HIStalk Interviews Julia Regan, CEO, RxLightning

Julia Regan, MBA is co-founder and CEO of RxLightning of New Albany, IN.

Tell me about yourself and the company.

I’m a long-time health tech innovator. I carried a bag in pharma and started my career in sales. Early on in my career, in the infancy of health technology, I worked for a manufacturer organization. I fell in love with the opportunity to connect different people, roles, and responsibilities across the healthcare continuum to try to create a better experience and world for patients.

The specialty medication market is one of the fastest growing spaces in the industry for drug spend, representing 52% of dollar volume with high-cost medications such as biologics, infusion meds, cell gene therapies, and even those involving personalized medicine. RXLightning brings that specialty medication process and journey for patients and providers into the digital arena.

Our end-to-end platform automates multiple steps of this process while connecting doctor, patient, specialty pharmacy, and drug manufacturers and  their support teams. Our digital platform, for the first time, creates visibility into the experience. The goal is to reduce administrative burden and waste in the healthcare system for the providers and those organizations that are working to help patients, but ultimately to get patients on therapy quicker in a more affordable way.

What is the overlap between specialty medication prescribing and prior authorization?

Prior authorization is definitely a component of gaining payer access and approval for these medications. But it’s not just the prior authorization, it’s also the cost component, which for these medications could range from tens of thousands of dollars up to a million dollars. Because the cost is so high, there’s an affordability component. Drug manufacturers create programs to help patients get access to therapy, helping go through that benefit investigation and that prior auth process, and also more affordability programs. That could be a bridge program, where patients get samples of the drug while they are navigating the access barriers; free drug for people who can’t afford it; and research around foundations and grants. It’s everything from access through affordability as well. We are a little different than the PA, but the PA is still a component of the journey.

What is the manual process that you replace?

If a specialty pharmacy is used, the doctor will send the prescription to the pharmacy and then wait. The pharmacy will reach out to them and say that a prior authorization required, so they will either complete a paper form or use a digital solution. The next step involves affordability. The pharmacy traditionally works through that process, but because the prescription doesn’t have any of the clinical information or patient financial information, there’s just a lot of back and forth among the pharmacy, the provider’s group, the payer, and even sometimes the manufacturer and their programs. This paper-based system is slow and creates inefficiencies due to missing information or ineligible information.  

RXLightning has created a technology solution for just under 1,300 medications that turns those processes into a single solution that walks a provider through that process digitally and also allows them to track their patients throughout. Instead of using Post-its, Excel, or manual processes that live outside the EHR, our technology system tracks that journey with a CRM type of tool.  

Why do manufacturers choose the specialty drug distribution model and what information do they require?

Because of restrictions and cost, a lot of parties along the way want validation that the clinical steps that are required for approval for a given patient have been documented. The traditional prescription information is one component, but it’s also contact information and caregiver information. Sometimes it includes the clinical history, not only from medications, but also height, weight, allergies, and medications that have been tried and failed. Many components that are part of that traditional prior authorization process are part of these referral forms and enrollment forms.

Then there are REMS medications, which are in the FDA’s Risk Evaluation and Mitigation Strategy because of serious safety concerns. Those have different criteria around authorization codes and compliance that in some cases must be submitted monthly.

Another component is consent, opting into different programs for the patient to share information from a HIPAA compliance perspective, as well as the provider consent to allow another party to work on behalf of them to help navigate through that experience. Also for sharing household income information if they are looking at grants, foundations, or free drug programs.

How laborious is the provider’s process and how long does the patient have to wait for approval before starting the drug?

The work of going through access, affordability, and patient data collection isn’t done while the patient is in the office. A patient who is sick now may have financial constraints with affording a medication that can change their life or even save their life. The provider has to call the patient and ask them to fill out forms. They either have to come in to the office or have it mailed to them, which could get lost.

That paperwork process can take weeks or months. With RxLightning, we see it done sometimes in less than 10 minutes. We communicate and capture the patient consent and information via text and email. The majority of referrals are completed in less than an hour compared to the 2-3 weeks it was taking before. 

