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APPENDIX
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Medical Necessity Criteria and Dispensing Quantity Limits for Exchange Formulary Benefits

Number 5.01.547*

Effective Date March 10, 2014

Revision Date(s) 03/10/14; 12/09/13

Replaces N/A

*This policy is managed through the Pharmacy benefit.

Policy

New regulatory requirements generated by implementation of the Affordable Care Act and the resulting creation of federal and state insurance exchanges have led to the creation of novel pharmacy benefit designs that differ substantially in structure, breadth of formularies and utilization management requirements. The following additional criteria will apply to these benefits:

  1. Step Therapy Protocol:

A step therapy edit is a requirement that one or more specified first step agents be tried and failed before coverage will be provided for another second step agent. When the step therapy requirement is met and recent member claims history shows that the required first step agent(s) have been tried, approval for coverage of a second step agent will be automatically processed electronically in real time at the point of service without inconveniencing the member, pharmacist or prescriber.

In the event, that such documentation is not available in recent claims history, manual review for medical necessity is required, based on the following criteria:

  • Use of a second step agent may be considered medically necessary when the prescribing provider has documented that the required number of first step agents were tried and these agents were ineffective, not tolerated or contraindicated; OR
  • Use of a second step agent may be considered medically necessary when the prescribing provider has documented a patient-specific reason why this agent should be used as first-line therapy. These requests will be evaluated on a case-by-case basis.

Drugs subject to the Step Therapy Protocol are listed in the following table:

Drug Class

Second Step Drugs

First Step Agents

Fluoroquinolones

Factive

ciprofloxacin, levofloxacin, moxifloxacin

Anticoagulants

Fragmin

enoxaparin

Eliquis, Pradaxa , Xarelto

Warfarin, enoxaparin

Antiemetics

Anzemet

ondansetron, granisetron

Cesamet

dexamethasone, granisetron. metoclopramide, ondansetron

Antifungals

Ertaczo, Exelderm, Naftin, Oxistat

econazole, ketoconazole, nystatin

Antigout

Uloric

allopurinol

Antiplatelet

Aggrenox , Brilinta, Effient

dipyridamole, cilostazol. clopidogrel

Benign Prostatic Hyperplasia (BPH)

Avodart

finasteride

Jalyn

finasteride, tamsulosin

Rapaflo

doxazosin, tamsulosin, terazosin

Fibrates

Fenoglide, Lipofen, Lofibra, Tricor, Triglide, Trilipix

fenofibrate, fenofibrate micronized, fenofibric acid

Inhaled Antibiotics

Cayston

tobramycin (inhaled)

MAO B Inhibitors

Azilect

selegiline

Nitroglycerin

Minitran, Nitro-Dur

nitroglycerin patch

Opioids, Long-acting

Exalgo ER,

hydromorphone, morphine er, OxyContin, fentanyl transdermal

Opioids, Long-acting

Nucynta ER

morphine er, OxyContin, fentanyl transdermal, tramadol hcl er

Opioids, Short-acting

Nucynta, Oxecta

morphine sulfate, oxycodone, hydromorphone, tramadol hcl

Overactive Bladder

Detrol LA , Enablex, Toviaz, Vesicare

oxybutynin chloride, tolterodine, trospium

Smoking Cessation

Chantix

bupropion

Statins

Crestor , Livalo

atorvastatin, lovastatin, pravastatin, simvastatin

Topicals, Acne

Azelex , Finacea,

benzoyl peroxide, clindamycin topical, erythromycin topical, metronidazole topical

Topicals, Acne

Tazorac, TRETIN-X

tretinoin

Topicals, Antibiotic

Cortisporin

neomycin/polymixin b

Topicals, Corticosteroid

Ala-Scalp

hydrocortisone

Topicals, Corticosteroid

ApexiCon E

diflorasone

Topicals, Corticosteroid

U-Cort

hydrocortisone + urea

Topicals, Corticosteroid

Cordran, Cordran SP

betamethasone valerate, hydrocortisone, fluocinolone acetonide

Topicals, Corticosteroid

Derma-Smoothe/FS

fluocinolone acetonide

Topicals, Corticosteroid

Halog

amcinonide, diprolene, betamethasone valerate

Topicals, Corticosteroid

Synalar

fluocinolone

Topicals, Corticosteroid

Ultravate PAC

halobetasol propionate cream or ointment

Topicals, Corticosteroid

Zonalon

alclometasone dipropionate, desonide, naproxen

Topicals, Misc

Alcortin A

iodoquinol-hc 1% topical

Topicals, Misc

Analpram E

hydrocortisone-pramox-e-pram kit, cream & wipe

Topicals, Misc

Condylox

podofilox

Topicals, Misc

Cortane-B

hc/pramoxine cream

Topicals, Misc

Lac-Hydrin

lactic acid lotion, lactic acid e cream

Topicals, Misc

Momexin

mometasone cream, ammonium lactate cream

Topicals, Misc

Solaraze

imiquimod

Topicals, Misc

Vectical

calcitriol

Topicals, Misc

Veregen

Podofilox

Topicals, Misc

Voltaren

Ibuprofen, meloxicam

Triptans

Axert , Frova, Relpax, Zomig, Zomig Nasal Spray, Zomig ZMT

naratriptan, sumatriptan, rizatriptan, zolmitriptan

  1. Dispensing Quantity Limits:

The following dispensing quantity limits are based on the maximum dose recommendations in the product’s FDA-approved labeling. This information is available for each product at the manufacturer’s Web site or www.fda.gov.

