1. HTA Uncovered
Is s u e N o. 4 – Fe br ua r y 2 0 14
Impact of accountable-care
organizations on
biopharmaceutical
reimbursement and access
Accountable care organizations (ACOs)
are a relatively recent phenomenon in
the United States healthcare system,
accelerated by the Patient Protection
and Affordable Care Act (PPACA) of
2009. ACO models generally have three
basic tenets vs. existing fee-for-service
provider health delivery models: (1) they
are accountable for quality and cost
management across the care continuum
for a population of patients; (2)
payments are linked to quality
improvements that reduce overall care
delivery costs; and (3) often involve
sophisticated
performance
measurement to track improvements. In
some models, outside of performance
dashboards, providers are responsible
for managing delivery of core service
groups within a fixed budget, more
pointedly
shifting
burden
of
management from the payer to the
provider.
“It will be critical for
manufacturers to anticipate
the different evidence needs
and decision drivers of at-risk
providers, understand the
extent their products may be
To understand the perceived impact of
ACOs on biopharmaceuticals, specialty
pharmaceuticals, and other high-cost
medical technologies, a survey was
conducted of medical directors at
impacted by ACO approaches,
and develop value
communications aligned with
managed-care
organizations
and
provider groups, with responses from 40
individuals in total. This survey was
supported by Quintiles and sponsored
by the Genomics Biotech Emerging
Medical Technology Institute of National
Association
of
Managed
Care
Physicians, a 10,000+ payer, providers
and healthcare purchasers‟ organization
in the US1.
Eight approaches to health technology
market access were assessed on a
scale of 1-10, with 1 being highly
unlikely and 10 being highly likely. Key
implications of ACO models, from the
perspective of US commercial payers,
are highlighted below (Figure 1).
The results of this survey suggest that
medical directors anticipate that greater
emphasis on clinical pathways and a
heightened level of provider value
scrutiny are likely or highly likely, with
70% to 80% of respondents suggesting
that how technologies fit into care
paradigms and overall levels of
supporting evidence for that fit are likely
to increase in the short term. Along with
this, over 60% of respondents anticipate
that the threshold for acceptance will
increase and potentially influenced
contract terms based upon relative
value assessments. This indicates that
technology manufacturers need to
Figure 1: Extent to which the following outcomes are seen as likely or unlikely for
new technologies as a result of ACO
this new provider
management model.”
Higher access hurdles targeting quality and/or pay
for performance
Eric Faulkner, Director, Global
New contracting requirements
Market Access, Quintiles
38%
32%
Preclude some new health technologies
Consulting and Executive
Clinical pathways for greater cost savings
Director, Genomics Biotech
Clinical pathways for improved efficacy
Emerging Medical Technology
Association of Managed Care
Increased provider scrutiny of value
Physicians
Unlikely
1
68%
54%
32%
46%
68%
22%
Carve-outs for certain HTAs
Institute of the National
62%
78%
64%
28%
36%
72%
Likely
For more information, please contact the study lead author, Eric Faulkner, at eric.faulkner@quintiles.com

2. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
understand how and to what extent ACO models will
impact acceptance and uptake of new health
technologies and that framing of value propositions
should consider overall relative value, fit within existing
care pathways, and how providers will increasingly play a
role as gatekeepers to technology access.
Respondents remain uncertain about the likelihood of
ACOs targeting technologies at the extremities of the
value spectrum via carve outs and preclusions. However,
results do suggest that payers and providers in the US
may be more receptive to novel approaches or
partnership terms that fit with evolving business models
and objectives. Contracting approaches, in tandem, may
also evolve compared to more historical static
approaches and terms may be open to innovative
negotiation, including monitoring and further value
demonstration of health technologies that may emerge in
the form of novel data collection approaches and/or
monitoring and management paradigms.
This also suggests that (a) development of a solid product
value story that looks beyond the product and considers
practical implementation in real world care settings
(including anticipation of impacts relevant to at-risk
provider organizations in the US) will become increasingly
important, as will (b) staying in touch with changing
provider requirements as ACO models expand/evolve,
including through early engagement, are cornerstones of
future success (assuming that they consider the
significant heterogeneity of existing models).
