Summary

No cost-effectiveness analysis of tavapadon had been published before the Institute for Clinical and Economic Review (ICER) evidence report of 16 September 2026. ICER built two semi-Markov models over a lifetime horizon using a placeholder price of $15,000 per year. In early Parkinson's disease (Model 1), tavapadon cost $26,500 more than levodopa and produced 0.015 fewer QALYs. As an adjunct to levodopa in participants with motor fluctuations (Model 2), tavapadon cost $16,900 more than a dopamine agonist market basket for a gain of 0.010 QALYs, or approximately $1.7 million per QALY gained from the health care sector perspective and $2.0 million from the modified societal perspective. No positive price made tavapadon cost-effective in Model 1; the health-benefit price benchmark in Model 2 was $6,598 to $6,861 per year (health care sector) and $4,764 to $5,026 per year (modified societal). In probabilistic analyses, tavapadon was cost-effective in 24.5% of Model 1 simulations at $200,000 per evLY gained and in fewer than 10% of Model 2 simulations at every threshold. AbbVie has published no price statement. Benzinga reported on 28 September 2026 that a William Blair analyst gave a list price of $4,900 per 30-day supply, or $58,800 per year, and ICER's public meeting slides of 1 October 2026 list a reported wholesale acquisition cost of $58,800 per year; ICER's published budget impact results use the $15,000 placeholder. GlobalData forecast United States tavapadon revenue of $199 million by 2034, and AbbVie targets more than $5 billion in combined peak sales for three Parkinson's disease products, one of which is tavapadon. Published economic evaluations of other adjunctive therapies report $46,900 per QALY for opicapone versus entacapone in the United States, and a Canadian review found safinamide dominated by other adjunctive treatments.

Published cost-effectiveness analyses of tavapadon

“Our systematic literature review did not identify any published cost-effectiveness analyses of tavapadon for Parkinson's disease. We therefore could not benchmark our results against a prior model of the same intervention.” (opens the source at this quote in a new tab)

ICER cost-effectiveness models: structure and populations

“We developed two de novo decision analytic models for this evaluation, informed by key clinical trials and prior relevant economic models.” (opens the source at this quote in a new tab)
“Costs and outcomes were discounted at 3% per year. Each model focused on an intention-to-treat analysis of a hypothetical cohort of patients with Parkinson’s disease. The first model (Model 1) evaluated patients with early Parkinson’s disease initiating first-line therapy and compared tavapadon with levodopa. The second model (Model 2) evaluated patients with Parkinson’s disease receiving levodopa and experiencing motor fluctuations and compared tavapadon with other dopamine agonists as add-on therapy. In both models, the cycle length was six months, based on prior published economic models and the available clinical data. Patients cycled through the health states based on transition rates fitted to real-world data from the Parkinson's Precision Medicine Initiative (PPMI).” (opens the source at this quote in a new tab)

ICER cost-effectiveness models: base-case results at the placeholder price

“Using two semi-Markov models built with real-world Parkinson’s disease data (Parkinson's Precision Medicine Initiative, Michael J Fox Foundation) and treatment effects from the TEMPO trials as well as the network meta-analyses (NMA), we estimated the cost-effectiveness of tavapadon for early Parkinson’s disease (versus levodopa) and as an adjunct to levodopa for Parkinson’s disease with motor fluctuations (versus other dopamine agonists added to levodopa). At the placeholder price of $15,000 per year, tavapadon was more costly and slightly less effective versus levodopa in early PD. The estimated cost-effectiveness for tavapadon compared with a market basket of dopamine agonists in patients already on levodopa was approximately $1.7 million per equal value life year (evLY) gained as well as per quality adjusted life year (QALY), based on a small estimate of overall benefit driven primarily by reductions in the rate of ICDs.” (opens the source at this quote in a new tab)
“Under the health care sector perspective, in Model 1 levodopa had total discounted costs of $1,056,000 with 6.716 QALYs, 6.716 evLYs, and 11.13 LYs, compared with $1,082,000, 6.701 QALYs, 6.701 evLYs, and 11.13 LYs for tavapadon; tavapadon was thus both more costly and slightly less effective than levodopa in this model. In Model 2, the dopamine agonist market basket had total discounted costs of $1,165,000 with 5.467 QALYs, 5.467 evLYs, and 9.63 LYs, compared with $1,182,000, 5.477 QALYs, 5.477 evLYs, and 9.63 LYs for tavapadon; tavapadon was thus somewhat more costly but slightly more effective than the market basket.” (opens the source at this quote in a new tab)
“In Model 1, tavapadon had an incremental cost of $26,500 and 0.015 fewer QALYs than levodopa in both the health system and modified societal perspectives. In Model 2, tavapadon had an incremental cost of $16,900 and 0.010 incremental QALYs versus the dopamine agonist market basket, yielding $1.7 million per QALY gained and per evLY gained; the cost per life year gained was not estimable because the therapies did not affect survival. In Model 2, the incremental cost rose from $16,900 under the health care sector perspective to $20,400 under the modified societal perspective, because tavapadon patients accrued more OFF-time and therefore greater productivity and care partner costs, yielding approximately $2.0 million per QALY gained.” (opens the source at this quote in a new tab)

