Viatris Pretomanid Named Patient Access Program for MDR TB

NAMED PATIENT ACCESS PROGRAMS (NPAP)

Patients with serious or life-threatening diseases may seek medical products that, while potentially approved by one of the regulatory authorities, have not yet been approved or made available in their respective country. ‘Named Patient Access Programs’ help address this need by providing eligible patients access to certain unapproved or investigational treatments which are approved in other countries. Below you’ll find additional details about this program for pretomanid.

WHAT IS PRETOMANID’s NPAP ACCESS PROGRAM?

Tuberculosis (TB) is the world’s leading cause of death from a single infectious disease. In 2021, an estimated 10.6 million people developed TB. There were an estimated 1.4 million TB deaths among Human Immunodeficiency Virus (HIV) - negative people in 2021 and an additional 187,000 deaths among HIV-positive people. In 2021, 71% of people (2.4/3.4 million) diagnosed with bacteriologically confirmed pulmonary TB were tested for rifampicin resistance. Among those tested, there were an estimated 141 953 incident cases of MDR/RR-TB (Multi Drug Resistant/Rifampicin Resistant Tuberculosis) and 25 038 cases of pre-XDR-TB/XDR-TB (Pre-Extensively Drug Resistant Tuberculosis/ Extensively Drug Resistant Tuberculosis).¹

On August 14, 2019, The United States Food and Drug Administration (USFDA) approved a drug called 'pretomanid'. Later it has been approved by many regulatory health authorities including European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO), India. Recently, pretomanid has received an additional indication by CDSCO in India. This additional indication is in alignment with the WHO guidelines for the treatment of Drug Resistant Tuberculosis (DR-TB).² The updated indication mentions that pretomanid is to be used as part of a combination regimen with bedaquiline and linezolid for the treatment of MDR-TB OR RR-TB in patients ≥14 years of age who have no previous exposure (defined as >1 month) to bedaquiline, Pretomanid, or linezolid, with moxifloxacin in the absence of baseline resistance to fluoroquinolones or without moxifloxacin if resistance to fluoroquinolones is presents (pre-XDR-TB)”. ^3,4

The pretomanid Named Patient Access Program (NPAP) allows the treating physician to submit a request for pretomanid prior to regulatory approval in their respective country on a named-patient basis, provided it is permitted by applicable local laws.

RR-TB: Resistance of Mycobacterium tuberculosis strains to rifampicin
MDR-TB: Resistance of Mycobacterium tuberculosis strains to at least isoniazid and rifampicin
Pre-XDR-TB: Resistance of Mycobacterium tuberculosis strains that fulfill the definition of MDR/RR-TB and which are also resistant to any fluoroquinolone*
XDR-TB: TB caused by Mycobacterium tuberculosis (M. tuberculosis) strains that fulfill the definition of MDR/RR-TB and which are also resistant to any fluoroquinolone and at least one additional Group A drug**
[*The fluoroquinolones include levofloxacin and moxifloxacin. **The Group A drugs are currently levofloxacin or moxifloxacin, bedaquiline and linezolid, therefore XDR-TB is MDR/RR-TB that is resistant to a fluoroquinolone and at least one of bedaquiline or linezolid (or both).]

Are you Eligible?

The following criteria* must be met by a patient in order to participate in Viatris' NPAP:

The patient seeking treatment has drug resistant TB (RR-TB^# OR MDR-TB^## OR Pre-XDR-TB^### patient of age ≥14 years and who have no previous exposure (defined as >1 month) to bedaquiline, Pretomanid, or linezolid and there is no satisfactory alternative therapy available to treat the disease
The patient is not eligible to enroll in a clinical trial
The potential benefit of treatment use outweighs the potential risk in the context of the disease to be treated as confirmed by the treating physician at the time of 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, linezolid, and moxifloxacin for treatment of RR-TB^# OR MDR-TB^##. In presence of baseline resistance to fluoroquinolones (pre-XDR-TB^###), moxifloxacin should be removed from the regimen

^*All above criteria are subject to local laws and regulations
^#RR-TB: Resistance of Mycobacterium tuberculosis strains to rifampicin.
^##MDR-TB: Resistance of Mycobacterium tuberculosis strains to at least isoniazid and rifampicin.
^###Pre-XDR-TB: Resistance of Mycobacterium tuberculosis strains that fulfill the definition of MDR/RR-TB and which are also resistant to any fluoroquinolone. The fluoroquinolones include levofloxacin and moxifloxacin.

SUBMIT A NPAP REQUEST

A request must be submitted by the treating physician on behalf of the patient. Request forms can be found below:

Please fill the request form below.