Drugs with Dispensing Quantity Limits are listed in the following table:

Drug

Dosage / Strength

Quantity Limit

Abstral

100 mcg

Limit: 90 units per 30 days

Abstral

200 mcg

Limit: 90 units per 30 days

Abstral

300 mcg

Limit: 90 units per 30 days

Abstral

400 mcg

Limit: 90 units per 30 days

Abstral

600 mcg

Limit: 90 units per 30 days

Abstral

800 mcg

Limit: 90 units per 30 days

Actiq (fentanyl citrate)

1200 mcg

Limit: 120 units per 30 days

Actiq (fentanyl citrate)

1600 mcg

Limit: 120 units per 30 days

Actiq (fentanyl citrate)

200 mcg

Limit: 120 units per 30 days

Actiq (fentanyl citrate)

400 mcg

Limit: 120 units per 30 days

Actiq (fentanyl citrate)

600 mcg

Limit: 120 units per 30 days

Actiq (fentanyl citrate)

800 mcg

Limit: 120 units per 30 days

Actonel

5mg

Limit: 30 tablets per fill

Actonel

30mg

Limit: 30 tablets per fill

Actonel

35 mg tablet

Limit: 4 tablets per 28 days

Actonel

150 mg tablet

Limit: 1 tablet per 30 days

ActoPlus Met (pioglitazone/metformin)

15/500mg

Limit: 90 tablets per fill

ActoPlus Met (pioglitazone/metformin)

15/850mg

Limit: 90 tablets per fill

ActoPlus Met XR

15/1000 mg

Limit: 60 tablets per fill

ActoPlus Met XR

30/1000 mg

Limit: 30 tablets per fill

Actos (pioglitazone)

15 mg tablet

Limit: 30 tablets per fill

Actos (pioglitazone)

30 mg tablet

Limit: 30 tablets per fill

Actos (pioglitazone)

45 mg tablet

Limit: 30 tablets per fill

Advair Diskus

100/50 with device (14 blister diskus)

Limit: 14 blisters per fill

Advair Diskus

100/50 with device (28 blister diskus)

Limit: 28 blisters per fill

Advair Diskus

100/50 with device (60 blister diskus)

Limit: 1 device per fill

Advair Diskus

250/50 with device (14 blister diskus)

Limit: 14 blisters per fill

Advair Diskus

250/50 with device (28 blister diskus)

Limit: 28 blisters per fill

Advair Diskus

250/50 with device (60 blister diskus)

Limit: 1 device per fill

Advair Diskus

500/50 with device (14 blister diskus)

Limit: 14 blisters per fill

Advair Diskus

500/50 with device (28 blister diskus)

Limit: 28 blisters per fill

Advair Diskus

500/50 with device (60 blister diskus)

Limit: 1 device per fill

Advair HFA (120)

45/21 mcg

Limit: 1 device per fill

Advair HFA (120)

115/21 mcg

Limit: 1 device per fill

Advair HFA (120)

230/21 mcg

Limit: 1 device per fill

Advair HFA (60)

45/21 mcg

Limit: 1 device per fill

Advair HFA (60)

115/21 mcg

Limit: 1 device per fill

Advair HFA (60)

230/21 mcg

Limit: 1 device per fill

Advicor

500/20

Limit: 30 tablets per fill

Advicor

750/20

Limit:60 tablets per fill

Advicor

1000/20

Limit: 60 tablets per fill

Alendronate

5 mg tablet

Limit: 30 tablets per fill

Alendronate

10 mg tablet

Limit: 30 tablets per fill

Alendronate

35 mg tablet

Limit: 4 tablets per 30 days

Alendronate

40 mg tablet

Limit: 30 tablets per fill

Alendronate

70 mg/75 ml solution

Limit: 4 bottles per 30 days

Alora

0.025 mg/day patch

Limit: 8 patches per 30 days

Alora

0.05 mg/day patch

Limit: 8 patches per 30 days

Alora

0.075 mg/day patch

Limit: 8 patches per 30 days

Alora

0.1 mg/day patch

Limit: 8 patches per 30 days

Altoprev

20 mg tablet

Limit: 30 tablets per fill

Altoprev

40 mg tablet

Limit: 30 tablets per fill

Altoprev

60 mg tablet

Limit: 30 tablets per fill

Alvesco

160 mcg (120 actuations) 9.6 g canister

Limit: 1 inhaler per fill

Alvesco

160 mcg(60 actuations) 6.1 g canister

Limit: 2 inhalers per fill

Alvesco

80 mcg (60 actuations) 6.1g canister

Limit: 1 inhaler per fill

Ambien (zolpidem)

5 mg tablet

Limit: 15 tablets per 30 days

Ambien (zolpidem)

10 mg tablet

Limit: 15 tablets per 30 days

Ambien CR (zolpidem er)

6.25 mg tablet

Limit: 15 tablets per 30 days

Ambien CR (zolpidem er)

12.5 mg tablet

Limit: 15 tablets per 30 days

Anzemet

50 mg tablet

Limit:3 tablets per fill

Anzemet

100 mg tablet

Limit: 3 tablets per fill

Arcapta neohaler

75 mcg powder

Limit: 1 package (30 capsules) per fill

Asmanex Twisthaler

110 mcg/inh (7 inhalations)

Limit: 1 inhaler per fill

Asmanex Twisthaler

110 mcg/inh (14 inhalations)

Limit: 1 inhaler per fill

Asmanex Twisthaler

110 mcg/inh (30 inhalations)

Limit: 1 inhaler per fill

Asmanex Twisthaler

220 mcg/inh (14 inhalations)

Limit: 1 inhaler per fill

Asmanex Twisthaler

220 mcg/inh (30 inhalations)

