Medicine for the Future: NGS Pricing and Precision Medicine Implementation in the Clinic

Mana Chandhok:
Hello everyone. Welcome to this podcast from Cambridge Health Tech Institute for Next Generation Diagnostic Summit which runs from August 23 to the 26 in Washington D.C. I'm Mana Chandhok, an associate producer. We have with us today one of our speakers from the inaugural health and wellness Screening symposium, Dr. Jamie Platt, managing director at BRIDGenomics.

Hi Jamie. How are you doing?

Jamie Platt:
I'm doing very well, thank you. It's a pleasure to be speaking to you today.

Mana Chandhok:
Let's start with our first question of the day. As the cost of next generations sequencing drops lower and lower how do you envision medicine changing?

Jamie Platt:
I believe we have to be wary or prudent in assuming that the decrease in cost of next generation sequencing or NGS will have any significant direct impact on medicine and healthcare. I say this for several reasons based on our decade of experience with NGS in the clinic.

Firstly, the true cost of next generation sequencing is not always fully represented. For example, in 2014 Alumina announced the first thousand dollar genome which has been the much anticipated milestone since I was in the sequencing community. However, as the cost of the genome was not fully burdened and did not reflect the cost of a true clinical genome. In [inaudible 00:01:13] in the clinic we must take into account many different factors including licensed personnel, bio informatics, clinical annotation, data storage, et cetera. One of the most important factors in the actual cost of clinical NGS is the overall test volume.

Laboratories that receive many samples for testing at the same time have a lower overall cost then those that don't receive very many samples being after the thousand dollar genome was based on a high volume system model. The association [inaudible 00:01:41] pathology or AMP has done an outstanding job in trying to assist clinical stakeholders in predicting an understanding the true cost of clinical NGS as it pertains to the GSP or genomic sequencing procedures. In 2014 AMP initiated a micro costing and held economic evaluation of several of the GSP CPT codes. This study, which is not published, has been very useful and really understanding the actual cost of performing clinical NGS.

Secondly, experience has shown us that the amount clinical labs actually get paid or reimbursed for NGS based tests is often much lower then their own direct cost. Again, the volume dependency as testing cost plays a major factor. The high volume labs can fair better then low volume labs. In addition, many payers only pay a fraction of what is published in the fee schedule by CMF. I know of labs that only receive 30% or 40% of the published fee. For a FSP CPT code or NGS test that is published on a fee schedule as being reimbursed at $600, labs may only receive $180 for testing. This for a test that is likely to cost them $600.

Thirdly, the FDA regulation as a development of LDTs may have an impact to the cost of the clinical lab, your [inaudible 00:03:05] labs at least with respect to the fact that the price of developing the NGS test will likely increase even if the cost of running the test does not increase.

Finally, I do believe diagnostics in medicine will eventually change as a result of NGS and genomic technologies, but I think this change may not be directly related to the cost but rather the prevalence and perception of genomic medicine by the public. A great example is NIPT, or non invasive prenatal testing, for down's syndrome and fetal [inaudible 00:03:37]. This largely NGS based application really took off and saw enormous market growth not because healthcare and payers embraced the benefits of this testing over existing higher risk and [inaudible 00:03:49] but because pregnant women were going into their OB/GYN's and demanding the testing. Patients believe in the value of the testing and were demanding it. It's this type of grassroots efforts along with the commoditization of next generation sequencing. I think we'll have the biggest direct impact on medicine.

Mana Chandhok:
What are some of the challenges for implementing more personalized medicine in a clinical setting?

Jamie Platt:
One of the biggest challenges I see is how to integrate different types of data from different technologies and transform that into information, information that is clinically useful which means they'd have to be understood by the clinician and/or the patients, especially with NGS. We are not dealing with massive amounts of data or big data. In general the healthcare diagnostic industry has not viewed themselves as being in the information business. Those that can successfully execute a tarragon shift internally move from operating as a service or healthcare provider to information provider will be the most successful.

I also believe that the use of deep learning and neuro networks will become increasingly important in improving personalized medicine. In addition, we see that the regulatory landscape is changing and must change to keep pace with the sheer volume of data and how that data is managed and used. Adapting and predicting how to best implement personalized medicine in a highly dynamic regulatory landscape is certainly challenging.

Finally, we need to better train clinicians and create medical training programs that focus on current methods, technologies and the big data of genomics and personalized medicine. Unfortunately I believe the majority of medical and clinical training programs fall short in really addressing personalized medicine. Most clinicians are simply not trained in how to use and interpret and really drive personalized medicine with their own patients. Changing the way clinicians are trained is going to be imperative.

Mana Chandhok:
We are looking forward to Next Generation Diagnostic Summit in general and the health and wellness genomic screening symposium in particular. As a speaker and an attendee what are your goals and expectations for the meeting?

Jamie Platt:
These meetings, as always, are a great networking opportunities. I'm always surprised to see the different strategies people are employing and to find out about the unmet needs. It's really nice in listening to the presentations and these different sessions to see what people are doing to drive personalized medicine. Also, understanding where the gaps still lie. I think understanding those gaps and how to fill those gaps and bridge the gaps that novel technologies, novel solutions, informatics is really where I think we get the most scientific insight. Even if it's not directly related to medicine in the clinic, I think for example, the health and wellness genomic screening symposium, that's sort of in a new area that's coming out of the clinical NGS area. I think there will be a lot of interesting topics discussed. Certainly looking at the speaker list there's a lot of wonderful speakers. I think information around new genomics and some of these other topics will be quite interesting. I think it's good for those that have been very clinically focused to think about some of these other potential applications as they're just now beginning to emerge.

Mana Chandhok:
Jamie, thank you for your time and your insights today.

Jamie Platt:
Thank you. It was a real pleasure. I look forward to the meeting.

Mana Chandhok:
That was Dr. Jamie Platt form BRIDGenomics. She'll be speaking at the Health and Wellness Genomics Screening Symposium at the upcoming Next Generation Diagnostic Summit taking place August 23 to 26 in Washington D.C. I'm Mana Chandhok. Thank you for listening.