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CLIENT CASE STUDIES

Biotech, Product Launch

With the upcoming launch of a major drug in the US market, the company was looking to ensure Contracting, Transactional, and Government Pricing capabilities were enabled ahead of the product launch. ​

CHALLENGES

  • Organizational and Business Process Gaps: the company did not have an existing team inhouse to manage chargebacks processing operations (previously outsourced functions)​
  • Wholesaler Connectivity: the company did not have direct connections set up for EDI transmissions with wholesalers​
  • System Risks / Impacts: a single platform was being used for existing products as well, and changes could impact current business, creating risk / compliance concerns​
  • Data: No existing data, trading partners, or contracts to use or leverage for testing​
  • Launch Schedule: Due to timing of the PDUFA date and certain dependencies (e.g. contract readiness), the schedule to perform system activities was limited​

SOLUTION

Marbls provided support to ensure that the company was operationally ready for the major product launch in the US:
  • Enabled all process areas including Membership Management, Institutional Contracting, Chargebacks, Admin Fee processing, and Government Pricing in Model N system​
  • Leveraged industry best practices to drive simplifications and meet timeline​
  • Heavy focus on training and SOPs to ensure readiness of the team​
  • Worked between client and wholesalers to setup EDI infrastructure and transmissions​
  • Used prior experience and industry knowledge to utilize “mock data” and simulate contract scenarios for testing due to lack of data​​

RESULTS

  • Project Go Live and technical readiness one month prior to FDA approval date​
  • First Price Notifications for contract pricing and eligibility sent to wholesalers and first sales made one month after FDA approval date​
  • Full end-to-end chargebacks processing with no disruptions to processing of sales for new product​
  • Transactions available for Government Pricing calculations to ensure smooth start to Medicaid, VA, and other Government programs​
  • End to end verification of Sales data post launch to confirm assumptions of mock data​
  • Full capabilities designed to also support future product launches​​

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With the upcoming launch of a major drug in the US market, the company was looking to ensure Contracting, Transactional, and Government Pricing capabilities were enabled ahead of the product launch. ​

  • Organizational and Business Process Gaps: the company did not have an existing team inhouse to manage chargebacks processing operations (previously outsourced functions)​
  • Wholesaler Connectivity: the company did not have direct connections set up for EDI transmissions with wholesalers​
  • System Risks / Impacts: a single platform was being used for existing products as well, and changes could impact current business, creating risk / compliance concerns​
  • Data: No existing data, trading partners, or contracts to use or leverage for testing​
  • Launch Schedule: Due to timing of the PDUFA date and certain dependencies (e.g. contract readiness), the schedule to perform system activities was limited​
  • Project Go Live and technical readiness one month prior to FDA approval date​
  • First Price Notifications for contract pricing and eligibility sent to wholesalers and first sales made one month after FDA approval date​
  • Full end-to-end chargebacks processing with no disruptions to processing of sales for new product​
  • Transactions available for Government Pricing calculations to ensure smooth start to Medicaid, VA, and other Government programs​
  • End to end verification of Sales data post launch to confirm assumptions of mock data​
  • Full capabilities designed to also support future product launches​​

Marbls provided support to ensure that the company was operationally ready for the major product launch in the US:

  • Enabled all process areas including Membership Management, Institutional Contracting, Chargebacks, Admin Fee processing, and Government Pricing in Model N system​
  • Leveraged industry best practices to drive simplifications and meet timeline​
  • Heavy focus on training and SOPs to ensure readiness of the team​
  • Worked between client and wholesalers to setup EDI infrastructure and transmissions​
  • Used prior experience and industry knowledge to utilize “mock data” and simulate contract scenarios for testing due to lack of data​​

Marbls partners with pharmaceutical and medical device and diagnostic manufacturers to provide practical, innovative services that address complex pricing, contracting and commercial excellence needs — driving the path of critical drugs, devices, and diagnostics to market. We invest in the long-term success of our clients by investing in our employees. As a team with world-class experience and a client-first philosophy, we create long term relationships based on success, service and trust. Our approach is results driven, hands-on and flexible to address the unique internal and external dynamics impacting our clients.

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