Therapeutics Committee

The AHCCCS Pharmacy and Therapeutics Committee met on August 16, 2016, to review and vote on various operational policies and upcoming meeting dates. Changes in meeting dates for 2016 and 2017 were discussed, along with protocols for pharmaceutical testimonies and public comments. The committee also reviewed different drug classes, including antipsychotics, stimulants, anticoagulants, pancreatic enzymes, and new products like Taltz and Epclusa. For more details, refer to the images shared in the content.

• AHCCCS
• Pharmacy
• Therapeutics Committee
• Meeting Summary
• Drug Classes

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1. AHCCCS Pharmacy and Therapeutics Committee August 16, 2016

2. 5-17-16 Minutes Review and vote Reaching across Arizona to provide comprehensive quality health care for those in need 2

3. P&T Meeting Date Changes 2016 Next Meeting Date: o Wednesday, October 19, 2016 2017 Meeting Dates: o Monday, January 16, 2017 o Thursday, April 13, 2017 o Tuesday, July 18, 2017 o Thursday, October 12, 2017 Reaching across Arizona to provide comprehensive quality health care for those in need 3

4. P&T Operational Policy Review and vote Reaching across Arizona to provide comprehensive quality health care for those in need 4

5. P&T Operational Policy: Pharma Testimony Not accepted: o Online publications o Poster presentations o Placebo-controlled, observational, open- label and non- randomized studies o Anecdotal reports Register to present at least 30 days prior to P&T Information presented is restricted to randomized double blinded active control studies and published or accepted for publication in peer reviewed journal(s) Limited to 3 minutes per drug per class and 1 representative per drug. Reaching across Arizona to provide comprehensive quality health care for those in need 5

6. P&T Operational Policy: In-Person Public Comment Protocol Register to present at least 14 days prior to P&T meeting. First-come, first serve and limited to 15 total in-person public testimonies. Presenters may not be employed by, speak on behalf of or represent a pharmaceutical manufacturer. Limited to 3 minutes per drug. Reaching across Arizona to provide comprehensive quality health care for those in need 6

7. Magellan Class Reviews Classes Antipsychotics (Atypical, long-acting injectables) Stimulants and Related Agents Anticoagulants Pancreatic Enzymes New Products (to Magellan PDL classes) Taltz (Cytokine and CAM Antagonists) Epclusa (Hepatitis C Agents) Reaching across Arizona to provide comprehensive quality health care for those in need 7

8. Antipsychotics Reaching across Arizona to provide comprehensive quality health care for those in need 8

9. Antipsychotics Oral Agents Abilify (aripiprazole) Saphris (asenapine) Rexulti (brexpiprazole) Vraylar (cariprazine) Clozaril (cariprazine) Fazaclo (clozapine) Versacloz (clozapine) Seroquel (quetiapine) Seroquel XR (quetiapine XR) Risperdal (risperidone) Geodon (ziprasidone) Fanapt (iloperidone) Latuda (lurasidone) Zyprexa (olanzapine) Symbyax (olanzapine/fluoxetine) Invega (paliperidone ER) Nuplazid (pimavanserin) Reaching across Arizona to provide comprehensive quality health care for those in need 9

10. Antipsychotics Injectable Agents (Long-Acting) Abilify Maintena (aripiprazole ER), monthly Aristada (aripiprazole lauroxil ER), monthly or 6 weeks Risperdal Consta (risperidone microspheres), 2 weeks Zyprexa Relprevv (olanzapine), 2-4 weeks Invega Sustenna (paliperidone palmitate), monthly Invega Trinza (paliperidone palmitate), 3 months Reaching across Arizona to provide comprehensive quality health care for those in need 10

11. Antipsychotics Class Overview - Product indications include*: Schizophrenia, Bipolar disorder, major depressive order, schizoaffective disorder, irritability associated with autism, Tourette s disorder, Parkinson's disease psychosis *Not inclusive of all product indications, all products differ in indication Reaching across Arizona to provide comprehensive quality health care for those in need 11

12. Antipsychotics New Product in Class: Vraylar (cariprazine) Treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder Black box warning for increased mortality in elderly patients with dementia-related psychosis Warnings include neuroleptic malignant syndrome, tardive dyskinesia, late-occurring adverse reactions (due to long half- life), metabolic changes, and orthostatic hypotension Dose should be halved when given concurrently with strong CYP3A4 inhibitors use with CYP3A4 inducers is not recommended Reaching across Arizona to provide comprehensive quality health care for those in need 12

