Table 1.
Legal requirement about reimbursement and pricing of orphan medicinal products with a focus on the biotechnological drugs.
| Availability of pharmacoeconomic/HTA guidelines | Special section for rare diseases and/ or orphan drugs in the guideline | Specific requirements for reimbursement decision | Specific requirements for reimbursement | Deadlines for making reimbursement decision | Pricing system | Discounts | |
|---|---|---|---|---|---|---|---|
| Bulgaria | +/+ | +/+ | The same as for all medicines | Clinical indication (e.g., state of the disease); Limitation in the number of patients; Age of the patients. |
90 days for HTA appraisal; Plus 90 days for pricing and reimbursement decision. |
External reference pricing, lower from 17 EU reference countries | Obligatory no less than 10% and confidential |
| Croatia | +/+ | +/+ | The same as for all medicines | According to the guidelines | 180 days for HTA appraisal and for pricing and reimbursement decision | Reference pricing, a combination of 5 EU reference countries | Compulsory no < 10% and also confidential |
| Estonia | +/+ | –/– | The same as for all medicines | Clinical indications need to be listed in a specific governmental act. | 180 days | Price cannot be higher than in Latvia, Lithuania and Slovakia. | Confidential additional discounts are possible. |
| Greece | -/- | –/– | –/– | Limited to exact approved indication | 4 months for pricing 2–3 months for reimbursement. |
Reference pricing: the average of the three lowest between 27 EU countries | Obligatory 14–30% scaled rebate depending on volume |
| Hungary | +/+** | –/– | The same as for all medicines | Clinical indication (e.g., state of the disease); Limitation in the number of patients; Age of the patients. |
90 days for Pricing & Reimbursement; 43days for the HTA appraisal |
External Referencing pricing | Confidential |
| Macedonia | -/- | –/– | The same as for all medicines | Non-defined | Non-defined | Public procurement by the Ministry of Health-criterion-the lowest price | - |
| Poland | +/+ | –/– | The same as for all medicines | No specific requirements | 90 days for reimbursement decision; 180 days for pricing and reimbursement decision according to the Transparency Directive |
External referencing pricing: 31 UE and EOG reference countries | No formal discounts; More popular and more often used are Risk Sharing Schemes (RSSs) |
| Romania | –/– | –/– | –/– | –/– | |||
| Serbia | –/–* | –/– | The same as for all medicines | Special agreement (PAS)—volume-, value-cap, risk-, or cost-sharing. Limitation in the number of patients, indication, the severity of disease, etc. |
For pricing—not specially defined, but not more than 90 days; For reimbursement-−120 days. |
Reference pricing: First basket: 3 EU countries; Second basket: EU country manufacturing drug or EU countries that have drug on the market. |
Depends on negotiated price and terms; Confidential. |
| Slovakia Ministry of Health (2011a). [Act No. 363/2011] | +/- | +/+ | The same as for all medicines |
Prescription restrictions; Medical indication restrictions; Restricted prescription only in specialized hospitals |
180 days for pricing and reimbursement decision according to the Transparency Directive |
External reference pricing methodology. The average of the three lowest prices in the EU countries |
Confidential additional discounts are possible. |
*
Not complete guideline, more certain aspects covered in legal Act.
**
The guideline is also available In English: http://www.ogyei.gov.hu/dynamic/Gyogyszereink_2017_1_eng.pdf. Ref: Professional healthcare guideline on the methodology of health technology assessment. (Gyógyszereink, 2017). 67. 1. (special issue). 1-23.