Belgian Hepatitis C Registry

The reimbursement conditions for 6 specific types of antiviral hepatitis C medication for the treatment of chronic hepatitis C patients will be extended and 2 new ones will be added[1]. This extended reimbursement will be active starting from 1.1.2017 and is agreed upon for a period of 2 years between RIZIV-INAMI and the 5 involved pharmaceutical companies via a contract of type Art.81 signed with the RIZIV-INAMI..

The hepatitis C antiviral medication is on the list of Chapter 4 medication, which requires the treating physician to fill out a dedicated form to apply for reimbursement. Apart from this information, the treating physician is also obliged to participate in the registration of follow-up data of his/her patients using this antiviral hepatitis C medication.

[1] The 8 pharmaceuticals involved are HARVONI, EXVIERA, VIEKIRAX, DAKLINZA, OLYSIO, SOVALDI, EPCLUSA (new) and ZEPATIER (new).

Data and Resources

National Institute for Health and Disability Insurance

Field	Value
Modified	2020-07-20
Release Date	2018-03-27
Identifier	e7b305c8-433b-43b8-8952-82f162dffdba
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Belgian Hepatitis C Registry
Name or abbreviated title of the project where available	HCV
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	National Institute for Health and Disability Insurance

Commissioner(s)

Organisation that commissioned this project
Name of organisation	National Institute for Health and Disability Insurance
Website(s) of organisation	Website

Source(s) of Monetary or Material Support

Organisation (1) providing support
Name of organisation (1)	AbbVie

Organisation (2) providing support
Name of organisation (2)	Bristol-Meyers-Squibb

Organisation (3) providing support
Name of organisation (3)	Gilead Sciences

Organisation (4) providing support
Name of organisation (4)	Janssen Pharmaceutica

Organisation (5) providing support
Name of organisation (5)	Merck Sharp Dohme

Governance

Governance
Is there a Steering / Accompanying committee?	No information available

General information

General information
Project description	The reimbursement conditions for 6 specific types of antiviral hepatitis C medication for the treatment of chronic hepatitis C patients will be extended and 2 new ones will be added[1]. This extended reimbursement will be active starting from 1.1.2017 and is agreed upon for a period of 2 years between RIZIV-INAMI and the 5 involved pharmaceutical companies via a contract of type Art.81 signed with the RIZIV-INAMI.. The hepatitis C antiviral medication is on the list of Chapter 4 medication, which requires the treating physician to fill out a dedicated form to apply for reimbursement. Apart from this information, the treating physician is also obliged to participate in the registration of follow-up data of his/her patients using this antiviral hepatitis C medication. [1] The 8 pharmaceuticals involved are HARVONI, EXVIERA, VIEKIRAX, DAKLINZA, OLYSIO, SOVALDI, EPCLUSA (new) and ZEPATIER (new).

Therapeutic area
Disease	Virus Diseases Digestive System Diseases

Objective of the project
Main objective of the project	Together with the Chapter 4 data, the follow-up data will be analysed to assess the effectiveness of each type of reimbursed antiviral hepatitis C medication.
Additional information	No additional information available

Scope
Scope	Pharmacoeconomic Therapy

Legal basis

Type of legal basis
Type of legal basis	Unknown

Design of the project

Data transfer frequency
Data transfer frequency	Unknown

Method of data transfer
Data transfer method(s)	Unknown

Sites involved in the project

Type of site(s)
Care Provider	Unknown

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Unknown
Specialty of physicians involved (encoding) in the project	Unknown
Type of paramedical professionals involved (encoding) in the project	Unknown

Informed consent

Informed consent
Are subjects informed?	No information available
How are subjects informed?	No information available
Do subjects have to give their consent?	No information available
How do subjects give their consent?	No information available
Is there a procedure to provide subjects the ability to consult their registered information?	No information available
Is there a procedure to provide subjects the ability to correct their registered information?	No information available
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	No information available

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No information available

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No information available

Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission)
Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)	No information available

Data dictionary

Classifications and Terminology
Name	Unknown

Data quality

Data quality
First year for which data is available	No information available
Procedures for checking and validating the source data	No information available
Data compilation process	No information available
Punctuality for the most recent completed data collection: the data collection was completed	No information available
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	No information available
Extent of the item non-response	The rate of item non-response is not known or unacceptably high (>50%)
Extend to which the collected data are comparable across the Belgian regions	Comparability across the Belgian areas is unknown
Comparable or reconcilable over time	Comparability over time is unknown
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	No information available
Additional information	No additional information available

Data storage

Data storage
The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?	Yes
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	No information available

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