on the afternoon of Saturday

13th June. The workshop will

focus on the EuroScan

Methods Toolkit with

presentations from members

on various aspects of early

awareness and alert systems.

When we are in Oslo we will

take time out to remember

our friend and EuroScan

member Dr Inger

Norderhaug who sadly

passed away on 25th May

2015. Inger first joined

EuroScan in May 2002 and

quickly became a valued

member of the collaboration

at a time when early

awareness and alert activity

was a relatively new discipline

in the HTA world. Inger was

the Registrar of EuroScan for

5 years, from January 2004

until December 2008,

championing EAA activities at

an international level and

internally strengthening the

collaboration.

Inger will be remembered

fondly for her friendly,

welcoming and enthusiastic

approach; her constructive

ways of finding solutions and

agreements, and her insight

into the field of new and

emerging technologies that

has been an inspiration to us

all. Our thoughts go to her

family and her colleagues at

NOKC.

EuroScan started 2015 with a

new Chair; Dr Roberta Joppi

who leads the Italian Horizon

Scanning Project (IHSP) in

Verona. Roberta took over

from Professor Brendon

Kearney who successfully lead

the network for four years.

IHSP joined EuroScan in 2008

at a EuroScan meeting in

Zurich. As well as being an

active member, Roberta was

previously the Registrar for

EuroScan (January 2013 -

December 2014). Our new

Registrar is Dr Sungkyu Lee

from NECA in South Korea.

EuroScan’s first meeting in 2015

was aptly in Zurich; hosted by

the Swiss Federal Office of

Public Health (SFOPH). The

venue, a hotel on the Üetliberg

mountain provided amazing

views over Zurich. The fresh

mountain air stimulated lots of

discussion including ideas for

EuroScan’s forward work

programme. This will be agreed

at the Autumn meeting.

Members also heard about

progress with the new

EuroScan website and database.

The current website is showing

its age (6 years old in July!) and

the database no longer meets

member requirements (and is

even older!). We apologise to

anyone who has recently visited

the website and experienced

problems but the good news is

that EuroScan will have a new

improved website in the next

few months. The database is

being designed to enable

members to easily upload

information on new and

emerging technologies, This in

turn will further address one

of EuroScan’s goals - To

improve the exchange of

information about new and

emerging health technologies

and their potential impact on

health services and existing

health technologies.

We are now almost half way

through the year. Many

EuroScan members will be

attending HTAi 2105 in Oslo

and will give presentations on

their organisations EAA

systems. EuroScan will also

hold a members meeting

followed by a collaboration

meeting with affiliated

networks . This will give us the

opportunity to discuss current

activity, needs and

expectations, and proposals

for collaboration on early

awareness and alert activities.

EuroScan is also running a pre-

conference workshop at HTAi

The year so far ….

I N S I D E T H I S

I S S U E :

Are horizon

scanning sources

useful in

identifying

possible

technologies for

disinvestment?

2

Cardiac

Contractility

Modulation

(CCM) therapy:

new results

coming.

3

New report on

artificial

pancreas device

systems in

development for

type 1 diabetes

4

What’s on the

horizon for

COPD

diagnostics and

monitoring

technologies?

5

Focus on new

and emerging

treatments for

Hepatitis C

Virus

6

HTAi Oslo 2015 8

Standardisation

of European

HTA –

Application of

the EUnetHTA

HTA Core

Model for Rapid

Relative

Effectiveness® in

Austria

9

4th HTAsiaLink

annual

conference

10

An Update from

INAHTA

11

CNESH Top 10

2015

12

J U N E 2 0 1 5 I S S U E 1 8

EuroScan Newsletter

P A G E 2

Caption describing

picture or graphic.

Are horizon scanning sources useful in identifying possible technologies for disinvestment? Leigh-Ann Topfer, CADTH

Recently, the HTAi special interest

group on disinvestment expanded to

include horizon scanning and early

awareness (Disinvestment and Early

Awareness). This makes sense as both

focus on particular, though distinct,

stages of the technological lifecycle.

But, is it possible to combine the tasks

of identifying both new and emerging

and potentially obsolete technologies?

In particular, are the sources of

information used for identifying new

and emerging technologies also helpful

for finding technologies that may be

appropriate for disinvestment?

In a 2009 study, researchers from the

Basque Office for Health Technology

Assessment (Osteba) surveyed HTA

agencies involved in disinvestment to

identify and rank the sources used to

identify potentially obsolete

technologies.1 In general, the sources

were similar to those used for health

technology assessments, for example,

The Cochrane Collaboration, other

HTA agencies and association web

sites, and key medical journals (JAMA

and the BMJ).1 Most of the sources

only indirectly identified obsolete

technologies.1 One agency relied

solely on the advice of experts to

identify possible technologies for

disinvestment.

The Osteba researchers also

conducted a pilot study to examine

the value of the EuroScan database as

a source for identifying potentially

obsolete technologies.2 Mainly, the

database was helpful as a source of

some possibly substitutive

technologies, but consultation with

clinical experts was ultimately seen as

the most useful way to identify

possibly obsolete

technologies.2 From these

studies, Osteba developed the

complementary SorTEK-ZaharTEK

databases (SorTEK for new technologies

and ZaharTEK for potentially obsolete

technologies).3

At the 2010 annual HTAi conference in

Dublin, researchers from the UK’s

National Institute for Health Research

Horizon Scanning Research &

Intelligence Centre presented a session

entitled: Out with the old, in with the new:

identifying health technologies for

disinvestment – can early awareness and

alert systems play a part?4 This work

included a literature review and survey

of health care decision makers and

providers. They also found that the

involvement of health professionals and

other relevant stakeholders was of key

importance in the identification of

potentially obsolete technologies.

