Rito Mitra Welsh April - NHS Wales - NOACs in Wales.pdf · 5.0% 10.0% Stroke Admission with AF 0.0%...

NOACs in Wales

Rito MitraWelsh Cardiovascular Society April 2015

DisclosuresDisclosures

• Speaker & conference fees from thefees from the following:A Z Pfi B h i• A‐Z, Pfizer, Boehringer, Menarini, Bayer, Lilly, S i B tServier, Boston Scientific, Biosensors

I'm not here to talk aboutI m not here to talk about …..

• Trial data• Efficacy• Efficacy• Side effects 'Although cost is a perceived

NICE ratified

• Drug interactions• Cost effectiveness

g pbarrier to the use of NOACs, NICE has concluded that the drugs are cost-effective and must be Cost effectiveness available to patients within their licensed indications'.

• Literature readily available

In WalesIn Wales ……..

• How good are we at stroke prevention in AF?• Who are prescribing NOACs in Wales?• How are they being prescribed?• How are they chosen? Should one size fit all?• How are they chosen? Should one size fit all?• Attacking AF prevalence: What happens when a Cardiologist is sent o t to a GP S rger ?Cardiologist is sent out to a GP Surgery?

• What are the Estimations and Projections?• Who should be prescribing NOACs in Wales?

Quality and Outcomes Framework 2015‐16 Future

• Biggest change for AF domain in QOF since 2011 has been the emphasis on anti‐coagulation treatment as opposed to treatment with anti‐coagulation or anti‐platelet. QOF 2015‐16 proposes to remove the use of anti‐platelets altogether.

Future

p g

http://www.nhsemployers.org/~/media/Employers/Documents/Primary%20care%20contracts/QOF/QOF%20Home%20Page/2015-16%20Summary%20of%20changes%20to%20QOF.pdf

QOF ‐ AF004 Proportion of Patients Anticoagulated (Net Exceptions)

100%

70%

80%

90%

Wales

50%

60%

70%

Anticoa

gulated

Wales Average 70%

30%

40%

Prop

ortio

n A

Wales Practices

10%

20%

0%Practices

http://gov.wales/statistics-and-research/general-medical-http://gov.wales/statistics and research/general medicalservices-contract/?lang=en#/statistics-and-research/general-medical-services-contract/?lang=en

Sentinel Stroke National Audit Programme g(SSNAP)( )

https://www strokeaudit org/results/nationalhttps://www.strokeaudit.org/results/national

Stroke Admissions with Atrial Fibrillation(J l 2013 S t 2014)

30.0%

(July 2013 – Sept 2014)

20.0%

25.0%

15.0%

Percen

tage

%

5.0%

10.0% Stroke Admission with AF

0.0%National Wales Abertawe Bro

Morgannwg Aneurin Bevan

University Health Betsi Cadwaladr University Health

Cardiff and Vale University Health

Cwm Taf University Health

Hywel Dda Health Board

University Health Board

Board Board Board Board

https://www.strokeaudit.org/results/national

Admitted with Stroke and AF ‐ OnMedicines Case Mix ‐ Stroke and AF

14%

Admitted with Stroke and AF On Anti‐platelet

5%

Medicines Case Mix Stroke and AF on Admission

Both anticoagulant and

45%

41%

14%

Yes

No

No but

33%

22% antiplatelet medication

Anticoagulant medication only

Antiplatelet medication only 41%

40%y

Neither medication

Post Stroke (with AF) Discharge ‐ On Anticoagulant

Admitted with Stroke and AF ‐ On Anticoagulant

2% 12%

Yes

No

38%

19%

Yes

No

86%

No but

43%

No but

11https://www.strokeaudit.org/results/national

Medicines Casemix in Patients Admitted for Stroke with Atrial Fibrillation

100.0%

(July 2013‐ Sept 2014)