13. Antipsychotics New Product in Class: Vraylar (cariprazine) continued Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness are the most common adverse effects Has not been adequately studied in pregnant women Given once daily, available in 1.5, 3, 4.5, and 6 mg capsules Reaching across Arizona to provide comprehensive quality health care for those in need 13

14. Antipsychotics New Product in Class: Nuplazid (pimavanserin) Treatment of hallucinations and delusions associated with Parkinson s disease psychosis Black box warning for increased mortality in elderly patients with dementia-related psychosis Warnings include QT interval prolongation Dose should be decreased by one half when given concurrently with strong CYP3A4 inhibitors; may need to be increased when given with strong CYP3A4 inducers Reaching across Arizona to provide comprehensive quality health care for those in need 14

15. Antipsychotics New Product in Class: Nuplazid (pimavanserin) continued Peripheral edema and confused state are the most common adverse effects There are no data with Nuplazid in pregnant women to inform a drug-associated risk Given once daily, available in 17 mg tablets Reaching across Arizona to provide comprehensive quality health care for those in need 15

16. Antipsychotics Product/Guideline Updates: Invega ,Orap and Abilify Discmelt are now available as a generics (September/October 2015) The American Psychiatric Association practice guidelines on the use of antipsychotics to treat agitation or psychosis in patients with dementia does not provide specific drug recommendations, but mentions risperidone and aripiprazole as effective. Risperidone and olanzapine are addressed as having potential drawbacks in terms of adverse effects. (May 2016) Reaching across Arizona to provide comprehensive quality health care for those in need 16

17. Antipsychotics Product/Guideline Updates: The FDA reported that DRESS (drug reaction with eosinophilia and systemic symptoms) will be added to olanzapine labeling (all formulations) as a warning. (May 2016) Reaching across Arizona to provide comprehensive quality health care for those in need 17

18. Stimulants and Related Agents Reaching across Arizona to provide comprehensive quality health care for those in need 18

19. Stimulants and Related Agents Class Overview: Immediate Release Products Amphetamine sulfate (Evekeo) Dexmethylphenidate IR (Focalin) Dextroamphetamine IR (Zenzedi) Dextroamphetamine solution (ProCentra) Methamphetamine (Desoxyn) Methylphenidate IR (Methylin, Ritalin) Mixed amphetamine salts IR (Adderall) Reaching across Arizona to provide comprehensive quality health care for those in need 19

20. Stimulants and Related Agents Class Overview: Extended Release Products Amphetamine ER (Adzenys XR-ODT, Dyanavel XR) Dexmethylphenidate ER (Focalin XR) Dextroamphetamine ER (Dexedrine) Lisdexamfetamine dimesylate (Vyvanse) Methylphenidate ER OROS (Concerta) Methylphenidate SR (Metadate ER) Reaching across Arizona to provide comprehensive quality health care for those in need 20

21. Stimulants and Related Agents Class Overview: Extended Release Products continued Methylphenidate ER (Metadate CD, Quillichew ER, Quillivant XR, Ritalin LA, Aptensio XR) Methylphenidate transdermal (Daytrana) Mixed amphetamine salts ER (Adderall XR) Reaching across Arizona to provide comprehensive quality health care for those in need 21

22. Stimulants and Related Agents Class Overview: Non stimulants Atomoxetine (Strattera) Clonidine ER (Kapvay) Guanfacine ER (Intuniv) Reaching across Arizona to provide comprehensive quality health care for those in need 22

23. Stimulants and Related Agents Class Overview: Product Indications ADHD (attention deficit hyperactivity disorder), narcolepsy Other: exogenous obesity, binge eating disorder Reaching across Arizona to provide comprehensive quality health care for those in need 23

24. Stimulants and Related Agents New Product in Class: Aptensio XR (methylphenidate) Treatment ADHD in patients six years and older Contraindications, warnings, adverse effects, and drug interactions are similar to those for other controlled-release methylphenidate capsules Given once daily in the morning and comes in 10, 15, 20, 30, 40, 50, and 60 mg extended-release capsules Reaching across Arizona to provide comprehensive quality health care for those in need 24

25. Stimulants and Related Agents New Product in Class: Adzenys XR ODT (amphetamine) Treatment of ADHD in patients six years and older Contraindicated with coadministration of MAO inhibitors Black box warning for high potential for abuse and dependence Warnings include serious cardiovascular events, serious psychiatric events, long-term growth suppression, increased blood pressure and heart rate, and peripheral vasculopathy Drug interactions include acidifying agents and alkalinizing agents, which can alter blood levels of amphetamine Reaching across Arizona to provide comprehensive quality health care for those in need 25