ICER cost-effectiveness models: sensitivity and probabilistic analyses

“These results were consistent under the health care sector and modified societal perspectives but varied substantially in sensitivity analyses, especially for the early PD population. The results were most sensitive to the estimates of the magnitude and durability of tavapadon benefits.” (opens the source at this quote in a new tab)
“In Model 1, the incremental cost effectiveness ratio was most sensitive to the UPDRS score disutility parameters mapping motor and functional scores to utility values.” (opens the source at this quote in a new tab)
“In Model 2, the incremental CE ratio was most sensitive to the impulse control disorder disutility and the dopamine agonist ICD hazard ratio, followed by the magnitude of the OFF-time reduction for tavapadon relative to dopamine agonists—the parameter that, at its most favorable value, most improved tavapadon's relative effectiveness.” (opens the source at this quote in a new tab)
“0.5% of simulations were cost-effective at $50,000 per evLY gained under both perspectives.” (opens the source at this quote in a new tab)
“It rose to 24.5% at $200,000 per evLY gained, meaning even at the highest threshold examined, tavapadon was cost-effective in fewer than one quarter of simulations. For Model 2, the probability remained below 10% at every threshold under both perspectives.” (opens the source at this quote in a new tab)

ICER cost-effectiveness models: scenario analyses

“Tavapadon remained less effective and more costly by levodopa in Model 1 in all scenarios except when the discontinuation rate is modified (see Table 4.6 below).” (opens the source at this quote in a new tab)
“In this scenario, the discontinuation rate for tavapadon is zero after cycle 1. In Model 1, tavapadon goes from more costly and less effective to having a very slight improvement in evLYs/QALYs resulting from a better AE profile in later cycles. The cost per evLY/QALY for tavapadon is roughly $15 million in both perspectives.” (opens the source at this quote in a new tab)
“halving the decrement therefore raised incremental QALYs/evLYs from 0.010 to 0.016 and lowered the incremental cost-effectiveness ratio to $1.1 million per QALY/evLY gained under the health care sector perspective and $1.3 million under the modified societal perspective, compared with base-case ratios of $1.7 million and $2.0 million.” (opens the source at this quote in a new tab)
“From the modified societal perspective in Model 2, the incremental cost reduced from $20,400 in the base case to $10,900 in this scenario analysis, with a cost per QALY/evLY gained of $1.1 million.” (opens the source at this quote in a new tab)
“Tavapadon therefore remained more costly and more effective than the dopamine agonist market basket under both perspectives, albeit at higher cost-effectiveness ratios ($6.7-$7.8 million per QALY/evLY) relative to the base case.” (opens the source at this quote in a new tab)

