Dabigatran in Atrial Fibrillation Question and Answers document to inform commissioners

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1 Dabigatran in Atrial Fibrillation Question and Answers document to inform commissioners West Midlands Commissioning Support Unit, Birmingham University /New Medicines Evaluation Unit, Keele University Introduction and background Dabigatran is a new oral anticoagulant which was licensed in 2011 for atrial fibrillation. INR monitoring is not required though renal function should be assessed before initiation and annually in patients over 75 years or those with suspected renal function decline. It has fewer interactions with other drugs and foodstuffs than warfarin. There is a considerable cost impact associated with the new drug Issues for Commissioners: 1. In March 2012 NICE issued a Technology Appraisal (TA249) 1 which states: Dabigatran etexilate is recommended as an option for the prevention of stroke and systemic embolism within its licensed indication, that is, in people with nonvalvular atrial fibrillation with one or more of the following risk factors: previous stroke, transient ischaemic attack or systemic embolism left ventricular ejection fraction below 40% symptomatic heart failure of New York Heart Association (NYHA) class 2 or above age 75 years or older age 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension. The decision about whether to start treatment with dabigatran etexilate should be made after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin. For people who are taking warfarin, the potential risks and benefits of switching to dabigatran etexilate should be considered in light of their level of international normalised ratio (INR) control. Under the proposed NICE Compliance Regime all NHS organisations must incorporate NICE technology appraisal decisions automatically into their local formulary. 2. There is a strong clinical view that the new anticoagulant agents will be of greatest benefit in patients who are unable to take warfarin due to intolerance or contraindications. 3. There are a number of other similar agents in development. Rivaroxaban was licensed for AF in 2011 and is currently in the NICE programme with a final TA expected in May Apixaban is expected to be released in the final quarter of Theoretical savings from the reduction in INR monitoring activity may be difficult to realise as some resource will always be needed and the average cost per patient will rise as overheads are spread over fewer patients. The increasing numbers of 1

2 patients being identified with AF may mean that no capacity can be withdrawn from anticoagulation monitoring clinics. 5. Costing on current AF populations should be treated with caution as the numbers are likely to rise with the current strategy of screening for AF in some areas. 6. NICE guidance states that The decision about whether to start treatment with dabigatran etexilate should be made after an informed discussion between the clinician and the person about the risks and benefits of dabigatran etexilate compared with warfarin. Therefore it may be valuable to provide patient information or clinician briefing sheets to aid discussion. 7. A clinical audit tool has been released by NICE but the costing template is not yet available. Key Points: 1. RE-LY study showed that dabigatran was non-inferior to warfarin in the prevention of stroke or systemic embolism in patients with atrial fibrillation at a dose of 110mg dabigatran bd (1.53% with dabigatran etexilate 110 mg vs. 1.71% with warfarin per year, p < 0.001). At a dose of 150mg bd, dabigatran was superior to warfarin (1.11% with dabigatran etexilate 150 mg vs. 1.71% with warfarin per year, p < , NNT over 2 years = 88, ARR 1.14%). 2. Fewer low-dose 110 mg bd dabigatran etexilate patients had a major bleed than those receiving warfarin treatment (5.4% vs. 6.7%, p = 0.003, NNT = 77 over 2 years). There was no significant difference in bleeding rates between the higher 150 mg bd dabigatran etexilate dose and warfarin. 3. There was no statistically significant difference in mortality rates; 8.3% with warfarin, compared with 7.5% with the 110 mg dabigatran etexilate dose (RR 0.91, 95% CI 0.8 to 1.03, p = 0.13 vs. warfarin) and 7.3% in the 150 mg dabigatran etexilate group (RR 0.88; 95% CI 0.77 to 1.00, p = vs. warfarin). 4. RE-LY was a two year study and there is currently no long-term data available. There is a follow-up study, RE-LY-ABLE, which is due to complete in April Further analysis of RE-LY appears to indicate that the time in therapeutic range (TTR) is important in determining the relative effectiveness of dabigatran in comparison to warfarin. Further work is required to understand this more. 6. Safety aspects of anticoagulation still apply as these drugs carry a bleeding risk. Patients with a high risk of haemorrhage should still be assessed individually as to their suitability for treatment. 7. The RE-LY study population included 33% of patients who would not have been treated with anticoagulants according to NICE guidelines for atrial fibrillation 2

