Tailored Expanded Access Programs
Durbin is a full-service, 360° Expanded Access partner to pharmaceutical and biotechnology manufacturers. We strategically design and implement tailored, value-added Expanded Access Programs (EAPs) in over 160 countries.
Tailored Expanded Access Programs
Durbin is a full-service, 360° Expanded Access partner to pharmaceutical and biotechnology manufacturers. We strategically design and implement tailored, value-added Expanded Access Programs (EAPs) in over 160 countries.
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Our specialized, full scope of EAP services has been developed to deliver the highest quality and end-to-end support for expanded access programs, while helping connect the ecosystem and providing all stakeholders with optimal value.
Success in Expanded Access Program Delivery
Durbin’s Expanded Access Programs help to provide patients with unmet medical needs with timely and reliable access to emerging therapies for improved patient outcomes. Global reach, local expertise and a passionate team of high-caliber experts ensure global EAP success.
Success in Expanded Access Program Delivery
Durbin’s Expanded Access Programs help to provide patients with unmet medical needs with timely and reliable access to emerging therapies for improved patient outcomes. Global reach, local expertise and a passionate team of high-caliber experts ensure global EAP success.
We are proven experts in delivering EAPs for rare diseases and specialty pharmaceutical products, including gene and cell therapies.
We take a tailored, strategic approach to EAP design for innovative and adaptive programs meeting the needs of all stakeholders.
We provide a high touch point, “white-glove” service that ensures exceptional support for sponsors, physicians and patients alike.
We replace risks and concerns with certainty and control. Our sophisticated and reliable global distribution capabilities and wholly-owned brick-and-mortar warehousing infrastructure make Durbin your logical partner for EAPs.
We have global reach from our wholly-owned warehousing and distribution hubs in the EU, the U.K. and the U.S.
As part of Uniphar, a diversified healthcare services company, we are a secure and reliable EAP provider, helping customers de-risk their EAPs.
With our sophisticated uniphi online portal underpinning all EAPs, we maximize stakeholder value and engagement by streamlining EAP processes, capturing Real-World Data (RWD) and generating powerful reporting and data insights.
We have assembled a strong and passionate team of experts from a broad set of pharmaceutical industry backgrounds, offering our clients their expertise across multiple therapeutic areas, drug types and a global perspective on EAPs.
We are dedicated to helping improve patient outcomes and to optimize physicians’ experiences with a tailored and patient-centric approach to program planning.
An Expanded Access Program, or EAP, gives patients with high unmet medical needs access to therapies that are not yet commercially available or approved in their country. Such programs are also known as "early access," "managed access" or "compassionate use programs," depending on the regulatory framework in different regions.
Often, patients with serious or life-threatening conditions, for which there are no other suitable treatments, are not eligible or able to participate in the clinical study for investigational drugs being developed for their condition. After clinical studies are complete, there can be a considerable time lag before the treatment reaches the commercial market, which can interrupt the availability of treatment for patients.
Expanded Access Programs offer patients an opportunity to receive treatments which otherwise may not be available to them.
Recent regulatory advances, including the PRIME scheme (EMA) and Breakthrough Therapy Designation (FDA), have improved that delay somewhat but it can still be lengthy. So, an EAP — whether it be offered for free or charged — is the only potential way during that window to make a significant difference to patients’ quality of life or to their outcome. For sponsors, offering their therapy via expanded access programs is a vital step in the commercial launch, with compliant stakeholder engagement, RWD collection to support payor and HTA negotiations, and increased awareness of the therapy.
Expanded Access can be run on a “named patient” or “compassionate use” basis, whereby there is no central protocol, and HCPs can request that individual patients take part. Alternatively, more formal programs known as “cohort” or “group” programs’ are designed with an indication-specific treatment protocol and are subject to local health authority approvals. A well-designed global EAP is responsive to the sponsor’s commercialization objectives and meeting patient demand, takes into account the complex global regulatory framework requirements, and utilizes the optimal regulatory pathways across its geography.
