27 May 2020, Geneva, Switzerland – On 28 October 2019, the Stop TB Partnership announced the addition of pretomanid to the Global Drug Facility (GDF) catalog as part of a BPaL regimen containing bedaquiline, pretomanid, and linezolid. GDF supplies pretomanid to countries in accordance with WHO recommendations for people with extensively drug-resistant (XDR) TB when used under operational research conditions.
Ten countries are in the process of or have already accessed pretomanid via GDF in amounts to treat more than 400 people with XDR-TB, according to the latest GDF data. While procuring pretomanid via GDF remains the preferred means to access the medicine, we are pleased today to share that Mylan announced the launch of the pretomanid Named Patient Access Program (NPAP) through the website www.accesspretomanid.com.
The NPAP is explicitly designed for those affected people who live in countries where regulatory approval or other access mechanisms for pretomanid are not yet available. The NPAP system was developed to ensure that physicians can consider pretomanid as a viable treatment option for people affected by XDR-TB irrespective of where they live. Physicians can access this product contingent on the affected person meeting the necessary eligibility criteria, and subject to final Mylan approval and local laws and regulations.
Eligibility criteria are as follows:
Ten countries are in the process of or have already accessed pretomanid via GDF in amounts to treat more than 400 people with XDR-TB, according to the latest GDF data. While procuring pretomanid via GDF remains the preferred means to access the medicine, we are pleased today to share that Mylan announced the launch of the pretomanid Named Patient Access Program (NPAP) through the website www.accesspretomanid.com.
The NPAP is explicitly designed for those affected people who live in countries where regulatory approval or other access mechanisms for pretomanid are not yet available. The NPAP system was developed to ensure that physicians can consider pretomanid as a viable treatment option for people affected by XDR-TB irrespective of where they live. Physicians can access this product contingent on the affected person meeting the necessary eligibility criteria, and subject to final Mylan approval and local laws and regulations.
Eligibility criteria are as follows:
- The affected person seeking treatment has highly drug-resistant TB (adults with pulmonary extensively drug-resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis) and there is no satisfactory alternative therapy available to treat the disease
- The affected person is not eligible to enroll in a clinical trial
- The potential benefit of treatment outweighs the potential risk in the context of the disease as confirmed by the treating physician at the time of the request
- The product is not yet approved by the local regulatory body in the treating physician’s respective country
- Pretomanid should be used as part of a combination regimen with bedaquiline and linezolid
How it works:
A qualified physician may submit a request for pretomanid for an affected person via the website www.accesspretomanid.com. Received requests will be forwarded to an independent panel of experts at the Global TB Consilium, a global initiative through the Global TB Network, which will assess the anonymized case. Per the panel’s recommendation, Mylan will either approve or reject the request and notify the requesting physician within seven business days of the original request. If approved, the physician will be directed to Mylan’s third-party service provider – WEP Clinical - which will work with the physician to collect the requisite documents (consents, waivers and permits) in order to import the drug. Physicians enrolling affected people under the NPAP will be required to treat them in accordance with the approved label.
A qualified physician may submit a request for pretomanid for an affected person via the website www.accesspretomanid.com. Received requests will be forwarded to an independent panel of experts at the Global TB Consilium, a global initiative through the Global TB Network, which will assess the anonymized case. Per the panel’s recommendation, Mylan will either approve or reject the request and notify the requesting physician within seven business days of the original request. If approved, the physician will be directed to Mylan’s third-party service provider – WEP Clinical - which will work with the physician to collect the requisite documents (consents, waivers and permits) in order to import the drug. Physicians enrolling affected people under the NPAP will be required to treat them in accordance with the approved label.