Beneficiary Advisory Panel Handout Uniform Formulary Decisions 08 Jan 2009

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Lawrence Hubbard
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1 Beneficiary Advisory Panel Handout Uniform Formulary Decisions 08 Jan 2009 PURE: The purpose of this handout is to provide BAP Committee members with a reference document for the relative clinical effectiveness presentations for each Uniform Formulary (UF) review. 08 January 2009 Beneficiary Advisory Panel Meeting Page 1 of 17

2 Table 1: Uniform Formulary Recommendations from the vember 2008 DoD P&T Committee Meeting UF Status / Period Generic Name (Brand) Formulations Generics Available? Nasal Allergy s Formulary n-formulary Recommended Azelastine (Astelin) nasal inhaler Flunisolide (Nasarel, generics) nasal inhaler Yes Fluticasone propionate (Flonase, generics) nasal inhaler Yes Mometasone (Nasonex) nasal inhaler Ipratropium (Atrovent) nasal inhaler Yes Beclomethasone (Beconase AQ) nasal inhaler Budesonide (Rhinocort Aqua) nasal inhaler Ciclesonide (Omnaris) nasal inhaler Fluticasone furoate (Veramyst) nasal inhaler Triamcinolone (Nasacort AQ) nasal inhaler Olopatadine (Patanase) nasal inhaler Short-Acting Beta Agonists (SABAs) Albuterol solution (Accuneb, generics) inhalation solution Yes Formulary n-formulary* Levalbuterol solution (Xopenex) inhalation solution Albuterol inhaler (Proair, Proventil HFA, Ventolin HFA) metered dose inhaler Levalbuterol inhaler (Xopenex) metered dose inhaler Metaproterenol solution (Alupent, generics) inhalation solution Yes Pirbuterol inhaler (Maxair) metered dose inhaler Recommended *: te regarding non-formulary SABAs: Generic formulations of albuterol metered dose inhaler and metaproterenol metered dose inhaler (Alupent) will no longer be marketed after 31 Dec 2008, due to ban of chlorofluorocarbon propellant 08 January 2009 Beneficiary Advisory Panel Meeting Page 2 of 17

3 Figure 1: Nasal Allergy s Nasal Allergy Utilization MHS Utilization of Nasal Allergy s 3,000,000 CICLESONIDE BECLOMETHASONE DIPROPIONATE BUDESONIDE FLUNISOLIDE FLUTI CA SONE FUROA TE FLUTICASONE PROPIONATE MOMETASONE FUROATE TRIAMCINOLONE ACETONIDE AZELASTINE HCL OLOPAT ADINE HCL IPRATROPIUM BROMIDE 2,500,000 Fluticasone propionate 2,000,000 Qty Dispensed 1,500,000 1,000,000 Mometasone furoate 500,000 Triamcinolo ne Azelastine 0 Oct-05 Dec-05 Feb -06 Apr- 06 Jun-06 Aug-06 Oct-06 Dec-06 Feb-07 Apr- 07 Jun-07 Aug-07 Oct-07 Dec-07 Feb-08 Apr- 08 Jun -08 Aug -08 Time 08 January 2009 Beneficiary Advisory Panel Meeting Page 3 of 17

4 Figure 2: Nasal Allergy s 900,000 Nasal Allergy Utilization MHS without Flonase AZELASTINE HCL BECLOMET HASONE DIPROPIONATE BUDESONIDE CICLESONIDE FLUNISOLIDE FLUTICASONE FUROAT E IPRATROPIUM BROM IDE MOMETASONE FUROATE OLOPATADINE HCL TRIAMCINOLONE ACETONIDE 800,000 M ometasone furoate 700, , , ,000 Azelastine 300, ,000 Triamcinolo ne 100,000 Ipratro pium Budesonide 0 Beclomethasone 10/31/05 11/30/05 12/ 31/ 05 01/31/06 02/ 28/ 06 03/31/06 04/30/06 05/31/06 06/30/06 07/31/06 08/31/06 09/30/06 10/31/06 11/30/06 12/31/06 01/ 31/ 07 02/28/07 03/31/07 04/30/07 05/31/07 06/30/07 07/31/07 08/31/07 09/30/07 10/ 31/ 07 11/30/07 12/31/07 01/31/08 02/29/08 03/31/08 04/30/08 05/ 31/ 08 06/30/08 07/ 31/ 08 08/31/08 09/30/08 08 January 2009 Beneficiary Advisory Panel Meeting Page 4 of 17

