Beneficiary Advisory Panel Handout Uniform Formulary Decisions 14 Jan 21 PURPOSE: 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) Class review. Page 1 of 17
Table 1: Uniform Formulary Recommendations from the v 29 DoD P&T Committee Meeting UF Status / Brand Name (Generic) Implementation Period Phosphodiesterase Type 5 Inhibitors (PDE-5 inhibitors) for Pulmonary Arterial Hypertension Formulary Revatio (sildenafil) n-formulary Adcirca (tadalafil) recommended for NF vember 29 Recommended implementation period 6 days Figure 1: PDE5 Inhibitors for Pulmonary Arterial Hypertension 7 Utilization By Rx s ALL POS Sep 7 Sep 9 6 REVATIO 5 Rx s 4 3 2 1 ADCIRCA Page 2 of 17
Table 2: Interferon beta 1b (Extavia): Uniform Formulary Recommendations from v 29 for the Multiple Sclerosis - Disease Modulating Drugs (MS-DMDs) Multiple Sclerosis - Disease Modulating Drugs (MS-DMDs) UF Status / Implementation Period Uniform Formulary Generic Name (Brand) Formulations Generics Available? IFN beta- 1a (Avonex) Injection IFN beta- 1a (Rebif) Injection IFN beta- 1b (Betaseron ) Injection Glatiramer acetate (Copaxone) Injection n-formulary Interferon beta 1b (Extavia) recommended for NF vember 29 Injection Recommended implementation period 6 days for Extavia Figure 2: MS-DMDs 1,2 Utilization By Rx s ALL POS Sep 7 Sep 9 COPAXONE 1, AVONEX (PREFILLED) Rx s 8 6 BETASERON 4 2 AVONEX w/albumin (VIAL) REBIF Page 3 of 17
Table 3: Milnacipran tablets (Savella), Bupropion hydrobromide extended release tablets (Aplenzin), and Bupropion hydrochloride extended release tablets (Wellbutrin XL): UF Recommendations from v 29 for the Antidepressant 1 (AD-1) Drugs UF Status / Implementation Period Generic Name (Brand) Antidepressant 1 (AD-1s) Formulations Generics Available? Serotonin-repinephrine Reuptake Inhibitors (SNRIs) Venlafaxine IR (Effexor) tabs Venlafaxine ER (Effexor XR) caps Venlafaxine extended release tablets (VERT) Tabs Selective Reuptake Inhibitors (SSRI) Fluoxetine (excludes Prozac Weekly, Sarafem) caps, syrup Citalopram tabs Paroxetine HCl IR tabs Paroxetine mesylate (Pexeva) tabs Sertraline (Zoloft) tabs Formulary Fluvoxamine (Luvox brand discontinued) tabs Serotonin-Antagonist/Reuptake Inhibitors (SARIs) Nefazodone tabs Trazodone tabs repinephrine and Dopamine Reuptake Inhibitors (NDRIs) Bupropion immediate release (Wellbutrin) tabs Bupropion sustained release (Wellbutrin SR) tabs Bupropion extended release (Wellbutrin XL) recommended to move from NF to UF vember 29 tabs Alpa-2 Receptor Antagonists Mirtazapine (Remeron) Tabs, n-formulary Recommended implementation period Serotonin-repinephrine Reuptake Inhibitors (SNRIs) Milnacipran (Savella ) recommended for NF vember 29 tabs Desvenlafaxine (Pristiq) tab Duloxetine (Cymbalta) caps repinephrine and Dopamine Reuptake Inhibitors (NDRIs) Bupropion hydrobromide ER tablets (Aplenzin) recommended for NF v 29 tabs Selective Reuptake Inhibitors (SSRIs) Fluoxetine weekly (Prozac Weekly) caps Fluoxetine in special packaging for premenstrual dysphoric disorder (Sarafem) caps, tabs Escitalopram (Lexapro) tabs Paroxetine ER (Paxil CR) Tabs 6 days for Savella 6 days for Aplenzin Immediate upon signing of the minutes for Bupropion XL (Wellbutrin XL, generics) Page 4 of 17
Figures 3 and 4: AD-1s 1,4, 1,2, Utilization - ALL POS Sep 7 Sep 9 EFFEXOR XR TOTAL QTY DISPENSED 1,, 8, 6, 4, 2, CYMBALTA LYRICA SAVELLA 6, Utilization XL S - ALL POS Sep 7 Sep 9 5, TOTAL QTY DISPENSED 4, 3, 2, 1, BUDEPRION XL WELLBUTRIN XL BUPROPION XL APLENZIN Page 5 of 17