3 1. Is dabigatran better than current therapy? The main trial for dabigatran is an open-label, non-inferiority, multicentre trial (RE-LY). It looked at the effectiveness of two doses of dabigatran (110mg bd and 150mg bd) in comparison to warfarin. The study population was patients with a CHADS 2 score of 1 or above (N.B. In the UK only patients at CHADS 2 score 2 or above are treated.) It demonstrated the following: The difference in stroke prevention between 150 mg bd dabigatran and warfarin was statistically significant. (1.11% with dabigatran etexilate 150 mg vs. 1.71% with warfarin per year, p < 0.001, NNT = 88 over 2 years, ARR: 1.14). There was no difference in the incidence of major bleeding between 150 mg bd dabigatran and warfarin. The lower 110 mg dose did show significantly fewer major bleeds than warfarin (absolute risk difference 1.3%, NNH of 77 over 2 years for warfarin vs. dabigatran 110 mg bd) but was no better at preventing strokes than warfarin. There was no difference in mortality rates. (See the supporting evidence in Appendix 2 for details of the RE-LY trial.) 2. How much does it cost per non-fatal stroke prevented if we are using dabigatran? According to NHS Improvement, 3 the cost per non-fatal stroke due to AF is estimated to be 11,900 in the first year. The cost of preventing one stroke with warfarin based on (1) an estimate of 220 for the cost of maintaining one patient on warfarin for one year including monitoring, and (2) annual NNTs of 25 for primary prevention of stroke in non-valvular AF patients the cost of 4 preventing one non-fatal stroke is: Drug NNT (primary prevention, vs placebo) Cost per patient per year Cost of preventing one stroke Warfarin (including 5,500 monitoring)* Dabigatran 25 # ,075 * Cost of warfarin monitoring will differ locally but 220 total cost is considered average for the West Midlands by clinicians. # A rebate scheme is available to primary care organisations In the RE-LY trial there was a statistically significant decrease of numbers of strokes experienced in the dabigatran 150mg bd group. There was an absolute risk reduction of stroke or systemic embolism of 1.14% which equates to an NNT of 88 i.e. in order to prevent one additional stroke using dabigatran you would have to treat 88 patients over 2 years with dabigatran instead of warfarin. Therefore the additional cost of preventing one stroke is 141,328 minus 11,900 = 129,428 3

4 3. How many patients are there in the West Midlands with AF potentially at increased risk of a stroke? (See the supporting information in Appendix 2 for a description of risk categories) From 2009/10 QOF data tables, the total number of patients in the West Midlands (WM) with atrial fibrillation (AF) is 82,156. For your PCT, see Appendix 1 4. How many WM patients are treated with warfarin? Warfarin has multiple indications so analysis of PACT prescribing data is difficult. An audit of 151,000 patients in primary care in Leeds 3 carried out by the West Yorkshire Cardiac and Stroke network found 2,119 patients with AF (1.4%). Of those patients, 1,106 were at high risk of a stroke, and 54% were receiving warfarin. If these percentages were applied to the West Midlands then: Assuming 52% of the WM AF population are at high risk = 42,721 Of this population: 54% of patients with AF at high risk would be taking warfarin = 23,069 46% of patients with AF at high risk would not be taking warfarin = 19,652 Assuming a total warfarin treatment cost of 220 per patient per year (including INR testing), then the current cost of warfarin treatment in the West Midlands is 5,075,180 (23,069 x 220) For your PCT, see Appendix 1 4

