The goal of the technology is to make a patient's at-home medication program more closely resemble treatment in a hospital setting, where information and feedback about a drug is gathered and assessed. “You can make data-driven decisions on what to do next,” says Dr. George Savage, co-founder and chief medical officer for Proteus Digital Health.
However, the company still faces an uphill battle to convince wary providers that making another investment in advanced technology will help solve adherence problems. Though the system has been deemed safe by the Food and Drug Administration, there still isn't scientific data showing it actually increases drug adherence among patients or that it reduces readmissions among patients suffering from repeat acute episodes of conditions like congestive heart failure.
While Proteus plans to conduct research that could convince skeptical hospital executives to make the investment, the results of studies conducted during the past few years that have looked at the impact of remote monitoring technology on reducing readmissions have been disappointing, says Dr. Ashish Jha, associate professor of health policy and management for the Harvard School of Public Health.
“Does technology have a role to play here? Absolutely,” Jha says. “My sense is that we're still in the early days. We haven't yet figured out how it's going to change behavior.”
Patients who adhere to their medications are more likely to report better health outcomes, and less likely to wind up in urgent care or the hospital. Yet it's estimated that half of chronically ill patients do not adhere to medication programs.
A study published in Health Affairs in 2011 found that improving medication adherence can lead to “substantial medical savings,” with value-based insurance design, electronic monitoring devices and counseling with pharmacists serving as the least costly alternatives.
“Adherence is a huge issue,” Jha says. “A majority of patients are not able to stay adherent to medication over the long run. You can do all of the quality measures you want, but if patients aren't going to take their medications, it's not going to take you very far.”
Proteus is undertaking an initiative to evaluate whether the technology can be used to help reduce readmissions of heart-failure patients, who would take the placebo pill with the sensor along with their post-discharge medications. The company aims to generate the kind of cost-effectiveness data that hospital administrators are likely to seek out before it begins marketing the technology.
While the FDA classified Proteus' digital feedback technology as a de novo device, an expedited pathway for low-risk devices with no predicate on the market, it is not required to conduct clinical trials that prove it can improve adherence or reduce readmissions. A safety-only clinical trial that tested the technology in 254 patients for 3,810 days showed the technology worked without adverse events.
Proteus isn't planning an efficacy study before it markets the technology to hospitals as a tool for reducing heart-failure readmissions. “It's less of a clinical trial in that we're not trying to prove that the product works. We know that,” Savage says. “And we're not trying to prove that if you can appropriately manage patients' fluid status you improve heart failure. We know that, too. What we're trying to prove is that we can reduce costs and deliver better patient care.”
Implementation of the cost-containment provisions of the healthcare reform law and ongoing economic strain have led to demand for medical technologies that can deliver clinical and financial results to hospitals that face a fiscally precarious future. Savage estimates a $1 billion market opportunity for the company's technology if it can help reduce readmission rates for heart-failure patients.
Last October, the CMS began imposing financial penalties on hospitals that have 30-day readmission rates for heart failure, heart attack and pneumonia that exceed the national average. The mandate is required by a provision in the Patient Protection and Affordable Care Act. Unnecessary readmissions are estimated to cost the CMS up to $12 billion each year.
Like others, Savage believes that technology alone won't lead to lower readmission rates. As part of the data study, expected to take place at several undisclosed hospitals starting in early 2013, the technology will be incorporated into a hospital's service for treating heart-failure patients. The company declined to provide additional information about the study.
“A key component is how physicians and hospital networks manage their heart-failure clinics and their heart-failure patients and how they might incorporate this product into that service,” he says.
Part of what makes readmission rates so challenging for providers is that medication adherence, while important, is one of several factors that impact whether a patient ends up back in the hospital. Other factors can include a patient's socioeconomic status and the type of social support network he or she may have.
That's why some observers believe technological fixes provide a partial solution to the problem at best. Harvard's Jha and Robert Maliff, director of applied solutions for the ECRI Institute, note that follow-up calls made by pharmacists, nurses, or health coaches who review discharge plans or appointment times with patients can play a huge role in reducing readmission rates.
“It's the hospital's focus on discharge planning process,” Maliff says. “There may be technology solutions that may improve that, but they have to be incorporated into the process after discharge.”
Proteus, founded 10 years ago, has brought in a wide-ranging group of investors that includes Kaiser Permanente Ventures, the for-profit venture arm of the health insurer, and drug and device companies such as Medtronic and Novartis.
One of the biggest hurdles for the company will likely be tied to the fact that it is offering a new solution to a traditional system.
“Healthcare has never been the speediest innovator,” says Dr. David Lawrence, former chairman and CEO of Kaiser Foundation Health Plan and Kaiser Foundation Hospitals and an advisory board member for Proteus.
However, in the current environment, which encourages providers to remain competitive and to move forward with new risk-sharing payment models such as accountable care organizations, improving care while lowering costs is a “double win,” he says.
Savage declined to say how much the platform will cost in the U.S. but says the system will not be an “expensive medical technology.”
“We're trying to create value,” he says. “We're trying to save the system money from day one and participate in the savings … Frankly, we think that's been part of the problem with escalating healthcare costs, that every new product is intrinsically very expensive.”
In addition to the cost-effectiveness study that it plans to undertake this winter, the company is applying the technology in a number of different therapeutic areas worldwide.
Proteus has established partnerships with Novartis and Otsuka Pharmaceutical Co., a Japanese drug company, to build the sensor into the companies' products and then seek separate approvals with the FDA and in Europe for specific integrated drugs. Clinical trials with both companies are currently under way in the U.S. The sensor was cleared by the FDA to be incorporated into a placebo pill.
It is also working with the Gates Foundation in China to test the technology with patients undergoing tuberculosis treatment.
In the United Kingdom, Proteus plans to launch a new program with Lloydspharmacy, a pharmacy chain, early next year. As part of the program, pharmacists will include sensors in the blister packs that they put together each week for certain patients. The company, which is targeting family caregivers, says the technology will be paid for by consumers.
“There are a number of different avenues for this technology over time,” Savage says.