Global trends in paying for healthcare: value and evidence · • Health Technology Assessment and...

Global trends in paying for healthcare: value and evidence matters August 12, 2011 Cali, Colombia Francis Ruiz Senior Adviser, NICE International

Overview • Building pressures • Payers response • Health Technology Assessment and evidence-based

policy making – a useful tool • Institutionalising HTA – examples from high income

countries • HTA and changing practice – evidence-informed “pay

for performance” • Institutionalising HTA in Colombia – the role of IETS • The importance (and challenge) of stakeholder

engagement • NICE International: meeting a growing demand

One world…

• LMIC: low and middle income countries • BRIC: Brazil, Russia, India, China • CIVETS: Colombia, Indonesia, Vietnam, Egypt, Turkey,

South Africa • Next 11… • FTSE advanced and secondary emerging markets list

*The New BRICS on the Block: Which Emerging Markets Are Up and Coming? January 19, 2011 Knowledge@Wharton

“Emerging markets are places where politics matter at least as much as economics to market outcomes” Ian Bremmer, Eurasia Group

Building Pressures…

Burden of chronic

disease and ageing

populations

Users’ expectations

and the promise of universal

coverage

Growth in technologies –

expanding marketplace

Finite budgets and financial

pressures

Health systems everywhere are

under pressure…

Policy and practice

Copyright © 2009 - 2010 NICE

More money... • China: Rural Health Reforms 2010-14: $126bn

– Access to 800 million farmers (from about 400m) – Co-pay reduction from 60% to 40% – More technologies and services

• USA: an extra $68.5bn on CMS in 2009, compared to 2008* – USA spends 17.6% of GDP on health - $2.5 trillion – Public to exceed private spending by 2012 – CMS spending grew 3 times faster than private spending

• India: Rural Health Mission and Universal Health Coverage: up to 2% from ~1% of GDP public spending

• UK: 50% increase in real terms in spending on NHS between 2002 and 2010 (now savings have to be made…)

*CMS NHE Factsheet, accessed 2011

But increased costs…

Median monthly costs of new anti-cancer drugs at launch

0 1000 2000 3000 4000 5000 6000 7000 8000

Mon

thly

tre

atm

ent c

osts

US$

at

200

7 pr

ices

Year Bach et al 2009

Johnston et al., Lancet Neurology, 2009

Greater need…

Two of three deaths each year are attributable to chronic disease. Four-fifths of these deaths are in LMIC, and a third are in people younger than 60 years.

Chronic disease death rates are nearly two-times higher in LMIC than in high-income countries.

By 2020, deaths from strokes and MIs in LMIC will be 4 times those rich countries

Beaglehole et al, Lancet, 2011

Chronic diseases cause 7 in 10 deaths each year in the United States.

About 133 million Americans—nearly 1 in 2 adults— live with at least one chronic illness.

More than 75% of health care costs are due to chronic conditions.

$218billion: Total costs of diabetes in the US in 2007

Centers for Disease Control and Prevention, 2011 American Diabetes Association, 2011

More products…

GSK to cut prices for developing countries, Andrew Jack, FT, Dec 2009

New vaccines

Imaging: MRI, CT, PET scanners

Drugs for chronic disease

3rd generation ARVs

…more marketing

GSK moving away from selling “white pills into western markets”

Social reasons

“…the government will greatly support reforms to the medicare system, with the aim of increasing the medicare coverage rate to 90 percent of the country's total population by the end of 2011. It will raise the level of subsidies for urban residents and for farmers…” 11th National People’s Congress, March 2011

Economic reasons

“…government spending on health, but not on education, has an impact in reducing urban household saving. The impact, moreover, is large. A 1 yuan increase in government health spending was associated with a 2 yuan increase in household consumption.”