70 0%

80.0%

90.0%

h d

50.0%

60.0%

70.0%

rcen

tage

%

Both Medications

Anticoagulant Only

Antiplatelet Only

Neither Medication

20.0%

30.0%

40.0%Per

0.0%

10.0%


Medicines Casemix in Patients Admitted for Stroke with Atrial Fibrillation (July 2013‐Sept 2014)

100.0%

(July 2013‐Sept 2014)

70.0%

80.0%

90.0%

Both anticoagulant and antiplatelet medication

50.0%

60.0%

rcen

tage

%

Anticoagulant medication only

Antiplatelet

20 0%

30.0%

40.0%Pe

pmedication only

Neither medication

0.0%

10.0%

20.0%

National Wales Abertawe Bro Aneurin Bevan Betsi Cadwaladr Cardiff and Vale Cwm Taf Hywel DdaNational Wales Abertawe Bro Morgannwg University

Health Board

Aneurin Bevan University

Health Board

Betsi Cadwaladr University

Health Board

Cardiff and Vale University

Health Board

Cwm Taf University

Health Board

Hywel Dda Health Board

https://www strokeaudit org/results/nationalhttps://www.strokeaudit.org/results/national

Atrial Fibrillation Prior to Stroke on Anticoagulant (J l 2013 S t 2014)

90 0%

100.0%

(July 2013 – Sept 2014)

70.0%

80.0%

90.0%

40.0%

50.0%

60.0%

Percen

tage

%

20.0%

30.0%

40.0%Yes

No

No, but

0.0%

10.0%


Atrial Fibrillation Prior to Stroke on Anticoagulant (J l 2013 S t 2014)

100.0%

(July 2013 – Sept 2014)

70 0%

80.0%

90.0%

50 0%

60.0%

70.0%

tage

%

Yes

30.0%

40.0%

50.0%

Percen

es

No

No but

10.0%

20.0%

30.0%

0.0%National WalesAbertawe Bro Morgannwg University Health BoardAneurin Bevan University Health BoardBetsi Cadwaladr University Health BoardCardiff and Vale University Health BoardCwm Taf University Health BoardHywel Dda Health Board


Anticoagulation on Discharge Post Stroke with Atrial Fibrillation (J l 2013 S t 2014)

90 0%

100.0%

(July 2013 – Sept 2014)

70.0%

80.0%

90.0%

40 0%

50.0%

60.0%

Percen

tage

%

20.0%

30.0%

40.0%Yes

No

No, but

0.0%

10.0%


Anticoagulation on Discharge Post Stroke with Atrial Fibrillation(J l 2013 S t 2014)

100.0%

(July 2013 – Sept 2014)

80.0%

90.0%

60.0%

70.0%

ge %

40.0%

50.0%

Percen

ta Yes

No

No but

20.0%

30.0%

0.0%

10.0%

National Wales Abertawe Bro Aneurin Bevan Betsi Cadwaladr Cardiff and Vale Cwm Taf Hywel Dda Health Morgannwg






Board


How good are we with SPAF in Wales?How good are we with SPAF in Wales?

• Pretty good once you’ve had a stroke.y g y

• Not so good for primary prevention• Not so good for primary prevention.

• Significant numbers on antiplatelets only.

Who are prescribing NOACs inWho are prescribing NOACs in Wales?

How are they being prescribed?

• Cwm Taf: Relatively large dataC&V D t i• C&V: Data emerging

• Other HBs: NA (at least for this presentation)

Prescriptions over last two yearsPrescriptions over last two years ….