Clinical practice guidelines, variations in

practice and comparative effectiveness

research have also been suggested as

other potential sources of candidate

technologies for disinvestment, but

further confirmation of their value is still

lacking.5

Several studies have examined the value

of different information sources in

horizon scanning for new and emerging

health technologies.6-11 To date,

searching for technologies for

disinvestment has been largely reactive.

“Moving to a more proactive model

requires the use of horizon scanning …

known as ‘obsolescence forecasting’ in the

information technology industry…”12 An

update on the experiences of Osteba

and other agencies, in combining

horizon scanning with scanning for

disinvestment opportunities would be

useful.

References

1. Ibargoyen-Roteta N, Gutierrez-Ibarluzea I, Asua J,

Benguria-Arrate G, Galnares-Cordero L. Scanning

the horizon of obsolete technologies: possible

sources for their identification. Int J Technol Assess

Health Care 2009;25(3):249-54.

2. Ibargoyen-Roteta N, Gutierrez-Ibarluzea I,

Galnares-Cordero L, Benguria-Arrate G, Arana-

Arri E. Estudio piloto de identificacion y evaluacion de

tecnologias sanitarias obsoletas a partir de las bases

de datos de tecnologias emergentes [Informes de

Evaluacion de Tecnologias Sanitarias. Osteba].

Vitoria-Gasteiz (Spain): Servicio de Evaluacion de

Tecnologias Sanitarias del Pais Vasco (Osteba);

2014. Available: http://

www.kultura.ejgv.euskadi.eus/r46-714/es/

contenidos/informacion/biblioteca_central/

es_9528/scp/216254.pdf.

3. Ibargoyen-Roteta N, Gutierrez-Ibarluzea I,

Benguria-Arrate G. Out with the old, in with the

new? The first strategy to integrate the

identification of new and emerging health

technologies with those that could be removed

from the health care system. EuroScan Newsletter

2009;(7):7. Available: http://euroscan.org.uk/mmlib/

includes/sendfile.php?id=73.

4. Osinowo A, Simpson S. Out with the old, in with

the new: identifying health technologies for

disinvestment - can early awareness and alert

systems play a part? [abstract]. In: 7th annual

meeting of HTAi: Maximising the value of HTA; June 6-

9, 2010; Dublin, Ireland. [Edmonton (AB)]: HTAi;

2010. p.88.

5. Haas M, Hall J, Viney R, Gallego G. Breaking up is

hard to do: why disinvestment in medical

technology is harder than investment. Aust Health

Rev 2012;36(2):148-52. Available: http://

www.publish.csiro.au/index.cfm?paper=AH11032.

6. Douw K, Vondeling H. Selecting new health

technologies for evaluation: can clinical experts

predict which new anticancer drugs will impact

Danish health care? Soc Sci Med 2007;64(2):283-6.

7. Douw K, Vondeling H, Eskildsen D, Simpson S.

Use of the Internet in scanning the horizon for

new and emerging health technologies: a survey of

agencies involved in horizon scanning. J Med

Internet Res 2003;5(1):e6. 8. Stafinski T, Topfer LA, Zakariasen K, Menon D.

The role of surgeons in identifying emerging

technologies for health technology assessment.

Can J Surg 2010;53(2):86-92. Available: http://

canjsurg.ca/vol53-issue2/53-2-86/. 9. Trindade E, Topfer LA, De GM. Internet

information sources for the identification of

emerging health technologies. A starting point. Int J

Technol Assess Health Care 1998;14(4):644-51.

10. Robert G, Gabbay J, Stevens A. Which are the

best information sources for identifying emerging

health care technologies? An international Delphi

survey. Int J Technol Assess Health Care 1998;14

(4):636-43.

11. Smith J, Cook A, Packer C. Evaluation criteria to

assess the value of identification sources for

horizon scanning. Int J Technol Assess Health Care

2010;26(3):348-53.

12. Joshi NP, Stahnisch FW, Noseworthy TW.

Reassessment of health technologies: obsolescence and

waste [Discussion Paper]. Ottawa: Canadian

Agency for Drugs and Technologies in Health

(CADTH); 2009. Available: https://www.cadth.ca/

reassessment-health-technologies-obsolescence-

and-waste.

Cardiac Contractility Modulation (CCM) therapy: new results coming. Antonio Migliore and Marina Cerbo, Agenas, Agenzia nazionale per i servizi sanitari regionali, Via Puglie 23 – 00187 Rome, Italy

P A G E 3 I S S U E 1 8

In January 2015, a

retrospective analysis of 81

patients implanted with a

CCM device between 2004

and 2012 showed significant

improvement of ejection

fraction, from 23.1 ± 7.9%

to 29.4 ± 8.6% (p < 0.05),

decrease in mean NT-

proBNP levels, from 4,395

± 3,818 to 2,762 ± 3,490ng/

l (p < 0.05), and an overall

clinical responder rate (at

least one class

improvement of NYHA

within 6 months or last

follow-up) of 74.1% [2].

Two studies are currently

registered on

clinicaltrials.gov:

FIX-HF-5C

(NCT01381172): is a

prospective, multicentre,

randomised study to

evaluate the safety and

efficacy of CCM signals

delivered by the

implantable OPTIMIZER™

System in patients with

NYHA class III/IV heart

failure and an ejection

fraction 25-45%. The study

will involve the recruitment

of 230 subjects at a total of

up to 40 sites (USA, Czech

Republic, and Germany).

Estimated completion date

is August 2015.

