As Health Innovation Week kicks off, before 1300 of our best friends arrive for the Health 2.0 Conference on Sunday-Tuesday, on Saturday we are hosting a Health 2.0 Code-a-thon in San Francisco at the PariSOMA loft (11am Saturday 25th to 3pm Sunday 26th). Spots are filling up fast but you can register here & yes, it’s free and there’s $10,000 in prizes at stake (not to mention pizza & beer). But it’s not just SiliValley techies who care. Big pharma Novartis is getting into challenges big time including sponsoring one at this very code-a-thon. THCB favorite (and CEO of Avado) Dave Chase explains more–Matthew Holt
“We’ve spent billions developing new drugs and we’ve spent billions marketing drugs but we’ve spent nothing on the actual use of our drugs.” That is how a senior executive at a major pharmaceutical company described the model in which they’ve operated historically. In a “do more, bill more” reimbursement environment, there was little economic incentive for a pharmaceutical company to pay close attention to what was happening with patients in clinical practice. This has been in stark contrast with clinical trials where a trial makes or breaks a drug. For obvious reasons, in clinical trials, there is a tremendous amount of attention paid to what happens with an individual’s use of a drug.
Times have changed. Not only have the first warning shots been fired across the bow of the pharmaceutical industry, the first shots have landed. Whether the payer is a national government or private insurance company, increasingly, they are refusing to pay for drugs that haven’t demonstrated efficacy in clinical practice (not just trials).
In this new environment, pharmaceutical companies can no longer turn a blind eye to how their drugs are being used (or not) and whether or not there’s clear efficacy. There’s also recognition that the gaps that persist between the results of many clinical trials and clinical practice are particularly harmful in an outcomes-centric reimbursement environment. Clinical trials that are very high touch can produce great outcomes as the patients are very closely monitored and medication adherence is very high as a result. Unfortunately, this high touch model doesn’t scale to clinical practice and can lead to less-than-ideal outcomes.
Pharmaceutical companies, as a result, are looking for approaches to clinical trials that are still high touch but can scale to clinical practice. Smart application of technology holds that promise.
This outcomes-focused trend has been broadly characterized as “Pharma 3.0” and has resulted in a major shift in mindset at pharmaceutical companies. The implications of this have yet to be fully seen but there are early examples that demonstrate just how far-reaching this gets. One expectation is that there is a much greater integration of health information technology and the biopharma communities.
Novartis has long been viewed as one of the most innovative pharmaceutical companies. Like most innovative companies, they recognize a key source of innovation can come from outside their organization. Recognizing this, they are signaling to innovators that they are “open for business” by sponsoring the Health 2.0 Code-a-thon at Health 2.0’s upcoming conference in San Francisco. [Disclosure: They are using my company’s system to enable the application services that they hope will emanate from this event.]
You might be wondering, like I was, what a large pharmaceutical company would be doing by publishing an API to encourage developers, informaticists and designers to utilize. The idea is as straightforward as it is potentially impactful. For every pharmaceutical product that is approved for marketing by the FDA, the manufacturer has to publish a Structured Product Labeling document (“SPL”). This information, while very important to patients and physicians who are using and prescribing the drug, is the same information that is printed in infinitesimally small print on the package inserts that largely go unnoticed by those who it is intended for. In other words while the content is relevant it is hardly consumable by the patients and physicians it is intended for. Therefore, Novartis wishes to expose this information through meaningful, “semantic” APIs. This will enable the consumption of SPL content by mobile and web applications (“Apps”) developed for patients and physicians using the product.
Such Apps, Novartis believes, are essential for creating a more “high touch environment” in clinical practice, stimulating interaction between patients and their treating physicians, or between patients and their “caregivers” (family doctor, neighbor, friend, relative), or patients amongst each other.
Details of contest
For this developer contest, Novartis is developing a semantic API to access the SPL data for Gleevec, a frequently prescribed drug in the treatment of Chronic Myeloid Leukemia (CML) and specific types of Gastrointestinal stromal tumor (GIST).
Through the API, Apps can access information about the indications and usage of the drug, its dosage and administration – both for varying patient populations, the known adverse reactions when taking the drug, known interactions with other drugs, information about clinical studies with the drug, and so on and so forth.
The combination of the SPL with the value-add ontology opens up opportunities for creative developers to create services for a “higher touch” treatment environment for these patients and physicians. This, in turn, will drive better outcomes of treatment in clinical practice, and thereby helps companies like Novartis prepare for a more outcomes driven healthcare market.
