MTF Quarterly Webcast: Updates and Review of May and August PT Committee Meetings

1. MTF Quarterly Webcast September 13, 2012

2. Greetings from the PEC Purpose of the Quarterly MTF Webcast DCO Ground Rules Type questions into the DCO system Put on mute, not on hold Contingency plan if DCO system stops working 2

3. Review of May 2012 P&T Committee Meeting Overview of August 2012 P&T Committee Meeting Questions 3

4. Angela Allerman PharmD, BCPS Angela Allerman PharmD, BCPS Clinical Pharmacist Clinical Pharmacist

5. Uniform Formulary Class Reviews Smoking Cessation Program Newer Sedative/Hypnotics Drug Class New Drugs in Previously Reviewed Classes Gabapentin enacarbil (Horizant) Gabapentin ER (Gralise) 5

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8. Change in Federal Law (2009 NDAA) allows smoking cessation drugs (Rx and OTC products) at MTF and Mail Order in select beneficiary groups (>18 yrs; non-Medicare eligible) P&T Committee to identify which prescription and OTC products would be included or excluded from the Smoking Cessation Program Final Rule is pending - implementation will occur when Final Rule is publicized

9. Generic Brand (Manufacturer) Strengths & formulations Varenicline tabs (Rx) Chantix (Pfizer) 0.5mg &1mg tabs; 28-day starter pack Bupropion SR tabs (Rx) Zyban (GSK) 150 mg SR tabs Nicotine Nasal Spray (Rx) Nicotrol NS (Pfizer) 100mg/10ml bottle 4 bottles/box Nicotine Inhalation (Rx) Nicotrol (Pfizer) 10mg cartridges (4mg delivered) 168 cartridges + 5 plastic inhalation adapters/box Nicotine Transdermal (OTC) Nicoderm CQ (GSK) 7, 14, 21 mg / patch; One patch / 24 hours 14 patches/box Available in clear formulation Habitrol (Novartis) Nicotine Transdermal (Novartis) 7, 14,21 mg /patch; One patch /24 hours 7 patches/box (Habitrol) 14 patches/box (nicotine transdermal) Nicotine Gum (OTC) Nicorette (GSK) 2mg or 4mg pieces Mint, cinnamon or white ice flavor Nicorelief (Major Pharm) Nicotine gum (Watson/Rugby) Nicotine Lozenge (OTC) Nicorette (GSK) 2mg or 4mg lozenges Mint or cherry flavor

10. Nicotine replacement therapy (NRT), varenicline (Chantix), and bupropion SR, and are efficacious versus placebo for improving long- term smoking abstinence. Combination therapy, especially nicotine patch plus gum, is more efficacious than monotherapy. Varenicline (Chantix) is the most efficacious monotherapy for smoking cessation. Varenicline safety issues include adverse neuropsychiatric effects (behavioral changes, agitation, suicide/suicidal ideation, and depression). Do not use Chantix in patients with a history of pre-existing psychiatric co- morbidities. In patients with pre-existing stable cardiovascular (CV) disease, generally the benefit of abstinence outweighs the increased adverse CV risk with varenicline.

11. Cost-minimization results: NRT: nicotine patch and gum were the least costly Non NRT: bupropion SR was the least costly Cost-effectiveness analyses > 10 cigarettes/day: Combination therapy: (nicotine patch plus gum) most cost-effective treatment for tobacco dependence, offering the greatest improvement in rates of long- term smoking abstinence Monotherapy: varenicline is a cost-effective option when evaluating abstinence rates, but is less cost- effective than combination therapy, with monotherapy

12. MTF Smoking Cessation Programs Local MTFs remain at liberty to design their own smoking cessation program, defining which elements will be included in that program. Quit Attempts Proposed Rule allows for 2 quit attempts, defined as 120-day periods, available annually Maximum allowed is 240 day supply/ rolling 365 day period 3rd attempt in one year allowed with prior authorization o Provider must document that patient will benefit from a 3rd attempt Quantity Limits 60-day supply limit/Rx claim Gum and lozenge o 600 pieces per 60 days/Rx claim rounded to nearest multiple of package size (e.g., boxes of 75 or 100) Deployment CENTCOM: Mod 11varenicline disqualifying/individual consideration

