Biogen and others are seeing the value in, particularly, non-prescription digital therapeutics, as complementary companion therapies to disease-modifying drugs.
Digital therapeutics can help enhance the disease-modifying drug development process.
Digital therapeutics are transitioning from curiosities to valuable additions to the pharmaceutical armamentarium, but they’re still not common in mainstream medicine.
These novel therapeutics aren’t necessarily designed to replace drugs. Instead, digital therapeutics are said to “wrap-around the pill” as “pill+” strategies to treat the symptoms the drug doesn’t manage.
“We’re entering an exciting phase of the field,” James R. Williams, Ph.D., head of external innovation and alliances at Biogen Digital Health, told BioSpace. “A lot of the initial digital therapy entrants targeted cognitive behavioral therapies and made them more broadly available during COVID. Now we’re now seeing other innovators entering, asking what more can be done. There are a lot of opportunities.”
Neuromodulation is one promising area. Biogen and MedRhythms have partnered to develop a prescription digital therapeutic (PDT) to improve the gait of multiple sclerosis (MS) patients. The digital therapeutic is similar to what MedRhythms designed for stroke patients and uses music to modulate the neural circuitry to improve patients’ ability to walk. Another company, Cognito Therapeutics, is using light modulation to clear amyloid beta from the brain. Additional projects focus on developing therapeutics that use magnetic or electrical stimulation to address other neurological disorders.
Companions to Disease-Modifying Therapies
Chronic disease offers a lot of opportunities for digital therapies, too, where they can be used in conjunction with the underlying disease-modifying therapy to provide more holistic care.
“The promise of digital therapeutics is that a lot of these therapies are low risk,” Williams said. “Many can be administered at home when it’s convenient for a patient, which also can make certain things more accessible…” by minimizing the need to travel to a therapist in a rehabilitation setting. Dealing with symptoms – such as stress, anxiety, depression, fatigue and pain – that the disease-modifying therapy may not address can help improve patients’ adherence to their prescription regimen,” Chris Wasden, chief strategy officer at Twill, a New York-based company designing digital therapeutics, told BioSpace.
Currently, digital therapeutics are divided into non-prescription digital therapeutics (NPDTs) and PDTs. “For pharmaceutical companies, the two have different value propositions…and different business models,” Williams said. “PDTs are designed to treat a medical condition or disorder, and NPDTs are designed to manage the symptoms of a disorder.” Both can be synergistic to drug- and biologic-based therapies.
The biopharma industry is interested in each, to varying degrees. “At Twill, we talk with the top 25 state-of-the-art pharmaceutical companies on a regular basis. They (largely) aren’t interested in PDTs, but they are interested in NPDTs,” Wasden shared. “Both are [U.S. Food and Drug Administration]-regulated products, but there is a significant difference in the amount of evidence required and market access.”
NPDTs Attractive to Big Pharma
To make his point, Wasden outlined the high cost of conducting clinical trials for PDTs and their significantly smaller return on investment compared to pharmaceuticals as a reason for the interest in NPDTs.
“A PDT will have to go through the FDA and probably have a randomized control trial. It may take two to three years and $5 million plus to bring it to market,” he said. “For pharmaceuticals, that’s a drop in the bucket, but for digital therapeutics, it’s a lot of money.” Then consider reimbursement. Currently, he said, “The most expensive digital therapeutic in the U.S. is priced at about $1,650.” In Germany, which has a framework for digital therapeutic regulation and reimbursement, digital therapeutics cost around $1,000 at the high end. A drug or biologic for multiple sclerosis, however, costs about $50,000 per patient per year. Therefore, Wasden concluded, “A PDT won’t make a material difference in (a biopharma company’s) profitability.”
NPDTs, however, have a lower burden of evidence and a different business model than pharmaceuticals.
“When companies embrace an NPDT, I think the synergies with the business model are toward patient services...such as in improving drug adherence and patient education, for example,” Williams said.
Therefore, “We see examples of biopharmaceutical playing in both arenas.”
In June, Biogen announced a collaboration with Twill (then known as Happify Health). Together, the companies will provide a digital solution for patient education and engagement for those with MS. The intent is to help MS patients manage their care, enhance well-being, learn about therapeutics and connect with other patients and disease experts.
A Lack of Infrastructure
The digital therapeutic space is being hampered by the lack of reimbursement infrastructure. In the U.S., “There are still barriers to reimbursement,” Williams pointed out. “There is no available CMS code (for Medicare and Medicaid) that lets providers bill for digital therapies.” That’s beginning to change.
Last March, the Access to Prescription Digital Therapeutics Act of 2022 was introduced in the U.S. House of Representatives as H.R.7051, where it was referred to the Subcommittee on Health; and the following day as S.3791 in the U.S. Senate, where it was referred to the Committee on Finance.
As the infrastructure around digital medicine matures, “Biogen is thinking about the opportunities to partner with companies in this space, bringing our experience in neurosciences from a clinical development perspective and also from a commercialization perspective to bring innovative solutions to address unmet patient needs,” Williams said.
Broadly speaking, collaborations between technology and biopharma companies are win-win endeavors that can help the digital therapeutic reach a larger audience than if the technology company operated alone, and bring innovative solutions to patients that are beyond the scope of drugs or biologics.
“We (as an industry) are still in the early days of piloting productive relationships that both benefit the patients we serve and make sense from a corporate collaboration perspective,” Williams said. “When it comes specifically to digital therapeutics, whether prescription or non-prescription, the entire field is still optimizing the go-to-market model,” trying to find a business model that is sustainable over the long term.
