Scoping the ‘value of innovation’

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Author / translator Michael Creek

Healthcare budgets are increasingly squeezed, and it is more and more important to measure the value of new technologies, to work out what is worth the investment. Decision makers typically take account of the price of the innovation and the clinical outcome. But what about additional effects on employment, economic benefits, efficacy, quality of life for patients and caregivers and other elements? How do we define value? Glossary: • Health Technology Assessment - HTA looks at many different aspects of an innovation to help people who fund, plan and invest in healthcare work out how valuable a particular medical treatment, procedure or service is in a systematic, transparent, unbiased, and robust manner. This can take into account not only clinical impact, but also social, economic, legal and ethical aspects. • Health-related quality of life - We can define health-related quality of life as the way a person perceives the effect of illness and treatment on their daily life, in terms of the physical, psychological and social aspects. • Cost-effectiveness analysis – Cost-effectiveness analysis is an appreciation of the value for money of a health technology, where costs are usually expressed in monetary units, while benefits are often measured in terms of a non-disease-specific unit called quality-adjusted life year. • Quality-adjusted life year - QALYs are a way to measure people's state of health, taking into account their ability to perform the activities of daily life, freedom from pain and mental disturbance. QALYs are recorded in terms of length of life, adjusted to reflect this quality of life. One QALY is equal to 1 year of life in perfect health. • Incremental Cost Effectiveness Ratio (ICER) – a cost-effectiveness analysis compares two technologies and asks: how many QALYs does one save, compared to the other, and how does that compare with their direct costs? • Direct costs - All costs directly related to a disease or technology, which can be inside the healthcare sector (e.g. equipment) as well as outside the healthcare sector (e.g. patients’ travel time). • Indirect costs – all costs resulting from consequences of a disease or technology, e.g. absence from work due to illness.

Aims of the game

- Clarify your opinions - Work towards a shared group goal - Make sure your voice is heard

Created 31 August 2015

Last edited 8 June 2018

Topics Health, Politics

Policy positions

Policy position 1

When assessing the value of innovative treatments, procedures or services in healthcare, we should focus on a cost-effectiveness analysis by asking: how many quality-adjusted life years will be saved with this innovation, and what are the direct medical costs of the innovation, compared to the best available alternative?

Policy position 2

When assessing the value of innovative treatments, procedures or services in healthcare, we should focus on a cost-effectiveness analysis as in policy position 1, and also ask: what impact will this innovation have on the costs of social care, unemployment, housing and disability benefits?

Policy position 3

When assessing the value of innovative treatments, procedures or services in healthcare, we should focus on a cost-effectiveness analysis which also looks at the impact of non-medical costs as in policy position 2, and also ask: what effects does this innovation have on the quality of life of informal caregivers and healthcare professionals?

Policy position 4

When assessing the value of innovative treatments, procedures or services in healthcare, we should focus on a cost-effectiveness analysis which looks at non-medical costs, quality of life of caregivers and healthcare professionals as in as in policy position 3, and also ask: what is the impact of this innovation on workplace productivity, jobs and the economy?

Story cards

I’m Jan-Alfred. I recently had to go into hospital for surgery, and I was given a tablet computer afterwards, with lots of information, ways to plan my recovery and tools to check how I was doing every day. It worked through some sort of app which followed the hospital’s own guidelines on recovery. It meant I could leave the hospital earlier, which I was relieved about, and I didn’t have to go back into the hospital quite as much for them to check on me – they could see what I’d uploaded. Made me feel sort of empowered, and helped me really stick to what I was supposed to be doing.

“The app made things easier”

I’m Björn, and I’ve been caring for my dad who’s chronically ill. We’re part of a local patient group, and I was invited by them to participate in a study because they were helping to assess the value of my dad’s treatment. And in my case, caring for my dad has triggered some mental health issues for me. Because of all this, I’m no longer planning to go back to university, and I’m currently struggling to work out how to ask my boss for even more time off work, this time for my anxiety.