13. BCF UF NF PA and QL Issues Comments Nicotine Products OTC Nicotine Transdermal System 7mg, 14mg, 21mg OTC Nicotine gum 2mg, 4 mg Other FDA-approved Products Bupropion SR 150 mg Covered in the Program (not BCF) Nicotine Nasal Spray (Nicotrol NS) Nicotine Inhalation ( Nicotrol) OTC Nicotine Lozenge Varenicline (Chantix) None Quantity limits apply to Nicotine gum and lozenge 600 pieces/60 days OTC nicotine replacement products can be covered and included on the BCF, but require a prescription 2 quit attempts/120 days allowed; 3 rd quit attempt requires PA

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15. Active Ingredient Brand (Manufacturer) Strengths & Formulation Schedule Patent Expiration Date Zolpidem IR Ambien (generics) 5,10mg tabs C-IV - Zolpidem CR Ambien CR (generics) 6.25 12.5mg ER tabs C-IV - Zolpidem Spray Zolpimist (Novadel) 5mg/spray C-IV 10/01/2017 Zolpidem SL Tab Edluar (Meda Pharma) 5, 10mg SL tabs C-IV 09/24/2019 Zolpidem SL Tab* Intermezzo (Purdue) 1.75, 3.5mg SL tabs C-IV Eszopiclone Lunesta (Sunovion) 1, 2, 3mg tabs C-IV 02/14/2014 Zaleplon Sonata (generics) 5,10mg caps C-IV - Ramelteon Rozerem (Takeda) 8mg tabs - 07/22/2019 Doxepin Silenor (Somaxon) 3,6mg tabs - 2013-2020 * Intermezzo will be reviewed as a new drug at an upcoming meeting; SL: sublingual

16. 16 Sleep onset (latency): improved with all the SED-1s compared to placebo. Sleep maintenance: improved with zolpidem IR, zolpidem CR, eszopiclone, and doxepin. Based on an indirect comparison, there do not appear to be clinically relevant differences between zolpidem CR and eszopiclone in terms of objective sleep measures. Doxepin (Silenor) improves insomnia due to sleep maintenance vs. placebo; no comparative data with other SED-1s. A recently published trial (Kripke, 2012) documented an increased risk of death with insomnia drugs. The interpretation of the results is hampered by several limitations in study design. No further recommendations regarding sedative hypnotic drug prescribing can be made at this time.

17. 17 Zolpidem oral spray (Zolpimist) does not have comparative clinical trials with other SED-1s. FDA approval was granted based on the data originally submitted with Ambien. Zolpimist may pose additional risk for abuse given its dosage form. Use the lowest dose necessary in elderly patients to decrease the risk of ADRs. All the drugs have the potential for abuse except for ramelteon and doxepin; Zolpimist may pose additional risk for abuse. A step therapy/PA requirement has been in effect for the SED-1s class since August 2007, requiring that new SED-1s users try the preferred agent, zolpidem IR, before the other drugs in the class May meeting: zaleplon added as a preferred product

18. BCF UF NF PA and QL Issues Comments Zolpidem IR Zolpidem ER Eszopiclone (Lunesta) Doxepin (Silenor) Zaleplon Rozerem (Ramelteon) Zolpidem SL (Edluar) Step therapy requires trial of zolpidem IR or zaleplon before any other SED-1 Zolpimist not covered

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21. Horizant Gralise Characteristics 600 mg BID Prodrug of gabapentin 3 x 600 mg tabs QD with food (high fat meal) Tablet swells to 3-4 times its size, resulting in gastric retention time of 8-9 hours FDA-Approval date* April 6, 2011 January 28, 2011 FDA Indication Restless Leg Syndrome (RLS) Postherpetic Neuralgia Postherpetic neuralgia (PHN) Off-Label Use Diabetic peripheral neuropathy (DPN) Diabetic peripheral neuropathy (DPN) *FDA approval obtained via 505(b)(2) process using original Neurontin drug application