Background
The ACO concept is the result of ongoing innovation in the
organization of payer/provider organizations that can be
traced to a 2006 conference presentation given by Dr. Elliot
Fisher of Dartmouth University2. Initial focus of Medicare
performance dashboards centered on but were not limited to
core financial drivers such as cardiovascular disease,
metabolic disease, and diabetes, though some models have
began to emerge in other specialty areas such as oncology3.
Medicare mandated development of ACOs under PPACA
stimulated commercial payer organizations to accelerate this
concept in the mid-2000s, developing more comprehensive
models than those required under Medicare. By early 2013,
more than 40% of Americans lived in primary care service
areas with at least one ACO4. Previous efforts at integration
of payers and providers included the health management
organizations (HMOs) of the 1990s, which failed due to an
imbalanced focus on cost reduction without sufficient
incentives to improve patient outcomes5. Modern ACOs are
keen to avoid making this pitfall6, and do so by making
improvement of care outcomes a top priority along with cost
reduction7. Although they currently comprise small
proportion of the healthcare provider landscape, they are
being carefully watched as incubators for future standards of
care delivery and financial management.
The integration of health technology management into ACO
structures remains an open question, with bio-
pharmaceuticals and specialty pharmaceuticals likely to be
ripe targets for ACO attention due to high up-front costs.
Prior to advent of ACO models and additional focus on more
proscriptive clinical pathways, some of the most important
tools for access management were public and private payer
coverage policy enforcement and contracting – though a
majority of coverage policy development has historically
focused on access management of high cost and/or volume
technologies. ACO models create the opportunity for more
focused performance management, but have heretofore
focused on a somewhat different mix of technologies vs. ACO
dashboards.
At present, initial HTA of emerging technologies remains
within the remit of the payer organizations developing
coverage policies. Alternatively, inclusion of technologies
under ACO models is more proportionally focused on
established technologies whose use is well characterized.
Currently,
ACO
evaluation
of
use
of
new
technologies/services is non-transparent and inclusive of
different business information drivers. Nonetheless,
manufacturers who are interested in the inclusion of
products on ACO formularies have a vested interest in
communicating the economic value of their products in
alignment with the metrics ACOs are evaluated upon (though
many technologies are not yet included in ACO dashboards
and subject to traditional payer management approaches).
NICE to aid implementation of HTA-based decisions in India
A Memorandum of Understanding (MoU) signed between Department of Health Research (DHR) India and NICE on 14 th
June 2013 indicates that Indian health policy makers and payers seem to moving towards a formal HTA process 8. Such
international collaboration may lead to a more active implementation of HTA in India and strengthen India‟s capacity in
the development of health care policy and evidence-based decision-making. NICE has successfully helped other
countries before. For example initial results from a recent pilot project to introduce evidence-based clinical pathways and
payment reform in China's rural hospitals9,10 resulted in a signicant drop in unnecessary medical services use without
revenue reduction11.
The MoU signed between NICE and DHR seems to be a step in the right direction. But the task in front of the nation is
challenging and will require significant resources. DHR intends to set up a “Health Technology Assessment Board” and
discusses capacity building by strengthening existing institutions responsible for turning evidence into policy. In addition
to collaboration with NICE, this will require introducing HTA science and pharmacoeconomics as an optional course of
References: 2American Hospital Association. 2010 Committee on Research. AHA Research Synthesis Report: Accountable Care Organization. 3Mehr SR.
Applying accountable care to oncology: developing an oncology ACO. Am J Manag Care. 2013 Mar-Apr;19 Spec No. 3:E2. 4Gandhi N. and Weil R. “The ACO
Surprise”. Oliver Wyman Health and Life Sciences, 2012. 5Coombs, J.G. The rise and fall of HMOs: an American health care revolution. Madison: University of
Wisconsin Press 2005. 6Gold J. FAQ On ACOs: Accountable Care Organizations, Explained. August 23, 2013. 7”Next Steps for ACOs” Health Affairs. 2012.
