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Reimbursement of anti-dementia drugs

Country comparisons


Introduction

No drug treatments can provide a cure for Alzheimer's disease or the other common forms of dementia. However, drug treatments have been developed that can temporarily slow down the progression of symptoms in some people with Alzheimer’s disease. Donepezil, rivastigmine and galantamine all work in a similar way and are known as acetylcholinesterase inhibitors. Memantine [1] works in a different way to the other three. [2]

Acetylcholinesterase inhibitors

Research has shown that the amount of a chemical called acetylcholine is diminishing in the brains of people with Alzheimer's disease. Acetylcholine is one of the many chemicals that nerve cells use to communicate and is a neurotransmitter that plays a critical role in memory and learning processes.

Donepezil, rivastigmine and galantamine have a common mode of action as all three drugs prevent an enzyme known as acetylcholinesterase from breaking down acetylcholine in the brain. However, rivastigmine inhibits both acteylcholinesterase and butyrylcholinesterase, the two enzymes that break down acetylcholine in the brain. Galantamine also appears to act on the nicotinic neuronal receptors in the brain, making them release more acetylcholine.

Increased concentrations of acetylcholine lead to improved communication between nerve cells involved in memory and learning, which may in turn temporarily improve or stabilise some of the key symptoms of Alzheimer's disease.

It is possible that one of these drugs might suit a particular individual better than another. The specialist may be able to advise whether there is any advantage associated with a particular drug.

At present acetylcholinesterase inhibitors are only used in people with mild to moderate Alzheimer's disease. They are not effective for everyone and may only temporarily improve memory or delay memory loss. Research is being undertaken to find out whether any of these drugs may be effective in the later stages of Alzheimer's disease. [3]

In February 2006, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, the European Commission granted rivastigmine EU Marketing Authorization for the symptomatic treatment of mild to moderately severe dementia associated with idiopathic Parkinson's disease (PDD).

Memantine

The action of memantine is different to that of the acetylcholinesterase inhibitors. Memantine blocks another neurotransmitter in the brain known as glutamate. Glutamate is released in excessive amounts when brain cells are damaged by Alzheimer's disease, causing the brain cells to be damaged further. Memantine is thought to protect brain cells by blocking this release of excess glutamate.

Memantine can temporarily slow down the progression of symptoms in people in the middle and later stages of the disease. This is the first time a drug has been available for this group of people. There is also a suggestion that memantine may slow down the disease process itself. [4]

At first memantine was licensed for the treatment of moderately-severe to severe Alzheimer’s disease, but following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in October 2005, the European Commission granted memantine an extension of the indication to the treatment of patients with moderate to severe Alzheimer’s disease.

[1] Donepezil is marketed in Europe under the name Aricept, rivastigmine as Exelon, galantamine as Reminyl and memantine as Ebixa or Axura.

[2] Alzheimer’s Society (UK), Information sheet on Drug treatments for Alzheimer's disease - Aricept, Exelon, Reminyl and Ebixa (August 2003)

[3] Alzheimer’s Society (UK), op. cit .

[4] Alzheimer’s Society (UK), op. cit.


Inequalities in access to Alzheimer treatments in Europe

In its Strategic Plan (2006-2010), Alzheimer Europe has provided a clear mission statement for its work. Its core objective is defined as ‘changing perceptions, policy and practice in order to improve the access by people with dementia and their carers to treatment options and care services’.

Access by European citizens to existing anti-dementia drugs is of course a key concern of Alzheimer associations throughout Europe and in 2005 and 2006, Alzheimer Europe coordinated a response of its national organisations to the appraisal document of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom on the treatments available for Alzheimer’s disease. In its response, the organisations expressed their grave concern about the proposal to limit access of UK citizens to treatments which are available to people with Alzheimer’s disease in other European countries.

As a follow-up to this response and as part of its European Commission financed project “European Collaboration on Dementia (EuroCoDe)”, Alzheimer Europe carried out an extensive survey of its members to highlight any inequalities within the European Union with regard to the access of people with Alzheimer’s disease to existing treatments. In its survey, Alzheimer Europe concentrated on finding out which of the available treatments were reimbursed under national health systems in different European countries, but also aimed at quantifying the delays experienced by different countries in granting such reimbursement, as well as any other access restrictions imposed by national health systems for the reimbursement of these medicines.


