By Akshay Kumar, Partner & Andrea Bernardini, Analyst
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Bulgaria introduced multiple reforms to their healthcare system since 2011. This included the introduction of health technology assessments in 2015. However, evidence has shown that these reforms have had so far little impact on improving effectiveness of care, patient access to treatments or cost containment.
To address this, the Bulgarian authorities have just conducted public consultations on the latest amendments to the pricing and reimbursement procedures for medicinal products. There are 3 key proposed changes to the legislation which can greatly impact patient access to orphan drugs. These are:
- Orphan drugs can only be included the Positive Drugs List (PDL) only if reimbursement for the same indication has been granted by at least 5 other EU markets from the countries which make up the external price referencing basket (Belgium, Greece, Denmark, Estonia, Spain, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Hungary, Finland, France and the Czech Republic)
- Drugs that treat a small population and for which there is insufficient data at launch, can now receive conditional reimbursement with the authorities setting a future date for a reassessment. Authorities can also now mandate real world data (RWD) collection to demonstrate the therapeutic efficacy in real life clinical settings. If the collected RWD is insufficient to have statistical reliability, the monitoring of the therapy’s effectiveness can continue for extra term (3 years), with the reimbursement status maintained
If enacted into law, these changes are intended to enable rare disease patients in Bulgaria to access innovative, novel treatments which otherwise would not have been included in the positive drug list due to a paucity of data at launch. However, the infrastructure within the healthcare system for the collection of this data is not yet in place, and details around how this RWD will be collected and assessed have not yet been published.
Ultimately, it is not yet clear whether this latest round of proposed reforms will actually have a material impact on patient access as it is unclear how the healthcare infrastructure will be optimised to enable RWD collection, and once assessed, how this will be factored in to the HTA process.