Legal & Regulatory > Brazil > HTA Dossiers in Brazilian Pharma

Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on HTA Dossiers and Data requirements in the Brazilian pharma market today. Buy The Pharma Legal Handbook: Market Access & HTA – Brazil here for £359.

HTA DOSSIERS

1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link)

Yes, but unfortunately only in Portuguese:

• Proposal Application Guideline.
• Guideline related to Cost-effectiveness.

2. Have local Authorities published guidelines surrounding value assessment dossiers? (If yes please add link)

Yes, but unfortunately only in Portuguese:

• Proposal Application Guideline;
• Methodological Guidelines – Budgetary Impact Analysis – Manual for the Brazilian Health System;
• Methodological Guidelines – Systematic Review and Meta-Analysis of Diagnostic Accuracy Studies.

3. Have local authorities published official guidelines surrounding the submission of value assessment dossiers? (If yes please add a link)

Yes, but unfortunately only in Portuguese.

• Document submission to the Ministry of Health

4. Describe the overall process of preparing and submitting a HTA dossier in your country.

Regarding the preparation of the dossier, it is mandatory that the initial document be the letter properly addressed to DGITS/SECTICS/MS, containing identification of the applicant, the subject (name of the technology and indication requested), the place, date and signature. It is also required that the application form is completed accurately, printed, signed, and then included in the dossier. (Further details on the required documents are described in item VI.5 below.)

After gathering all the required documents, the dossier must be submitted to the Secretariat of Science, Technology, Innovation and Health Complex (“SECTICS”) through the Digital Register of the Ministry of Health, which can be accessed using this link. The system only allows files in pdf, html, xls and xlsx format, with up to 50MB.

5. Describe the overall content of the HTA dossier in your country.

The dossier for requesting the incorporation of technology into SUS must contain:

• Letter:
  • The letter must be on the first page of the process and must contain: identification of the applicant; identification of the recipient (DGITS/SECTICS/MS); subject (name of technology and indication requested); place, date and signature.
• Applicant documentation
  • For legal entities: articles of Incorporation of the company (notarized copy); and power of attorney of the applicant (in case the person responsible for signing the application is not included in the articles of incorporation).
• Application form
  • The application form must be filled out and submitted using this link.
• Main document
  • The document must contain: description of the disease/health condition related to the use of the technology; description of the technology; description of the scientific evidence of the technology compared to the one(s) already available at SUS (Systematic Review or Technical-Scientific Opinion); economic evaluation study from the perspective of SUS; budgetary impact analysis; bibliographic references; appendix (copy of package insert or instructions for use approved by ANVISA).

• Scientific studies
• Foreign language articles
  • Foreign articles not in English or Spanish must contain a sworn translation into Portuguese.

• Economic and budget impact studies
  • The studies must be available in .xlsm (Excel Macro Enabled Workbook File) or .trex (TreeAge) formats.

6. Which are the questions to focus on when preparing a HTA dossier in your country?

The dossier should focus on demonstrating to Conitec the advantages of the HTA that justify its incorporation into the Brazilian public health system, such as its efficacy, safety and, especially, cost-benefit.

7. Which are the other strategic considerations to take into account when preparing a HTA dossier in your country?

The same considerations mentioned in item VI.6 above.