Decision-making on the funding of Decision-making on the funding of new drugs: International experiencesnew drugs: International experiences

1st Latin American Workshop of the Knowledge Network on Health Benefits Packages

Santiago de Chile, 4-6 October 2010

Ellen NolteEllen Nolte

Athanasios Nikolentzos, Simo Goshev, Nicholas Mays

BackgroundBackground

Review of policies on the funding /regulation of access to Review of policies on the funding /regulation of access to licensed pharmaceuticals under the statutory system licensed pharmaceuticals under the statutory system (2008/2010)(2008/2010)

11 European countries + Australia, Canada & New Zealand11 European countries + Australia, Canada & New Zealand

www.international-comparisons.org.ukwww.international-comparisons.org.uk

Characteristics of health systems in 14 Characteristics of health systems in 14 countries under reviewcountries under review

Provide (near) universal coverage of their populationProvide (near) universal coverage of their population Main mode of funding of the statutory system is taxation and/or social Main mode of funding of the statutory system is taxation and/or social

health insurance (60-80% of total health expenditure)health insurance (60-80% of total health expenditure) Spend between 2700 US$ PPP per capita (NZ) to 5000 (Norway) on Spend between 2700 US$ PPP per capita (NZ) to 5000 (Norway) on

health (2008; average: US$ 3600)health (2008; average: US$ 3600) Statutory system principally covers primary and specialist/hospital Statutory system principally covers primary and specialist/hospital

services, and (variously) preventive care, prescription drugs, mental services, and (variously) preventive care, prescription drugs, mental health care, dental care etchealth care, dental care etc

Cost sharing arrangements common, in particular for Cost sharing arrangements common, in particular for pharmaceuticals and dental carepharmaceuticals and dental care

Mechanisms to protect selected groups through exemption from charges (e.g. older people in Spain), annual caps on expenditure (e.g. Norway, Sweden), and complementary private health insurance covering statutory user charges (France)

4

Total health expenditure in 14 countries Total health expenditure in 14 countries (2008*)(2008*)

Source: OECD Health Data 2010 * 2007: Australia, Denmark

5

Health expenditure by source in 13 Health expenditure by source in 13 countries (2008*)countries (2008*)

Source: OECD Health Data 2010 * 2007: Australia, Denmark

6

Expenditure on pharmaceuticals in 13 Expenditure on pharmaceuticals in 13 countries (2008*)countries (2008*)

Source: OECD Health Data 2010 * 2007: Australia, Denmark

GP/specialist Inpatient care Pharmaceuticals Dental services

Australia No

Canada No No

Denmark No No

Finland

France

Germany

Italy No No

Netherlands No No ()

New Zealand No

Norway No No

Spain No No

Sweden

Switzerland

UK/England No No

Cost sharing arrangements in 14 Cost sharing arrangements in 14 countriescountries

Source: adapted from Thomson et al. 2009

Primary body responsible for assessing new drugs Role

Australia Pharmaceutical Benefits Advisory Committee (PBAC) Advisory

Canada Canadian Expert Drug Advisory Committee (CEDAC) Advisory

Denmark Danish Medicines Agency (DKMA) Regulatory

Finland Pharmaceutical Pricing Board (PPB) Regulatory

France High Authority for Health (HAS) (Transparency Commission (CT) & CEPS) Advisory

Germany Federal Joint Committee (G-BA) Regulatory

Italy Italian Medicines Agency (AIFA) (Technical Scientific Committee (CTS)) Regulatory

Netherlands Health Care Insurance Board (CZV) (Pharmaceutical Aid Committee (CFH)) Advisory

New Zealand Pharmac Board Regulatory

Norway Norwegian Medicines Agency (NoMA) Regulatory

Spain Direccion General de Farmacia y Productos Sanitarios (DGF) at the MoH Regulatory

Sweden Pharmaceuticals Benefits Board (LFN) Regulatory

Switzerland Federal Office for Public Health (OFSP) Regulatory

UK/England National Institute for Health and Clinical Excellence (NICE) Regulatory

Assessing new (outpatient) drugs for Assessing new (outpatient) drugs for funding in 14 countries (1)funding in 14 countries (1)

Assessing new (outpatient) drugs for Assessing new (outpatient) drugs for funding in 14 countries (2)funding in 14 countries (2)

Decisions on drug formularies used in hospital vary, with some Decisions on drug formularies used in hospital vary, with some leaving it to hospitals while others (Italy, Spain, Sweden, UK) leaving it to hospitals while others (Italy, Spain, Sweden, UK) use the process in place for outpatient drugsuse the process in place for outpatient drugs

In most countries, new drugs have to be included in positive In most countries, new drugs have to be included in positive lists; Germany and the UK principally fund every new licensed lists; Germany and the UK principally fund every new licensed drug under the statutory system (with important exceptions)drug under the statutory system (with important exceptions)