188188

160180200

120140160

Apixaban

7058

6080

100 DabigatranRivaroxaban

261320

4060

0Royal Glam UHW

N = 446 N = 97

Who are the Prescribers?Who are the Prescribers?190200 190

160150

200

3357

3734

100

33 37 262 1 2

34

0

50

Royal Glam UHW

C di l St k M di iCardiology Stroke MedicineMental Health Primary Care PrivateMissingMissing

Reasons for prescriptionsReasons for prescriptions

229250Warfarin

200 FailureLogistics

87100

150Patient Choice

4219 19

59

12 1650

100Other

Unclear91

9412 16

0RGH UHW

Unclear

RGH UHW

NOAC use at Cwm Taf HB for SPAFNOAC use at Cwm Taf HB for SPAF

• Initiated in secondary carecare

• Maintained in primary (andprimary (and secondary) care

• Long term use –compliance and renal function/comorbidity

The ‘Bucket Dear Dr, The Bucket Letter’

RE: Name DOB Address: Your have recently referred this patient to the Cardiology

department with a diagnosis of atrial fibrillation. As you are aware our current waiting times exceed several months and this mayour current waiting times exceed several months and this may represent a significant thromboembolic risk for an untreated patient with AF.

If the CHA2DS2-VASc risk score of a thromboembolic event and HASBLED bleeding risk score indicate that the patient is appropriate for anticoagulation and they wish to proceed with this

Your ref/eich

appropriate for anticoagulation and they wish to proceed with this please consider referring directly to the Pharmacy-led anticoagulation service for initiation of Warfarin. This service is available to all GP practices in our catchment area. Their contact number is 01443 443500 if referral forms are required. Please

ref/eichcyf:Our

ref/ein cyf:GS/

Date/dyddi

note they are an initiation service only and will not undertake risk assessment – this should be undertaken by the responsible clinician prior to referral.

The Cardiology ATTRACT e-mail service can provide advice including ECG review where appropriate.

ad:Tel/ffôn: 01443 443450Fax/ffacs:

Email/[email protected]

g pp pThen one of two sentences depending on situation:EITHER – As this patient’s AF is long standing and your

letter states no other indication for a cardiology referral, this patient will not be placed on the waiting list at this time.

OR For new onset or symptomatic AF This patient will bet:@

Dept/adran:

CARDIOLOGYOR- For new onset or symptomatic AF- This patient will be

added to the Cardiology waiting list and will be seen in due course.

Yours sincerely,Geraldine Swarfield

d f C d l ( b h lf f l GlLead Nurse for Cardiology (on behalf of Royal Glamorgan Hospital Consultant Cardiologists)

Warfarin Initiation by Hospital-led S i t C T fServices at Cwm Taf

NOAC formNOAC form @ Cwm Taf

NOAC formNOAC form (back)

Anticoagulation pharmacists at Cwm Taf

NOAC Card

• Initiation and counselling of NOAC: < 1 week

• Initiation and counselling of Warfarin < 2 weeks

What is happening in other HBs?C&V

Th UHB B d t d th d ti f• The UHB Board supported the recommendations of the prioritisation panel, but the UHB cannot afford the full amount of all 3 recommendations. The Boardthe full amount of all 3 recommendations. The Board hasn’t yet signed off its financial framework for 2015‐16 and the amount that will be allocated to NICE d h t t b ti l t d Wh thiNICE drugs has not yet been stipulated. When this amount is clear Sharon and Graham will discuss apportionment across the 3 drug areas; we will letapportionment across the 3 drug areas; we will let you know as soon as we can.

What is happening in other HBs? Hywel Dda 1What is happening in other HBs? Hywel Dda 1• 1) Potential discrepancy between Local/All Wales guidance and NICE Guidance• I raise this in response to the email sent out a few months ago from Ceri BrownI raise this in response to the email sent out a few months ago from Ceri Brown

highlighting the case from Kent where a court found against a local commissioning group on the basis that local guidance could not override the recommendations of NICE and there was a duty of care to deliver guidance as per NICE recommendation.

• If I interpret correctly our current Health Board Guidance mandates the use of warfarin as a first line anticoagulant limiting NOACS as first line only in specificwarfarin as a first line anticoagulant‐limiting NOACS as first line only in specific situations

• If a patient is offered anticoagulation but chooses a NOAC rather than warfarin (as many well informed pts do)‐then if we say no then we could potentially be open to litigation if that pt goes on to have a stroke.

