Customized Patient Care through Patient Support Programs for Rare/Orphan Drugs
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The document discusses patient support programs for rare and orphan drugs. It notes that orphan drugs have unique challenges including small patient populations, difficulty in diagnosis, and reimbursement challenges. Patient support programs aim to help patients access therapy and navigate reimbursement and clinical support. They provide services like financial assistance, nursing care, pharmacy services, and adherence programs. The goal of these programs is to allow patients access to treatment, assist them in coordinating care, and generate real-world data on drug effectiveness outside of clinical trials to help demonstrate value to payers and accelerate patient access.
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Customized Patient Care through Patient Support Programs for Rare/Orphan Drugs
- 1. Customized Patient Care through Patient Support Programs for Rare/Orphan Drugs March 5, 2015
- 3. Why Orphan Drugs are Different Difficult to diagnose Population size Unique patient and caregiver needs Cost Reimbursement challenges Wait times for Specialist Large amount of stakeholders involved to get patient on therapy There is no clear path to get Orphan Drugs Funded 3
- 4. Patient Support Programs for Rare/Orphan Drugs To help patients access therapy and navigate them through reimbursement and clinical support Diagnosis Confirmed: HCP writes RX for Patient Enrolment Medical directive Prescription Reimbursement Financial Assistance Bridging doses Nursing and Infusion Clinics Integrated Pharmacy & Distribution Web Portal Health Outcome Communication Adherence: Education Scheduling, Product questions & Reminder calls 4
- 5. Capitalize on PSP to generate real world data 5 Patient Support Programs — Objectives Allow patients to access commercial therapy Assist in the navigation of multidisciplinary services Coordinate patient logistic services (F/A, Pharmacy, Distribution, Nursing) Post – Marketing Surveillance and Real World Data - Objectives To track outcomes in real world setting To illustrate and prove value of drug Reimbursement – Objectives To gain coverage and funding with payers To gain coverage on behalf of patients Clinical Research To prove clinical efficacy and safety (Phase I–III) SAP NOC pre-launch post-launch
- 6. Managed Access: To demonstrate real world effectiveness and value to accelerate access for patients Health Outcomes Research Value to Payers Patient Support Program Demonstrate Real World Effectiveness and Value Our ultimate objective is to build a different framework for Orphan Drugs which will ultimately prove their value, and shorten the timelines for access 6
Editor's Notes
- Access & Evidence What does the future look like, and how will trends impact innovation? Patient Services What can you do to leverage your PSP to ensure confidence in data collection for Payers (Public and Private)? Business Strategy What are some best practices for building a commercialization strategy for an orphan product, and how should you leverage opportunities for repurposing existing products to meet the needs of orphan / rare disease patients? We want to present the “Current State” of Patient Support Programs – traditionally barriers which include: Diagnosis: time to diagnosis has been a hurdle for many rare diseases Enrolment: Ensuring trust in your PSP health case manager or care coach to assist patients in navigating the Canadian health care landscape Reimbursement: No existing regulatory pathway for rare or orphan diseases – the PSP is a strong advocate for patients to ensure they have the opportunity to access their prescribed therapy. Want to present the “Future State” of PSPs, with a targeted focus on: Data: There is a heightened need from payers to ensure that data captured from PSPs is credible. The goal is to ensure that the data is as credible as that of clinical trial data. With credible data, there is a more likely chance that Payers will cover products in a timely fashion. For the purposes of today’s talk we will endeavor to show: Current state of PSPs Future State of PSPs, including discussing the regulatory pathways to achieve coverage, and what solutions you can tie into your PSP to ensure future coverage.
- Current State PSP Model: The current model relies heavily on the following roles: Case Manager, and, Reimbursement Specialist Both roles are integral to any PSP for rare and orphan disease. A key role of the PSP is the integration of all services to support each patient. By tying all services together, the PSP can ensure adequate patient care through tailored health coaching and follow-up. Additionally, the manufacturer is able to drive patient and drug level data, both of which can substantially help in obtaining coverage or lobbying for coverage in Canada.
- Slide Animation: 1 This slide starts with Phase I, II, and III data collection: We want to discuss the parallel in collecting this clinical data to achieve regulatory HC approval (NOC), and the commonality this has with what payers are now asking for (real world effectiveness data). 2nd to this is SAP – this largely depends on what is currently available on the market – but typically in rare disease SAP is a great way to collecting data on patients. 3rd – we receive regulatory Health Canada approval (no change) 4th – we see Real World Data and PSPs as one. Typically, PSPs start upon NOC, however we may find a way to bridge the gap in starting a PSP. The benefit of doing this is collecting designing and collecting patient data up front. This will help to establish a regulatory orphan framework in Canada. Both should be tied together in any PSP, and both are largely dependent on the services that are offered through the program. It is our belief, that if you start these in combination and in tandem with the SAP / NOC process, then companies may have a greater leverage with payers in achieving coverage. 5th – Demonstrates the ways to collect information for purposes of achieving coverage with payers. It is our belief, that if we change PSPs to a registry based type of program, we will be able to collect pertinent information for payers. This information will ensure credibility of data, and will restore trust from a payer perspective in the data that programs can present as a means to obtain reimbursement 6th – Reimbursement (both private and public) – the types of information payers are requesting has changed dramatically over the past two years alone. For instance, some private payers require PLAs to achieve coverage, BIAs, and real world data. Additionally, with the onset of PPNs, payers are increasingly looking to PSPs to ensure patients remain adherent to therapy because of cost parameters.
- Payers are critical in the level of real world data that is collected by PSPs. More and more, payers are looking for credible sources from PSPs to demonstrate real world effectiveness data for coverage. More and more, Private Payers want to ensure that the drug the patient is taking, is actually working as it should (dosing, administration, etc.). By incorporating a registry or health outcomes data to your PSP you are able to track a patients journey on drug x and can demonstrate to payers the effectiveness of the drug.