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Personalised anti-coagulation: an example of how
technology drives efficacy and efficiency.
Simon Jones
Dr Harsh Sheth
Content
• Personalised medicine
• Alignment of the right treatment with the right patient to achieve the greatest
clinical outcomes and cost effectiveness
• Using technology to test sensitivity prior to treatment
• The more we understand before embarking on course of treatment the more
effective it should be
• Optimised medication regimes
• Once on treatment regime – let’s optimise it
Personalised anti-coagulation pathway
• Two main treatments – Warfarin, NOAC
• Both NICE approved
• Both appropriate treatment options
• Huge cost differential
• Given health gain from each drug it’s important to understand cost v health
gain
• Inconsistent prescribing patterns
• Local variations on which treatment to use
• Some based on cost others on more clinically based protocols
The Warfarin Patient
A patient now
Mary, 58 with AF. GP prescribes warfarin, misses appointments, collapses, severe
internal bleeding, lucky to survive…
In the future
….. Mary is one of the 4-5% who metabolise warfarin slowly…. .Mary’s GP does a quick
pharmacogenetics test using special equipment in the surgery…… starts on lower, safer
dose of warfarin… suited to personal genetic makeup.
OR… test shows Mary is sensitive to Warfarin so GP prescribes NOAC.
Pirmohamed M et al, New England Journal of Medicine 2013
In a multi centre trial involving Newcastle, genotype guided dosing
resulted in participants reaching the therapeutic window earlier and
with fewer episodes of over dosing
A simple test of three variants responsible for
two thirds of the interpersonal variation
Routing of patients to warfarin/ NOAC based on
genotype
Reduced bleeding with endoxaban in sensitive and highly sensitive responders compared to
warfarin (low dose P=0.0036; high dose P=0.0066)
Mega et al. Lancet 2015
6mg,
24%
5mg,
7%
4mg,
31%
4mg,
4%
4mg,
1%
3mg,
0.5%
4mg,
8%
3mg,
6%
3mg,
1%
3mg,
13%
2mg,
3%
2mg,
0.1%
1mg,
0.2%
1mg,
0.1%
2mg,
1%
1mg,
0.3%
2mg,
0.2%
2mg,
2%
Patient self-tests INR
at home on agreed
date
Using either an automated phone
call or on-line submission, the
patient provides their INR reading,
current warfarin dose, and
questions around bleeding and
medication
Patient follows new
dosing regime and
notes date of next test
The service can integrate directly
with 4S-DAWN or INRstar. This means
that clinic staff can dose from within
their existing system, or from the
Inhealthcare portal if the clinic uses a
different decision support system
The service then informs the
patient of their warfarin dose
and the date of next INR test
Patient INR Self-Testing
• There are 1.2 million people in the UK that are on
warfarin, creating 17 million out-patient appointments
per year to have their blood tested (INR tests)
• This service allows patients on warfarin to self-test their
INR at home instead of attending out-patient clinic, and
then for them to receive their new warfarin dose at home
• When assessed, the self-testing patients had a higher
level of compliance than clinic-based patients, meaning
that the time
that their INR was in a safe range increased from 59% to
72%.
Evaluation data from 200 clinical patient pilot at NHS County Durham
and Darlington NHS Foundation Trust
North East Project
Stage 1
• Request genotyping on all “problem cases” and new cases of AF
• Consider switching “high risk” cases to NOAC
• Increase numbers of self testing – to secure increased TTR
Stage 2
Redesign anti-coagulation pathway so we can:
• Genotype all new referrals
• Accelerate induction of “wild type”
• Align appropriately those patients who would achieve better outcomes through self testing
Summary
• Introduction of 3 innovations to the clinical pathway- rapid genotyping,
self testing INR and cloud based warfarin dose adjustment
• Objective stratification of patients to warfarin or NOAC treatment
• Improved INR control, improved drug adherence, reduced risk of
bleeding events and reduced clinic visits
• Overall cost saving of ~£3 million in Newcastle area alone
• Please come and see us on stand 73
• Any questions?
• Follow Inhealthcare on Twitter @InHealthcareUK

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Applying Technology to Anticoagulation

