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Michigan Pharmacy and Therapeutics Committee September 9, 2014 at 6:00 PM Kellogg Center, East Lansing, Michigan

Agenda: • Introductions • Approval of Minutes of July 8, 2014 Meeting • P & T Business • Review of the New Drugs with monographs:

1. Velphoro (sucroferric oxyhydroxide) chewable tablets –phosphate binder indicated for lowering phosphate levels in patients with chronic disease on dialysis. [PDL class- Electrolyte Depleters. Non-prefer.] ( PDL page 17)

2. Zohydro ER (hydrocodone bitartrate) capsule –. C-II indicated for severe pain requiring around-the-clock management [PDL class – narcotic . Non-prefer.] (PDL page 1)

3. Luzu 1% (luliconazole) cream –indicated for treatment of interdigital tinea pedis, tinea cruruis and tinea corporis. [PDL class-Topcial Antifungals. Non-prefer.] ( PDL page 3)

4. Anoro Ellipta (/) inhaler – Once daily inhaler for COPD (only). [PDL class- COPD Agents – Non-prefer.] (PDL page 5)

5. Hetlioz (tasimelteon) capsule – indicated for non-24-hour sleep-wake disorder. [ PDL class – Sedative/Hypnotics. Non-prefer.] (PDL page 13)

6. Xartemis XR (oxycodone/acetaminophen) capsules – indicated for acute pain severe enough to require opiod treatment and for which alternative treatment options are inadequate. [PDL Class – Narcotic analgesics. Non-prefer.] (PDL page 1)

7. Orenitram ER (treprostinil diolamine) tablet – indicated for pulmonary arterial WHO Group 1 to improve exercise capacity. [Not a PDL class.]

8. Otezla (apremilast) tablet –indicated for the treatment of adults with active psoriatic arthritis. [PDL Class – Biologic Immunomodulators. Non-prefer.] (PDL page 17)

Recommendation of workgroup to add to criteria for approval for both Otezla and Xeljanz : the request come from, or documentation of consultation with, a rheumatologist.

• Line Extensions: None

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• Review of the Gastrointestinal Drug Class (PDL Page 15):

1. Nausea Agents: Oral a. Make Sancuso non-preferred.

2. Substance P Receptor Agonist a. Make Emend packs (only, not tablets) non-preferred.

3. Pancreatic Enzymes a. Make all products except generic pancrealipase non-preferred.

4. Progestins for Cachexia a. No changes

5. Proton Pump Inhibitors a. Add Nexium OTC to posted PDL as preferred.

6. Ulcerative Colitis a. No changes.

• Review of the Diabetes Drug Class ( PDL List pages 13-15):

1. Amylin Analogs: a. No changes

2. Incretin Mimetics a. No changes.

3. Insulin, Basal a. No changes

4. Insulin, Rapid Acting a. No changes

5. Insulin, Mixes a. No changes.

6. Insulin, Traditional a. No changes

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• Diabetes continued:

7. Oral Hypoglycemics – Alpha Glucosidase Inhibitors a. No changes

8. Oral Hyoglycemics – Biguanides

a. Make Metformin ER (generic for Fortamet) non-preferred. Keep Metformin ER – Glucophage XR generic version - as preferred.

9. Oral Hypoglycemics - Combinations a. Make Duetact non-preferred.

b. Make pioglitazone/metformin non-preferred

c. Make Prandimet non-preferred.

10. Oral Hypoglycemics – Dopamine Receptor Agonits a. No changes

11. Oral Hypoglycemics – DPP4 Inhibitors a. Drugs in this class are clinically equivalent. Department may choose preferred drug based on price.

12. Oral Hypoglycemics - Meglitinides a. Make repaglinide generic preferred.

13. Oral Hypoglycemics – 2nd Generation a. No changes

14. Oral Hypoglycemics – SGLT2 Inhibitors a. Make Farxiga preferred. i. Note: this class already has a step edit that requires a metformin containing product in the claims history in order for the claim to pay without Prior Authorization

15. Oral Hypoglycemics - Thiazolidineiones a. No changes

• Miscellaneous Drug Class (PDL Pages 17 – 19):

• Anticoagulants a. No changes

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Miscellaneous Drug Class continued:

• Biologic Immunomodulators a. No changes

b. Make new drug Otezla non-preferred. Add requirement to both Otezla and Xeljanz : request from, or documentation of consultation with, a rheumatologist.