ICER health-benefit price benchmark

“In Model 1, tavapadon monotherapy was not projected to produce incremental QALY or evLY gains relative to levodopa. Because incremental health benefits were zero or negative, no positive price for tavapadon would produce an incremental cost-effectiveness ratio at or below $100,000 or $150,000 per QALY or evLY gained.” (opens the source at this quote in a new tab)
“From the health care sector perspective, the annual threshold prices for tavapadon as an adjunct to levodopa were $6,598 at $100,000 per QALY or evLY gained and $6,861 at $150,000 per QALY or evLY gained. The HBPB for tavapadon as adjunctive therapy is therefore $6,598 to $6,861 per year from the health care sector perspective, compared with the placeholder annual price of $15,000. From the modified societal perspective, the corresponding annual threshold prices were $4,764 at $100,000 per QALY or evLY gained and $5,026 at $150,000 per QALY or evLY gained, yielding an HBPB range of $4,764 to $5,026 per year.” (opens the source at this quote in a new tab)

ICER correction between the draft and revised evidence reports

“An error was discovered in the calculation of costs associated with switching therapy in Model 2, resulting in an overstating of the difference in costs between tavapadon and DA agonist comparator therapy. While our overall conclusions regarding cost-effectiveness did not change, correction of the error increased threshold prices and (in this version of the report) our ultimate health benefit price benchmark estimates substantially.” (opens the source at this quote in a new tab)

Economic considerations stated in a meta-analysis

“The established dopamine agonists against which it would compete, notably pramipexole and ropinirole, have been available as generics for more than a decade and are inexpensive, so a novel branded once-daily agent would enter a market in which the incumbent oral agonists carry very low acquisition costs. On motor efficacy alone, for which the present analysis provides moderate-certainty evidence of a benefit broadly comparable to that of existing agonists, it is therefore unlikely that tavapadon could be shown to be cost-effective against low-cost generics.” (opens the source at this quote in a new tab)
“That advantage is presently untested, as set out above, so any cost-effectiveness estimate would at this stage be speculative.” (opens the source at this quote in a new tab)

Forecast United States revenue for tavapadon

“The revenue for Tavapadon is expected to reach an annual total of $199 mn by 2034 in the US based off GlobalData’s Expiry Model.” (opens the source at this quote in a new tab)

Manufacturer peak sales target for the Parkinson's disease portfolio

“Overall, we believe our Parkinson's portfolio with VYALEV, tavapadone, and DUOPA will be a substantial commercial opportunity. We continue to expect collective Parkinson's peak sales of more than $5 billion.” (opens the source at this quote in a new tab)

Analyst expectations for launch uptake

“Citi analysts had previously said the launch was expected in the third quarter of 2026, but that uptake was likely to be gradual as negotiations progressed on the drug’s Medicare coverage.” (opens the source at this quote in a new tab)
“AbbVie continued to target more than $5 billion in combined Parkinson’s disease sales, Citi added.” (opens the source at this quote in a new tab)

William Blair forecast of tavapadon sales, channel mix, and Medicare coverage timing

“Overall, we believe the Juvmo approval adds to an important Parkinson’s disease franchise for the company (we estimate sales of $1.4 billion in 2040)…” (opens the source at this quote in a new tab)
“While AbbVie expects Juvmo to eventually achieve broad access, Phipps expects coverage to build gradually, with broad Medicare coverage unlikely until 2028.” (opens the source at this quote in a new tab)
“Medicare access should remain limited in 2026 and 2027 due to formulary timing, with exemptions and appeals providing initial access.” (opens the source at this quote in a new tab)
“Commercial coverage is expected to begin through a bridge program and expand over time. Juvmo’s channel mix is projected at roughly 80% Medicare, 15% commercial and 5% Medicaid.” (opens the source at this quote in a new tab)
“William Blair revised its model to reflect limited initial coverage and a slower launch while maintaining its Juvmo peak-sales forecast.” (opens the source at this quote in a new tab)
“Phipps projects $8 million in 2026 sales and $70 million in 2027, with a European launch assumed in 2028.” (opens the source at this quote in a new tab)

Opicapone versus entacapone as adjuncts to levodopa, United States payer perspective

“To assess from a US payer perspective the relative cost-effectiveness of the catechol-O-methyltransferase inhibitors opicapone and entacapone when used adjunctively to levodopa/carbidopa (LD/CD) in patients with Parkinson's disease (PD), based on the drugs' effects to reduce absolute OFF-time hours in PD patients.” (opens the source at this quote in a new tab)
“Opicapone treatment was associated with an average of 1,187 fewer OFF-time hours per patient and an increase of 0.07 QALYs compared with entacapone. Total lifetime costs for opicapone were $3,100 higher than entacapone, resulting in an incremental cost-effectiveness ratio of $46,900 per QALY.” (opens the source at this quote in a new tab)

