Ideas of drugs reimbursement system changes.

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

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Abstract

The rules of reimbursement and defining the prices of medicines are included into a set of regulations that aim to ensure the convergence with European transparency directive. The process of products qualification to the system of refund is monitored by the MoH and it is permanently criticised. There are attempts of reforming it undertaken quite often. On the end of 2005 the MoH created the specific Committee of Experts to elaborate a system to set priorities in pharmaceutical reimbursement.

Purpose of health policy or idea

In practice one can see that in current regulations the reimbursement costs are paid from the public resources and are not enough in the context of the fulfilment of patients health needs. Patients in fact do not have access to effective therapy especially to the new forms of treatment. It may be problematic that still patients have to carry the main part of the costs for pharmaceuticals. The introduction of rational rules for reimbursement list creation as well as rules of medical products refund accompanied by the creation of an effective monitoring system should resolve the problem of the  costs of refunds. It would help in case of new (and expensive) pharmaceutical financing.  In order to elaborate the proposal of changes in the system of phrmaceutical refund in Poland (understood widely) that would result in optimum use of public recourses that cover expenses for pharmaceuticals a group of experts (by the Ministry of Health) was established in 2005. The document entitled: "Proposition of changes in the phrmaceutical reimbursement system" has been elaborated by this group. It should be mentioned that the document is to be a base for the future legislation on changes in the indicated system and as such it was a subject of multi-resorts agreements as well as public consultations (with the participation of medical professions and pharmaceutical companies representatives).

Main points

Main objectives

The main purpose of the work on the document is rationalising the changes in the reimbursement system (the optimum use of public resources). In the document the diagnosis of current situation has been presented indicating the main problems in this sphere. On the basis of the assumption that the true diagnosis of the current state is a condition of quality changes, the group of experts states many of systemic changes propositions that include for instance: a.       Creation of reimbursement lists (taking into account the number and different legal documents the proposition focuses on the creation of one legal document - the law on fundamental rules for medical products reimbursement.

b.       Establishing the reimbursement commission replacing the current inter- sectoral committee for drugs management.

c.       Introduction (replacement of existing rules) of two new lists of refundable drugs:

· the list of refundable drugs that are generally used;

· the list of refundable drugs  that are used for specialised use (limited use).

The above mentioned changes include also the list ofgrugs for  long term diseases liquidation.

The important change connected to the lists includes the proposition of actualisation of lists in one regulation and one time a year (it should guarantee a transparency rule realisation). Each product would last at one on the lists for the defined period of time (5 years- after that time the renewed application would be necessary).

d.      Changes in the procedure of drugs  reimbursement introduction. The proposition takes as a base the EMEA solutions, the qualification of medicaments has to be adequate to the health priorities (published by Ministry of Health) and to the financial recourses of NHF  as well as National Health Policy. The document mentions only one priority: specific rules for prevention medicaments and medicaments used in case of curable diseases and indicates detailed condition for including the medicament into the list.

e.       The proposition divides all medicaments in two categories (and states rules of refund):

·        Generics medicaments

·        Innovative medicaments

The generics,  important for the costs reason, may- be reimbursed only under one condition - if the bio equivalency tests were provided  (it does not include medicaments in the midterm period, accordingly to the Treaty on Accession). The second condition concerns the price of the generic - it has to be more that 30% lower than the original one.

In case of  innovative medicaments the inclusion into the list depends of the relation between effectivity and the price. 

f.        Exclusion procedure and criteria.

The main role play three criteria: the price, the health effect and the therapy indicator, however there is one exception: if the medicament is not significantly worse in a sense of a clinical effect but significantly cheaper.

g.       Levels of payment.

The final solution foresees three levels: flat-rates, 30% and 50%. The amendment removes the category of free medicaments (no payment at all).

The level of reimbursement has to be recommended by the Reimbursement Commission. The flat rates level medicament are recommended on the basis of DDD ( Defined Daily Dose).

h.       The document describes two possible variants for defining the prices and profit margin. The first variant introduces official "fixed price" and official fixed regressive profit margin wholesale and retile profit margin for all refunded medical products.  The second variant introduces maximum official prices for sale and official fixed regressive profit margin wholesale and retile profit margin for all refunded medical products. Giving for both detailed reasoning.