2

3. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
The introduction and use of HTA
study in postgraduate training programs
in key medical and pharmacy teaching
institutions across the country. The HTA
Board will, in due course of time, have
to set up a NICE-like HTA center that
will prioritize therapeutic areas and
disease entities for study and set out to
map treatment algorithms informed by
systematic technology assessment.
Academics in India have also been
discussing the possibility to introduce
HTA through a structured quick
assessment
(SQA)
of
all
pharmaceuticals (both patented and
generic) applying for public funding in
India12. The authors recommend to
establish an independent department in
the Drug Controller General‟s office at
Central
Drugs
Standard
Control
Organization in New Delhi to oversee
these assessments.
in healthcare decision-making
HTA in India
in India should be good news for
the pharmaceutical and health
technology industries. It should
make the basis of adoption of
new technologies in the country
more data-driven, transparent
and predictable. Companies will
have to gear up to generate the
data to justify product
positioning and pricing.
Conversely, HTA should help
guide pricing in a market where
companies have sometimes gone
horribly wrong with pricing.
The need for data is likely to
spawn growth in outcomes
research services and
publications and feed demand
for appropriately qualified and
trained personnel”
Shoibal Mukherjee, Vice President
& Head Asia Medical Sciences
Group, Quintiles, India
At present there is no formal HTA
process taking place in India. Many
indirect ways of ensuring value for
money are being used and all
reimbursement decisions are made on a
case-by-case basis by organizations
such as Employee State Insurance
Scheme (ESIS), Central Government
Health Scheme (CGHS), Rashtriya
Swasthya Bima Yojana (RSBY), and
private insurance companies. Table 1
presents an overview of the key public
and state health insurance schemes in
India.
The need to seek value or HTA is not
entrenched in the decision-making
process of these payers as the impact
of reimbursement of patented drugs is
relatively small. The availability of
generic drugs and the so-called notion
of them being affordable has limited the
concept of seeking value. Increasingly
as budgetary reviews are being done,
value for new patented drugs are being
questioned. There is an expectation that
this is set to change in coming years as
more patients receive patented drugs.
The federal price control system could
be better targeted with HTA inputs.
Therapies and technologies that offer
better value for money could be
prioritized over those that offer less net
benefit, and price controls could be
calibrated to optimize overall value of
“Anticipating that in next 3-5
years HTA will become routine in
India, being ahead of the curve
mandates that health economic
endpoints are incorporated in
trials performed in India and
disease-specific or drug classspecific patient registries are
established”
Harsha Doddihal, Associate
Medical Director, Quintiles, India
new
technologies.
Medicines
procurement programs and formularies
could be better managed by application
of HTA, thus providing a better value for
the taxpayer money while setting
procurement standards to put decisionmaking on a firmer footing in line with
pharmacoeconomic logic and away
from arbitrary influences. A formal HTA
will pave way for treatment guidelines,
closer scrutiny of pharmacovigilance
data, and establishment of patient
registries.
HTA reports could also be a valuable
input to other government agencies
tasked
with
public
health
responsibilities. Thus, preventive health
programs run by the federal and state
governments could benefit enormously
from HTAs, as can disease control
programs for endemic diseases such as
malaria, tuberculosis, kala-azar, and
AIDS.
A first step was taken recently when the
ISPOR India Chapter developed and
presented
“Proposed
Pharmacoeconomics
Guidelines
for
India
(PEG-I)”13. The following guidance was
proposed:
 Primary target of
pharmacoeconomic research:
Ministry of Health and Family
Welfare, Government of India
 Perspective: all costs and benefits
from a societal perspective should be
included (irrespective of who actually
bears the costs or receives the
benefits)
 Comparator: ideally, the current
3

4. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
most cost-effective option should be selected as a
comparator
 Analytical technique: CUA, CEA, or CMA can be
carried out
 Time horizon: must enable valid and reliable
statements to be made regarding the effects and costs
of the treatments being compared
 Discounting: 3% rate should be considered for both
costs and effects.
