Designing a compliant patient navigation framework for high-risk cardiovascular patients

Challenges

High-risk patients aren't always following up on secondary prevention

Cardiovascular events are among the strongest signals that a patient needs active, ongoing cholesterol monitoring. But in practice, many patients who've had a heart attack, stroke, or cardiac procedure aren't returning for regular LDL-C testing, missing a critical window for preventing a second event.

The gap wasn't awareness of cardiovascular risk in general. It was the absence of a clear, low-friction path from "I should probably get my cholesterol checked" to "I booked a test." Traditional disease awareness campaigns create interest but don't connect it to action, and pharma's regulatory guardrails make it difficult to build a direct-response patient journey without crossing promotional lines.

The brand needed a patient awareness program that could identify high-risk individuals, educate them without promoting a specific treatment, and route them to clinically appropriate next steps, all within Medicines Australia Code of Conduct requirements.

Solutions

A brand-agnostic awareness and navigation program, MLR-approved end to end

RoseRx partnered with the brand and their creative agency to design a full patient navigation framework. The program was built on four principles:

• Brand-agnostic by design. The platform provides disease education and care navigation only. It does not promote, recommend, or reference any specific medicine, brand, or treatment.

• Multiple clinically appropriate pathways. After completing an eligibility screener, patients choose between an LDL test at a participating community pharmacy, a telehealth GP consultation for pathology referral and specialist care, or an in-person GP appointment. No pathway is prioritised over another.

• Vetted partner ecosystem. Community pharmacy partners for in-person LDL testing and a vetted telehealth provider for virtual consultations, with AHPRA-registered clinicians, formal clinical governance, and medical director oversight.

• Data minimisation throughout. De-identified screener responses, aggregated engagement metrics, and optional email only. No clinical records, no Medicare numbers, no consultation notes stored on the platform.

The program included a complete governance framework, pre-launch compliance and privacy review, change control for screening questions and partner relationships, incident management procedures, and a risk register covering compliance, reputational, privacy, operational, and partner risk areas.

Program design outcomes

A regulator-ready patient navigation framework, built once and reusable

Together with the brand and their creative agency, RoseRx delivered:

• A complete MLR-approved disease awareness and navigation program, from campaign creative to landing page to screener logic to post-screener routing

• Three operational next best action pathways, integrated with vetted pharmacy and telehealth partners

• A full governance framework covering data handling, privacy, clinical governance, incident management, and partner oversight

• Documentation aligned with Medicines Australia Code of Conduct, HIPAA safeguards, SOC 2 Type II standards, and AHPRA clinical governance requirements

• A provider-agnostic platform architecture that can support alternative or additional service partners without modification

The framework is reusable across other cardiovascular awareness initiatives and demonstrates a repeatable model for pharma-sponsored disease awareness programs that meet regulatory, compliance, and patient experience standards simultaneously.