Type of incentives

In case of drug policy the financial incentives always play the key role.

1. Pharmaceutical companies are interested in fulfilment of conditions needed for including the product into the reimbursement list.  In this context they will have to comply with for instance the  cost- effectivity relation.

In health care spending the reimbursement of medicaments take the first or second place (depends on the data source) - due to this fact from the health care system perspective it is very important what kind of medicaments (and for which price) have been listed on the reimbursement lists.

Groups affected

Ministry of Health, Pharmaceutical company, Patients

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

1. The idea is not innovative one and for a long time still controversial.
2. It has a great impact on the whole system especially the cost of health care
3. The discussion engages professional environment : main stakeholders but not the media and the public.

Political and economic background

After the government elections the new Ministry of Health , as usual, elaborated the plan of medicaments reimbursement correspondent to the overall policy. The new Ministry established the Committee of Experts at the first week of governing. The law on medicaments prices from 2001 has been issued in order to comply with the EU transparency directive 89/105EEC ., however the idea of this piece of legislation in practice has not worked properly - there was very high criticism, opposite voices were raised by different stakeholders: health providers, patients and by experts (high costs of health care system indicated as a result of wrong decisions in this sphere , lack of transparency and lack of rational management). The policy proposed in the document is derived from the overall policy on health care system (during last month there have been presented - on the Ministry of health - few projects  of main laws connected with main systematic problems: the law on Emergency Service, the new project of the law on health care services financed from public resources,  the new law on sanitary inspection etc). 

Change of government

see above

Complies with

EU regulations

Eu regulation - As it was mentioned above, the new law on prices from 2001 has been issued in order to comply with the EU transparency directive but still the problems of divergences exists ? that is why the document has been elaborated.

Other

On the Ministry of health web sites there is an experts report ?Green Book? invoked - elaborated and accepted by the Ministry of Health in 2004- indicates the drugs costs (within the system) as ~4,25 thousands million euro.

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Origins of health policy idea

The idea was generated by Ministry of Health because mostly this organ has the power to influence the  medicaments market rules. The great role plays the pharmaceutical industry that is said to be one of the most influential stakeholder of national health policy. The main purpose is to ensure true  transparency in the reimbursement system  and lowering the level of medicaments costs in the system. It is also aimed in such use of public finances that the maximum effect (patients benefit) would be accessible for the minimum possible price. In the context of the proposed changes the main actors like: mentioned pharmaceutical companies, patients, service providers, NHF and the distributors should be taken into account

Initiators of idea/main actors

• Regierung: The initiator is Ministry of Health (see above)

Approach of idea

The approach of the idea is described as:
renewed: Discussion started at the first changes of the whole political and economic system in Poland (eg. privatisation of distributors ?pharmacies process), deep changes at the beginning of the health care reform ? 1999 (eg.2001- the new law on the prices intro

Stakeholder positions

1. Pharmaceutical companies: the position of pharmaceutical companies was indicated above. In fact they are not interested in changes that aim to limit public spending . Establishing the new lists of reimbursement that fulfil the rule of transparency always raises pharmaceutical companies reaction - not always in a positive sense (corruption).
2. Patients: patients were described as neutral for the fact that they are a very influencial sensitive and theirs attitude strongly depends on media information and comments. Patients position due to this is also very changeable and their influence quite weak.
3.  NHF: Payer is strongly interested in costs limitation and will support       the idea of rationalisation of medicaments reimbursement process.

 

Actors and positions

Regierung
Pharmaceutical companies	sehr unterstützend		stark dagegen
Patients	sehr unterstützend		stark dagegen
NHF	sehr unterstützend		stark dagegen

Influences in policy making and legislation

The idea lead to  following regulations:  

·        Ministry of Health Executive law from 18th of November 2005 amending  the executive law from 17th of December 2004 on the list of basic and complementary  medicaments  and the level of payment for the complementary medicaments (OJ No 274, clause. 2725 and from 2005  No 46, clause. 441 and No 192, clause 1608).

·        Ministry of Health Executive law from 18th of November 2005 amending the executive law from 17th of December 2004 on the list of diseases and the list of medicaments and medical products that due to these diseases are prescript free or flat-rate payment or partial payment (OJ No 275, clause. 2730 and from 2005  No 46, clause. 442 and No 192, clause 1609).