“A proactive approach from
pharmaceutical industry in demonstrating
cost-effectiveness is needed to address
purchasing power parity and compulsory
licensing challenges. A recent launch of a
cardiovascular drug which demonstrated
Although HTA is in its infancy in India, the awareness
regarding the costs of interventions does present. A
review of the Centre for Review and Dissemination
database (University of York) revealed that several
pharmacoeconomic studies have been published over the
past 5 years in India. The majority of these studies14-16
focused on communicable diseases like HIV, tuberculosis,
rotavirus, leishmaniasis, which despite socio-economic
development still remain a high burden in the South-East
Asia region17. But also chronic diseases and injuries,
chemotherapy and psoralen have recently been
evaluated18-20. These examples indicate that HTA is
gaining more attention in India and may become part of
standard practice in the near future.
pharmacoeconomic value is an example of
how the future could look like”
Harsha Doddihal, Associate Medical
Director, Quintiles, India
Table 1: Public and state health insurance schemes in India
Type
HI Scheme
Population
No of beneficiaries
(million)
Funding
Benefits package
Public
CGHS
Central government
employees
3
GOI
Beneficiaries
Public
ESIS
Employers
Employees
55.5
Public/State
RSBY
BPL population
131*
Public/State
RSBY Plus
(HP)
BPL population
enrolled in RSBY
NA
Beneficiaries
Employers
State
25% State
75% GOI
100% State
Public/State
ASBY (Delhi)
BPL population
enrolled in RSBY
NA
100% State
Public/State
Rajiv
Aarogyasri
Scheme (AP)
Kalaignar (TN)
BPL but went ahead
to almost the entire
population (85%)
BPL
70
100% State
Outpatient; inpatient;
preventive and ambulatory
services; mainly tertiary
Outpatient; inpatient;
preventive and ambulatory
services; all levels
Inpatient, secondary care;
chronic diseases
Inpatient, tertiary care;
complementary to RSBY
coverage
Inpatient, tertiary care
Complementary to RSBY
coverage
Inpatient, tertiary care;
chronic diseases
Over 50
100% State
Vajapayee
Arogyasri
Scheme (KN)
Yeshasvini
(KN)
BPL
1.6
100% State
Registered in
cooperative
societies, both BPL
and APL
3
40% State
Beneficiaries
Public/State
Public/State
Community/
NGOs
Inpatient, tertiary care;
chronic diseases
Inpatient, secondary and
some tertiary care; chronic
diseases
Outpatient; inpatient tertiary
care; chronic diseases
Source: Reddy KS et al. A Critical Assessment of the Existing Health Insurance Models in India. Public Health Foundation of India. 31 January
2011. *Number of beneficiaries are reported as per 2010, except for RSBY where the calculation of beneficiaries assumes an average of 3.5
members per family enrolled and 37.7 million active cards currently in this scheme.
References: 8UK and India to work together on evidence-informed healthcare policy and practice. 14 June 2013. https://www.gov.uk. 9Cheng TM. A pilot project
using evidence-based clinical pathways and payment reform in China's rural hospitals shows early success. Health Aff (Millwood). 2013 May;32(5):963-73. 10NICE.
Supporting the evaluation of Clinical Pathways in rural China. 11Pittman D. Case-Based Pay Pays Off in China. MedPage Today. April 2013. 12ISPOR Asia
Consortium Newsletter. Vol 2 No 3. Sep-Nov 2013. 13ISPOR India Chapter. Draft of proposed Pharmacoeconomics Guidelines for India (PEG - I). Oct 2013.
4

5. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
Background
India alone accounts for 21% of the world’s global burden of
disease21 and is the world's third-largest pharmaceutical
market in terms of volume22. In 2011, India’s total
expenditure on health as % of GDP was 3.9% (Table 3).
With a continuing increase in healthcare spending by the
Indian government (from 6.7 billion USD in 2005-2006 to
11.7 billion in 2008-2009), as well as number of insured
people increasing from 300 million in 2010 to an estimated
655 million in 202023, both government and private payers
will seek to assess value for money.
