1.  Health Technology Assessment

Under the terms of the partnership MoU between NICE and the MoHFW Department of Health Research (DHR), and linking to the bilateral India-UK MoU, a Joint Steering Committee (JSC) linking with the Medical Technology Advisory Board (MTAB) has been established. The Committee is comprised of senior members from DHR , the India Council of Medical Research (ICMR), the National Health Systems Resource Centre (NHSRC), iDSI and NICE. The JSC provides strategic guidance and advice on how India can implement a system for health technology assessment (HTA) and priority setting and strengthen evidence-informed healthcare policy and practice. A work programme has now been defined for 2016, including training (Health Economics) and HTA demonstration projects on HTAs. This will be a significant step for India towards Universal Health Coverage, improving the way that the heath budget is spent by prioritising cost effective practices. Prime Minister Narendra Modi and Prime Minister David Cameron acknowledged this valuable partnership in a Joint Statement following a recent UK visit by the Indian Prime Minister: “The two Prime Ministers welcomed the cooperation in the health sector between the two countries and the on-going Memorandum of Understanding covering areas including Medical Education and Training, Universal Health Coverage, containment of Anti-Microbial Resistance (AMR), improving patient safety through quality, safe and efficacious drugs and the collaboration between NICE International, UK and the Department of Health Research in India on medical technology assessment

2.  Standard Treatment Guidelines (STGs)

As a part of its efforts towards Universal Health Coverage the National Health Mission (NHM) has established an STG Task Force, one of four coordinated by NHSRC. Its aim is to oversee the development of authoritative, national STGs for healthcare services, including those covered by existing large scale insurance schemes (RSBY), and to help expand access to care that is affordable, equitable and effective. NICE International is helping NHSRC and the ten Clinical Subgroups, both from the public and private sectors that have been convened to develop STGs in 12 prioritized topics, based on robust evidence and using a transparent and inclusive process. STGs on hypertension and the diabetic foot have been sent to the MoHFW for public consultation before approval by the Directorate General of Health Services (DGHS). As part of this engagement, NICE International is a member of the Working Group (including AIIMs, WHO, NHSRC) that is developing the process and methods manual underpinning the STGs and associated Quality Standards for India. The manual aims to guide the STG developers in producing STGs that are inclusive, of high quality and relevant to India

3.  STG Implementation and Primary Care

NICE International is working closely with the Primary Care Task Force to implement the STGs at state-level. It is a member of the Primary Care Implementation Group responsible for designing the action plan and prioritising topics for implementation, focusing on better management of non-communicable diseases (NCDs) in primary care. NICE International brings in its experience of working in partnership with the Government of Kerala (National Health Mission) and the Kerala Federation of Obstetricians & Gynecologists (KFOG) to help reduce maternal mortality through Quality Standards for maternal care, and specifically on post-partum haemorrhage and hypertensive disorders in pregnancy. The Government developed quality measures to improve the care mothers receive during delivery, in both public and private hospitals, and these have been implemented in several hospitals in Kerala leading to improvement of care and outcomes.

In addition to these three work packages, NICE International has engaged with policy makers in Bihar and Odisha and hosted delegations from Karnataka, ICMR, NHSRC, MTAB and the main health insurers at NICE. RSBY also contributed to an international workshop held under iDSI on the development of Health Benefit Packages.

NICE International work in India is funded by DFID and the Bill and Melinda Gates Foundation.

The workshop focused on developing Quality Standards and indicators for AMR. It was jointly organised by the Department of Medical Services Administration (MSA) of the Ministry of Health and the National Hospital for Tropical Diseases and attendees included members of the AMR subcommittee programme as well as representatives from relevant MoH institutes and universities.

A  plan for developing standards to improve AMR management in hospitals in Vietnam has now been drawn up and will be operationalized with relevant partners over the next 12 months.

Dr Cluzeau with AMR workshop participants

Controlling antimicrobial resistance requires a determined action and effort, and the objective of this partnership is to create an evidence-informed methodology and a governed working process to develop and implement policies and guidelines. NICE International’s role is to advise on the development and implementation of quality standards and indicators for AMR, based on previous collaboration with Vietnamese policymakers and clinicians on developing quality standards for acute stroke.

