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Unmet Need

Unmet need is health care a person needed but did not receive; in drug regulation, unmet medical need is a condition without adequate treatment.

Last reviewedDarrin Baines IP Ltd

Concept Architecture

Unmet Need: Measuring Care Not Received, and Unmet Medical Need in Regulation and HTA

Health economists use "unmet need" in two senses. In access and equity analysis it counts people who needed health care but went without it, usually through household surveys; Eurostat reports that 3.8% of people aged 16 or over in the EU had an unmet need for a medical examination or treatment in 2024. In regulation and health technology assessment, "unmet medical need" describes a condition for which existing treatment is absent or inadequate, and it opens expedited approval routes and enters value judgements about new medicines. This page separates need from demand and use, explains the EU-SILC indicator and its two denominators with an illustrative calculation, covers its use in equity analysis, sets out EU and US regulatory definitions, and shows how the NICE manual folds unmet need into severity. Access to care and the access barriers behind unmet need have their own pages.

Need, demand and use: where the gap sits

The gap makes sense only once need is separated from what people ask for and what they get. Wright, Williams and Wilkinson, writing on health needs assessment, describe need in health care as the capacity to benefit, which requires an effective intervention to exist. They describe demand as what patients ask for, and supply as the health care provided. Unmet need is need that is not matched by care received.

The three quantities can diverge. Wright and colleagues note that demand can be induced by supply, so high use is no proof that need is met (see supplier-induced demand). Low use is no proof of unmet need either, because the population may simply need less care.

Two kinds of unmet need follow. Self-reported unmet need rests on the person's own judgement that care was needed and not received; assessed unmet need rests on a professional judgement of capacity to benefit, such as people with a diagnosed condition who are not receiving an effective treatment. The two need not agree, since a person may not recognise a need that a clinician would identify.

How the EU-SILC survey measures unmet need

The best known population indicator comes from the EU statistics on income and living conditions (EU-SILC). Allin and Masseria report the question as asking whether there was any time in the last twelve months when the respondent, in their own opinion, needed a medical examination or treatment for a health problem but did not receive it. Follow-up questions record the main reason: cost, waiting lists or distance, but also waiting to see whether the problem got better, not knowing a good doctor, fear or lack of time.

Eurostat builds two indicators from these answers. The first divides the people reporting an unmet need by all people aged 16 or over, including those who reported no need at all, and shows how widespread unmet need is in the population. The second divides by the people who reported a need, and gives a sharper picture of access among people seeking care.

The 2024 results show why the reasons matter. Of the 3.8% with an unmet need, 2.5 percentage points gave cost, distance or waiting lists as the reason; waiting lists (1.4%) and expense (1.0%) were the most common single reasons. The share reporting unmet medical need because of expense fell from 2.1% in the lowest income quintile to 0.2% in the highest. The European core health indicators measure equality of access as self-reported unmet need for financial reasons, waiting times or distance.

Worked example: one survey, two denominators

This illustrative example uses invented numbers to show how the denominator changes the size of an income gap. A survey interviews 2,000 adults in the lowest income group and 2,000 in the highest. In the lowest group 1,500 report a need for medical care in the past year and 90 report an unmet need for cost, distance or waiting reasons; in the highest group 1,000 report a need and 30 report an unmet need.

$$ U_{pop} = \frac{n_{u}}{N}, \qquad U_{need} = \frac{n_{u}}{n_{n}} $$

where $U_{pop}$ is the population-based rate, $U_{need}$ is the rate among people reporting a need, $n_{u}$ is the number reporting an unmet need, $n_{n}$ is the number reporting a need and $N$ is the number interviewed.

1. Population-based rates. In the lowest group $U_{pop} = 90 / 2000 = 4.5%$; in the highest $U_{pop} = 30 / 2000 = 1.5%$. The ratio between groups is 3.0.

2. Rates among people with a need. In the lowest group $U_{need} = 90 / 1500 = 6.0%$; in the highest $U_{need} = 30 / 1000 = 3.0%$. The ratio is 2.0.

3. Interpretation. Both measures show a disadvantage for the lower income group, but the population-based ratio is larger because it combines two effects: more people in that group have a need, and more of those with a need go without care. The rate among people with a need isolates the second effect, which is the access question. Neither rate counts people who did not perceive a need.