What is the implementation process? Do you work individually with providers in a health system, or do they need to reach consensus as a group?

Our platform is extremely flexible and nimble, so we can support all of the different scenarios that are out there. If a large health system wants to install it, we go through a corporate business associate agreement, because PHI and patient data is being entered into our system. We traditionally go through security assessments, and we are HITRUST certified.

We have crawl, walk, or run approaches to implementation. We have a standalone portal that providers and users can be up on within minutes once we get through the business associate agreement and security assessment, if it’s required. The crawl approach is that we use our standalone portal and power it with Secure File Transfer Protocol, or SFTP, data exchange. That’s really just around how we are going to exchange information, pulling exports out of the EHR, having that load patients into our system, and then pushing the data from our system back into the EHR.

Our run is being able to do fully single sign-on capabilities or API integrations with the EHR and embedding our platform into those systems. That requires an implementation group and technical support from the health system. Our standalone platform is completely free to provider groups. 

How are insurers managing biosimilars? Are they asking patients to change their specialty drug prescriptions or do they require a different process?

That’s a really interesting question, and I don’t think there’s a exact answer. Each payer is going to create their clinical policies into their rules based upon what their clinical team assesses coverage should look like. There are multiple steps in this process, and our platform does pharmacy referrals. If a health system doesn’t have access to limited distribution and it’s at a single-source distribution pharmacy, they can send the clinical information and package it up over to that pharmacy. Then we close the loop back to the health system pharmacy with the details so they can create a better experience for the patient.

We handle the investigation, pricing, and coverage. There is a PA component of our platform that could be used. It’s very modular, though, so if they already have a solution in one of those, we could plug those into the platform. Then we handle all of the foundation, grant, free drug, and affordability components in our platform. What we’ve looked at is that across that end-to-end experience, we’ve created a tool where it’s up to the health system, providers, and users on how they want to navigate through it and use it. 

Regardless of what the payer criteria are or the decision-making, around the biosimilars, for example, offices can use our platform to navigate those decision points, and complete the processes for all of them in one location, to navigate the patient quickly and efficiently to a therapy that the payer is going to cover and approve.

How have market conditions affected your strategy?

They haven’t impacted our strategy. So many inefficiencies exist across this journey that health systems and provider groups need a solution. RxLightning has approached it from a brand- and drug-agnostic perspective. We haven’t isolated it to one therapy, one disease state, or a limited portion of drugs. We’ve opened it up and said that we are going to try to solve this process for all of these medications across all of these different steps, which today is being done by different vendors or organizations, most of the time on paper. Organizations see that our platform solves many inefficiencies on their team and the work that they are doing. RxLightning helps alleviate provider burnout  because it makes this process so efficient.

It’s not just about the efficiencies upstream, because when you use paper and faxes, inefficiencies happen while you are awaiting a response. The communication back to the provider’s offices creates call lags and call volumes and it’s sometimes uncontrollable for organizations. We work to plug into the different destinations across this journey — manufacturers, different specialty pharmacies, different parts of the process — to close the loop with information back.

If a provider has a patient who needs a cancer medication and can’t afford it, they can go in our system, see all the grant information, and make a decision whether to apply for a grant. If the grants aren’t of open and foundations aren’t open, they can do the manufacturer’s program. We will provide the response back around the approvals or the denials so they don’t have to constantly look, make phone calls, or answer phone calls. That gives transparency through that whole process while also allowing the patient to see updates across the journey.

What will be important to the company over the next few years?

We are looking to expand our provider base. We know that when our platform is used, it saves much time for offices and helps patients get on therapy much quicker in a more affordable way. We are used by some of the largest healthcare systems today, so growing that base and then providing all the digital connectivity points into the drug manufacturer programs, the hubs, and the specialty pharmacies to have a 100% digital, interoperable ecosystem that exchanges information is critical to the success for the industry, patients, providers.