Inceptua Medicines Access Consulting brings together all the broad experience in Pre-approval Access held within Inceptua Medicines Access to provide our clients with expert insight and supportive services to help you navigate the Pre-approval and Access space and derive the greatest value from your access program.
The Medicines Access Consulting team provides rapid, expert support and insight across all issues relating to Pre-approval Access Programs. Examples of the services we provide include:
Pre-approval Access Strategy and Policy
The 21st Century Cures Act prompted a rush for companies to create public-facing policies on ‘compassionate use’, to satisfy the requirements of the Act. We believe that a simple external policy needs to be supported by a detailed internal policy, which in turn should be built upon a global corporate strategy around access. Inceptua Medicines Access Consulting has experience in developing such detailed strategies and policies, from small biotechs, through to the largest pharma companies.
Pre-approval Access Programs are designed to be outwardly straightforward for good reason, but there are many nuances which must be taken into account to ensure that any strategy/policy is fit to support any one company’s expectations and ambitions around pre-approval access. Some companies prefer to remain reactive and conservative with regard to pre-approval access, but more and more are making use of the potential collateral benefits associated with a well-run program. We can help you ensure your strategy/policy is fit for purpose, regardless of which camp you fall into. Even if you have a policy in place, it is still worthwhile considering how it may be further developed by aligning it with an overall strategy.
Pre-approval Access Communications
Inceptua Medicine Access has unparalleled experience in managing compliant communications around Pre-approval Access Programs to ensure patients in need of your medicine know that access is possible. We can provide guidance around appropriate communications at conferences and satellite symposia, with the content and look and feel of any printed materials, and with the design, location and content of any microsite developed for the program.
Promotion of an unlicensed medicine is strictly prohibited in most territories. No claims of safety or efficacy can be made for unlicensed medicines. Inceptua Medicines Access adheres strictly to these guidelines at all times. However, it is legitimate to undertake ‘non-promotional awareness-raising’ of a Pre-approval Access Program, to ensure that physicians and patients who are seeking information about access can find information about the program.
Inceptua Medicines Access Consulting can assist you to make sure you navigate this area safely and compliantly, ensuring that physicians who are seeking information about your access program can find it.
Pre-approval Access Insights
A Pre-approval Access Program is the first opportunity for physicians outside of your clinical trials investigators to gain experience with your product.
In the crucial few months prior to commercial launch insights from physicians on a Pre-approval Access Program can legitimately provide you with vital information to help fine tune your launch plans. Such advance feedback can shed light on issues such as; effectiveness of pre-launch messaging (where did physicians hear about your product? what are their expectations for your product?), understanding of current treatment pathways, likelihood of future use based on initial experience, adherence, and even issues related to packaging and administration.
Inceptua Medicines Access Consulting can assist you in compliantly gathering such insights from physicians on your Pre-approval Access Program.
Pre-approval Real-World Insights
Whilst the purpose and intent of a Pre-approval Access Program is always to satisfy an unmet need within the patient and physician communities, once the decision to implement a program has been made based on these criteria, it is within the regulations* to capture data (down to clinical data) from the program.
The Inceptua Medicines Access team has extensive real-world evidence experience and can assist you in compliantly capturing fully anonymised data on outcomes of the patients on your Pre-approval Access Program.
*there is some variation between national regulations regarding whether data can be captured, and what detail can be captured.
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