Opicapone versus entacapone as adjuncts to levodopa, English National Health Service perspective

“This study developed a cost-effectiveness model (CEM) of opicapone compared with entacapone from the perspective of the English National Health Service (NHS) and personal social services (PSS).” (opens the source at this quote in a new tab)
“The deterministic base case indicates that an individual treated with opicapone accrues fewer costs and more QALYs compared with each entacapone comparator and, therefore, is considered cost-effective.” (opens the source at this quote in a new tab)

Catechol-O-methyltransferase inhibitors versus no adjunct, South Korea

“Two COMT-i (OPC and ENT) were identified as a cost-effective option compared to no COMT-i.” (opens the source at this quote in a new tab)
“Although ENT may be the preferred option over OPC economically because of its lower price, OPC can be acceptable if the drug price is reduced by 17%.” (opens the source at this quote in a new tab)

Catechol-O-methyltransferase inhibitors versus no adjunct, South Korea: model structure, perspective, and time horizon

“Cost-effectiveness was assessed using model simulation. The model consisted of the following two stages: Phase 1 was composed of a decision-tree model based on the results of the BIPARK clinical trial for 15 weeks; and Phase 2 used the Markov model, wherein each cycle period was one year.” (opens the source at this quote in a new tab)
“The base-case analysis used an analytic period of 37 years (lifetime), that can be captured until all 10,000 hypothetical cohort die, was conducted from the perspective of the healthcare system.” (opens the source at this quote in a new tab)
“A 4.5% discount rate recommended in Health Insurance Review and Assessment Service (HIRA)’s new drug economic evaluation guidelines was applied to both costs and outcomes in our analysis.” (opens the source at this quote in a new tab)
“We defined the following three health states corresponding to the relative level of OFF-time, an indicator of the severity of advanced PD: (1) OFF-time < 25%, (2) OFF-time ≥ 25%, and (3) Death. At the start of the cohort, 10.84% of PD patients were classified under the OFF-time < 25% state and 89.16% under the OFF-time ≥ 25% state, reflecting the patient distribution at the start of BIPARK.” (opens the source at this quote in a new tab)
“In cycle 1, the probability of OFF-time improvement was 36.97% and 34.85% in patients receiving OPC and ENT, respectively.” (opens the source at this quote in a new tab)
“The probability of progression from OFF-time < 25% to ≥ 25% (0.238) was used by converting the 6-month transition probability (0.127) of the non-COMT-i group from previous literature into an annual probability.” (opens the source at this quote in a new tab)
“ICER is a measure of cost-effectiveness, and we assumed that if it is less than one GDP per capita of Korea per one quality-adjusted for quality of life (QALY), it is considered cost-effective because of its high acceptability.” (opens the source at this quote in a new tab)
“All costs were converted to the 2022 standard using the consumer price index and expressed in USD using an exchange rate of 1,300 Korean won (KRW) per one USD in early 2022” (opens the source at this quote in a new tab)

Catechol-O-methyltransferase inhibitors versus no adjunct, South Korea: cost and utility inputs

Input	Quoted value
Opicapone drug cost per day (USD)	“2.05”
Entacapone drug cost per day (USD)	“0.78”
No COMT inhibitor (levodopa) drug cost per day (USD)	“0.11”
Prescription cost per year (USD)	“111.91”
Health state cost per year, OFF-time less than 25% (USD)	“789.4”
Health state cost per year, OFF-time 25% or more (USD)	“2,429.8”
Utility, OFF-time less than 25%	“0.780”
Utility, OFF-time 25% or more	“0.630”
Utility, OFF-time less than 25%, after 10 cycles	“0.643”
Utility, OFF-time 25% or more, after 10 cycles	“0.555”
Utility, OFF-time less than 25%, after 20 cycles	“0.387”
Utility, OFF-time 25% or more, after 20 cycles	“0.299”
Disutility, dyskinesia	“0.070”