26. Stimulants and Related Agents New Product in Class: Adzenys XR ODT (amphetamine) Loss of appetite, dry mouth, abdominal pain, and insomnia are among reported adverse effects It is in pregnancy category C Given once daily in the morning It is available as a extended-release orally disintegrating tablet in six different strengths (orange flavor) Reaching across Arizona to provide comprehensive quality health care for those in need 26

27. Anticoagulants Reaching across Arizona to provide comprehensive quality health care for those in need 27

28. Anticoagulants Class Overview Injectable Agents Oral Agents Eliquis (apixaban) Fragmin (dalteparin) Pradaxa (dabigatran) Lovenox (enoxaparin) Savaysa (edoxaban) Arixtra (fondaparinux) Xarelto (rivaroxaban) Coumadin (warfarin) Reaching across Arizona to provide comprehensive quality health care for those in need 28

29. Anticoagulants Class Overview - Product indications include*: DVT and PE prophylaxis and treatment Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction Treatment of acute ST-segment elevation myocardial infarction managed medically or with subsequent percutaneous coronary intervention To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation *Not inclusive of all product indications, all products differ in indication Reaching across Arizona to provide comprehensive quality health care for those in need 29

30. Anticoagulants Class Overview (Product indications include)*: Prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement Reduce the risk of death, recurrent myocardial infarction, and thromboembolic events, such as stroke or systemic embolization after myocardial infarction *Not inclusive of all product indications, all products differ in indication Reaching across Arizona to provide comprehensive quality health care for those in need 30

31. Anticoagulants Product/Guideline Updates: Praxbind, an intravenous reversal agent for Pradaxa, is now available (October 2015) Pradaxa is now indicated for prophylaxis of DVT/PE in patients who have undergone hip replacement surgery, along with a new 110 mg strength for dosing convenience (December 2015) Select portions of the American College of Chest Physicians guidelines were updated in 2016 to include Savaysa as a treatment option along with other oral anticoagulants (DVT/PE treatment) (March 2016) Reaching across Arizona to provide comprehensive quality health care for those in need 31

32. Pancreatic Enzymes Reaching across Arizona to provide comprehensive quality health care for those in need 32

33. Pancreatic Enzymes Class Overview: Products Zenpep Creon Viokace Pancreaze Pertzye Ultresa Reaching across Arizona to provide comprehensive quality health care for those in need 33

34. Pancreatic Enzymes Class Overview: Product Indications Pancreaze, Pertzye, Ultresa, and Zenpep are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions in both adults and children Creon is indicated for these conditions, as well as exocrine pancreatic insufficiency due to chronic pancreatitis and pancreatectomy Other conditions that may result in exocrine pancreatic insufficiency include ductal obstruction from a neoplasm and gastrointestinal bypass surgery Reaching across Arizona to provide comprehensive quality health care for those in need 34

35. Pancreatic Enzymes Class Overview: Product Indications Viokace is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in combination with a proton pump inhibitor in adults only Reaching across Arizona to provide comprehensive quality health care for those in need 35

36. New Products (to Magellan PDL classes) Reaching across Arizona to provide comprehensive quality health care for those in need 36

37. Taltz (ixekizumab) Humanized IgG4 monoclonal antibody that inhibits the interleukin-17A (IL-17A) cytokine Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Warnings include serious infections, tuberculosis, and exacerbations of inflammatory bowel diseases Live vaccines should not be administered with Taltz Injection site reactions, upper respiratory tract infections, nausea, and tinea infections are the most common adverse effects Reaching across Arizona to provide comprehensive quality health care for those in need 37

38. Taltz (ixekizumab) There are no data in pregnant women to inform a drug- associated risk Given as two 80 mg subcutaneous injections at weeks 0 followed by one 80 mg injection at weeks 2, 4, 6, 8, 10, and 12, then one 80 mg injection every four weeks It is available as a 80 mg/mL solution for injection in a prefilled autoinjector or syringe Reaching across Arizona to provide comprehensive quality health care for those in need 38

39. Taltz (ixekizumab) Three multicenter, randomized, double-blind, placebo- controlled trials - total of 3,866 adult patients with plaque psoriasis o Two studies included an active comparator arm in which subjects were also randomized to etanercept 50 mg twice weekly for 12 weeks o Trials evaluated the changes from baseline to Week 12 in 2 co- primary endpoints: 1) PASI 75 and 2) sPGA of 0 (clear) or 1 (minimal) o Patients treated with Taltz experienced greater improvement in both primary endpoints than etanercept, as well as statistically significant improvements in itch severity when compared to etanercept at week 12 Reaching across Arizona to provide comprehensive quality health care for those in need 39

