REQUEST FOR PROPOSAL for Health Economic Evaluation of Zoliflodacin Introduction in Thailand and South Africa

21 October 2024

ABOUT GARDP FOUNDATION
The Global Antibiotic Research & Development Partnership (GARDP Foundation) is a not-for-profit global health organization registered in Geneva, Switzerland. GARDP’s mission is to accelerate the development and access of treatments for drug-resistant bacterial infections. It does so by forging public-private partnerships all over the world to develop and expand access to treatments for serious bacterial infections and sepsis in adults, children and newborns, as well as sexually transmitted infections (STIs).

GARDP Foundation responds to the crisis in antimicrobial resistance. In 2015, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance. The following year, to deliver on this plan, WHO and the Drugs for Neglected Diseases initiative created GARDP. In 2018, the GARDP Foundation was legally established as an independent entity.

Since then, GARDP Foundation has developed a portfolio of antibiotic treatments that targets WHO priority pathogens, priority diseases and key populations/regions that are especially affected by drug resistance. It is also pioneering new access initiatives with innovator, manufacturing and distribution partners.
As of 2024, the GARDP team consists of about 100 people who collectively share extensive cross-sector R&D and access experience. They work with the key public and private sector stakeholders and partners, such as the research and development community, donors, industry and implementing countries.

 

PROJECT BACKGROUND & PURPOSE OF THE RFP

Background to project
Management of Sexually Transmitted Infections (STIs) differs significantly among countries, and even within the country, depending on the level of care (i.e. STI or public health clinic, private practitioner, pharmacy). WHO issues treatment guidelines that are used as a basis for country recommendations although most LMICs adapt WHO STI guidance1 to their specific circumstances. Still, most countries recommend ceftriaxone intra-muscular injection for the treatment of uncomplicated gonorrhoea. The dose recommended varies from 250mg to 1g in a single dose. Some guidelines recommend co-administration with azithromycin 1g oral in a single dose.

Zoliflodacin, a new antibiotic developed by GARDP that recently reported positive phase 3 results, could be an oral alternative to ceftriaxone injection. Before this new antibiotic is introduced in countries, there is a need to assess the economic benefit and impact.
Therefore, the objective of this work is to build a cost-effectiveness model that will not only add quantifications of care-pathway costs (how a new oral antibiotic such as Zoliflodacin would benefit the society and the health care system vs. keeping only a ceftriaxone injectable), but will also quantify the health, cost and health system consequences of ceftriaxone sensitive and resistant infections.

Purpose of RFP
The economic model will be developed for target countries;South Africa and Thailand. These two countries have been chosen as they represent two different epidemiological situations: However, the creation of an open-source generic model could allow adaptation of this model to different settings.

 

SCOPE OF WORK
The current work aims to assess cost-effectiveness of Zoliflodacin in relevant populations and communities to support policy decisions on the introduction of Zoliflodacin for the treatment and/or prevention of NG infections in two different epidemiological situations represented by the epidemic profile in the target LMICs (South Africa and Thailand).

The specific objectives are:

  • To quantify the social value of key scenarios for the use of Zoliflodacin (e.g. partner therapy, restricting use to specific high-need populations or for 2nd line use…) in relation to standard care, including policy-relevant stewardship and surveillance options.
  • To quantify the cost of using IM in hospitals and/or in primary settings compared to an oral drug like Zoliflodacin.
  • To evaluate costs and effects of Zoliflodacin use in patients with ceftriaxone/cefixime resistant and susceptible NG infection from a healthcare and societal perspective, compared to the standard of care (SOC).
  • To quantify the economic and broader social value for the use of Zoliflodacin, like carer impacts and out-of-pocket costs for patients and their close network.
  • To conduct appropriate quantification of the impacts of antimicrobial resistance – ensuring link with recently started project that will predict infection and resistance over time across a range of relevant scenarios of use in two key countries.

Expected outcomes
Collect empirical evidence from primary and secondary sources to inform the economic model, including evidence from literature and data collected across other GARDP projects, completed by expert opinion where empirical evidence is lacking.
Build an open-source generic cost-effectiveness decision model to assess cost-effectiveness, considering: cost per QALY gained (with variable QALY values by country), cost per DALY averted, cost per infection averted, and cost per resistant-infection averted, taking into consideration also AMR and impacts beyond health. A scenario analysis that considers different use cases of Zoliflodacin, target groups, background resistance and prevalence of gonorrhoea, treatment recommendations and diagnostic approaches should be included.

The model should be transparently published to allow others to use and employ the same methodology. Groups from target countries (South Africa and Thailand) and/or partnerships with groups in these countries are encouraged.

 

DELIVERABLES

  1. Proposed protocol
  2. Country specific models developed for the target countries (South Africa and Thailand) that are also useful for building other country-specific models in the region adapted to different epidemic situations, and a generic model to be made freely available for future country-specific adaptations.
  3. A project report on the expected clinical and economic impacts of different scenarios of use of Zoliflodacin for the treatment of NG. The report should include, at a minimum, report methodology, summary of empirical evidence, analysis and results, and outcomes.
  4. Power point presentation and summary.
  5. Timeline: 18 months from February 2025.

If you are interested to participate, please send a request to: RFP_Procurement@gardp.org to receive complete documentation of this RFP

Due/closing date: November 25th 2024