Availability and access to orphan drugs for rare cancers in Bulgaria: analysis of delays and public expenditures

Description

This repository contains the data and code used for the article "Availability and access to orphan drugs for rare cancers in Bulgaria: analysis of delays and public expenditures" The repository is organized into the following main directories:

📦 Availability and access to orphan drugs for rare cancers in Bulgaria
 ┣ 📂 ./data
 ┃ ┣ 📂 ./cost_hospital_level
 ┃ ┣ 📂 ./shapefiles
 ┃ ┣ 📜 d.csv
 ┃ ┗ 📜 ema.csv
 ┣ 📂 ./figures
 ┣ 📂 ./scripts
 ┃ ┣ 📜 analysis.R
 ┃ ┗ 📜 data-merging-and-cleaning.R
 ┗ 📜 README.md

Data

• ./data: contains the raw data used in the analysis
  • ./cost_hospital_level: contains data on the costs of orphan cancer drugs at the hospital level for each period of the study in excel format
  • ./shapefiles: contains shapefiles for Bulgari used in the analysis
  • d.csv: contains cleaned and merged data from the ./cost_hospital_level using the data-merging-and-cleaning.R script. The data contains the following columns:
    • region: region of the hospital where the expenditure was made
    • hospital: name of the hospital
    • atc: Anatomical Therapeutic Chemical Classification System code
    • аmount: amount of the drug
    • n_in_package: number of units in the package
    • icd: International Classification of Diseases code
    • n_patients: number of patients
    • market_name: name of the drug
    • packages: number of packages
    • costs: costs of the drug (in BGN)
    • date: date of the expenditure
    • inn: International Nonproprietary Name
    • year: year of the expenditure
    • month: month of the expenditure
    • quarter: quarter of the expenditure
  • ema.csv: The EPAR data from the European Medicines Agency (EMA) contains the following columns:
    • category: category of the drug (human or veterinary)
    • market_name: name of the drug
    • Therapeutic area: therapeutic area of the drug
    • inn: International Nonproprietary Name
    • Active substance: active substance of the drug
    • Product number: product number
    • Patient safety: patient safety
    • status: status of the drug
    • atc: Anatomical Therapeutic Chemical Classification System code
    • Additional monitoring: additional monitoring
    • Generic: generic
    • Biosimilar: biosimilar
    • Conditional approval: conditional approval
    • Exceptional circumstances: exceptional circumstances
    • Accelerated assessment: accelerated assessment
    • Orphan medicine: orphan medicine (yes or no)
    • Marketing authorisation date: date of marketing authorisation
    • Date of refusal of marketing authorisation: date of refusal of marketing authorisation
    • Marketing authorisation holder/company name: marketing authorisation holder/company name
    • Human pharmacotherapeutic group: human pharmacotherapeutic group
    • Vet pharmacotherapeutic group: veterinary pharmacotherapeutic group
    • Date of opinion: date of opinion
    • Decision date: decision date
    • Revision number: revision number
    • Condition / indication: condition/indication
    • Species: species (if veterinary)
    • ATCvet code: Anatomical Therapeutic Chemical Classification System for veterinary use
    • First published: first published
    • Revision date: revision date
    • URL: URL

Scripts

• ./scripts: contains the R scripts used in the analysis
  • analysis.R: contains the code used to analyze the data and generate the results and figures presented in the article
  • data-merging-and-cleaning.R: contains the code used to clean and merge the raw data from the ./data/cost_hospital_level directory

Figures

• ./figures: contains the figures generated by the analysis.R script in their full resolution

Citation

If you find this repository helpful, please consider citing it as follows:

@article{Kostadinov_2024, 
  title={Availability and Access to Orphan Drugs for Rare Cancers in Bulgaria: Analysis of Delays and Public Expenditures}, 
  volume={16}, 
  rights={http://creativecommons.org/licenses/by/3.0/}, 
  ISSN={2072-6694}, 
  url={https://www.mdpi.com/2072-6694/16/8/1489}, 
  DOI={10.3390/cancers16081489}, 
  number={8}, 
  journal={Cancers}, 
  author={Kostadinov, Kostadin and Popova-Sotirova, Ivelina and Marinova, Yuliyana and Musurlieva, Nina and Iskrov, Georgi and Stefanov, Rumen}, 
  year={2024},
  pages={1489}, 
  language={en} 
}