Managed access programs – also known as compassionate use, early access, and named-patient programs- have clear benefits for patients and physicians. These programs provide an alternative regulatory pathway to help patients access potentially life-altering drugs when they are ineligible for clinical trials or the drug has not been approved in their home country.
Historically, the benefits for pharma have been less obvious, though. Some companies feared that there could be risks involved that could derail marketing authorization – or at best pose an unwelcome distraction to product launch planning,
Rethinking Managed Access
All of this is changing. Forward-thinking drug developers are beginning to recognize that managed access programs have multiple benefits for companies as well as patients. This is especially true with rare diseases, when time is of the essence and there is great unmet need.
Planning a managed access program as part of your overall product strategy can help patients at a time of critical need – and it can also benefit you by:
- Providing aligned and enriched data capture for treated patients not in the clinical trial
- Driving early exposure, experience and uptake of the treatment, so KOLs can share real experiences and data pre-approval
- Developing a bigger cohort of early adopters and opinion makers by giving a broader group of clinicians insight into the efficacy of the product in the real world
- Setting benchmarks for price, treatment protocols and standard clinical practice within different territories before the treatment is approved
- Providing additional data and safety data available at the point of regulatory filing
- Increasing the commercial benefits when launching a product into competitive markets
Finding A Good Partner
Of course, all of these benefits can only be achieved if you have a good strategy in place. For one thing, regulations surrounding managed access programs vary from one country to another. To navigate global markets, you need a partner with a deep understanding of local regulatory requirements who will deliver a fully compliant, timely and cost-effective solution.
A strategic partner can also help you leverage the opportunity to collect real-world evidence at the point of care. This clear insight into the patient’s experience and response can provide invaluable business intelligence to optimize lifecycle management and product strategies to meet commercial expansion.
Our model delivers better outcomes for you and your patients. With deep operational expertise and proprietary technology, we provide a seamless program delivering real-world evidence. If you need support in developing your approach to managed access, we will consult on the development of global medicines access strategies, designing solutions to meet the needs of clients and their patients.
Our team includes biopharma industry, healthcare and patient services professionals who share a passion for excellence and unmatched expertise, with more than 25 years of experience in global managed access and rare disease. We believe our offering is different and will help your products achieve full commercial potential.