“Not easy being a caregiver”

I’m Joao, I’m a nurse, and my hospital is working with cancer patients on a specific pilot project aimed at getting them back into work. Patients have four meetings with me in order to rehabilitate them, as well as a meeting with the specialist to make a return-to-work plan. I actually get in touch with these patients before they start their cancer treatment. The aim is to get them working again, and hopefully give them a better quality of life once they’re feeling better. It’s amazing to see how important it is to their self-esteem and feeling of self-worth, to get back to their jobs. The pilot project seems really promising but I’m wondering how feasible it would really be to carry this out on a large scale.

“Getting people back into work”

I’m Pilvi, and when I turned 27 I learned that I suffer from multiple sclerosis. Even since then I have managed to live an active life controlling my condition with drugs. Nevertheless, I live with the possibility that these drugs may one day stop being effective. I heard that the national health system denied a new treatment for my disease, finding it not cost effective (not “worth it” for society). At the same time it is paying for the treatment of one girl with a rare condition that costs €100,000 year while treatment for my more common disease (affecting between 1 and 1000 people) would only cost €15000 a year. I feel really concerned about this.

“What do we mean by cost-effective?"

I’m Kris de Bock. I work for a private company that produces innovative solutions in healthcare. We’ve come up with a range of innovations, including hospice-at-home programmes and apps which enable more connected support, and there is a great deal of evidence to show that this can greatly improve end-of-life care. What we’re finding is that as healthcare budgets are cut, health authorities are reluctant to invest in this kind of programme. It worries me that we’re not supporting people as well as we could in the late stages of their illnesses.

“What about end-of-life care?”

I’m Elisa Bisello, I’m the manager of a large hospital. We don’t have a specific HTA unit but I’m increasingly having to decide what health technologies to invest in, when these decisions are not taken at national level. My region is not a wealthy one, and there’s sometimes pressure to approve technologies from local producers, creating jobs in the region. I do have trouble balancing this out against the effectiveness of the technology and the money I save.

“Pressure to invest locally”

I’m Petra, I work for a patient group on asthma in Finland. Asthma used to be under-diagnosed here. But there was a National Asthma Programme, implemented between 1994 and 2004, connecting professionals, which really helped the disease be recognised, diagnosed and treated. The result was a big saving in treatment costs, and costs for society too, with a 76% decrease in the number of asthma patients claiming disability pension. I think collaboration like this on a national level can make a big difference.

“Savings for society”

I’m Virve Aare, an oncologist specialising in cervical cancer. One thing I’ve noticed about my patients is that we often forget to take into account what an effect this type of cancer has on their lives – not only the side effects of every cancer treatments, but the effects on their sex lives and sense of self, related to how they feel as women. I sometimes see patients leave my care without being sure whether they are really getting all the support they need to cope with that, and that’s definitely a concern of mine.

“Cancer is more than an illness.”

I’m Nina Daniels and I run an SME. Business has been going well, but like many manufacturers we were hit hard by the crisis and struggle to compete with low cost-base countries. One issue I’ve really been having a hard time with in recent years is that of my team of five managers, one has been off sick with chronic illness. And now another member of the team would like to go down to part-time hours in order to care for a relative. This is a very tough situation for both of them of course, puts a lot of pressure on me, and really affects morale, not to mention turnover. We’re struggling to pull together as a team.

“Pressure on employers”

INFO CARDSISSUE CARDS

Health-related quality of life is hard to measure

One aspect of the value of a medicine is the health-related quality of life it can bring to a patient. However, it is difficult for experts to measure health-related quality of life since the current used standard tools are not sensitive enough and do not capture all the relevant effects of treatment.

How do we choose which treatments to assess?

Should all new medical treatments be assessed as soon as they become licensed and available? Or should we select which new treatments to assess, according to their priority areas?

Who should be around the table when deciding on health technology assessment?

Which stakeholders should be involved in this process: policymakers, industry, patient interest groups, medical experts, other experts?

Individual interests or society interests?

When deciding about the value of a treatment, we are essentially asking: how important are the best interests of the individual needing treatment, compared to the best interests of society?