Limit: 1 inhaler per fill

Asmanex Twisthaler

220 mcg/inh (60 inhalations)

Limit: 1 inhaler per fill

Asmanex Twisthaler

220 mcg/inh (120 inhalations)

Limit: 1 inhaler per fill

Atelvia

35 mg tablet

Limit: 4 tablets per 30 days

Atrovent HFA

12.9 gm Aerosol

Limit: 2 inhalers per fill

     

Avandamet

1 mg/500 mg tablet

Limit: 60 tablets per fill

Avandamet

2 mg/500 mg tablet

Limit: 60 tablets per fill

Avandamet

2 mg/100 mg tablet

Limit: 60 tablets per fill

Avandamet

4 mg/500 mg tablet

Limit: 60 tablets per fill

Avandamet

4 mg/100 mg tablet

Limit: 60 tablets per fill

Avandia

2 mg tablet

Limit: 60 tablets per fill

Avandia

4 mg tablet

Limit: 60 tablets per fill

Avandia

8 mg tablet

Limit: 30 tablets per fill

Avandryl

4 mg/1 mg tablet

Limit: 30 tablets per fill

Avandryl

4 mg/2 mg tablet

Limit: 30 tablets per fill

Avandryl

8 mg/2 mg tablet

Limit: 30 tablets per fill

Avandryl

8 mg /4 mg tablet

Limit: 30 tablets per fill

Avinza

30 mg capsule

Limit: 60 tablets per 30 days

Avinza

45 mg capsule

Limit: 60 tablets per 30 days

Avinza

60 mg capsule

Limit: 60 tablets per 30 days

Avinza

75 mg capsule

Limit: 60 tablets per 30 days

Avinza

90 mg capsule

Limit: 60 tablets per 30 days

Avinza

120 mg capsule

Limit: 60 tablets per 30 days

Avonex

30 mcg prefilled syringe

Limit: 4 syringes per 30 days

Avonex

30 mcg vial

Limit: 4 vials per 30 days

Avonex Admin Pack

30 mcg

Limit: 4 kits per 30 days

Avonex Pen

30 mcg/0.5 ml pen

Limit: 1 box (4 pens) per 30 days

Betaseron

0.3 mg vial

Limit: 14 prefilled diluent syringes per 30 days

Binosto

70 mg effervescent tablet

Limit: 4 tablets per 30 days

Boniva

150 mg tablet

Limit: 1 tablet per 30 days

Brovana Inhalation Solution

15mcg/2ml vial

Limit: 2 cartons per fill (60 vials)

Bydureon

2 mg vial

Limit: 1 carton (4 single-dose trays) per fill

Byetta

1.2 ml (250 mcg/ml)

Limit: 1 syringe per fill

Byetta

2.4 ml (250 mcg/ml)

Limit: 1 syringe per fill

Caduet (amlodipine/atorvastatin)

10/10 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

10/20 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

10/40 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

10/80 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

2.5/10 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

2.5/20 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

2.5/40 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

5/10 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

5/20 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

5/40 mg tablet

Limit: 30 tablets per fill

Caduet (amlodipine/atorvastatin

5/80 mg tablet

Limit: 30 tablets per fill

Cesamet

1 mg capsule

Limit: 30 capsules per fill

Climara (estradiol)

0.025 mg/day patch

Limit: 4 patches per 30 days

Climara (estradiol)

0.0375 mg/day patch

Limit: 4 patches per 30 days

Climara (estradiol)

0.05 mg/day patch

Limit: 4 patches per 30 days

Climara (estradiol)

0.06 mg/day patch

Limit: 4 patches per 30 days

Climara (estradiol)

0.075 mg/day patch

Limit: 4 patches per 30 days

Climara (estradiol)

0.1 mg/day patch

Limit: 4 patches per 30 days

Climara Pro

0.045 mg/ 0.015 mg/day patch

Limit: 4 patches per 30 days

Combivent Respimat

20mcg-100mcg

Limit: 2 inhalers per fill

Copaxone

20 mg prefilled syringe

Limit: 1 kit (30 prefilled syringes) per 30 days

Crestor

5 mg tablet

Limit: 30 tablets per fill

Crestor

10 mg tablet

Limit: 30 tablets per fill

Crestor

20 mg tablet

Limit: 30 tablets per fill

Crestor

40 mg tablet

Limit: 30 tablets per fill

Dalmane (flurazepam)

15 mg capsule

Limit: 15 capsules per 30 days

Dalmane (flurazepam)

30 mg capsule

Limit: 15 capsules per 30 days

Divigel

0.1% (0.25 g/packet)

Limit: 30 packets per fill

Divigel

0.1% (0.5 g/packet)

Limit: 30 packets per fill

Divigel

0.1% (1g/packet)

Limit: 30 packets per fill

Doral (quazepam)

7.5 mg tablet

Limit: 15 tablets per 30 days

Doral (quazepam)

