Joint Session. Clinical challenges to the use of NOACs in Portugal. João Morais. Centro Hospitalar Leiria Pombal

Transcrição

1 Joint Session Clinical challenges to the use of NOACs in Portugal João Morais Centro Hospitalar Leiria Pombal

2 João Morais Consulting and lecture fees Astra Zeneca; Bayer Healthcare; JABA Recordati; Lilly / Daiichi Sankyo; Merck Sharp and Dhome; Pfizer/BMS Grant for clinical research Servier (CLARIFY REGISTRY)

3 The problem

4 Portuguese reality Estudo FAMA n=10447 Idades anos ( ) Bonhorst D et al Rev Port Cardiol 2010;29

5 The problem Recent estimates are suggesting that in Portugal only 40% of patients requiring anticoagulants are really medicated Less than 50% of patients taking warfarin are doing it under a good supervision of the INR Portugal is a country with a dramatic rate of incidence of stroke

6 The problem STROKE Is the major cardiovascular problem in Portugal

7 INR control in Portugal In the best setting of patient management in one anticoagulation clinic with a large experience in this field, 71% of INR were in the therapeutic range (this doesn't mean TTR of 71%) Cruz E. Rev Port Cardiol 2012;31:51-57 In another also perfect setting of a clinical trial (RE-LY stud) in Portugal TTR was estimated around 60% In the real world an optimistic perspective is pointing to 50%

8 TTR by country RE-LY experience

9 Coimbra University Hospital. Stroke Unit Patients admitted with a stroke 37.3% cardioembolic in origin Luis Cunha Rev Port Cardiol. 2012;31(Supl.I):23-27

10 Coimbra University Hospital. Stroke Unit Patients admitted with a stroke Almost 30% of these patients are being discharged without anticoagulation Luis Cunha Rev Port Cardiol. 2012;31(Supl.I):23-27

11 The problem Portugal is leading the rate of stroke in Europe It is spending millions of Euros to manage these patients per year Per capita it is the 2 nd country in Europe regarding the costs of stroke management

12 Costs per capita to manage stroke patients

13 The relationship between economy and stroke Stroke. 2012;43: An important connection between the national economy and stroke epidemiology

14 The relationship between economy and stroke Stroke rate Fatality rate per capita gross domestic product Stroke. 2012;43:

15 The relationship between economy and stroke Hemorragic stroke rate Age at stroke onset per capita gross domestic product Stroke. 2012;43:

16 The relationship between economy and stroke Summary A lower per capita gross domestic product is associated with: qonset of cerebrovascular disease at younger age qa higher proportion of intracerebral hemorrhages qa higher incident risk of stroke and mortality Stroke. 2012;43:

17 Accessibility to new pharmaceutical compounds Dentro dos países europeus, Portugal é o país em que mais tarde são lançados novos produtos e onde menos produtos são lançados. Apenas em termos de números em bruto, uma politica de preços baixos dos medicamentos em Portugal tem resultado em estarem disponíveis no mercado nacional menos produtos do que noutros países da União Europeia. E os produtos que são introduzidos têm um atraso temporal bastante significativo

18 Despesa em medicamentos per capita

19 Antithrombotics in Portugal ( ) Observatório do Medicamento e Produtos de Saúde INFARMED 2005

20 The NOACs in Portugal Dabigatran 75 mg Dabigatran 110 mg Dabigatran 150 mg Rivaroxaban 10 mg Rivaroxaban 15 mg Rivaroxaban 20mg Atrial Fibrillation Reimbursement not approved

21 Expectations for the NOACs in Portugal Reduction of intra-cerebral bleeding Estudo Fármaco HIC novo ACO HIC Anti-VK HR (IC 95%) Valor de p RELY* * estudo aberto Dabigatrano 110 mg 2id 150 mg 2id 0.23%/ano 0.30%/ano 0.74%/ano 0.31( ) 0.40( ) <0.001 <0.001 ROCKET-AF Rivaroxabano 0.50%/ano 0.70%/ano 0.67( ) 0.02 ARISTOTELE Apixabano 0.33%/ano 0.80%/ano 0.42( ) <0.001

22 Expectations for the NOACs in Portugal Reduction of other major bleeding RELY* Estudo Fármaco Tipo de hemorragia * estudo aberto Dabigatrano 110 mg 2id 150 mg 2id life-threatening HR (IC 95%) 0.68( ) 0.81( ) Valor de p <0.001 =0.04 ROCKET-AF Rivaroxabano causing death 0.50( ) ARISTOTELE Apixabano TIMI major 0.57( ) <0.001

23 Expectations for the NOACs in Portugal Expectations for the new drugs q to facilitate the access to oral anticoagulation q to breakdown the traditional concern of physicians about the risk of ICH with oral AC q to overcome the traditional low TTR with AVK q to improve the adherence and compliance To reduce the incidence of stroke in Portugal To reduce the economical burden of stroke To reduce the social impact of stroke

24 Evolução da Quota de Mercado no mercado da anticoagulação 60 % 50 Antagonistas da Vitamina K % 8% 9% 10% 9% 10% +114% 11% 12% 12% 13% 14% 15% Heparinas Novos Anticoagulantes Orais 0 Abr 2012 Mai 2012 Jun 2012 Jul 2012 Ago 2012 Set 2012 Out 2012 Nov 2012 Dez 2012 Jan 2013 Fev 2013 Mar 2013 informaçao IMS

25 Evolução da Quota de Mercado no mercado da anticoagulação Abril 2012 Março 2013 Anti-VK Heparinas NOACs 57% 53% 36% 32% 7% 15% informaçao IMS

26 Fighting against stroke