Value Summit USA 2018

Nov 7, 2018 - Nov 8, 2018, Philadelphia

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Could Digital Medicines Improve Access For All?

Digital medicines could provide a new roadmap to reimbursement and regulatory approval.

The first edition of the new open-access journal npj Digital Medicine launched at the beginning of 2018. This brazen acknowledgment of the capabilities of this exciting and transformative field was tempered somewhat, by an accompanying editorial suggesting that digital medicine was “on its way to just being plain medicine”.

Defined as using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized, the concept of digital medicines still sounds vaguely futuristic – except that they are already here, with the first fully integrated digital drug approved by the Food and Drug Administration last year, and with over 25 others in widespread use as a result of pharmacy repackaging of drug plus sensor.

These transformative products have far-reaching implications for the entire healthcare ecosystem, but especially so when it comes to the ever-growing access conundrum.

This magazine has previously covered how the first FDA approved fully integrated digital medicine —Abilify MyCite® (aripiprazole tablets with sensor) is being brought to market by Otsuka Pharmaceutical Co., Ltd. (Otsuka) in partnership with Proteus Digital Health, the company that has created the enabling digital medicine technology.

As they gear up for launch, John Bardi, VP, Public Affairs and Digital Medicine Business Development at Otsuka explains that this collaboration is merely “the first move” when it comes to digital medicines.

“This has the sensor component embedded in the actual medicine and is the first time that I can recall a medicine delivering a medical device [the sensor] rather than the other way around. We are in the early stages because we are the first movers, but stakeholders in the healthcare ecosystem are watching carefully to see how this goes.”

Andy Thompson, CEO of Proteus Health, says there are three major value propositions to a “full digital medicines experience” such as Abilify MyCite and other solutions already being used to treat cardiovascular disease, diabetes and hepatitis C.

 “The first is patient outcomes – these products get the results that medicines promise but don’t always deliver because people don’t always take them,” he tells eyeforpharma.

This leads on to number 2 – patient access. “If you are confident you are able to deliver the outcomes then you are much more likely to ensure patients access especially to more expensive medications where they might otherwise be denied. The other side of access is that you can prevent patients being  prescribed expensive medications that they don’t need and save them enormous amounts of money,” Thompson explains.

Thirdly, this ultimately means a much more sustainable model for patient-focused innovation in pharmaceuticals.

A no-brainer, you would imagine. Yet as the watchers wait and see, the practicalities of getting these products over the line and the potential impact they could have on outcomes-based agreements remains up in the air. Or is it?

“If you are asking is there a regulatory pathway for this, the answer is yes,” asserts Otsuka’s Bardi.

“We worked very hard with the FDA to determine what would be required for approval, and now that Abilify MyCite was approved in November of 2017, that clearly signals to industry watchers that there is a regulatory path forward for digital medicines.”

Still, questions remain as this nascent area undergoes the usual teething problems. Nonetheless, Bardi only sees it becoming more straightforward as time goes on. “The future has to do with should products like this go through the existing pathways and evaluations as traditional medicines or should they follow a different path? Those are the questions that remain on the table.  There is an FDA regulatory path for digital medicines today.  However, the FDA might decide based on this experience to develop a different regulatory path for the future.”

“There is a streamlined regulatory path today, but we hope the future regulatory path will be even more efficient and allow for the market to grow and expand in a quicker way.”

The insurance industry appears to be receptive to this newly-approved combination product, he adds.

“In terms of coverage for digital medicines, we are actively discussing the evidence plan required to pay for this innovative product and support a formulary position.  I am optimistic about the ability of Otsuka’s initial launch approach to demonstrate a viable national scale commercialization pathway,” he says.

“The Psychiatric Provider networks and their patients will want to be assured access to digital medicines, and the Otsuka Digital Medicine Team is working very hard to help make that a reality.   New categories for benefit coverage and reimbursement will need to be considered over time as we learn more about how digital medicine will integrate into the existing healthcare ecosystem.”

