Newer Anticoagulants and Newer Diabetic Drug Classes. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013

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1 Newer Anticoagulants and Newer Diabetic Drug Classes Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013

2 Apixaban Newer Anticoagulants Dabigatran etexilate Rivaroxaban 2

3 February 2013 P & T Motion After considering the evidence of safety, efficacy and special populations for newer anticoagulant drugs for the prevention of stroke or systemic embolism in patients who are medically ill, undergoing surgery or with nonvalvular atrial fibrillation, I move that apixaban, dabigatran, and rivaroxaban are safe and efficacious for their approved indications. Apixaban, dabigatran, and rivaroxaban cannot be subject to therapeutic interchange in the Washington preferred drug list. 3

4 Criteria FDA approved indications and dosing Initial criteria includes trial of warfarin or reason given why unable to use warfarin (includes patient or provider refusal). This was added due to new products on market without long term safety, and ability to reverse anticoagulant effect if needed. 4

5 Eliquis (apixaban) Indication: Non-valvular atrial fibrillation, to reduce the risk of stroke and systemic embolism Dosing: 5 mg BID 2.5mg BID if at least 2 of the following: age 80 years, body weight 60kg, or serum creatinine 1.5 mg/dl 5

6 Pradaxa (dabigatran etexilate) Indication: Non-valvular atrial fibrillation, to reduce the risk of stroke and systemic embolism Dosing: 150mg BID if creatinine clearance (CrCl) >30 ml/min 75mg BID if CrCl ml/min 6

7 Indications: Xarelto (rivaroxaban) Non-valvular atrial fibrillation, to reduce the risk of stroke and systemic embolism Treatment of deep vein thrombosis (DVT) Treatment of pulmonary embolism (PE) Reduction in the risk of recurrence of DVT and PE after initial 6 months treatment for DVT and/or PE prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery 7

8 Xarelto (rivaroxaban) continued Dosing: A-fib: CrCl >50 ml/min: 20mg QD CrCl 15 to 50 ml/min: 15mg QD Treatment DVT and PE: 15mg BID x 21 days, then 20mg QD Reduction in risk of recurrence of DVT/PE: 20mg QD Hip replacement: 10mg QD x 35 days Knee replacement: 10mg QD x 12 days 8

9 Medicaid experience with PA For all newer anticoagulants there are requests for off-label use, including valvular a-fib. For all newer anticoagulants there are requests for incorrect dosing. Pradaxa approved first & have limited to non-valvular a-fib. Have received requests for valvular a-fib. 9

10 continued Pradaxa FDA warning issued not to use in patients with mechanical prosthetic heart valves due to increased risk of strokes, heart attacks, and blood clots forming on the mechanical heart valves than users of the anticoagulant warfarin. The use of Pradaxa valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended. 10

11 Questions? Clinical questions specific to Newer Anticoagulants? 11

12 Amylin agonist Pramlintide Newer Diabetes Drugs DPP-4 inhibitor Linagliptin Saxagliptin Sitagliptin GPI-1 agonist Exenatide Liraglutide 12

13 February 2013 P & T Committee Amylin Agonist Motion After considering the evidence of safety, efficacy and special populations for the treatment of Diabetes I move that the Amylin Agonist pramlintide is safe and efficacious. Amylin Agonist cannot be subject to therapeutic interchange in the Washington preferred drug list. 13

14 February 2013 P & T Committee DPP-4 Motion After considering the evidence of safety, efficacy and special populations for the treatment of Diabetes I move that DPP-4 inhibitors linagliptin, saxagliptin, and sitagliptin are safe and efficacious. DPP-4 inhibitors can be subject to therapeutic interchange in the Washington preferred drug list. 14

15 February 2013 P & T Committee GPI-1 Motion After considering the evidence of safety, efficacy and special populations for the treatment of Diabetes I move that GLP-1 Agonists exenatide, and liraglutide are safe and efficacious. GLP-1 Agonist can be subject to therapeutic interchange in the Washington preferred drug list. 15

16 Criteria FDA approved indications and dosing Trial of metformin or reason why can not use metformin (preferred initial therapy if tolerated & not contraindicated in the American Diabetes Association (ADA) guidelines and the American Association of Clinical Endocrinologist (AACE)/American College of Endocrinology (ACE) treatment algorithm) Safety criteria or contraindications specific to the drug 16

