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Dawn 2008

COAGULATION CASCADE. STEPS IN COAGULATION. DRUG. . Tifacogin NAPc2GVllai. TG/Vlla. INITIATION. . . . . . . IX. IXa. . . X. VlllaVaXa. . II. TTP 889. Protein C Drotrecogin (activated)-alpha sTM. Fondaparinux IdraparinuxDX9065aRazaxabanBAY59-7939LY 517717. . . IIa. PROPAGATION. THROMBIN ACT

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Dawn 2008

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    1. Dawn 2008 Will the new oral direct thrombin inhibitors be too expensive for routine use ? Eric Watts Basildon Hospital

    3. Public demand Clip from day time TV

    5. Biggest market, atrial fibrillation 2.3 million people with Af in USA, x 5 risk of CVA Warfarin reduces the rate by 65% but, slow onset of action, individual variation in metabolism, food & drug interactions +++ Need for monitoring Approx 50% of Af patients receive warfarin

    10. RE-MODEL ; JTH 2007 2076 patients TKR; 3/12 follow up VTE - composite % bleeding % (venographic & symptomatic) Clexane………………… 38 …. 1.3 Dabigatran 220mg O….. 36 …. 1.5 Dabigatran 150mg …….. 40 …. 1.3

    11. RE-NOVATE ; Lancet 2007 3494 patients THR ; median Rj 30 days VTE (composite) enoxaparin 40 mg OD ……… 6.7% Dabigatran 220mg OD………..6.0% Dabigatran 150mg OD ……….8.6% “no significant difference in bleeding rates”

    13. RE-MOBILISE ; J Arthroplasty 2008 TKR 1896 patients 12-15 days Rj VTE –composite Enoxaparin 30mg BD …………. 25% Dabigatran 220mg OD ……..... 31% Dabigatran 110mg OD ……….. 34% “no significant difference in bleeding rates”

    17. RE-LY trial Randomised Evaluation of Longterm Anticoagulant therapY

    20. PETRO - Prevention of Embolism & ThROmbosis in AF Dabigatran +/- aspirin Dose ranging study 502 patients 12 weeks

    23. From Bayer’s website Bayer Audioresearch Innovative protection against thrombosis 6:35 min. broadcast Center April 8, 2008 - Rivaroxaban is a novel substance currently in development for the prevention and treatment of thrombosis. It could revolutionize clinical practice. link for your podcast client: download mp3 Further available audio player Add to iTunes Bayer Audio research (requires that iTunes be installed)   More Subscriptions from Bayer

    24. RECORD 1 NEJM June 2008 REgulation of Coagulation in ORthopaeDic surgery 3,153 pts ; 35/7 Rj Event (%) Major PE NFPE DVT Enoxaparin ….…….. ….2 ……..0.1 …… 3.4 Rivoroxaban 10mg….. 0.2 ……..0.3 ….. 0.8 (p<0.001) ( p<0.001) Bleeding Major Non Major Enoxaparin 0.1 2 Rivoroxaban 10mg 0.3 2.9

    26. RECORD 3 – NEJM ; JUNE 2008 2531 patients 13/7 Rj Event (%) PE DVT Enoxaparin 40mg OD. ...… 0.5 ………18.2 Rivoroxaban 10mg OD …... 0 ………..9.6 ( p<0.001) Bleeding Major Non Major Enoxaparin 40mg OD. ….0.5 ………4.8 Rivoroxaban 10mg OD ….0.6 ……...4.9

    27. RECORD 4 10mg once-daily rivaroxaban was compared to the NorthAmerican-approved regimen for enoxaparin of 30mg injected twice-daily. Rivaroxaban demonstrated a 31 per cent RRR in total VTE in patients undergoing TKR surgery compared to enoxaparin, with a similar safety profile. Both treatments were continued for 10–14 days. Results from this study were presented in May at the 9th Annual Meeting of the EuropeanFederation of National Associations of Orthopaedics & Traumatology (EFORT) in Nice, France.

    29. EISTEIN –DVT Dose ranging Study Blood 15/9/2008 543 patients 84 days Rj Dose 20mg 30mg 40mg Hep & Warf Rivoroxaban Death …… 0 ………1.8 ……..0.8 ………..0 PE …… 0.9 ………0.9 …….. 0 …………1 RecDVT ..1.9 ………0.9 ……..0.8 ……….7 Bleeding Major ….. 0.7 ………1.5 …… 0 ………….1.5 Non Major 5.2 ………4.5 …. .. 2.2 ……….7.3

    30. Problems with new drugs Monitoring – the marketer’s intention – no monitoring (some like monitoring) Reversability - a valid concern SSR12517 a biotinylated version of idraparinux Affordability

    35. QALY 1= perfect health 0= dead Aspirin = 0.998 Warfarin = 0.987 Xi (1st 6/12) = 0.989 Xi (post 6/12) = 0.994

    36. UK costs Aspirin £5.00 pa Warfarin (5mg) £9.60 pa 14 INRs @ £3.00 £52-combined £57pa “Clinic” visits £10.00-£1,000 Dabigatran £?4.00/day (prohpylactic dose) £1,460

    37. UK clinic visit costs Basildon – automated service - computer ‘phones patient -£3.10 Ideal service doctor or specialised practitioner sees patient & carries out comprehensive clinical review-PbR £80 per visit GPwSI £150 - £200

    38. Cost of treating complications Minor Hge $50 Major Hge without residua $3,620 ICH (one time) $31,000 ICH /month $4,690

    39. Summary Dabigatran & rivoroxaban are effective with acceptable bleeding rates in orthopaedic prophylaxis They have not been shown to be better than warfarin in Af They will be more expensive

    40. NHS implications Who pays ? Natural solution – discharge patients from hospital to GP PCTs will (probably) refuse to prescribe more expensive Rj (little benefit to the patient & more work for them) More entrepreneurial PCTs will take on the patients but withdraw cost of warfarin management (£10.0- £1,000)

    41. New providers PCTs may contract the service from GPs or pharmacies Opportunities for collaborative working Labs can provide QC advice Haematologists can provide clinical advice (if asked) Audit arrangements ? (eg Dawn Benchmarking)

    42. Conclusion The newer drugs appear to be at least as good as warfarin but more expensive Stable patients will probably continue on warfarin There will be a niche for the newer drugs The race is on to establish the market leader

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