“Considering that utility values for PD among South Koreans have not been previously reported, we applied values from the results of Palmer et al., which were also adopted in a recent cost-effectiveness study in PD.” (opens the source at this quote in a new tab)
“Fourth, because drug-induced dyskinesia can be managed by adjusting the levodopa drug dose, it was assumed that disutility and costs owing to dyskinesia would appear only for 15 weeks (cycle 1).” (opens the source at this quote in a new tab)

Catechol-O-methyltransferase inhibitors versus no adjunct, South Korea: base-case incremental costs and QALYs

“The total cost per patient over the 37-year period was estimated to be $38,554 for the OPC group, $34,281 for the ENT group, and $41,535 for the no COMT-i group, resulting in a difference of -$2,981 (Incremental Cost-Effectiveness Ratio [ICER] 1a: OPC vs. no COMT-i) and -$7,254 (ICER 1b: ENT vs. no COMT-i), respectively.” (opens the source at this quote in a new tab)
“The modeled simulation over 37-year horizon demonstrated that a patient receiving OPC gained 0.919 more QALYs (8.41 vs. 7.49) than a patient receiving no COMT-i, and a patient receiving ENT gained 0.838 more QALYs (8.33 vs. 7.49) than a patient receiving no COMT-i. As a result, ICERs for OPC therapy compared with those for no COMT-i were estimated at −$3,243/QALY and −$3,121/LYs gained, and ICERs for ENT therapy compared with those for no COMT-i were estimated at −$8,656/QALY and −$8,324/LYs gained” (opens the source at this quote in a new tab)
“ICERs for OPC compared with ENT were estimated at $52,780/QALYs (ICER 2) and $50,993/LYs gained. The cost-effective OPC price compared to the ENT price at the South Korean threshold ($34,748) was estimated to be $1.60 per capsule (current price per capsule, $1.93).” (opens the source at this quote in a new tab)

Catechol-O-methyltransferase inhibitors versus no adjunct, South Korea: sensitivity analyses

“The COMT-i vs. no COMT-i DSA result indicated that the time horizon was the most influential variable. When the time horizon is reduced to 5 or 10 years, the ICER for the OPC vs. no COMT-i group decreased to −$6,349 and −$5,775, and that for the ENT vs. no COMT-i group, the ICER decreased to −$14,129 and −$12,401” (opens the source at this quote in a new tab)
“All ICERs were below 0 and none exceeded the South Korean WTP threshold in the COMT-i (OPC and ENT) vs. no COMT-i group DSA results” (opens the source at this quote in a new tab)
“In contrast to the DSA results in the COMT-i vs. no COMT-i group, ICERs were most sensitive to clinically important variables such as the OFF-time improvement probability of OPC and ENT.” (opens the source at this quote in a new tab)
“At a 5-year time-horizon setting, the ICER was $106,871, roughly doubling the base-case ICER.” (opens the source at this quote in a new tab)
“If the WTP (indicating cost-effective threshold) was set as one gross domestic product (GDP) per capita ($34,758 in 2022), 89.0% of the OPC simulations and 98.0% of the ENT simulations remained the preferred option over no COMT-i for PD patients” (opens the source at this quote in a new tab)
“Supplement Figure 4C shows that the probability of OPC being cost-effective compared to ENT was 39.1% at a WTP threshold of $34,758 per QALY gained.” (opens the source at this quote in a new tab)

Catechol-O-methyltransferase inhibitors versus no adjunct, South Korea: model assumptions and limitations

“Second, discontinuation of COMT-i resulted from drug AEs, and it was assumed that the drug was not discontinued owing to the lack of OFF-time improvement.” (opens the source at this quote in a new tab)
“Second, levodopa dose adjustment was not reflected in the model because of the uncertainty associated with whether and when COMT-i could be re-administered according to levodopa dose adjustment.” (opens the source at this quote in a new tab)
“Third, we conservatively estimated caregiver costs. Caregiver costs were applied only to hospitalization, and other caregiver costs or time costs for outpatient visits were not considered.” (opens the source at this quote in a new tab)

