Providers across the world are under tremendous pressure to manage their budget and deliver better services. The cost containment measures in place do not guarantee a superior treatment outcome to patients. Approaches assessing both costs and outcomes at providers’ levels start emerging as a new method to assess medical technologies.
In today’s healthcare environment providers face significant challenges to address both payers’ requirements and demographic changes. Pressure from both payers and healthcare authorities increases to improve hospital efficiency and value delivered to patients. At the same time, ageing populations and increasing burden of non-communicable diseases are changing the nature of healthcare services delivered.
The World Health Organization (WHO) anticipates that the global population aged 60 and above will rise from 600 million in 2000 to 2 billion in 2050. In Asia, the number of people aged 65 and above will increase from 207 million in 2000 to 857 million in 2050, according to the United Nations.
Non-communicable diseases (NCDs) kill more than 36 million people worldwide each year. Nearly 80 per cent of NCD deaths, or 29 million, occur in low-and middle-income countries.
Simultaneously, new and innovative healthcare technologies have brought significant improvements in treatment safety and efficacy. Patients’ quality of life and life expectancies have increased.
Ageing populations, increasing prevalence of non-communicable disease and rapid introduction of new healthcare technologies have put significant pressure on healthcare budgets. Delivering the best possible outcome for patients and managing increasing costs have become global challenges for healthcare decision makers both at national and local levels.
Over the last 20 years health technology assessment methods have been used to assess increasing demands from patients for new technologies and their impact on healthcare systems with scarce resources. Health Technology Assessment (HTA) helps decision makers to identify which interventions provide the best value for money and prioritise their investments accordingly. Three main international HTA organisations have respectively proposed a more formal definition of the process:
HTA is a multi-disciplinary field of policy analysis that studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.
The systematic evaluation of the properties and effects of health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision-makers regarding health technologies.
A multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method.
The beginning of evidence-based medicine can be traced back to several thousand years. In India, archeological findings suggest that medical interventions were performed as early as 7000 B.C. in the sub-continent. About 3000 years ago a more formal scientific approach emerged with the Ayurveda system. China’sHuang-Di Nei-Jing might be the oldest medical text book in the world and was written probably in the third century B.C. In the code of Hammurabi published around 1780 B.C., physicians were punished for bad surgical outcomes: “If a physician makes a large incision with the operating knife, and kill him, or open a tumour with the operating knife, and cut out the eye, his hands shall be cut off.”(Code of Hammurabi 218).
In western medicine the first clinical trials and evidence-based medicine are considered to have appeared in the 17th and 18th centuries. In 1662 a Belgian pharmacist suggested to divide patients into two groups; one receiving a new treatment and the other a traditional treatment. In 1747 James Lind, a Scottish physician, conducted a prospective controlled experiment to compare the efficacy of six treatments for scurvy in 12 patients. A French physician Pierre-Charles-Alexandre Louis (1787-1872) introduced the ‘method enumerique’. He demonstrated that bloodletting was a valid use only in the late stages of pneumonia. More recently, in a famous 1972 publication Archie Cochrane recommended the development and use of randomised controlled trials to improve the medical decision-making process. Starting in the mid-seventies, health technology assessment has had a rapid development first in the academic field and then amongst policy makers to improve allocation of health resources.
HTA is relatively new. The Health Intervention and Technology Assessment Program (HITAP) was established in Thailand in 2006.In 2008, Taiwan started Health Technology Evaluation for drugs with the Center for Drug Evaluation (CDE) and thus the National Evidence-based Healthcare Collaborating Agency (NECA) was founded in Korea.
China: The China National Health Development Research Center (CNHDRC) is a HTA body, part of the ministry of health.
Japan: Reimbursement of new drugs and devices is decided by the Ministry of Health Labour and Welfare after consultation with the Central Social Insurance Medical Council (Chuikyo).
Singapore: The Ministry of Health has created a HTA unit in 1995. This health technology assessment branch is a part of the Performance and Technology Assessment Division. It performs health technology assessment to inform policy-makers within the ministry of health. It also publishes clinical practice guidelines for medical practitioners in Singapore.
Malaysia: The addition of a new drug to the Ministry of Health drug list is based on clinical advantages over best and current treatment options and the treatment costs.
The Philippines: In 1999 a HTA Committee was established by the Philippine Health Insurance Corporation (PhilHealth). It reviews the drugs for their inclusion in the PhilHealth positive list. The committee evaluates the safety and effectiveness of medical devices and surgical procedures as well.
HTA was mainly in use to keep policy makers informed during ‘decision-making at a macroeconomic level. A need to develop more specific approaches for hospitals and other healthcare organisations have emerged over the past 10 years for several reasons, including:
A HTA Agency may not exist in the country. Even if an agency does exist, it may not evaluate the medical technologies such as medical devices
Decision-making tends to be more decentralised in healthcare systems nowadays. Purchase and acquisition of new technologies are performed more at the regional or local level and less at the central level. Therefore, hospitals are under increasing pressures to control budgets and increase their efficiency
Importance of the context. The benefit and risk related to the use of any of the health technologies depends on the specific context of the healthcare organisation where the technologies have been implemented.
In the hospital context it is extremely challenging to perform a comprehensive HTA evaluation every time a decision has to be made on the acquisition of a new technology.
A hospital’s economic decision-makers and clinicians need tools to better manage the allocation of resources to improve the clinical governance. Hospital-based HTA has been developed to address the specific challenges of technology evaluation in hospital settings. The Hospital-based HTA consortium has developed a specific definition of a hospital based HTA: It ‘consists in the implementation of processes and methods of HTA at hospital level. The contextualisation of HTA to a specific hospital brings into the assessment process the consideration of its unique characteristics, such as the choice of an available comparator and the specific organisational patterns of the hospital. Hospital-based HTA can be performed by a team of professionals working at the hospital, or by an external team of professionals’
At the hospital level, health technology assessment may be applied in different formats. The Health Technology Assessment International (HTAi) Interest sub-group hospital-based health technology assessment has adopted a conceptual model to describe how HTA is performed within hospitals. The model identifies four different groups depending on (i) the focus of the action and on (ii) the level of complexity of the organisation solution implemented to perform HTA.