| About database |
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What is the new WiRKliR database (Clinical and Reimbursement Directives and Recommendations) and what purposes does it serve? What part does it play in the creation of a new IT tool which shall apparently serve as a replication of already existing data which is accessible via domestic and foreign websites set up by institutions representing health care? Should a potential recipient – an oncological patient or their relatives – make a decision to explore the database? May a collection of information regarding 200 substances and 475 oncological drugs be of any interest to them? What exactly are clinical directives and reimbursement recommendations? We shall attempt to answer these questions by analysing the contents of the database itself.
When exploring the database with a view of obtaining information on a given substance, we can gain direct access to the latest and most current clinical directives regarding the application of this substance. Additionally, there exists a possibility of accessing CRD (the Centre for Reviews and Dissemination) database, which contains secondary research on the substance in question, as well as ClinicalTrails database for research which is currently in progress.
Clinical guidelines (clinical practice guidelines) constitute a collection of recommendations for medical procedures (methods of treatment) which are characterised by well-proven and verified efficiency. The guidelines present recommendations on how to act, therefore they are not strict standards (besides, the terms guidelines and standards ought not to be used interchangeably). They represent only one of the factors which are useful in the process of selecting the method of treatment by a specialist. The guidelines refer to an "average" patient and rarely take into account potential concurrency of other diseases. They are not to be treated uncritically. A doctor in charge of a given medical case shall take decision on the method of treatment depending on the patient's individual predispositions.
When exploring database for information on a particular drug we shall obtain information on drug packaging available, registered indications for application, i.e. diseases in which the medication is applied, including information on whether its efficacy, and safety profile were confirmed through trustworthy clinical trials. There is a possibility of comparing a medication registered in Poland and an equivalent one, registered for instance in the United States. There is also a possibility of checking if the newest clinical guidelines allow for a wider range of applications for our drug than the leaflet attached to the packaging indicates. The medications are related to documents referred to as reimbursement recommendations, which are issued by state agencies (such as the Polish AOTM – Agency for the Assessment of Medical Technologies) or the British government agency – NICE – (National Institute for Health and Clinical Excellence), which were set up with a view of verifying the legitimacy of reimbursement decision taken with reference to a particular medical procedure (for instance conducting a dialysis), or a substance/ a medication. Such institutions operate based on reliable scientific evidence, on the efficacy and safety of treatment, as well as the efficacy of funds allocation in accordance with EBM (Evidence Based Medicine). The recommendations are not legally binding documents (i.e. they do not automatically introduce amendments), they are only certain indications for those in charge, tips on whether investment in a particular procedure or a medication is worth the cost. Additionally, a group of public health specialists created a document referred to as "The Almanac"( separately for each substance and medication) which is an analysis of reimbursement decisions made in Poland in the course of the recent dozen years, relating to medical substances and medications. It is a collection of all reimbursement decisions made by the Minister of Health, relating to particular drugs or the directives issued by the President of NFZ (the National Health Fund), which determine the allocation of funds (or non-allocation of funds) for a given substance within the framework of the catalogue of active substances applied in chemotherapy ot therapeutic medical programmes. In conclusion, the WiRKliR database creates new possibilities by enabling us to obtain necessary information on oncological drugs reimbursement decisions in Poland faster, and to compare them with reimbursement decisions taken in other countries (England, Scotland and Australia, amongst other countries). At the same time, it is a tool which shall be applied in an effort to execute a summary report on the transparency of reimbursement decisions in Poland, based on decisions regarding oncological drugs. |