Payers Respond…

Payers’ responses

• Accumulating debt • (Arbitrary) price cuts • Divergence between coverage (in principle) and access • Cost-shifting to service users and their families • Comparative effectiveness research • Price negotiations • Risk sharing and Value-Based Pricing • Institutionalising technology adoption decisions:

Health Technology Assessment agencies • A combination of the above…

Arbitrary price cuts

• “…some of the cuts have been significant. Gilead said Greece implemented a 27% price cut in May, while Spain implemented a 7.5% decrease in June and Germany is set to impose a 10% reduction in August. Genzyme Corp. detailed similar price moves.” WSJ, 2010

Cost-shifting and foregoing care

• “…Physician visits and hospital admissions are dropping this year, according to Thomson Reuters. Doctor visits have declined each month this year, including a 7.6% drop in May 2010 compared to May 2009, according to Thomson Reuters, which surveys doctors and hospitals. Likewise, hospital admissions dropped in three of the first four months of this year compared to those months last year, including being down 2.3% in April 2010 from April 2009.” WSJ, 2010

USA Today, 2009

United States: Comparative Effectiveness Research (1)

• Patient Protection and Affordable Care Act in 2010 establishes the Patient-Centered Outcomes Research Institute to set priorities for CER and disseminate its findings to health care decision makers.

• “Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.” HHS, 2011

United States: Comparative Effectiveness Research (2)

• The 2010 Act makes it clear that the Institute shall ensure that its research findings are not construed “as mandates for practice guidelines, coverage recommendations, payment, or policy recommendations”

• PCORI “shall not develop or employ a dollars per- quality adjusted life year (or similar measure that discounts the value of a life because of an individual’s disability) as a threshold to establish what type of health care is cost effective or recommended”.

• PCORI is funded by a number of sources, notably a levy on all medical insurance premiums and appropriations from general treasury funds.

Price negotiations

• USA: Medicare Independent Payment Advisory Board – “We will cut spending on prescription drugs by using

Medicare’s purchasing power to drive greater efficiency.” Obama, budget deficit speech, April 2011

– “…the IPAB can make only nonbinding recommendations to Congress regarding private payments. In the long run, Congress may not be able to cap Medicare expenditures without addressing private expenditures as well. If the IPAB opens the door to rate setting for all payers, it may well be the most revolutionary innovation of the ACA.” Jost, NEJM, May 2010

The deal provides for a straight 12.5 percent discount to bring the cost of Votrient to the NHS into line with that of Pfizer's Sutent, and also guarantees a financial rebate if Votrient proves inferior to Sutent in the clinical trial.

"We are moving in the direction where price is driven by value and value is driven by evidence, and therefore we can start to construct different sorts of arrangements where we can balance this off.” Simon Jose, GSK

Risk Sharing

UK: Value Based Pricing

• “We will pay drug companies according to the value of new medicines…” The Coalition: our programme for government, July 2010

• “…the Government would set a range of thresholds or maximum prices reflecting the different values that medicines offer…”

• Price premium for disease severity, therapeutic innovation and wider societal benefits Consultation document on VBP, December 2010

Not a magic bullet… • “There is this unrealistic belief in the government’s mind

that the result is that prices will fall, but I don’t think we know, actually…Value based pricing is thoroughly logical, but not a magic bullet” DG ABPI

“Just by having a price negotiation it could lead to delays in access…While the goal of the system is to improve access, it may actually do the opposite” Eli Lilly UK

A changing paradigm?

Andrew Witty [CEO, GSK] has also signalled his willingness to negotiate on price, in a climate where value for money is increasingly discussed and other countries are contemplating setting up a version of Nice

Health Technology Assessment – a brief overview

What is Health Technology Assessment?

• Health Technology: “The drugs, devices, and medical and surgical procedures used in health care, and the organisational and supportive systems within which such care is provided”a – Contraceptives; dialysis machines; mastectomy; screening for

cancer; intensive care unit • Health Technology Assessment: “a multi-disciplinary

field of policy analysis, which studies the medical, social, ethical and economic implications of development, diffusion and use of health technology.”b

a: Office of Technology Assessment. Assessing the efficacy and safety of medical technologies. Washington DC: U.S. Government Printing Office, 1978; b: International Network of Agencies for Health Technology Assessment (INAHTA)

Milestones in HTA evolution

• Establishment of Office for Technology Assessment, USA – 1972

• Emergence of Health Economics as a discipline – Kenneth Arrow – 1963; USA, UK, 1970s and 1980s

• Evidence Based Medicine movement – McMaster’s, Canada, 1980s

• Cochrane Collaboration – UK, 1992


Evidence Based Medicine

• “EBM is the conscientious, explicit and judicious use of current best evidence in making decisions about patient care” (Sackett et al, 1996) – individual clinical expertise – best available external clinical evidence from

systematic research


Dimensions of HTA

• Comparative clinical effectiveness • Comparative cost-effectiveness • Service delivery organisation aspects • Legal framework • Ethical, social implications – equity, fairness and other

societal norms


HTA audiences

• Policy-makers - payers • Medical products developers – industry • Healthcare professionals • Academic community - researchers • General public: taxpayers; insured population • Patients and their families


‘Best practice’ for Health Technology Assessment/Appraisal

• Drummond et al on behalf of the International Working Group for HTA Advancement, proposed a set of fifteen key principles to guide HTA programs including: – HTA should be an unbiased and transparent exercise – HTA should incorporate appropriate methods for

assessing costs and benefits – Those conducting HTAs should actively engage all key

stakeholder groups – The link between HTA findings and decision-making

processes needs to be transparent and clearly defined • These and other key principles are relevant to most

researchers and HTA users in Latin America (Pinchon-Riviere et al, 2010) despite their current low level of application.

Changing HTA: international trends

• Macro: – Increasing number of HTA agencies in developed

and developing countries – Cross-country networks: INAHTA; EUnetHTA; HTAi

and attempt to standardise – Formal two-way organisational links between HTA

agencies and decision-makers


International Examples of HTA entities • NICE, UK • HAS, France • IQWiG, Germany • PBAC, Australia • ………………………. • HIRA, S Korea • OHTAC, Ontario • HITAP, Thailand • (IETS, Colombia…)

From Chalkidou et al., CMWF, 2009; Milbank 2009


0

3,000

6,000

9,000

12,000

15,000

18,000

Vaccination at theage of 15 years




HPV price threshold at 1X GDPHPV price threshold at 3X GDP

48%55%

61%

26%

86%

74%

37%

97%

Source: HITAP 2008

Vacc

ine

pric

e in

Tha

i Bah

t Thailand’s HTA agency and the HPV vaccine

The decision

• Late 2007, HITAP undertakes HTA (using mainly local data)

• The study reaffirmed the government’s position not to fund the vaccine

• Pap smear and VIA were introduced as HPV vaccine’s comparators in the economic analysis and results were used to encourage the improvement of the screening programs

Source: HITAP 2008

• The current immunisation programme includes 12 childhood vaccines at $29m pa

• HPV vaccine would cost an additional $80m pa

Ministry rejects use of vaccine Published on September 18, 2007

High cost cited as main reason for decision The Public Health Ministry has rejected a recommendation from health experts to register the Human Papilomavirus (HPV) vaccine, which could prevent cervical cancer, because a national vaccination programme would be too expensive.

Source: HITAP 2008

In early 2009 companies reduce price of HPV vaccine

Changing HTA: international trends

• Micro: – Cost matters: formal economic evaluation – From drugs to diagnostics, surgery and services – Implementation support and impact assessment – Broader stakeholder involvement – lay people – Primary research part of HTA agency remit


The Tallinn Charter • “Fostering health policy and systems research and

making ethical and effective use of innovations in medical technology and pharmaceuticals are relevant for all countries; health technology assessment should be used to support more informed decision-making.”

2008 WHO/European Region Ministerial Conference, The Tallinn Charter


National Indian Commission on Macroeconomics and Health, 2005 “Disease burden estimations…cost-effectiveness studies of interventions…independent evaluations of programme implementation are examples of the kind of work that needs to be undertaken. In the absence of such capacity, current policy-making is ad hoc and driven by individual perceptions.”


Institutionalising HTA

HTA - Conditions for success

• Local data: epidemiology, risks, costs, QoL, utilisation patterns…

• Local capacity: analysts, health economists, clinical and political champions

• Local institutions that are: – legitimate: transparent, independent,

accountable, inclusive, scientific – home-grown: driving technology adoption and

clinical practice based on truly local priorities

Overview of some HTA institutions – high income countries (1)

• England and Wales – National Institute for Health and Clinical Excellence (NICE);

• Germany – Institute for Quality and Efficiency in Health Care (IQWiG); German Agency for HTA at DIMDI (DAHTA)

• Netherlands – Health Care Insurance Board (College voor Zorgverzekeringen, CVZ)

• Australia – Pharmaceutical Benefits Advisory Committee (PBAC) • All have one or more independent agencies or committees responsible for

carrying out/using HTA and for making decisions based on HTA and other evidence

• Source of funding – Most publicly funded (< 0.1% of healthcare budget) – IQWiG – insurance levy – PBAC – fees from industry (cost recovery)


• HTA is used in different health care systems – E.g. Germany and Netherlands social insurance,

competing insurers – E.g. Australia and England & Wales tax financed

• Variation in roles / responsibilities / accountability frameworks – E.g. CVZ, NICE and PBAC clear responsibilities directly

linked to decisions on pricing and on coverage within the healthcare system

• But... Increasing government control over what get subsidised? (PBAC)

– E.g. Decision making in Germany resides in the Federal Joint Committee. IQWiG provides advice the Federal Joint Committee is not bound by that advice


• Some variation in methods…E.g. – Economic evaluation is used in all cases but

Germany is using a ‘new’ approach (“Efficiency Frontiers”)

• Reduced role for EE in Germany in future? – Quality-adjusted life years are used as a measure of

health benefit (Germany?) – Probabilistic sensitivity analysis preferred in NICE

assessments (not in Australia…) • Variation in stakeholder engagement / contestability

– E.g. NICE – well established, detailed procedures

Arzneimittelmarktneuordnungsgesetz (AMNOG)

• The new German AMNOG drug pricing act - Jan 2011 – comparative clinical assessment for all new drugs before

launch in German market (company submission) – if additional benefit, then price negotiations with health

insurance – if negotiations fail, economic evaluation commissioned

(e.g. from IQWIG) – if no additional benefit, then reference pricing or cost-

minimisation – orphan drugs (incl some cancer drugs) with annual sales

<€50m, are exempt

HTA – a tool to change practice and inform incentives

Role of NICE in the UK The National Institute for Health and Clinical Excellence

(NICE) is a publicly funded body established in 1999. • Produce clear recommendations on cost-effective

clinical and public health practice, for health professionals and the public

• Reduce variation in access to and quality of care • Create standards against which the National Health

Service can be monitored


NICE’s Programmes

1. Clinical: – Technology appraisals – Clinical guidelines – Interventional procedures – Medical devices & Diagnostics (new)

2. Public health: – Interventions and programmes

3. NICE quality standards 4. NHS Evidence / NICE Pathways

Role of cost effectiveness in NICE guidance

• “Those developing clinical guidelines, technology appraisals or public health guidance must take into account the relative costs and benefits of interventions (their ‘cost effectiveness’) when deciding whether or not to recommend them.” (Principle 2, SVJ, NICE 2008)

BUT • “Decisions about whether to recommend interventions

should not be based on evidence of their relative costs and benefits alone. NICE must consider other factors when developing its guidance, including the need to distribute health resources in the fairest way within society as a whole.” (Principle 3)

• See: http://www.nice.org.uk/media/C18/30/SVJ2PUBLICATION2008.pdf

http://www.nice.org.uk/media/C18/30/SVJ2PUBLICATION2008.pdf�

The Process

Review Assessment

Appraisal Guidance

Scoping

Submission

Consultation


Published NICE guidance (1st June, 2011)

Type Numbers Technology appraisals 224

Clinical guidelines and cancer service guidance

133

Interventional procedures 349

Medical Technologies 3

Public health 35

Total 744

NICE “Quality Standards” • A set of 5-10 statements that are:

– markers of high-quality, cost effective clinical care for a particular condition

– derived from the best available evidence – produced collaboratively with the NHS and social

care

• Quality measures - high level quality indicators • Audience descriptors

- A description of what the quality standards mean for a variety of audiences


Example: quality statement for stroke

In a high quality service for patients with stroke ...

Quality Statement 2 (Stroke) Patients with acute stroke receive brain imaging within 1 hour of admission if they meet any of the indications for immediate imaging Directly based on NICE clinical guideline recommendation

Quality Standards topics Pilot topics 2009-10 • Stroke • Dementia • Prevention of venous thromboembolism • Specialist neonatal care

Topics 2010-11 • Diabetes • COPD • Breast cancer • Depression • Chronic kidney disease • Glaucoma • Chronic heart failure • End of life care • Alcohol dependency


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The future…Quality standards by NICE: an explicit menu of services

National commissioning guides to measure

performance and real outcomes

NHS payment systems for 1o

and 2o care

Informing patients and the public of their entitlement

for NHS care

NICE Quality

Standards will form the

basis for:

Paying doctors to perform …

Tim Hunkin Under the Pier Show Southwold , Suffolk, UK

Quality and Outcomes Framework (QOF)

• QOF came into effect in 2004 as part of the new GP contract • QOF is a voluntary programme for all GP surgeries. It is

designed to resource and reward good practice in all GP surgeries

• The QOF contains groups of indicators against which practices score points – and receive financial rewards – according to how well they perform (up to 25% of the average practice funding/income)

• Since 2009 NICE became responsible for producing an annual “menu” of new, evidence-based clinical and cost-effective indicators.

• A more independent and transparent process for reviewing and developing indicators (and ‘retiring’ indicators that are no longer ‘fit for purpose’)


Commissioning for Quality and Innovation (CQUIN) payment

• English secondary/tertiary care incentive system • “The CQUIN payment framework enables commissioners to reward

excellence, by linking a proportion of English healthcare providers' income to the achievement of local quality improvement goals” (Department of Health)

• “The CQUIN framework will be important for implementing NICE Quality Standards, for improving patient experience and for driving improvement against outcomes”

• Been in operation since April 2009 • Acute schemes had to include two specified national goals on

reducing the impact of VTE and improving responsiveness to personal needs of patients

• CQUIN requires information about quality and since 1 April 2009 the NHS has become the first healthcare system in the world to routinely collect patient-reported outcome measures (PROMs)

An estimated 25,000 people die from DVT each year. Ministers said trusts that fail to act on the guidelines are likely to face financial penalties. Hospitals that fail to screen at least 90% of their patients will be penalised by withholding payments. From 1 April 2010, a hospital could stand to lose 0.3% of its income through the new Department of Health commissioning for quality and innovation framework.

DVT and financial penalties for hospitals

Developing (evidence informed) incentives: a stepwise process

Priorities

• Policies/politics • Addressable disease burden and distribution of access and outcomes • Budget impact and growth trends

“Evidence”

• International and local evidence base (clinical and cost effectiveness) • Local cost, risk and utilisation data • Values and politics • System structure

Relevant product

• Evidence-informed statement • Measurable metric • Efficient financial incentive • Practical cash flows

Evaluation

• Pilots and ‘scaling up’ • Evaluation of impact • Review and improvement


Levers for changing Practice Example: high blood pressure

• Meaningful engagement with professionals – cooperation and consensus building – Joint NICE – British Hypertension Society guidance

• Monetary incentives for primary care physicians – BP 5: The percentage of patients with hypertension

in whom the last blood pressure (measured in last 9 months) is 150/90 or less

Levers for changing Practice Example: high blood pressure (cont.)

• Clear audit criteria for monitoring provider performance

Audit criterion Exception Definition of terms Patients newly diagnosed with essential hypertension who are aged 55 or older, or black and any age, are offered a calcium-channel blocker or a thiazide-type diuretic as the first choice for initial drug therapy

None Black patients are those of African or Caribbean descent, and not mixed race, Asian or Chinese patients


• Making a business case for cost savings and better outcomes

•£220m savings from preventing unnecessary hospitalisations •Preventing 10,000 strokes and 12,000 heart attacks, per year


• Inform patients of their rights to best treatment

• All guidance produced in versions for patients and the public, known as “Understanding NICE Guidance”

• Plain-English translation of guidance

Monthly trend in drugs used to treat hypertension in primary care in England, total prescription items as a %

0%

5%

10%

15%

20%

25%

30%A

pr-0

2

Jul-0

2

Oct

-02

Jan-

03

Apr

-03

Jul-0

3

Oct

-03

Jan-

04

Apr

-04

Jul-0

4

Oct

-04

Jan-

05

Apr

-05

Jul-0

5

Oct

-05

Jan-

06

Apr

-06

Jul-0

6

Oct

-06

Jan-

07

Apr

-07

Jul-0

7

Oct

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Month

Num

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Source: ePACT.net

NICE Guideline published

NICE Guideline consultation - new pharmacological section

Evidence of impact

Institutionalising HTA in Colombia

Context (1)

• Since the Plan Obligatorio de Salud (POS) was first adopted in 1994, there have been no consolidated and systematic reviews and updates of the POS.

• No systematic, scientific, independent, transparent and widely accepted process for priority setting in Colombia.

• One of the aims of the recent Law 1438 2011 is to address this lack of clarity.