Unmet need in equity analysis

Self-reported unmet need is used alongside need-standardised measures of service use in the study of horizontal equity. Allin and Masseria summarise early EU-SILC evidence that any unmet need was concentrated among people with lower income, shown by a negative concentration index in every country studied. After adjusting for health, which is worse at lower incomes, the income relationship persisted in all countries except Luxembourg, Norway and Spain.

The same authors show why the indicator has to be split by reason. In the 2004 EU-SILC, 13% of people in Sweden reported an unmet need for any reason, but only 1.5% when the reasons were restricted to cost and availability. They separate reasons that matter for policy, such as cost and waiting lists, from reasons such as waiting to see whether a problem resolves, which are less clearly relevant to policymakers and may reflect preferences.

Allin, Grignon and Le Grand, using a 2003 Canadian survey, separated unmet need due to waiting times, access barriers and personal reasons. People reporting unmet need because of waiting times used more health services than their observable characteristics predicted, while the other two groups showed no consistent pattern of use. Adding unmet need to the analysis left estimates of income-related inequity unchanged. The authors conclude that reports of unmet need linked to access barriers add policy-relevant information that complements conventional measures of inequity.

Unmet medical need in regulation

Regulators use the term for a condition and a medicine, not a person. In the EU, Commission Regulation (EC) No 507/2006 allows a conditional marketing authorisation on less comprehensive clinical data only if four requirements are met, one of which is that "unmet medical needs will be fulfilled". Article 4(2) defines unmet medical needs as a condition with no satisfactory authorised method of diagnosis, prevention or treatment or, where one exists, a condition for which the new medicine will be of major therapeutic advantage to those affected. The European Medicines Agency's PRIME scheme requires a medicine to show the potential to address an unmet medical need to a significant extent.

The US Food and Drug Administration's 2014 guidance on expedited programmes defines an unmet medical need as a condition whose treatment or diagnosis is not addressed adequately by available therapy. It includes both an immediate need for a defined population and a longer-term need for society, such as the development of resistance to antibacterial drugs. The guidance covers routes such as accelerated approval.

The EU Regulation on health technology assessment, Regulation (EU) 2021/2282, uses the term without defining it. Unmet medical needs are the first criterion listed in Article 17(3) for selecting medicines and devices for joint scientific consultation, and Article 7(3) allows a medicine to enter joint clinical assessment earlier than the general timetable where it has the potential to address an unmet medical need, among other grounds. A new EU pharmaceutical directive would add a legal definition: in the Council's first-reading position of 28 September 2026, which still needed the European Parliament's approval in October 2026, Article 85 covers a life-threatening or severely debilitating disease with no authorised medicine, or where the medicine gives a clinically relevant improvement in efficacy, or in safety with at least comparable efficacy, and Article 84 adds 12 months of market protection.

Definitions vary: of 16 definitions found by Vreman and colleagues, all 16 referred to the adequacy of available treatments, 6 to disease severity or burden and 1 to patient population size.

How the NICE manual folds unmet need into severity

The NICE manual (PMG36, section 6.2.12) handles unmet need through severity. It defines severity as the future health lost by people living with the condition with standard care in the NHS, and states that the extent of unmet health need is reflected within the severity definition; the severity modifier is not initially applied to appraisals of HealthTech. Severity is measured by the absolute shortfall and proportional shortfall in QALYs compared with the general population of the same age and sex, and Table 6.1 sets a QALY weight of 1.2 for a proportional shortfall of 0.85 to 0.95 or an absolute shortfall of 12 to 18, and 1.7 at or above 0.95 or 18. Whichever measure implies the greater severity applies.

Illustrative calculation. Suppose people of the same age and sex without the condition expect 20.0 discounted QALYs, and people with the condition on current care expect 4.5. The absolute shortfall is $S_{a} = 20.0 - 4.5 = 15.5$ QALYs, within the 12 to 18 band. The proportional shortfall is $S_{p} = 15.5 / 20.0 = 0.775$, below 0.85, so it implies no weight; the absolute measure gives the greater severity and the weight is 1.2. If a new technology adds 0.5 QALYs at an extra cost of GBP 15,000, the unweighted incremental cost per QALY is $C = 15000 / 0.5 = 30000$ GBP, and with QALYs weighted by 1.2 it is $C_{w} = 15000 / 0.6 = 25000$ GBP. The weight responds to how much health the condition takes away under current care.