5 5. What subgroups are there? Potential subgroups of patients for whom warfarin is less effective or contraindicated are: People with inadequate warfarin control: o defined as a time in therapeutic range (TTR) for less than 50% of the time. o Alternatively, a study in Cardiff of warfarin control in patients with AF who had been receiving warfarin treatment for at least six months 5 defined stable control as being within target INR range for over six months. In the Cardiff study, 5 50 to 55% of people over 75 taking warfarin were still not stabilised after six months treatment. If this percentage were applied to the West Midlands, assuming 54% of high-risk patients are taking warfarin, then: There are potentially 12,422 AF patients at high risk of stroke with inadequate warfarin control in the West Midlands (assuming 50% of those patients at high risk currently receiving warfarin would be unstable or have inadequate warfarin control) If these patients were treated with dabigatran instead of warfarin: the additional cost of treatment in the West Midlands assuming no reduction in warfarin monitoring services = 9,291,656 (( ) x 12,422) the additional cost of treatment in the West Midlands assuming reduced warfarin monitoring costs would be 7,242,026 (( ) x 12,422) (The actual level of off-setting savings from reduced warfarin monitoring will depend on the local service model and the costs, and the potential to partially decommission existing services) (For your PCT see Appendix 1) People with contraindications to warfarin: according to the NICE AF costing report, 6 about 14% of over 75 s with AF have at least one contraindication to warfarin. The recommendation from NICE in 2006 was to give those patients aspirin. If this percentage were applied to the 46,007 AF patients at high risk of stroke in the West Midlands then there would be 6,441 with contraindications to warfarin. If these patients were treated with dabigatran instead of aspirin, then the additional cost of treatment in the West Midlands would be 5,107,713 (6,441 x ( ) In an analysis of the reasons for non-prescription of warfarin in patients later admitted with acute ischaemic stroke and AF 7, valid reasons were considered to be: patient refusal non-compliance with INR monitoring bleeding diathesis and thrombocytopenia (platelets < ) patients with a history of primary intracerebral haemorrhage (ICH) poorly controlled hypertension (consistently >160/90) since it results in higher risk of ICH 5

6 People who are housebound or immobile: In 2008/09 there were 473,000 people in England receiving homecare according to NHS information centre statistics. 8 We have not found any data for the percentage of these who may have AF. People with fear of needles: no data on prevalence 6. Are there patients for whom dabigatran is not suitable? Patients with severe renal impairment: patients with a creatinine clearance less than 30 ml/min were excluded from the RE-LY trial 9. Guidelines have been issued by the MHRA for use in patients with renal impairment. Patients whose medication is managed using monitored dosage systems: dabigatran has a stability problem and should not be removed from the foil packaging until administration. This may apply particularly to patients living in: o care homes o alone at home, who need help managing their medication o those with manipulation problems unable to manage packaging In the RE-LY trial 9 (see Appendix 2): o Significantly more patients on dabigatran had gastrointestinal adverse events than those on warfarin, this could potentially affect compliance (about 11% of dabigatran patients vs. 5.8% of warfarin-treated patients, p < 0.001) o Significantly more patients on dabigatran discontinued the trial early than warfarintreated patients. After two years treatment, 20.7%, 21.2% and 16.6% of dabigatran 150 mg, dabigatran 110 mg and warfarin-treated patients respectively had discontinued treatment (p < for both dabigatran etexilate doses vs. warfarin). 6

7 Appendix 1: PCT level data on atrial fibrillation population, taken from 2009/10 QOF data No. Patients with AF in West Midlands No. patients who should be receiving warfarin according to NICE 2 Based on Leeds Audit 4 54% of patients at high risk are taking warfarin 46% at high risk should be taking warfarin and are not Of the 54% of patients potentially taking warfarin: 50% unstable or inadequate warfarin control 5 55% unstable or inadequate warfarin control 5 14% with contraindications to warfarin 2 5PG West Midlands SHA 82,156 46,007 24,844 21,163 12,422 13,664 6,441 BIRMINGHAM EAST AND NORTH PCT 5,460 3,058 1,651 1, MD COVENTRY PCT 4,022 2,252 1,216 1, MX HEART OF BIRMINGHAM PCT 1, CN HEREFORDSHIRE PCT 3,385 1,896 1, PE DUDLEY PCT 5,099 2,855 1,542 1, PH NORTH STAFFORDSHIRE PCT 3,731 2,089 1, PF SANDWELL PCT 4,547 2,546 1,375 1, M2 SHROPSHIRE COUNTY PCT 5,465 3,060 1,653 1, TAM SOLIHULL CARE TRUST 3,512 1,967 1, M1 SOUTH BIRMINGHAM PCT 4,795 2,685 1,450 1, PK SOUTH STAFFORDSHIRE PCT 9,424 5,277 2,850 2,428 1,425 1, PJ STOKE-ON-TRENT PCT 3,952 2,213 1,195 1, MK TELFORD & WREKIN PCT 2,162 1, M3 WALSALL TEACHING PCT 3,732 2,090 1, PM WARWICKSHIRE PCT 8,315 4,656 2,514 2,142 1,257 1, MV WOLVERHAMPTON CITY PCT 3,574 2,001 1, PL WORCESTERSHIRE PCT 9,314 5,216 2,817 2,399 1,408 1,

