One of the main challenges for the development and implementation of precision medicine is the lack of reimbursement for genetic tests in most countries. There are many examples of clinically useful information available through newly developed genetic tests. While some health insurance plans in the US cover the cost of genetic testing when recommended by a physician, other forms of genome sequencing are usually not included, especially not in the EU and most Asian countries.
Without question, genomic medicine will revolutionize clinical practice in the coming years. As such, it is essential that genetic testing reimbursement processes are improved, particularly for whole-genome sequencing. To change the status-quo, recently, Shivom, together with other entrepreneurs from all over the EU including the Netherlands, Italy, France, Germany, UK, and Hungary joined forces with experts from the healthcare industry, including insurers and policymakers during a policy perspective meeting of the European Commission in The Hague/Netherlands.
A hot topic of this policy perspective meeting was the reimbursement of genetic tests because uncertain or inadequate reimbursement by public and private payers of genetic tests creates one of the most significant barriers to the development and adoption of precision medicine. We at Shivom think that genome sequencing, in general, should be subject to reimbursement, including direct to consumer (DTC) genetic testing, which enables consumers or patients to access their genetic information directly from a testing company.
Dr. Axel Schumacher, CEO of Shivom: “To have access to your DNA sequence may be necessary for many reasons, including for predicting individual predispositions to diseases or conditions, or for preventive, therapeutic, reproductive, or life planning measures. Lack of a positive reimbursement decision disincentivizes patient participation and creates a barrier to the use of modern genomic medicine by authorizing clinicians and patients. As long as a whole genome sequencing test is scientifically valid (of high quality), it should be reimbursed; even more so because it has to be done only once in a person’s life.”
At Shivom, we strongly believe that now is the time to foster a new era of precision medicine through policy changes that empower patients, researchers and healthcare providers to work together toward development of personalized care.