Is the current EU healthcare system sustainable?

Governments struggle to afford world-class care for populations that are living longer, often with chronic disease. The costs of care continue to increase steadily as new more expensive treatments are introduced and adherence with prescribed treatment regimens remains low.

The problem of silos

There is a lack of integration between European health systems, employment and welfare policy, because the budget for each department tends to be structured into silos.

Privacy and ethical issues using health records

More systematic use of health records can help speed up the development and deployment of new technologies. How can we ensure privacy and ethical concerns are respected, when using this personal data?

How effective is the WHO’s Essential Medicines list?

The World Health Organisation’s list of priority medicines covers most essential and affordable medicines to be provided worldwide. But is there a lack of quality data and multi-stakeholder engagement behind this list?

Who bears the financial burden?

Findings have shown that pharmaceutical policies in Europe have led to purchasing efficiency and saved governments money. But has the financial burden shifted to patients, increasing inequality of access to medicines? Can this be avoided?

HTA variation from country to country

Since each EU country determines value of innovations independently, different medicines are approved for use in different countries. How does the issue of cross-border healthcare affect health technology assessment?

The utilitarian approach

In making decisions regarding ethical dilemmas, this approach tries to bring the greatest good to the greatest number of people. Does this solidarity principle hold in the long term, considering trends towards healthcare privatization and economic inequalities?

A centralised European HTA agency?

Europe already has a centralised agency for regulating medicinal products. Today it is the standard go-to-market route for new market entries in Europe. Could we see the same happening for HTA?

A culture of excess?

The Lancet Oncology Commission reported that wealthy countries operate in a culture of excess: “excessive diagnostic tests, excessive interventions and excessive promises that create unrealistic expectations for patients and their families.”

Who is responsible for keeping medicines affordable?

Governments or industry?

Defining future value

How do we reconcile short-term and long-term benefits in our definition of value?

Measuring non-monetary, non-health benefits

Policy reports recognize the value of non-monetary benefits outside the health system, but how can we realistically quantify these benefits?

Concerns of survivors of illness

After recovery, people’s main concerns have been found to be their academic, career, personal and social expectations. How can we ensure the healthcare system is tailored to people’s needs?

Measuring value of contribution to R&D

Most recognize that innovation contributes to our society in ways other than monetary. But if we can’t measure those benefits, how can we include them in our definition of value?

Benefits and risks: for patients or populations?

When we talk about value, we talk about risks and benefits. But what’s beneficial or risky for a patient isn’t necessarily beneficial or risky for a population. Where should the balance lie?

Who helps informal caregivers manage work and care?

Informal caregivers play a crucial role in patients’ recovery, but they also have to hold down jobs. To what extent should it be down to health authorities that support them in this? What should the role of employers be?

Recognition of the role of informal caregivers

The role of informal caregivers is acknowledged, but not always formalized in health and social policy development.

Hard to measure quality of life

Research into the non-monetary benefits of innovation on quality of life for patients and caregivers is currently limited. How can we include those benefits in our definition of value, if we can’t measure them?

End-of-life care can have little monetary economic benefit

If we choose a model of value that places a strong focus on the economic benefits of getting patients back to work, do we risk neglecting treatments for end-of-life care, where the need is to prevent unnecessary suffering and maintain quality of life?

One model fits all?

Can we really define value using one model which addresses all types of care, from medicinal to psycho-social?

Whose voice should be heard loudest?

When defining a model of value of innovation, should all stakeholders have an equal voice, or do some need to be heard louder than others?

Lack of trust among stakeholders

If governments, healthcare practitioners, NGOs and industry don’t trust each other, how can they work together to determine value?

The value of adherence

It is not enough to develop therapies that work. We need therapies that patients can take and fit into their lifestyles.

Assessing value: a continuous process

A good system of assessing the value of a treatment can be used not only upon the release of a new technology, but to continually monitor its benefits. This means that value can be re-assessed as evidence on benefits and risks accumulates over time.