15 mg tablet

Limit: 15 tablets per 30 days

Duetact

30/2mg tablet

Limit: 30 tablets per fill

Duetact

30/4mg tablet

Limit: 30 tablets per fill

Dulera

100mcg/5mcg

Limit: 1 inhaler per fill

Dulera

200mcg/5mcg

Limit: 1 inhaler per fill

Edluar

5 mg tablet

Limit: 15 tablets per 30 days

Edluar

10 mg tablet

Limit: 15 tablets per 30 days

Elestrin gel

0.06% gel meter dose pump

Limit: 52 grams (2 pumps) per fill

Emend

40 mg capsule

Limit: 1 capsule per fill

Emend

80 mg capsule

Limit: 2 capsules per fill

Emend

125 mg capsule

Limit: 1 capsule per fill

Emend

150mg injection

Limit: 1 vial per fill

Emend

Bifold pack

Limit: 1 pack per fill

Emend

Trifold Pack, contains one 125 mg and two 80 mg capsules

Limit: 1 pack (package size 3) per fill

Estraderm

0.05 mg/day patch

Limit: 8 patches per 30 days

Estraderm

0.1 mg/day patch

Limit: 8 patches per 30 days

Estrasorb

4.35 mg per 1.74 g pouch

Limit: 56 packets (97.44 g) per fill

Estrogel

0.06% 50 gm pump

Limit: 1 pump per fill

Evamist

1.53 mg spray

Limit: 2 pumps per fill

Exalgo

8 mg tablet

Limit: 60 tablets per 30 days

Exalgo

12 mg tablet

Limit: 60 tablets per 30 days

Exalgo

16 mg tablet

Limit: 60 tablets per 30 days

Exalgo

32 mg tablet

Limit: 60 tablets per 30 days

Extavia

0.3 mg kit

Limit: 15 blister units/vials per 30 days

Extavia

0.3 mg vial

Limit: 15 blister units/vials per 30 days

Fentora

100 mcg

Limit: 240 units per 30 days

Fentora

200 mcg

Limit: 240 units per 30 days

Fentora

300 mcg

Limit: 120 units per 30 days

Fentora

400 mcg

Limit: 120 units per 30 days

Fentora

600 mcg

Limit: 120 units per 30 days

Fentora

800 mcg

Limit: 120 units per 30 days

Flovent Diskus

Powder 100mcg (1 device = 60 doses)

Limit: 1 inhaler per fill

Flovent Diskus

Powder 250mcg (1 device = 60 doses)

Limit: 4 inhalers per fill

Flovent Diskus

Powder 50mcg (1 device = 60 doses)

Limit: 1 inhaler per fill

Flovent HFA

Aerosol 10.6 gm (120 doses; 44 mcg/dose)

Limit: 1 inhaler per fill

Flovent HFA

Aerosol 12 gm (120 doses; 110 mcg/dose)

Limit: 1 inhaler per fill

Flovent HFA

Aerosol 12 gm (120 doses; 220 mcg/dose)

Limit: 2 inhalers per fill

Foradil

1 device (12 blisters)

Limit: 1 package (package size 12) 12 capsules per fill

Foradil

1 device (60 blisters; 12mcg/inh)

Limit: 1 package (package size 60) 60 capsules per fill

Forteo

600 mcg/2.4 mL prefilled pen

Limit: 1 pen per 30 days

Fosamax (alendronate)

70mg tablet

Limit: 4 tablets per 30 days

Fosamax Plus D

70 mg/2800 IU

Limit: 4 tablets per 30 days

Fosamax Plus D

70 mg/5600 IU

Limit: 4 tablets per 30 days

Granisetron

1 mg tablet

Limit: 6 tablets per fill

Halcion (triazolam)

0.125 mg tablet

Limit: 15 tablets per 30 days

Halcion (triazolam)

0.25 mg tablet

Limit: 15 tablets per 30 days

Intermezzo

1.75 mg tablet

Limit: 15 tablets per 30 days

Intermezzo

3.5 mg tablet

Limit: 15 tablets per 30 days

Invokana

100 mg tablet

Limit: 30 tablets per fill

Invokana

300mg tablet

Limit: 30 tablets per fill

Ipratropium/albuterol

3ml vial

Limit: 180 vials per fill

Janumet

50/500 mg tablet

Limit: 60 tablets per fill

Janumet

50/1000 mg tablet

Limit: 60 tablets per fill

Janumet XR

50/500 mg tablet

Limit: 30 tablets per fill

Janumet XR

50/1000 mg tablet

Limit: 60 tablets per fill

Janumet XR

100/1000 mg tablet

Limit: 30 tablets per fill

Januvia

25 mg tablet

Limit: 30 tablets per fill

Januvia

50 mg tablet

Limit: 30 tablets per fill

Januvia

100 mg tablet

Limit: 30 tablets per fill

Jentadueto

2.5/500 mg tablet

Limit: 60 tablets per fill

Jentadueto

2.5/850 mg tablet

Limit: 60 tablets per fill

Jentadueto

2.5/1000 mg tablet

Limit: 60 tablets per fill

Kadian (morphine sulfate er caps)

10 mg capsule

Limit: 90 capsules per 30 days

Kadian (morphine sulfate er caps)

20 mg capsule

Limit: 90 capsules per 30 days

Kadian (morphine sulfate er caps)

30 mg capsule

Limit: 90 capsules per 30 days

Kadian

40 mg capsule

Limit: 90 capsules per 30 days

Kadian (morphine sulfate er caps)

50 mg capsule

Limit: 90 capsules per 30 days

Kadian (morphine sulfate er caps)

60 mg capsule

Limit: 90 capsules per 30 days

Kadian

70 mg capsule

Limit: 90 capsules per 30 days

Kadian (morphine sulfate er caps)

80 mg capsule

Limit: 90 capsules per 30 days

Kadian (morphine sulfate er caps)

100 mg capsule

Limit: 90 capsules per 30 days

Kadian

130 mg capsule

Limit: 90 capsules per 30 days

Kadian

150 mg capsule

Limit: 90 capsules per 30 days

Kadian

200 mg capsule

Limit: 90 capsules per 30 days

Kazano

12.5 mg/500 mg Tablet

Limit: 60 tablets per fill

Kazano

12.5 mg/1000 mg Tablet

Limit: 60 tablets per fill

Kombiglyze XR

2.5/1000 mg tablet

Limit: 60 tablets per fill

Kombiglyze XR

5/500 mg tablet

Limit: 30 tablets per fill

Kombiglyze XR

5/1000 mg tablet

Limit: 30 tablets per fill

Lazanda

100 mcg NS

Limit: 23 units per 30 days

Lazanda

400 mcg NS

Limit: 23 units per 30 days

Lescol (fluvastatin sodium)