5 Figure 3: Short-Acting Beta Agonists Metered Dose Inhaler 2,500,000 Inhaler Utilization All Oct 05 - Sept 08 UTILIZATION IN MLS/GMS 2,000,000 1,500,000 1,000,000 ALBUTEROL 500,000 0 Oct-05 Dec-05 Feb-06 Apr-06 Jun-06 Aug-06 Oct-06 De c-06 Feb-07 Apr-07 Jun-07 Aug-07 Oct-07 Dec-07 Feb-08 Apr-08 Jun-08 Aug-08 PRO VENTIL XO PENEX VENT OLI N PROAIR MAXAIR ALU PENT 08 January 2009 Beneficiary Advisory Panel Meeting Page 5 of 17

6 Figure 4: Short-Acting Beta Agonists Inhalation Solution 3,500,000 Soln Utilization All Oct 05 - Sept 08 3,000,000 TOTAL QUAINITY DISP IN MLS 2,500,000 2,000,000 1,500,000 1,000,000 ALBUTEROL SULFATE LEVALBUTERO L 500,000 0 Oct-05 Dec- 05 Feb-06 Apr-06 Jun-06 Aug-06 Oc t -06 Dec-06 Feb-07 Apr- 07 Jun-07 Aug-07 Oct-07 Dec- 07 Feb-08 Apr-08 Jun -08 Aug January 2009 Beneficiary Advisory Panel Meeting Page 6 of 17

7 Table 6: Uniform Formulary Summary Meeting n-formulary Medications ) by v 08 Inhaled Short Acting Beta Agonist Metaproterenol inhaled solution Pirbuterol CFC MDI (Maxair) 1, , v 08 Nasal Allergy s Beclomethasone (Beconase AQ) Budesonide (Rhinocort AQ) Ciclesonide (Omnaris) Fluticasone Furoate (Veramyst) Triamcinolone (Nasacort AQ) Olopatadine (Patanase) 34, ,017 6, Nasal corticosteroids reviewed v 05, no changes to UF other than Patanase and Omnaris made non-formulary (1,794 users) Aug 08 Self-Monitoring Blood Glucose System Test Strips One Touch (for One Touch Ultra 2, Ultra Mini, and Ultra Smart meters) TrueTrack strips (for TrueTrack meter) Accu-chek Comfort Curve strips (for Accu-chek Advantage meter) Accu-chek Compact Plus drum (for Accu-check Compact Plus meter) Accu-chek Simplicity, Ascensia Autodisk, Ascensia Breeze 2, Ascensia Elite, Assure, Assure 3, Assure II, Assure Pro, Bd Test Strips, Chemstrip Bg, Control AST, Dextrostix Reagent, Easygluco, Easypro, Fast Take, Freestyle test strips (other than Freestyle Lite), Glucofilm, Glucolab, Glucometer Dex, Glucometer Elite, Glucose Test Strip, Glucostix, Optium, Precision Pcx, Precision Pcx Plus, Precision Q-I-D, Precision Sof-Tact, Prestige Smart System, Prodigy, Quicktek, Sidekick, Sof-Tact, Surestep, Surestep Pro, Test Strip, 58,142 12,271 33,658 12, Allow time for patients to receive new meters 08 January 2009 Beneficiary Advisory Panel Meeting Page 7 of 17