The reimbursement of Alzheimer treatments in Europe

Reimbursement systems in Europe vary quite considerably, but each European country has a system in place that guarantees that essential medicines are made available to patients at an affordable price which is at least partly underwritten by the national health systems.

The following table shows whether the four drugs available for the treatment of Alzheimer’s disease have been authorised (A) and whether they are part of the reimbursement system (R) of the respective countries. However, the table does not give any indications as to the level of reimbursement provided or the access restrictions imposed by the reimbursement systems.

Country

Donepezil

Rivastigmine

Galantamine

Memantine

 

A

R

A

R

A

R

A

R

Austria

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Belgium

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Bulgaria

Yes

No

Yes

No

Yes

No

No

No

Cyprus

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Czech Republic

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Denmark

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Estonia

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Finland

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

France

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Germany

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Greece

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Hungary

Yes

Yes

Yes

Yes

No

No

Yes

Yes

Iceland

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Ireland

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Italy

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Latvia

Yes

No

Yes

No

Yes

No

Yes

No

Lithuania

Yes

Yes

No

No

Yes

No

Yes

Yes

Luxembourg

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Malta

Yes

No

Yes

No

Yes

No

Yes

No

Netherlands

No

No

Yes

Yes

Yes

Yes

Yes

Yes

Norway

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Poland

Yes

Yes [1]

Yes

Yes

Yes

No

Yes

No

Portugal

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Romania

Yes

Yes

Yes

Yes

No

No

Yes

Yes

Slovak Republic

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Slovenia

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Spain

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Sweden

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Switzerland

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Turkey

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

United Kingdom

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No [2]

                   

As can be seen from the above table, with the exception of Bulgaria, Latvia and Malta, one or more acetylcholinesterase inhibitors are reimbursed in all the European countries, covered by the Alzheimer Europe survey, even if there may be slight variations as to which of the medicines are available and reimbursed. Memantine, as the more recent drug approved for the treatment of Alzheimer’s disease, has not yet been made subject to a reimbursement decision in Bulgaria, Italy, Latvia, Malta, Norway and Poland. Similarly, most health trusts in the United Kingdom do not cover memantine under the National Health System.

[1] Reimbursement of donepezil is limited to the generic versions of this product.

[2] Although individual health trusts are free to reimburse memantine, the Scottish Medicines Consortium rejected their use through the NHS and the opinion of the National Institute for Health and Clinical Excellence (NICE) was pending when this publication went to print.


Access and reimbursement restrictions

The question of whether treatments for Alzheimer’s disease are reimbursed under the national health systems provides important information on the existing inequalities in access to treatment in Europe. Nevertheless, it does not provide a complete picture since various conditions imposed by the health systems may impose further restrictions on the access of people with Alzheimer’s disease to existing treatments.

The proposed changes by the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom would for example limit the reimbursement of anti-dementia drugs to people in the moderate stages of the disease and exclude people with mild Alzheimer’s disease.

Similarly, some countries have reserved reimbursement to treatment decisions made by specialist doctors or in specialist centres. Some have gone further by also requiring a continuing treatment decision to be made by a specialist doctor. Also, reimbursement may not be made available to people with Alzheimer’s disease living alone or living in nursing homes. Other systems require specific examinations to be carried out prior to a reimbursement decision being made. Finally, there are quite considerable differences between European countries which have defined upper and lower MMSE score limits for the initiation and discontinuation of treatment [1] . It is therefore not surprising that a recent article [2] warned about the “alarming arbitrariness” of these prescription and reimbursement criteria in Europe.

