2015 was the year marked by the Bulgarian government’s upgrade of the pricing and reimbursement system by introducing changes in the Law on the Medicinal Products in Human Medicine, the Law on Health Insurance and in several regulations. Some of the main highlights are presented below.
Introducing Health Technology Assessment (HTA). Prior to December 2015 there were no written guidelines concerning HTA in existence. Considering that for the inclusion of new INNs into the Bulgarian Positive Drug List (PDL) the applicants were required to present a pharmacoeconomics report, the National Council on Prices and Reimbursement (the Council) published guidance on the documentation for assessment of efficacy, safety, and pharmacoeconomics in an effort to fill in this regulatory gap. In December 2015 a new Regulation on the Rules and Conditions of Health Technology Assessment was published. The HTA applies to new INNs entering the PDL and is a part of the periodical maintenance of the reimbursement status.
Introducing new procedure to maintain the reimbursement status. The medicinal products included in the PDL will now undergo a reimbursement status maintenance procedure every 3 years from the date of inclusion in the list. The Council will perform the assessment based on the evidences for efficacy, therapeutic effectiveness and pharmacoeconomics analyses. The procedure ensures that the medicinal products listed in the PDL meet the reimbursement requirements not only at the initial point but throughout their inclusion.
Introduction of mandatory discounts. One of the major pitfalls when imposing (administratively) the lowest prices in one of the smallest markets in the EU is to have the pharmaceutical companies discouraged by the possibility of facing price erosion on other markets due to the price reference systems largely adopted throughout Europe. To this end the Bulgarian government allowed the negotiation of discounts between Marketing Authorisation Holders (MAHs) and the National Health Insurance Fund (NHIF). One of the ideas behind this decision was that such discounts could not be used for reference by other member states. The next stage is the introduction of mandatory discounts for certain types of medicinal products: mainly medicinal products for outpatient treatment (Annex 1 of PDL) and oncology medicinal products for hospital use paid by the NHIF (Annex 2 of PDL). Generally, this applies in case of new applications for new INNs to be included in the PDL or in case there is only one MAH for a product with a given INN (or within a given referent group) already included in the PDL – situations in which the internal reference system would expectedly not affect the pricing of such medicines.
Limit of the patient co-payment (price corridor) for products for outpatient treatment reimbursed by the NHIF. This affects mainly products in cases when the internal reference system has reduced the referent price paid by the NHIF (within a given PDL referent group) but the external reference system has allowed a much higher registered maximal price and the difference is paid by the patient. The patient co-payment cannot be higher than 60% above the referent (internal reference) price for the concerned pack. The limitation was planned to be introduced at pharmacy level and to come into force in February 2016* but it was causing disturbances and tensions in the the sector and never came into force.
Improvement of the external referent system by introducing price limitations for cases when there is no referent price of the concerned manufacturer within the referent basket of countries.
The list of diseases for which the NHIF pays for the outpatient treatment is now in the hands of the Supervisory Board of the NHIF which is expected to provide a more quick and flexible approach in amending the list. However, we have yet to see this put into practice.
Improved system for cleaning “ghosts” out of the PDL. In case no payment has been made for 6 months by the NHIF for products intended for outpatient treatment or the amount paid by the NHIF is less than 1% of the total amount paid for the concerned PDL referent group, the concerned product can be excluded from the PDL at the initiative of the NHIF. This rule is expected to help excluding those products listed in the PDL but not actually placed on the market or having a minor share. Such “ghost” entries could knock off the referent price within the internal referent group affecting other products without truly providing a cheaper alternative.
In conclusion we will say that reimbursement is becoming even more challenging. The Council and NHIF have new leverages now and MAHs have new obligations if they want their products reimbursed. The big question is whether the new changes put to practice will prove to be balanced enough: reducing the public expenditures but keeping the medicines availability in the reimbursement list (and the market) and in the same time not allowing abuse of the reimbursement system by bad parallel export practices.
*Update February 19th, 2016: postponed until September 1st, 2016.
*Update September 20th, 2016: postponed until January 1st, 2017.
*Update December, 2016: price corridor is planned to be dismissed due to expected negative impact on current the reimbursement list; draft amendment pending.
* Update January 2017: the price corridor rule was repealed.