Canadian reimbursement review of safinamide cost-effectiveness

“Safinamide mesylate is available as 50 mg and 100 mg tablets at a submitted price of $6.90 per tablet, regardless of strength. The recommended starting dose of safinamide is 50 mg daily, which may be increased to 100 mg daily after two weeks based on clinical need and tolerability. At the recommended dose, the annual cost of treatment with safinamide is $2,520.” (opens the source at this quote in a new tab)
“In line with the sponsor’s submitted base case, CADTH found that both safinamide 50 mg and 100 mg were dominated (i.e., associated with greater costs and fewer QALYs) by other treatments for PD. However, several limitations were identified that could not be addressed in the submitted model, most notably the exclusion of discontinuation due to lack of efficacy. Further, the CDR Clinical Review identified major limitations with the methods for the ITC that prevent definitive conclusions being drawn regarding the comparative efficacy and safety of safinamide. As such the true cost-effectiveness of safinamide is uncertain.” (opens the source at this quote in a new tab)

Pramipexole versus levodopa as initial therapy in early Parkinson's disease, United States randomized clinical-economic trial

“301 subjects with early PD were randomized to either pramipexole or levodopa and followed every 3 months over a 2-year period.” (opens the source at this quote in a new tab)
“Pramipexole strategy was an estimated 2,138 dollars (SE = 1,182 dollars) more expensive than levodopa strategy. The incremental cost-effectiveness of pramipexole compared with levodopa was 106,900 dollars/QALY (EQ-5D), compared with pramipexole being dominated by levodopa using the EQVAS.” (opens the source at this quote in a new tab)

On-demand therapy for OFF episodes: apomorphine sublingual film, United States payer perspective

“To develop a cost-effectiveness analysis model comparing APL versus SC-APO and CVT-301 for treatment of patients with PD experiencing “OFF” episodes from a US payer perspective.” (opens the source at this quote in a new tab)
“APL was dominant over CVT-301 in terms of incremental cost per “OFF” hour, and dominant over both CVT-301 and SC-APO in terms of incremental cost per QALY gained.” (opens the source at this quote in a new tab)

Device-aided therapy for advanced Parkinson's disease: carbidopa-levodopa enteral suspension, United States

“CLES compared to SoC was associated with incremental costs ($1,031,791 vs. $1,025,180) and QALY gain (4.61 vs. 3.76), resulting in an incremental cost-effectiveness ratio of $7711/QALY.” (opens the source at this quote in a new tab)

ICER potential budget impact analysis: definition and link to the cost-effectiveness models

“We used results from the cost-effectiveness models to estimate the total potential budgetary impact of tavapadon for the Parkinson’s disease population. Potential budget impact is defined as the total differential cost of using tavapadon rather than relevant existing therapy for the treated population, calculated as differential health care costs (including drug costs) minus any offsets from averted health care events.” (opens the source at this quote in a new tab)
“The intent of our approach to budgetary impact is to document the percentage of patients that could be treated at selected prices without crossing a budget impact threshold that represents a potential trigger for policy mechanisms to improve affordability, such as changes to pricing, payment, or patient eligibility.” (opens the source at this quote in a new tab)

Derivation of the potential budget impact threshold

“this threshold is based on an underlying assumption that health care costs should not grow much faster than growth in the overall national economy. From this foundational assumption, our potential budget impact threshold is derived using an estimate of growth in US gross domestic product (GDP) +1%, the average number of new drug approvals by the FDA over the most recent five-year period, and the contribution of spending on retail and facility-based drugs to total health care spending.” (opens the source at this quote in a new tab)

ICER potential budget impact analysis: time horizon and discounting

“All costs were undiscounted and estimated over a five-year time horizon.” (opens the source at this quote in a new tab)
“All costs were undiscounted and estimated over one- and five-year time horizons.” (opens the source at this quote in a new tab)

