QR Group analyzes regulatory impacts and what companies need to consider in the commercialization of gene, cell and tissue therapies
The Drug Market Regulation Chamber (CMED) has started a targeted consultation on the pricing of advanced therapies — such as gene, cell, and tissue therapies. The measure aims to receive contributions from the regulated sector, civil society and the scientific community to structure specific guidelines for these highly complex products.
QR Group, a specialist in health product regulation, explains the impacts of this public consultation and guides companies on how to prepare for the next steps in the economic regulation of these therapies in Brazil.
What is at stake in the targeted consultation?
The consultation promoted by CMED aims to subsidize the construction of a specific technical standard for pricing advanced therapies, which involve highly innovative technologies, with high cost and application in conditions of difficult treatment.
Among the points raised are:
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Alternative pricing models based on therapeutic value;
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Possibility of pay-for-performance;
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Evaluation of long-term effectiveness and cost-effectiveness;
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Integration with real-life data and pharmacoeconomics.
The complexity of these therapies requires specific criteria for regulatory and economic evaluation, which consider not only the cost of production, but the clinical and social impact of the innovations.
Challenges for companies that work with gene and cell therapies
The advancement of the economic regulation of advanced therapies will bring new challenges to companies in the sector:
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Preparation of more robust pricing dossiers, with clinical and economic data;
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Need to adapt to CMED criteria, distinct from conventional medicines;
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Discussion of innovative reimbursement models, such as installment or result-based payments;
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Close monitoring of effectiveness in real use (real world evidence).
To ensure the commercial viability of these therapies in Brazil, it will be essential to build solid technical arguments and adopt regulatory strategies in line with the new requirements.
How QR Group can support companies in the advanced therapies landscape
QR Group offers specialized technical support for companies that work with highly complex therapies. Our services include:
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Strategic consulting for pricing and submission to CMED;
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Preparation of technical-economic dossiers and opinions of therapeutic value;
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Support in the relationship with regulatory authorities, such as ANVISA and CMED;
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Monitoring of public consultations and technical contributions.
With operations focused on innovation, compliance and market viability, QR Group helps your company transform cutting-edge technology into safe and sustainable access for patients.
Talk to QR Group
Does your company work with advanced therapies and need to understand the requirements of CMED?
Talk to QR Group and get full support in pricing, dossiers and market access strategies.
Source: QR Group
