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.
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:
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
Our PA-NPP Case Studies
Sponsor FAQs
PA-NPPs allow Biopharmaceutical Companies to make their medicine, which has only just been approved in one country, available to patients worldwide and ahead of additional regulatory approvals.
No, there is no requirement for companies to make their medicine available following first commercial launch. However, physicians in other countries may wish to access the medicine via this route for their patients where no alternative options exist.
It is also important to have a formal program in place to ensure safe use of the medicine, avoid its diversion from the existing supply chain and reduce costs to the prescriber and healthcare providers
- Allow physicians and patients access to important new commercial medicines not yet available to them in their country
- Manage unsolicited requests for their medicine worldwide while maintaining the highest quality, regulatory and safety standards for patients without diversion of product from the supply chain
- 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
WEP manages PA-NPPs in an ethical and compliant way. We will help you decide patient eligibility criteria and any limitations during program setup.
Patient eligibility is usually aligned to the approved Prescribing Information (PI) or Summary of Product Characteristics (SPCs) in the first commercial launch country. However, patients can be included where there is a high unmet need and compelling clinical data to support unsolicited requests from phtysicians and use in that setting.
No, WEP conducts rigorous Patient Eligibility checks as part of request management in a PA-NPP.
If a patient meets the entry criteria for an active clinical trial, the physician will be advised to follow this route.
It is a regulatory requirement in most countries for patients to enter into a clinical trial if available, rather than be treated with an unlicensed medicine
One of the benefits of providing a PA-NPP is that companies can collect Real World Data (RWD) from patients enrolled in the program. When compiled and analyzed, this data becomes Real World Evidence (RWE) which can be used to supplement clinical trial data when seeking marketing approval for an investigational drug and to support Market Access activities in HTA markets.
To find out more, check out WEP Clinical’s RWE offering and WEP Clinical’s Market Access offering.
The PA-NPP program represents physician and patient access to a commercially available new medicine not yet available in their country. The price used can be the existing commercial price in the launch market. However, WEP Clinical will work with you to understand your global commercial strategy alongside our Pricing and Market Access team to decide the best approach to take for your PA-NPP. This may include free of charge supply, if relevant, to address specific patients or countries.
USING A PA-NPP TO CREATE ACCESS FOR A CANADIAN-APPROVED PRODUCT IN EUROPE
Condition: Genetic metabolic disorder Approved in: Canada