Table 4: Oxybutynin 1% topical Gel (Gelnique): Uniform Formulary Recommendations from v 29 for the Overactive Bladder (OAB) Drugs Overactive Bladder Drugs UF Status / Implementation Period Generic Name (Brand) Formulations Generics Available? Darifenacin (Enablex) tabs Oxybutynin IR (Ditropan) tabs, syrup Oxybutynin ER (Ditropan XL) tabs Formulary Oxybutynin transdermal (Oxytrol) patch Solifenacin (Vesicare) tabs Tolterodine ER (Detrol LA) caps Trospium ER (Sanctura XR) caps Oxybutynin 1 % gel (Gelnique) recommended for NF vember 29 topical gel n-formulary Fesoterodine ER (Toviaz) tabs Tolterodine IR (Detrol) tabs Sanctura IR (Trospium IR) tabs Recommended implementation period ER: extended release IR: immediate release Figure 5: OABs 6 days for Gelnique Utilization - ALL POS Sep 8 Sep 9 1,8, TOTAL QTY DISPENSED 1,6, 1,4, 1,2, 1,, 8, 6, 4, OXYBUTYNIN CHLORIDE ER DETROL LA VESICARE ENABLEX 2, DITROPAN XL SANCTURA XR OXYTROL TOVIAZ GELNIQUE Page 6 of 17
Figure 6: OABs Con t Utilization - ALL POS Sep 8 Sep 9 7, TOTAL QTY DISPENSED 6, 5, 4, 3, 2, ENABLEX OXYBUTYNIN CHLORIDE ER VESICARE 1, DITROPAN XL SANCTURA XR OXYTROL TOVIAZ GELNIQUE Page 7 of 17
Table 5: Tapendatol (Nucynta) and Tramadol ER (Ryzolt): Uniform Formulary Recommendations from v 29 for the Narcotic Analgesics Narcotic Analgesics Uniform Formulary High-potency single analgesic agents Long-acting agents (> 12 hour duration) Fentanyl transdermal system (Duragesic) patch Morphine sulfate ER 24 hr (Kadian, Avinza) cap Morphine sulfate ER 12 hr (MS Contin, Oramorph) tab, soln, supp, inj Oxycodone ER (Oxycontin) tabs Oxymorphone (Opana ER) tabs Short acting agents (<12 hour duration) Codeine tabs, soln, inj Fentanyl citrate buccal (Fentora) tabs Fentanyl citrate transmucosal (Actiq) lozenges Hydromorphone (Dilaudid) tab, inj, liquid, except for 1 mg tab Levorphanol (Levo-Dromoran) tab, inj Meperidine (Demerol) tab, soln, inj Meperidine / promethazine (Mepergan Fortis) caps Methadone (Dolophine) tab, oral conc, soln, inj Morphine sulfate IR tabs Opium tincture Opium / belladonna alkaloids supp Oxycodone IR caps, oral conc, soln Oxymorphone IR (Opana) tabs High-potency combination agents Oxycodone /APAP (e.g., Percocet, Tylox, others) tab, cap, soln Oxycodone / ASA (Percodan) tabs Low potency single analgesic agents Buprenorphine (Buprenex) inj (excludes SL tabs) Butorphanol (Stadol) nasal spray, inj Pentazocine / naloxone (Talwin NX) tabs Propoxyphene (Darvon) caps, tabs Nalbuphine (Nubain ) not a controlled substance) Inj Tramadol IR(Ultram) not a controlled substance tab Low potency combination agents Codeine / APAP (Tylenol with codeine) tabs, elixir, oral susp Codeine / ASA tabs Codeine / ASA / carisoprodol (Soma) tabs Codeine / caffeine / butalbital / APAP (Fioricet with codeine) caps Codeine / caffeine / butalbital / ASA (Fiorinal with caffeine) caps, tabs Dihydrocodeine / caffeine / APAP e.g., Panlor DC, Panlor SS) caps, tabs Dihydrocodeine / caffeine / ASA (Synalgos-DC) caps Hydrocodone / APAP (Lortab, Lorcet, Vicodin) caps Page 8 of 17
n-formulary Recommended implementation period Pentazocine / APAP (Talacen) tabs Propoxyphene / APAP (Darvocet) tabs Propoxyphene / ASA / caffeine (Darvon Compound 65) caps Tramadol/APAP (Ultracet) not a controlled substance tab Low potency single analgesic agents Tramadol extended release (Ultram ER) tab Tramadol extended release (Ryzolt) Recommended for NF v 29 tab High potentcy single analgesic agents; short-acting agents (<12 hours duration) Tapentadol (Nucynta) Recommended for NF v 29 tab 6 days for Nucynta 6 days for Ryzolt Figure 7: Narcotics Narcotics Utilization By Rx s - ALL POS Sep 7 Sep 9 3, 2,5 MORPHINE IR RX s 2, 1,5 OXYCODONE IR 1, 5 NUCYNTA Page 9 of 17
