Reform to improve access to healthcare in Bulgaria

| Full text of the analysis |

The results of the Bulgarian market study reflect the conclusions of previous analyses, such as the one commissioned by the European Commission in 2019, concerning the positive effects of the entry of biosimilar medicines into European markets. In other words, price competition between biosimilar medicines and reference medicines (together and among themselves) allows for a reduction in the average cost of treatment per patient against the backdrop of an increasing need for medicinal products. You can read our full study on the topic here.

As a result of intragroup competition for the studied drugs:

• The number of treated health-insured persons increased from 36.6 thousand in 2015 to 46 thousand in 2018.
• The increase in treated persons is 25% against the backdrop of a moderate decrease in the cost of treatment per health-insured person.
• Example with the medicinal product trastuzumab: the average annual cost for a health-insured person before the introduction of a biosimilar analogue was BGN 23.3 thousand. After the introduction of the biosimilar medication in 2018 - the cost of treatment for a health-insured person with it was BGN 3.3 thousand or 84% lower.
• The potential savings from this product alone for 2018 are BGN 26.5 million, which could increase access to drug therapy for about 8 thousand health-insured individuals. The potential savings from increased market penetration of the investigated biosimilar medicinal products in the period 2015-2018 amount to about BGN 44 million, which represents 8.5% of the costs for medicines in the same period, amounting to BGN 517 million.
• The potential savings could provide increased access to drug therapy for about 126 thousand health-insured individuals in the period 2015-2018, which is an increase of nearly 76%.

From the analysis of the Bulgarian and European experiences in the regulation of biosimilar medicines, the following conclusions can be drawn:

In 60% of the countries surveyed, various incentives have been created for prescribing biosimilar medicines.

• Regarding price regulations:

Among the main practices, the differentiated treatment in terms of price referral of biosimilar medicines stands out, which aims to facilitate and retain the specific medicine with the aim of increased competition and price reduction, as well as increasing access for patients; quotas for prescribing biosimilar medicines, aimed at retaining medicines on the market, free price competition;

• Regarding incentives:

Other countries provide financial incentives to doctors who prescribe biosimilar therapies if they can prove at the end of the year that they have saved the health fund. It is also common practice, with biosimilar medicines in hospital care, to return a percentage of the money saved to the departments in order to improve the medical infrastructure and increase the salaries of the staff. It is important to emphasize that in each of the countries studied, with the exception of Bulgaria, a policy of informing medical specialists and patients about what biosimilar medicines are is implemented.

Bulgarian reality:

At the beginning of 2019 , Bulgaria introduced a price-binding of the biosimilar medicine with the reference biological product, with the price having to be 20% lower than the original. This reduces the reference value paid by the NHIF through internal price referencing. In exchange for the biosimilar product, there are no reliefs or additional advantages when prescribing it by medical specialists. This circumstance, as well as certain vicious practices in the tender procedures, lead to the risk of the biosimilar product leaving the Bulgarian market or being considered for refusal to enter the market, which creates the risk of all negative consequences of eliminating competition. These practices, in turn, create the risk of increasing the cost of treatment for one health-insured person and reducing access for others.

Our Recommendations for Reform:

• Conduct a broad information campaign by the Ministry of Health, the National Health Insurance Fund, the Executive Agency for Medicines and the National Council for Prices and Reimbursement of Medicinal Products on the benefits of using and prescribing biosimilar medicines. The campaign should be aimed at both medical specialists and pharmacists, as well as patients.
• Regarding price incentives:
  • Differentiated treatment of biological and biosimilar medicines in pricing in order to avoid artificially lowering the price below the cost of the product;
  • Listing biosimilar products at the same prices in order to maintain market presence and maintain competition;
• Regarding prescribing incentives:
  • Incentives for medical professionals prescribing biosimilar medicines;
  • Incentives for hospitals using biosimilar medicines in hospital care and strict compliance with the rules set out under the Public Procurement Act;
  • Developing clear rules regarding the possibility of interchangeability at equal or better cost-effectiveness;
  • Prescribing biosimilar medications to new patients at equal or better cost-effectiveness indicators;
• Ensuring appropriate competitive, administrative and regulatory conditions to prevent shortages of medicines for common diseases and life-saving medications.
• Introduction of the electronic prescription for the purpose of timely analysis of the pharmaceutical market and monitoring compliance with Article 92, item 4 of the Health Act, namely: The treating physician is obliged to inform the patient about diagnostic and therapeutic alternatives.

| Full text of the analysis |

Did you like it? Take a minute to support the EKIP on Patreon!