In India, health insurance coverage, vaccination, medical
facilities and state reimbursement widely vary from state to
state. The public healthcare system is underdeveloped, with
almost half the population having to travel over 100
kilometers to access an acceptable level of care24. The
majority of Indian population does not have a health
insurance and pays for health care out-of-pocket. Limited
width and depth of health insurance and the lack of a safety
net makes families highly vulnerable to catastrophic
healthcare spending that can wipe out a lifetime of
savings25,26. About 25% of the population is currently
insured, out of which 5% by the Central Government Health
Scheme (CGHS) and Employee State Insurance Scheme
(ESIS) schemes, and the rest by Rashtriya Swasthya Bima
Yojana (RSBY) and state initiatives with different coverage
levels (Table 1). Interestingly, two states have achieved
particularly high coverage (Andhra Pradesh 87% and Tamil
Nadu 62%). Although insurance programs exist in India,
they, with a few exceptions, do not reimburse medicines.
Typically, for those people who are insured, only tertiary and
sometimes secondary inpatient care is covered with an
exception of CGHS and ESIS schemes which provide a full
coverage including reimbursement of drugs27. In case of
CGHS and ESIS reimbursement of medicines is not through
any formal mechanism: any drugs will be reimbursed at the
CGHS and ESIS approved centers based on the physician’s
justification of the need.
Pricing controls in India operate via the Drugs Prices Control
Order (DPCO)28-30. Approval and pricing of drugs are two
separate processes. DPCO classifies drugs as scheduled (e.g.
“First Schedule”) or non-scheduled and provides
requirements on how ceiling prices for scheduled drugs
should be calculated. The latest, 4th edition of National
Formulary of India was introduced in 2010 by the Indian
Pharmacopoeia Commission (IPC) and published in 2011
Table 2 Key Figures India
Total population
Over 1.2 billion
Political administration
28 states and 7 union
territories
GDP based on purchasingpower-parity per capita ($)
3,991
Life expectancy at birth m/f
(years)
67.3/69.6
Source: International Monetary Fund; Health and family welfare
statistics in India 2013.
after a gap of more than 30 years31. The NFI 2010 is an
important guide for health care professionals as it promotes
the rational use of medicines in the country. There is also a
National List of Essential Medicines (NLEM) which currently
contains 348 commonly used drugs in India32. All of these
drugs are under price control33. This list was last updated in
2011 and is based on the World Health Organization’s
(WHO) Essential Drugs List. The National Pharmaceutical
Pricing Authority (NPPA) fixes and monitors the prices of all
scheduled
drug
formulations
(both
manufactured
domestically and imported).
The prices of non-scheduled medicines (medicines that do
not fall under the price control) are simply monitored for
price increases. Prices of non-scheduled patented drugs are
set by manufacturers. However, there is a 10% ceiling on
annual price increases of non-scheduled drugs, and the
NPPA can take corrective measures (including price fixing)
for products with prices that increase by more than 10% in a
year30. Also when the government feels that the high price of
patented drug is limiting its availability, it can introduce
compulsory licensing. This, for example, was applied to
Bayer’s Nexavar (sorafenib)34.
Table 3 Indian Health care expenditure
Indicator
India
OECD
average
Health expenditure as a
share of GDP, 2011
3.9%
9.3%
Health expenditure per
capita, 2011 ($)
141
3,322
Practicing doctors per
1,000 population, 2011
0.7
3.2
Source: OECD. Health at a Glance 2013.
References:14Venkatesh KK et al. Clinical impact and cost-effectiveness of expanded voluntary HIV testing in India. PLoS One. 2013 May 31;8(5). 15Verguet S. et
al. Public finance of rotavirus vaccination in India and Ethiopia: an extended cost-effectiveness analysis. Vaccine. 2013 Oct 1;31(42):4902-10. 16Hass B et al. Health
technology assessment and its role in the future development of the Indian healthcare sector. Perspect Clin Res. 2012 Apr;3(2):66-72. 17Gupta I, Guin G.