Sandman and Hofmann argue that unmet need largely overlaps with the severity of a condition, that using both risks double counting, and that condition severity should generally replace it.

Limitations and common misreadings of unmet need

The survey measure and the regulatory term carry different weaknesses. Most misreadings treat a headline rate as a clean measure of access, or a regulatory label as a measure of value.

  • Self-reports are subjective. Eurostat notes that answers reflect respondents' perceptions and social and cultural background, that the indicators are not age-standardised, and that national implementation can differ.
  • Coverage cuts both ways. EU-SILC covers private households only; Eurostat notes that leaving out institutions, whose residents are in worse health but have care readily available, may understate health problems but overstate unmet need.
  • Reported unmet need is not the same as low use. In Canada, people reporting unmet need used more services than expected for their health. Allin and Masseria read this as a sign that unmet need may partly represent dissatisfaction with the health system, consistent with higher educated Canadians being more likely to report it.
  • The two senses have different units. Population unmet need describes people; unmet medical need describes a condition and its available treatments, and says nothing about whether patients can reach existing care.
  • Unmet medical need is not evidence of value. Regulation (EC) No 507/2006 still requires a positive risk-benefit balance, and in the NICE manual unmet health need changes the QALY weight through severity, so a technology with no health gain gains nothing from it.

Sources

Library

Publications

9
  • Journal article

    Subjective unmet need and utilization of health care services in Canada: what are the equity implications? — Allin S, Grignon M, Le Grand J, Vol. 70, No. 3, pp. 465-472 ed., 2010 (Social Science & Medicine)

    Study of a 2003 Canadian survey that split self-reported unmet need into waiting-time, access-barrier and personal reasons, cited for its findings that people reporting waiting-time unmet need used more services than predicted, that adding unmet need left income-related inequity estimates unchanged and that barrier-related reports complement conventional inequity measures.

    Journal ArticleView source →
  • Journal article

    Unmet need as an indicator of health care access — Allin S, Masseria C, Vol. 15, No. 3, pp. 7-9 ed., 2009 (Eurohealth)

    Short article on unmet need as an indicator of access to care, cited for the EU-SILC question and its follow-up reasons, early evidence that unmet need was concentrated among lower-income people, the Swedish gap between 13% for any reason and 1.5% for cost and availability, and the dissatisfaction reading of Canadian findings.

    Journal ArticleView source →
  • Other

    Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use — European Commission, OJ L 92, pp. 6-9 ed., 2006 (Official Journal of the European Union)

    EU regulation on conditional marketing authorisation of medicines, cited for its four requirements including that unmet medical needs will be fulfilled, the Article 4(2) definition of unmet medical needs and the requirement of a positive risk-benefit balance.

    Web (Open Access)View source →
  • Other

    Position of the Council at first reading with a view to the adoption of a Directive on the Union code relating to medicinal products for human use — Council of the European Union, 7106/2/26 REV 2, Brussels, 28 September 2026 ed., 2026 (Council of the European Union)

    Council of the European Union first-reading position on the proposed directive on the Union code for medicinal products, cited for its Article 85 definition of unmet medical need and the extra 12 months of market protection in Article 84, pending approval by the European Parliament.

    PDFView source →
  • Other

    PRIME: priority medicines — European Medicines Agency, Web page, accessed 3 October 2026 ed., 2026 (European Medicines Agency)

    European Medicines Agency web page on the PRIME priority medicines scheme, cited for the requirement that a medicine must show the potential to address an unmet medical need to a significant extent to be accepted for the scheme.

    Web (Open Access)View source →
  • Other

    Unmet health care needs statistics — Eurostat, Web article, data extracted July 2025 ed., 2025 (Eurostat, Statistics Explained)

    Eurostat Statistics Explained article on EU-SILC unmet health care needs, cited for the 3.8% of people aged 16 or over in the EU reporting an unmet need in 2024, the two denominators, the breakdown by reason, the income gradient and the limitations of the self-reported indicator.

