On April 1st, 2019, several regulations concerning drug pricing and inclusion in the Positive Drug List (the Formulary) were updated and in force. Since April 1, 2019 amendments to directive 10 and 9 are in effect.
Major changes include (but are not limited to):
- Change in the set of reference countries, now 10 countries will be referred, instead of 17. According to the new regulation, the lowest MNF drug price from BE, EL, ES, IT, LT, LV, RO, SK, SL & FR will be taken as a reference price.
- Rules for the inclusion of products in the Positive Drug List (the Formulary). And specifically:
- A product will be included in the PDL only if it is reimbursed by at least one public health care fund in one of the following countries: BE, EL, DK, EE, ES, IT, LT, LV, PL, PT, RO, SK SL, HU, FI, FR or CZ.
- New generic drugs MNF price must not exceed 70% of the reference product price / Biosimilars MNF price should not exceed 80% of the reference product price.
- A drug will be listed in the Positive Drug List, only if a favorable HTA opinion has is already granted in one of the following countries: UK, FR, DE or SE.
- Pricing rules regarding products that already included in the Positive Drug List (the Formulary) and Rx pharmaceutical products. For instance, the lowest MNF drug price from BE, EL, ES, IT, LT, LV, RO, SK, SL & FR will be used as a reference price.
- More changes that allow NHIF to charge pharmaceutical companies if they exceed sales (value) registered in previous periods. Read more here.
- The fact itself that a favorable HTA opinion in the UK is among the criteria to include a drug in the Positive Drug List (the Formulary) in Bulgaria may suggest that further revisions of the current amendments may be relevant.
Here is a summary of the rules that can impact drug prices directly in Bulgaria in one slide.