Early access programs – benefits, challenges and the Sciensus solution
You have a novel therapy making significant progress in clinical trials and are already receiving requests for access from various markets. It’s a common scenario for pharmaceutical companies today. They face the challenge of supporting patients who lack alternative treatments, don’t meet trial qualifications, and often endure severe, if not life-threatening, conditions.
The challenge arises: when should companies contemplate the concept of early access? Some engage as early as phases I and II, while others wait until phase III/IIIb. The old saying holds true— it’s never too early to start thinking about your early access strategy!
Access programs broaden patient access by including those who don’t meet clinical trial eligibility criteria or by extending access to patients who have completed a trial. Despite the lengthy process of gaining marketing approval and finalizing product availability, access programs operate effectively in such markets.
The benefits of running an access program for both the pharmaceutical company and the patient are considerable.
Benefits for Patients
Considering early access presents various challenges. Despite no recent legislation limiting access, the interpretation of increased access varies widely. For instance, in Europe, the multiple procedures for marketing authorization complicate matters, leading to varying timelines for access in different countries. Navigating these diverse procedures and managing the associated hurdles becomes a critical task. Furthermore, anticipating both licensed and unlicensed supply in various markets during commercialization becomes necessary, requiring careful planning by pharmaceutical companies.
The risk of adverse events potentially disrupting a future commercial launch looms, emphasizing the crucial nature of well-structured access programs and patient eligibility criteria. Managing safety requirements and adverse event reporting is paramount. However, regulations surrounding early access limit product promotion, necessitating robust governance.
Balancing patient demand and supply, especially in the context of potential parallel clinical trials, presents another challenge. Furthermore, inequality may be perceived if access programs are only available in countries where the product can be monetized. Addressing these complex challenges is crucial for a successful early access strategy.
Access programs can be a huge success for both the Pharma company and the patients involved but it may be wise to seek support from a specialist provider such as Sciensus who have experience of running multiple programs across many markets.
Our project management approach for early access programs:
1. Navigating the Regulatory Challenges
Sciensus will support you with a full regulatory assessment of the countries you are interested in running an access program. This will cover advice on type of access program most suited to your needs, whether it can be charged for or not, what data you may be able to collect. We can also advise on your communication strategy. You will be supported by a dedicated project manager, and a multilingual customer service team. We will ensure health care professionals are properly validated and given access to our online ordering portal Sciensus Axcess. Registered healthcare professionals will be able to view documentation for the access program including product information and any relevant training materials.
2. Supply Chain Management
Our logistics teams will ensure product is delivered most of the time within 24hrs of order confirmation. We will ensure there is full track and trace capability to allow auditing of all activity. We can provide a full order to cash service. We will deal with any issues in an efficient, ethical and regulatory compliant manner.
3. Patient Support
If you require additional support for your patients, we can advise on a range of support services via our nurse lead patient support programs. We can support your clinicians with Individual funding requests as required. You will be provided with full transparency on the activities we carry out on your behalf with accompanying adherence to a range of mutually agreed KPIs.
When your access program completes as you move to commercialization in that country, we can also handle all your support needs for commercial supply.