Country

Initial treatment decision

Continuing treatment decision

Special examinations required

Upper and lower MMSE scores (ACHI) [3]

Upper and lower MMSE scores

(memantine) [4]

Austria

Specialist doctors

Specialist doctors

MMSE

26-10

14-3

Belgium

Specialist doctors

Specialist doctors

Diagnostic protocol

>10

15-0

Bulgaria

No reimbursement

Cyprus

No information

Czech Republic

Specialist doctors

Specialist doctors

MMSE

20-13

16-6

Denmark

No restrictions [5]

No restrictions

Diagnostic protocol

None

None

Estonia

No information

Finland

No [6] restrictions

No restrictions

None

None

None

France

Specialist doctors

No restrictions

None

26-10

15-0

Germany

No restrictions

No restrictions

None

None

None

Greece

Specialist doctors

No restrictions

None

None

None

Hungary

Specialist doctors

Specialist doctors

Diagnostic protocol

26-10

18-0

Iceland

No restrictions [7]

No restrictions

Diagnostic protocol

None

None

Ireland

No restrictions

No restrictions

None

None

None

Italy

Alzheimer Evaluation Unit

Alzheimer Evaluation Unit

Diagnostic protocol

26-10

N/A

Latvia

No information

Lithuania

   

MMSE

None

20-0

Luxembourg

No restrictions

No restrictions

Diagnostic protocol

26-10

15-0

Malta

No reimbursement

Netherlands

Specialist doctors

Specialist doctors

Diagnostic protocol

26-10

14-3

Norway

No restrictions [8]

No restrictions

MMSE

> 12

N/A

Poland

No restrictions

No restrictions

MMSE

26-10

N/A

Portugal

Specialist doctors

Specialist doctors

None

None

None

Romania

Specialist doctors

Specialist doctors

Diagnostic protocol

> 12

> 12

Slovak Republic

Specialist doctors

Specialist doctors

MMSE

24-13

24-13

Slovenia

Specialist doctors

No restrictions

MMSE

26-10 [9]

26-10

Spain

Specialist doctors

Specialist doctors

MMSE

None

None

Sweden

No restrictions

No restrictions

None

None

None

Switzerland

No restrictions

No restrictions

MMSE

>10

>3

Turkey

Specialist doctors

No restrictions

None

None

None

United Kingdom

Specialist doctors

No restrictions [10]

MMSE

30-12

N/A

[1] The Mini-Mental State Examination (Folstein et al. 1975) is a quick test which gives an overall estimate of a person’s intellectual capacity and can therefore be used to give a rough assessment of the progress of dementia over time. It gives a score from 30 (full mental capacity) to 0 (severe impairment).

[2] R.C. Oude Voshaar, A. Burns, M.G.M. Olde Rikkert : Alarming arbitrariness in EU Prescription and reimbursement criteria for anti-dementia drugs, Int J Geriatr Psychiatry ; 2006 ; 21 :29-31

[3] Unless obtained from our member organisations, we included data from R.C. Oude Voshaar et.al., op.cit

[4] Unless obtained from our member organisations, we included data from R.C. Oude Voshaar et.al., op.cit

[5] Although an application for reimbursement can be made by any doctor on behalf of a patient, the diagnosis must have been made by a specialist (neurologist, psychiatrist or geriatrician).

[6] Any doctor can prescribe anti-dementia drugs, but reimbursement can only be done if the diagnosis has been established by a specialist.

[7] Although prescriptions can be filled in by any doctor, the diagnosis needs to be confirmed by a specialist.

[8] Norway specifies that treatment decisions should be made by a doctor with an interest in and knowledge of dementia, but does not restrict treatment decisions to specialist doctors.

[9] For patients with MMSE scores higher than 26, more extensive neuropsychological examinations have to be carried out that indicate cognitive decline consistent with Alzheimer’s disease.

[10] The NICE guidance in existence (September 2006) allows general practitioners to continue treatment under shared care protocols.


Market access delays

A final aspect that Alzheimer Europe covered in its survey on the availability of anti-dementia drugs concerned the dates of the market authorisation, product launches and reimbursement decisions in the different countries. While differences in market authorisations already point to significant delays in some countries for the approval of new medicines, these delays are further exacerbated by the time it takes for pricing decisions to be made and for products to be launched, as well as for new treatments to be included in the reimbursement system.

The following table shows the delays experienced in some countries for the market authorisation, the launch or the reimbursements decisions for three of the Alzheimer medicines.