FIX-HF-5

(NCT00112125): is a

prospective, multicentre,

study to evaluate the

safety and efficacy of CCM

signals delivered by the

Cardiac Contractility

Modulation (CCM) therapy

consists of the delivery of

non-excitatory electrical

signals to the heart muscle

during the absolute

refractory period. These

signals are applied to

moderate to severe heart

failure with the aim of

modifying the properties of

the heart (i.e. enhancing the

force of contraction).

The German company

Impulse Dynamics launched

this technology in 2002

with the OPTIMIZER™

System. Today, the system

is at its fourth generation,

the OPTIMIZER™ IVs. The

system is similar to a

cardiac pacemaker: it is

implanted under local

anaesthetic and is

connected to three

pacemaker leads implanted

transvenously into the right

side of the heart (one lead

senses the atrial activity, the

other two sense ventricular

activity and deliver the

signals). The new

OPTIMIZER™ IVs device

consists of: an implantable

pulse generator unit (which

has sensing and signal

delivery functions), a

charger (which allows

patients to recharge the

pulse generator at home),

and a programmer system

(which allows healthcare

professionals to customise

the CCM signal parameters

specifically for the patient)

[1].

implantable

OPTIMIZER™ System in

patients with NYHA class

III/IV heart failure. The

study will involve the

recruitment of

approximately 420

subjects at up to 50 sites

across the USA.

Estimated completion

date is July 2017.

Recently (October 2014)

the company announced

the enrolment of the first

patient in a new study, the

IMPULSE-HF study, at the

Karolinska Institute,

Stockholm (Sweden).

IMPULSE-HF is designed to

provide additional

evidence related to the

clinical benefit of CCM

therapy in symptomatic

NYHA II/III patients having

normal QRS complex and

ejection fraction in the

range 25-45% [3].

Results that will soon be

published, starting from

2015, will contribute to

define the real clinical

effectiveness of this

therapy.

References

[1] Horizon Scanning

Centre – National

Institute of Health

Research.

OPTIMIZER™ system

for chronic heart

failure http://

www.hsc.nihr.ac.uk/

files/

downloads/2476/2663.

21e67718.FinalOptimi

zer.pdf

[2] Kuschyk J, Roeger

S, Schneider R,

Streitner F, Stach K,

Rudic B, Weiß C,

Schimpf R, Papavasilliu

T, Rousso B, Burkhoff

D, Borggrefe M.

Efficacy and survival in

patients with cardiac

contractility

modulation: Long-

term single center

experience in 81

patients. International

Journal of Cardiology

183 (2015) 76–81.

[3] Impulse Dynamic

press release –

October 2014. http://

www.impulse-

dynamics.com/int/

news/impulse-

dynamics-announced-

first-enrollment-

impulse-hf-european-

randomized-efficacy-

study/ (accessed on 11

May 2015).

P A G E 4

“In addition to

providing a

technology

overview, our report

also presents a

qualitative analysis

of the views

expressed by

healthcare

professionals and

members of the

public with type 1

diabetes “

New report on artificial pancreas device systems

in development for type 1 diabetes Sara Trevitt , NIHR Horizon Scanning Research & Intelligence Centre (HSRIC)

In March the NIHR

Horizon Scanning

Research & Intelligence

Centre (NIHR HSRIC)

published a report on

artificial pancreas device

systems being developed

for the closed-loop

control of type 1

diabetes. Type 1 diabetes

is a life-long autoimmune

condition in which the

normal mechanism for

controlling blood glucose

levels does not work. It

usually begins in

childhood, and affects

over 250,000 people in

the UK. The condition

requires ongoing daily

management, either by

the person themselves

or with the help of a

carer (such as a parent).

An artificial pancreas

device (APD) system is a

small, portable medical

device that uses digital

communication

technology to carry out

the function of a healthy

pancreas in regulating

blood glucose levels. It

has three functional

components: (1) a

continuous glucose

monitor, (2) an insulin

pump, and (3) a

digital controller

that links the other

two to form a

closed-loop.

Continuous glucose

monitors and insulin

pumps are

already available

and are used by

some people with

type 1 diabetes. The

innovative feature of

closed-loop APD systems

is the addition of the

wireless digital controller

(the ‘brain’) to these

existing technologies. This

new combination could

potentially provide an

option for automated self-

management for people

with type 1 diabetes.

However, using such a

system would require the

person to wear several

devices on their bodies

which might raise issues

around user acceptability.

Our research identified 18

APD systems, all of which

are currently in the

research stage of

development (mainly in

phase I and II clinical

trials). Six of the systems

are being tested in the

home setting, whilst the

others are being studied

in clinic and outpatient

environments. Some of

the systems are fully

automated whilst others

still require a manual meal

-time bolus. Most of the

systems use insulin only,

whereas some use a bi-

hormonal approach,

delivering both insulin and

glucagon. Other key

features of the systems

are the type of algorithm

that the controller is

based on and their

strategy for glycaemic

control (treat-to-target or

treat-to-range control). It

is expected that the first

systems will appear on the

market from late 2016

onwards.

In addition to providing a

technology overview, our

report also presents a

qualitative analysis of the

views expressed by

healthcare professionals

and members of the public

with type 1 diabetes and

their carers who we

engaged with to provide

input. This included

conducting an open-access

public survey using the

social media platform

Facebook. Comments

were made about what

benefits people thought

this new form of

technology might bring,

what the key issues will be

concerning its use and

adoption into the

healthcare system, and the

important features that

they would like to see in

commercial products

when they become

available. In addition to

emphasising the

importance of safety,

reliability and accuracy,

preferences were

expressed about the

physical design,

characteristics and

functionality that these

systems should have if

they are to be acceptable

to users.

