|28th August 2018
In April 2018, Medicare & Medicaid Services announced patients with advanced cancer will have free access to genetic testing. This pioneering policy will help match patients with existing therapies or clinical trials, which are likely to improve their cancer treatment.
The US government will cover the costs, signalling their commitment to more precise treatment that will drive better outcomes for patients across the U.S. However, several recent studies reveal many clinicians lack confidence in their knowledge of genomics, specifically around DNA testing.
Now, a new stakeholder is helping doctors overcome these challenges. Genetic counsellors are educating healthcare professionals, while also translating the complex genetic data into actionable insights that can be used to make treatment decisions.
There are more than 70,000 different genetic testing products available on the US market in 2018 with 10 new tests entering the market daily. This is challenging for clinicians, who feel bombarded by the different types of genetic tests flooding the market, which each promise similar results.
Doctors ordering multigene genomic tests experience further challenges. Multigene panels can analyse from as few as two genes to hundreds of genes and many companies offer a variety of panels of different sizes in the same disease area.
There is also variance around the type of panels, which range from those including the most established genes to others focusing on the location of a tumour, and some feature hundreds of genes along with less known cancer therapy recommendations.
As a result, hospitals are sending multiple tests to a variety of different labs, which each specialise in a different area of genomics. This has prompted leading experts to call for standardisation of genetic tests and better information for doctors to ensure patients receive the best treatment options.
The prolific number of direct to consumer genetic tests on the market has also heightened confusion for the general public. “Patients have no idea what they are ordering and no idea how to incorporate that into clinical management,” explains Vicki Kiesel, Ms, BS, RGC, CGC, Genetic Director at GeneHealth.
“For example, one company provides lots of different examples of genetic testing and includes BRCA testing, but only for three mutations. If a woman is not Jewish and takes the test, it tells her nothing about her BRCA gene, but she thinks she has been tested.”
"It’s dangerous. Patients’ don’t understand what they are being tested for and they don’t understand the implications"
Vicki is concerned about the impact this has on patients’ long-term physical health, as well as the psychological and behavioural repercussions of these genetic tests. “It’s dangerous,” she reveals. “Patients’ don’t understand what they are being tested for and they don’t understand the implications.
“Genetics is not just a yes or no answer, it’s not just that there is a mutation or there isn’t a mutation. Often it can be inconclusive, meaning there is a variant in the gene and the medical community don’t yet know what that means for a patient.
“Patients have absolutely no way of interpreting that so they either completely ignore it or much worse, they think it’s a mutation and they have an added risk of the disease.”
Although a majority of oncologists think genomic testing is important, more than half think the tests themselves are overhyped, and they also feel ill-equipped to implement the technology.
Historically, many doctors would not have studied genomic science. These physicians are less likely to order a genetic test, which means the patient may not receive the best treatment.
A 2017 study of more than 2,500 women with stage-0 to stage-2 breast cancer, carried out by researchers at Stanford University School of Medicine, found physicians often failed to recommend genetic testing to high-risk breast cancer patients, despite the women asking for tests. Worryingly, often the women did not learn of genetic mutations that could lead to additional cancers and could be passed on to their family members.
“The fact that many women are not offered genetic testing after a diagnosis of breast cancer is an important illustration of the challenges of driving advances in precision medicine into the exam room,” said Steven Katz, MD, MPH, Professor of Medicine and of Health Management and Policy at the University of Michigan, and co-author of the study.
“It is likely that some doctors don’t realise the benefit that genetic testing provides,” said Allison Kurian, MD, Associate Professor of Medicine and of Health Research and policy at Stanford.
“They may also lack the ability to explain the testing process and results clearly with patients. Priorities for the future should include strategies to expand the genetic counsellor workforce and interventions to improve physicians’ skills in communication and cancer risk assessment.”
Genetic counsellors help healthcare professionals and patients to understand the science behind new innovations.
A survey carried out at Sarah Lawrence College found 85% of genetic counsellor regularly influence healthcare professionals by giving lectures and attending intrahospital meetings such as tumour boards and grand rounds. They are even taking on a consultancy role, giving recommendations for testing, management, referrals, and interpreting results.
Vicki reveals: “There are a lot of clinicians out there with a limited understanding of genetics, so we provide them with education and most importantly tell them where to go to get information. It’s quite overwhelming for them. “We’re trying to train the experts, but they possess a huge wealth of medical information already. It’s difficult because we want to respect their knowledge. We’re trying to teach them more about genetics to strike a balance.”
"85% of genetic counsellor regularly influence healthcare professionals"
During a recent pilot of an oncologist-led counselling process, oncologists and oncology nurses were given training on pretest genetic counselling techniques and how to discuss BRCAm testing with patients.
The training resulted in faster treatment decisions and more efficient use of resources. Additionally, the median waiting time from initial counselling to receiving test results reduced from 9.1 weeks to 4.1 weeks.
Not only did the education of the healthcare professionals make a difference to the clinical process, more than 99% of patients said they were satisfied with the service and more than 80% of oncologists said the testing worked well, revealing counselling was an efficient use of their time.
With the lightening speed developments in research and development, these results highlight the importance of keeping healthcare professionals informed through clear and relevant medical content.
Both genetic counsellors and healthcare professionals alike are trawling the internet to run random literature searches for the latest information on genetics and genetic testing.
However, pharma companies are well-equipped to bridge this gap. In a world where it is possible to match therapies to a patient’s specific DNA, healthcare professionals will ask highly specific questions and will search for unbiased, easily digestible information. They will also expect to gain answers instantly and at the point of need.
"In the future, I hope pharma will have experts to explain new information to different physicians"
In 2018, it is no longer enough to create cutting-edge therapies. To turn the dream of precision medicine into reality pharma companies will need to create a support network for patients and healthcare professionals navigating these complex treatments.
“In the future, I hope pharma will have experts to explain new information to different physicians, including genetic counsellors,” says Vicki. “There will also be a requirement for pharmacologists and genetic counsellors to work in collaboration with the main physician to ensure they have the right information about how these drugs interact and how they should be prescribed. Obviously, the clinician will have the final say about the dosage or medication, but ultimately they need the rest of the information to ensure patients are correctly treated.
“It’s going to be very exciting,” she reveals. “There’s a huge upward curve for learning, it’s almost unimaginable where we will be in 5 to 10 years’ time.”
At Blue Latitude Health, we have worked across a variety of precision medicines to help our clients develop their commercial strategy from initial research to execution. Contact firstname.lastname@example.org to find out more.
|18th November 2019
In this special pack, we provide a comprehensive outlook of launch excellence. We cover topics ranging from gathering effective insights, to understanding the current landscape, and the importance of pre-launch strategy for improving relationships between the customer and the brand.
|1st November 2019
In 2017 the approval of the first CAR-T treatment took the world by storm, transforming the way cancer is treated, but two years later more than 500 CAR-Ts are in development. So how can pharma ensure its product stands out from the crowd?