17 Symlin (pramlintide) Diabetes type 1 or type 2 Indicated as an adjunct treatment with prandial insulin Maximum dose 180 mcg/day for type 1; Maximum dose 360 mcg/day for type 2 Contraindications: Gastroparesis Poor awareness of hypoglycemia 17

18 Symlin (pramlintide) continued Should NOT be considered for Symlin therapy: poor compliance with insulin regimen or blood glucose monitoring HbA2c >9% recurrent severe hypoglycemia requiring assistance in the past 6 months require use of drugs to stimulant gastrointestinal motility hypoglycemia unawareness gastroparesis 18

19 Tradjenta (linagliptin) Diabetes type 2 Tried metformin or reason for not using metformin Maximum dose 5mg once a day 19

20 Onglyza (saxagliptin) Diabetes type 2 Tried metformin or reason for not using metformin Maximum dose 5mg once a day for CrCl >50 ml/min 2.5mg once a day for CrCl 50 ml/min including hemodialysis 20

21 Januvia (sitagliptin) Diabetes type 2 Tried metformin or reason for not using metformin Maximum dose 100mg once a day for CrCl 50 ml/min 50mg once a day for CrCl 30 to < 50 ml/min 25mg once a day for CrCl < 30 ml/min 21

22 Diabetes type 2 Byetta (exenatide) Tried metformin or reason for not using metformin Maximum dose 10 mcg twice a day Not recommended to use: with prandial insulin history of pancreatitis severe renal impairment (CrCl < 30 ml/min) gastroparesis 22

23 Bydureon (exenatide ER) Diabetes type 2 Tried metformin or reason for not using metformin Maximum dose 2mg every 7 days Contraindicated: Personal or family history of medullary thyroid carcinoma (MTC)or multiple endocrine neoplasia (MEN 2) 23

24 Bydureon (exenatide ER) cont. Not recommended to use: with insulin history of pancreatitis severe renal impairment (CrCl < 30 ml/min) gastroparesis 24

25 Diabetes type 2 Victoza (liraglutide) Tried metformin or reason for not using metformin Maximum dose1.8mg per day Contraindicated: Personal or family history of MTC or MEN 2 Not recommended to use: with prandial insulin History of pancreatitis 25

26 Medicaid experience with PA Dosing not adjusted for renal disease Use with insulin when not recommended (most are now ok to use with insulin) Use in patients not recommended for use (gastroparesis, pancreatitis) 26

27 Questions? Clinical questions specific to Newer Anticoagulants? 27

28 Source of Criteria Current criteria in these drug classes was established through HCA s internal Drug Evaluation Matrix Committee, prior to selection as PDL classes Not previously brought to the DUR Board under Authorization program because criteria are specific to FDA labeling and use of less costly alternatives 28

29 DUR Board review As per earlier presentation: Use of generic(s) as first line agents for PDL classes explicitly requires review under RCW (unlike authorization program) Limiting product selection / endorser DAW according to FDA labeled indications requires review under RCW 29

30 Agency Recommendations Newer Anticoagulants - Approve requirement to use warfarin first line, with lenient exceptions including preference, convenience, or compliance factors - Approve requirement for use within FDA labeling - Eliminate DAW, requiring clinical justification by prescriber for selection of non-preferred product 30

31 Agency Recommendations Newer Diabetics - Approve requirement to use metformin first line, or clinical justification of why metformin would be inappropriate for client - Approve requirement for use within FDA labeling - Allow DAW, endorsers could select from preferred or nonpreferred products as long as use was within FDA labeling 31

32 Stakeholder Input Newer Anticoagulants Newer Diabetic Drugs 32

33 Motion: Newer Anticoagulants Require warfarin first line? Limit use to FDA labeling, including dosing requirements? Remove DAW privilege? Modifications to criteria by DUR Board? 33

34 Motion: Newer Diabetic Require metformin first line? Limit use to FDA labeling, including dosing requirements? Remove DAW privilege? Modifications to criteria by DUR Board? 34

35 Questions? More Information: or Nicole N. Nguyen PharmD, Senior Clinical Pharmacist Health Care Services Tel: