Medicines Access

When patients have a life threatening or debilitating illness, their physicians have exhausted current treatment options or there simply aren’t any treatment options available or they are unable to enter a clinical trial, mechanisms exist across the globe to enable access to pre-approval or unlicensed medicines. Healthcare professionals often seek to access these medicines for their patients and biopharmaceutical companies developing innovative medicines are increasingly making these medicines available to patients through pre-approval and unlicensed medicines access programs.

‘Pre-approval access’ is an umbrella terminology that is becoming more commonly used to describe the process of making a medicine available to a patient (or group of patients), when it is unlicensed in the country of intended use. A number of other terms for this process are in use, including: ‘expanded access’, ‘early access’, ‘compassionate use’, ‘named patient supply’, and ‘managed access’. These terms are used interchangeably, which can cause confusion, so Inceptua prefer the use of the ‘pre-approval access’ terminology

Consulting and delivery

The Inceptua Medicines Access management team pioneered many of the support services which are now standard across the industry, including:

• Corporate pre-approval access strategy development, and associated policy development (strategies developed for many Top 10 Pharma companies, through to small, niche biotechs)
• Pre-approval Access Viability Assessments – a high-level assessment to determine whether to move forward with planning for a pre-approval access program for a particular asset
• Product-specific Feasibility Analysis, a global, detailed analysis to determine whether a program is suited to your asset, and how and where to implement a program to ensure success
• Pre-approval access-specific real-world data (RWD) collection, to easily obtain robust outcomes data from patients on your pre-approval access program
• Physicians Perceptions Analysis – understand prescribers views of your product (likelihood of prescribing commercially, thoughts on price, dosing, administration, adherence etc.) prior to commercial launch

At Inceptua we constantly strive to deliver value for our clients. We continually refine our offerings, based on client feedback, to ensure we maintain our position as the thought leader within this industry. Inceptua can support you whatever your need is, and we can create customized services to address your specific requirements.

If you are at the early stages of considering pre-approval access to one of your medicines, but aren’t quite ready to move ahead and engage with a vendor, then please take a look at our Ask Inceptua service, through which we commit to answering up to 10 questions you may have about pre-approval access, in a no-obligation setting.