Despite these known unknowns, Bardi says the payer community is open to learning more about the digital space. The data insights afforded by these products should ultimately inform better and more cost-effective treatment decisions.

“The data is going to help improve the work around creating RWE because you are creating daily data points that can be translated into outcomes. That is the really exciting thing about digital medicine and its potential.

And given that digital medicines inherently generate RWE, this could, and should, shape a new generation of outcomes-based agreements. For example, with Abilify Mycite, because it tracks ingestion, the uncertainty of whether the patient took their meds or not is completely negated. This kind of knowledge can have a significant impact on such agreements, says Bardi.

“Think of the outcomes-based deals or value-based arrangements that have been struck in the last couple of years. How do they account for non-compliance to the medication under those types of arrangements? What digital medicines do is help to solve the question of whether the patient is taking their medicine as prescribed.”

Bardi adds that the accumulation of such data over time offers a real opportunity to hone in at the population health level, and could potentially help inform more targeted treatment decision-making and thus outcomes-based agreements.

“Right now we are helping at the localized level, helping patient and doctor treatment teams make the right management decisions. But the data can also help inform trends and prescribing patterns… you can look at patterns around patient types and what protocols and standards might be applied or changed based on the broader aggregated data across the population. Then we can identify subsets of patients that do better based on what we learn through this,” he explains.

The beauty of the data gathered by ingestibles is its consistency, and according to Thompson, the real-world evidence is “very consistent in every experience that we have”.

Proteus Digital Health is active not only in the psychiatry space, but also within cardiovascular/metabolic and infectious diseases, such as tuberculosis and hepatitis C (where many of the patients successfully treated have psychiatric co-morbidities, emphasizing the universal applicability of digital medicines solutions) .

“All of our studies show that patients wear the patch around 90 percent of the time and have between 85-95 percent on-time adherence.  The therapeutic effects are significant, happen quickly, and are sustained over time.  The majority of patients who use digital medicines for three months sustain outcome effects 12 months after going back to regular medicines.”   

Peer reviewed studies in high-risk patients who have been on regular drug therapy for at least six months and have failed their clinical endpoints who are then put onto digital therapy, demonstrate that 98 per cent of them achieve their blood pressure goal within 90 days with significant drops in their lipids and HbA1c.

The consistency of the data gathered by digital medicines is increasingly seen as a major selling point. Recently presented abstracts in TB indicate that wirelessly observed therapy using a digital solution captures 50 per cent more doses than the gold standard of directly observed therapy. All stakeholders benefit from the associated cost savings and convenience of this, Thompson states.

“TB patients are typically required to visit the clinics, so you can observe them taking their medicines. If you put them on wirelessly observed therapies then they can go to work. It is very dignifying for the patient and very empowering for the care team – instead of watching 10 people they can watch 10,000. From a population health perspective and an individual access to care perspective that’s a very good thing.”

In another example, patients were denied access to prescription refills for hepatitis C medications because the measured blood level of drug wasn’t high enough. “Then we show the reimbursement company the actual data on the patient’s consistent use of drug and that enables the prescription to be fulfilled – that’s another access point. When patients take drugs appropriately and prove that, then denial of follow-on prescriptions can be avoided.”

And so, the trillion-dollar question – will digital medicine become just plain medicine? Thompson gives an emphatic yes.

“In 10 years, our view is that every drug in the supply chain will be a digital product. You will know if a drug works or not – our children and grandchildren will laugh at the idea that we once put drugs inside our bodies without knowing whether they were real or fake, in date or out of date, the right drug or the wrong drug, the right dose or the wrong dose. All of these questions are answered by a digital medicine…today.”

If you want to hear more from John Bardi and other key influencers in the industry, check out our upcoming Value Summit USA 2018 event in November. 


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Value Summit USA 2018

Nov 7, 2018 - Nov 8, 2018, Philadelphia

Achieve real-world enlightenment