2. How the assessment has been undertaken?

Study objectives

This study is conducted to analyse the long-term cost-effectiveness of Rosuvastatin

compared with generic Atorvastatin in the treatment of patients at high cardiovascular
risk (Systematic COranary Risk Evaluation [SCORE] ≥ 5%) and patients with prior
cardiovascular disease in Spain.

Study Perspective

The analysis was carried out from the perspective of the Spanish National Health
System with a 20-year time horizon, all costs being expressed as year 2010 euros.

Pharmacoeconomic method

This study is considered as a true cost-effectiveness analysis. The resources (cost)

consumed and the outcome (health benefits) are defined and measured in natural
units. The value of resources is expressed in terms of cost per QALY gained with
Rosuvastatin compared with generic Atorvastatin, in thousands of euros. The outcome
is express in natural units which is reduction of LDL-C level to its targeted value for
sub-group of patient with high risk of CVD event and pre-existing CVD event.

Study design

A locally calibrated Markov model is adapted in this study to determine the treatment
efficacy with costs of treatment in CV events. The model calculates the costs and
incremental effects of the options compared using the formula,

where is cost include the initial and long-term costs of

CV events and the efficacy expressed in terms of QALYs. This model able to
calculate the meant cost per patient of each treatment option, including
pharmacological costs and the costs of various CV complications. The analysis was
performed for patient with high CV risk (primary prevention) and patient prior with
CVD (secondary prevention).

Choice of intervention

The therapeutic options for treating dyslipidemia in patient at high CV risk are
Rosuvastatin 10mg/day and Atorvastatin 20 mg/day initial doses with target LDL-C
100mg/dL for secondary prevention and 70mg/dL for primary prevention. The dose is
tapper up to 40mg for Rosuvastatin and 80mg for Atorvastatin every 12 weeks until
the patient achieve the target LDL-C goal.

Cost and consequences

The economic implications of using different treatments were assessed using three
major types of healthcare costs: (1) the acquisition cost of the statins, (2) the initial
costs of managing CV events, (3) long-term costs of follow-up for patients.

The consequences measured is based on cost used to achieved the targeted LDL. The
result presented in terms of cost per QALY gained with rosuvastatin compared with
generic atorvastatin. The values under €30,000 denote that Rosuvastatin is an efficient
option.

Discounting

Both costs and effects (QALYs) were discounted using an annual rate of 3%

Sensitivity analysis

A sensitivity analysis was carried out to assess the effect of a possible 5% reduction in
the price of generic Atorvastatin on the results.

3. Results

Study Objective The study objective is clearly stated. The

study is conducted to analyse the long-
term cost-effectiveness of Rosuvastatin
compared with generic Atorvastatin in
the treatment of patients at high
cardiovascular risk (Systematic COranary
Risk Evaluation [SCORE] ≥ 5%) and
patients with prior cardiovascular disease
in Spain.
Study Perspective The perspective of the study is also been
addressed in this article which is the
 analysis was carried out from the
perspective of the Spanish National
Health System.
Pharmacoeconomics Method From the title, it is clearly stated the type
of study conducted.
 It is a study of cost-effectiveness
analysis.
 The resources (cost) consumed and
the outcome (health benefits) are
defined and measured in natural
units.
 The value of resources is expressed
in terms of cost per QALY gained
with Rosuvastatin compared with
generic Atorvastatin, in thousands of
euros.
 The outcome is express in natural
units which is reduction of LDL-C
level to its targeted value for sub-
group of patient with high risk of
CVD event and pre-existing CVD
event.

Study Design  It is a prospective study where a

locally calibrated Markov model is
adapted in this study to determine the
treatment efficacy with costs of
treatment in CV events.

 The
model calculates the costs and
incremental effects of the options
compared using the formula, where
is cost include the initial and long-
 term costs of CV events and the
efficacy expressed in terms of
QALYs.
 This model able to calculate the
meant cost per patient of each
treatment option, including
pharmacological costs and the costs
of various CV complications. The
analysis was performed for patient
with high CV risk (primary
prevention) and patient prior with
CVD (secondary prevention).

Choice of Intervention The therapeutic options for treating

dyslipidemia in patient at high CV risk
are Rosuvastatin 10mg/day and
Atorvastatin 20 mg/day initial doses with
target LDL-C 100mg/dL for secondary
prevention and 70mg/dL for primary
prevention. The dose is tapper up to
40mg for Rosuvastatin and 80mg for
Atorvastatin every 12 weeks until the
patient achieve the target LDL-C goal.

Cost Consequences The economic implications of using

different treatments were assessed using
three major types of healthcare costs: (1)
the acquisition cost of the statins, (2) the
initial costs of managing CV events, (3)
long-term costs of follow-up for patients.
The consequences measured is based on
cost used to achieved the targeted LDL.
The result presented in terms of cost per
QALY gained with rosuvastatin
 compared with generic atorvastatin. The
values under €30,000 denote that
Rosuvastatin is an efficient option.
Discounting Both costs and effects (QALYs) were
discounted using an annual rate of 3%
Sensitivity Analysis A sensitivity analysis is clearly stated
which is the iCERs. iCERs was carried
out to assess the effect of a possible 5%
reduction in the price of generic
Atorvastatin on the results.

Relevancy of the data with current The finding of the study is relevant
practice because the study is based on the clinical
trial STELLAR. Therefore, the use of
Rosuvastatin in high CV risk patient as
primary and secondary prevention can be
generalizable.
Limitation The study only focuses on Spain
population. Thus, the CEA results might
not suitable to be used for other countries.
However, the PE analysis method is
clearly outlined and can be followed by
other countries.