• 2) How can we deliver antiocoagulation services to patients with AF (including NOACS)

• Current HB guidance suggests that GP’s cannot initiate NOAC’s and yet there is no capacity/provision in secondary care to deliver the counselling and administrationcapacity/provision in secondary care to deliver the counselling and administration necessary. Cardiology and haematology clinics are already struggling with long waits.

• I propose one of 2 options• 1) Develop a nurse led AF service (across the 3 counties) that incorporate

anticoagulation as part of the service (This is done in many areas in the UK)anticoagulation as part of the service (This is done in many areas in the UK)• 2) Allow initiation in primary and as per NICE recommendation‐encourage local GP

‘champions’‐recognising that not all GP’s can experts in anticoagulation. This could be supported by a training day covering issues of AF, anticoagulation and specific issues relating to the NOACS and appropriate counselling. Those wishing (perhaps I am being over optimistic!) to become champions could be ‘signed off as to having theover optimistic!) to become champions could be signed off as to having the appropriate training and knowledge.

What is happening in other HBs?Hywel Dda 2

• We do not have a policy other than the NICE guidance and AWMSG. We tend to use both to be honest and when we do elect to use a NOAC we arrange counselling with either the cardiac nursearrange counselling with either the cardiac nurse or clinical pharmacist. I choose the agent based on age, renal function, stroke risk and compliance likelihood.likelihood.

• The delay is in getting the counselling underway, this is just one of the reasons that warfarin remainsthis is just one of the reasons that warfarin remains first line as we can arrange anticoagulation on the day of clinic. We are working on streamlining the NOAC patients to prevent delays. We have a form th t f lli th t i i d b ththat we use for counselling that is signed by the patient and nurse at the end of the session and we have a compliance form we ask the patient to sign prior to cardioversionprior to cardioversion.

Warfarin or NOAC?Warfarin or NOAC?

• Monitoring issues• InteractionsInteractions• Longterm data• Antidote• Valvular AF : WarfarinValvular AF : Warfarin• Mechanical heart valves: Warfarin• Coronary stents: ? Warfarin• Unknown clinical scenarios: ? Warfarin• Unknown clinical scenarios: ? Warfarin• CKD 5: Warfarin

How I choose a NOACHow I choose a NOAC …….

• I don’t always have a ready answer……….I don t always have a ready answer……….

• Assess clinical factors (Things that I do)

• Offer patient three questions…. (Things I ask the patient to do)

Patient Question 1Patient Question 1

• Which is worse for you: having a stroke orWhich is worse for you: having a stroke or having a bleed?

• The best stroke medicine will have roughly the g ysame bleeding risk as Warfarin.


• Do you want equivalent stroke protection riskDo you want equivalent stroke protection risk but lower bleeding risk than Warfarin?


• Would you prefer once a day or twice a day?• Are you good with tablets?

Questions I think aboutQuestions I think about …

• History of MI?History of MI?• Drug interactions?• GI bleeding risk / dyspepsia?• Renal function?Renal function?• Compliance?• Tablet box / dispensing issues?

Should one size fit all in Wales?Should one size fit all in Wales?

• So far these drugs are being initiated / approved by Senior Clinicianspp y

• Ample evidence in local data that switches are occurring due to variety of reasonsoccurring due to variety of reasons

• Evidence shows that these drugs are not all the same: each has unique advantages / disadvantagesdisadvantages

• Database shows specific reasons for ibi diff t NOACprescribing different NOACs

• Current treatment practice in Wales suggests case

In WalesIn Wales ……..

• How good are we at stroke prevention in AF?• Who are prescribing NOACs in Wales?• How are they being prescribed?• How are they chosen? Should one size fit all?• How are they chosen? Should one size fit all?• Attacking AF prevalence: What happens when a Cardiologist is sent out to a GP Surgery?Cardiologist is sent out to a GP Surgery?

• What are the Estimations and Projections?• Who should be prescribing NOACs in Wales?