Communicable diseases in the South-East Asia Region of the World Health Organization: towards a more effective response. Bulletin of the World Health
Organization 2010; 88: 199-205. 18Patel V et al. Chronic diseases and injuries in India. Lancet 2011; 377: 413–28. 19Ranade AA et al. Clinical and economic
implications of the use of nanoparticle paclitaxel (Nanoxel) in India. Annals of Oncology 24 (Sup 5): v6–v12, 2013. 20Aggarwal K et al. Comparison of clinical and
cost-effectiveness of psoralen + ultraviolet A versus psoralen + sunlight in the treatment of chronic plaque psoriasis in a developing economy. Int J Dermatol. 2013
Apr;52(4):478-85. 21WHO Country Cooperation Strategy Brief. India (2013). 22Industry review at a glance. Pacific Business Review International Vol 6, Issue 6, Dec
2013. 23India Pharma 2020. Propelling access and acceptance, realising true potential. McKinsey&Company. 24Bose A, Mehta R. Enabling Access to Long-Term
Finance for Healthcare in India. Oct 2013. 25La Forgia G, Nagpal S. Government-Sponsored Health Insurance in India. Are You Covered? The World Bank 2012.
26
Catastrophic Payments and Impoverishment due to Out-of-Pocket Health Spending. Economic & Political Weekly Vol xlvi No 47 Nov 2011. 27Reddy KS et al. A
Critical Assessment of the Existing Health Insurance Models in India. Public Health Foundation of India. January 2011. 28Price Controls on Pharmaceutical Products
in India 2007 National University of Singapore. 29Narayan S. Price controls on pharmaceutical products in India. ISAS Working Paper No. 20. Mar 2007. 30National
Pharmaceuticals Pricing Policy, 2012. The Gazette of India, 7 Dec 2012. 31Gitanjali B. The National Formulary of India 2010: Thorough and extensive revision of the
preprint version needed. J Pharmacol Pharmacother. 2011;2(4): 219–20. 32Bansal D, Purohit VK. Accessibility and use of essential medicines in health care:
Current progress and challenges in India. J Pharmacol Pharmacother 2013;4:13-8. 33Francis PA. Revision of NLEM. 2013. 34Ghangurde A. Indian govt working on
list of drugs fit for compulsory licensing? Scrip Magazine January 2013.
5

6. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
HTA figures around the globe during
2012-2013
Digging into our HTA Watch database, we were able to
provide some interesting insights on the HTA activity
worldwide during the past two years. Supporting the feel
of a generalised fast-growing HTA activity in all parts of
the world with actual figures, our statistics can help get a
more precise idea on the current status and give a hint of
the future evolution.
A general increase in the number of reports published
was observed worldwide. As appreciated in Figure 1, two
of the agencies with the highest increase were NCPE in
Ireland and pCODR in Canada with an increase of 60%72% in the number of published reports in 2013 in
comparison with 2012. Both NICE and SMC incremented
their publications, while AWMSG remained stable. The
overall HTA activity by these three bodies in the United
Kingdom increased considerably (around 20%).
Nevertheless, not all agencies augmented their output.
INESSS published slightly less reports in 2013 compared
with 2012 (a notable decrease of 22%), similar to
CADTH. The overall production in Canada showed a
decrease of 14%. Similar relative decrease was observed
in the Netherlands for CVZ (around 13%). HTA activity
remained overall stable in France, Sweden, Spain (results
not shown) and Australia.
Facts and Figures
In the course of 2013, 1,659 HTA reports were completed
and published worldwide, exceeding the 1,530 reports
published during 2012.
 France’s Haute Autorité de Santé (HAS) had the highest
number of publications with 208 reports during 2013,
followed by Sweden’s Tandvårds-ochLäkemedelsförmåns Verket (TLV) with 125 reports.
NICE, Canada’s National Institute for Excellence in
Health and Social Services (INESSS), Scotland’s Scottish
Medicines Consortium (SMC) and UK’s National Horizon
Scanning Centre (NHSC) all published approximately a
hundred reports in the same time period (101, 98,


97 and 96 respectively).
