Anti-Coagulation in a Healthcare System that Cannot Afford Direct Oral Anticoagulants for Everyone

Transcription

1 Anti-Coagulation in a Healthcare System that Cannot Afford Direct Oral Anticoagulants for Everyone Doreen Tan Cardiology Specialist Pharmacist

2 Navigation Map Atrial Fibrillation What s the fuss? The Evidence for anticoagulation in SPAF Safety & Efficacy of DOACs vs Warfarin in Asians If I were the Min of Health, who would I fund?

3 All About Atrial Fibrillation 1. Yap KB et al. Journal of Electrocardiology 41 (2008) Department of Statistics, Singapore: Accessed 6 Aug National Institute for Health and Care Excellence. Support for commissioning: anticoagulation therapy. May Available at: Last accessed November Lin, H.J., Wolf, P.A., Kelly-Hayes, M. et al. Stroke severity in atrial fibrillation: the Framingham Study. Stroke. 1996;27: NHS Improvement. Heart and stroke improvement: commissioning for stroke prevention in primary care the role of atrial fibrillation Available at: commissioning_guide.pdf Last accessed November 2015.

4 Stroke Prevention 4 th leading COD (SG 2015) out of 10 Strokes have AF (SG NDR, ) 2 Asian AF greater risk of Stroke 3 Aspirin is useless for SPAF 4 Stroke: A fate worse than death Accessed 2 Apr Stroke Registry Report National Registry of Diseases Office (NRDO). Date May Oral anticoagulants for Asian patients with atrial fibrillation. Sabir, I. et al. Nat. Rev. Cardiol. 11, (2014) 4. Lipi et al. A tailored treatment strategy: a modern approach for stroke prevention in patients with atrial fibrillation. J Int Med doi: /joim LaHaye et al. Evaluation of patients' attitudes towards stroke prevention and bleeding risk in atrial fibrillation. Thromb Haemostasis 2013; 111 (3) :

5 Stroke Prevention 4 th leading COD (SG 2015) out of 10 Strokes have AF (SG NDR, ) 2 Asian AF greater risk of Stroke 3 Aspirin is useless for SPAF Accessed 2 Apr 2017 Stroke: A fate worse than death 5 2. Stroke Registry Report National Registry of Diseases Office (NRDO). Date May Oral anticoagulants for Asian patients with atrial fibrillation. Sabir, I. et al. Nat. Rev. Cardiol. 11, (2014) 4. Lipi et al. A tailored treatment strategy: a modern approach for stroke prevention in patients with atrial fibrillation. J Int Med doi: /joim LaHaye et al. Evaluation of patients' attitudes towards stroke prevention and bleeding risk in atrial fibrillation. Thromb Haemostasis 2013; 111 (3) : Ng et al. Direct medical cost of stroke in Singapore. Int J Stroke 2015; 10:75-82

6 Total number of strokes Number of ischaemic strokes Approximate number of strokes with AF PMH 13.9% 12% 8.3% 14.1% 1. Stroke Registry Report National Registry of Diseases Office (NRDO). Date May Ng et al. Direct medical cost of stroke in Singapore. Int J Stroke 2015; 10:75-82

7

8 How effective are OACs for SPAF? Dabigatran Rivaroxaban Apixaban Warfarin Aspirin AVERROES RE-LY ROCKET- AF AFASAK, SPAF series etc ARISTOTLE

9 15.3% 6.5% 10.9% 9.2% Chiang et al. Asian strategy for stroke prevention in atrial fibrillation. Europace (2015) 17, ii31 ii39

10 Stroke/systemic embolization events Ischaemic stroke Dabigatran 150mg BD better across all endpoints for Asians Haemorrhagic stroke Myocardial Infarction Dabi 150 the only SS one for lowering IS in Asians Apixaban effective in CHADS 2 of 3-6 but not in 1-2 Effect of DOACs in Asians across different CHADS 2 scores only reported in ROCKET-AF Chiang et al. Asian strategy for stroke prevention in atrial fibrillation. Europace (2015) 17, ii31 ii39

11 Major Bleeding Intracranial Bleeding Appears ss favourable for maj bleeding except Rivarox DOACs clearly safer WRT ICH in Asians GI Bleeding Bleeding of any cause No info on Apixaban and Rivarox GIB for Asian subgroups Bleeding of any cause ss lower for all except rivarox

12 Real World Not quite a walk in the Cherry Tree Park BMJ 2015;350:h1857 Whilst NOACs are cost-effective in the younger elderly compared to warfarin, their benefits appear to be offset by worsened risk profile in older elderly, especially in non-controlled settings. Decisions on appropriate AF treatment should balance treatment-related benefits, risks, and patient preference. Risk of GIB increased after age 65 by age 76, risk exceeded that of warfarin increasing age = diminishing returns?

13 Median Concentration Our very own data. 300 Comparison of Median Concentrations 250 All p-values are < mg, N = 7 20mg, N = Cmin,ss (15mg) Cmax,ss (15mg) Cmins,ss (20mg) Cmax,ss (20mg) Caucasian Asian Locals have lower peak and trough concentrations compared to Caucasians

14 Subgroup Analysis of the C max,ss Rivaroxaban 15mg (n=7) Rivaroxaban 20mg (n=23) P-value Median Age <75y (n=28) Age 75y (n=9) Median Weight <60kg (n=6) Weight 60kg (n=24) Median BMI <30kg/m 2 (n=21) BMI 30kg/m 2 (n=9) Median

15 re not all the same

16 $2,034 (2010) $3,052 (2016) Warfarin $ Rivarox $1, Apixaban $1, Dabigatran $2, Stroke Registry Report National Registry of Diseases Office (NRDO). Date May 2016 (Table 4.7.1) 2. Ng et al. Direct Medical costs of Type 2 Diabetes in Singapore. PLoS ONE 10(3): e doi: /journal.pone

17 Let s call ACE in on this.

18 Who should get tax-payers money to pay for DOACs? Cost of Drugs & Labs, N = 1098 $/year Warfarin $391,188 Rivaroxaban $1.29m Apixaban $1.52m Dabigatran $2.32m

19 So, who should get DOACs? Increased risks of GIB or ICH Benefit of DOACs in reduction of bleeds Age < 75yo Productive life-years left; diminishing returns Poor TTR of < 65% TTR of at least 65% reduces the gain of DOACs Trial of Warfarin x 3 6mths first?

20 Questions

21 ARISTOTLE N Engl J Med Sep 15;365(11):981-92