Step Therapy - Essential

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

• adapalene/benzoyl peroxide gel 0.1-2.5% (generic Epiduo)
• Altabax (retapamulin ointment 1%)
• Atrovent HFA (ipratropium bromide hfa)
• Belsomra (suvorexant)
• Cayston (aztreonam lysine for inhal soln)
• Clindesse (clindamycin vaginal cream 2%)
• Febuxostat (generic Uloric)
• Xepi (ozenoxacin) cream

Criteria for Approval of Restricted Product(s):

1. The request is for adapalene/benzoyl peroxide gel 0.1-2.5% (generic Epiduo); AND
   1. The patient has tried and failed or has a clinical intolerance/contraindication to adapalene 0.1%; OR
2. All other requests:
   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; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   

Duration of Approval: 365 days (1 year)

Restricted Product(s) Subject to Two-Step Requirements

• Alocril (nedocromil sodium ophth soln 2%) 
• Alomide (lodoxamide tromethamine ophth soln 0.1%)
• Angeliq (drospirenone-estradiol) 
• Besivance (besifloxacin hcl ophth susp 0.6%)
• Calcitriol 3mcg/gm ointment 
• Chlordiazepoxine-amitriptyline tab 
• Combipatch (estradiol-norethindrone) 
• Cortisporin-TC (neomycin-colistin-hc-thonzonium otic susp 3.3-3-10-0.5 mg/ml) 
• Cyclomydril (cyclopentolate w/ phenylephrine ophth soln) 
• Cystagon (cysteamine bitartrate) 
• Cystaran (cysteamine hcl ophth soln 0.44%) 
• Diazepam oral sol 5mg/5mL 
• Diuril (chlorothiazide suspension) 
• Duavee (conjugated estrogens-bazedoxifene) 
• Ery pad 2% (erythromycin pads 2%) 
• Fluticasone propionate HFA (authorized generic Flovent)
• Fluphenazine hcl elixir 2.5mg/5ml 
• Fluphenazine hcl conc 5mg/ml 
• Galzin (zinc acetate) 
• Gynazole-1 (butoconazole nitrate vaginal cream 2%) 
• Halog 0.1% ointment 
• Ilevro (nepafenac ophth susp 0.3%) 
• Impavido (miltefosine) 
• Increlex (mecasermin inj) 
• Ketoprofen ER 
• Lacrisert (artificial tear ophth insert) 
• Lithostat (acetohydroxamic acid) 
• Lotemax (loteprednol etabonate ophth oint 0.5%) 
• Meclofenamate sodium 
• Miconazole 3 (miconazole nitrate vaginal supp) 
• Molindone hcl tab
• Natroba (spinosad susp 0.9%) 
• Neupro (rotigotine patch) 
• Nizatidine oral solution 15mg/ml 
• Nitromist (nitroglycerin lingual aerosol) 
• Norpace CR (disopyramide phosphate ER) 
• Paser (aminosalicylic acid ER granules packet) 
• Perphenazine/amitriptyline tab 
• Prednisone solution 5mg/5ml 
• Pred-G (gentamicin-prednisolone ace ophth susp) 
• Prefest (estradiol/estrad-norgestimate) 
• Simbrinza (brinzolamide-brimonidine tartrate ophth susp 1- 0.2%) 
• Spinosad susp 0.9% 
• Stimate (desmopressin acetate nasal soln) 
• Sulfadiazine 500mg tab 
• Sulfamylon (mafenide acetate cream 85mg/gm) 
• Theo-24 (theophylline ER cap) 
• Tirosint (levothyroxine capsule) 
• Tirosint-sol (levothyroxine oral solution)
• Trecator (ethionamide) 
• Tobramycin Nebu Soln 300mg/5ml (authorized generic Kitabis Pak) 
• Tuzistra XR (codeine polist-chlorphen polist ER suspension) 
• Valchlor (mechlorethamine hcl gel 0.016%) 
• Velphoro (sucroferric oxyhydroxide chew) 
• Zerviate (cetirizine hcl ophth soln 0.24%) 
• Zirgan (ganciclovir ophth gel 0.15%

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; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

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.

February 2025: Criteria change (Fluticasone propionate HFA): Added Fluticasone propionate HFA to policy.

January 2025: Criteria update: Removed HC Butyrate 0.1% cream, Lumigan, and Phospholine from policy.

April 2024: Criteria update: Removed Tolmetin Sodium, Dilatrate SR, Guanidine, Lastacaft, and Primsol from policy.

August 2023: Criteria update: Restriction removed from Natacyn.

July 2023: Criteria update: Added HC Butyrate 0.1% cream and Halog 0.1% ointment to policy.

June 2023: Criteria update (Isoniazid): Removed Isoniazid 50mg/5mL syrup from the policy.

June 2023: Criteria update (Xepi, Altabax): Added Xepi to policy. Moved Altabax to one step requirement.

May 2023: Criteria update: Added generic adapalene/benzoyl peroxide 0.1-2.5% (generic Epiduo) to policy. Moved Clindesse and Atrovent HFA to one step requirement. Moved Santyl and Regranex to Wound Care policy.

April 2023: Criteria update (Cayston): Moved Cayston from Two-Step Requirements to One-Step Requirement as the medications it was stepping through have the same active ingredient (tobramycin).

December 2022: Criteria update (Restricted Access): Added products to policy that historically utilized the Restricted Access policy. Added quantity limit section to policy.

September 2022: Criteria update (Uloric): Moved febuxostat (generic Uloric) to policy.

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

July 2022: Criteria change (NSAIDs): Removed Arthrotec, Daypro, Diclofenac cap, EC-Naprosyn, Feldene, Fenortho, Indocin, Indomethacin, Ketoprofen 25mg, 75mg capsules, Lodine, Meloxicam suspension, Mobic, Nalfon, Naprelan, Naprosyn, Naproxen ER, Qmiz ODT, Relafen DS, Tivorbex, Vivlodex, Zipsor, Zorvolex from policy. Criteria change (Hypnotics): Removed Dayvigo, Edluar, Rozerem, Silenor, Zolpimist from policy.

May 2022: Criteria update (Topical Antibiotics): Removed Aktipak and Duac (obsolete products)

March 2022: Criteria update (Topical Antibiotics): Removed generic Dapsone 7.5% from the policy due to MSC code flip from M to Y.

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

November 2021: Criteria update (NSAIDs): Removed Diclofenac 25mg tablet from policy due to MSC change.

October 2021: Criteria update (NSAIDs): Added Relafen DS to policy. Duration of approval changed to 365 days. Added new to market Diclofenac 25mg tablet to policy.

September 2021 (Topical Antibiotics): Criteria update: Removed Clindamycin 1% gel (authorized generic Cindagel) from policy due to MSC code flip from M to Y.

July 2021: Criteria update (Topical Antibiotics): Added Dapsone 7.5% back to the policy due to MSC code flip from Y to M.

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

February 2021: Criteria update (Topical Antibiotics): Removed Dapsone 7.5% from the policy due to MSC flip. Revised trial and failure language.

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

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