8 n-formulary Medications ) by Relion Ultima, Uni-Check Plus all other store/private label brand strips not included on Uniform Formulary (see the BCF/ECF column) Aug 08 Overactive Bladder s Tolterodine IR (Detrol) Trospium IR (Sanctura) 4, ,210 2, Desvenlafaxine (Pristiq) New drug in already reviewed class; low utilization Aug 08 Antidepressant 1s Original Meeting v 05 paroxetine HCl CR (Paxil) fluoxetine 90 mg for weekly administration (Prozac Weekly) fluoxetine in special packaging for PMDD (Sarafem) escitalopram (Lexapro) duloxetine (Cymbalta) bupropion extended release (Wellbutrin XL) Aug 08 Nisoldipine geomatrix (Sular geomatrix) Calcium Channel Blockers Original Meeting Aug 05 amlodipine (rvasc) o v 07: removed from NF status isradipine IR (Dynacirc) isradipine ER (Dynacirc CR) 2, , New drug in already reviewed class; low utilization 08 January 2009 Beneficiary Advisory Panel Meeting Page 8 of 17

9 n-formulary Medications ) by nicardipine IR (Cardene, generics) nicardipine SR (Cardene SR) verapamil ER (Verelan) verapamil ER for bedtime dosing (Verelan PM, Covera HS) diltiazem ER for bedtime dosing (Cardizem LA) Jun 08 Triptans Almotriptan (Axert) Frovatriptan (Frova) Naratriptan (Amerge) 3, , (26 v 2008) 90 days Jun 08 Osteoporosis Agents Salmon-calcitonin (Miacalcin) 2, ,948 1,021 (26 v 2008) 90 days Jun 08 Newer Antihistamines (NAs) (new drug in previously reviewed class); Original decision Aug 07 Levocetirizine (Xyzal) 19, ,254 0 Original Meeting Aug 07 desloratadine (Clarinex) desloratadine/pseudoephed. (Clarinex D) 27, ,102 7,234 (29 Oct 2008) New drug in already reviewed class Jun 08 Leukotriene Modifiers (LMs (new drug in previously reviewed class); Original decision Zileuton extended release (Zyflo CR) Aug 07 Original Meeting Aug 07 zileuton (Zyflo) (29 Oct 2008) New drug in already reviewed class; low utilization 08 January 2009 Beneficiary Advisory Panel Meeting Page 9 of 17

10 n-formulary Medications ) by Jun 08 Beta Adrenergic Receptor Blockers (ABAs) (new drug in previously reviewed class); Original decision v 07 Nebivolol (Bystolic) 2, ,462 0 Original Meeting v 07 ( drugs designated non formulary) (29 Oct 2008) New drug in already reviewed class; low utilization meds moved to non-formulary status ARB/CCB combos (Jun 08) Olmesartan / amlodipine (Azor) 2, ,641 0 (29 Oct 2008) New drug in already reviewed class with current low utilization ARB/CCB combos (v 07) valsartan / amlodipine (Exforge) 2, ,376 0 (16 Apr 2008) New drug in already reviewed class with current low utilization Jun 08 Renin Antihypertensive Agents (RAAs) (new drug in previously reviewed class); ARBs (May 07 meeting) eprosartan (Teveten) eprosartan HCTZ (Teveten HCT) irbesartan (Avapro) irbesartan HCTZ (Avalide) olmesartan (Benicar) olmesartan HCTZ (Benicar HCT) valsartan (Diovan) valsartan HCTZ (Diovan HCT) ACE/CCB combos Feb 06 meeting felodipine/enalapril (Lexxel) verapamil/trandolapril (Tarka) ACE Inhibitors (Aug 05 meeting) moexipril (Univasc), moexipril / HCTZ (Uniretic) perindopril (Aceon) quinapril (Accupril) quinapril / HCTZ (Accuretic) ramipril (Altace) meetings for for each subclass 08 January 2009 Beneficiary Advisory Panel Meeting Page 10 of 17