A review of AF cases in the community: Ferndale Medical Centrecommunity: Ferndale Medical Centre

2015

• Serves 7600• GPs = 2 (+2)GPs 2 ( 2)• Anticoagulation

i Yservices = Yes• Aim: Review of stroke prevention in AF casesAF cases

• Industry support

Ferndale: Population statisticsFerndale: Population statistics

Prevalence of AFPrevalence of AF

S Stewart et al. Heart 2001;86:516-521

Age and sex specific prevalence of atrial fibrillationAge and sex specific prevalence of atrial fibrillation (AF) in a population cohort from the west of Scotland.

Ferndale: Expected AF prevalenceFerndale: Expected AF prevalence

• N (expected) =• N (expected) = 274 cases

• Cases onCases on Register = 126

MethodsMethods

• Ferndale Surgery AF Register• Arrhythmia Nurse review AF Register

• Patients identified for Cardiologist + Cardiac Ph i t i i 1Pharmacist review

• All patients invited to clinicR t bl d d

Review 1: Records

• Recent bloods done• Housebound cases had notes

review Review 2:review• Results entered into database• Patients offered informed

Review 2: Patients

• Patients offered informed choice

Exclusion & Inclusion criteriaExclusion & Inclusion criteria

E l iExclusions: Inclusions:

• RIP = 3• Cognitive impairment = 1

h i l l

• Suspected Poor TTR = 14• Antiplatelets only• Mechanical valves = 2

• CHADS2Vasc 0 = 3• Bleeding 1

Antiplatelets only

• Bleeding = 1• Previous decision not to

anticoagulate = 1anticoagulate 1• Terminal illness = 1

Results Review 1: Arrhythmia Nurse

66

60

70• N = 126 on AF Register • Male 48%

28

1830

40

50 • 2/3 cases on anticoagulation

1814

0

10

20 • 52% on Warfarin• 14% on NOAC

Warfarin Antiplatelets NOACS Nil • Excluded = 12 (9.5%)

Prevalence of different NOACsPrevalence of different NOACs

10

12

8

10

4

6 N

2

4

0Dabigatran Apixaban Rivaroxaban

Results Review 2: Cardiologist + Cardiac Pharmacist

• Reviewed = 42 • Age range 49 – 95 years• Not in AF = 9 (9/126 = 7%)• Not in AF = 9 (9/126 = 7%)• Mean CHADS2Vasc = 3.1• On Warfarin = 14• No conclusion / unsuitable = 6No conclusion / unsuitable 6• New Cardiology = 12 (12/126 = 9.5%)

Results Review 2 (contd)Results Review 2 (contd)

• Changes made = 13 (13/126 = 10.3%)• New Warfarin = 2 (2/126 = 1.6%)• New NOAC = 8 (8/126= 6.4%)• Switch Warfarin to NOAC = 3 (3/66 = 4.5%)• Refused anticoagulation = 2 (2/126 = 1.6%)e used a coagu a o ( / 6 6%)

Anticoagulation after reviewAnticoagulation after review66 6566 65

6070

28 294050

28

1718

29

146

2030

6

010

Pre Post

Warfarin Antiplatelets NOACS NilWarfarin Antiplatelets NOACS Nil

NOACs after reviewNOACs after review

14

16

10

12

6

8 PrePost

2

4

0Dabigatran Apixaban Rivaroxaban

Study Conclusions 1Study Conclusions 1

• Good turnout 88%Good turnout 88%• 7% do not have AF • 52% are established on Warfarin• No conclusion / unsuitable: 18/126 = 14 3%No conclusion / unsuitable: 18/126 = 14.3%• 11% have Rx changes for stroke prevention• 9.5% new Cardiology referrals generated

Study Conclusions 2Study Conclusions 2

• Majority of patients on warfarin are stable in a practice run via Anticoagulation specialists (95.5%)

• No significant change in Warfarin total numbers:No significant change in Warfarin total numbers: switches offset by new prescriptionsNOAC i ti i b 9% (f 14% t• NOAC prescriptions increase by 9% (from 14% to 23%)