Expanded Access can be a complex area, but we can help clear up the many questions different stakeholders — manufacturers, HCPs, patient groups, patients and caregivers — often have.
What is an Expanded Access Program (EAP)?
Expanded Access Programs provide therapies that are not yet commercially available to patients who cannot participate in a clinical study, but who have a serious or life-threatening disease for which their physician has determined there are no appropriate treatment options. Expanded Access Programs are also referred to as Managed Access Programs, Compassionate Use or Early Access.
Are sponsors required to have an EAP for their investigational drugs?
There are no regulations that require companies to provide an EAP for their investigational or locally unlicensed drugs. However, as patient and physician demand for access to investigational/unlicensed drugs outside of clinical trials grows, many companies now actively offer EAPs for their therapies for several reasons. First, EAPs help address the unmet medical needs of patients, while also allowing sponsors to build awareness, gather valuable Real-World Data and assess market demand.
To comply with the 21st Century Cures Act, sponsors with ongoing Phase 2/3 clinical trials in the U.S. are required to publish EAP policies on their company website.
What are the benefits to sponsors of conducting an EAP?
Offering an EAP for a rare disease therapy is now a vital step in the pre-commercial launch process.
Allowing access to a therapy via an EAP can prove beneficial in the following ways
Patients in need get access
EAPs can help address critical unmet needs, fairly and sustainably
Increased awareness of therapy
Early access to a therapy through an EAP can open doors to new potential prescribers in advance of any commercial launch
Positive press & stakeholder engagement
EAPs strengthen company reputation and CSR
Faster post launch prescribing decisions & improved diagnostic knowledge
Increased awareness and confidence in a therapy as a result of an EAP often translates to faster prescribing decisions post-commercial launch.
Tests the market
An EAP will give a good indication of likely demand and expected post-launch sales
Ability to collect real world data
In many cases Real-World Data (RWD) may be collected from patients participating in an EAP
Can a sponsor refuse to enroll patients in an EAP?
As with clinical trials, EAPs have inclusion and exclusion criteria set by the Sponsor. The Sponsor reserves the right to refuse access requests.
Can a sponsor limit the number of patients they include in their EAP?
Yes. In certain cases, a sponsor may choose to restrict the number of patients who can gain access to their EAP. This may be due to limited resources being available or manufacturing constraints, among other potential reasons.
In which countries can you run an EAP?
The vast majority of countries have regulations that allow for patients to access locally unlicensed therapies; however, these vary significantly between countries. Durbin has significant experience in helping sponsors navigate these complex global regulatory pathways.
Can sponsors charge for therapies provided through an EAP?
Yes. In the majority of countries sponsors are permitted to charge for access to a therapy through an EAP. Durbin’s team of experts can provide detailed guidance on which countries allow for charging, including any restrictions.
Can sponsors collect data from patients participating in an EAP?
Yes. EAPs offer a great opportunity in which to collect additional RWD from patients on treatment. As a result of this, most sponsors choose to include some element of RWD collection in their EAPs.
The reporting of safety data, such as adverse events during EAPs, is often mandatory and governed by local country regulations.
Durbin utilizes its proprietary online portal, uniphi, to facilitate the collection of high-quality RWD, such as Patient Reported Outcomes (PROs), that may be used for a variety of purposes.
Our team is more than happy to start a conversation regarding your drug assets and goals, expanded access program options, and questions.
Our experience, people and global capabilities make Durbin one of the leading expanded access service providers in the rare disease and specialty product space.
Having designed and implemented successful EAPs for well over two decades, we have built enviable global regulatory knowledge, therapeutic area expertise, robust processes and a deep understanding of the needs of different stakeholders.
We can handle every aspect of the design and management of your EAP. We partner with you throughout and beyond the life cycle of your project, from design and implementation of your EAP, to global regulatory compliance, site management, physician training and shipment logistics.
Our expert team contributes heavily to the ongoing Expanded Access global discourse. Our Resource Center offers a range of key insights into EAPs and a space growing in its significance to all relevant stakeholders.