11 n-formulary Medications ) by v 07 Benign Prostatic Hypertension (BPH) Alpha Blockers (ABs) tamsulosin (Flomax) 64,783 1,426 40,161 23,196 (16 Apr 2008) 60-days 3 rd class for Yes v 07 Targeted Immunomodulatory Biologics (TIBs) etanercept (Enbrel) anakinra (Kineret) 7,397 1,939 4,149 1,309 (18 Jun 2008) 90-days v 07 Attention Deficit Hyperactivity Disorder (ADHD) / Narcolepsy agents (new drug in previously reviewed class); Previous decision v 06 lisdexamfetamine (Vyvanse) 2,200 Rxs 0 2,200 Rxs 0 Original decision v 06 Dexmethylphenidate IR (Focalin) Dexmethylphenidate SODAS (Focalin XR) Methylphenidate transdermal patch (Daytrana) 3,078 (1.7% of patients receiving an ADHD drug) 62 2, (16 Apr 2008) 18 Apr 07 New drug in already reviewed class with current low utilization v 07 Contraceptive Agents (new drug in previously reviewed class); Previous decisions May 06, v 06 EE 20 mcg / levonorgestrel 0.09 mg (Lybrel) 290 Rxs 2 Rxs 263 Rxs 25 Rxs (16 Apr 2008) New drug in already reviewed class with current low utilization Previous meetings May 06 & v 06 EE 30 mcg / levonorgestrel 0.15 mg in special packaging for extended use (Seasonale) EE 25 mcg / norethindrone 0.4 mg (Ovcon 35) 23,221 (4% of patients receiving a contraceptive) 3,128 19, Jan 07 (180 days) Seasonale, packaged as a 3- month supply; Loestrin 24 FE and Seasonique to coincide with 08 January 2009 Beneficiary Advisory Panel Meeting Page 11 of 17

12 n-formulary Medications ) by EE 50 mcg / norethindrone 1 mg (Ovcon 50) EE 20/30/35 mcg / norethindrone 1 mg (Estrostep Fe) EE 20 mcg/1 mg norethindrone- 24 day regimen (Loestrin 24 Fe) EE 30/10 mcg/ 0.15 mg levonorgestrel for extended use (Seasonique) Seasonique: 161 (from Apr 06-Oct 06) Loestrin 24 Fe: 2,227 (from Apr 06-Oct 06) 0 Rxs 112 Rxs 4 Rxs 22 Rxs 3,417 Rxs 64 Rxs Seasonale decision Aug 07 Nasal Corticosteroid Agents (new drug in previously reviewed class); Original decision v 05 fluticasone furoate (Veramyst) Original Decision: v 05 beclomethasone dipropionate (Beconase AQ, Vancenase AQ) budesonide (Rhinocort Aqua) triamcinolone (Nasacort AQ) TMOP & TRRx: 60- days for current users; $22 co-pay in effect immediately for new users : later than 19 Jan 06 New drug in already reviewed class with current low utilization Substantial number of Aug 07 Growth Stimulating Agents (GSAs) somatropin (Genotropin, Genotropin Miniquick) somatropin (Humatrope) somatropin (Omnitrope) somatropin (Saizen) TMOP & TRRx: 60- days for current users; : later than Low number of May 07 Antilipidemic II Agents (LIP-2s) fenofibrate nanocrystallized (Tricor) fenofibrate micronized (Antara) omega-3 fatty acids (Omacor) colesevelam (Welchol) 83,612 18,849 44,402 20, Oct 07 May 07 5-Alpha Reductase Inhibitors (5-ARIs) dutasteride (Avodart) 20,917 1,087 12,830 7, Oct January 2009 Beneficiary Advisory Panel Meeting Page 12 of 17

13 n-formulary Medications ) by May 07 (Update from Feb 05) May 07 (Update from Feb 05) Feb 07 Feb 07 Feb 07 Feb 07 v 06 v 06 PPIs ARBs Newer Sedative Hypnotics lansoprazole (Prevacid) omeprazole/sodium bicarbonate (Zegerid) pantoprazole (Protonix) rabeprazole (Aciphex) eprosartan (Teveten) eprosartan HCTZ (Teveten HCT) irbesartan (Avapro) irbesartan HCTZ (Avalide) olmesartan (Benicar) olmesartan HCTZ (Benicar HCT) valsartan (Diovan) valsartan HCTZ (Diovan HCT) Ramelteon (Rozerem) Zaleplon (Sonata) Zolpidem ER (Ambien CR) 453, , ,120 63, ,581 68, ,595 50,930 40,447 5,878 31,550 3,019 Narcotic Analgesics Tramadol ER (Ultram ER) 1, ,042 Glaucoma Agents MAOI Antidepressants ADHD Older Sedative Hypnotics Travoprost (Travatan, Travatan Z) Timolol maleate (Istalol) Timolol hemihydrate (Betimol) Brinzolamide (Azopt) 17,139 1,735 12,267 3,117 Selegiline transdermal system (Emsam) Dexmethylphenidate IR (Focalin) Dexmethylphenidate SODAS (Focalin XR) Methylphenidate transdermal patch (Daytrana) 3,078 (1.7% of patients receiving an ADHD drug) 62 2, Oct v 07 (120 days) 1 Aug 07 1 Aug 07 1 Aug 07 1 Aug Apr Apr 07 Aug 06 TZDs t applicable Reservations regarding ESI ability to handle First time automated PA with step edit medications moved to nonformulary status medications moved to nonformulary status Yes Yes 08 January 2009 Beneficiary Advisory Panel Meeting Page 13 of 17

