prior claim for a formulary generic oral PPI within 120 days (chunk 0).
Drizalma sprinkle products: prior claim for two formulary generic triptans within 365 days (chunk 18).
Topiramate oral solution: prior claim for generic topiramate within 120 days (chunk 22).
Eslicarbazepine: prior claims for two generic anticonvulsants within 365 days (chunk 23).
High‑intensity statin pathway: 25‑day trial of a formulary generic high‑intensity statin within 120 days or a step exception is required (chunk 28).

Step Therapy
Step therapy placement and requirements
Step 2 placement is enforced by the listed product‑specific prior‑claim requirements; providers must submit prior pharmacy claim documentation for the specified generic alternatives within the stated lookback periods to demonstrate step failure/trial.
Lookback windows used in examples include 120 days and 365 days (chunks 22, 18, 28).
Absence of the required prior claims may require a step exception request when noted (chunk 28).

Documentation Required
Part B vs Part D payment determination
For Part B vs Part D payment determinations, 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; other indications require a Part B vs D determination through the formulary exception process.
Lookback window: 120 days for Part B vs D consideration.
All other indications require a Part B vs D determination via the formulary exception process before approval (chunk 9).

Documentation Required
Required prior-claim documentation
Documentation of prior pharmacy claims for the specified formulary generic medications within the stated lookback periods is required to meet Step 2 criteria; include claim dates and drug names to show the required number of prior trials (examples listed in the criteria).
Examples: two formulary generic triptan claims within 365 days; generic topiramate claim within 120 days; two generic anticonvulsant claims within 365 days; generic fenofibrate within 120 days (chunks 18, 22, 23, 27).
Provide prior claim evidence (dates and drug names) when submitting authorization requests.

Denial Risk
Prior claim requirements
Failure to document required prior claims or trials for the specified generic alternatives within the stated timeframes (for example, no prior generic oral PPI claim within 120 days for esomeprazole granules, or no two formulary triptan claims within 365 days for dihydroergotamine) may result in denial of the Step 2 product request.
Denial triggers include absence of required prior claims within the stated lookback windows (chunks 0, 18, 22, 23).
If prior generic high‑intensity statin trial is not met, a step exception request is required (chunk 28).

Initial coverage requires prior trials of specified formulary generics before Step 2 products are approved.

General initial requirement for Step 2 products: Prior claim(s) or trials of the specified formulary generic alternative(s) within the stated lookback period are required as prerequisites to initial therapy for Step 2 products; see the product‑specific nodes for the exact agent(s) and timeframe.See product‑specific criteria (120 or 365 days)

Examples include 2 formulary generic triptans in 365 days, generic topiramate within 120 days, 2 generic anticonvulsants within 365 days, generic fenofibrate within 120 days, or 2 generic oral antipsychotics within 365 days as applicable.

Comfort Touch, Embrace, InControl, Healthwise pen needle variants (31G, 32G, 33G; multiple lengths).

Products Affected — syringe volumes, gauges, lengths

Insulin syringe volumesInsulin syringes listed include 0.3 mL, 0.5 mL, and 1 mL U-100 syringe volumes.

HEALTHWISE INSULIN SYRINGE 0.3 ML 31 GAUGE X 5/16"

Exact product listingHEALTHWISE INSULIN SYRINGE 0.3 ML 31 GAUGE X 5/16"

ContextListed in the payer's 'Products Affected' inventory among other syringe SKUs.

Use for PA requestsDocument this exact model/description when requesting coverage or referencing products affected.

Products Affected — summary

Repeated product groupingsHEALTHWISE insulin syringes and pen needles are repeated across multiple chunks indicating multiple SKUs (0.3 mL, 0.5 mL, 1 mL; 30G–31G pen needles).

Other branded SKUsHEALTHY ACCENTS UNIFINE PENTIP and DROPLET insulin syringes appear among Products Affected.

Inventory purposeThis section functions as an inventory of affected injection supplies and related items to be referenced in requests.

Products Affected — injection supplies (named SKUs)

Named injection supply productsINSULIN SYRINGE U-100 WITH NEEDLE (0.5 mL and 1 mL variants) in gauges 27–31 and multiple lengths; HEALTHWISE INSULIN SYRINGE 0.5 ML and 1 ML variants; HEALTHY ACCENTS UNIFINE PENTIP needles.

Actionable noteWhen submitting a request, include the exact product SKU (brand, volume, gauge, length) as listed in the Products Affected section to match payer inventory.

Products Affected — syringes/pen needles

Insulin syringe and pen needle entriesMultiple entries name insulin syringes and pen needles with gauge and length specifications (e.g., INSULIN SYRINGE U-100 WITH NEEDLE 0.3 ML 31 GAUGE X 5/16").

Gauze and topical suppliesGAUZE PAD 2" X 2" and GAUZE BANDAGE 2" X 2" are listed among Products Affected.

Most actionable SKU detailInclude exact SKU text from the list (brand + gauge + length + volume) when referencing Products Affected for coverage or PA requests.

Products Affected — injection supplies and variants

Syringe SKUs enumeratedDROPLET insulin syringes (0.3 mL, 0.5 mL) and INSULIN SYRINGE U-100 with needles across 0.3 mL, 0.5 mL, 1 mL are listed.

Inventory guidanceProducts listed are the payer's accepted supply SKUs — unlisted products may not be covered.

Products Affected — representative SKUs

Representative SKUsHEALTHWISE INSULIN SYRINGE 0.3 ML 30 GAUGE X 5/16", HEALTHWISE INSULIN SYRINGE 0.5 ML 31 GAUGE X 5/16", HEALTHWISE INSULIN SYRINGE 1 ML 31 GAUGE X 5/16".

Gauge rangePen needles and syringes listed across the document include gauges from 27G up to 33G (most commonly 27–32G).

Most actionable SKU examplesHEALTHWISE PEN NEEDLE 31 GAUGE X 3/16" and INSULIN SYRINGE U-100 WITH NEEDLE 1 ML 27 GAUGE X 1/2" are explicit examples to reference in requests.