** = Required

Location**

Treating physicians from Canada follow Health Canada's special access programs (SAP). Please reach out to the Viatris Canada Customer Service/CAN customerservice.ca@viatris.com for further assistance.

Physician Information

Title

Name**

Name of institution/hospital/practice**

Department (if applicable)

Address

City & State**

Country Code**

Phone number**

Email**

Pretomanid NPAP request

Disease to be treated
(Please do not include any patient identifiers): ** RR-TB MDR-TB Pre-XDR-TB

Number of bottles of pretomanid requested (Each bottle contains 26 tablets)**

Rationale for request**

Additional information* (E.g., previously used therapies, summary of patient history):**

*Please provide specific information to aid decision-making. However, do not include any patient identifiers.

I confirm that:

I am the treating physician for the patient
The patient seeking treatment has drug resistant TB (RR-TB^# OR MDR-TB^## OR Pre-XDR-TB^### patient of age ≥14 years and who have no previous exposure (defined as >1 month) to bedaquiline, Pretomanid, or linezolid) and there is no satisfactory alternative therapy available to treat the disease
The patient is not eligible to enroll in any clinical trial for a medical product
The potential benefit of treatment use outweighs the potential risk in the context of the disease
The product is not yet approved by the local regulatory body in my respective country
Pretomanid would be used as part of a combination regimen with bedaquiline, linezolid, and moxifloxacin for treatment of RR-TB^# OR MDR-TB^##. In presence of baseline resistance to fluoroquinolones (pre-XDR-TB^###), moxifloxacin should be removed from the regimen
The patient is aware that their personal data will be shared with Viatris and third parties working with Viatris in relation to this program and has consented to this information being shared for these purposes

^#RR-TB: Resistance of Mycobacterium tuberculosis strains to rifampicin.
^##MDR-TB: Resistance of Mycobacterium tuberculosis strains to at least isoniazid and rifampicin.
^###Pre-XDR-TB: Resistance of Mycobacterium tuberculosis strains that fulfill the definition of MDR/RR-TB and which are also resistant to any fluoroquinolone. The fluoroquinolones include levofloxacin and moxifloxacin.

I Agree

Next Steps: How it works

Register your account on TB Consilium
Submit the TB Case through TB Consilium
Receive a written decision from Viatris within 7 business days

FAQs

If my request is approved, what happens next?

If your request is approved by Viatris, Viatris will share an agreement with you for your signature. After that, you will be directed to WEP Clinical who will work directly with you to obtain all consents, waivers and permits required under your country’s applicable laws to import pretomanid for your patient.
What will pretomanid cost?

Viatris is making pretomanid available for this program. Our partner, WEP Clinical will work with you to obtain all necessary approvals to enable pretomanid to be provided in your country. As soon as your request is approved, they will provide relevant logistic details including costs that may be applicable. Special considerations have been made to ensure affordability for low-income and lower middle-income countries as defined by the World Bank; these countries will be offered a price on par with the Global Drug Facility price.
What happens if pretomanid is already approved in my country?

If pretomanid is approved in your country, the patient would not be eligible for the NPAP. Please reach out to your country’s national TB program or directly to Viatris (accesspretomanid@viatris.com)
How long will this process take from start to finish?

Your request will be reviewed within 7 business days from when the original request is made. Following this, timelines will depend on your country’s regulatory requirements and processes for importing unapproved product for patients on a named basis. WEP Clinical will help guide you on timelines once your request is approved.
Can you help me obtain the other drugs in the regimen?

NPAPs are designed to provide access to new drugs in countries that have not yet issued regulatory approval. Please contact your national TB program for information regarding accessing bedaquiline, linezolid, and moxifloxacin, which must be used along with pretomanid per the CDSCO (India) approved label.

For any other questions on the Viatris NPAP, please reach out to accesspretomanid@viatris.com

References:

Global tuberculosis report [Internet]. WHO. 2022 [cited 23 May 2023]. Available from: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022
WHO announces updated definitions of extensively drug-resistant tuberculosis [Internet]. WHO. 2021. [Cite 23 May 2023] Available from: https://www.who.int/news/item/27-01-2021-who-announces-updated-definitions-of-extensively-drug-resistant-tuberculosis
Pretomanid Tablet 200 mg [package insert - India]. Bengaluru: Mylan Laboratories Limited; 2023.
World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: treatment-drug-resistant tuberculosis treatment, 2022 update. World Health Organization; 2022 Nov 30.
Tiberi S, Pontali E, Tadolini M, D'Ambrosio L, Migliori GB. Challenging MDR-TB clinical problems - The case for a new Global TB Consilium supporting the compassionate use of new anti-TB drugs. Int J Infect Dis. 2019 Mar; 80S:S68-S72. doi: 10.1016/j.ijid.2019.01.040.

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