Managed Access Outlook, 2023 and beyond

By Nicky Wisener, VP Business Development, Managed Access

Celebrating 35 years of Managed Access

2022 is a special year for us. While it is a moment of celebration, it is also an opportunity to reflect upon what we have achieved together with our partners and customers and look ahead to what the future holds for Managed Access.

35 years of access – Looking back

Since 1987, Clinigen has delivered over 400 access programs globally. As a key player in the progression of the sector, we have seen a significant shift during the last 35 years:

Current Outlook

The need for early access continues to grow with the development of more complex and personalised treatments and a growing focus on emerging markets. As the industry continues to shift towards a more value-based, patient-centric model with more barriers to launch and a greater need for data, it will become essential to proactively address this demand with viable Managed Access Programs (MAPs).

Post-trial access on the rise                                      

10 years ago, post-trial access (PTA) programs were uncommon. Now, an estimated 50% of the programs Clinigen manages are PTAs. With greater awareness of managed access as an option for patients to continue on study drug as clinical trials come to an end, MAPs are now increasingly seen as a more flexible, ethical and cost-efficient way to continue access to drugs outside of the clinical trial environment if treatment benefit has been seen.

Real World Data: strengthening market access

In the past, collating data other than safety information via a MAP was usually discouraged, legislated against or simply omitted from guidance or legislation. Over time, delays in the approval of new treatments have driven the need to provide additional, supportive data showing population benefits in addition to clinical trial results. The benefits of RWD are now widely accepted. In specific cases like France, regulators are mandating data collation during MAPs, and in others, they're starting to give more precise guidance. In the future, the awareness of the value of RWD from MAPs as part of a market access strategy will continue to increase as more countries provide distinct routes for compliant data capture.

Shift in supply routes

In the past, supply routes for medicines were an estimated 96% via commercial channels, 3-4% through clinical trials, and less than 1% through MAPs. The MAP route is likely to increase due to continued delays to market and the cost and complexity of extending clinical trials for access purposes only. Overall, MAPs will continue to evolve from being perceived as a 'last chance' option with many unknown factors to a viable, planned supply strategy.

Further accelerated by unlicensed product demand during COVID-19, early access is now embedded in the development process of a drug. In the future, we expect a more holistic approach to access, with better alignment of different stakeholder groups facilitating the move to become an integral part of the overall market access strategy, sometimes even impacting pricing and reimbursement.

Managed Access – a strategic decision for commercialisation

While companies are changing their approach to MAPs, regulators and patient advocacy groups are driving simplicity and more transparency. The geographical scope is evolving: strategically important countries like China now allow MAPs via a limited but regulated route. In the future, companies will need to define in an earlier development phase how their MAP links into their commercial launch strategy. This is particularly true for products that are intended for very small populations. The commercial benefit and the patient benefit will increasingly go hand in hand, for example, enabling Pharma and Biotech companies to work more closely with countries earlier to define pricing and commercialisation strategy and allowing for better transparency and partnerships with regulators.

Market Access and Pricing

Until recently, Managed Access was kept at arms-length from the more commercially focused Market Access, pricing and launch strategy. However, for many small companies, the only financially sustainable option to make a drug accessible in certain countries is a charged-for MAP - particularly if the drug is already approved in a major market and a commercial pack is available. Instead of having big global launches in every market, companies are starting to look into managed access as an alternative where commercial launches aren't commercially viable. And more importantly, companies and regulators are seeing that MAPs can play an important role in future market access strategy without damaging the integrity of the program objectives.

Changes in charging strategy     

Overall, we saw the number of charged MAPs increase in recent years as regulations develop and companies seek cost-efficient supply routes. In 2020-21, 52% of all initiated MAPs started free of charge. However, regulations in Italy, the United Kingdom, Spain, France, and Germany now allow charging where a commercial pack is supplied, such as a US commercial pack, making these markets more viable for smaller companies with innovative products prior to commercial launch. Clinigen's shipments to these five countries have doubled in the last two years.

To learn more on this topic, please join our workshop 'Unlicensed supply, the current EU regulatory environment and charging strategy' at the World Orphan Drug Congress 2022 in Sitges, Spain on Mon, 14th of Nov 2022.

As the global leader in Managed Access, Clinigen will continue to drive change in 2023 and beyond by working closely with all stakeholders and ensure we meet the evolving demands throughout the lifecycle of a medicine.

Will MAPs become a formal part of a product's market access strategy in the future, and will regulators insist on early access provision in certain cases?

Contact us to discuss these questions and learn how we can support your project.


Nicky Wisener VP Business Development, Managed Access

Kieron Lewis Director of Strategic Consulting, Managed Access