HTA/Payer Real-World Data Context to Support Outcomes-Based Managed Entry Agreements (OBMEA) / Conditional Reimbursement with Data Collection

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In this section, please provide information about:

1. Your national healthcare system organisation:

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2. Your national healthcare system funding:

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Please answer the questions below and provide resources or references wherever possible.

1. Does each patient in your health system have a unique patient ID that enables data linkage?

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2. How is access to data governed (e.g. legislation, data permits, register of uses)? Are there differences in governance between national and regional datasets?

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3. What other information do we need to know about data governance and accessibility in your health system?

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4. Is there a centralised source or service where information is available about the use of health system data in OBMEA or conditional reimbursement? If yes, please list the source or provide a link.

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5. Is there a service available to help data users identify suitable datasets or data sources for secondary use, such as feasibility assessments for a specific OBMEA/conditional reimbursement purpose?

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6. Can prescribing records be linked with the indication? Please answer separately for:

a. Medicines dispensed from community pharmacies (e.g., outpatient prescriptions, electronic prescriptions):

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b. Medicines administered in hospital settings (e.g., inpatient treatments, ward-based medication records):

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c. If yes, how is the linkage made (e.g., via diagnosis codes, structured fields, free text)?

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d. If no, what are the main barriers (e.g., technical, legal, organisational)?

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Please answer the questions below and provide resources or references wherever possible.

1. Are there secure processing environments in your country that enable access to health data for approved secondary uses, such as HTA or payer evaluations? If yes, please list the environments or provide a link to more information

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2. How is access to data governed (e.g. legislation, data permits, register of uses)? Are there differences in governance between national and regional datasets?

Upload any supporting materials

3. What other information do we need to know about data governance and accessibility in your health system?

Upload any supporting materials

4. Is there a centralised source or service where information is available about the use of health system data in OBMEA or conditional reimbursement? If yes, please list the source or provide a link.

Upload any supporting materials

5. Describe any collaboration your country/region is undertaking to enable HTA/Payer health data access across borders?

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1. Outline any major initiatives planned or underway to improve data infrastructure or accessibility in your country.

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2. Any other comments?

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I understand that the information provided will be reviewed by the RWE4Decisions Secretariat and considered for publication on the RWE4Decisions website or used to inform multi-stakeholder discussions on enhancing these Actions.

HTA/Payer Real-World Data Context to Support Outcomes-Based Managed Entry Agreements (OBMEA) / Conditional Reimbursement with Data Collection

1. Contact Information

2. National Healthcare System Context

3. National Health Data Landscape

4. Data Access and Use

5. Additional information