14 n-formulary Medications ) by Aug 06 H2 Antagonists / GI protectants t applicable medications moved to nonformulary status Aug 06 Antilipidemic I Agents Rosuvastatin (Crestor) Atorvastatin / amlodipine (Caduet) 44, ,133 6,921 1 Feb 07 May 06 Antiemetics Dolasetron (Anzemet) Sept 06 (), and acute nature of treatment (e.g., chemotherapy) May 06 update for new drugs v 06 Contraceptive Agents Original Decision May 06 EE 30 mcg / levonorgestrel 0.15 mg in special packaging for extended use (Seasonale) EE 25 mcg / norethindrone 0.4 mg (Ovcon 35) EE 50 mcg / norethindrone 1 mg (Ovcon 50) EE 20/30/35 mcg / norethindrone 1 mg (Estrostep Fe) v 06 EE 20 mcg/1 mg norethindrone- 24 day regimen (Loestrin 24 Fe) EE 30/10 mcg/ 0.15 mg levonorgestrel for extended use (Seasonique) 23,221 (4% of patients receiving a contraceptive) Seasonique 161 (from Apr 06-Oct 06) Loestrin 24 Fe: 2,227 (from Apr 06-Oct 06) 3,128 19, Rxs 112 Rxs 4 Rxs 22 Rxs 3,417 Rxs 64 Rxs 24 Jan 07 (180 days) Jan (; to coincide with Seasonal) Relatively low number of, but a high proportion are receiving Seasonale, which is packaged as a 3-month supply 08 January 2009 Beneficiary Advisory Panel Meeting Page 14 of 17

15 n-formulary Medications ) by Feb 06 OABs tolterodine IR (Detrol) oxybutynin patch (Oxytrol) trospium (Sanctura) 19,118 2,596 13,471 3, July 06 Recommended 60- day overturned; 90-day BAP recommendation accepted Feb 06 Misc Antihypertensive Agents felodipine/enalapril (Lexxel) verapamil/trandolapril (Tarka) 5, ,472 1, July 06 Recommended 60- day overturned; 90-day BAP recommendation accepted Feb 06 GABA-analogs pregabalin (Lyrica) 30,649 1,120 27,566 1, Jun 06 () v 05 Alzheimer s s tacrine (Cognex) Apr 06 v 05 Nasal Corticosteroid Agents beclomethasone dipropionate (Beconase AQ, Vancenase AQ) budesonide (Rhinocort Aqua) triamcinolone (Nasacort AQ) 96,999 13,556 73,381 10, Apr 06 Substantial number of v 05 Macrolide/ Ketolide Antibiotics azithromycin 2 gm (Zmax) telithromycin (Ketek) number not provided; antibiotics are used to treat acute infections 22 Mar 06 (), Medication used to treat acute (not chronic) infections not likely to require therapy change v 05 Antidepressants I paroxetine HCl CR (Paxil) fluoxetine 90 mg for weekly administration (Prozac Weekly) fluoxetine in special packaging for PMDD (Sarafem) escitalopram (Lexapro) duloxetine (Cymbalta) bupropion extended release (Wellbutrin XL) 182,916 52, ,582 11, Jul 06 (180 days) Substantial number of 08 January 2009 Beneficiary Advisory Panel Meeting Page 15 of 17