22. Horizant Post-Herpetic Neuralgia: Placebo comparison studies showed statistically significant improvement with Horizant o No studies with 600mg approved dose as primary endpoint Diabetic Peripheral Neuropathy (off-label use): There was no statistically significant differences in pain control vs. placebo with Horizant Gralise Only 2 of 3 placebo comparison studies for Diabetic Peripheral Neuropathy (off-label) and Post-Herpetic Neuralgia (FDA approved indication) demonstrated a statistically significant improvement in pain intensity scores compared to placebo

23. Both drugs are associated with high incidence of somnolence and fatigue Horizant carries a specific warning for driving impairment Dosing conversion guidelines between Horizant, Gralise, and generic gabapentin are not available and these agents are not interchangeable due to differing pharmacokinetic properties. Gralise requires a large tablet burden to reach recommended dosing. Gabapentin enacarbil (Horizant) and gabapentin (Gralise) offer no distinct clinical advantages to non- opioid pain syndrome agents already on the UF.

24. Drug BCF UF NF Comments Depression and Non-opioid Pain Syndrome Agents/ GABA analog subclass None None gabapentin enacarbil (Horizant) gabapentin ER (Gralise) For step therapy: Horizant and Gralise are NF and non-step- preferred All new users of are required to try gabapentin first

25. Gabapentin enacarbil (Horizant) non-formulary Gabapentin (Gralise) non-formulary Step Therapy Applies to the Non-Opioid Pain Syndrome class Gabapentin: preferred Horizant and Gralise: NF and non-preferred (behind the step) All new users of Horizant or Gralise are required to try gabapentin first

26. Subclasses Prescribed Medication Step 1 Look-Back (180 days) Message to Pharmacy SNRI Cymbalta for Pain Group C drugs (pain) - SNRIs, milnacipran, TCAs, cyclobenzaprine, GABAs (gabapentin, pregabalin) Must try at least one of the following first : SNRIs, milnacipran, TCAs, cyclobenzaprine, gabapentin, or pregabalin GABAs Lyrica Gabapentin Must try gabapentin first GABAs Horizant Gralise Gabapentin Must try gabapentin first SNRI Savella Group C drugs (pain) - SNRIs, milnacipran, TCAs, cyclobenzaprine, GABAs (gabapentin, pregabalin) Must try at least one of the following first : SNRIs, milnacipran, TCAs, cyclobenzaprine, gabapentin, or pregabalin 26

28. Uniform Formulary Class Reviews Testosterone Replacement Therapies (transdermal and buccal formulations) Low Molecular Weight Heparins New Drugs in Previously Reviewed Classes Abatacept SC (Orencia) - RA Famotidine/ibuprofen (Duexis) - RA/OA with high risk of GI ulcer Ketorolac nasal spray (Sprix) - pain Linagliptin/metformin (Jentadueto) DM2 Sitagliptin/metformin ER (Janumet XR ) DM2 Tafluprost ophthalmic solution (Zioptan) - Glaucoma 28

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30. Cost-effective generic formulations now available for Plavix Xalatan ophthalmic solution LMWH (Lovenox and Arixtra) Maximize purchasing of the generic formulations for these medications

31. New PEC Formulary Search Tool http://pec.ha.osd.mil/formulary_search.php?subme nuheader=1 Some technical issues Email questions to PECUF@amedd.army.mil PECUF@amedd.army.mil For other questions, formulary clarification, etc Next webcast will be held on the 14 th of December, 2012 at 0900 and 1700 EST

32. Questions?

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34. 210-295-1271 (DSN 421-1271) For PEC Clinical Staff 1-866-ASK 4 PEC (275-4732) Pharmacy Operation Center PECWEB@amedd.army.mil o Website issues pdts.ameddcs@amedd.army.mil o Questions, assistance with PDTS, Business Objects PECUF@amedd.army.mil o Clinical, formulary questions