8 Appendix 2: Supporting RCT evidence and stroke risk categories There is only one phase 3 RCT that evaluated the efficacy of dabigatran for the indication of stroke prevention in patients with non-valvular atrial fibrillation (AF), the RE-LY trial. 9 In that trial, open-label warfarin was compared with two doses of dabigatran 110 mg or 150 mg twice daily (patients and assessors unaware of dose assigned) in patients with AF at increased risk of stroke. Patients were followed up for a minimum of 12 months. The primary efficacy outcome was the incidence of stroke or systemic embolism. The primary safety outcome was the incidence of major haemorrhage. Results of RE-LY Incidence of stroke or systemic embolism: Both doses of dabigatran etexilate were non-inferior to warfarin. During a median of two-years follow up, significantly fewer patients receiving the high dose of dabigatran etexilate had a stroke than warfarintreated patients (1.11% with dabigatran etexilate 150 mg vs. 1.69% with warfarin per year, p < 0.001, NNT = 172). There was no significant difference in stroke incidence between warfarin and the lower 110 mg twice daily dabigatran etexilate dose. Incidence of major haemorrhage: Significantly fewer low-dose 110 mg bd dabigatran etexilate patients had a major bleed than those receiving warfarin treatment (5.4% vs. 6.7%, p = 0.003, NNT = 77). There was no significant difference between the higher 150 mg bd dabigatran etexilate dose and warfarin. Incidences of death from any cause were not significantly different between groups: 8.3% with warfarin, compared with 7.5% with the 110 mg dabigatran etexilate dose (RR 0.91, 95% CI 0.8 to 1.03, p = 0.13 vs. warfarin) and 7.3% in the 150 mg dabigatran etexilate group (RR 0.88; 95% CI 0.77 to 1.00, p = vs. warfarin). The rates of discontinuation for 110 mg dabigatran etexilate, 150 mg dabigatran etexilate and warfarin were 14.5%, 15.5% and 10.2% respectively at one year, and 20.7%, 21.2% and 16.6% at two years (p < for both dabigatran etexilate doses vs. warfarin). Serious adverse events: significantly more dabigatran etexilate patients discontinued treatment due to a serious adverse event than warfarin-treated patients (2.7% for both dabigatran etexilate doses vs. 1.7% for warfarin, p < 0.001). Other adverse events: the only adverse event that was significantly more common with dabigatran etexilate than warfarin was dyspepsia, occurring in 11.8% and 11.3% of patients treated with dabigatran etexilate 110 mg or 150 mg respectively, compared with 5.8% in the warfarin treatment group (p < 0.001). Grid of NNT and NNH values calculated from RE-LY trial data 9 : Comparison Dabigatran 110 mg bd vs. warfarin Dabigatran 150 mg bd vs. warfarin NNT for stroke prevention No significant difference 88 over 2 years NNH major bleeding 77 over 2 years with dabigatran instead of warfarin to get one less major bleed No significant difference NNH for MI No significant difference 263 over 2 years 8

9 Notes about the evidence: The trial was open-label, so patients were aware of the treatment they were receiving. This increases the risk of bias by allowing the possibility that both the investigators and participants will unconsciously or consciously change the way they report outcomes. For example there were significantly more discontinuations in the dabigatran group than in the warfarin group. The patients awareness of the treatment they were receiving may have affected their reporting of adverse events or their decisions on whether or not to continue treatment. To mitigate the effect of the open label design the trial outcomes assessment was blinded to minimise the chance of bias during analysis. Longer-term safety data are needed. The trial evaluated treatment over a median of two years, but stroke prevention requires long-term use. Subgroup analysis of the RE-LY trial Wallentin et al 10 published a sub-group analysis of the RE-LY trial that aimed to determine if the outcomes measured (incidence of stroke, bleeding etc) were affected by the quality of INR control. In the absence of any indicator of anticoagulation status in the dabigatran groups, the average TTR that each centre achieved in its patients treated with warfarin was used as an approximation of quality of INR control for all its patients. cttrs for treatment centres were calculated as an average of all TTR measurements for individual patients who were receiving warfarin at that centre. Interquartile ranges were identified from the data as < 57.1%, 57.1 to 65.5%, 65.5 to 72.6% and > 72.6%. The change in event rates with increasing INR control for patients receiving warfarin was compared with the changes in event rates in dabigatran patients for a number of primary and secondary outcomes. Results Stroke, systemic embolism and bleeding There were no significant interactions between cttr and the outcome of stroke and systemic embolism with either dose of dabigatran versus warfarin. The rates of intracranial bleeding in the warfarin group were not associated with the cttr and were consistently lower in both dabigatran groups than warfarin irrespective of cttr The rate of non-haemorrhagic stroke and systemic embolism seemed to be lower with higher cttr in the warfarin group. The rate of major bleeding, as well as major gastrointestinal bleeding was numerically lower at higher cttr quartiles in the warfarin group. When comparing major bleedings between the 150 mg dose of dabigatran and warfarin, there were benefits at lower cttr but similar results at higher cttr. There was a higher rate of major gastrointestinal bleeding with 150 mg dabigatran than warfarin at higher cttr. There was an increase in total bleeding rate with increasing cttr in all three treatment groups without any significant interactions between groups. 9