Cost effectiveness is an explicit criterion in decision-making on Cost effectiveness is an explicit criterion in decision-making on new drugs 8 of 14 countries, although not necessarily the only new drugs 8 of 14 countries, although not necessarily the only criterion. Other countries are moving towards formalising use criterion. Other countries are moving towards formalising use of cost effectiveness criteria (Denmark, France, Germany)of cost effectiveness criteria (Denmark, France, Germany)

Cost-effectiveness is an overt criterion for the decisions to fund a drug

Australia plus: importance of clinical area; availability of alternative treatments; likely effect on health system and other therapeutic activities

Canada Processes and rules for differ among provinces; all provinces (except Quebec) consider CEDARs’ recommendations; budget impact analysis => CEA

Denmark No May be undertaken but not mandatory (only relevant for drugs that contain new active agent)

Finland Therapeutic benefit, patient benefit, cost effectiveness and budget impact

France (No) Decision making based on clinical /epidemiological data with financial impact of drug considered; plans for full economic evaluations

Germany (No) Decision making based on medical need and efficiency; CEA mandated from 2008

Italy No

Netherlands Efficacy, safety, effectiveness, cost effectiveness, financial impact, quality of life, social/ethical/legal considerations

New Zealand

Health needs; availability and suitability of existing treatments; clinical risks and benefits; cost-effectiveness; budget impact; costs to service users; government priorities; other

Norway

Spain No

Sweden Therapeutic benefit, patient benefit, cost effectiveness, availability of therapeutic alternatives, equity

Switzerland Appropriate, effective and value for money

UK/England Strength of available evidence, health impact, acceptability, clinical and government priorities, health need

Delegating (difficult) decisionsDelegating (difficult) decisions

Assumption that organisations outside the Ministry of Health are better placed to make (or advise on) decisions : “[...] the arrival of the HAS which is independent and gives public advice,

which can be followed or not, did change the landscape and has allowed the Ministry to rely on scientific expertise to engage in this way with disinvestment [which was] not really useful before.” (HAS, France)

Delegation of such decisions also seen as a means to separate politics from the decision-making process and so increase their acceptability

Yet, separation of the two not always possible

Source: Ettelt et al., 2010

Making difficult decisions (1)Making difficult decisions (1)

Decisions about service coverage (including pharmaceuticals) tend to affect interests of range of stakeholders and those to exclude or terminate funding of an existing service (‘de-listing’) tends to be most controversial

Even where decision-making is formally delegated to other actors (e.g. NICE, G-BA), public pressure is typically directed at the Ministry of Health “We always emphasise that we do not have a socialised [i.e. state-run]

system […]. But of course we do have political responsibility for the functioning of the overall system. And of course, the moment the Federal Joint Committee de-lists a service […] all lobbying and publicity efforts will concentrate on the Ministry.” (Federal Ministry of Health, Germany)

Ministr(ies) of health seem to be almost universally seen as responsible for what is covered by the health system, despite apparent differences in their legal and technical remit concerning such decisions

Source: Ettelt et al., 2010

Making difficult decisions (2)Making difficult decisions (2)

Ministries and their ministers may be put in the spotlight irrespective of their legal mandate and as a consequence, the ministry might decide to intervene despite a limited mandate:

– “The G-BA did not implement these new more expensive medicines [artificial nutrition support] due to a lack of evidence, whereupon the ministry strongly intervened. […] It was also clear that politicians and particularly the administration of the ministry were concerned that reports would appear in the Tagesthemen [German prime-time news programme] or somewhere else, saying, ‘Health insurance no longer pays for high quality artificial nutrition support for severely-ill cancer patients’.” (G-BA, Germany)

Role of commercial /industry interests and general public pressure in prompting intervention against the scientific evidence: “The politicians were behind the introduction of [the] HPV [vaccine], with

demands in the parliament. The patients demanded [it], they went to the politicians. So the Minister couldn’t do otherwise, it was a losing battle, so there was nothing to be done; he had to introduce the free vaccination for everybody.” (Danish Medicines Agency, Denmark)

Source: Ettelt et al., 2010

ConclusionsConclusions

Pharmaceutical policies with regard to regulation of access to Pharmaceutical policies with regard to regulation of access to drugs vary widely, largely reflecting countries’ institutional, drugs vary widely, largely reflecting countries’ institutional, political, social and historical contextspolitical, social and historical contexts

All countries have established (independent) bodies All countries have established (independent) bodies responsible for the assessment of new (and existing) drugs for responsible for the assessment of new (and existing) drugs for inclusion in the statutory benefits package inclusion in the statutory benefits package

Tensions between authorities (governmental or non-Tensions between authorities (governmental or non-governmental) responsible for reimbursement decisions exist governmental) responsible for reimbursement decisions exist in all settingsin all settings