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Durbin Expanded Access Programs

Durbin is a full-service specialist 360° partner to pharmaceutical and biopharmaceutical organizations. We strategically design and implement tailored, value-added Expanded Access Programs (EAPs) wherever and whenever required.

Durbin Expanded Access Programs

Durbin is a full-service specialist 360° partner to pharmaceutical and biopharmaceutical organizations. We strategically design and implement tailored, value-added Expanded Access Programs (EAPs) wherever and whenever required.

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Why choose Durbin for your EAP?

Our full-service EAP capabilities have been carefully curated to design and implement end-to-end programs that connect the ecosystem and provide all stakeholders with optimal value.

globe
180
countries served
medal
25
years' EAP experience
Caring ribbon
20000
rare and oncology disease patients treated

Expanded Access Programs

Durbin’s Expanded Access Programs provide patients with unmet medical needs timely and reliable access to emerging therapies for improved patient outcomes. Global reach, local expertise and a passionate team of experts ensure global EAP success.

Expanded Access Programs

Durbin’s Expanded Access Programs provide patients with unmet medical needs timely and reliable access to emerging therapies for improved patient outcomes. Global reach, local expertise and a passionate team of experts ensure global EAP success.

rare diseases

We are experts in delivering EAPs for rare diseases and specialty products, including gene and cell therapies

Tailored

We take a tailored, strategic approach to EAP design to develop innovative and adaptive programs meeting the specific development and commercialization goals for the drug asset, and the needs of all stakeholders.

White glove

We provide a high touchpoint, ‘white glove’ service that ensures exceptional support for sponsors, physicians and patients alike.

Risks

We replace risks and concerns with certainty and control. Our sophisticated and reliable global distribution capabilities and bricks-and-mortar infrastructure make Durbin your logical partner for EAPs.

Worldwide

We are established worldwide, with wholly owned distribution infrastructure in the EU, the UK and the US.

Diversified

As part of a diversified healthcare services company, Uniphar Group, we are a secure and reliable EAP provider, helping customers de-risk their EAPs.

Online

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.

Backgrounds

We have assembled a strong and passionate team of people 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.

Outcomes

We are dedicated to help improve outcomes and to optimize physicians’ experiences, with a tailored and patient-centric approach to program planning.


What is an Expanded Access Program?

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’, 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. Expanded Access Programs offer such patients an opportunity to receive treatments, which otherwise may not be available to them, and to make a significant difference to patients’ quality of life or to their outcome.

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.

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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.


FAQs

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. Firstly, 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 US 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, amongst 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 have 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 Real World Data (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.

Can’t find what you’re looking for?

Our team is more than happy to start a conversation regarding your drug assets and goals, expanded access program options, and questions. 

Learn more

Our experience, people and global capabilities make Durbin one of the leading service providers in the rare disease and specialty product space.

25 years' experience
25 years' experience

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.

360° full-service program offering
360° full-service program offering

We can handle every aspect of the design and management of your EAP. We partner with you throughout and beyond the lifecycle of your project, from design and implementation of your EAP, to global regulatory compliance, site management, physician training and shipment logistics.

Valuable insights
Valuable insights

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.