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Genetic counselling - decision support or a tool for rationing?

9 September 2013
By Alastair Kent and Nick Meade
Genetic Alliance UK
Appeared in BioNews 721

This week, the new policy of American health insurer, Cigna, that requires genetic counselling before access to BRCA genetic testing will come into effect. Reaction to this announcement has been mixed. We thought it would be interesting to compare this new policy with how genetic testing for BRCA cancer risk is delivered in the UK. Some commentators have expressed concern that this requirement is an attempt to restrict access to the test.

Genetic testing for familial breast cancer is available on the NHS in the UK, and of course we have measures in place to prioritise the use of NHS funds and to ensure that it is those most likely to benefit from a test who receive it. The UK Genetic Testing Network (UKGTN) approves testing criteria for genetic tests in the UK, and in this case the UKGTN follows the NICE clinical guideline on familial breast cancer. This lays out risk levels that candidates for testing need to meet before they may access a test. For example, a person with no personal history of breast cancer and no available affected relative to test needs to have a combined BRCA1 and BRCA2 carrier probability of ten percent or more to access a test. This risk is assessed by examining how many relatives with breast or ovarian cancer they have, what age they had cancer, and how closely related they are.

The assessment of carrier probability is performed by a risk calculation model. This process might be carried out by GPs in their surgeries using a tool provided by their regional genetics service, or it may be carried out after referral to a genetics service. In some cases, this may be performed by a genetic counsellor, but it is important to recognise that this is not genetic counselling. Eligibility is assessed before genetic counselling, which is then universally provided before a familial breast cancer genetic test is provided on the NHS. We imagine that an eligibility assessment would also be a requirement prior to a genetic test for familial breast cancer risk funded by Cigna.

It is important to recognise that the vast majority of breast cancer is not related to BRCA1 or BRCA2 mutations. Breast cancer is a common condition, and breast cancer related to BRCA1 or BRCA2 mutations is a small subset of all breast cancers. Without this eligibility assessment we would be struggling to find the true positive test results in a haystack of false positives.

One of the key functions of genetic counselling is to ensure that a person having a genetic test understands the nature of the information that they will receive from the process. You cannot 'unknow' the results of a genetic test, and your status is permanent. If the result is positive the next step will be to consider the options to manage the high risk of breast cancer that one of these mutations confers. Management options pose a new set of difficult decisions. The results will have implications for your relatives, it may be necessary to inform other at-risk relatives, who will then have to think about going through the process themselves.

Genetic counselling is non-directive. It is a process which facilitates an informed decision by the person choosing whether or not to have a test. Inevitably some may choose they do not want a test, but if the genetic counselling is done properly, then this choice will be taken because the test is not the right option for them at this stage in their life. They may reconsider in the future.

We would hope that the genetic counselling required by Cigna would provide the scope and information necessary for informed decision making and degree of thought and consideration in situations where candidates for testing have this available to them. If this is the case, then their requirement is a reasonable one; provided of course that this requirement does not become a barrier, or unduly delay any instances where genetic testing is urgent.

Where we are looking at other forms of genetic test, for example diagnostics for prescribing drugs, or over-the-counter tests for genetic predisposition to common conditions, a requirement for counselling may not be appropriate or feasible. Over-the-counter tests are self-purchased so mandating counselling prior to purchase is not an option. Companies should provide a clear, layperson-friendly explanation of the validity and utility of the information that may be revealed, so the purchaser can make an informed decision whether or not to proceed. Which, for most tests not available as part of health service provision, would result in the purchaser folding his or her money away and putting it back in their wallet!

SOURCES & REFERENCES
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