• BPH Agents a. Add Cardura and generic to PDL. b. Make Cardura and Cardura XL non-preferred.

• Combination Benzoyl Peroxide/Clindamycin a. Make generic clindamycin/benzoyl peroxide products (both) non-preferred

• Electrolyte Depleters a. Make Renvela powder non-preferred.

b. Make sevelamer capsules non-preferred.

• Fibromyalgia Agents a. Add duloxetine generic to posted PDL as preferred.

• Growth Hormones a. Make Genotropin products non-preferred.

• Hematopoietic Agents a. No changes

• Osteoporosis Agents: Bisphosphonates a. Make alendronate oral solution non-preferred.

• Osteoporosis Agents: Other a. No changes

• Osteoporosis Agents: SERMS a. Add generic raloxifene as preferred.

b. Make Evista brand non-preferred.

• Platelet Aggregation Inhibitors a. No changes

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• Skeletal Muscle Relaxants a. Make methocarbamol non-preferred. Ask the DUR Board to look at prolonged and/or repeated use of drugs in this class. Committee suggests consideration of a future limit to a 30 day supply no more than 3 times in 12 months.

• Topical Immunomodulators a. Make Protopic non-preferred.

• Urinary Tract Antispasmodics a. No changes

• Topical : Low potency (New PDL Class) Recommend future reviews in December. a. Add as preferred: i. acetate cream and ointment ii. Hydrocortisone cream, gel, lotion, solution and ointment iii. Aclometasone dipropionate ointment and cream b. Add as non-preferred: i. Hydrocortisone-aloe ointment and gel ii. Neosporin iii. Salpicin iv. Hydrocortiosn/mineral oil/petrolatum ointment v. Verdeso vi. Texacort vii. /urea viii. Capex shampoo ix. ointment, cream and lotion x. Desonate gel xi. Derma-smooth-FS xii. 0.01% oil xiii. Desowen lotion xiv. Aqua glycolic HC xv. Pediaderm TA

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• Topical Steroids: Medium potency (New PDL Class) a. Add as preferred: i. furoate ointment, cream and solution ii. ceam, ointment and solution iii. propionate cream and ointment b. Add as non-preferred: i. Dermatop cream and ointment ii. Pandel iii. Elocon ointment, cream and solution iv. Curivate cream and lotion v. Luxiq vi. Colderm vii. Synalar solution, cream and ointment viii. Flucinolone acetonide cream, lotion and solution ix. Synalar TS kit x. ointment xi. cream and ointment xii. Locid lipocream xiii. Momexin xiv. Cordran tape xv. foam

• Topical Steroids: High potency (New PDL Class) a. Add as preferred: i. acetonide cream, ointment and lotion ii. cream, ointment and gel iii. Betamethasone valerate ointment and cream b. Add as non-preferred: i. Betamethasone dipropionate/propylene glycol cream, lotion and ointment ii. Diprolene AF cream and ointment iii. Fluocinonide emollient and solution iv. Betamethasone valerate lotion v. Bethamethasone dipropionate cream, gel and ointment vi. Halog ointment and cream vii. Vanos viii. cream and gel ix. Kenalog aerosol x. Diprolene ointment xi. Trianex ointment xii. diacetate cream and ointment xiii. Topicort cream, spray and ointment xiv. lotion and ointment

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19 Topical Steroids: Very High potency (New PDL Class) a. Add as preferred: i. propionate solution, cream, ointment and gel ii. Halobetasol propionate ointment and cream b. Add as non-preferred: i. Clobex lotion, spray and shampoo ii. Clobetasol emollient and lotion iii. Temovate ointment iv. Clobex shampoo v. Olux vi. Ultravate X PAC cream and ointment vii. Halonate viii. Olux-E ix. Apexicon E x. foam

20. Public Comments:

• Ndidi Yaucher, Pharm.D., MBA: Novartis Pharmaceuticals, Gilenya

• George Anderson, Ph.D., Astra Zeneca, Symbicort

• Kirsty Kerin, Ph.D., Vanda Pharmaceuticals, Hetlioz

• Jay Mehta, Pharm.D., Biogen, Plegridy

Next Meeting: Tuesday, December 9, 2014

Next Drug Categories: Analgesics & CNS

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