Molecular diagnostics are what make medicines personal. Diagnostics are how drugs can be made “safer” -- through “safe use.” They make the “four rights” (right medicine for the right patient in the right dose at the right time) possible. And the four rights lead to lower costs through better outcomes.
Case in point: Warfarin, the most widely used anti-coagulant medication in the world. Prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes, patients can display markedly different responses to the drug. Doses vary enormously between individuals; so achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, while those who receive too low a dose may remain at risk of life-threatening blood clots. Via molecular diagnostics specifically called out in the amended FDA label, physicians will prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And this “safer use” is estimated to save $1.1 billion annually. And that’s the mid-range.
But diagnostics are in trouble. And that trouble comes in the form of skittish reimbursement and ambiguous regulation.
On the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial.
Case in point: Herceptin. Studies show that Her2 testing for breast cancer delivers savings that are 65x its cost. For a very powerful presentation on the economics of the Her2 test and molecular diagnostics in general see here.
In short, reimbursement should be based on value rather than activity. This is an essential (you should excuse the expression) paradigm shift.
On the regulatory front clarity and predictability are required. FDA approved the molecular diagnostic for warfarin based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. But guidance on diagnostic approvals are vague as is the pathway. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
Unless and until the reimbursement and regulatory issues are addressed, investment in developing these tools will languish, patients will needlessly suffer and our healthcare system will continue to be burdened by unnecessary costs.
If the popular culture clarion call is for “safer drugs,” then the path forward shouldn’t include beating up Big Pharma or reversing FDA preemption authority – it’s via molecular diagnostics.
Case in point: Warfarin, the most widely used anti-coagulant medication in the world. Prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes, patients can display markedly different responses to the drug. Doses vary enormously between individuals; so achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, while those who receive too low a dose may remain at risk of life-threatening blood clots. Via molecular diagnostics specifically called out in the amended FDA label, physicians will prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And this “safer use” is estimated to save $1.1 billion annually. And that’s the mid-range.
But diagnostics are in trouble. And that trouble comes in the form of skittish reimbursement and ambiguous regulation.
On the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial.
Case in point: Herceptin. Studies show that Her2 testing for breast cancer delivers savings that are 65x its cost. For a very powerful presentation on the economics of the Her2 test and molecular diagnostics in general see here.
In short, reimbursement should be based on value rather than activity. This is an essential (you should excuse the expression) paradigm shift.
On the regulatory front clarity and predictability are required. FDA approved the molecular diagnostic for warfarin based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. But guidance on diagnostic approvals are vague as is the pathway. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
Unless and until the reimbursement and regulatory issues are addressed, investment in developing these tools will languish, patients will needlessly suffer and our healthcare system will continue to be burdened by unnecessary costs.
If the popular culture clarion call is for “safer drugs,” then the path forward shouldn’t include beating up Big Pharma or reversing FDA preemption authority – it’s via molecular diagnostics.