The pharmaceutical industry is important to the EU

The EU is the major world trader in medicinal and pharmaceutical products. In 2012, pharmaceutical exports contributed €106 353 027 million to the EU.

The costs of cancer

Cancer cost the EU €126 billion in 2009, with health care accounting for 40% of that. 34% was losses in productivity because of early death, and lost working days made up 7%. 18% of that was informal care.

Europe’s ageing population

The share of the population aged 65 years and over is increasing in every EU Member State – in the last decade it grew by 2%. During the period from 2013 to 2080 the share of the population of working age is expected to decline steadily. Those aged 65 years or over will account for 29% of the EU’s population by 2080, compared with 18% in 2013.

Case study: economic burden of rheumatoid arthritis

The UK National Rheumatoid Arthritis Society estimated that the economic burden on society of rheumatoid arthritis is 12 times higher than taxpayers’ contribution to treatment.

Case study: cancer in Norway

Studies in Norway show that cancer is associated with a 7% decline in income. Childless men with low education and low prior earnings were worst affected. Lymphomas and lung cancer accounted largely for these unfavorable effects.

Case study: caregivers of brain tumour patients

When caregivers of patients with brain tumours were interviewed in the UK in 2013, more than half said it had affected their jobs, education, hobbies and relationships. 80% said it had affected their emotional well-being.

Lack of EU coordination on health technology assessment

The EU has one regulatory system for the approval of new medicines. Pricing and reimbursement, however, are decided at national level, rather than European. The emerging EU collaboration on Health Technology Assessment aims to bring convergence in the assessment of value of new medicines and patient outcomes.

The problem of prescription adherence

Studies have shown that on average only one-third of patients actually adhere to prescribed dosing regimens. Similar adherence issues apply to procedures and services. They compromise effectiveness and put tremendous strain on healthcare systems through wastage, re-testing and acute medical care, as well as on social systems through reduction in productivity.

The complexity of pharmaceutical innovation

Of 5,000 compounds that enter pre-clinical testing, only five, on average, are trialled on humans and only one is approved for use. Increasing demand to demonstrate effectiveness over existing treatments adds further complexity and costs to the development process.

The societal impact of cancer

Over the next decade the incidence of cancer is expected to increase by approximately 60%. This increase, due to an ageing population and improved treatment, has led to more patients living with cancer for many years. Cancer patients require regular checkups, often require hospitalization for continued care and have long-term physical and psychological complications.

Effects of the crisis

Health spending growth ground to a halt in 2010 in the wake of the global financial and economic crisis. Spending per capita fell by 11.1% in Greece and 6.6% in Ireland between 2009 and 2011. Spending on health across the OECD increased slightly in 2013, and this increase is expected to continue.

WHO view of the costs of disability

The World Health Organisation recognizes that the economic and social costs of disability are significant, but difficult to quantify. They include direct and indirect costs, some borne by people with disabilities and their families, friends and employers, and some by society.

Lobbying for caregivers

The European Federation of Families of People with Mental Illness campaigns for adequate resourcing of mental health support across Europe so families are not held legally or financially responsible for their family member affected by mental health.

Quality of life effects often ignored

A French survey on the management and needs of women with breast and gynaelogical cancer showed that problems related to daily life, material life and social life were poorly identified and remained largely unmanaged.

Where does the healthcare budget go?

In developed countries, 80% of the healthcare budget is spent on staff. Pharmaceutical costs represent 10%.

Genetic testing affects lives

Studies have shown that the fact of having had a genetic test before being diagnosed can make a huge positive difference to how patients experience their diagnosis, their illness and their life after recovering.

Cancer survival statistics

50% of people diagnosed survive cancer for 10 or more years, according to recent data for England and Wales. Cancer survival in the UK has doubled in the last 40 years, although there is huge variation in survival between cancer types.

Socioeconomic status affects health

Studies show that people with a lower socioeconomic status are more likely to develop cancer and have shorter survival rates after diagnosis, for example.

What are health technologies?

The International Network of Agencies for Health Technology Assessment defines healthcare technology as “prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained.”