10 Mortality and cardiovascular outcomes Total mortality was lower at higher cttr in the warfarin group than in the dabigatran groups. For all cardiovascular events, including total mortality and major bleeding, there were significantly lower event rates at higher cttr in the warfarin group. There was a significant interaction between cttr and the composite of all cardiovascular events when comparing 150 mg bd dabigatran versus warfarin (p = ) and with 110 mg bd dabigatran versus warfarin (p = 0.036). What are the risk categories? Patients can be considered at low, moderate or high risk of stroke. The NICE guideline on atrial fibrillation 11 used the following descriptions of the different groups: An alternative method uses the CHADS 2 score, a stroke risk score where one point each is assigned to the risk factors: congestive heart failure, hypertension, age over 75, diabetes mellitus and two points to a previous stroke or TIA. 11 Combining the two, the NICE high risk category equates to a CHADS 2 score of 2 and the moderate category to a CHADS 2 score of 0 or 1. The NICE guideline on AF recommends that all patients at high risk of a stroke should be receiving anticoagulation with warfarin (target INR 2.5, range 2.0 to 3.0) unless they have contraindications to warfarin, in which case, they should be receiving aspirin 75 to 300 mg per day. Patients at moderate risk of stroke should be receiving warfarin or aspirin, and patients at low risk should be receiving aspirin. In the NICE costing report supporting the AF guideline it is stated that 56% of patients with AF should be receiving anticoagulation with warfarin. This percentage includes all patients at high risk of stroke and 50% of moderate-risk patients. This guidance is based upon the published information available in English at the time the drug was considered. It remains open to review in the event of significant new evidence emerging. References 1. Dabigatran exilate for the prevention of stroke and systemic embolism in atrial fibrillation. TA 249. London: NICE; cited available from URL 10

11 2. Correction: newly identified events in the RE-LY trial N Engl J Med 2010;363: Heart and Stroke Improvement: commissioning for stroke prevention in primary care - the role of atrial fibrillation. (online) NHS Improvement cited available from URL 4. Aguilar MI, Hart R, Pearce LA. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database Syst Rev 2007 Issue 3. Art no CD DOI: / CD pub 2 5. Currie CJ, McEwan P, Emmas C, Morgan CL, Peters JR. Anticoagulation in patients with non-valvular atrial fibrillation: an evaluation of stability and early factors that predict longer-term stability on warfarin in a large UK population. Curr Med Res Opin 2005;21: Atrial fibrillation: the management of atrial fibrillation: costing report. (online) NICE cited Partington SL, Abid S, Teo K, Oczkowski W, O'Donnell MJ. Pre-admission warfarin use in patients with acute ischemic stroke and atrial fibrillation: the appropriate use and barriers to oral anticoagulant therapy. Thromb Res 2007;120: Community Care Statistics : Social Services Activity Report, England. (online) NHS Information Centre for health and Social Care cited ommunity_care_statistics_200910_social_services_activity_report_england.pdf 9. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh M et al Dabigatran versus Warfarin in Patients with Atrial Fibrillation. NEJM 2010;361: Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Grazia Franzosi M et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010;376: Atrial fibrillation: the management of atrial fibrillation.cg36. London: NICE; cited

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