    Web (Open Access)View source →
  • Journal article

    Why we don't need "unmet needs"! On the concepts of unmet need and severity in health-care priority setting — Sandman L, Hofmann B, Vol. 27, No. 1, pp. 26-44 ed., 2019 (Health Care Analysis)

    Conceptual analysis of unmet need and severity in health care priority setting, cited for its argument that unmet need largely overlaps with the severity of a condition, that using both risks double counting and that condition severity should generally replace it.

    Journal ArticleView source →
  • Journal article

    Unmet medical need: an introduction to definitions and stakeholder perceptions — Vreman RA, Heikkinen I, Schuurman A, Sapede C, Garcia JL, Hedberg N, et al., Vol. 22, No. 11, pp. 1275-1282 ed., 2019 (Value in Health)

    Review of definitions and stakeholder perceptions of unmet medical need, cited for its finding that all 16 definitions identified referred to the adequacy of available treatments, while 6 referred to disease severity or burden and 1 to patient population size.

    Journal ArticleView source →
  • ReportFeatured

    Fair Society, Healthy Lives: The Marmot Review (Strategic Review of Health Inequalities in England Post-2010) — Michael Marmot, Peter Goldblatt, Jessica Allen, et al., 2010 Edition ed., 2010 (The Marmot Review / UCL Institute of Health Equity)

    The landmark strategic review of health inequalities in England, articulating the social determinants of health and the "social gradient" and setting out six policy objectives for reducing inequalities — the defining reference for health-inequalities policy in the UK.

    PDFView source →

Frequently Asked Questions (6)

  • What is unmet need?

    Unmet need is health care a person needed but did not receive; in drug regulation, unmet medical need is a condition without adequate treatment.

    Source: Eurostat 2025; FDA 2014

  • What gap does unmet need describe?

    Unmet need describes the gap between the healthcare a person needs and the care they actually receive. It arises when a barrier, whether of availability, affordability, or another kind, stands between the need and its fulfilment, so a real requirement for care goes unaddressed. Measuring it reveals where a health system is failing to reach people, making it a direct signal of access barriers at work. The shortfall between needed and received care is what it names. Penchansky and Thomas (1981) set out the access dimensions.

    Source: Penchansky & Thomas 1981

  • What causes unmet need?

    Unmet need is caused by barriers preventing a person from obtaining needed care, such as lack of availability, unaffordability, or other access barriers, leaving a gap between need and care received. So unmet need is caused by access barriers, which is why it reflects a gap, since barriers of availability, affordability, or other kinds prevent obtaining needed care, and these obstacles cause unmet need by leaving people unable to obtain the care they need, creating the gap between their needs and the care they actually receive.

    Source: Penchansky & Thomas 1981

  • How does unmet need arise?

    Unmet need arises when a person needs care but does not receive it because of barriers, so their healthcare needs exceed the care they obtain, leaving a gap. So unmet need arises from barriers to obtaining needed care, which is why it is a gap, since when barriers prevent obtaining care the needs go unmet, and unmet need arises whenever a person's healthcare needs are not fully met by the care they receive, owing to obstacles such as availability, affordability, or other barriers.

    Source: Penchansky & Thomas 1981

  • Why does unmet need matter?

    Unmet need matters because it means people are not receiving care they need, which can harm their health and reflects barriers to access, so measuring and reducing it is important for health and equity. So unmet need matters for health and access, which is why it is a concern, since needed care not obtained can worsen health and indicates access barriers, and unmet need, the gap between needs and care received, is important to identify and reduce because it reflects people going without needed care, affecting outcomes and equity.

    Source: Penchansky & Thomas 1981

  • How does unmet need relate to access barriers?

    Unmet need relates to access barriers in that barriers cause it: access barriers prevent people obtaining needed care, producing the gap between need and care received that constitutes unmet need. So unmet need results from access barriers, which is why they are connected, since barriers of availability, affordability, or other kinds impede obtaining care and leave needs unmet, and unmet need is the outcome of access barriers, reflecting the care people need but do not receive because obstacles prevent them obtaining it.

    Source: Penchansky & Thomas 1981

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Verified by Dr Darrin Baines

British health economist

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Verification date: 3 Oct 2026

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