The report is available at

http://

www.hsric.nihr.ac.uk/

outputs/other-reports/

Artificial pancreas. Source: http://

www.hcplive.com/articles/Artificial-Pancreas-

Provides-Tight-Glucose-Control-in-Youth

What’s on the horizon for COPD diagnostics and monitoring technologies? Louise Dixon and Derek Ward, NIHR Horizon Scanning Research & Intelligence Centre (HSRIC)

P A G E 5 I S S U E 1 8

Chronic Obstructive Pulmonary

Disease (COPD) poses a large and increasing burden on patients, carers

and health services. Despite being a disease with significant impact, there

remain several key issues facing its management: diagnosis is often

delayed until the disease is in its moderate to severe stages, resulting in patients missing out on appropriate

care early in the development of their disease; and the empirical treatment

of COPD exacerbations exposes some patients to inappropriate

antibiotic and corticosteroid therapy, a particular concern given the

increasing development of antibiotic resistance and the potentially

significant side effects of corticosteroids. To determine

whether technologies already in development could address these

issues, the NIHR HSRIC undertook a review of new and emerging

technologies for the diagnosis and monitoring of COPD, aiming to identify all technologies within 2 years

of launch or in the early post-launch phases, and evaluate these for

innovativeness, patient acceptability, and likelihood of health service and

patient impact.

Comprehensive searches identified a total of 80 technologies covering a

wide variety of technology areas, including telehealth, vital sign

monitoring technologies, questionnaires, imaging, biomarker

tests, spirometry and wearable technologies. Evaluation of individual

technologies was undertaken by both a panel of clinicians and a panel of patients with COPD. The clinician

panel incorporated views from across the multidisciplinary team (specialist

nurses, general practitioners and specialist respiratory physicians) and

an existing patient and public involvement group (Birmingham Lung

Improvement StudieS, BLISS) was used in order to reflect potential

users’ opinions and contrast these

against those of the clinician panel.

Biomarker tests were the largest

identified field, with tests using samples of sputum, saliva or blood

in order to diagnose, monitor or identify exacerbations of COPD.

Most innovatively, the Home Use Sputum Test (Aseptika Ltd., UK)

aims to provide advance warning of an exacerbation of COPD through a

small sputum sample at the point of care. This could enable treatment of

exacerbations to begin earlier and limit antibiotic and corticosteroid use to where it is necessary. In

addition, several novel molecular point of care tests aim to identify

the specific bacterial or viral pathogen responsible for an

exacerbation (such as RESPOC, developed by Ateknea Solutions,

Hungary), a development welcomed

by the clinician panel.

Telehealth technologies were also

frequently identified. Devices were generally aimed towards patient self-

monitoring, with the ability for one or two-way messaging between the

patient and healthcare professionals. However, evaluation by the clinician panel was generally negative,

concluding that although telehealth has been demonstrated to reduce

the odds of A&E attendance and hospitalisation, it did not improve

quality of life or mortality, and is not

currently considered cost-effective.

Wearable technology was also an

area of significant development.

Devices designed to be worn across the chest, such as the WHolter vest

-like breathing monitor (iSonea Ltd., Israel), were not favourably rated by

the patient panel, who commented that they were unwilling to wear a

“cumbersome” looking device, and were concerned about “the idea of having the restriction of a band around

[the] chest”. In contrast, wrist-based monitoring devices, such as the

BuddyWOTCH (Aseptika Ltd., UK), were praised for their compact,

wearable design and ability to record blood oxygenation,

temperature, heart rate and physical activity. Such devices aim to detect

the early signs of exacerbations, enabling early treatment and

preventing unnecessary

hospitalisation.

The most promising technologies

identified by this review were recommended as a focus of future translational and clinical research

funding, ultimately to facilitate their timely evaluation and adoption

within the NHS. These diagnostic and monitoring technologies have

the potential to meet an unmet need in COPD care through supporting

earlier diagnosis, the provision of appropriate treatment and the

timely recognition of acute exacerbations, while those with the

potential to determine the cause of an exacerbation may enable

treatment to be better targeted at the underlying pathology, potentially

avoiding inappropriate use of

antibiotics and corticosteroids.

The review report will be published on the HSRIC website in mid-June

2015 (www.hsric.nihr.ac.uk). Further information can be obtained from

Dr Derek Ward d.j.ward@bham.ac.uk

P A G E 6

Focus on new and emerging treatments for Hepatitis C Virus Joppi R, Pase D, Poggiani C, IHSP

Epidemiology of the disease

Hepatitis C Virus (HCV) is a single

stranded, positive sense RNA virus

first described in 1989. It infects more than 180 million people

worldwide, corresponding to about 3% of the global population, with

high prevalence (>3.5%) in central

and eastern Asia, North Africa, and

the Middle East; moderate prevalence in South and South East

Asia, sub- Saharan Africa, Central and South America, Australasia, and

Europe [1]. The prevalence of HCV in Europe is nearly 1%, but this varies

geographically along a north-south

gradient, ranging from approximately 0.5% in Northern countries to 2% in

Mediterranean areas [2].

Hepatitis C becomes chronic in 75%

of adults, and 80% of children.

Others will spontaneously clear their infection, usually within months.

Reinfection is possible in people who

spontaneously cleared HCV, or were successfully treated. Consequences

of untreated chronic HCV infection include depression, cardiovascular

and autoimmune disorders and liver scarring. After 20 years of infection,

16% of adults develop cirrhosis; this increases exponentially to 40% after

30 years. People with cirrhosis are at risk for hepatocellular carcinoma

and liver failure. Each year, 700,000

people die from HCV-related causes.

Hepatitis C genotypes

There are seven known HCV genotypes,

each with dozens of subtypes. The high

genetic variability of HCV (>30% nucleotide difference between

genotypes, 15% to 30% nucleotide difference among subtypes) has made it

difficult to develop universally effective

vaccines and treatments.

