As drugs go to market, pharma companies must navigate multiple revenue challenges to succeed: from understanding how to provide truly patient-centric care that supports each person on therapy to differentiating from other drugs at every stage of the drug’s journey (from launch through to loss of exclusivity), while also considering how to secure a fair price for therapies and a favorable formulary position from payers and providers.
Due to these challenges, software medical devices (SaMD) have often struggled to secure adoption in the pharma industry. An important barrier to this has been the lack of a clear regulatory framework that allows companies to make claims about the clinical benefit that these solutions provide to the drug asset.
In 2023, this changed with the introduction of draft guidance by the FDA — “Prescription Drug Use-Related Software” (PDURS) — that addresses this challenge by providing a regulatory framework that enables SaMD to be added to a drug label. This framework should enable companies to capitalize on the many opportunities and benefits of using SaMD, including Digital Therapeutics (DTx).
This blog will explore how to navigate PDURS to generate value for branded drug products. Below, you will find everything from the opportunities and challenges presented by the regulatory framework to what its introduction means for the future of the industry.
PDURS enables SaMD to be added to the drug label (typically in the clinical study section of the label). This framework is flexible, and the SaMD can be prescribed to patients who find it most beneficial. Not making it mandatory for everybody enables care to be tailored to each patient’s needs and preferences. To qualify as a PDURS, SaMDs should provide meaningful safety or efficacy clinical benefits to the drug. Pharma is then able to directly promote the value it provides to the drug to patients, doctors, and payers. The regulatory pathway is a supplementary NDA or BLA submission to the FDA with a moderate level of clinical evidence.
PDURS sits on the continuum of regulatory strategies available to pharma for SaMD and DTX. It compares with other SaMD and DTx regulatory options:
While PDURS offers many advantages to pharma, real challenges must be addressed in the PDURS draft guidelines and navigated together with the FDA. Pharma feedback on the draft guidance has identified the following main challenges:
While PDURS is a draft guideline, we recommend that Pharma interacts early with FDA to align on the approach to be taken with their PDURS, and leverage FDA’s latest thinking on the PDURS pathway and reflections on industry feedback.
Deciding whether to choose the SaMD or DTx route is a strategy question, and it is critical to determine the benefit of adding PDURS to the drug label.
Existing DTx are designed to address targeted disease areas that constitute a meaningful defined patient population, living with a disease or condition, that has a commercial path to market, and can be clinically proven to have an impact as a standalone prescription digital therapeutic (see figure for the set of DTx that have secured listing in Germany’s DiGA).
Partnering with a DTx that addresses the target population and strategic intent can be a good option for pharma. The key aspects to assess are the extent that the DTx has proven clinical evidence, secured regulatory approval, and demonstrated adoption and persistence to the DTx in a real-world setting. And then whether a win-win business model can be created, that delivers value to the pharma drug asset at a cost-point that makes it worthwhile for incremental value added to the drug.
Unlike traditional molecules, digital therapeutics require continuous evolution and active market engagement to maintain their therapeutic effect, as their efficacy is inherently tied to ongoing software updates and user engagement. The pharma company needs a voice in DTx roadmap discussions to ensure that changes crucial to its patients and therapies are prioritized.
Another viable option for pharma is to create a dedicated, differentiated, and crafted SaMD. Here pharma has control over the solution but will need to identify a partner who can deliver at a solution level so that pharma does not need to specify and manage each detail of the development and operations of the SaMD.
There is a category of digital health platform companies (including S3 Connected Health) that have the ability to quickly create differentiated solutions and take on more system-level responsibilities to overcome these challenges.
In both cases, the Pharma company would need to invest in the clinical study that shows the impact of the SaMD on the drug product. This study design would need to be aligned with the FDA in advance to ensure that it meets the agency’s interpretation of a ‘well-controlled study’
SaMD and DTx are software and content (such as videos, text, audio, etc.). They must be kept up to date to secure and retain product market fit. Pharma has two main pathways to manage this in the US:
We see PDURS as an important piece of the puzzle to address key challenges for pharma. PDURS enables pharma to make claims to patients, doctors, the FDA, and payers as to the clinical impact software medical devices have on the drug, and add it explicitly to the drug label.
Assuming the FDA takes on board industry feedback, we anticipate that for many medicines, a SaMD under PDURS may become a necessary part of drug asset strategy to:
To learn more about how S3 Connected Health acts as a digital health partner for Pharma to create and operate customized, disease and therapy focused software medical devices, reach out to us.