However, UK’s HTA agencies together accounted for
approximately one fourth of all reports published
worldwide (411), followed by Canada (224) and
France (208). Reports from these three countries
comprise half of the evaluations published around the
globe.
As observed in all individuals quarters, cancer and
cardiovascular were the most reviewed

therapeutic areas worldwide. Among cancer studies,
breast and prostate cancer were mostly evaluated,
followed by Non Small Cell Lung Cancer (NSCLC),
colorectal cancer, renal cell carcinoma and melanoma.
Diabetes-related indications, such as
diabetes, diabetic nephropathy or macular oedema, take
the lead as the most reviewed indications worldwide
during 2013 with 133 published evaluations.
Figure 2: Reports published by selected agendies during
2012-2013
pCODR
+80%
2013
AWMSG
0%
G-BA
+12%
CONITEC
+71%
NCPE
2012
+67%
CVZ
-14%
PBAC
+5%
INESSS
-22%
NICE
+28%
SMC
+18%
TLV
-1%
CADTH
-13%
HAS
+2%
0
100
200
300
400
Number of reports published
500
In the Latin American fast-growing front, CONITEC
started its trajectory in Brazil in the end of 2011 as a
successor of CITEC and showed an increase of 71% in
published assessments in 2013 compared with 2012 (see
Figure 1), which is expected to rise even more in the
coming years. Adding to the HTA growing activity, new
bodies have made their appearance during 2013.
Colombia had its premiere with the Instituto de
Evaluación Tecnológica en Salud (IETS) in late 2013 with
more than 50 evaluations and clinical practice guidelines.
Keep an eye on our next issue for more insights on Latin
America.
Back to Europe, the Therapeutic Positioning Reports
announced as a centralised HTA evaluation process in
Spain (see also our HTA Uncovered Issue #1) made their
way to the public domain on the Spanish Drug Agency
website (AEMPS). Two reports were already published in
2012 and 5 more saw the light during 2013. The Finnish
Medicine Agency (FIMEA) has also launched HTA drug
evaluation activities and published its first report in 2011,
one more in 2012 and four in 2013.
Regarding the therapeutic areas assessed by selected
agencies (PBAC, pCODR, INESSS, CADTH, G-BA, CVZ,
NICE, SMC, AWMSG, NCPE, CONITEC, TLV), while
cardiovascular are among the mostly evaluated
indications, there was a decrease in the number of
publications in this area (25%). Central nervous system
indications also dropped considerably, while cancer
remained on the top of the list. Diabetes and digestive
system indications also showed a considerable increase
(Figure 2).
Note that not all HTA agencies have the exact same
scope. For example, some of the selected HTA agencies
publish clinical practice guidelines along with HTA
evaluations, which may increase the total number of
publications (eg. NICE, CADTH and CONITEC), whereas
others are limited to drugs (eg. SMC). Data for HAS and
PBAC showed in figure refer only to drug evaluations.
6

7. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
Upcoming publications and events
 Meet us at the Pharma Pricing & Market Access
Outlook Europe 2014 (London; 25-26 February 2014).
To register visit:
http://www.healthnetworkcommunications.com/conferen
ce/pharma-pricing-market-access/
 Meet us at the DIA 26th Annual EuroMeeting
(Vienna, Austria; 25-27 March 2014).
o The effect of Patient Reported Outcomes on
Health Technology Assessment recommendations
in oncology in France, Germany and UK.
 Meet us at the Pharmaccess Leader Forum, (Paris; 1921 May 2014). To register visit:
http://springpharmaccess2014.nextlevelpharma.com/
 Learn more about our HTA insights at the ISPOR 19th
Annual International meeting (Montreal, Canada; 31
May-4 June 2014).
Glossary
Next time in HTA Uncovered
HTA insights from Turkey
 The Turkish Government is midway through the
implementation
of
the
“Health
Care
Transformation Program” that was initiated in
2004. The program is intended to be the driver of
greater public access to health services and
treatments. The program coincides with findings
that innovative drugs are a key driver for
increasing life expectancy in Turkey and that the
percentage of Turkey‟s population with health
insurance is also increasing.