Globally, genotype 1 predominates

(46.2%, or 83.4 million cases), followed

by genotype 3 (30.1%, or 54.3 million cases), genotype 2 (9.1%, or 16.5 million

cases), genotype 4, (8.3%, or 15 million cases), genotype 6 (5.4%, or 9.8 million

cases), and genotype 5 (<1%, or 1.4 million cases); there is a single known

case of genotype 7 (Fig. 1) [3,4].

Treatments: goals and evolution

The goal of HCV treatment is cure (also

referred to as sustained virologic response [SVR]). Being cured reduces

the risk of liver-related and all-cause morbidity and mortality. The standard

of care for HCV has improved dramatically. Pegylated interferon and

ribavirin - a partially effective regimen with potentially debilitating side effects -

is being replaced by safe, tolerable oral

direct-acting antivirals (DAAs). These drugs have cured >90% of people in

clinical trials, in only 12 weeks [5].

The HCV encodes three structural and seven non-structural proteins. DAAs can

inhibit three major non-structural

proteins: the NS3/4A protease, the

NS5A protein, and the NS5B RNA

dependent RNA polymerase [1].

New and emerging drugs for

patients with Chronic HCV

Due to the predominance of HCV

genotype 1- especially in high-income

countries - it has been the focus of DAA development. All DAA classes

work against genotype 1. The most common strategy for treating HCV

genotype 1 is using DAAs from multiple classes, to shorten

treatment and increase cure rates. Although cure rates in trials

combining DAAs from 3 classes have topped 95%, those who are not

cured may be left with few options.

Currently, sofosbuvir is the optimal

drug for a first-line regimen, since it is pan-genotypic, can be used in

cirrhosis, has a low propensity for drug-drug interactions, and a high

resistance barrier. Pairing it with a pan-genotypic NS5A inhibitor

obviates pre-treatment genotypic testing, and will minimise safety and

efficacy monitoring during and after

treatment. The weakness of NS5A inhibitors is baseline or emergent

drug resistance that may limit their

effectiveness.

Candidates in phase II development

(AbbVie’s ABT-530, Achillion’s ACH-3102, and Merck’s MK-

8408) are purported to

be more potent, and active against drug

resistant virus [5].

Tables 1a and 1b summarise the new drugs

recently approved along with the combinations in

phase III of development

to be used in naïve and previously treated

patients, respectively.

Figure 1. Used from: Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C

virus genotypes. Hepatology. 2015 Jan;61(1):77-87.

Emerging treatments for HCV continued...

P A G E 7 I S S U E 1 8

HCV Treatment Criteria

and Strategies Each year, 700,000 people die

from complications of HCV, a curable virus. HCV treatment

has individual and public

health benefits [6]. Current HCV treatment rates are low,

ranging from 1% to <5%, in part due to the high cost of

DAAs [7-10]. This has led to restrictions and prioritising

people with the most advanced liver disease; a

strategy that will reduce HCV-associated illness and death,

but won’t stop the epidemic

from spreading [11-13].

Although there are several barriers to universal HCV

treatment access, high DAA prices are the greatest

obstacle. The same steps that have led to drastic reductions

in the price of HIV antiretrovirals can be used

with DAAs. In fact, they can be mass-produced profitably,

and remain affordable [14,15].

Using a public-health

approach to HCV treatment, one regimen for everyone,

will simplify procurement and delivery of treatment,

especially if duration does not vary by genotype, subtype or

cirrhosis. Some regimens do

not require genotyping and subtyping, which are

expensive and not always

available [5].

Future research

HCV drugs have been developed primarily by

pharmaceutical companies, driven by commercial

interest, instead of collaborating with public

health authorities to identify

optimal DAA regimens with

best-in-class drugs and

therefore delayed development of, and access to

promising regimens. This leaves many questions about

DAA safety and efficacy in certain populations (although

registries will provide additional information on

DAA use and outcomes outside of clinical trials) [5].

Some of the remaining questions include: need for

ribavirin in certain

populations; treatment safety and efficacy in understudied

or excluded populations; clinical relevance of drug

resistance; treatment sequencing;

pharmacogenomics; genotypes 5 and 6; DAAs in

acute HCV infection; best treatment regimens in HCV-

HIV; and best treatment for recurrent HCV in liver

transplant recipients [1,5].

References

[1] Feeney ER, Chung RT. Antiviral

treatment of hepatitis C. BMJ. 2014 Jul

7;348:g3308. doi: 10.1136/bmj.g3308.

[2] Touzet S, Kraemer L, Colin C, et al.

Epidemiology of hepatitis C virus

infection in seven European Union

countries: a critical analysis of the

literature. HENCORE Group. (Hepatitis

C European Network for Co-operative

Research. Eur J Gastroenterol Hepatol.

2000 Jun;12(6):667-78.

[3] Messina JP, Humphreys I, Flaxman A, et al.

Global distribution and prevalence of

hepatitis C virus genotypes. Hepatology.

2015 Jan;61(1):77-87. doi: 10.1002/

hep.27259.

[4] Smith DB, Bukh J, Kuiken C, et al.

Expanded classification of hepatitis C

virus into 7 genotypes and 67 subtypes:

updated criteria and genotype

assignment web resource.

Hepatology.2014 Jan;59(1):318-27. doi:

10.1002/hep.26744.

[5] Swan T. Overview of New Treatments

for Hepatitis C Virus: Moving Towards a

Public Health Agenda http://

www.who.int/selection_medicines/

committees/expert/20/reviews/overview

-new-treatments-HEP-C_13-Apr-15.pdf

(accessed 19 May 2015)

[6] Global Burden of Disease 2013

Mortality and Causes of Death

Collaborators. Global, regional, and

national age–sex specific all-cause and

cause-specific mortality for 240 causes

of death, 1990–2013: a systematic

analysis for the Global Burden of

Disease Study 2013. The Lancet, Vol.

