Trends in individual reimbursement of orphan drugs in Latvia in 2008–2011

Orphan drugs (ODs) are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than 5 in 10 000 people in the European Union (EU). These drugs are called “orphans” because the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing products intended for only a small number of patients suffering from very rare conditions. Because of the small market, ODs are often very expensive. Whereas decisions surrounding orphan designation and marketing authorization of ODs are taken at the EU level, decisions governing pricing and reimbursement of ODs are a member state responsibility. In Latvia drug reimbursement covers drugs which are included in the national reimbursement drug list or, based on the medical council's decision, drugs can also be reimbursed within the framework of individual reimbursement system with limit of 10 000 LVL (€ 14 229) per patient per year. Due to the big costs and the small number of patients ODs are often not included in the reimbursement list and therefore are reimbursed individually.