In addition, for non-developers (physicians, designers, informaticists, etc.) there will be a platform provided that allows the drag and drop creation of patient feedback loops, patient education and more.
Examples of what Apps you could build
Sadly enough, many of us have a friend or relative among us who have been battling these or other forms of cancer, and we have close experience with the terrible battles these patients and their loved ones wage with their diseases. Yet it is from these trying experiences that also emerge the most creative and powerful ideas how to make a difference for these patients through the innovative use of new technologies. And it is this creativity and zeal that Novartis is trying to unleash by sponsoring events like this code-a-thon.
Examples of Apps that could be build to create this higher touch treatment environment are numerous and varied:
- A new prescription could trigger a CML or GIST Tracker that encompasses an array of information and provides automated reminders regarding that condition, including trackers of activities of daily living, patient education information (e.g., expectations of how one might feel in the first week of a prescription while their body adjusts), reminders of when to take the medication and notifications of when to schedule doctor appointments.
- As current research suggests that disease understanding promotes treatment adherence and thereby improved health outcomes, Apps could be used to educate patients about the information on the SPL, including adverse reactions and drug reminders (as highlighted above), drug administration (should you take the drug with a meal or on empty stomach?), use in specific populations (nursing mothers),…
- Data from the Tracker could be visualized and reported to the physician upon a next patient visit, so that the physician has instant insight into “the patient history”. When this approach was tested in the treatment of diabetes, participating physicians were quoted to say “this is the first time they can treat the disease rather than manage the symptoms.”
- This could be combined with immediate alerts to physicians based upon disease progression and adverse reactions – e.g. if those reactions differ considerably from those reported on the SPL.
- Patients could volunteer to connect with other patients who are reporting similar disease experiences through the Tracker.
- In this contest, Novartis wants to leave the scope of the App entirely up to the creativity of the development teams, promoting the development of truly patient- and physician centric apps as opposed to product-centric Apps.
Why Novartis is doing this
While a big part of the idea of a code-a-thon is to spur ideas that wouldn’t have otherwise come to the sponsoring organization, Novartis hopes to spark creative new ideas with a bit of input. Joris Van Dam, Strategic Projects Lead in Translational Sciences states that their goal as follows. “One of the main conclusions we came to in our recent work is we know there is so much we don’t know. Yet what we do know is this. Patients and physicians need Apps to create a higher touch treatment environment that fosters better treatment outcome and higher quality of life. We also know that such apps should not be developed by the product manufacturer; we need patient- and physician centric Apps, not product-centric Apps, that support patients in all their health and wellness needs and irrespective of what combination of drugs they need to be on at that time. Yet we want to learn how we can lend a hand in the development of those Apps, and why not start with liberating data about the products we provide?”
One of the other questions yet unanswered, and one of the reasons that venture capital is relatively cautious to venture into the business of developing such Apps, is who will pay for the use of such Apps in the end. Is it the patient? Their insurers? The much anticipated Accountable Care Organizations? The Pharmaceutical manufacturers? Much is yet to be learned, yet it is the Apps developed in code-a-thons like these that will deliver the showcases and prototypes that will drive those discussions, that create real and visual examples of a future healthcare market that we should all aspire to.
In the Pharma 3.0 world, there is no room for lengthy, incomprehensible, small print package inserts, and hard to find public repositories. Rather, as you pick up your prescription medication at your local pharmacy, and scan the 2D barcode on its packaging, your favorite Health App will kick in and connect to the API of the product you just picked up. It will tell you how to use it and when to take it. It will remind you when it’s time for your next dose. It will explain the mechanism of action. It will monitor your vitals and alert your physician if there is no progression (he may want to change the prescription). It will help you in the event you are experiencing adverse reactions. It will connect you with fellow patients who just started similar treatment. And while you are on holiday, and pick up some generally innocuous painkiller at the local pharmacy, it will warn you of potential interaction with your prescription medication. The benefits of Health Apps in this Parma3.0 world are munificent, diverse, yet all hold great potential in improving health outcomes for many patients worldwide. And we can make a great step towards establishing that Pharma 3.0 world in the very code-a-thons like these.
For ambitious informaticists, developers and designers, Novartis sponsorship of the code-a-thon has created a seminal opportunity to affect clinical practice in a way that hasn’t been possible before. This isn’t merely an opportunity to mash up a government dataset. Rather, it’s a direct opportunity to affect the people affected by some of the most grueling forms of cancer. Further, they can show the way for the entire Biopharma category how Pharma 3.0 can go from a concept to reality.