16 n-formulary Medications ) by Aug 05 Aug 05 Aug 05 May 05 May 05 updated for new drug v 06 Alpha Blockers for BPH CCBs ACE Inhibitors & ACE Inhibitor / HCTZ Combinations PDE-5 Inhibitors Topical Antifungals* tamsulosin (Flomax) 89,926 26,692 47,674 15,560 amlodipine (rvasc) o v 07: amlodipine removed from NF status isradipine IR (Dynacirc) isradipine ER (Dynacirc CR) nicardipine IR (Cardene, generics) nicardipine SR (Cardene SR) verapamil ER (Verelan) verapamil ER for bedtime dosing (Verelan PM, Covera HS) diltiazem ER for bedtime dosing (Cardizem LA) moexipril (Univasc), moexipril / HCTZ (Uniretic) perindopril (Aceon) quinapril (Accupril) quinapril / HCTZ (Accuretic) ramipril (Altace) sildenafil (Viagra) tadalafil (Cialis) econazole ciclopirox oxiconazole (Oxistat) sertaconazole (Ertaczo) sulconazole (Exelderm) miconazole 0.25%, zinc oxide 15%, white petrolatum 82.35% (Vusion) 274, , ,345 39, ,101 77,159 57,982 22, ,007 55,161 49,850 22,996 49,743 14,266 33,430 2, (Apr 06-Oct 06) (UU not applicable) Feb 06 (120 days) 15 Mar 06 (150 days) 16 Feb 06 (120 days) 12 Oct Aug 05 (30 days) 21 Feb 07 () May 05 MS-DMDs t applicable Substantial number of Substantial number of Substantial number of Substantial number of Medication used to treat acute (not chronic) infections not likely to require therapy change Small numbers of medications moved to nonformulary status 08 January 2009 Beneficiary Advisory Panel Meeting Page 16 of 17

17 n-formulary Medications ) by Feb 05 ARBs eprosartan (Teveten) eprosartan/hctz (Teveten HCT) 2, , Jul 05 Recommended 30- day overturned; 90-day BAP recommendation accepted Feb 05 PPIs esomeprazole (Nexium) 138,739 6, ,520 14, Jul 05 Substantial number of BCF = Basic Core Formulary; ECF = Extended Core Formulary; ESI = Express-Scripts, Inc; MN = Medical Necessity; TMOP = TRICARE Pharmacy; TRRx = TRICARE Pharmacy program; UF = Uniform Formulary CR = controlled release; ER = extended release; IR = immediate release; LA = long-acting; SR = sustained release; XL = extended release 5-ARI = 5-Alpha Reductase Inhibitors; ADHD = Attention Deficit Hyperactivity Disorder; ACE Inhibitors = Angiotensin Converting Enzyme Inhibitors; ARBs = Angiotensin Receptor Blockers; BPH = Benign Prostatic Hypertrophy; CCBs = Calcium Channel Blockers; EE = ethinyl estradiol; GSAs = Growth Stimulating Agents; GI = gastrointestinal; GABA = gamma-aminobutyric acid; H2 = Histamine-2 receptor; HCTZ = hydrochlorothiazide; Leukotriene Modifiers = LMs; LIP-1s = Antilipidemic I; LIP-2s = Antilipidemic II; MAOI = Monoamine Oxidase Inhibitor; MS-DMDs = Multiple Sclerosis Disease-Modifying s; NAs = Newer Antihistamines; OABs = Overactive Bladder Medications; PDE-5 Inhibitors = Phosphodiesterase-5 inhibitors; PMDD = Premenstrual Dysmorphic Disorder; PPIs = Proton Pump Inhibitors; RAAs = Renin Antihypertensive Agents; SODAS = spheroidal oral drug absorption system; TZDs = thiazolidinediones *The topical antifungal drug class excludes vaginal products and products for onychomycosis (e.g., ciclopirox topical solution [Penlac]) 08 January 2009 Beneficiary Advisory Panel Meeting Page 17 of 17

Beneficiary Advisory Panel Handout Uniform Formulary Decisions 17 September 2008

Beneficiary Advisory Panel Handout Uniform Formulary Decisions 17 September 2008 PURPOSE: The purpose of this handout is to provide BAP Committee members with a reference document for the relative clinical