Health Economics Research on Non-surgical Biomedical HIV Prevention: Identifying Gaps and Proposing a Way Forward

Torres-Rueda, Sergio; Terris‐Prestholt, Fern; Gafos, Mitzy; Indravudh, Pitchaya; Giddings, Rebecca; Bozzani, Fiammetta; Quaife, Matthew; Ghazaryan, Lusine; Mann, Carlyn; Osborne, Connie; Kavanagh, Matthew M.; Godfrey‐Faussett, Peter; Medley, Graham; Malhotra, Shelly

doi:10.1007/s40273-022-01231-w

Cited by 3 publications

(6 citation statements)

References 74 publications

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“…To examine variation in HIV incidence and oral PrEP adherence, a scenario testing lower HIV incidence and a hypothetical adherence improvement that yields a 20% improvement in oral PrEP efficacy was included in the scenario analysis, and the CAB–LA pathway remained cost-effective. Further study of PrEP efficacy among cisgender women in alternate geographical locations is warranted, but health equity considerations suggest that inclusion of cisgender women in economic analyses is essential now to help estimate the value of the available PrEP options for this underserved and understudied population [ 4 – 6 , 8 , 43 , 44 ].…”

Section: Discussionmentioning

confidence: 99%

“…Thus, lifetime QALY losses for individuals who acquired HIV-1 infection (calculated to include only individuals diagnosed with CD4 cell counts above 350 cells/μL) and the duration of first-line ARV treatment differentiation for individuals with PrEP-related resistance mutations were taken from somewhat dated studies by Farnham et al [ 29 ] and Beck et al [ 36 ], respectively. Data on HIV incidence among TGW and cisgender women eligible for PrEP were also not available, as most studies have focused on MSM [ 43 ]. Thus, base HIV incidence for TGW was assumed equal to that of MSM, and base HIV incidence for cisgender women at risk was calculated based on available published data (Online Resource Table S-1).…”

Section: Discussionmentioning

confidence: 99%

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Cost-effectiveness of Cabotegravir Long-Acting for HIV Pre-exposure Prophylaxis in the United States

Brogan,

Davis,

Mellott

et al. 2024

PharmacoEconomics

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Objective Cabotegravir long-acting (CAB–LA) administered every 2 months was approved in the USA as pre-exposure prophylaxis (PrEP) for individuals at risk of acquiring human immunodeficiency virus (HIV)-1 infection based on the HIV Prevention Trials Network (HPTN) 083 and HPTN 084 clinical trials, which demonstrated superior reduction in HIV-1 acquisition compared with daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in men who have sex with men (MSM), transgender women (TGW), and cisgender women. A decision-analytic model was developed to assess the lifetime cost-effectiveness of initiating CAB–LA versus generic oral FTC/TDF for HIV PrEP in the USA from a healthcare sector perspective. Methods PrEP-eligible adults entered the Markov model receiving CAB–LA or FTC/TDF and could continue initial PrEP, transition to a second PrEP option, or discontinue PrEP over time. Efficacy was taken from the HPTN 083 and HPTN 084 clinical trials. Individuals who acquired HIV-1 infection incurred lifetime HIV-related costs, could transmit HIV onwards, and could develop PrEP-related resistance mutations. Input parameter values were obtained from public and published sources. Model outcomes were discounted at 3%. Results The model estimated that the CAB–LA pathway prevented 4.5 more primary and secondary HIV-1 infections per 100 PrEP users than the oral PrEP pathway, which yielded 0.2 fewer quality-adjusted life-years (QALYs) lost per person. Additional per-person lifetime costs were $9476 (2022 US dollars), resulting in an incremental cost-effectiveness ratio of $46,843 per QALY gained. Results remained consistent in sensitivity and scenario analyses, including in underserved populations with low oral PrEP usage. Conclusions Our analysis suggests that initiating CAB–LA for PrEP is cost-effective versus generic daily oral FTC/TDF for individuals at risk of acquiring HIV-1 infection. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-023-01342-y.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of Cabotegravir Long-Acting for HIV Pre-exposure Prophylaxis in the United States

Brogan,

Davis,

Mellott

et al. 2024

PharmacoEconomics

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“… Early engagement may provide legal certainty that affordable generic versions of a product could become available in LMICs. This may be important for stakeholders in charge of downstream aspects of normative guidance, financing, procurement, rollout, uptake and scale‐up, helping ensure comprehensive rollout plans are ready (and barriers that could cause unnecessary delays are addressed) by the time generics become available [ 6 , 40 , 41 ]. …”

Section: Discussionmentioning

confidence: 99%

Voluntary licensing of long‐acting HIV prevention and treatment regimens: using a proven collaboration‐ and competition‐based mechanism to rapidly expand at‐scale, sustainable, quality‐assured and affordable supplies in LMICs

Gaayeb,

Das,

James

et al. 2023

J Int AIDS Soc.