• Antiplatelet prescription fell from 11% to 4.8%• 80% of new Rx are NOACs80% of new Rx are NOACs

Stats Wales via QOFStats Wales via QOF

Atrial fibrillationWales 60348Betsi Cadwaladr University Local Health

Board 14607

Powys Teaching Local Health Board 2786y g 2786Hywel Dda Local Health Board 9034Abertawe Bro Morgannwg University

L l H lth B d 10925Local Health Board 10925

Cwm Taf Local Health Board 5168Cardiff and Vale University Local Health 7481Cardiff and Vale University Local Health

Board 7481

Aneurin Bevan Local Health Board 10347

https://statswales.wales.gov.uk/Catalogue/Health-and-Social-Care/NHS-Primary-and-Community-Activity/GMS-Contract/PatientsOnQualityAndOutcomesFramework-by-LocalHealthBoard-DiseaseRegister

The bigger picture 1: gg pExtrapolations Cwm Taf UHB

fi f hi kwww.afinfographic.co.uk

Cwm Taf extrapolations (contd)Cwm Taf extrapolations (contd)

• Assuming 2/3 already on appropriate anticoagulation (52% warfarin 14% NOAC):g ( )

• 1633 need stroke prevention reviewL 7% AF 1519• Less 7% no AF = 1519

• Less 14.3% no conclusion / unsuitable = 1302/• Less 1.6% refuse anticoagulation = 1281• Predicted new Warfarin scripts = 256• Predicted new NOAC scripts = 1025Predicted new NOAC scripts 1025• Predicted switches from Warfarin to NOAC 4 5% 115

The bigger picture 2: Extrapolations Wales

Wales extrapolations (contd)Wales extrapolations (contd)

• Assuming 2/3 already on appropriate anticoagulation (52% warfarin 14% NOAC):g ( )

• 19596 need stroke prevention reviewL 7% AF 18224• Less 7% no AF = 18224

• Less 14.3% no conclusion / unsuitable = 15618/• Less 1.6% refuse anticoagulation = 15368• Predicted new Warfarin scripts = 3073• Predicted new NOAC scripts = 12294Predicted new NOAC scripts 12294• Predicted switches from Warfarin to NOAC 4 5% 1376

Prevalence not Incidence!Prevalence not Incidence!

• These calculations do not take into account N f AFNew cases of AF

• Incidence rates may help predict numbers of y p pnew prescriptions

Who should be prescribing NOACs in Wales? Food for thought

• Cardiologists …… but!!!!• Physicians• GPs ……… Starting with those who already run Level 4 Anticoagulation Services and those interestedAnticoagulation Services and those interested

• Role of Anticoagulation Pharmacists and AF Nurses• C m Taf proposition of centralised anticoag lation• Cwm Taf proposition of centralised anticoagulation services for HB

ConclusionsConclusions

• There is an urgent large currently unaddressed need in SPAF in Wales

• In addressing this need, substantial non‐AF related k ill b d f C di lwork will be generated for Cardiology

• A substantial increase in NOAC prescriptions can be di t dpredicted

• Current NOAC prescriptions show individualisationh ill h b i l i f• There will have to be capital investment from Health Boards: cost effectiveness has been validated by NICEvalidated by NICE

Thanks / QuestionsThanks / Questions

• Helen Mardon‐Davies, Sue Wooller, Rowena Havard, Angharad Thomas: Anticoagulation / g gCardiac Pharmacists

• Consultant Cardiologists Cwm Taf UHB• Consultant Cardiologists Cwm Taf UHB• Freya Lodge, Hansraj Shetty, Tim Kinnaird• Mandie Welch, Dawn Watkins Arrhythmia NursesNurses

• Ravi Srivastava: Practice Manager @ Ferndale• Anticoagulation implementation group Cwm Taf UHB

Rito Mitra Welsh April - NHS Wales - NOACs in Wales.pdf · 5.0% 10.0% Stroke Admission with AF 0.0%...

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