ICER potential budget impact analysis: eligible population and uptake

“The analysis included patients starting tavapadon as first-line treatment and patients starting tavapadon as add-on therapy to levodopa, corresponding to the two modeled populations.” (opens the source at this quote in a new tab)
“To size the first-line candidate population, we multiplied the US population averaged over the next five years (342,339,134)” (opens the source at this quote in a new tab)
“by the prevalence of Parkinson’s disease (approximately 0.34%)” (opens the source at this quote in a new tab)
“by the proportion of patients not yet treated with any pharmacologic therapy (37.6%),” (opens the source at this quote in a new tab)
“yielding 436,786 patients. To size the add-on candidate population, we multiplied the same population and prevalence by the proportion treated with levodopa (43.7%),” (opens the source at this quote in a new tab)
“yielding 508,141 patients, for a total eligible population of 944,927. For this analysis, we assumed 20% of eligible patients would initiate treatment in each of the five years, or 188,985 patients per year (87,357 first-line and 101,628 add-on).” (opens the source at this quote in a new tab)

Prevalence of Parkinson's disease among United States adults by age and insurance type, 2024

“Among U.S. adults in 2024, an estimated 1.09 million individuals have PD and approximately 120,000 have AP.” (opens the source at this quote in a new tab)
“The majority (86%) of the PD population are eligible for Medicare coverage.” (opens the source at this quote in a new tab)

Characteristic	Quoted number of persons estimated to have Parkinson's disease	Quoted population	Quoted prevalence
Age 18 to 49 years	“51,719”	“141,792,556”	“0.04%”
Age 50 to 64 years	“222,591”	“61,660,017”	“0.36%”
Age 65 to 74 years	“340,161”	“35,223,309”	“0.97%”
Age 75 years and older	“478,036”	“26,298,663”	“1.82%”
Insurance: private	“99,423”	“138,862,094”	“0.07%”
Insurance: Medicare	“945,452”	“73,280,221”	“1.29%”
Overall	“1,092,506”	“264,974,545”	“0.41%”

Antiparkinsonian drug use and drug class use among Medicare beneficiaries with prevalent Parkinson's disease, 2007 to 2010

“This was a retrospective analysis of prevalent cases of PD using annual cross‐sections of Medicare beneficiaries from 2007 to 2010.” (opens the source at this quote in a new tab)
“The majority of PD patients (range, 81–82%) were prescribed at least 1 anti‐Parkinson drug each year.” (opens the source at this quote in a new tab)
“Of the treated patients, 90% were on l‐dopa therapy. This was followed by therapy with dopamine agonists (29–31%), MAOB inhibitors (9–11%), amantadine (7–8%), COMTIs (6–8%), and anticholinergics (5–6%) (Table 2).” (opens the source at this quote in a new tab)

Measure	Quoted value, 2007	Quoted value, 2008	Quoted value, 2009	Quoted value, 2010
Total number of patients with Parkinson's disease	“9482”	“9626”	“9566”	“9503”
Number of antiparkinsonian drug users	“7721”	“7872”	“7835”	“7725”
Use of any antiparkinsonian drug, %	“81”	“82”	“82”	“81”
Levodopa use, %	“90”	“90”	“90”	“90”
Dopamine agonist use, %	“31”	“31”	“30”	“29”
MAO-B inhibitor use, %	“9”	“9”	“10”	“11”
Amantadine use, %	“8”	“7”	“7”	“7”
COMT inhibitor use, %	“8”	“7”	“7”	“6”

Untreated share and first-line medication in newly diagnosed Parkinson's disease, United States claims, 2014 to 2017

“Incident PD cases were identified in the IBM MarketScan database between January 1, 2014 and June 30, 2017.” (opens the source at this quote in a new tab)
“Of the 113,647 patients who had at least one diagnosis code for PD in the IBM MarketScan database, 11,280 fulfilled the study criteria and were included in the US study.” (opens the source at this quote in a new tab)
“In the US, 4241 (37.6%) of the patients with PD did not have documented PD medication prescriptions filled during the study period, whilst 7039 (62.4%) patients received PD treatment during the follow-up period.” (opens the source at this quote in a new tab)
“Levodopa was the most common first-line PD treatment, prescribed to 70.1% of treated patients.” (opens the source at this quote in a new tab)

Initial medication	Quoted number (%) of treated patients
Levodopa	“4932 (70.1)”
Rasagiline	“579 (8.2)”
Ropinirole	“357 (5.1)”
Pramipexole	“324 (4.6)”
Amantadine	“169 (2.4)”
Rotigotine	“79 (1.1)”

