Step Therapy - Enhanced

Restricted Product(s) Subject to One-Step Requirements:

• Belsomra® (suvorexant)
• Dayvigo® (lembroexant)
• EdluarTM (zolpidem tartrate sublingual)
• EzallorTM Sprinkle (rosuvastatin)
• QuviviqTM (daridorexant)
• ZolpimistTM (zolpidem tartrate oral spray)
• Zypitamag® (pitavastatin)

Criteria for Approval of Restricted Product(s):

1. The patient has tried and failed ONE unrestricted alternative medication; OR
2. The patient has a clinical intolerance/contraindication to ALL unrestricted alternative medications.

Duration of Approval: 365 days (1 year)

Restricted Product(s) Subject to Two-Step Requirements

• Adhansia XR™ (methylphenidate extended release)
• Adzenys XR-ODTTM (amphetamine ER dispersible)
• Adzenys ERTM suspension (amphetamine ER suspension)
• Amphetamine ER suspension 1.25 mg/mL (branded generic Adzenys ERTM suspension)
• Amzeeq™ 4% aerosol (minocycline hcl)
• Azelex® (azelaic acid)
• Chlorzoxazone 250mg tablet
• Cotempla XR ODT™ (methylphenidate ER ODT)
• Diclofenac cap (authorized generic Zorvolex®)
• DyanavelTM XR (amphetamine extended release)
• Ery 2% pad (erythromycin)
• Fenoprofen (authorized generic Fenortho®)
• Fenortho® (fenoprofen calcium)
• Finacea® 15% aerosol (azelaic acid)
• Gelnique® (oxybutynin topical gel)
• Gemtesa® (vibegron)
• Indomethacin 20mg capsule
• Jornay PMTM (methylphenidate extended release)
• Ketoprofen 25mg capsules
• Ketoprofen ER
• Kiprofen 25mg capsules
• Meclofenamate sodium
• Methylphenidate ER OSM (authorized generic Relexxii)
• Noritate® (metronidazole)
• Oxybutynin 2.5mg tablet
• Oxytrol® (oxybutynin transdermal patch)
• QelbreeTM (viloxazine extended release)
• Qmiiz ODT™ (meloxicam)
• QuillichewTM (methylphenidate extended release)
• Quillivant XR® (methylphenidate extended release)
• Relafen® DS (nabumetone)
• RelexxiiTM (methylphenidate ER Osmotic Release)
• Tivorbex® (indomethacin)
• Tolectin (tolmetin sodium)
• Tolmetin sodium
• XelstrymTM (dextroamphetamine transdermal patch)
• ZilxiTM (minocycline hcl)
• Zorvolex® (diclofenac)

Criteria for Approval of Restricted Product(s):

1. The patient has tried and failed TWO unrestricted alternative medications; OR
2. The patient has a clinical intolerance/contraindication to ALL unrestricted alternative medications.

Duration of Approval: 365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

May 2024: Criteria update: Added new to market Tolectin to policy.

March 2024: Criteria update: Removed QL from stimulant ADHD products.

March 2024: Criteria update: Added new to market Kiprofen 25mg capsules to policy.

March 2024: Criteria update: Removed Metadate CD from policy.

January 2024: Criteria update: Removed Indocin from policy.

November 2023: Criteria update: Added new Relexxii 18mg, 27mg, 36mg, and 54mg strengths to policy.

November 2023: Criteria update: Removed Livalo from policy.

October 2023: Criteria update: Removed Mydayis from policy.

October 2023: Criteria update: Removed Onexton gel from policy.

October 2023: Criteria update: Restriction removed from Azstarys.

August 2023: Criteria update: Restriction removed from Antara, Edarbi, Edarbyclor, febuxostat, fenofibrate capsules, fenofibrate micronized cap, fenofibrate tabs, fenofibric acid, Fibricor, Lipofen, Tekturna, Triglide, Uloric.

March 2023: Criteria update: Added new to market Oxybutynin 2.5mg tablets to policy.

December 2022: Criteria update: Added new to market Methylphenidate ER Osmotic Release (AG Relexxii) 45mg and 63mg to policy.

December 2022: Criteria update: Removed Methylphenidate ER 10mg capsule & tablet

November 2022: Criteria update: Removed Naprelan, Naproxen ER 750 MG (AG Naprelan), and Indomethacin (AG Tivorbex) from policy.

November 2022: Criteria update: Added new to market Xelstrym to policy.

November 2022: Criteria update: Moved Chlorzoxazone 250mg tablet to policy. Nalfon removed from restricted products.

October 2022: Criteria update: Corrected Qelbree ER 200mg tablets QL to 3 tablets per day.

September 2022: Criteria update (ADHD): Moved Adhansia XR, Adzenys ER, Adzenys XR-ODT, Azstarys, Cotempla XR ODT, Dyanavel XR, Jornay PM, Metadate CD, Methylphenidate ER 10mg, Methylphenidate ER OSM, Mydayis, Qelbree, Quillichew, Quillivant XR, Relexxii, Zenzedi to policy. Adderall, Adderall XR, Aptensio XR, Concerta, Daytrana, Dexedrine, Dexedrine XR, Focalin, Focalin XR, Intuniv, Kapvay, Methlyn, Ritalin, Ritalin LA, Straterra from restricted products. Criteria update (Uloric): Moved Uloric and febuxostat (generic Uloric) to policy.

August 2022: Criteria update (Topical Antibiotics): Moved Amzeeq, Azelex, Ery 2% pad, Finacea 15% aerosol, Noritate, Onexton, Zilxi to policy. Removed Aczone, Acanya, Benzaclin, Benzamycin, Cleocin-T, Clindagel, Erygel, Evoclin, Finacea 15% gel, Klaron, Metrocream, Metrogel and Metrolotion from restriction.

July 2022: Criteria update: Removed Exforge HCT from policy. Removed Toviaz from policy. Criteria update (ADHD): Zenzedi 7.5mg and 15mg quantity limit updated to 3 per day.

July 2022: Criteria change (ARB-RI): Duration of approval changed to 365 days. Removed Atacand, Atacand HCT, Avapro, Avalide, Azor, Benicar, Benicar HCT, Cozaar, Diovan, Diovan HCT, Eprosartan, Exforge, Hyzaar, Micardis, Tekamlo, Tribenzor, Twynsta from policy. Criteria change (Fibrates): Removed Fenoglide, Lopid, Tricor and Trilipix from policy. Criteria change (Hypnotics): Removed Rozerem and Silenor from policy. Criteria change (NSAID): Removed Arthrotec, Daypro, EC-Naprosyn, Feldene, Lodine, Meloxicam suspension, Mobic, Naprosyn, Naproxen 75mg caps, Vivlodex, Zipsor from policy. Criteria change (OAB): Removed Detrol, Detrol LA, Ditropan XL, Enablex and Vesicare from policy. Vesicare LS moved to Non-Standard formulation policy.

January 2022: Criteria update (Statins): Created Enhanced only policy. Duration of approval changed to 365 days. Criteria update (ADHD): Removed generic Adderall XR from restriction. Brand Adderall XR added to policy. Notation of restriction on AG Relexxii added.

December 2021: Criteria update (NSAIDs): Added fenoprofen (AG Fenortho) to policy.

November 2021: Criteria update (Fibrates): Added new to market Fenofibrate micronized cap (authorized generic Antara) 30mg, 90mg. Criteria update (NSAIDs): Removed Diclofenac 25mg tablet from policy due to MSC change.

October 2021: Criteria update (NSAIDs): Added new to market Diclofenac 25mg tablet to policy. Criteria update (ADHD): Adzenys ER suspension updated to a branded generic product.

October 2021: Criteria update (NSAIDs): Added Relafen DS to policy. Duration of approval changed to 365 days.

July 2021: Criteria update (Fibrates): Removed unrestricted alternatives section from policy. Duration of approval decreased to 365 days. Criteria update (ADHD): Added Azstarys to the policy. Duration of approval decreased to 365 days.

April 2021: Criteria update (ADHD): Added Qelbree to restricted products. Requests for brand meds with an unrestricted generic equivalent required to t/f the associated generic product.

March 2021: Criteria change (Hypnotics): Annual criteria review. Require t/f of generic equivalent of branded medications.

March 2021: Criteria change (NSAIDs): Annual criteria review. Require t/f of generic equivalent of branded medications. Removed discontinued products Anaprox DS and Ponstel.

Jan 2021: Criteria update (NSAIDs): Added new authorized generic to Naprelan CR 750mg (naproxen ER 750mg) to the policy. Criteria update (ADHD): Added Brand Concerta to restricted products.

** Further historical changes and criteria updates available upon request from Corporate Pharmacy.