20 mg capsule

Limit: 30 tablets per fill

Lescol (fluvastatin sodium)

40 mg capsule

Limit: 60 tablets per fill

Lescol XL

80 mg tablet

Limit: 30 tablets per fill

Lipitor (atorvastatin calcium)

10 mg tablet

Limit: 30 tablets per fill

Lipitor (atorvastatin calcium)

20 mg tablet

Limit: 30 tablets per fill

Lipitor (atorvastatin calcium)

40 mg tablet

Limit: 30 tablets per fill

Lipitor (atorvastatin calcium)

80 mg tablet

Limit: 30 tablets per fill

Liptruzet

10/10 mg tablet

Limit: 30 tablets per fill

Liptruzet

10/20 mg tablet

Limit: 30 tablets per fill

Liptruzet

10/40 mg tablet

Limit: 30 tablets per fill

Liptruzet

10/80 mg tablet

Limit: 30 tablets per fill

Livalo

1 mg tablet

Limit: 30 tablets per fill

Livalo

2 mg tablet

Limit: 30 tablets per fill

Livalo

4 mg tablet

Limit: 30 tablets per fill

Lunesta

1 mg tablet

Limit: 15 tablets per 30 days

Lunesta

2 mg tablet

Limit: 15 tablets per 30 days

Lunesta

3 mg tablet

Limit: 15 tablets per 30 days

Maxair Autohaler

0.2 mg/actuation

Limit: 1 inhaler per fill

Menostar

14 mcg/day patch

Limit: 4 patches per 30 days

Mevacor (lovastatin)

10 mg tablet

Limit: 30 tablets per fill

Mevacor (lovastatin)

20 mg tablet

Limit: 60 tablets per fill

Mevacor (lovastatin)

40 mg tablet

Limit: 60 tablets per fill

Minivelle

0.0375 mg patch

Limit: 8 patches per 30 days

Minivelle

0.05 mg patch

Limit: 8 patches per 30 days

Minivelle

0.075 mg patch

Limit: 8 patches per 30 days

Minivelle

0.1 mg patch

Limit: 8 patches per 30 days

MS Contin (morphine sulfate er tabs)

15 mg tablet

Limit: 120 tablets per 30 days

MS Contin (morphine sulfate er tabs)

30 mg tablet

Limit: 120 tablets per 30 days

MS Contin (morphine sulfate er tabs)

60 mg tablet

Limit: 120 tablets per 30 days

MS Contin (morphine sulfate er tabs)

100 mg tablet

Limit: 120 tablets per 30 days

MS Contin (morphine sulfate er tabs)

200 mg tablet

Limit: 120 tablets per 30 days

Nesina

6.25 mg tablet

Limit: 30 tablets per fill

Nesina

12.5 mg tablet

Limit: 30 tablets per fill

Nesina

25 mg tablet

Limit: 30 tablets per fill

Nucynta

50 mg tablet

Limit: 181 tablets per fill

Nucynta

75 mg tablet

Limit: 181 tablets per fill

Nucynta

100 mg tablet

Limit: 181 tablets per fill

Nucynta ER

50 mg tablet

Limit: 60 tablets per 30 days

Nucynta ER

100 mg tablet

Limit: 60 tablets per 30 days

Nucynta ER

150 mg tablet

Limit: 60 tablets per 30 days

Nucynta ER

200mg tablet

Limit: 60 tablets per 30 days

Nucynta ER

250mg tablet

Limit: 60 tablets per 30 days

Onglyza

2.5mg tablet

Limit: 30 tablets per fill

Onglyza

5mg tablet

Limit: 30 tablets per fill

Onsolis

200 mcg

Limit: 90 units per 30 days

Onsolis

400 mcg

Limit: 90 units per 30 days

Onsolis

600 mcg

Limit: 90 units per 30 days

Onsolis

800 mcg

Limit: 90 units per 30 days

Onsolis

1200 mcg

Limit: 90 units per 30 days

Opana ER

5 mg tablet

Limit: 90 tablets per 30 days

Opana ER

7.5 mg tablet

Limit: 90 tablets per 30 days

Opana ER

10 mg tablet

Limit: 90 tablets per 30 days

Opana ER

15 mg tablet

Limit: 90 tablets per 30 days

Opana ER

20 mg tablet

Limit: 90 tablets per 30 days

Opana ER

30 mg tablet

Limit: 90 tablets per 30 days

Opana ER

40 mg tablet

Limit: 90 tablets per 30 days

Oramorph SR

15 mg tablet

Limit: 120 tablets per 30 days

Oramorph SR

30 mg tablet

Limit: 120 tablets per 30 days

Oramorph SR

60 mg tablet

Limit: 120 tablets per 30 days

Oramorph SR

100 mg tablet

Limit: 120 tablets per 30 days

Oseni

12.5-15 mg tablet

Limit: 30 tablets per fill

Oseni

12.5-30 mg tablet

Limit: 30 tablets per fill

Oseni

12.5-45 mg tablet

Limit: 30 tablets per fill

Oseni

25-15 mg tablet

Limit: 30 tablets per fill

Oseni

25-30 mg tablet

Limit: 30 tablets per fill

Oseni

25-45 mg tablet

Limit: 30 tablets per fill

OxyContin

10mg tablet

Limit: 90 tablets per 30 days

OxyContin

15 mg tablet

Limit: 90 tablets per 30 days

OxyContin

20mg tablet

Limit: 90 tablets per 30 days

OxyContin

30 mg tablet

Limit: 90 tablets per 30 days

OxyContin

40mg tablet

Limit: 90 tablets per 30 days

OxyContin

60 mg tablet

Limit: 120 tablets per 30 days

OxyContin

80mg tablet

Limit: 120 per 30 days

Perforomist

20mcg/2 mL vial

Limit: 1 carton (60 vials) per fill

PrandiMet

1mg/500mg

Limit: 150 tablets per fill

PrandiMet

2mg/500mg

Limit: 150 tablets per fill

Pravachol (pravastatin sodium)

