You Should Know:
Genetic technologies have a rapidly expanding role in medical care. Scientific advancements in genetic medicine are enabling better means to diagnose disease, to predict risk, and to direct and personalize treatment.

• Some testing, such as prenatal or newborn genetic screening, is already part of mainstream medicine. The use of genetic technologies in other areas of disease prediction and treatment is beginning to emerge.
• Genetic testing to predict individual risk of developing certain diseases, such as breast or colon cancer, can greatly reduce the risk of developing disease by timely intervention strategies.
• Genetic markers also can be used to predict an individual’s response to drug therapy. This “personalized medicine” approach aims to direct specific drug therapy only to individuals who can respond to it and avoid it in individuals who cannot benefit. Results include improved drug efficacy; less delay in initiating effective therapies; the avoidance of ineffective therapies and their harmful side effects in individuals who cannot benefit; and potential cost savings when compared to the usual “trial and error” approach to drug treatment. Examples include:
  • In some children with leukemia, thiopurine s-methyltransferase (TPMT) testing can identify patients who are poor metabolizers of common anticancer drugs and may develop severe side effects if they receive standard doses of drugs.
  • HER2 testing can identify breast cancer patients who would benefit from new forms of treatment.
  • The genetic makeup of the hepatitis C virus influences the duration of drug therapy. However, increased use of genetic testing and genetic-based therapies also poses challenges to the health care system.
• Genetic medicine is developing quickly, outpacing physician and patient knowledge, and the availability of trained genetic clinicians.
• Genetic medicine can be costly.
• The public has favorable attitudes about genetic testing, but patients remain concerned about the privacy and appropriate use of their genetic information.

Trends at a glance

• Availability of genetic technologies and their adoption by clinicians and consumers is increasing dramatically. We have seen:
  • A 10 percent increase in the availability of new genetic tests every year.¹ There are now 1,000 conditions for which genetic tests are available.²
  • A 20 percent increase in annual use of genetic-based diagnostic tests, vs. 1-3 percent for non-genetic tests.³
  • A rapid increase in the availability of new biologic medications. Since 2000, biologics represent 25 percent of all new FDA-approved drugs.⁴
• Genetic science is complex and its correct use in clinical practice is challenging for most clinicians. Also, consumers have difficulty understanding how genetic technologies can factor into their care.
  • There is a shortage of well-trained genetic medicine clinicians with fewer than 2,000 certified genetic counselors in United States. ⁵
  • 72 percent of physicians not specializing in genetics rate their knowledge of genetics as fair to poor.⁶
  • Fewer than 7 percent of Americans are scientifically literate.⁷
• Genetic technologies are generally expensive, and their costs tend to rise more rapidly than their conventional counterparts.
  • Some newer diagnostic tests are very expensive. A full-sequence DNA analysis of breast cancer genes, BRCA1 and BRCA2, costs $2,600.
  • Per-prescription costs of biologic drugs increased 29 percent from 2001 to 2003 compared to 16 percent for conventional drugs during the same time period.⁸

The Aetna difference
Aetna has led the industry in recognizing the importance of genetic medicine, in promoting access to medically appropriate genetic services, and in pioneering a clinical management program that improves quality and cost effectiveness of medical therapy based on genetic information:

• In 1998, Aetna developed a comprehensive program around BRCA testing for inherited breast and ovarian cancer, including innovative access and coverage policies, clear privacy provisions, education for physicians about the appropriate use of the test, and coverage for genetic counseling services. This program earned the 2000 American Health Insurance Plans/Wyeth HERA Award.
• In 2002, Aetna expanded member education around appropriate use of genetic technologies, by developing an online interactive genetic testing guide that won a 2003 World Wide Web (WWW) Health Award from the Health Information Resource Center (HIRC).
• In 2002, Aetna was the first health plan to craft and implement a privacy policy describing appropriate and inappropriate uses of genetic data. This policy was adopted by America’s Health Insurance Plans and is now an industry standard.
• In 2005, Aetna incorporated genetic medicine guidelines into a hepatitis C clinical management program.
• In 2006, Aetna adopted an employment genetic nondiscrimination policy.

How Aetna’s hepatitis C program works
Hepatitis C is the most common cause of chronic liver failure and liver transplant in the U.S. In 2002, the National Institutes of Health (NIH) issued drug treatment guidelines based on the genetic makeup of the hepatitis C virus.⁹

Aetna uses genotype tests as part of a precertification process to help health care providers treat the appropriate members for the right length of time with the injectable medications used to treat hepatitis C. The nurses and pharmacists at Aetna Specialty Pharmacy then support members on the therapy and help them stick with what is described as a grueling course of treatment.

The results:

• According to Aetna’s study, approximately 15 percent of members treated for hepatitis C were on drug therapy inconsistent with the NIH guidelines.
• Aetna’s internal analysis demonstrated that approximately $4.5 million in savings resulted from management of therapy based on NIH treatment guidelines.
• 94 percent of members treated for hepatitis C who received compliance support through Aetna Specialty Pharmacy are compliant with their treatment as opposed to 49 percent who receive their medications at retail pharmacies.¹⁰

Aetna policy on the appropriate use of genetic data

Aetna believes that health plans should:

• Cover genetic testing among individuals shown to be at risk, where results may affect the course of treatment of the insured.
• Cover genetic testing for a family member where the family member is not otherwise insured, and results may affect the course of treatment of an at-risk insured member.
• Cover consultation with qualified counselors and physicians, and facilitate the appropriate interpretation for genetic testing results.
• Support physician education in the appropriate use and interpretation of genetic tests and pharmacogenetic therapies.
• Craft and adopt privacy policies to promote and protect the confidentiality of genetic information for the maximum benefit of the member.

Aetna believes that health plans should not:

• Establish rules for health coverage eligibility based on genetic testing.
• Request or require genetic testing as a condition of providing health insurance coverage.
• Use genetic testing for risk selection or risk classification purposes in provision of health coverage.
• Disclose genetic test results that may come into a health plan’s possession without member authorization.