The first workshop [report in Vietnamese] in September 2015, hosted by the Ministry of Health, was attended by delegates from different ministries, national and international agencies, and external AMR experts. Its purpose was to share operational experience, coordination and cooperation to prevent drug resistance in Vietnam, caused in part by overuse of antibiotics. Dr. Nguyen Thi Xuyen, Deputy Minister of Health, highlighted the need to implement the National Action Plan on prevention of drug resistance to combat this issue. A second workshop in Hanoi is planned for 10-11 December 2015, and will cover the development and implementation of quality standards and indicators for AMR.

This work will be one component of iDSI’s ongoing practical support for Vietnam, alongside further health technology assessment capacity building and strategic roadmap development to inform the health benefits plan.

In December 2015, Francoise travelled to Hanoi for a workshop to develop QS in AMR, which you can read more about here

“The two Prime Ministers welcomed the cooperation in the health sector between the two countries and the on-going Memorandum of Understanding covering areas including Medical Education and Training, Universal Health Coverage, containment of Anti-Microbial Resistance (AMR), improving patient safety through quality, safe and efficacious drugs and the collaboration between NICE International, UK and the Department of Health Research in India on medical technology assessment.”

The Memorandum of Understanding between NICE and the Department of Health Research, Ministry of Health and Family Welfare, Government of India referred to in the statement  was signed in 2013  and has resulted in  several collaborative activities, including a study visit to NICE from ICMR  staff and  relevant policy makers. One particularly important event was an iDSI organised high level policy workshop in New Delhi in October 2014. Here representatives from NICE International, in partnership with representatives from other iDSI partners such as HITAP (Thailand), the Center for Global Development, and the CNHDRC (China) raised awareness of, priority-setting and health technology assessment as tools to help make better decisions for health and enhance the drive towards Universal Health Coverage in India.

NICE International continues to work with the Ministry of Health and Family Welfare to explore options and build institutional capacity for establishing health technology assessment and standard treatment guidelines. Looking to the future, India will continue to be a key iDSI partner.

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We needed to know who were making priority-setting decisions in the respective health systems, how these decisions were being made and financed, what technical capacity countries had to implement HTA processes, as well as the key challenges facing their health systems. But at the time, there was no comprehensive literature covering all of these issues of relevance to priority-setting, within a broad enough geographical scope. Existing surveys on HTA (including those done by NICE International and HITAP) tended to focus narrow on its technical aspects, whereas studies from the health systems research field didn’t go deep enough into the important facets of priority-setting such as who are the stakeholders, what evidence is used, and so on.

With the end goal of selecting a country to offer iDSI practical support that would be feasible, in demand, and generate significant impact, we set out to assess how ready countries were for priority-setting support. We developed a conceptual framework, methods (including a country selection process), qualitative and quantitative indicators, and data collection tools (including questionnaires and interview guides) for priority-setting readiness. The mapping combined published and grey literature, insights from iDSI partners, and primary data collection from in-country key opinion leaders. And thanks to the hard work of iDSI partners worldwide, we successfully completed mapping of 17 countries within the space of 7 months.

Since completing the mapping, we have used it to select Indonesia as our focal country partner, where HITAP, NICE International and PATH are working in collaboration with local decision makers and academics to support HTA development. We have also subsequently secured additional funding to support a Sub-Saharan African regional hub for priority-setting around PRICELESS SA, South Africa.

One year on from the HITA resolution, there has been a proliferation of regional mapping exercises for priority-setting capacity, coinciding with the global momentum to support HITA. These include WHO-led efforts as well as iDSI partnerships with WHO regional initiatives (such as the Asia Pacific Observatory on Health Systems and Policies, and Advance HTA with PAHO). As the global health and political scene is so fast moving, some of the findings in the iDSI mapping report are inevitably already out of date. My hope is that these latest efforts will add to our global knowledge and provide practical insights to international donors and development partners, in order to support country partners in building capacity for better priority-setting in health.

The NHS is doing more harm than good by approving expensive drugs for a limited number of conditions such as advanced cancer, which use up funds that would benefit other parts of the health service…

Claxton says the patients who lose out are invisible and have no say in the argument over how limited NHS resources are spent – by contrast patients with conditions such as advanced cancer are often featured in the media whenever a new drug with a very expensive price tag is turned down by Nice.

The full report by Claxton et al. is published in the NIHR Health Technology Assessment journal.

And here is the full response from the ‘decision maker’, Sir Andrew Dillon, Chief Executive of NICE:

At the other end of the spectrum, we obviously can’t just say yes to anything and everything… Whether we’ve got the balance right is a question for everyone to reflect on; it’s certainly not a decision just to be left to health economists.