  • 1. Personalised anti-coagulation: an example of how technology drives efficacy and efficiency. Simon Jones Dr Harsh Sheth
  • 2. Content • Personalised medicine • Alignment of the right treatment with the right patient to achieve the greatest clinical outcomes and cost effectiveness • Using technology to test sensitivity prior to treatment • The more we understand before embarking on course of treatment the more effective it should be • Optimised medication regimes • Once on treatment regime – let’s optimise it
  • 3. Personalised anti-coagulation pathway • Two main treatments – Warfarin, NOAC • Both NICE approved • Both appropriate treatment options • Huge cost differential • Given health gain from each drug it’s important to understand cost v health gain • Inconsistent prescribing patterns • Local variations on which treatment to use • Some based on cost others on more clinically based protocols
  • 4. The Warfarin Patient A patient now Mary, 58 with AF. GP prescribes warfarin, misses appointments, collapses, severe internal bleeding, lucky to survive… In the future ….. Mary is one of the 4-5% who metabolise warfarin slowly…. .Mary’s GP does a quick pharmacogenetics test using special equipment in the surgery…… starts on lower, safer dose of warfarin… suited to personal genetic makeup. OR… test shows Mary is sensitive to Warfarin so GP prescribes NOAC.
  • 5. Pirmohamed M et al, New England Journal of Medicine 2013 In a multi centre trial involving Newcastle, genotype guided dosing resulted in participants reaching the therapeutic window earlier and with fewer episodes of over dosing A simple test of three variants responsible for two thirds of the interpersonal variation
  • 6. Routing of patients to warfarin/ NOAC based on genotype Reduced bleeding with endoxaban in sensitive and highly sensitive responders compared to warfarin (low dose P=0.0036; high dose P=0.0066) Mega et al. Lancet 2015 6mg, 24% 5mg, 7% 4mg, 31% 4mg, 4% 4mg, 1% 3mg, 0.5% 4mg, 8% 3mg, 6% 3mg, 1% 3mg, 13% 2mg, 3% 2mg, 0.1% 1mg, 0.2% 1mg, 0.1% 2mg, 1% 1mg, 0.3% 2mg, 0.2% 2mg, 2%
  • 7. Patient self-tests INR at home on agreed date Using either an automated phone call or on-line submission, the patient provides their INR reading, current warfarin dose, and questions around bleeding and medication Patient follows new dosing regime and notes date of next test The service can integrate directly with 4S-DAWN or INRstar. This means that clinic staff can dose from within their existing system, or from the Inhealthcare portal if the clinic uses a different decision support system The service then informs the patient of their warfarin dose and the date of next INR test
  • 8. Patient INR Self-Testing • There are 1.2 million people in the UK that are on warfarin, creating 17 million out-patient appointments per year to have their blood tested (INR tests) • This service allows patients on warfarin to self-test their INR at home instead of attending out-patient clinic, and then for them to receive their new warfarin dose at home • When assessed, the self-testing patients had a higher level of compliance than clinic-based patients, meaning that the time that their INR was in a safe range increased from 59% to 72%. Evaluation data from 200 clinical patient pilot at NHS County Durham and Darlington NHS Foundation Trust
  • 9. North East Project Stage 1 • Request genotyping on all “problem cases” and new cases of AF • Consider switching “high risk” cases to NOAC • Increase numbers of self testing – to secure increased TTR Stage 2 Redesign anti-coagulation pathway so we can: • Genotype all new referrals • Accelerate induction of “wild type” • Align appropriately those patients who would achieve better outcomes through self testing
  • 10. Summary • Introduction of 3 innovations to the clinical pathway- rapid genotyping, self testing INR and cloud based warfarin dose adjustment • Objective stratification of patients to warfarin or NOAC treatment • Improved INR control, improved drug adherence, reduced risk of bleeding events and reduced clinic visits • Overall cost saving of ~£3 million in Newcastle area alone
  • 11. • Please come and see us on stand 73 • Any questions? • Follow Inhealthcare on Twitter @InHealthcareUK

Editor's Notes

  1. Now lets return to Europe where we know pharmacogenetic guided dosing works well. In 2003, a genetics white paper was presented to the parliament where the role of genetics in delivering personalised medicine was discussed. They used the example of warfarin treatment for a patient named Mary……….. Its been more than 13 years since this white paper was published. So the question is, have we reached to the point where we can prescribe personalised dose of warfarin?
  2. Fast forward to 2013 where results of the EU-PACT trial were published which looked into whether prescribing genotype-guided dosing was superior to standard dosing in spending higher time in the target INR range. The results showed that people who were given genotype guided dose reached target INR range quickly and spent longer time in the target INR range compared to people given standard dosing.