CEE Expert Guide on the reimbursement of orphan drugs in Hungary

Currently there is no legal definition of orphan drugs under Hungarian law. However, Hungarian legislation governing the reimbursement of medicines includes the following relevant categorisations:

a. are used exclusively for the most effective and efficient treatment and prevention of serious chronic diseases and disorders that require continuous or lifelong treatment; and that:

1. are used to treat rare manifestations of rare or hereditary diseases resulting in a worse form of a disease; or
2. fall under the scope of European Parliament and Council Regulation 141/2000/EC of 16 December 1999 on orphan drugs.

b. are life-endangering without continuous medical treatment; or
c. initiate irreversible processes and significantly adversely affect life expectancy or quality of life; or

a. are used exclusively for the most effective and efficient treatment of serious chronic diseases and disorders that require continuous or lifelong treatment, and that:

1. are life-endangering without continuous medical treatment, or
2. initiate irreversible processes and significantly adversely affect life expectancy or quality of life, or

b. are used to treat rare manifestations of rare or hereditary diseases resulting in a worse form of a disease; or
c. fall under the scope of European Parliament and Council Regulation 141/2000/EC of 16 December 1999 on orphan drugs.

Yes, they are subject to the same reimbursement/admission rules as other medicines. There is no separate procedure for orphan drugs in Hungary. In 2017, a separate department was established dedicated to deal with orphan drugs in the competent central Hungarian agency, the National Health Insurance Fund of Hungary (the “Authority”).

In Hungary, medicines approved for marketing can be approved for reimbursement if the Authority has determined they are eligible for reimbursement in an official procedure. Procedures related to reimbursement for medicines are initiated by application, notification or ex officio. For procedures initiated by application, the Authority decides on the inclusion of the given drug in the social security system. It is also important to note that there is a standard application procedure for all types of medicines in Hungary, as mentioned above in question No. 2. For procedures initiated by notification, the holder of the marketing authorisation is obliged to report specific changes to the Authority affecting an already reimbursed medicine (such as price reduction or name change) as listed in the relevant legislation. As for the ex officio procedures, they form part of the Authority’s annual review of granted reimbursements, when it decides whether to exclude any approved drug from reimbursement, or to modify the amount, category and method of support. The details of the procedure initiated by application is set out below.

An application can be submitted to the Authority by the holder of the marketing authorisation, which is then evaluated during an official procedure before the Authority. The holder of the marketing authorisation can submit the application to determine the subsidy that can be provided for the price of the given medicine in a form specified by law. The applicant must pay an administrative service fee specified by law, which is currently HUF 1.5 million (EUR 3,700) in the case of medicines. The applicant must provide evidence of the payment of the administrative service fee and the existence of a marketing authorisation for the given medicine. According to the governing legislation, the Authority must decide the application within 90 days from receiving the application form and the necessary supporting evidence. In certain cases, the Authority may suspend the procedure for 90 days, in which case the decision must be made after the expiry of the suspension, i.e. on the workday following the 90th day.

The conditions for obtaining reimbursement are:

• the holder of the marketing authorisation has applied for reimbursement of the given medicinal product in accordance with the process set out above;
• the National Institute of Pharmacy and Nutrition has recognised the safety and effectiveness of the given product and authorised it to be placed on the market;
• the cost-effectiveness of the drug has been verified;
• the drug is economically and expediently available for therapeutic use;
• the applicant undertakes to comply with the rules regarding insurance costs;
• the necessary social security funds are available or can be secured;
• the holder of the marketing authorisation undertakes to distribute the drug (for a minimum of three years) and to stock it.

Medicines are approved for reimbursement in different reimbursement categories. The Authority determines the reimbursement at a percentage level (percentage basis and key) or in a specified (fixed) amount. The following reimbursement categories are established in Hungary at the percentage level depending on the severity of disease: (i) priority (100%) (ii) high (90, 70 or 50%); (iii) above average (normative 80%); (iv) average (normative 55%); (v) below average (normative 25%); (vi) without value (0%). A fixed amount of reimbursement can be established for medicines containing the same active ingredient, or for a group of medicines for the treatment of the same disease. To ensure compliance with the budget framework, the Authority may conclude a subsidy volume contract with applicants. The medicine can only be supported within the framework of a subsidy volume contract if reimbursement is requested for an active ingredient or indication that is not already supported. Subsidy volume contracts can be concluded for a maximum of four calendar years.

In addition to the above procedure, the Authority can also approve reimbursement, within the framework defined in its budget, based on individual fairness. This procedure can be initiated by submitting a fairness request, which must be submitted before the drug is used. The administrative deadline for deciding a fairness request is 60 days (in some cases it may be shorter).

In practice, based on the information provided by the Authority, orphan drugs are admitted in the following reimbursement categories in Hungary: priority 100%, high 90%, fixed amount, without value 0% and on a fairness request.

Reimbursement can be provided only temporarily. On the one hand, the reimbursement period will be a minimum of three years (where no subsidy volume contract exists) or up to four years (where a subsidy volume contract does exist). On the other hand, annual reviews by the Authority are required by law, which means that the Authority is entitled to revise, and if necessary, modify or cancel the amount of reimbursement granted to given medicine(s) on a yearly basis. Please note that in the case of individual fairness procedures, the reimbursement can be granted up to a maximum of one calendar year.

Yes, the Authority has the capacity to evaluate the given medicine and set up its own categorisation from a reimbursement point of view, with the help of the Health Technology Assessment Committee, and to provide reimbursement to the given orphan drug regardless of the EMA register.

A public, central database is available for all types of medicines operated by the Authority. Based on the Authority’s information, 20 orphan brands currently receive reimbursement.

In general, the Authority decides applications for reimbursement within 90 days from submission. For more details, please see the answer under question No. 3.

As Hungary is a small market, we currently do not see any trends that would lead to changes in this area in the future.