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Hovilpri (pritelivir)

Refractory mucocutaneous herpes simplex virus infection in immunocompromised adults

Also known as AIC316
Last updated
239 sources

Section 5 of 6

Economic information and modeling report

21 evidence topics · 13 sources

Modeling overview

Summary

No published budget impact model, cost-effectiveness analysis, or health technology assessment of pritelivir has been identified. This leaf holds public inputs a model could draw on: Asahi Kasei and AiCuris estimates of the United States population, prescription share targets, and revenue projections; a market research assumption for the monthly wholesale acquisition cost in a 2025 AiCuris presentation; treatment duration and carton sizes from the prescribing information; foscarnet course length, adverse events, hospitalization, and kidney injury in three cohorts; treatment escalation and adverse event counts in a claims analysis funded by AiCuris; and a published cost-effectiveness model of maribavir in refractory cytomegalovirus infection after transplantation.

Company estimate of the eligible U.S. population and second-line share

“Pritelivir is anticipated to address approximately 15,000 immunocompromised patients in the U.S. and is projected to achieve meaningful penetration in the second-line setting, potentially approaching 70%, subject to market conditions.” (opens the source at this quote in a new tab)

Company patient funnel for the United States: investor briefing slide

ElementBriefing material
Slide heading“Estimated number of patients in the U.S.”
Patients at first-line treatment“≈180,000”
Patients at second-line treatment“≈15,000”
Share moving from first-line to second-line treatment“5-20% (Depending on the underlying disease)”
Trigger for second-line treatment“When symptoms fail to improve and acyclovir resistance is suspected, 2nd line treatment is initiated”
Basis“Based on internal investigation”
Share target“As the first oral agent in the 2nd-line treatment, targeting a 70% prescription share in the 2nd-line market”

Company description of foscarnet administration on the same slide

“foscarnet IV injection in hospital setting 1–2 hours per dose,1–3 times per day (daily administration during treatment period [period depends on condition])” (opens the source at this quote in a new tab)

Company peak revenue projections

“Peak revenue from pritelivir is projected to exceed $400 million in the mid- to late 2030s.” (opens the source at this quote in a new tab)

“with Aicuris revenue expected to reach $500 million by fiscal 2030, excluding AIC468.” (opens the source at this quote in a new tab)

“Pritelivir is expected to achieve peak sales of over $400 million after the mid 2030s” (opens the source at this quote in a new tab)

Basis of the 70% share assumption stated by the company

“Market research suggests that prescribing will likely shift significantly toward pritelivir compared to the existing drug foscarnet, which requires intravenous infusion at hospitals, since pritelivir is administered orally once daily. However, market research for new drugs often shows higher prescription intent than actual clinical adoption. Taking this into account, we set the prescription share target conservatively at 70%.” (opens the source at this quote in a new tab)

Difference between the Asahi Kasei projection and the earlier AiCuris projection

“In previously published materials from Aicuris, assumptions were presented indicating a 75% prescription share and peak sales of $2 billion.” (opens the source at this quote in a new tab)

“This discrepancy arises because Aicuris' previously disclosed sales assumptions included revenues from markets outside the U.S., whereas our projections do not incorporate such international sales. Additionally, Aicuris' prior assumptions included sales potential from expanding the indication to a broader population of general HSV infection patients, whereas we calculated the market size primarily targeting immunocompromised patients.” (opens the source at this quote in a new tab)

Pre-approval market research price assumption and peak opportunity: AiCuris corporate presentation

ElementCorporate presentation
Slide title“Market research suggests up to 2bn annual peak sales for acute therapy with Pritelivir”
Research base“Large Scale Market Research with ~800 Health Care Professionals (HCP) was conducted in 3 waves”
Price assumption“Monthly per-patient WAC in US~$30K”
Treatment course assumed“(assumes 28-day treatment course)”
Base case“WW Peak Opportunity ~$1.4B”
Base case share“55% peak share”
Upside case“WW Peak Opportunity ~$2B”
Upside case share“75% peak share”

U.S. population counts by immunocompromising condition on the same market research slide

PopulationPatientsAcyclovir resistant patients
Hematopoietic stem cell transplant“N=23K”“N=2.3K”
Solid organ transplant“N=43K”“N=1K”
Blood cancer“N=186K”“N=2.4K”
HIV“N=516K”“N=30K”
Other“N=950K”“N=20K”

Earlier company patient funnel for the United States and the European Economic Area

Funnel stepUnited StatesEuropean Economic Area
Severely immunocompromised patients“767,800”“733,900”
With HSV infections“492,000 with HSV infections”“476,900 with HSV infections”
With acyclovir resistance“27,200 patients with ACV resistance”“24,800 patients with ACV resistance”
Additional moderately immunocompromised patients with acyclovir resistance“Additional upside: 128K ACV-R moderately immunocompromised patients”“Additional upside: 136K ACV-R moderately immunocompromised patients”

“Market research Trinity, multiple references (on file at AiCuris).” (opens the source at this quote in a new tab)

Health economic materials and distribution channel the developer planned for launch

“NTAP, HECON model and a BIM at launch for Hospital scripts, ensure we are working with all third-party payers” (opens the source at this quote in a new tab)

“Availability for retail patients is ensured via our specialty pharmacy network.” (opens the source at this quote in a new tab)

Commercial coverage of target facilities stated at the acquisition

“Coverage of ≈50% of pritelivir target facilities enabled by Veloxis’s commercial infrastructure with transplant physicians based on Envarsus XR, supporting a rapid launch post-approval” (opens the source at this quote in a new tab)

