Medical Costs per QALY of Statins Using the Swiss Medical Board (SMB) assumptions: Observed Effects in Two Large Primary Prevention Cohorts from Germany and Switzerland

Michel Romanens1, Franz Ackermann1, Thomas Szucs2, Isabella Sudano3, Ansgar Adams4

1 Vascular Risk Foundation (Varifo), Olten 2 European Centre of Pharmaceutical Medicine (ECPM), Basel 3 University Heart Center Cardiology, University Hospital Zürich, Zürich,

Switzerland,4 Gesundheitsvorsorge und Sicherheitstechnik GmbH, Bonn, Germany

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

Background

- In June 2014 the SMB publishes a report showing costs per quality

adjusted life years (Costs/QALY) to be extremely unfavorable (210’000

SFr) for statins in primary care in subjects having an ESC risk of 0.9% in

5 years.

- As a consequence, in otherwise cardiovascular healthy subjects without

diabetes mellitus or familial hypercholesterolemia, the SMB recommends

statins in primary care only in subjects with a calculated ESC risk of

≥7.5% in 10 years.

- The rationale for this apparent gap warrants further elucidation.

- Further, costs/QALY at various cutoffs and it’s effect in cardiovascular

disease prevention at the primary care level have not yet been reported.

- The SMB Statin report is available at http://www.medical-

board.ch/fileadmin/docs/public/mb/Fachberichte/2014-07-

21_Bericht_Statine_Final_Anpassung.pdf

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

AIMS

- We aim to determine Costs/QALY for various cutoffs of ESC risk using

the SMB assumptions.

- We aim to determine, whether Costs/QALY at different ESC risk levels

correlate with the number needed to treat (NNT) in the SMB

assumptions.

- Based on various NNT, we aim to derive the ideal ESC risk cutoff for

costs/QALY, allowing an NNT of 25 to be adequate.

- We aim to test various ESC risk cutoffs in two large healthy populations

from Switzerland (CH) and Germany (DE) to detect a coronary risk

equivalents defined by the total carotid plaque burden, a highly sensitive

and specific marker of future fatal and nonfatal myocardial infarction.

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

METHODS (1)

- The EFFECT MODEL of the SMB to calculate costs/QALY is:

- for 1 fatal AMI, 4.5 nonfatal AMI occur

- relative risk reduction per 1 mmol/l LDL is 22%

- cost per fatal AMI is CHF 8'500, per nonfatal AMI is CHF 25'000 in

the first year and CHF 8'000 in subsequent years

- loss of QALY is 1.0 for fatal and 0.2 for nonfatal AMI

- annual preventive medical cost per individual including statin costs

CHF 470 SFr

- all AMI events occur uniformly after 50% of the total observation

time.

- The calculations are available at www.varifo.ch/QALYVarifo.xlsx

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

METHODS (2)

- We defined the numbers of subjects exhibiting a coronary risk equivalent

using carotid atherosclerotic plaque imaging and calculated the

sensitivity (SENS) and the specificity (SPEC) of various ESC cutoffs to

detect these subjects.

- SENS: sensitivity deals with the diseased subjects

- [true positives] / [true positives and false negatives]

- SPEC: specificity deals with the healthy subjects

- [true negatives] / [true negatives and false positives]

- NNT: 1 / absolute risk reduction

- Examples:

- 10% absolute risk reduction = 100/10 = NNT 10

- 1% absolute risk reduction = 100/1 = NNT 100

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

METHODS (3)

- Carotid imaging were obtained by ultrasound (linear probe 7-14 MHz)

- Imaging was performed with the identical imaging technique in CH and

DE

- Total Carotid Plaque Burden was determined from both carotid arteries

- Each carotid plaque was traced longitudinally and added together,

ending up with the total plaque area (TPA) in mm2.

- we used TPA ≥80 mm2 (TPA80) to define high long-term (≥20% in ≥10

years) coronary risk (Arterioscler Thromb Vasc Biol. 2014;34:226-230)

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

RESULTS (1)

- 1

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

RESULTS (1)

- 1

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

Results (2)

CH

2203

1083 (49%)

57±7

22%

60/79

30/93

11/98

4/99

DE

2942

989 (34%)

46±10

15%

30/95

7/100

2/100

0.5/100

Population (N)

Female (%)

Mean age (years±SD)

TPA ≥80 mm2

SENS/SPEC ESC 1.8% 10 years

SENS/SPEC ESC 3.3% 10 years

SENS/SPEC ESC 5.0% 10 years

SENS/SPEC ESC 7.5% 10 years

Sensitivity and specificity of ESC risk cutoffs the detect a

coronary risk equivalent defined by carotid plaque imaging

(TPA)

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

Discussion (1)

- Using the Costs/QALY assumptions of the SMB we find that the effect of

statins correlates with the NNT.

- Using a model with an ESC risk of 0.9% in 5 years, costs/QALY are

210’000 SFr. (NNT 91)

- Using a Model with an ESC risk of 7.5% in 10 years, costs/QALY are

2’089 SFr. (NNT 11)

- The middle way cutoff may be more suitable:

- Using a Model with an ESC risk of 3.3% in 10 years, costs/QALY are

40’261 SFr. (NNT 25)

NNT

Costs

/QA

LY

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

Discussion (2)

- The conclusion of the SMB has to be questioned, since there is a gap

between the presented costs/QALY of 210’000 SFr and the

recommended cutoff of ESC 7.5% to treat with statins.

- Using the SMB cutoff of ESC 7.5% would leave near 100% of healthy

subjects with a coronary risk equivalent untreated with statins.

- Using the SMB cutoff of ESC 7.5% creates an obsolescence for

measuring Cholesterol in primary care.

Medical Costs per QALY of Statins Using SMB assumptionsSGIM Annual Meeting 2015 (FM277): M. Romanens et al / www.varifo.ch

Conclusion

- We find statins to have costs per 1 mmol/l of LDL reduction of CHF

40'000/QALY (NNT 25) for an ESC risk of 3.3%, when we use the SMB

assumptions.

- With ESC 7.5% (SMB guide), many subjects with confirmed high risk

atherosclerosis would presumably not be treated (SENS 4% in CH, 0.5%

in DE), creating a situation, where there is an obsolescence for

Cholesterol measurements (because high LDL would not be treated

anyway).

- Further studies are needed to test the SMB statin effect assumptions,

since the SMB assumptions have not been evidenced in reality.

- In the future, costs per QALY should be calculated with inclusion of

medical and social costs.

- In the mean time, we strongly recommend to adhere to the international

guidelines for initiation of statin treatments in healthy subjects.