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Impact of Genomics on Insurers − Part 6

Will our Babies Be Engineered in the Future?Genomics in Reproductive Medicine

The application of genetic testing and genetic editing to human embryos has far-reaching potential to impact society, and – in the long-term – also insurers.

What is preimplantation genetic diagnosis?

In the context of in vitro fertilization, preimplantation genetic diagnosis (PGD) is a frequently discussed topic. In this type of testing, one or more cells are taken from each of a set of early-stage embryos and genetically profiled. Embryos can then be selected for implantation based on their genotype to control the phenotype of a baby.

Why use preimplantation genetic diagnosis?

Embryo selection based on PGD can reduce the risk of conceiving a child affected with a known genetic disease. Parents who know they are carriers of a severe inheritable disease can thus profit from PGD, as it allows the termination of already established pregnancies to be avoided. It’s important to be aware, however, that these techniques only increase the chances of detecting abnormalities, but cannot guarantee an outcome. It is therefore recommended that patients receive counseling whenever PGD is applied. This should include genetic counseling, since the impact of genetic findings can have a wider impact, as we explained in our previous article about gene therapy.

PGD can in principle also be used to select embryos for other traits with a known genetic contribution, such as gender, looks, a lower risk of certain chronic illnesses, and athletic or intellectual performance. The trend of technological progress and falling prices for genetic testing and genome sequencing, as well as the increasing body of knowledge with regard to genetic contributors to phenotypic features, make it likely that PGD will be used more often in reproductive medicine – and not only by parents who have a family history of hereditary disease.

What comes after PGD? Gene editing?

An extension of diagnosis could be to alter genetic variations in a targeted fashion: gene editing. Today, diseases with a genetic cause are mostly treated at the symptom level without addressing the underlying genetic root cause. PGD provides a way of preventing the transmission of the disease from one generation to the next by selecting non-affected embryos. Recently, the development of procedures that allow the alteration of the DNA sequence in embryos and thereby inhibit the transmission of these diseases has enabled new strategies for the eradication of such diseases. The recently developed CRISPR/Cas[1] system allows the DNA sequence to be altered at very specific sites on the genome.

In 2015, Chinese scientists became the first to successfully edit the genomes of non-viable human embryos using CRISPR/Cas[2]. Although promising, their results show that additional work is needed before the tool can be applied in practice. For example, in their approach, only a fraction of the studied embryos received the replacement strand, and off-target mutations were common.

The potential of gene editing in embryos is high; it could potentially eradicate certain genetic diseases from the human gene pool. But concerns about the fact that germline modifications are heritable also need to be assessed, especially with regard to unwanted effects on future generations.

[1] CRISPR: Clustered regularly interspaced short palindromic repeat; Cas: CRISPR-associated nuclease
[2] Liu et al. (2015) in Protein & Cell

Current regulatory situation

Assisted reproductive technology (ART) is a hotly debated topic, and a variety of regulations have been introduced in the past few years. Most western countries, but only a fraction of countries in the rest of the world, have regulated the use of PGD. Europe is the continent with the most widespread use and regulation of ART, while most other countries with a developed ART industry, such as the USA, tend to rely on voluntary guidelines. The USA also has a rather laissez-faire approach to the use of PGD. This contrasts with most European nations, which have limited the use of PGD to medical applications. Depending on the country, embryo selection based on PGD is allowed, restricted, or completely forbidden. As a result, there is active “ART tourism,” where parents from more restrictive countries seek ART treatment in more liberal countries.

Impact on society

ART in combination with PGD (or in the future also gene editing) is rather expensive, and interested parents may face regulatory restrictions. Therefore, not all interested parents are or will be able to afford the latest treatments available. Especially if the technology is in future also used to influence non-medical traits such as psychological or physical fitness or the risk of obtaining chronic diseases with age, this could lead to economic segregation between those who can afford the procedure and those who cannot. Current applications of PGD without medical indication – for example to select gender – indicate that this assumption is not too far-fetched.

Not just individuals, but whole nations might become more economically segregated, as they compete − as the example of CRISPR/Cas application to human embryos in China indicates. While ethical concerns may lead to further regulation in some nations, others may strategically exploit the promise of what is technologically possible. Furthermore, we can expect that at some time in the future, the technological possibilities discussed above will help further prolong human lifespan, especially if applied to reduce individuals’ risk of cancer or chronic diseases – or even directly target the genetic mechanisms of aging itself.

Impact on the insurance industry

ART is covered at least partially by the public health system in most European countries. In the United States, some states offer coverage, but most provide no coverage at all. However, most public and private health insurers do not cover PGD. New products including specific cover or counseling already would have significant potential today and will gain in attractiveness in the future.

Indeed, as soon as effective treatment and prevention are achieved, less money needs to be spent on long-term patients with genetic diseases. Two often-cited studies on the subject use as an example the cost-effectiveness of PGD for couples diagnosed as carriers of cystic fibrosis in the American healthcare system[1]. The conclusions of the articles are that, especially for women under 40 years of age, the application of PGD could result in savings in the range of USD 100,000 to USD 1,000,000 per patient.

Because of the relative novelty of this technology, studies on how an increased use of PGD affects healthcare spending are still rare.

[1] Davis et al. (2010) in Fertility and Sterility; Tur-Kaspa et al. (2010) in Reproductive BioMedicine Online.

Synpulse is currently conducting an online survey with insurance experts on the impact of genomics on insurers. Upcoming articles in this series will present our findings. Stay tuned!

  • Dr. Dominik Langer
  • Ingo Muschick
Dr. Dominik Langer
Associate Partner | Head of Competence Center Digital Transformation
dominik.langer@synpulse.com
Dr. Dominik Langer
Ingo Muschick
Partner
ingo.muschick@synpulse.com
 Ingo Muschick
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