40. Taltz (ixekizumab) Taltz is the second approved IL-17A inhibitor o Secukinumab (Cosentyx) is approved for plaque psoriasis as well as psoriatic arthritis and ankylosing spondylitis Taltz joins a list of several other biologics indicated for the treatment of psoriasis Reaching across Arizona to provide comprehensive quality health care for those in need 40

41. Epclusa (sofosbuvir/velpatasvir) Indicated for the treatment of chronic hepatitis C (all genotypes) in adults, with or without cirrhosis Warnings include bradycardia with amiodarone co- administration If given with ribavirin, contraindications and warnings for that drug also apply Drug interactions occur with P-gp inducers and moderate- to-potent CYP inducers; use of Epclusa with these products is not recommended Reaching across Arizona to provide comprehensive quality health care for those in need 41

42. Epclusa (sofosbuvir/velpatasvir) Fatigue and headache are the most common adverse effects There are no data available in pregnant women to inform a drug-associated risk Epclusa is given once daily for 12 weeks in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) and 12 weeks with ribavirin in patients with decompensated cirrhosis (Child-Pugh B, C) It is available as sofosbuvir 400 mg and velpatasvir 100 mg combination tablets Reaching across Arizona to provide comprehensive quality health care for those in need 42

43. Epclusa (sofosbuvir/velpatasvir) The efficacy and safety of Epclusa in patients with chronic HCV infection were evaluated in 4 randomized, multicenter, phase 3 trials: the ASTRAL trials o Primary outcome of sustained virologic response at 12 weeks after the end of treatment (SVR12) o Epclusa and resulted in treatment success rates of over 95% in all trials Reaching across Arizona to provide comprehensive quality health care for those in need 43

44. AASLD/IDSA Guideline Recommendations* Genotype 1a and 1b Zepatier for 12 weeks (compensated cirrhosis) Harvoni for 12 weeks (compensated cirrhosis) o Harvoni + ribavirin for 12 weeks (decompensated cirrhosis) Epclusa for 12 weeks (compensated cirrhosis) o Epclusa + ribavirin for 12 weeks (decompensated cirrhosis) Daklinza + Sovaldi for 12 weeks o Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis) Viekira + ribavirin for 12 weeks (1a) o Viekira for 12 weeks (compensated cirrhosis) (1b) Sovaldi + Olysio for 12 weeks *Treatment Na ve (not including alternative therapies), July 2016 Reaching across Arizona to provide comprehensive quality health care for those in need 44

45. AASLD/IDSA Guideline Recommendations* Genotype 2 Epclusa for 12 weeks (compensated cirrhosis) Epclusa + ribavirin for 12 weeks (decompensated cirrhosis) Daklinza + Sovaldi + ribavirin for 12 weeks for decompensated cirrhosis Genotype 3 Epclusa for 12 weeks (compensated cirrhosis) o Epclusa + ribavirin for 12 weeks (decompensated cirrhosis) Daklinza + Sovaldi for 12 weeks (for 24 weeks with or without ribavirin for compensated cirrhosis) o Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis) *Treatment Na ve (not including alternative therapies), July 2016 Reaching across Arizona to provide comprehensive quality health care for those in need 45

46. AASLD/IDSA Guideline Recommendations* Genotype 4 Zepatier for 12 weeks (compensated cirrhosis) Harvoni for 12 weeks (compensated cirrhosis) Harvoni + ribavirin for 12 weeks (decompensated cirrhosis) Epclusa for 12 weeks (compensated cirrhosis) Epclusa + ribavirin for 12 weeks (decompensated cirrhosis) Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis) Technivie + ribavirin for 12 weeks (compensated cirrhosis) *Treatment Na ve (not including alternative therapies), July 2016 Reaching across Arizona to provide comprehensive quality health care for those in need 46

47. AASLD/IDSA Guideline Recommendations* Genotype 5/6 (with or without cirrhosis) Harvoni for 12 weeks Epclusa for 12 weeks *Treatment Na ve (not including alternative therapies), July 2016 Reaching across Arizona to provide comprehensive quality health care for those in need 47

48. BH Drug List Sara Salek Reaching across Arizona to provide comprehensive quality health care for those in need 48

49. New Drug Reviews Sarah Martinez, PharmD Provider Synergies Reaching across Arizona to provide comprehensive quality health care for those in need 49

50. NEW DRUG REVIEWS Cabometyx - Cabozantinib Descovy Emtricitabine &Tenofovir Alafenamide Fumarate Odefsey - Emtricitabine, Rilpivirine, & Tenofovir Alafenamide Fumarate Veltassa - Patiromer Sorbitex Calcium Venclexta - Venetoclax Reaching across Arizona to provide comprehensive quality health care for those in need 50

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