385, No. 9963, p117–171.

[7] Helfand C. Hello, hep C pricing war

Gilead hits back at AbbVie with

exclusive CVS deal. Fierce Pharma.

January 5, 2015. http://

www.fiercepharma.com/story/gilead-hits

-back-abbvie-exclusive-cvs-hep-c-

deal/2015-01-05 (accessed 19 May 2015)

[8] Hirst EJ. AbbVie lowers price of

hepatitis C drugs to win deal with

Express Scripts. Chicago Tribune.

December 22, 2014. http://

www.chicagotribune.com/business/

breaking/ct-abbvie-hepatitis-c-drug-1223

-biz-20141222-story.html (accessed 19

May 2015)

[9] Jerzyk E. R.I. Medicaid limits supply of

hepatitis C drug due to cost. The Brown

Daily. December 4, 2014. http://

www.browndailyherald.com/2014/12/04/

r-medicaid-limits-supply-hepatitis-c-drug

due-cost/ (accessed19 May 2015)

[10]Venteicher W. Most

Illinois Medicaid Patients

Denied New Hepatitis C

Drugs. Chicago Tribune.

November 19th, 2014.

http://

kaiserhealthnews.org/

news/most-illinois-

medicaid-patients-denied

-new-hepatitis-c-drugs/

(accessed 19 May 2015)

[11]Huet N. France uses tax

to put pressure on

hepatitis C drug prices.

Reuters. September 30,

2014. http://

www.reuters.com/

article/2014/09/30/france

-deficit-gilead

idUSL6N0RV27X201409

30. (accessed 19 May

2015)

[12]Sevillano EG. Spanish

hepatitis C patients to

march for access to

expensive new drugs.

January 6, 2015. El Pais.

http://elpais.com/

elpais/2015/01/06/

inenglish/1420544396_01

7257.html (accessed 19

May 2015) [13]Whalen, J. Patients

blame cost for coverage

delay in England of

Gilead Drug. January 15,

2015. Wall Street Journal

Pharmalot. http://

blogs.wsj.com/

pharmalot/2015/01/22/

coverage-for-gileads-

sovaldi-is-delayed-in-

england-over-cost/

(accessed 19 May 2015)

[14]Hill A, Cooke G..

Medicine. Hepatitis C

can be cured globally, but

at what cost?Science.

2014 Jul 11;345

(6193):141-2. doi:

10.1126/

science.1257737.

[15]MSF. Untangling the

web of antiretroviral

price reductions. 17th

Edition. July 2014. http://

www.msfaccess.org/sites/

default/files/

MSF_UTW_17th_Editio

n_4_b.pdf (accessed 19

May 2015).

Table 1a Table 1b

P A G E 8

“With the support

of the Norwegian

Knowledge Centre

and HTA agencies

from Sweden,

Denmark and

Finland, HTAi is

preparing to

welcome delegates

from over 55

countries.”

HTAi Oslo 2015 Chris Sargent, HTAi

Over 1,000 HTA

practitioners and policy

makers will discuss

‘Global Efforts in

Knowledge Transfer:

HTA to Health Policy

and Practice’. Lancet

Editor-in-Chief Richard

Horton and Norwegian

Knowledge Centre

researcher Andrew

Oxman will share the

stage with the

Norwegian Health

Minister Bent Høie, high

profile plenary speakers,

30 panels, and hundreds

of oral and poster

sessions. On June 13-14,

HTAi will also host two-

days of pre-meeting

workshops.

With the support of the

Norwegian Knowledge

Centre and HTA

agencies from Sweden,

Denmark and Finland,

HTAi is preparing to

welcome delegates from

over 55 countries.

Behind the scenes, HTAi

Interest Groups are also

planning for delegates to

arrive. The

ten HTAi

Groups

serve as

experience-

sharing hubs

among HTA

producers

and users worldwide and

they have a powerful

role in promoting HTA

in the areas of

Conditional Coverage/

Access with Evidence

Development,

Disinvestment and Early

Awareness, Ethics,

Hospital-based HTA,

HTA-Regulatory

Interactions, HTA in

Developing Countries,

Early Career Network,

Information Resources,

Patient and Citizen

Involvement and the

Impact of Public Health

Interventions and

Nutrition.

Several of these Groups

and their members have

provided expert input

into the Annual

Meeting’s scientific

program. But the impact

of the work of the

interest groups goes

beyond this. Of special

note is HTAi’s Patient/

Citizen Involvement

group. They have

developed practical

tools for the

implementation of

Values and Quality

Standards for patient

involvement in HTA.

They are going to

present these at a panel

to discuss progress

made over the past year

in implementing these

values and standards in

both established and

emerging HTA agencies,

across various countries

HTAi also asks

members to consider

attending our Annual

General Meeting on

June 15 in Oslo. HTAi’s

President, Carole

Longson will be

presenting the HTAi

2015-20 Strategic Plan

and welcoming several

new people to the HTAi

board, including Vice

President Sean Tunis,

Treasurer Don

Juzwishin, Secretary

Americo Cicchetti and

Director David

Grainger. President-

elect Guy Maddern will

also take over as

President following this

meeting.

Finally, do not forget

about the fantastic social

events planned,

including HTAi’s

Welcome Reception,

free to all registrants, to

be held at the Oslo City

Hall or Oslo Rådhus .

This building is

considered the city's

"Structure of the

Century", and is best

known for hosting The

Nobel Peace Prize

Ceremony every

December.

