Post-Approval Named Patient Programs
A Post-Approval Named Patient Program (PA-NPP) allow Sponsors to make their approved medicines available in countries where they are not yet approved or commercially available.
Sponsors can make their product available through a PA-NPP after they have received regulatory approval in at least one country.
These programs are for patients suffering from a serious or debilitating illness and who have no locally approved alternative treatments available. This means that:
- There are no locally approved treatments available for the specific type of disease in the patient’s home country
- There are locally approved treatments available, however, the physician has tried them without success
- The patient cannot enroll in an active clinical trial for their specific stage of disease
How Sponsors Benefit
- Manage unsolicited requests for your medicine worldwide while maintaining the highest quality, regulatory and safety standards for patients
- Provide physicians with early experience of your new medicine through local access schemes prior to commercial approval
- Develop an expert KOL network and Real World Evidence (RWE) in new countries critical for future Market Access and Regulatory agency interactions
- Generate revenue from the PA-NPP to fund the program and re-invest in bringing new medicines to market
Our PA-NPPs
Here is a list of some of the products for which we currently have a PA-NPP in place. If you are a healthcare professional, please click on each to access the appropriate contact details and information about each program.
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
For Emergency Product Orders and Enquiries:
Please note, the contact information provided above is intended for healthcare professionals only.
For information on this PA-NPP, check out our program announcement using the link below:
Our PA-NPP Services
- Regulatory Approval Management
- Patient Advocacy Engagement
- Real World Data Collection
- Product Warehousing & Distribution
- Market Access services and transition to commercial supply
- Local access scheme and reimbursement support
- Dedicated Project Management
- Medical Oversight
- SAE Reporting
- Physician Training and On-Going Support
- Physician Request Management covering > 120 countries
- WEP cross-functional team
SUPPORTING A MEDICINE THROUGHOUT THE DEVELOPMENT JOURNEY
Condition: Rare autoimmune disease Approved in: US and Europe