Acquisition price of the developer

“Asahi Kasei announced it has entered into a definitive agreement to acquire all issued shares of Aicuris Anti-infective Cures AG, a German-based biopharmaceutical company, for approximately €780 million” (opens the source at this quote in a new tab)

“Approximately $919 million at exchange rate of $1.178/€ as of February 25, 2026” (opens the source at this quote in a new tab)

“The valuation for this acquisition was primarily calculated based on royalty income from the out-licensed product and the value of pritelivir, which completed Phase 3.” (opens the source at this quote in a new tab)

Company statements on generic entry timing and markets outside the United States

“We currently anticipate the patent will remain valid until the mid-2030s.” (opens the source at this quote in a new tab)

“If drug prices were set significantly lower outside the U.S., this could lead to substantial reductions in U.S. drug prices as well.” (opens the source at this quote in a new tab)

Treatment duration and package sizes in the prescribing information

“Across the 51 participants treated with HOVILPRI, the mean duration of treatment was 27.1 days (range 6–43).” (opens the prescribing information at this quote)

“33 % of participant in the HOVILPRI arm extended treatment up to 42 days, whose lesions were improving by Day 28.” (opens the prescribing information at this quote)

“HOVILPRI is available in cartons of 16 or 32 film-coated tablets.” (opens the prescribing information at this quote)

Comparator course length, nephrotoxicity, and second-line use in a U.S. multicenter transplant cohort

“A total of 110 patients (88%) received second line therapy(ies), including foscarnet (94), intravenous cidofovir (6), and/or topical antivirals (21). Mean treatment durations (SD) were 21.8 days (13.8), 20.3 (10.1), and 41.0 (37.5) for foscarnet, cidofovir, and topicals, respectively.” (opens the source at this quote in a new tab)

“Nephrotoxicity was reported during 40.4% of foscarnet and 50.0% of cidofovir courses, respectively.” (opens the source at this quote in a new tab)

Comparator course length and adverse events in a U.S. multicenter foscarnet cohort

“Median duration of foscarnet was 16 days (range, 6–85 days).” (opens the source at this quote in a new tab)

“At least 1 adverse event during therapy was reported in 26 (84%) treatment episodes including 23 (74%) that were considered drug related.” (opens the source at this quote in a new tab)

“Foscarnet was discontinued in 10 episodes (32%) due to an adverse event, including 6 due to kidney dysfunction.” (opens the source at this quote in a new tab)

Hospitalization, kidney injury, and hemodialysis in a U.S. single-center transplant cohort

“Complications derived from acyclovir-resistant HSV infection and its treatment included hospitalization in nine (50%) patients, acute kidney injury secondary to antivirals in nine (50%) patients, and hemodialysis subsequent to kidney injury in four (22%) patients.” (opens the source at this quote in a new tab)

Treatment escalation and adverse event counts in a sponsor-funded U.S. claims analysis

“Upward dose titration occurred in 7.6% (n=9,138), switching between first-line agents in 11.8% (n=14,196), and route changes in 5.3% (n=6,367); escalation from first-line to second-line therapy agents occurred in 1% (n=1,247)” (opens the source at this quote in a new tab)

“Among the study cohort (n=152,835), 6.8% (n=10,412) were IC.” (opens the source at this quote in a new tab)

“AEs occurred in 7% of patients receiving 1L therapy (n=8,394) and in 14% of those receiving 2L therapy (n=250). Among patients treated with IV therapy (n=443), 40% (n=179) experienced at least one AE within 30 days.” (opens the source at this quote in a new tab)

“These patterns were proxies, not confirmation of R±R HSV.” (opens the source at this quote in a new tab)

“Funding: AiCuris Anti-infective Cures AG” (opens the source at this quote in a new tab)

Analog cost-effectiveness model in refractory cytomegalovirus infection after transplantation: structure

“This study evaluated the cost-effectiveness of maribavir versus investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for post-transplant refractory cytomegalovirus (CMV) infection with or without resistance.” (opens the source at this quote in a new tab)

“A two-stage Markov model was designed using data from the SOLSTICE trial (NCT02931539), real-world multinational observational studies, and published literature.” (opens the source at this quote in a new tab)

“Total costs (2022 USD) and quality-adjusted life years (QALYs) were estimated for the maribavir and IAT cohorts.” (opens the source at this quote in a new tab)

Analog cost-effectiveness model in refractory cytomegalovirus infection after transplantation: cost components

“Maribavir had higher acquisition costs compared with IAT ($80 531 vs $65 285), but lower costs associated with administration/monitoring ($16 493 vs $27 563), adverse events (AEs) ($11 055 vs $16 114), hospitalization ($27 157 vs $33 905), and graft loss ($4516 vs $5081), thus making treatment with maribavir cost-saving.” (opens the source at this quote in a new tab)

“Compared with IAT, maribavir had lower costs ($139 751 vs $147 949) and greater QALYs (6.04 vs 5.83), making it cost-saving and more cost-effective.” (opens the source at this quote in a new tab)

Budget impact model

Approach and framework

No evidence found.

Perspective and time frame

No evidence found.

Epidemiology and eligible population inputs

No evidence found.

Cost assumptions

No evidence found.

Model outcomes

No evidence found.

Results

Base case

No evidence found.

Scenario analyses

No evidence found.

Budget impact model discussion

No evidence found.