Standardisation of European HTA – Application of the EUnetHTA HTA Core Model for Rapid Relative Effectiveness® in Austria Dr. Med. Anna Nachtnebel, MSc, LBI-HTA

P A G E 9 I S S U E 1 8

The European HTA Network,

EUnetHTA, has developed several

tools for the production of “reliable,

timely, transparent and transferable

information”. Amongst them are the

HTA Core Model for Rapid Relative

Effectiveness Assessments (REA)® and

guidelines on methodological

challenges frequently encountered by

assessors of rapid REAs [1].

The HTA Core Model for Rapid REA®

includes four different domains (see

figure 1). Within these four domains,

generic research questions have been

formulated which are usually contained

in HTAs. Authors go through these

generic research questions and select

those which are considered relevant

for the intervention under assessment.

Most other aspects usually comprised

in comprehensive HTAs such as

ethical, organisation, legal or

administrative aspects are covered

within a brief checklist. Cost

considerations were specifically

excluded based on recommendations

of the High Level Pharmaceutical

Forum.

By standardising the elements

contained in HTAs, a shared

understanding of HTA is facilitated and

the international use of results

promoted. The HTA Core Model for

Rapid REA® therefore aims at guiding

the production of joint assessments in

European collaboration. These

assessments should then serve as a

basis for local HTAs; by using the joint

assessments and by integrating context

-specific information on, for example,

data on prevalence, incidence or costs,

the fast production of local HTAs

should be facilitated and

concurrently duplications reduced.

Besides guiding collaborative

assessments within EUnetHTA,

these tools can also be used for the

production of national or local

HTAs. Applying common methods in

the local context could further

contribute to the re-use of HTA

results and thus to the reduction of

redundancies and to a more efficient

use of scarce scientific resources.

In 2015, the Austrian Ludwig

Boltzmann Institute for Health

Technology Assessment (LBI-HTA)

used the HTA Core Model for Rapid

REA® for the first time for

compiling reports on new hospital

interventions. On an annual basis,

the Ministry of Health commissions

the LBI-HTA to assess resource-

intense interventions, such as costly

surgical procedures or high-tech

based interventions, for which

inclusion in the catalogue of benefits

is sought. The application of the

HTA Core Model for Rapid REA®

led to structural changes in terms of

presentation of the results and lay-

out of the reports, and also to a

change of the publication language; to

increase the likelihood of re-use, the

reports were for the first time

written in English supplemented by a

detailed summary in German. All

reports will be publicly available on

our website starting from the 15th of

July [2].

Overall, our experiences with using

the HTA Core Model for rapid

REA® were positive, since authors

found the structured way of

producing answers to the individual

research questions very helpful.

Accordingly, a second programme

line of the LBI-HTA that is “Horizon

Scanning in Oncology” will also be

adapted to the HTA Core Model in

2015.

References

[1] EUnetHTA. 2015 [cited 12 May 2015];

Available from: http://www.eunethta.eu/

outputs [2] Ludwig Boltzmann Institute for Health

Technology Assessment. [cited 12

May 2015]; Available from: http://

hta.lbg.ac.at/page/bewertung-

medizinischer-einzelleistungen-mel-

2015

P A G E 1 0

4th HTAsiaLink annual conference Sungkyu Lee, NECA H-SIGHT

The 4th HTAsiaLink

annual conference with

the theme of “Sharing

Experiences of Health

Technology Assessment

(HTA) for Universal

Health Coverage (UHC)

in Asia” successfully took

place in Taipei, Taiwan

on 13-15 May 2015,

preceded by the pre-

conference on 12 May

2015. A welcome speech

from Dr. Ming-Neng Shiu,

Vice Minister of the

Ministry of Health and

Welfare, Taiwan

introduced the first day

of the conference.

There were four

important plenary

sessions, one of which

was the Leaders Forum,

highlighting issues from

high-level decision

makers on HTA for

UHC. Decision-makers

from Taiwan, Thailand,

Korea, and Indonesia

were invited to discuss

various issues related to

HTA including the role of

politicians, how to engage

with industries and

patient groups, and how

to ensure transparency in

the HTA process.

Dr. Ryan Li from NICE

International, United

Kingdom presented on

policymaker and

academic collaboration in

HTA based on UK

experiences and

International Decision

Support Initiative (iDSI)

activities. iDSI was

launched by NICE

International in

November 2013 in order

to support low and

middle income

governments in making

better healthcare

spending decisions. It is

an innovative global

partnership between

government institutes,

universities such as the

University of York, and

Meteos, which is a not-

for-profit think tank and

strategy company.

The HTAsiaLink

conference has a unique

format customised to

develop member agency’s

capacity from its inaugural

conference. All the

presentations except

plenary and issue panel

sessions were presented

by junior staff from each

member agency, followed

by in-depth feedback from

international expert

commentators in order to

promote the quality of

HTA projects presented.

There were

approximately 60

presentations regarding

economic evaluation or

healthcare systems.

Experts from the

University of York,

University of Toronto,

University of Glasgow,

University of Adelaide,

and Australian Safety and

Efficacy Register of New

Interventional Procedures

-Surgical (ASERNIP-S)

were invited as

commentators.

An Update from INAHTA Tara Schuller, MSc, Executive Manager, INAHTA Secretariat

P A G E 1 1 I S S U E 1 8

EuroScan focuses on emerging

technologies through the Early

Awareness and Alert Systems

(EAAS) and INAHTA focuses on

the promotion of health

technology assessment at

different points along the

technology lifecycle, including

early adoption, optimal use,

obsolescence, and disinvestment

within health systems. Many

INAHTA agencies use horizon

scanning to inform their topic

identification and prioritisation

processes.

