Clinical Assessment Program (CAP)

No, the CAP SaaS modules for pharma are designed for use by clinics, not patients or caregivers.

This is related to our Access module and we recognize that some MDs want to have the PSP forms populated into their EMRs and clients are making investments into these. However, there are some MDs that won’t and don’t use them – so our Access module will be useful for those MDs. That said, the Access Module is an option and can be something you test during the 30-day trial period.

No, the CAP SaaS modules purchased by clients do not collect reportable AEs. The modules simply “turn on” functionality to data that is already in use by physicians and highlight client-specific, evidence-based, information of interest, auto-populate forms and generate anonymous, de-identified, aggregated reports. Like an EMR, any identified AEs are reported by physicians per their local guidelines.

No, CAP is not a PSP and is not geared at patients or caregivers. The CAP is a clinical assessment tool geared at clinics to support the easy and expedited identification of their patients who are ready and formulary eligible to start a specialty therapy.

No, CAP simply consolidates existing information into a single easy to use screen for clinics. This allows for expedited identification of patients ready and formulary eligible to start specialty therapies.

No, CAP is not a medical device per Software as a Medical Device (SaMD): Definition and Classification. Section 2.2 Exclusion Criteria.

Data flows to and from the patient record in several ways depending on physician/clinic workflow and EMR usage. Our system allows for clinics to transfer/integrate data via download/upload protocols. When a clinic is first onboarded, we work to understand their workflow and EMR usage (which we have found to vary widely). We can download data from the EMR into the CAP system.

CAP can be used with new patients who are immediately identified as moderate to severe as a way to monitor during the use of methotrexate etc., OR for patients currently on a specialty therapy. Depending on clinic workflow and patient record resources, we may go back as few as the last 2 clinic visits.

As we need to be fair balanced, all specialty products will be represented in CAP with publicly available formulary criteria. That said, only companies that participate in CAP modules will enable the ways to differentiate to prescribers within CAP.

• Integration of patient profiles/special programs to help flag patients who are ready and eligible for therapy (identification module)
• Integration of PSP forms (for auto population), special access forms and any poster evidence or other info that they wish to have reach MDs for the halo effect of time and cost savings for both clients and for MDs (Access module)
• Integration of reporting preferences – so that the right people at the client can access the deidentified, aggregated, clinic-level data

HOWEVER, in these early launch days, there are some first mover advantages as well, because clients will be able to provide some input on our clinic notifications and data point collection (clinic level and patient level).

Lyceum’s CAP is a SaaS platform delivering standard service offering. Pharma is not involved in, nor does it influence, the design of the platform and does not have ownership of it.

No, Lyceum’s CAP does not act on behalf of the pharmaceutical industry with patients, caregivers and HCPs. The CAP is an “above the brand” product that provides certain benefits to pharma clients without acting on their behalf. Pharma clients remain at arm’s length and there is no connectivity between Pharma and clinics or their patients.

No, CAP is not a program where the purpose is to solve practice inefficiency, day to day administration or operational responsibilities of the practice. CAP is a medical practice activity that has the sole purpose of closing gaps to improve patient care by helping physicians access data to determine patient readiness and formulary eligibility. IMC 15.1.2.

No, the CAP system has been independently developed and is maintained independently by Lyceum (analogous to an EMR add on). What clients pay for are SaaS modules inside Lyceum’s CAP that enable functionality to (a) highlight client-specific information for clinics that expedites identification of patient candidates ready and eligibility for therapy, (b) improve awareness and utilization of drug access programs and (c) receive anonymous, de-identified, aggregated reports.

The price for Lyceum’s CAP services are comprised of integration (set up) along with variable amounts based on usage of the SaaS modules available. Cost is dependent on which modules are chosen and if customization is involved. Trial prices are available to allow clients to try the CAP and scale as they deem appropriate.

We tailor the reports for pharma based on their internal requirements (medical vs marketing vs sales) and the reports can be released periodically OR on demand through Lyceum’s client portal.

Patients own their data, physicians are the custodians of the data and Lyceum has certain approved access to the data to create aggregate trend and activity reports.

All data is stored in Canada.

All data is encrypted in transit and at rest and is regularly and rigorously penetration tested by a 3rd party.

Lyceum applications adhere to all Canadian privacy and security laws and regulations. No personally identifiable patient data is shared with clients.