Galantamine

Market autorisation dates

Memantine

Launch dates

Rivastigmine

Reimbursement dates

First country

Sweden (03/2000)

Germany, Denmark, Iceland (08/2002)

Switzerland (03/1997)

Within 6 months

Austria, Belgium, Denmark, Finland, Iceland, Ireland, Norway, Switzerland, United Kingdom

Austria, Greece, Ireland, Netherlands, Norway, Sweden, United Kingdom

 

Within 6 – 12 months

France, Germany, Greece, Italy, Luxembourg, Poland, Portugal, Spain

Finland, France, Hungary, Slovenia, Spain

 

Within 1 to 2 years

Czech Republic, Lithuania, Slovak Republic, Slovenia

Belgium, Czech Republic, Poland, Portugal, Romania, Slovak Republic, Switzerland, Turkey

France, Germany, United Kingdom

Within 2 to 3 years

 

Croatia, Italy, Serbia-Montenegro

Spain, Netherlands

Within 3 to 4 years

Latvia, Malta, Netherlands

Cyprus

Ireland

Over 4 years

Cyprus

 

Austria, Belgium, Hungary

Although it was impossible to find data for all the countries covered in our survey, the findings point to significant delays in some countries as to the access of people with Alzheimer’s disease to treatment options available to patients in other countries. With the decision to centralise market authorisations for drugs for the treatment of neurodegenerative diseases, such as Alzheimer’s disease, at the level of the European Medicines Agency, the delays between the Member States of the European Union will disappear.

Nevertheless, due to the pricing discussions in some countries or internal company decisions, the launch dates of products will continue to vary and some people with Alzheimer’s disease will have earlier access to new treatments than others.

Similarly, true access to anti-dementia drugs is only obtained by patients, once these drugs are part of the reimbursement system, as otherwise treatment with these drugs may be limited only to those people who can afford to pay for them themselves. As can be seen from the above table, although rivastigmine was authorised through the centralised procedure with European wide marketing authorisation on 12 May 1998, there were significant differences as to the dates when individual countries included this treatment in their reimbursement systems.

For Alzheimer Europe, these differences are unacceptable as the organisation campaigns for people with Alzheimer’s disease throughout Europe to have equal access to a high standard of care services and treatment options.


Treatment rates

The Alzheimer Europe survey shows important differences between European countries as to the numbers of people with Alzheimer’s disease having access to existing treatments. Other recent publications similarly aimed at identifying differences as to the numbers of people with Alzheimer’s disease being treated.

A survey conducted by Pfizer amongst 200 carers from 6 different European countries (France, Germany, Italy, Poland, Spain and United Kingdom) showed that a majority of physicians recommended treatment at the time of diagnosis. Nevertheless, there were marked differences between countries, with UK carers reporting that treatment was recommended at the time of diagnosis in only 51% of cases, whereas carers in Poland or Spain reported that this was the case in 86% of cases.

As to the treatment recommended, carers reported mainly prescription medicines (98%), either specific Alzheimer’s treatments (86%) or medication to treat mood and behaviour (61%). Other therapies, such as counselling (29%), day care (26%), cognitive therapy (21%) or support groups (15%) were less often recommended by doctors. [1]

Similarly, a recent study by Waldemar [2] et. al. calculated the rates of people with Alzheimer’s disease who receive treatment by combining the Alzheimer Europe prevalence rates with data obtained from International Marketing Services about the sales of donepezil, galantamine, rivastigmine and memantine.

Country

Percentage of carers reporting treatment at diagnosis [3]

Percentage of patients treated [4]

Austria

 

32

Belgium

 

30

Bulgaria

 

6

Czech Republic

 

9

Denmark

 

28

France

83

50

Germany

78

26

Greece

 

97

Hungary

 

3

Ireland

 

46

Italy

85

18

Netherlands

 

8

Poland

86

16

Portugal

 

33

Slovak Republic

 

10

Spain

86

40

Sweden

 

47

Switzerland

 

28

United Kingdom

51

18

[1] D. Wilkinson et. al. Inequalities in dementia care across Europe : An Agenda for Change, Int J Clin Pract, March 2005, 59 (Suppl. 146), 17-24

[2] G. Waldemar, K.T.T. Phung, A. Burns, J. Georges, F. Ronholt Hansen, S. Iliffe, C. Marking. M. Olde Rikkert, J. Selmes, G. Stoppe, N. Sartorius, Access to diagnostic evaluation and treatment for dementia in Europe, in press Int J Geriatr Psychiatry

[3] D. Wilkinson, op.cit.