Context (2) • Different governmental institutions at the national level

have over the years attempted to prioritise and define the POS

• Judges and Constitutional Court’s mandates have challenged the legitimacy and technical capacity of different institutions and have had a major role in determining the depth and scope of POS

• The financial burden from Comités Técnico Científico (CTC) and tutelas has been significant (COL$ 1,700 billion in 2009, and COL$ 770 billion by the first quarter of 2010).

• Establishment of an HTA agency seen as one (important) tool in a drive to improve quality and efficiency • Broader institutional changes and system

strengthening also needed!

Establishing IETS

• Law 1438; 2011 empowers the MoSP to create “the Institute for Health Technology Assessment (IETS), as not-for-profit, public-private organisation to: – develop evidence-based HTA, clinical guidelines and

protocols to guide the use of medical procedures and of medicines included in POS [basic package]

– design evidence-based clinical guidelines and protocols, to be used as standards for service provision by providers”.

• NICE International has been supporting the MoSP in its desire to introduce HTA / evidence based approaches to support quality and efficiency Colombian healthcare system

Challenges (1) • Accountability and independence • How will the HTA body (IETS) be funded? • Assessment (=evaluation)/Appraisal

(=deliberation) of the evidence – who does what? And how are key actors selected?

• Who makes the final decisions? – Within the HTA agency or some other body

(e.g. G-BA in Germany) • Addressing immediate problems

– POS update, recobros

Challenges (2)

• Engagement of professionals (e.g. as stakeholders and/or decision makers)

• Involving industry and the public – establishing the ‘rules’ of engagement

• Choice of preferred methods (e.g. cost-utility analysis) • Scope of activities – start small and then grow? (e.g.

NICE UK) • Contestability mechanisms – avoiding the courts • Using HTA to change behaviour through

incentives/penalties (“pay for performance”)

The importance (and challenge) of stakeholder engagement – a view from NICE

What are stakeholders? A large constituency • Those responsible for delivering the care (professionals,

managed care programmes). • Those receiving it (consumers or patients and their

caregivers). • those financing it (governments, health insurers, the

public, and employers). • those managing care (policy makers, public health

services). • those monitoring care (quality assurance companies) • Employers • Pharmaceutical/device industry

Why involve stakeholders (1)

• Evidence is imperfect – Often of low quality – Complex to interpret – May not address appropriate outcomes

• Recommendations are constructed through a deliberative process – Evidence rarely translates directly into recommendations – Process includes consideration of evidence quality, weighing

harms & benefits – Also includes preferences, values, judgments – A process that should be inclusive

Why involve stakeholders (2)? • Guidelines/guidance are interventions

– Aim at improving outcomes – Excluding stakeholders’ perspective jeopardizes uptake

• The process needs to be transparent – Conflicts of interest need disclosing – Involving the public opens the process to scrutiny

• Guidelines can have policy status – Those developed with national funding can influence institutions – Legal considerations – Guidelines can threaten commercial interests (e.g. drug

companies) who may take legal action

What can patients/carers contribute?

1. Clinical effectiveness • What the condition is really like? • What are the expectations of treatment? • Has the QoL measures captured all the relevant

dimensions of the condition and its treatment?

2. Cost effectiveness • Are there special considerations? • If so, have these been taken into account?

The patient perspective: examples (1)

• Insulin pumps (TA151) for diabetes – “The patient expert described the stress that being

the parent of a child with diabetes entails and the effects of this on a person’s social and professional life.”

– “The Committee was persuaded by the clinical specialists and patient experts that the use of insulin pumps yielded quality of life benefits, such as flexibility, autonomy, and improved sleep and socialisation”.

The patient perspective: examples (2) • Cetuximab – first line therapy in colorectal cancer (TA

176) – Cetuximab is associated with an increase in an

acne-like rash affecting a person’s upper trunk, gastrointestinal adverse effects such as diarrhoea, and fatigue.

– “The clinical specialists and patient experts explained that the acne-like rash may be indicative of response to cetuximab treatment and would not usually cause admission to hospital. Therefore, it is often interpreted by people as a positive effect because it suggests that the drug is working, outweighing any negative effects of the rash.”

The patient perspective: examples (3) • Abatacept for the second-line treatment of moderate to

severe rheumatoid arthritis (ongoing appraisal) – The Committee noted that the manufacturer’s approach

to estimating utility values resulted in the possibility of clinical scenarios where having rheumatoid arthritis would be worse than being dead.

– “The Committee heard from the patient experts and noted from the consultation comments that it was possible that some people with rheumatoid arthritis may experience such a low quality of life.”

