LONDON, UK, July 12, 2013 — The development of personalized medicine in the United Kingdom and internationally is being thwarted by regulation and pricing systems that are not set up to enable its widespread adoption, according to a new report — “Realizing the Potential of Stratified Medicine” — from the Academy of Medical Sciences (AMS), the British equivalent of the Institute of Medicine.
UW School of Pharmacy Professor Lou Garrison (pictured at left), a health economist, contributed to the report as a member of the Oversight Group. He led the subgroup focusing on pricing and reimbursement issues from a health system perspective. Garrison is on sabbatical leave from the UW as Visiting Senior Research Fellow at the Office of Health Economics (OHE) in London, a pharmaceutical policy think tank.
The aim of personalized medicine (called “stratified medicine” in the UK) is to identify how genes and other biomarkers can be used to individualize drug therapies to make drugs safer and more effective for each person. This tailored approach can help healthcare providers optimize the use of targeted prescription medication therapies. For example, a genetic test has been developed for patients with HIV to check their compatibility with an anti-HIV medication known as Ziagen (abacavir). Ziagen has been found to cause severe reactions in 2 to 9 percent of patients with a particular genetic makeup, who are now prescribed alternative treatments.
However, despite such advances in personalized medicine research and technology, existing systems for clinical development, regulation, pricing and reimbursement are slowing the development and adoption of personalized medicine. “The barriers and solutions identified in this report apply to the United States and other developed countries as well as the UK,” said Garrison.
Professor Sir John Bell, past AMS president and chair of the AMS-sponsored group that produced the report, also said that progress in personalized medicine will require the collection, storage, and analysis of significant amounts of data regarding the molecular and genetic basis of diseases. To that end, the report emphasizes a need to harmonize and link databases and biobanks (places that store biological samples for use in research), both nationally and internationally.
Among other things that the report recommended are for the system to change so that medication prices reflect the changing value of a product, thus providing a greater incentive to develop personalized medicines. In addition, it highlights an urgent need to incentivize the generation of evidence of reliable and accurate diagnostic tests. It notes the need to minimize the risk presented by the use of unregulated, “generic” in-house tests.
Working closely with OHE Director Professor Adrian Towse, Garrison contributed particularly to Recommendations 14 and 15 in the AMS report, which suggest a new possible way to reward the innovation inherent in the combination of the medicine and companion diagnostic that are both needed for targeted disease treatment. Both need to be rewarded in proportion to their contribution to value in order to support the evidence generation necessary for personalized medicine. The recommendations also suggest that reimbursement needs to be adjustable as new evidence becomes available on health and cost outcomes.
“My contribution to this report builds on work on value-based pricing and reimbursement in personalized medicine that my colleagues and I in the UW Pharmaceutical Outcomes Research and Policy Program have been doing for the past nine years,” said Garrison, who is also part of the UW Center for Genomics and Healthcare Equality.
Ultimately, the report concludes that academia, healthcare systems, industries, research funders, regulators, health technology assessment bodies, and patient groups in the United Kingdom and elsewhere must come together to take forward the recommendations. Garrison will be involved in a follow-up stakeholder meeting in London in early September. “Personalized medicine holds great promise as a global public good to benefit all of humankind in the coming decades,” said Garrison. “I hope these recommendations can speed up its development.”
- AMS Press Release
- Health Service Journal
- Read the full report, “Realizing the Potential of Stratified Medicine” (PDF).