Figure 1: Extent to which the following outcomes are seen as likely or unlikely for new technologies as a result of ACO

28%

64%

22%

32%

54%

32%

38%

72%

36%

78%

68%

46%

68%

62%

Increased provider scrutiny of value

Carve-outs for certain HTAs

Clinical pathways for improved efficacy

Clinical pathways for greater cost savings

Preclude some new health technologies

New contracting requirements

Higher access hurdles targeting quality and/or pay for performance

Unlikely Likely

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

HTA Uncovered Issue No.4 – February 2014

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.

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

“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

impacted by ACO approaches,

and develop value

communications aligned with

this new provider

management model.”

Eric Faulkner, Director, Global

Market Access, Quintiles

Consulting and Executive

Director, Genomics Biotech

Emerging Medical Technology

Institute of the National

Association of Managed Care

Physicians

1For more information, please contact the study lead author, Eric Faulkner, at eric.faulkner@quintiles.com

2

HTA Uncovered : Issue No.4 - February 2014

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).

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.

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 14th

June 2013 indicates that Indian health policy makers and payers seem to moving towards a formal HTA process8. 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

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-

Background

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).

3

HTA Uncovered : Issue No.4 - February 2014

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.

HTA in 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

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 decision-

making 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 Pharmaco-

economics 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

“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 class-

specific patient registries are

established”

Harsha Doddihal, Associate

Medical Director, Quintiles, India

The introduction and use of HTA

in healthcare decision-making

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

4

HTA Uncovered : Issue No.4 - February 2014

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.

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.

“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

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 bene-ficiaries (million)

Funding Benefits package

Public CGHS Central government employees

3 GOI Beneficiaries

Outpatient; inpatient; preventive and ambulatory services; mainly tertiary

Public ESIS Employers Employees

55.5 Beneficiaries Employers State

Outpatient; inpatient; preventive and ambulatory services; all levels

Public/State RSBY BPL population 131* 25% State 75% GOI

Inpatient, secondary care; chronic diseases

Public/State RSBY Plus (HP)

BPL population enrolled in RSBY

NA 100% State Inpatient, tertiary care; complementary to RSBY coverage

Public/State ASBY (Delhi) BPL population enrolled in RSBY

NA 100% State Inpatient, tertiary care Complementary to RSBY coverage

Public/State Rajiv Aarogyasri Scheme (AP)

BPL but went ahead to almost the entire population (85%)

70 100% State Inpatient, tertiary care; chronic diseases

Public/State Kalaignar (TN) BPL Over 50 100% State Inpatient, tertiary care; chronic diseases

Public/State Vajapayee Arogyasri Scheme (KN)

BPL 1.6 100% State Inpatient, secondary and some tertiary care; chronic diseases

Community/ NGOs

Yeshasvini (KN)

Registered in cooperative societies, both BPL and APL

3 40% State Beneficiaries

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: 8

UK 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. 10

NICE. 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. 13

ISPOR India Chapter. Draft of proposed Pharmacoeconomics Guidelines for India (PEG - I). Oct 2013.

5

HTA Uncovered : Issue No.4 - February 2014

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 purchasing-power-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.

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.

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.

References:14

Venkatesh KK et al. Clinical impact and cost-effectiveness of expanded voluntary HIV testing in India. PLoS One. 2013 May 31;8(5). 15

Verguet 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. 17

Gupta 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. 20

Aggarwal 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. 21

WHO Country Cooperation Strategy Brief. India (2013). 22

Industry 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. 25

La 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. 27

Reddy 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. 29

Narayan S. Price controls on pharmaceutical products in India. ISAS Working Paper No. 20. Mar 2007. 30

National 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. 32

Bansal 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.

6

HTA Uncovered : Issue No.4 - February 2014

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.

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-och-

Läkemedelsförmåns 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.

Facts and Figures

Figure 2: Reports published by selected agendies during

2012-2013

0 100 200 300 400 500

HAS

CADTH

TLV

SMC

NICE

INESSS

PBAC

CVZ

NCPE

CONITEC

G-BA

AWMSG

pCODR

Number of reports published

2013

2012

+2%

-13%

-1%

+18%

+28%

-22%

+5%

+67%

+71%

+12%

0%

+80%

-14%

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.

7

HTA Uncovered : Issue No.4 - February 2014

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.

HTA dissemination and current developments in

Latin America

Despite the socioeconomic and health provision

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.

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; 19-

21 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

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

HP Himachal Pradesh

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

TN Tamil Nadu

WHO World Health Organization

8

HTA Uncovered : Issue No.4 - February 2014

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.

*Any assessments or evaluations are provided by Quintiles as a service for information purposes only, and are based on the HTA reports referenced above.

Copyright © 2013 Quintiles. 14.30.02-082013

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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

Copyright © 2014 Quintiles. 14.30.04-022014