Whether or not the current threshold is indeed to high, and whether or not NICE is ever able to adopt this suggested dramatically lower threshold, this debate highlights very important issues about the real opportunity costs of paying for expensive health technologies; the invisible patient who suffers and never has a voice; who should decide the rules (and how); and, fundamentally, the importance of having robust, defensible mechanisms of health technology assessment, so that society is informed as to what we are paying for, and at what cost.

It is commendable that the technical experts and decision makers are able to have this honest, open discussion about what the threshold should be. Further, it demonstrates the very principles which crucially underpin the work of NICE: transparency, participation (in particular, a collaborative and productive relationship between decision makers and an independent academic network), and weighing scientific evidence in the context of social and ethical values, for the broader interests of society.

As part of iDSI, our colleagues at the University of York are also leading research to explore the use of cost-effectiveness thresholds in low- and middle-income countries.

It might be new and expensive cancer drugs in the UK, or high-tech viral load monitoring for HIV in Uganda, but reality is the same everywhere: each pound or dollar spent on one part of the health system, means denying that pound or dollar from being spent on something and someone else.

With thanks to Yot Teerawattananon, and Kalipso Chalkidou

In 2007, there were an estimated 58 million deaths worldwide and, according to the WHO, more than half (35 million) were caused by chronic diseases. Another study estimates that deaths caused by chronic diseases will rise to 50 million in 2020. The economic burden of these diseases is enormous. By 2015, an estimated reduction of 5% on GDP will be due to funds channeled into healthcare spending on just two of these diseases – diabetes and cardiovascular disease. Studies show that low- and middle-income countries, elderly patients, and those coming from lower income brackets bear the brunt of the increasing risk and economic burden of these diseases. Despite this, chronic kidney disease (CKD) is generally not included in the list of priorities for governments and international donors. And with governments around the world committing to Universal Health Coverage (UHC) for their citizens, priority-setting for treatments of chronic diseases – and CKD – is a must.

Preferred treatment is usually the more expensive and less logistically efficient in-clinic hemodialysis (HD) rather than the home kit peritoneal dialysis (PD). PD has several advantages: it is three times less expensive than HD, it can be done at home and reduce the three whole-day trips per week done for the HD procedure, less manpower is required, and there is no difference between HD and PD in clinical outcomes. As a result of their UHC commitment, several governments (Thailand and Hong Kong, in particular) have successfully enacted the ‘PD First’ policy as their primary treatment for renal diseases. Implementing such a policy in other countries increasingly became vital.

On November 27-28, 2014, an international forum on elevating this topic as a priority in Asia was conducted through the collaboration of Thailand’s Department of Medical Services under the Ministry of Public Health, the Nephrology Society of Thailand, the National Health Security Office, the Kidney Foundation of Thailand, Mahidol University Global Health unit, the Rockefeller Foundation, NICE International, and the Health Intervention and Technology Assessment Program (HITAP). The objectives were important for developing and developed countries considering such a scheme: to share knowledge and experiences about enacting this policy; strengthen institutional and international networks to push the policy through; and spread awareness of the PD First Policy beyond their borders, regionally and globally.

The two-day forum was opened by the Minister of Public Health, Dr. Ratchata Ratchatanawin, and had an informative field visit to various hospitals and patients’ homes with PD treatments. Topics spanned the range from the global burden of the disease, end stage renal disease (ESRD) experiences and policies in Thailand and the UK, the policy challenges in implementing PD First policy under the UHC for ESRD patients, clinical innovation to improve quality of care in PD, and psychosocial innovation for PD for improved quality of life. Delegates came from both the public and private sectors in Cambodia, Hong Kong, India, Indonesia, Lao, Malaysia, the Philippines, Singapore, Thailand, Taiwan and the United Kingdom; speakers included prominent movers and shakers in the field. Such that the physical, psychological and economic burden is mitigated for the individual patient and the government(s), collaboration among and between countries to push this policy forward was also discussed, and future conferences were considered to explore next steps and ways on progressing in this goal. Lessons learned, information, and outcomes from this forum will be documented in a report to be made available early next year on the International Decision Support Initiative (iDSI) and HITAP websites.