10mg tablet

Limit: 30 tablets per fill

Pravachol (pravastatin sodium)

20mg tablet

Limit: 30 tablets per fill

Pravachol (pravastatin sodium)

40mg tablet

Limit: 30 tablets per fill

Pravachol (pravastatin sodium)

80mg tablet

Limit: 30 tablets per fill

Proair HFA

8.5gm Inhaler

Limit: 2 inhalers per fill

Prosom

1mg tablet

Limit: 15 tablets per 30 days

Prosom

2mg tablet

Limit: 15 tablets per 30 days

Proventil HFA

6.7gm aerosol

Limit: 2 inhalers per fill

Pulmicort Flexhaler

90mcg/actuation

Limit: 1 inhalers per fill

Pulmicort Flexhaler

180mcg/actuation

Limit: 2 inhaler per fill

Pulmicort Respules (budesonide)

0.25mg/2 mL

Limit: 60 respules per fill

Pulmicort Respules budesonide)

0.5mg/2 mL

Limit: 60 respules per fill

Pulmicort Respules budesonide)

1mg/2 mL

Limit: 30 respules per fill

Qvar HFA

40mcg

Limit: 2 inhalers per fill

Qvar HFA

80mcg

Limit: 3 inhalers per fill

Rebif

22mcg syringe

Limit: 12 syringes per 30 days

Rebif

44mcg syringe

Limit: 12 syringes per 30 days

Rebif

Titration pack

Limit: 1 package per 30 days

Relenza

5 mg Diskhaler

Limit: 40 blisters (2 cartons) per 30 days

Restoril (temazepam)

7.5 mg capsule

Limit: 15 capsules per 30 days

Restoril (temazepam)

15 mg capsule

Limit: 15 capsules per 30 days

Restoril (temazepam)

22.5 mg capsule

Limit: 15 capsules per 30 days

Restoril (temazepam)

30 mg capsule

Limit: 15 capsules per 30 days

Rozerem

8 mg tablet

Limit: 15 tablets per 30 days

Sancuso

3.1 mg/24 hour patch

Limit: 1 patch per fill

Serevent

Diskus (28 blisters; 50mcg/inh)

Limit: 1 package per fill

Serevent

Diskus (60 blisters; 50mcg/inh)

Limit: 1 package per fill

Silenor

3 mg tablet

Limit: 15 tablets per 30 days

Silenor

6 mg tablet

Limit: 15 tablets per 30 days

Simcor

500/20mg tablet

Limit: 30 tablets per fill

Simcor

500/40mg tablet

Limit: 30 tablets per fill

Simcor

750/20mg tablet

Limit: 60 tablets per fill

Simcor

1000/20mg tablet

Limit: 60 tablets per fill

Simcor

1000/40mg tablet

Limit: 30 tablets per fill

Sonata (zaleplon)

5 mg capsule

Limit: 15 tablets per 30 days

Sonata (zaleplon)

10 mg capsule

Limit: 15 tablets per 30 days

Spiriva

18 mcg capsule for use with inhalation device, 30 capsules

Limit: 1 package per fill

Spiriva

18 mcg capsule for use with inhalation device, 6 capsules (1 blister card)

Limit: 1 package per fill

Spiriva

18 mcg capsule for use with inhalation device, 90 capsules (6 blister cards)

Limit: 1 package (90 doses) per fill

Suboxone

12/3 mg film

Limit: 60 films per fill

Suboxone

2/0.5 mg film

Limit: 90 films per fill

Suboxone

2/0.5 mg tablet

Limit: 90 tablets per fill

Suboxone

4/1 mg film

Limit: 90 films per fill

Suboxone

8/2 mg film

Limit: 90 films per fill

Suboxone

8/2 mg tablet

Limit: 90 tablets per fill

Subsys

100 mcg SL spray

Limit: 90 spray units per 30 days

Subsys

200 mcg SL spray

Limit: 90 spray units per 30 days

Subsys

400 mcg SL spray

Limit: 90 spray units per 30 days

Subsys

600 mcg SL spray

Limit: 90 spray units per 30 days

Subsys

800 mcg SL spray

Limit: 90 spray units per 30 days

Subsys

1200 mcg SL spray

Limit: 90 spray units per 30 days

Subsys

1600 mcg SL spray

Limit: 90 spray units per 30 days

Symbicort

80/4.5 mcg inhaler

Limit: 1 package per fill

Symbicort

160/4.5 mcg inhaler

Limit: 1 package per fill

Symlin

0.6 mg/ml vial

Limit: 6 vials (OBS 02/09/12) per fill

Symlin

60 pen injector

Limit: 7 pens per fill

Symlin

120 pen injector

Limit: 7 pens per fill

Tamiflu

6 mg/ml suspension

Limit: 6 bottles per 30 days

Tamiflu

12 mg/ml suspension

Limit: 6 bottles per 30 days

Tamiflu

30 mg capsule

Limit: 40 capsules per 30 days

Tamiflu

45 mgcapsule

Limit: 20 capsules per 30 days

Tamiflu

75 mg capsule

Limit: 20 capsules per 30 days

Tradjenta

5 mg tablet

Limit: 30 tablets per fill

Tudorza Pressair

400 mcg inhaler

Limit: 1 inhaler per fill

Ventolin HFA

18 gm aerosol

Limit: 2 inhalers per fill

Ventolin HFA

8 gm aerosol

Limit: 1 inhaler per fill

Victoza

18 mg/3 ml pen (package 2 pens)

