We were unable to collect data relevant to Slovenia, which is a restriction of the study. In addition, we used the Kappa coefficient to analyze the concordance between recommendations and reimbursement status. However, the kappa compliance coefficient could only be calculated for countries that made both positive and negative recommendations, in order to provide an overview of how the reimbursement policy based on HTA-rated medicines works. In addition, the coefficient may have been influenced by the levels of the variables analysed and can therefore be treated as a descriptive statistic rather than an inferred statistic. As in other statistical tests, only cases (drugs) were available, resulting in different rates of drugs used to calculate Kappa coefficients in different countries, but this approach is appropriate given that the use of drugs that have not even been considered for health technology assessment, analysis of the analysis could lead to distortions of competition. In addition, we observed that most of the Kappa coefficients in this study were identical to 1. This could be explained by the fact that countries differ significantly when it comes to DHTA processes, which translates into a significant gap between the proportions of positive and negative recommendations. In some countries, the advisory councils have made only positive recommendations. In Bulgaria, during the monitoring period, recommendations on the reimbursement of a given orphan medicinal product are issued by the HTA Commission, the situation was subsequently updated and the National Pricing and Reimbursement Council implements the procedure for evaluation, pricing and inclusion in PDLs. A positive recommendation from the Commission is one of the conditions for reimbursement.
The final decision on reimbursement and inclusion on the list of positive drugs is taken by the National Council for Drug Prices and Reimbursement. Another mandatory condition is the signing of a managed entry agreement with the payer. Only the positive reports of the Commission are published (on the website of the National Centre for Public Health and Analysis, as well as full reports on hypertension). Orphan medicinal products to be reimbursed do not necessarily have to be cost-effective and additional evaluations are also taken into account. HPA requirements include the results of clinical, pharmaco-economic and budgetary impact assessments as well as ethical considerations. No additional analysis is required. Bulgarian HTA regulations require that application products do not have a negative assessment of hypertension in the UK, France or Germany. Today, however, it has changed and it is necessary to make a positive assessment in the United Kingdom, France, Germany or Sweden (Table 4). The HTA TPA submission form should be used to inform the HTA of new agreements with third parties. For more information on Third Party Agreements (TPAs), click here.
The fact that, where a third-party contract is entered into by the licensee or the person designated on behalf of the licensee after the issuance of a licence, the licensee or designated person must first notify the HTA and the HTA is informed of the suitability of the relevant premises proposed by a third party is a standard condition: before proceeding with a licensed activity. by the third party on behalf of the licensee. Viera AJ, Garrett JM. Understanding the coherence of the interobserver: kappa statistics. Fam Med. 2005; 37 (5): 360-3. The organization and the third party must provide the HTA (upon request) with all records related to a SAEAR and assist in each investigation process. This operation must be clearly specified in the third-party agreement. The designated person should also ensure that records relating to the SAEAR, including any follow-up reports, are kept. . . .