Although the Thai Universal Healthcare Coverage (UHC) excluded ART for HIV/AIDS when it was introduced in 2002, it included ART for all eligible patients the following year due to the Prime Minister’s announcement during the World AIDS Conference in Bangkok. Whether this inclusion was based on evidence, careful consideration, or political bravery, it has 070-667 been considered as another success story by champions for HIV and the story was used to inspire other low- and middle-income countries (LMICs) to follow the path of providing universal access to ART.

Until March 2014, almost 300,000 HIV-infected persons received ART. The current ART guidelines indicate that HIV-infected persons with CD4 lower than 350 cells/mm³ are eligible. This change two years ago in the CD4 threshold from 250 cells/mm³ was the result of a long standing debate between two opposing groups: One opposed the change because they estimated that almost 33,000 patients with CD4 lower than 250 cells/mm³ were not able to access ART due to several reasons, including unknown HIV status. The other supported the change because scientific evidence proved a greater health benefit of HIV patients. The central theme of the debate surrounded the issue of whether Thailand should devote their limited resources to patients who could not access ART by identifying unknown HIV infections versus giving the benefits to those who already knew of their HIV status but did not qualify for the CD4 threshold.

On 31 July 2013, the national AIDS committee approved an ‘end AIDS’ policy, with the ultimate goal of zero mother-to-child HIV transmissions, reducing new
070-684 HIV infections to less than 1000 persons/year or 10% of the current statistic, and providing ART to all known HIV-infections. A key strategy of this policy is to provide ART regardless of CD4 levels. Although there is no evidence to support the benefit of ART for HIV patients at CD4 above 500 cells/mm³, a study in Africa showed that early ART can reduce HIV transmission. So ART at an early stage is mainly for the benefit of society and perhaps at the cost of the patients’ health due to potential adverse reactions and drug resistance. Surprisingly, there is not much debate at this time, which may be due to the previous painful debate.

The national AIDS committee produced a report indicating that the policy was based on economic evidence, produced by overseas AIDS experts. The evidence suggests that expanding or scaling up ART to all HIV-infected individuals would offer good economic return to the country: spending USD $95 million over 10 years would result in a return of investment amounting to over USD $300 million. In other words, the benefit to cost ratio of the scale up is equivalent to 3:1.

HITAP was requested by the National Health Security Office (NHSO) to assess the feasibility of this policy because the NHSO needs to be responsible for financing major activities of this end AIDS policy. HITAP carefully examined the evidence presented by the AIDS committee and the respective national plan proposed by the public authorities responsible for policy implementation. Two obvious issues arose from the review. First, the report provided an optimistic estimate of the effectiveness of HIV screening, which is a crucial success factor of the end AIDS policy. It suggests that 1 new HIV case would be detected for every 26 screened. This is in contrast to the empirical evidence in Thailand, showing that scaling up HIV screening would significantly increase the number of screenings needed to identify a new HIV case to more than 200. Secondly, the bigger issue is that the report informs us that the USD $95 million needed for the policy is of a net present value (discounting all future investments in the current value of money). This figure was referred to by the AIDS committee and used as an absolute number, saying that the policy needs USD $100 million of investments over 10 years or an additional USD $10 million per annum on top of the current HIV budget. HITAP’s estimation is that if the net present value is converted to an absolute number, the policy will require USD $380 million or an average of USD $38 million per annum.

The review results were presented in a stakeholder consultation meeting last month and created debate about the financial sustainability of this policy and feasibility of devoting human resources for HIV screening and early ART, especially in making asymptomatic patients adhere to the treatment in order to prevent the development of drug resistance in patients with poor ART adherence. Drug resistance would lead to a higher burden of finances and human resources in offering more expensive second-, third-, and fourth-line ART drugs, which is not properly incorporated in the economic analysis.

It remains to be seen how the NHSO will decide on this case, but one thing is certain: this circumstance illustrates the benefits of having evidence-based policy decisions. All decisions are made based on publicly available evidence for all stakeholders to carefully consider and discuss. However, it also shows that making evidence available for policy decisions is not enough. Decision makers and other stakeholders need to be empowered to access and appropriately interpret the available evidence to be able to claim that policy decisions are well-informed by evidence. This showcase is very much in line with the scope of iDSI in which we try to build up local capacity of researchers and decision makers to be able to generate and make use of evidence appropriately, across health problems as opposed to specific diseases or technologies. The process takes time, effort, and compassion but leads to sustainable health development.

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