– But: overall, the Committee believed the manufacturer’s model used assumptions and inputs that favoured the use of the technology (‘final’ guidance does not recommend the use of abatacept)

Controversies…funding of cancer drugs

• All diseases are equal but is cancer is more equal than others?

• A need for consistency… – NICE recognises that when it is making its decisions

it should consider the needs of present and future patients of the NHS who are anonymous and who do not have people to argue their case. SVJ Guideline to NICE committees, 2008

• But having to compromise…

The top ups debate of 2008

“End of Life” guidance • Consider recommending seemingly cost-ineffective

treatments which may be: “…life-extending for patients with short life expectancy, and which are licensed for indications affecting small numbers of patients with incurable illnesses.” NICE Supplementary Guidance to its Advisory Committees – January 2009

CONDITIONS: 1. Life expectancy <24 months 2. At least 3 months life extension 3. Small patient population GUIDANCE TO COMMITTEES: 1. Ensure you are convinced of the robustness of the data 2. Quantify (and state) extra weight necessary to be deemed CE 3. Be satisfied that assumptions used in the reference case economic

modelling are plausible, objective and robust.

Some were happy… • “This is a most welcome move. It is not tolerable for

patients in other countries to have standards of care which are higher than those in England/Wales, especially when the nature of the illness is life limiting.” Patient

• “We would like to congratulate NICE for proposing this

scheme which we feel has the potential to make a significant difference to the way in which new treatments for patients nearing the end of life are appraised.” Pharmaceutical industry

…and others were not. • “I believe that all claimants on NHS resources should be

treated the same, regardless of the nature and cause of their health problem. For the first ten years of its life, this was the Institute’s position…There was little point spending so much effort establishing your reputation for independence and robustness, only to roll over now.

• The claim that those terminally ill value life highly is correct,

but do not those with deteriorating sight value their continuing ability to see, those with mental health problems value their ability to maintain their mental functioning, those with pain from chronic disease value a pain-free state, just as highly? Others who depend on the NHS will pay the opportunity costs of extra funding for cancer drugs, and the equity of the service will be damaged.” NHS professional

HM Government, 20 May 2010

And then came the national election…

“We will create a Cancer Drugs Fund to enable patients to access the cancer drugs their doctors think will help them, paid for using money saved by the NHS through our pledge to stop the rise in Employer National Insurance contributions from April 2011.”

NICE International: meeting a growing demand

• Empowers decision makers in low

and middle income countries by identifying and helping them to act on their own policy priorities • Focuses on institutional structure, longer-term capacity building and system governance • Offers collaborative problem-solving and hands-on support, drawing on people and experience, from the UK and abroad, to adapt evidence and policies to countries’ local context

Where we work… • Evidence-based performance metrics and P4P in Turkey: elective C-

section pilot • Health insurance reforms in Colombia: public engagement mechanisms;

legal challenge and health economics evaluation • Tackling chronic disease in Jordan: guideline on hypertension – rational

drug use in primary care settings • Rural health mission – AP, India: tackling MDGs 4+5 in rural areas • Rural health reforms in China: using technologies rationally – cost

containment and quality improvement – Chinese NICE • Health insurance reform, Estonia: economics and systematic reviewing

training; methods for establishing a basic package • Building institutional capacity for quality standard development in Georgia:

clinical guideline pilot and capacity building • Adapting clinical guidelines in Kuwait: awareness raising amongst

clinicians • Technical and institutional capacity building in Brazil: training and hands-

on MTA pilot with ANVISA/MoH and PAHO support

What do fellow policy makers ask us for? • Technical training and capacity building: prioritisation, reviewing,

CEA, budget impact, administration… • Linking research and IT systems with policy: policy-based

evidence-making, data collection mechanisms and pragmatic trials • Legitimate processes and good governance: consultation,

contestability, managing conflicts of interest, engaging with industry, involving patients…

• Implementation and impact assessment: regulatory and financial incentives, P4P, e-databases and registers…

• Stakeholder engagement and building consensus: awareness raising amongst senior policy-makers and clinicians, links with UK institutions

• National institution-strengthening: governance, legal, contractual, ethical, operational, financing, business plans for local NICEs…

Thankyou… Any Questions?

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Global trends in paying for healthcare: value and evidence · • Health Technology Assessment and...

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