Roadmap Preview: Bringing Precision Dosing To New Therapeutic Areas

One of the main objectives of the InsightRX Nova platform is to help our customers get to the right dose for their patient as quickly and efficiently as possible. We developed a pharmacokinetic model auto-select to choose the model likely to provide the most accurate predictions for different patient subpopulations. We will continue to refine this model auto-select, incorporating the findings of our Data Science team to help choose the best model for every patient. 

Our team is also developing an outlier level detection feature, which assesses for the possibility of a faulty or erroneous drug level sample based on how well it aligns with the other measure levels for your patient. If an outlier is detected, you will be alerted that this particular level is likely to be faulty, and will be given the option to exclude it from calculations. 

Most excitingly, in 2022 InsightRX is expanding beyond our core modules—vancomycin and  aminoglycosides in infectious disease, and busulfan, fludarabine and anti-thymocyte globulin (ATG) in bone marrow transplant—to new areas of focus. Specifically, we are focusing on three key areas: azole antifungal drugs, solid organ transplant drugs, and inflammatory bowel disease biologics. 

TDM and Drug Formulation Selection for Azole Antifungals 

We are developing modules for nearly every commercially available azole antifungal, including voriconazole and posaconazole, as well as itraconazole, isavuconazole, and even fluconazole. Clinicians clearly want to be able to improve dosing in azole antifungals, whether to meet the challenge of dosing adjustments with the non-linear kinetics of voriconazole, or to better navigate the logistical challenges and limitations of sampling when there is limited laboratory capability to process samples. 

The transition from intravenous to oral administration can also prove difficult when trying to ensure therapeutic exposure. To help meet this challenge, we are building the drug modules with the capability to include both oral and intravenous formulations for dose administrations, and to allow clinicians to look at predictions for both intravenous and oral regimens, all within the same user-friendly dashboard.

TDM and Regimen-Based Outpatient Dosing for Solid Organ Transplant Drugs 

We are also developing modules for a suite of solid organ transplant drugs, headed up by tacrolimus, and including mycophenolate, cyclosporine, sirolimus and everolimus. Clinicians practicing in solid organ transplant tell us that one of the primary challenges in dosing these drugs is getting patients to a therapeutic exposure quickly in the period immediately following transplant surgery. Meeting this challenge is important, as it is often a key component to being able to discharge a patient from the hospital. And beyond rapid target attainment, there is a growing movement in the literature, just as with the azole antifungals, to forego dosing targeted to troughs in favor of AUC-guided dosing.

After discharge, the outpatient arena presents a whole host of new challenges. Patients are often on these medications for years, and between medication adherence issues and poor historians, it can be nearly impossible to document an accurate dosing history. Patient preferences also come into play, with many patients desiring a drug regimen that suits their lifestyle, including the option for a “drug holiday.” To help with these outpatient-specific challenges, InsightRX is developing an outpatient dosing mode, allowing clinicians to enter a regimen history rather than a dosing history. Instead of entering every individual dose, clinicians will be able to enter just the drug regimen and start date, as well as any changes made to that regimen, and have the platform interpret the levels accordingly. 

Managing Anti-Drug Antibodies, TDM, and Prior Authorizations for Inflammatory Bowel Disease Drugs

Inflammatory Bowel Disease (IBD) has traditionally been managed by gastroenterologists, to the exclusion of pharmacists. However, with the increasing need for therapeutic drug monitoring and knowledge of pharmacokinetics in managing these drugs, that structure has been changing. InsightRX is working closely with physician groups to develop our IBD monoclonal antibody drug modules, and we see it as an exciting new opportunity for pharmacist/physician collaboration.  Among the monoclonal antibodies used in treatment of IBD, we are focusing first on infliximab, followed by adalimumab, certolizumab, golimumab, and vedolizumab. 

When it comes to optimization of monoclonal antibodies, a primary challenge is the slow titration period; in the absence of software, levels are traditionally drawn at approximate steady-state. Even with an intense induction period, getting to steady-state exposures can take longer than six weeks, which means that any dose titration has inevitably had to occur over the course of months. 

InsightRX is able to interpret levels at any point in therapy, even after a single dose. This means we have the ability to dramatically shorten the titration period for these drugs. With state-of-the art pharmacokinetic models, our platform can also incorporate anti-drug antibodies into predictions. With this feature, clinicians can make informed decisions regarding whether a low exposure from anti-drug antibodies can be overcome by an increase in dosing, or if it would be best to switch to a different drug altogether. 

For IBD, physicians tell us they often struggle to get approval for dose escalations, as it can be difficult to present evidence-based data that supports dose escalation in a single patient. With the regimen- and patient-specific exposure predictions in InsightRX, we can demonstrate that a higher dosing regimen would bring the patient’s levels to within the accepted therapeutic range, whereas the current regimen may result in an unacceptably low exposure.

 To make this even easier, we are working with physician groups and payer groups to develop exportable documentation for use with prior authorization requests. InsightRX will automatically export exposure information into the document, and clinicians will be able to further customize the content to provide all the information that a payer will need to make an authorization decision.