Limit: 1 package (2 pens) per fill

Victoza

18 mg/3 ml pen (package 3 pens)

Limit: 1 package (3 pens) per fill

Vivelle

0.025 mg patch

Limit: 8 patches per 30 days

Vivelle

0.0375 mg patch

Limit: 8 patches per 30 days

Vivelle

0.05 mg patch

Limit: 8 patches per 30 days

Vivelle

0.075 mg patch

Limit: 8 patches per 30 days

Vivelle

0.1 mg patch

Limit: 8 patches per 30 days

Vivelle-Dot

0.025 mg patch

Limit: 8 patches per 30 days

Vivelle-Dot

0.0375 mg patch

Limit: 8 patches per 30 days

Vivelle-Dot

0.05 mg patch

Limit: 8 patches per 30 days

Vivelle-Dot

0.075 mg patch

Limit: 8 patches per 30 days

Vivelle-Dot

0.1 mg patch

Limit: 8 patches per 30 days

Vytorin

10-10 mg tablet

Limit: 30 tablets per fill

Vytorin

10-20 mg tablet

Limit: 30 tablets per fill

Vytorin

10-40 mg tablet

Limit: 30 tablets per fill

Vytorin

10-80 mg tablet

Limit: 30 tablets per fill

Zocor (simvastatin)

5 mg tablet

Limit: 30 tablets per fill

Zocor (simvastatin)

10 mg tablet

Limit: 30 tablets per fill

Zocor (simvastatin)

20 mg tablet

Limit: 30 tablets per fill

Zocor (simvastatin)

40 mg tablet

Limit: 30 tablets per fill

Zocor (simvastatin)

80 mg tablet

Limit: 30 tablets per fill

Zofran (ondansetron)

4 mg tablet

Limit: 9 tablets per fill

Zofran (ondansetron)

8 mg tablet

Limit: 9tablets per fill

Zofran (ondansetron)

24 mg tablet

Limit: 1 tablet per fill

Zofran (ondansetron)

4mg/5ml solution

Limit: 2 bottles per fill

Zofran ODT (ondansetron ODT)

4 mg tablet

Limit: 9 orally disintegrating tab per fill

Zofran ODT (ondansetron ODT)

8 mg tablet

Limit: 9 orally disintegrating tab per fill

Zolpimist

5 mg oral spray

Limit: 1 bottle per 30 days

Zubsolv

1.4 mg/0.36 mg tablet

Limit: 90 tablets per fill

Zybsolv

5.7 mg/1.4 mg tablet

Limit: 90 tablets per fill

Zuplenz

4 mg soluble film

Limit: 9 films per fill

Zuplenz

8 mg soluble film

Limit: 9 films per fill

Related Policies

5.01.541

Medical Necessity Exception Criteria for Closed Formulary Benefits and Dispense as Written (DAW) Exception Reviews

5.01.605

Medical Necessity Criteria for Pharmacy Edits

Policy Guidelines

N/A

Description

Formulary

A formulary is a list of drugs approved by the Pharmacy and Therapeutics Committee (P&T) for routine use. A well-designed formulary should provide adequate drug selection to meet the treatment needs of most patients; however, there will always be exceptional cases where a nonformulary drug may be the best therapeutic choice.

Formulary Drug

A formulary drug (also known as a preferred drug) is a drug that is on the formulary list. Drugs that are not on the list are referred to as non-formulary drugs.

Closed Formulary Benefit

A closed formulary benefit is one that routinely covers only formulary (preferred) drugs. A nonformulary drug may be covered when its use has been determined to be medically necessary after a review of the individual clinical case circumstances.

Step Therapy

A step therapy edit is a requirement that one or more specified first step agents be tried and failed before coverage will be provided for another second step agent. Step therapy requirements are based upon evidence from published, peer-reviewed clinical studies demonstrating that first-line use of the first step agents is clinically reasonable in most circumstances.

Quantity Limits

A quantity limit is the maximum amount of a medication that may be dispensed during a given calendar period or at one prescription fill without an exception request. Dispensing of a larger quantity may be approved, based on individual case review. A specified larger quantity may be approved when patient-specific circumstances require it, or when published clinical evidence supports a higher dose protocol.

(Note: Dispensing quantity limits are not intended to apply in circumstances where logistics may dictate otherwise. These circumstances include but are not limited to member vacation or business travel, disruption of normal prescription supply chains due to adverse weather events or other disasters and members living in remote areas where travel to the nearest pharmacy may sometimes be problematic.)

Label

Product label refers to the FDA approved prescribing information that is available for every legend drug approved for use in the U.S. The label includes indications, contraindications, recommended dosing, warnings, precautions, side effects, drug interactions and information on safety in pregnancy and other special populations. The drug’s pharmacology, pharmacokinetics, and available dosage forms are also provided. The current format also includes a summary of the pivotal clinical trials that were submitted to FDA in support of the New Drug Application.

