Currnt | How to maximize value of Personalized medicine while managing risks/compliance with the Genetic Information Nondiscrimination Act (or similar)?

Health plans seek to save $, while improving access to care and health outcomes.
Over 90% of the population has at least one genetic variation affecting their drug response and combining pharmacogenomic (PGx) insights with traditional clinical data is an intervention that improves the safety and effectiveness of medication therapy for an individual.
Strong evidence exists supporting the use of genomics to inform prescribing decisions and guidelines are available in curated databases regarding gene-drug pairs to help inform decisions about switching medications or altering doses.
It is an established science, but new in practice and application. How can health plans leverage claims and data to select individuals who would benefit most from #personalized medicine? How to ensure compliance with GINA?

Veronika Litinski
79 months ago

2 answers

Not only are health plans reluctant -- because the science is NOT settled -- innovators do not want to limit prospective patient access by conducting the corresponding clinical trials and having a limited label indication. Tough sledding here. Insurance payers will be on board when there is a clear cost benefit. For example, pre-surgical testing saves lives and reduces complications, so it has become routine.

Meg B
79 months ago

Very true, looking at it from the PoV of the manufacturers/innovators. However, science is settled for many older drugs, which constitute a large number of CURRENT prescriptions. https://www.pharmgkb.org/labels. For many indications the science is even promoted: - Veronika 79 months ago

https://directorsblog.nih.gov/tag/warfarin-dosing/; - Veronika 79 months ago

First link is not available. Second one says tests are not being used for the old drug Warfarin. I vaguely recall a specific esterase test for response to anesthesia but mostly other tests are for titration, not prediction. - Meg 79 months ago

Here is the first link - I tried to be "precise" ;) and get a link to the portion of the site with 200 drug labels.... here is the original source: https://cpicpgx.org - Veronika 79 months ago

As far as using genomics to guide warfarin dozing, there are new Factor X inhibitors, which can be used instead of Warfarin (again, different price points and they have their own story of risk/benefits). As you say, clinical value is specific to application. For every therapeutic area, there are meaningful genomic insights that can lead to a safer medication course. - Veronika 79 months ago

Thanks Veronika. An interesting web site but a confusing. I don't see which labels clearly mandate that a genetic test result is recommended prior to a drug being used for a particular indication. - Meg 79 months ago

Well, it looks like we've ventured through this discussion into the crux of the precision medicine challenge: the main clinical beneficiary of ensuring a good fit between genetics and drugs being prescribed is the Patient. Although physicians represent the best interests of the Patient, they don't have the time/knowledge to take genomic insights into consideration. - Veronika 79 months ago

You say that "Strong evidence exists supporting the use of genomics to inform prescribing decisions...". An obvious answer is already in your question. Prescribing physicians should be qualified enough to know where to obtain meaningful information on possible connections between genetic make up and prescribed drug, when relevant to get this information about patients, and make an informed decision which drug to prescribe. All that is needed from health systems / insurers is to implement appropriate codes to be used when claiming for such services.

Karel Petrak
79 months ago

In practice, qualified physicians increasingly rely on various decision tools to choose treatment options. Genomics is a vast new data stream (largely not well understood.... yet) that is just entering routine practice. - Veronika 79 months ago

So, you have your answer. It is now a matter of implementation. Prescribing physicians need to catch up with new development; they are trusted, and well paid for treating patients correctly, right? - Karel 79 months ago

It is not up to the physian to do anything other than read the label/prescribing information to find out if a test is required. - Meg 79 months ago

in the ideal world, yes. In the real world, there must be a payment stream associated with ANY new activities within a clinical workflow. - Veronika 79 months ago

.(????) Meg: So all that is needed is to read package inserts; great! Now I know why it takes four years and costs some $300,000 to train a physician... four years and some $300,000 - Karel 79 months ago

That's right. Off label use and designing treatment protocols opens a physician to liability. Unless that is what you think that "practicing medicine" really means just that and what you get to do for the cost of admission. - Meg 79 months ago

I don't think switching a patient from Warfarin to Xeralto is a matter of genomics. More about cost and convenience. - Meg 79 months ago

Manufacturers have no incentives to conduct studies that limit their potential addressable market. Even more true for older drugs, which are largely generic but are widely prescribed. A little Canadian perspective for you. :). - Veronika 79 months ago

TMI and no clear mandates. - Meg 79 months ago

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