Last year, INAHTA launched a

new strategic plan for the years

2014-2017. This plan outlines a

model tailored to support the

‘network way of working’. This

emphasises and supports the

connections between members

to produce both tangible and

intangible results. INAHTA has

defined four value networks that

span topic areas that are of

interest to their wide range of

membership:

1. Member Agency Assessment

Programs, Processes &

Methods

2. Knowledge Transfer, Uptake

and Impact of HTA Reports

3. Education and Training for

INAHTA Member Agency

Staff

4. Agency Development and

Capacity Building

Over the past year in each of

these value networks, both

tangible and intangible results

have been – and continue to be –

produced. Several internal

policies and processes (tangible

outputs) have been developed

through collaboration in task

groups, webinars, and email

exchanges, which build familiarity

and trust (intangible outputs)

amongst contributing members.

The intangible outputs are

further amplified since

supplemental information is

often shared through these

groups and activities - not about

to the project at hand, but about

separate topics and personal

exchanges about member

agencies and individuals who

work there.

For the coming year, INAHTA

will focus on supporting the

formation of communities of

practice (CoPs) amongst

members. These are groups of

peers held together by a

common sense of purpose,

where sharing knowledge and

experiences across members of

a CoP is of benefit to the daily

work of the members. There is

a very rich storehouse of tools,

expertise, and front-line

experience in INAHTA member

agencies for the production and

dissemination of HTA products,

for example, and the CoPs will

help to facilitate the circulation

and exchange of these tangible

and intangible assets in a

network way of working.

Health care decision making

requires the right evidence at the

right time. Every day there are

new health technologies available

that can improve patient

outcomes and refine health

system efficiency. Health

technology assessment (HTA) is

a multidisciplinary tool to review

technologies and provide

evidence of the value these

technologies can deliver to

patients and their families, health

system stakeholders, and to

society more broadly.

The International Network of

Agencies for Health Technology

Assessment (INAHTA) was

established in 1993, and today

connects 54 publicly-funded

HTA agencies that support

evidence based decision making

that affects the lives of nearly 1

billion people in 34 countries

around the globe.

The connection between

EuroScan and INAHTA traces

back many years, and many

EuroScan members are also

members of INAHTA. In 2010,

a formal Memoranda of

Understanding was signed

between EuroScan and INAHTA.

The work of these two

Networks is complementary:

both promote the adoption and

use of safe, effective and cost-

effective health technologies

through different approaches.

information on innovative

technologies in healthcare in order

to support decision-making and the

adoption and use of effective, useful

and safe health-related technologies.

We are also the principal global

forum for the sharing and

development of methods for the

early identification and early

assessment of new and emerging

health-related technologies and their

potential impact on health services

and existing technologies.

EuroScan International Network is

committed to work with a high level

EuroScan - the International

Information Network on New and

Emerging Health Technologies - is a

collaborative network of member

agencies for the exchange of

information on important new and

emerging health technologies.

Mission

EuroScan International Network is

the leading global collaborative

network that collects and shares

of transparency and professionalism,

and in partnership with researchers,

research centres, governments and

international organisations to

produce high quality information

and effective early awareness and

alert systems for our respective

constituencies.

We are also committed to support

the development of existing and

new not-for-profit public agencies

working in the early awareness and

alert field.

Visit http://www.euroscan.org.uk to find out more about EuroScan, its work and

how to become a member.

Views of individual authors are not necessarily the views of the editor or EuroScan members

Position Current Post Holder End of term

Chair Dr Roberta Joppi, IHSP 31/12/16

Vice Chair Dr Marianne Klemp, NOKC 31/12/15

Registrar Dr Sungkyu Lee, NECA H-SIGHT 31/12/16

Treasurer Dr Anna Nachtnebel, LBI-HTA 31/12/16

Head of Secretariat Dr Claire Packer, NIHR HSC n/a

Executive Committee

If you have any feedback, questions, would like to know more or have any articles that would be of interest

for the next edition of the newsletter please contact Louisa Hamilton, EuroScan Network Co-ordinator,

NIHR HSC, University of Birmingham, Public Health Building, Edgbaston, Birmingham, B15 2TT

Euroscan@contacts.bham.ac.uk +44 121 414 7656

CNESH Top 10 for 2015 The Canadian Network for

Environmental Scanning in Health

(CNESH) has released its Top 10

New and Emerging Health

Technology Watch List for 2015

(see https://www.cadth.ca/

environmental-scanning/cnesh/top-

10-new-and-emerging-health-

technology-watch-list ).

The purpose of the list is to identify

new and emerging health

technologies that have the potential

to transform the delivery of health

care through their impact on clinical

effectiveness, patient survival, quality

of life, patient safety, or costs to the

health care system. The list includes

drugs, diagnostics, devices, and

procedures that are soon to be

launched, are recently approved, or

are in the early stages of diffusion.

The process for selecting the

CNESH's Top 10 involved inviting

stakeholders to submit

technologies , a filtration stage

carried out by of a small group to

ensure only technologies meeting

the inclusion criteria were included ,

a verification stage and prioritization

stage.

Technologies included in the 2015

Top 10 are:

andexanet alfa for bleeding

episodes,

electrically stimulated

underwear for pressure ulcers,

eravacycline antibiotic for

multidrug-resistant infections,

LCZ696 for heart failure,

nivolumab for melanoma,

molecular breast imaging system

with cadmium zinc telluride

detector,

pediatric vision scanner for

detection of strabismus

(misaligned eyes) and amblyopia

(lazy eye) in preschool children,

remote monitoring of cardiac

devices,

secukinumab for psoriasis

toraymyxin for sepsis.