30 November 2009

Genetic testing – to the masses!

American healthcare providers are launching a new program designed to select the most cost-effective and expedient from the flow of genetic tests. Per Lofberg, chairman and co–founder of Pharma Capital Ventures, has set a goal to expand the access of the general population to genomic medicine by overcoming one of the most serious barriers - the solvency of insurance companies or patients themselves in relation to the ever-increasing number of genetic tests entering the medical services market. To achieve this goal, he founded the company Generation Health, designed to "sift" all new genetic tests – from predicting individual risk of heart disease or cancer to tests that determine the effectiveness of the drug on the patient. Lofberg's main goal is to find and select tests that provide maximum medical effect and cost–effectiveness.

To begin with, in cooperation with another company, CVS Caremark, which serves insurance payments to almost 50 million people, Generation Health plans to analyze the effectiveness of 17 drugs (including those used in the treatment of heart disease, cancer and HIV infection), depending on the individual genetic characteristics of patients, and identify tests that CVS will provide to my clients. "Now there is an opportunity to make genetic analyses available to all CVS Caremark customers, and this is a wonderful prospect," says Raju Kucherlapati, a geneticist at Harvard Medical School in Boston.

To date, there are a number of genetic tests that can significantly influence medical decision-making by the attending staff. Such a test, for example, can tell you exactly which drug and in what amount should be prescribed to the patient. However, at the moment only a limited number of genetic tests are widely used. First of all, this is due to economic considerations. On the sidelines of one of the conferences on personalized medicine, forum participants reported that insufficient financial coverage is the main obstacle to the spread of pharmacogenomics. There is also a general skepticism on the part of clients regarding the clinical effectiveness and cost-effectiveness of tests. And as for medical companies, not only do they not receive any compensation yet, but they may even lose income, since tests may show that some procedures are not necessary. In addition, the variety of genetic tests known today makes it difficult for patients and doctors to choose and use them.

In some cases, genetic tests can reduce treatment costs by reducing the number of recommended medications or procedures that are obviously ineffective for the patient. But, at the same time, the costs may increase. According to experts from the UK, it is cheaper to prescribe the blood-thinning drug heparin to all patients undergoing surgery than to conduct genetic tests for a tendency to thrombosis. On the other hand, the drug Herceptin, used in the treatment of breast cancer, is most effective only in patients with an increased concentration of a special protein – "human epidermal growth factor receptor 2", and is cost-effective if doctors can identify a small percentage of patients susceptible to the drug. Such testing has already become a routine procedure in the treatment of breast cancer.

The information required to classify a test into one or another accessibility category is complex and often contradictory. For example, the US Food and Drug Administration (FDA) in 2007 included in the label of the antithrombotic drug warfarin information that there are two variants of one of the genes that affect the patient's sensitivity to the drug. And this is despite the fact that there are still disputes among doctors, insurers and other specialists about whether genetic testing is effective and cost-effective compared to traditional methods of controlling the reaction to warfarin.

According to Lofberg, genetic testing is a rapidly growing industry, but still extremely disorganized from the point of view of consumers of medical services. He compares his company's approach to pharmacological efficiency management, which seriously declared itself on the market of medicines 15 years ago and offered to select the most profitable funds and develop tools to reduce medical errors and inappropriate procedures on the part of doctors. The company intends to use the data of scientific research and statistics of insurance payments to develop models for the use of genetic tests, and then to provide appropriate services to its customers, insurers and employers.

The world's pharmaceutical giants are experiencing quite fierce competition from each other, so they have to constantly be in search of new services and offers, including in the field of pharmacogenomics. Medco has already entered this field, funding research on the genetic testing of warfarin and the anti–cancer drug tamoxifen - some women have genetic characteristics that reduce the effectiveness of assimilation of the active form of the drug. The company has also developed a special computer program that automatically recommends genetic tests if a patient is prescribed warfarin or tamoxifen.

Generation Health creates a network of laboratories that perform a variety of tests. The company also develops information and training materials for patients and medical professionals.

One of the tests that Generation Health is going to study is of great interest – it is a test for the antithrombotic drug Plavix, prescribed to patients with a coronary stent. In order for the drug to work, it must be metabolized into an active form in the body. A recent study published in the New England Journal of Medicine found that almost 30 percent of Europeans are carriers of a malfunctioning gene responsible for the production of a drug-metabolizing enzyme, which increases their likelihood of heart attack and death after surgery. This drug is widely used in medical practice, and a preliminary check of the feasibility of its use can give a noticeable clinical effect.

Ruslan Kushnir
Eternal Youth Portal www.vechnayamolodost.ru based on Technology Review: Enhancing Access to Genomic Medicine30.11.2009

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