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Case Study: Market Access Support for an Oncology Drug with Agency for Care Effectiveness (ACE) in Singapore


Case Study: Market Access Support for an Oncology Drug with Agency for Care Effectiveness (ACE) in Singapore

Artixio’s regional Market Access Team in Singapore helped a biotech company that has developed a new drug for an oncology indication with the Agency for Care Effectiveness (ACE) submission. This project involved a strategic approach to generate clinical, safety, and economic evidence, aligning with ACE guidelines. Additionally, a local Singapore consultant was engaged to facilitate the end-to-end submission process.


Project Objective: Market Access Support for an Oncology Drug with Agency for Care Effectiveness (ACE) in Singapore

The primary objectives were as follows:

  1. ACE Submission for an Oncology Drug: The goal was to prepare a comprehensive submission to ACE, ensuring that the drug met the necessary criteria for funding and reimbursement.

  2. Clinical Evidence, Safety, and Economic Evidence Generation: The project aimed to compile robust evidence supporting the drug’s efficacy, safety, and cost-effectiveness.

  3. Engage a Local Singapore Consultant/Partner: A local expert was sought to strategize and execute the entire submission process, considering ACE’s specific requirements.


Project Phases:

The project unfolded in three distinct steps:

Step 1: Review, Engage & Initiate

In this initial phase, the following activities took place:

Review:

  • ACE Regulatory Guidelines and Evaluation Methods: A thorough review of ACE’s regulatory guidelines was conducted. This included understanding the application process, evaluation criteria, and assessment methods.

  • Company’s Product and Related Materials: The drug’s preclinical and clinical evidence status, as well as its regulatory standing, were assessed.

Pre-submission Process (Section 1):

  • Application Initiation: The application process was initiated, marking the formal start of the submission journey.

  • Presubmission Meeting and Consultation with ACE: Key stakeholders engaged in a presubmission meeting with ACE. This allowed for early alignment and clarification of expectations.

  • Recommendations:

  • Identified gaps during the review and engagement process were addressed.

  • Actionable steps were recommended to enhance the submission.

Outcome of Step 1:

  • Comprehensive Understanding of the Application Process: The team gained insights into the entire submission process, including critical milestones.

  • Actionable Insights and Alignment: Recommendations bridged gaps identified during the review. The submission strategy was aligned with ACE’s feedback.

As an additional activity during Step 1, Artixio conducted Primary Research to assess the landscape:

  • Mapping and Engaging Key Stakeholders:

  • Subject Matter Experts (SMEs)

  • Key Opinion Leaders (KOLs)

  • Patient organizations

  • ACE representatives

  • Synergies were explored to develop a robust submission strategy.


Step 2: Prepare and Submit

This phase involved meticulous preparation and submission of evidence:

Systematic Literature Review (Section 2):

  • A comprehensive literature review was conducted to gather relevant clinical evidence.

  • Safety data were synthesized to support the drug’s profile.

Economic Evaluation (Section 3):

  • Cost-Effectiveness Analysis: The economic impact of the drug was assessed, considering its benefits and costs.

  • Cost Minimization: Strategies to minimize costs while maintaining efficacy were explored.

  • Local Clinical Practice Utilization:

  • The drug’s fit within local clinical practice was evaluated.

  • Consideration was given to its practical implementation.

Financial Impact (Section 4):

  • The financial implications of funding the drug were analyzed.

  • Final Review and Submission:

  • All evidence and evaluations were meticulously reviewed.

  • The submission package was prepared for ACE.


Step 3: Clarify and Resubmit

This step was contingent on ACE’s initial decision:

  • Post-Decision Meeting:

  • A meeting was requested to understand any evidence gaps or concerns raised by the Drug Advisory Committee (DAC).


In summary, the project successfully culminated in the submission of evidence and evaluations to ACE, paving the way for potential funding and patient access to the oncology drug.

 

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