 A key strategic objective is the highest possible
patient access to health technologies that would
ensure that Turkish citizens benefit from
innovative therapeutics once on the market. In
order to achieve this objective robust pricing and
reimbursement procedures need to be established
in order to attract further investment from
pharmaceutical sponsors.
 Therefore with no formal Health Technology
Assessment process in place, the speed at which
new health technologies are able to gain access
to the Turkish market remains a „known unknown‟.
A Statement released from the Ministry of Health
indicates the Turkish Government‟s intent for a
national HTA unit to develop in line with
established Western European HTA agencies.
Future HTA‟s will be an evaluation of clinical
effectiveness and patient safety coupled with
economic, social and ethical aspects.
 In our next edition we will examine the proposed
status of HTA in Turkey.
ASBY
Apka Swasthya Bima Yojna
AP
Andhra Pradesh
APL
Above Poverty Line
BPL
Below Poverty Line
GDP
Gross Domestic Product
CEA
Cost-effectiveness analysis
CGHS
Central Government Health Scheme
CMA
Cost-minimization analysis
CUA
Cost-utility analysis
DPCO
Drugs Prices Control Order
DHR
Department of Health Research
ESIS
Employees‟ State Insurance Scheme
GOI
Government of India
HTA
Health Technology Assessment
HTA dissemination and current developments in
Latin America
HP
Himachal Pradesh
 Despite the socioeconomic and health provision
IPC
Indian Pharmacopoeia Commission
ISPOR
International Society For Pharmacoeconomics
and Outcomes Research
KN
Karnataka
NFI
National Formulary of India
NICE
National Institute for Health and Care Excellence
NLEM
National List of Essential Medicines
NPPA
National Pharmaceutical Pricing Authority
OECD
Organisation for Economic Co-operation and
Development
PEG-I
Proposed Pharmacoeconomics Guidelines for
India
RSBY
Rashtriya Swasthya Bima Yojana
SQA
Structured Quick Assessment
differences in the countries of Latin America, there
is a common effort towards improved allocation of
resources and global health coverage.
 HTA initiatives have been present since at least
1985 in some of the countries, but did not
necessarily assess economic aspects. These
have started to get incorporated in the past
decade and have resulted in Networks of
Collaboration, such as the Andean Network of
HTA or the Network of HTA (RedETSA), the latter
including members of both Andean and Mercosur
economic groups.
 The next issue of HTA Uncovered will examine
the current landscape and efforts in the region and
discuss the challenges to be overcome.
TN
Tamil Nadu
WHO
World Health Organization
7

8. HTA U nco v e red : Is s u e N o. 4 - F e bru ar y 2 0 14
More information about
Quintiles’ HTA Solutions
HTA Watch
Quintiles‟ HTA Watch is a web-based service offering instant access to a global repository of published HTA
reports from nearly 100 agencies in 32 countries, providing regularly updated assessments to inform life sciences
and healthcare companies‟ strategic decision-making. Our industry and regional experts track and monitor this
vast network of global agencies, providing summaries that include key clinical and economic outcomes, agency
comments, and final recommendations. Direct web links to the full report detail are available, minimizing the need
to navigate multiple agency websites.
Please contact us if you would like to receive a demonstration.
Contact us
Quintiles Consulting
Toll free: +1 866 267 4479
Direct telephone: +1 973 850 7571
International: +31 23 567 0991
On the web: www.quintiles.com/consulting
Email: consulting@quintiles.com
Anke van Engen
Office: + 31 (0) 23 5670990
Mobile: + 31 (0) 6 46236510
anke.vanengen@quintiles.com
Lars Heemstra
Office: + 31 (0) 23 5671013
Mobile: + 31 (0) 6 46436563
lars.heemstra@quintiles.com
HTA factsheet
Available from
http://www.quintiles.com/hta-watch
8
Copyright © 2014 Quintiles. 14.30.04-022014
*Any assessments or evaluations are provided by Quintiles as a service for
information purposes only, and are based on the HTA reports referenced above.