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.
Ambassador model (Q1): Clinicians recognised as ‘opinion leaders’ play the role of ambassadors of the HTA ‘message’ inside the healthcare organisation. They may not take part in the assessment but play a key role in the diffusion of results within hospitals.
Mini HTA (Q2): Individual professionals participate in the assessment by collecting data at an organisational level to inform decision makers at higher levels.
Internal Committee (Q3): Evidence is produced by multidisciplinary groups (called internal committees) representing different perspectives and taking the responsibility of reviewing evidence to issue recommendations that are useful hospital-wide.
HTA Unit (Q4): The formal organisational structure is based on specialised HTA personnel working on a full time basis within the unit. This is the highest degree of structure for the hospital HTA.
To implement a health technology assessment process in a hospital setting may be challenging. Potential hurdles limiting the implementation of hospital based health technology assessment include the lack of dedicated resources and limited skills to conduct literature research and evidence evaluations.
In order to foster the development of hospital based health technology assessment, the European Commission has provided a three-year (01/09/2012 – 31/08/2015) research grant to a collaboration of 10 institutions in Europe for their project AdHopHTA, or Adopting hospital-based health technology assessment.
The key objective of the project is ‘to perform a critical analysis of existing hospital-based HTA Initiatives and to evolve methods, instruments and processes to evaluate technology in hospital settings’.
The AdHopHTA project will facilitate the start of new hospital-based HTA programmes and improve the quality and efficiency of existing ones.
As mentioned previously, starting formal health technology assessment in hospital settings may be challenging. To facilitate the process the Danish Center for Evaluation and HTA has developed a practical tool that can be used in hospital settings when considering the evaluation of a new technology.
The guide identifies key questions to be asked to perform the technology evaluation. These include:
Introduction: Who is the proposer (hospital, department, person)? What is the name and designation of the new technology? Which parties are involved in the proposal?
The technology: Based on which indications is the technology going to be used? In which way is the proposal new compared to the usual practice? Has an assessment of the literature been carried out and what is the level of evidence available? What is the effect of the proposal on patients in term of diagnosis, treatment, care, rehabilitation and prevention? Does the proposal imply any risks or adverse events? Are there any on-going studies on the proposal in your country or abroad of the effect of the proposal? Has the proposal been recommended by any scientific societies or other evaluation agencies? Has the department previously apply for the introduction of the new technology?
The patient: Does the proposal entail any specific ethical or psychological considerations? Is the proposal expected to influence the patients’ quality of life, social or employment situation?
The organisation: What are the effects of the proposal on the staff in terms of information, training or working environment? Can the proposal be accommodated within the present physical setting? Will the proposal affect other department or service functions in the hospital? How does the proposal affect the cooperation with other hospitals, region or the primary care sector? When can the proposal be implemented? Was the proposal being implemented in other hospitals in your country or abroad?
The economic aspects: Are there any start-up costs of equipment, rebuilding, training? What are the consequences in terms of activities in the next coming years? What is the additional or saved cost for the hospital in the next couple of years? What uncertainties apply to these calculations?
There is a clear global trend that providers should focus on strategies to deliver superior outcome for patients. As significant competition exists among healthcare providers, competing on outcome is seen as a way to differentiate themselves. When providers deliver superior outcome more efficiently, patients, payers and physicians, all win.
As providers are one of the first entry levels for the introduction of new innovative technologies, there is a need to identify which health technologies will provide significant added value for the patient. Hospital-based HTA can help hospital managers and clinicians to identify which interventions provide the best ‘value for money’ for the patients and prioritise their investments accordingly.