As I was refreshing my original Innovative Licensing and Access Pathway (ILAP) blog, I realised just how much there was to unpack about this process. So I’ve decided to break it down into more manageable chunks and explore each aspect a bit more.
The focus of this blog is on the Innovation Passport.
The Innovation Passport (IP) application is the first step in ILAP and is available to applicants in the pre-clinical trial stage through to the mid-development phase of their programme.
The data needed for a product to satisfy the criteria will depend on where in the development programme the product is and can be based on non-clinical data.
Typically you are expected to submit evidence concerning your lead indication and you must apply for an Innovation Passport for each individual medicinal product (different actives). However, a single positive Innovation Passport can cover multiple indications for the same medicinal product (active substance) in the Target Development Profile (TDP). The Target Development Profile blog goes into further details.
There are three criteria which must be fulfilled to gain an Innovation Passport.
Criteria 1: Details of the condition, patient or public health area:
- the condition is life-threatening or seriously debilitating or
- there is a significant patient or public health need
Useful tip: This first criterion defines the grounds for the need to develop a medicinal product in a particular area.
For situations where the condition is life-threatening or seriously debilitating, you will be expected to provide an outline of the condition and the life threatening or seriously debilitating nature including symptoms, life span and quality of life factors and current treatment landscape.
In circumstances where there is a significant patient or public health need; you are required to submit clearly defined evidence of the specific need, putting the need into the context of the current patient or public health setting. This evidence may be gained from patient engagement activities or from information in the public domain. For a justification of ‘significant’, the magnitude of the issue(s) should be explored in a problem statement together with the identified gaps that exist in the current treatment landscape.
Criteria 2: The medicinal product fulfils one or more of a specific area
- innovation – such as an advanced therapy medicinal product (ATMP) or new chemical or biological entity or novel drug device combination
- clinically significant new indication for an approved medicine
- rare disease and/or other special populations such as neonates and children, elderly and pregnant women
- development aligning with the objectives for UK public health priorities such as the Chief Medical Officer, Department of Health and Social Care (DHSC) or Life Sciences Sector Deal (including those in Devolved Administrations, where appropriate)
You can indicate which of the above are relevant in your submission.
Depending on the area, you are required to provide the following:
- product description (full regulatory info e.g. name of active, pharmaceutical form, route of administration, mechanism of action)
- details of new indication in the context of the patient group, including the novelty of the plan
- description of use in a specific population
- information of where and how the product will address public health priorities
Criteria 3: The medicinal product has the potential to offer benefits to patients
Present an outline of how patients are likely to benefit from the product or indication coming to market. This could comprise proposed improved efficacy or safety, contribution to patient care or quality of life, compared to alternative therapeutic options. This should be based on data from the applicant with the product.
The claims can be evidenced either by data from valid non-clinical models of the condition or, if justified, extrapolated from another relevant model.
Any existing clinical data in a relevant population of patients can be provided (depending on the development stage of the product). Applicants are firmly advised to include the perspectives of patients or patient groups around the benefits of a product in their evidence, if available.
- Innovation Passport: £3,624
Useful tip: The Innovation Passport does not replace the Promising Innovative Medicine (PIM) Designation of the Early Access to Medicines Scheme (EAMS) and you can apply for both initiatives.
Look out for my other ILAP-related blogs in this series…
Fusion Pharma have experience in this area. If you would like to discuss how Fusion Pharma can support you with ILAP, please email us at firstname.lastname@example.org or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.