HTA Uncovered February 2014_Talks about emerging trend of Health Technology Assessment in India, different government insurance schemes and Impact of Accountable Care Organizations on reimbursement in US

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Health & Medicine

Published on February 28, 2014

Author: harshadoddihal



Being the 3rd largest healthcare market in the world, India's government has taken the first step towards using HTA in health-care decision-making.Impact of accountable-care
organizations on biopharmaceutical reimbursement and access

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

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

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

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. 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

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

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

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: 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:  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

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: Email: Anke van Engen Office: + 31 (0) 23 5670990 Mobile: + 31 (0) 6 46236510 Lars Heemstra Office: + 31 (0) 23 5671013 Mobile: + 31 (0) 6 46436563 HTA factsheet Available from 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.

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