[4] G. Waldemar, op.cit.


Conclusions

The Alzheimer Europe survey and other studies in this field confirm that people with Alzheimer’s disease do not have equal access to existing dementia treatments in Europe. Rather, access is subject to a great many restrictions and there are huge variations in access between European countries.


Acknowledgements

Alzheimer Europe gratefully acknowledges the input of the following individuals without whom it would have been impossible to collect this information:

  • ABELA Stephen, Malta Dementia Society, Malta
  • ALLARD Patrice, France Alzheimer, France
  • BARTSCH Roswitha, Alzheimer Angehörige Austria, Austria
  • BEDNARZ Bartosz, Novartis, USA
  • BASTIANI Pierluigi de, A.I.M.A., Italy
  • BLOM Marco, Alzheimer Nederland, Netherlands
  • BYL Brigitte, Janssen-Cilag, Belgium
  • ESKILDSEN Thomas, Lundbeck, Denmark
  • GRANÖ Sirpa, Alzheimer-keskusliitto, Finland
  • GYLFADÓTTIR Guðrún, Social Security Department, Iceland
  • HAUKSSON Helgi Johann, FAAS, Iceland
  • HENRY Sabine, Ligue Alzheimer, Belgium
  • HIMMER Eva, Hungarian Alzheimer’s Association, Hungary
  • HOLMEROVA Iva, Czech Alzheimer’s Society, Czech Republic
  • ILIEVA Irina, Alzheimer Bulgaria, Bulgaria
  • JACQUES Alan, Alzheimer Scotland, United Kingdom
  • JANSEN Sabine, Deutsche Alzheimer Gesellschaft, Germany
  • JOHANNSEN Peter, Alzheimerforeningen, Denmark
  • KLASUPA Ilva, State Agency of Medicines, Latvia
  • KOGOJ Ales, Slovenian Alzheimer’s Society, Slovenia
  • KOTRAS Nina, GAADRD, Greece
  • LECLERC Nathalie, Novartis, France
  • LONEUX Sylvie, Ligue Alzheimer, Belgium
  • O’CALLAGHAN Sarah, Alzheimer Society of Ireland, Ireland
  • PETITPRE Jean, France Alzheimer, France
  • RAUDSEPP Kristin, State Agency of Medicines, Estonia
  • RODRIGO Jesus Maria, CEAFA, Spain
  • SADOWSKA Alicja, Polish Alzheimer’s Association, Poland
  • SALVINI Gabriella, Federazione Alzheimer Italia, Italy
  • SCERRI Charles, Malta Dementia Society, Malta
  • SELMES Micheline, Fundación Alzheimer España, Spain
  • SHARP Samantha, Alzheimer’s Society, United Kingdom
  • SPARR Sigurd, Nasjonalforeningen Demensförbundet, Norway
  • TARISKA Peter, National Institute of Psychiatry and Neurology, Hungary
  • TELARANTA Pirkko, Alzheimer-keskusliitto, Finland
  • TSOLAKI Magda, GAADRD, Greece
  • TUDOSE Catalina, Societatea Alzheimer, Romania
  • TRAYKOV Latchezar, Alzheimer Bulgaria, Bulgaria
  • WILSON Gillian, Alzheimer Scotland, United Kingdom
  • WOLFENSBERGER Marianne, Association Alzheimer Suisse, Switzerland
  • WORTMANN Marc, Alzheimer Nederland, Netherlands
  • ZINKE DOS REIS Maria do Rosario, APFADA, Portugal

 

 
 

Last Updated: lundi 15 mars 2010

 

 
 

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