Figure 8: Narcotics 7, Narcotics Utilization - All POS Sep 7 Sep 9 6, TOTAL QTY DISPENSED 5, 4, 3, 2, ULTRAM ER 1, RYZOLT Page 1 of 17
Table 6: Valsartan / Amlodipine / Hydrochlorothiazide (Exforge HCT) Uniform Formulary Recommendations from v 29 for the Renin Angiotensin Antihypertensives (RAAs) ARB / CCB / Diuretic Combinations ARB /CCB Combinations Direct Renin Inhibitors & Combinations ARBs ACE Inhibitors ACE/CCB Combinations Recommended implementation period Renin Angiotensin Antihypertensives (RAAs) UF n-formulary UF UF n-formulary UF NF UF n-formulary Valsartan /amlodipine / hydrochlorothiazide (Exforge HCT) recommended for UF vember 29 Olmesartan / amlodipine (Azor) Valsartan / amlodipine (Exforge) Aliskiren hydrochlorothiazide (Tekturna HCT) Aliskiren (Tekturna) Candesartan (Atacand) Candesartan /HCTZ (Atacand HCT) Losartan (Cozaar) Losartan/HCTZ (Hyzaar) Telmisartan (Micardis) Telmisartan/HCTZ (Micardis HCT) Candesartan (Atacand) Eprosartan (Teveten) Eprosartan/HCTZ (Teveten HCT) Irbesartan (Avapro) Irbesartan/HCTZ (Avalide) Olmesartan (Benicar) Olmesartan/HCTZ (Benicar HCT) Valsartan (Diovan) Valsartan/HCTZ (Diovan) Benazepril and combo with HCTZ (Lotensin, Lotensin HCT; generics) Captopril and combo with HCTZ (Capoten, Capozide; generics) Enalapril and combo with HCTZ (Vasotec, Vaseretic; generics) Fosinopril and combo with HCTZ (Monopril, Monopril HCT; generics) Lisinopril and combo with HCTZ (Prinivil, Zestril, Prinzide, Zestoretic; generics) Trandolapril (Mavik) Moexipril (Univasc) and combo with HCTZ (generics) Perindopril (Aceon) Quinapril (Accupril) and combo with HCTZ (generics) Ramipril (Altace; generics)) Amlodipine / benazepril (Lotrel; generics) Felodipine / enalapril (Lexxel) removed from market Verapamil sustained release / trandolapril (Tarka) t applicable for Exforge HCT (recommended to retain UF status) ACE: Angiotensin Converting Enzyme Inhibitor; ARB: Angiotensin Receptor Blocker; CCB: Calcium Channel Blocker; HCTZ: hydrochlorothiazide Page 11 of 17
Figure 9: RAAS Utilization By Rx s TMOP May 7 Sep 9 2, 1,8 LISINOPRIL-HCTZ 1,6 Rx s 1,4 1,2 1, 8 6 MICARDIS HCT 4 2 TEKTURNA HCT EXFORGE HCT Page 12 of 17
Formulary Implementation Plan Summary 29 to present Meeting v 9 v 9 Drug Class PDE-5 Inhibitors for Pulmonary Arterial Hypertension Multiple Sclerosis- Disease Modulating Drugs (last reviewed Aug 25) n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date tadalafil (Adcirca) 56 52 4 6 days Interferon Beta-1b injection (Extavia) Aug 25: drugs made n formulary Step Therapy ; step for the class for erectile dysfunction 6 days v 9 bupropion hydrobromide extended release Aplenzin 1488 1 77 141 6 days v 9 milnacipran (Savella) 91 91 6797 522 6 days v 9 Antidepressants-1 (reviewed in v 25, Aug 8 [Pristiq]) te: Bupropion hydrochloride extended release (Wellbutrin XL, generics) recommended to move from n formulary to UF Aug 8 desvenlafaxine(pristiq) Original Meeting v 5 paroxetine HCl CR (Paxil) fluoxetine 9 mg for weekly administration (Prozac Weekly) fluoxetine in special packaging for PMDD (Sarafem) escitalopram (Lexapro) duloxetine (Cymbalta) N/A See previous BAP meetings Page 13 of 17
