Case Studies

Case Study 1

Complete Value Dossier

A UK based pharmaceutical (GW Pharmaceuticals) needed to outsource development of a Value Dossier in support of its market access efforts in the United States for its new drug indicated for childhood epilepsy (Epidiolex®). MYO developed the reimbursement Value Dossier in cooperation with Strategic Health Resources (Los Angeles, CA) with strict adherence to the Academy of Managed Care Pharmacy (AMCP) Guidelines, which are up to the highest academic standards and are designed to maintain a very high level of objectivity. Epidiolex became the first drug to get FDA approval for Dravet syndrome in the United States.

Case Study 2

Health Policy Advisory in support of HTA capacity building. A World Bank project

In a project funded and managed by the World Bank, MYO consultants were part of a international group of experts that provided Technical Assistance to the Albanian Government, to support capacity building for Health Technology Assessment (HTA).
  • Evaluated baseline situation in relation to health technology, defined range of technologies to be studied
  • Evaluated and analyzed national HTA capabilities and identified potential partners for training and capacity building
  • Elaborated a strategy for the institutionalization of HTA
  • Prepared draft HTA standards
  • Supported knowledge transfer and commissioning of HTA software
  • Designed and conducted HTA and evidence-based medicine training

Case Study 3

Systematic Literature Review (SLR), meta-analysis and publication

A US-based medical device manufacturer (Medivance) was interested to assess the potential for its body-cooling technology to improve clinical and economic outcomes in patients with neurogenic fever due to stroke or traumatic brain injury
  • We conducted a systematic literature review (SLR) of the clinical and health economics literature, to document the impact of thermoregulation in treating patients with neurogenic fever
  • We used findings to conduct a statistical meta-analysis
  • At the client’s request, we co-authored a clinical article presenting relevant findings
  • We ensured publication in one of the most prominent international medical journals in the area of stroke [D Greer, S Funk, N Reaven, M Ouzounelli, G Uman. Impact of fever on outcome in patients with stroke and neurologic injury. Stroke 2008;39(11):3029-35]

Case Study 4

Systematic Literature Review and custom-made clinical Database in support of client's needs

As subcontractors to a California-based consulting group and on behalf of an insulin pump manufacturer, MYO conducted a systematic literature review (SLR) on diabetes, including disease incidence and demographics, as well as treatments, their complications and associated costs and use of resources. We used this input to populate a comprehensive database, which enabled US diabetes physicians, as well as the client's own Marketing, Sales and R&D staff to have a global overview of literature findings in a tiny fraction of the time it would normally take. One of the most useful features of this database was the inclusion of standardized 1-page summaries for all clinical studies involving the client's technology.