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Introduction:Emerging long-acting (LA) prevention and treatment medicines, technologies and regimens could be gamechanging for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential. To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the United Nations-backed, not-for-profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low-and middle-income countries (LMICs). Discussion: While voluntary licensing may unlock the possibility for generic competition to take place ahead of patent expiry, there are additional elements-of amplified importance for more complex LA HIV medicines-that need to be taken into consideration. This paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at-scale, sustainable, quality-assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs: 1. Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders 2. Consolidating a multidisciplinary network and strengthening early-stage coordination and collaboration to foster innovation 3. Embedding public health considerations in product design and delivery 4. Building innovative partnerships for product development and commercialization 5. Raising awareness of and creating demand for emerging LA products 6. Estimating the market size, ensuring sufficient competition and protecting sustainability 7. Using technology transfer and hands-on technical support to reduce product development timelines and costs 8. Exploring de-risking mechanisms and financial incentives to support generic manufacturers 9. Optimizing strategies for generic product development and regulatory filings 10. Aligning and coordinating efforts of stakeholders across the value chain.Conclusions: Rapid access to emerging LA prevention and treatment regimens and technologies can be facilitated by voluntary licensing-catalyzed and supplemented by enabling collaborative and non-duplicative efforts of various other stakeholders. This can effectively lead to improved-accelerated and cheaper-access to quality-assured medicines for populations in LMICs.

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“…This is an important time for costing experts and decision-makers to ensure that standards are in place for the comprehensive primary costing of LAP. Health economic studies are instrumental to policy and programme planning and should broaden the scope of costed activities to better reflect the real-world implementation, as also noted by Torres-Rueda et al [35].…”

Section: Table 7 Economic Analysis Features and Analytic Approaches O...mentioning

confidence: 94%

“…Co‐authors (DC, SF, CJH, NT, JW and KK) extracted relevant data from the included studies into REDCap [ 34 ]. Co‐authors (FB, FTP and STR) conducted an independent review to supplement this review's findings [ 32 , 35 ].…”

Section: Methodsmentioning

confidence: 99%

Implementation and resource needs for long‐acting PrEP in low‐ and middle‐income countries: a scoping review

Castor,

Heck,

Quigee

et al. 2023

J Int AIDS Soc.

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Introduction Several low‐ and middle‐income countries (LMICs) are preparing to introduce long‐acting pre‐exposure prophylaxis (LAP). Amid multiple pre‐exposure prophylaxis (PrEP) options and constrained funding, decision‐makers could benefit from systematic implementation planning and aligned costs. We reviewed national costed implementation plans (CIPs) to describe relevant implementation inputs and activities (domains) for informing the costed rollout of LAP. We assessed how primary costing evidence aligned with those domains. Methods We conducted a rapid review of CIPs for oral PrEP and family planning (FP) to develop a consensus of implementation domains, and a scoping review across nine electronic databases for publications on PrEP costing in LMICs between January 2010 and June 2022. We extracted cost data and assessed alignment with the implementation domains and the Global Health Costing Consortium principles. Results We identified 15 implementation domains from four national PrEP plans and FP‐CIP template; only six were in all sources. We included 66 full‐text manuscripts, 10 reported LAP, 13 (20%) were primary cost studies‐representing seven countries, and none of the 13 included LAP. The 13 primary cost studies included PrEP commodities (n = 12), human resources (n = 11), indirect costs (n = 11), other commodities (n = 10), demand creation (n = 9) and counselling (n = 9). Few studies costed integration into non‐HIV services (n = 5), above site costs (n = 3), supply chains and logistics (n = 3) or policy and planning (n = 2), and none included the costs of target setting, health information system adaptations or implementation research. Cost units and outcomes were variable (e.g. average per person‐year). Discussion LAP planning will require updating HIV prevention policies, technical assistance for logistical and clinical support, expanding beyond HIV platforms, setting PrEP achievement targets overall and disaggregated by method, extensive supply chain and logistics planning and support, as well as updating health information systems to monitor multiple PrEP methods with different visit schedules. The 15 implementation domains were variable in reviewed studies. PrEP primary cost and budget data are necessary for new product introduction and should match implementation plans with financing. Conclusions As PrEP services expand to include LAP, decision‐makers need a framework, tools and a process to support countries in planning the systematic rollout and costing for LAP.

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Health Economics Research on Non-surgical Biomedical HIV Prevention: Identifying Gaps and Proposing a Way Forward

Cited by 3 publications

References 74 publications

Cost-effectiveness of Cabotegravir Long-Acting for HIV Pre-exposure Prophylaxis in the United States

Cost-effectiveness of Cabotegravir Long-Acting for HIV Pre-exposure Prophylaxis in the United States

Voluntary licensing of long‐acting HIV prevention and treatment regimens: using a proven collaboration‐ and competition‐based mechanism to rapidly expand at‐scale, sustainable, quality‐assured and affordable supplies in LMICs

Implementation and resource needs for long‐acting PrEP in low‐ and middle‐income countries: a scoping review

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