Meeting Drug Class n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date Step Therapy v 9 Overactive Bladder Drugs (1 st reviewed Feb 6, updated Aug 8; May 9-Toviaz;) v 9 Oxybutynin 1% topical gel May 9 Fesoterodine ER (Toviaz) Update Aug 8; 1 st review Feb 6 Tolterodine IR (Detrol) Trospium IR (Sanctura) v 9 Tapentadol (Nucynta) 1998 1654 344 6 days See previous BAP meetings 488 3 455 3 6 days v 9 Narcotic Analgesics (1 st reviewed Feb 27) v 9 Tramadol ER (Ryzolt) 1876 52 1761 63 6 days Feb 7 Tramadol ER (Ultram ER) See previous BAP meetings v 9 Renin Antihypertensive Agents (RAAs) v 9 te: Exforge HCT recommended to remain as UF N/A Page 14 of 17
Meeting Drug Class n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date Step Therapy (reviewed Feb 95, May 7, v 7 [Exforge], Jun 8 [Azor] ARB/CCB combos (Jun 8) Olmesartan / amlodipine (Azor) Jun 8 Valsartan/amlodipine (Exforge) v 7 ARBs (May 7 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 6 meeting felodipine/enalapril (Lexxel) verapamil/trandolapril (Tarka) ACE Inhibitors (Aug 5 meeting) moexipril (Univasc), moexipril / HCTZ (Uniretic) perindopril (Aceon) quinapril (Accupril) quinapril / HCTZ (Accuretic) ramipril (Altace) See previous BAP meetings Aug 9 Phosphodiesterase Type 5 Inhibitors (PDE-5 inhibitors) for Erectile Dysfunction Aug 9; May 7 sildenafil (Viagra) tadalafil (Cialis) note: step therapy requiring trial of vardenafil (Levitra) first 14,524 (new users that will hit step) 12,86 2438 6 days (3 Dec 29) Aug 9 Targeted Immunomodulatory Biologics (TIBs) Aug 9 certolizumab (Cimzia) golimumab (Simponi) v 7 etanercept (Enbrel) anakinra (Kineret) See previous meeting below 25 149 37 6 days (3 Dec 29) Page 15 of 17
Meeting Drug Class n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date Step Therapy Aug 9 Alpha-1 blocker BPH Agents Aug 9 silodosin (Rapaflo) v 7 Tamsulosin (Flomax) 695 2 559 134 6 days (3 Dec 29) May 9 Fenofibrate acid (Trilipix) May 9 Antilipidemic II Agents (LIP-2s) Update May 7; 1 st review May 7 fenofibrate nanocrystallized (Tricor) fenofibrate micronized (Antara) omega-3 fatty acids (Omacor) colesevelam (Welchol) 4,37 4 3,128 885 6 days (28 Oct 9) May 9 Overactive Bladder Drugs May 9 Fesoterodine ER (Toviaz) Update Aug 8; 1 st review Feb 6 Tolterodine IR (Detrol) Trospium IR (Sanctura) 12 1 86 15 6 days (28 Oct 9) May 9 Azelastine with Sucralose (Astepro) 6 days (28 Oct 9) May 9 Nasal Allergy Drugs Original Meeting v 8 Beclomethasone (Beconase AQ) Budesonide (Rhinocort AQ) Ciclesonide (Omnaris) Fluticasone Furoate (Veramyst) Triamcinolone (Nasacort AQ) Olopatadine (Patanase) 34,271 44 27,17 6,814 6 (8 Apr 9) May 9 PPIs May 9 Dexlansoprazole delayed release tabs (Kapidex) May 7 Update; Feb 5 1 st review lansoprazole (Prevacid) See previous meeting below 6 days (28 Oct 9) Page 16 of 17
Meeting Drug Class n-formulary Medications Total Beneficiaries Affected (# of patients affected) Beneficiaries Affected by POS MTF Retail Mail Order Implementation Plan First Wednesday X days after the decision date Step Therapy omeprazole/sodium bicarbonate (Zegerid) pantoprazole (Protonix) rabeprazole (Aciphex) May 9 Antiemetics May 9 Granisetron transdermal system (Sancuso) Original Meeting May 6 Dolasetron (Anzemet) 852 14 668 17 6 days (28 Oct 9) 27 Sept 6 (6 days) Feb 9 Inhaled Corticosteroids Beclomethasone HFA MDI (Qvar) Budesonide DPI (Pulmicort Flexhaler) Ciclesonide HFA MDI (Alvesco) Flunisolide CFC MDI (Aerobid) Flunisolide CFC MDI with Menthol (Aerobid M) Triamcinolone CFC MDI (Azmacort) 13,489 3,556 7,831 2,12 12 (1 Sep 9) Feb 9 Long-Acting Beta Agonists Formoterol inhalation solution (Perforomist) 19 2 44 63 12 (1 Sep 9) Feb 9 Inhaled Corticosteroids / Long-Acting Beta Agonist Combinations (no drugs made non-formulary) N/A N/A N/A N/A N/A N/A Page 17 of 17