This prescribing information is included as a package insert with the product and is available on the manufacturer’s Web site.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

This policy applies only to closed formulary pharmacy benefits designed to be sold on state and federal insurance exchanges. (See definitions in Description section above.) As used in this policy, “Formulary” refers to the applicable formulary list specified in a member’s contract. The policy does not apply to open benefit designs in which nonformulary drugs are covered, though in some cases at a higher tier.

Rationale

Step therapy edits are designed to channel utilization toward drugs that are at least as safe and effective and lower cost than other similar drugs that are also available. In many cases, the first step drugs in a particular edit algorithm are generics and the second step alternatives are brands that are more expensive and offer no proven incremental clinical benefit compared to the first step drugs. Step therapy, prior authorization and other similar utilization management tools are designed to steer members toward more cost-effective therapeutic choices and are thus an important component of affordable benefit designs.

Recent trends in prescription drug prices in the United States have led to an increased pressure on health care providers to keep down the cost of prescription medication while maintaining high levels of availability to the patient. Mandatory controls will become more important in plan designs that meet the Essential Health Benefit (EHB) requirements of the Affordable Care Act. In making care more accessible to members, the EHB requirements limit some of the financial incentives that have been developed to incent members to select lower cost alternatives. Furthermore, many manufacturers provide copay coverage, eliminating any additional cost impact to the member. Well designed and clinically based step therapy programs thus encourage proper drug selection without negative effects on members.

Motheral and colleagues published a retrospective database analysis of three step therapy programs implemented in a 20,000 member plan in 2002. The three edits targeted proton pump inhibitors, selective serotonin reuptake inhibitors and nonsteroidal anti-inflammatory drugs, respectively. The investigators studied two years’ worth of pharmacy claims of the intervention group against a comparator group of members from similar plans that did not have the three step therapy programs. Per member per month costs (PMPM) decreased by $0.83 in the intervention group, compared to a $0.10 rise on in the comparator group. A mailed self-administered member survey found that 30% received a generic, 23% were granted an exception and received the originally requested drug, 16% paid the full prescription price and 17% received no drug. Patients were 8 times more likely to receive a covered medication when the pharmacist called the prescriber. Failure to receive a covered medication reduced member satisfaction. The authors concluded that step therapy programs do reduce plan cost, but improving members’ and providers’ understanding of the programs would improve their outcomes and member satisfaction. (1)

A major objection to step therapy and other prior authorization programs has always been the administrative effort by provider office staff required to process exception requests. Historically, studies that attempted to measure this have reported conflicting results. A recent study by Morley, et al. estimated an average annual cost of $2,161 to $3,430 per clinic physician FTE. Over 50% of the staff time spent on prior authorization processing was by clerical staff. Less that 10% was by physicians, the remainder being provided by nurses and physician assistants. (2) The authors believe that further analysis is warranted, and with the expected improvement in ubiquity and interoperability of health information systems, it is likely that the administrative effort will be further reduced. A small convenience sample study at the Cambridge Health Alliance psychiatric emergency department found that prior authorization requirements for medications did add much to the time spent in ER prior to discharge.(3)

Prior authorization, step therapy and quantity limits are typical features of managed Medicare and Medicaid programs. Soumerai and colleagues, Hoadley and others have studied the effect of these interventions and generally report that they save plan cost and move utilization toward lower cost generic and preferred brand drugs without major impact on adherence. (4),(5),(6)

Quantity limits in this policy are based on maximum FDA approved dose as stated in the product label. These limits represent the upper bound of the dose range that has been shown to balance safety and efficacy as demonstrated by clinical trial data contained in the New Drug Application (NDA) or supplemental application (sNDA) for higher labeled dosing.(7) Quantities in excess of the limits in this policy may be approved based on adequate evidence from published peer reviewed clinical studies.

References

  1. Motheral BR, Henderson R, Cox ER. Plan sponsor savings and member experience with point-of-service prescription step therapy. Am J Manag Care 2004;10:457-464.
  2. Morley CP, Badolato DJ, Hickner J, et al. The impact of prior authorization requirements on primary care physician’s offices: report of two parallel network studies. J Am Board Fam Med. 2013;26(1):93-95.
  3. Funkenstein A, Malowney M, Boyd JW. Insurance Prior Authorization Approval Does Not Substantially Lengthen the Emergency Department Length of Stay for Patients With Psychiatric Conditions Ann Emerg Med 2013;61(5):596-597.
  4. Hoadley JF, Merrell K, Hargrave E, et al. In Medicare Part D plans, low or zero copay and other features to encourage the use of generics could save billions. Health Aff (Millwood) 2012;31(10):2266-2275.
  5. Lu CY, Law MR, Soumerai SB, et al. Impact of prior authorization on the use and costs of lipid-lowering medications among Michigan and Indiana dual enrollees in Medicaid and Medicare: results of a longitudinal, population-based study. Clin Ther. 2011;33(1):135-44.
  6. Law MR, Lu CY, Soumerai SB, et al. Impact of prior authorization on the use and costs of lipid-lowering medications among Michigan and Indiana dual enrollees in Medicaid and Medicare: results of a longitudinal, population-based study. Clin Ther. 2011;33(1):135-44.
  7. 21 CFR 201.5: Labeling Requirements for Prescription Drugs. Adequate Directions for Use. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201. Last accessed February 27, 2014.

Coding

Codes

Number

Description

 

 

This policy is managed through the Pharmacy benefit.

Appendix

N/A

History

Date

Reason

09/09/13

New policy, add to Prescription Drug section.

12/09/13

Replace policy. Policy section reflects updates to the Step Therapy and Dosing Limits tables.

03/10/14

Replace policy. Step Therapy Protocol and Dosing Limit Tables updated within the Policy section.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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