·        Ministry of Health Executive law from 18th of November 2005 amending the executive law from 17th of December 2004 on the establishing the prices limits for medicaments and medical products given to the service providers free or flat-rate payment or partial payment (OJ No 274, clause. 2727 and from 2005  No 16, clause. 139 and No 46, clause 443, No 192, clause 1610).

·        Ministry of Health Executive law from 24th of November 2005 amending the executive law from 20th of December 2004 on the establishing the official whole sale and retile prices for medical goods and medical products (OJ No 275, clause. 2733 and from 2005  No 16, clause. 140 and No 46, clause 444, No 192, clause 1611).

 

Legislative outcome

n/a

Actors and influence

Regierung
Pharmaceutical companies	sehr groß		kein
Patients	sehr groß		kein
NHF	sehr groß		kein

Positions and Influences at a glance

Adoption and implementation

As it was mentioned above the main actors involved in the implementation process will be Ministry of Health, pharmaceutical companies and NHF. The described document is a policy paper and has to be transformed into the executive law form. To the successful implementation the compromise between main stakeholders has to be reached. By the implementation patient will be directly affected (see above) as well as distributors (pharmacies). The main obstacles are connected to the strong influences of pharmaceutical companies. The most important incentives influencing the implementation process depend on how the experts opinions, research and data will be taken into account. In order to convince the pharmaceutical companies to the ideas of the policy and to the necessity of  transparency rule abidance they have been invited to participate in the discussion.

Monitoring and evaluation

The document foresees the replacement of current Committee on medicaments management by the described Reimbursement Commission that will have some competencies on  monitoring (RC experts) and it also foresees that the Agency for Health Technology Assessment will actively control and monitor the process (the outside monitoring). Employed by the Agency highly educated objective professionals ( undergoing the permanent verification) will take part in the monitoring process and the results of their analysis and papers  will be publicly accessible.

Review mechanisms

Abschlussevaluation (intern), Abschlussevaluation (extern)

Dimensions of evaluation

Struktur, Prozess, Ergebnis

Results of evaluation

The influence the policy on medicaments reimbursement can be seen in the whole health care system and it very it often dominates the overall health policy.

Expected outcome

At this stage it is difficult to assess the effects. The unexpected and undesirable effects  are connected to the actual interest of main stakeholders. Such interest is not always, however in case of Ministry of Health it should be, the transparency rules abidance.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

1. The quality of health care services strongly depends on medicaments, medical products used during the therapy and on the access to the medicaments (price)
2. The rational policy in the sphere of reimbursement influences the equity of the system (generics).

The decision on including the product into the reimbursement list has been subjected to the cost-efficiency relation in the document.

References

Sources of Information

• EU transparency directive 89/105EEC

·        Ministry of Health Executive law from 18th of November 2005 amending  the executive law from 17th of December 2004 on the list of basic and complementary  medicaments  and the level of payment for the complementary medicaments (OJ No 274, clause. 2725 and from 2005  No 46, clause. 441 and No 192, clause 1608).

·        Ministry of Health Executive law from 18th of November 2005 amending the executive law from 17th of December 2004 on the list of diseases and the list of medicaments and medical products that due to these diseases are prescript free or flat-rate payment or partial payment (OJ No 275, clause. 2730 and from 2005  No 46, clause. 442 and No 192, clause 1609).

·        Ministry of Health Executive law from 18th of November 2005 amending the executive law from 17th of December 2004 on the establishing the prices limits for medicaments and medical products given to the service providers free or flat-rate payment or partial payment (OJ No 274, clause. 2727 and from 2005  No 16, clause. 139 and No 46, clause 443, No 192, clause 1610).

·        Ministry of Health Executive law from 24th of November 2005 amending the executive law from 20th of December 2004 on the establishing the official whole sale and retile prices for medical goods and medical products (OJ No 275, clause. 2733 and from 2005  No 16, clause. 140 and No 46, clause 444, No 192, clause 1611).

Author/s and/or contributors to this survey

Anna Mokrzycka, Iwona Kowalska

Empfohlene Zitierweise für diesen Online-Artikel:

Anna Mokrzycka, Iwona Kowalska. "Ideas of drugs reimbursement system changes.". Health Policy Monitor, April 2006. Available at http://www.hpm.org/survey/pl/a7/1