PH3_2017 - page 9

CARLO M. BUONAMICO
TKS publisher
7
focus on Pharma Packaging and Excipients
PHARMA HORIZON –
vol. 1(3) 2017
socioeconomic impact (e.g. productivity loss
impact, re-allocation of freed healthcare resources)
are not clearly integrated into HTA decision
frameworks. MCDAmethods may ensure that these
attributes are considered with the relevant weights;
2) there is a need to support research on constraint
optimisation modelling with associated research
on disease burden.
As for the
policies
involved:
3) whenever requested, all medicines should be
eligible for HTA.
There should be no legislative or regulatory
barriers preventing companies from pursuing
HTA for value added medicines. A dedicated HTA
programme may be considered for value added
medicines where the manufacturer would not have
to provide a full HTA submission (abbreviated HTA)
but would only provide evidence on the benefits of
value added medicines;
4) whenever requested, all medicines should be eligible
for early HTA dialogue at national or European
level (multi-HTA advice or parallel scientific advice
– EMA/multi-HTA advice). All medicines claiming
added value should be eligible for multi-HTA early
dialogue and parallel scientific advice (EMA-Multi-
HTA early dialogue), in order to better shape their
clinical development plan;
5) HTA decision frameworks should encompass all
attributes recommended by the EUnetHTACore
Model®, under the following nine domains: Health
Problem andCurrent Use of theTechnology;
Description and technical characteristics of
technology; Safety; Clinical Effectiveness; Costs and
economic evaluation; Ethical analysis;Organisational
aspects; Patients and Social aspects; Legal aspects.
These attributes should be integrated in a
standardised and explicit way through a transparent
and reproducible deliberative process, i.e. with
explicit metrics and reported in HTA reports.
For attributes recommended by the EUnetHTA
Core Model® which are not yet included in HTA
decision frameworks or informally included, it is
suggested to include these attributes as modifiers
of the existing HTA frameworks (i.e. as modifiers
of incremental cost-effectiveness ratio [ICER]
threshold or as modifiers of added clinical benefit
assessment scoring). Such changes in HTA decision
frameworks may ensure that all benefits of value
added medicine are appropriately captured;
6) HTA decision frameworks should be patient-
centric and consider the patient perspective,
including patient-reported outcomes, patient-
centered outcomes, and patient preferences.
There is a need to promote research to identify
the outcomes that are patient-centric, so that HTA
agencies can value them appropriately;
7) beyond randomised clinical trials (RCTs), HTAdecision
frameworks should consider alternative study designs
(e.g. pragmatic design, adaptive design, observational
studies), whenmore appropriate to address the
research question. RCTs are generally regarded as
the “gold standard” study designwith respect to
minimising the risk of bias for evidence generation.
However, if RCTs are designed tomaximise internal
validity, theymay have some limitations regarding
external validity (e.g. restriction in patient population
due to strict eligibility criteria) andmay not be the
most appropriate study design for answering all the
evidence questions potentially relevant toHTAbodies;
8) HTA organisations should encourage the use of
coverage with evidence development, to allow
some benefits that may be complex to demonstrate
during development to be captured post launch.
Real-world evidencemight bemore appropriate to
demonstrate some benefits of value addedmedicines;
9) HTA decision frameworks should adopt a broader
perspective in order to better reflect patients’ and
society’s views of healthcare.
Due to the potentially substantial impact of
productivity costs on cost-effectiveness outcomes,
they should be considered in HTA decision
frameworks.This may enhance the ef
fi
ciency
related to usage of medicines (including value added
medicines) to improve overall society performance;
10) a broad range of stakeholders, including patients,
healthcare professionals, society representatives
(citizens), andhospital administrators, shouldbe voting
members of HTA committees in order to integrate a
broad perspective into the final recommendation.
REFERENCES
1. Toumi M, Rémuzat C. Value added medicines: what
value repurposed medicines might bring to society?
J MarkAccess Health Policy. 2017; 5(1): 1264717.
What is HealthTechnology Assessment
Health technology assessment (HTA) refers to the the systematic evaluation of properties, effects, and/or impact of health
technology. It is a multidisciplinary process to evaluate the social, economic, organisational and ethical issues of a health
intervention or health technology. The main purpose of conducting an assessment is to support decision-making policies.
Health technology is defined as the application of organised knowledge and skills in the form of medicines, medical devices,
vaccines, procedures and systems developed to solve a health problem and improve quality of life.
Source:World Health Organization website
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