First treatment class after diagnosis in incident Parkinson's disease, United States claims, 2008 to 2016

“Retrospective cohort study using claims data from the United States between 2008 and 2016.” (opens the source at this quote in a new tab)
“Out of the full PD cohort, 68,532 (81.5%) patients had insurance drug coverage (as well as medical) and were therefore eligible for treatment pattern analyses.” (opens the source at this quote in a new tab)
“Of the 49,737 (72.6%) patients whose first treatment was observed during follow-up, 70.3% were prescribed levodopa/combination therapy, making it by far the most commonly used treatment class.” (opens the source at this quote in a new tab)
“First-line use of monotherapy MAO-Bi was reported in 8.3% of patients and first-line use of amantadine was 3.1%.” (opens the source at this quote in a new tab)

First treatment class	Quoted number of patients	Quoted % of patients eligible for treatment pattern analysis	Quoted % of patients treated
Levodopa and levodopa combinations	“34,977”	“51.0”	“70.3”
Dopamine agonists	“7,729”	“11.3”	“15.5”
MAO-B inhibitors	“4,112”	“6.0”	“8.3”
Amantadine	“1,521”	“2.2”	“3.1”

Adjunctive treatment classes among levodopa-treated patients with and without OFF episodes, United States

“In addition to carbidopa/levodopa, patients were also prescribed antiparkinsonian treatments from other pharmacologic classes, including dopamine agonists (25%), catechol-O-methyl transferase inhibitors (17%), monoamine oxidase type B inhibitors (16%), and N-methyl-D-aspartate antagonists (13%; Table 1).” (opens the source at this quote in a new tab)

Quoted current prescribed treatment class	Quoted overall (N = 722)	Quoted patients without OFF episodes (n = 401)	Quoted patients with OFF episodes (n = 321)
“Carbidopa/levodopa”	“722 (100.0)”	“401 (100.0)”	“321 (100.0)”
“COMT inhibitor”	“119 (16.5)”	“48 (12.0)”	“71 (22.1)”
“Dopamine agonist”	“177 (24.5)”	“73 (18.2)”	“104 (32.4)”
“MAO-B inhibitor”	“118 (16.3)”	“50 (12.5)”	“68 (21.2)”
“NMDA receptor antagonist”	“90 (12.5)”	“24 (6.0)”	“66 (20.6)”

Concomitant medication classes at levodopa initiation among Medicare fee-for-service beneficiaries, 2017 to 2019

“The study population included 201,241 Medicare beneficiaries aged 65–90 years with PD who received at least one prescription for a carbidopa–levodopa-containing regimen.” (opens the source at this quote in a new tab)
“Medications were considered concomitant if there was a claim within 30 days of levodopa initiation on either side of the first levodopa claim, that is, 30 days before or after the first levodopa medication claim.” (opens the source at this quote in a new tab)
“The use of concomitant medications increased with increasing LEDD, specifically for dopamine agonists (6.6–13.5% for lowest LEDD group; 31.9–43.8% for highest LEDD group); COMT inhibitors (1.7–6.7% for lowest LEDD group; 5.0–14.3% for highest LEDD group); and amantadine (1.1–4.7% for lowest LEDD group; 13.8–18.3% for highest LEDD group).” (opens the source at this quote in a new tab)

Concomitant medication class	Levodopa equivalent daily dose group (mg)	Quoted n (%), immediate-release carbidopa-levodopa	Quoted n (%), controlled-release plus immediate-release carbidopa-levodopa	Quoted n (%), controlled-release carbidopa-levodopa	Quoted n (%), extended-release carbidopa-levodopa
Total patients	150 to 350	“N = 67,851”	“N = 2355”	“N = 4363”	“N = 918”
Total patients	351 to 600	“N = 57,919”	“N = 5558”	“N = 4065”	“N = 1489”
Total patients	601 to 900	“N = 26,134”	“N = 5801”	“N = 1461”	“N = 1257”
Total patients	901 to 10,000	“N = 14,884”	“N = 5372”	“N = 480”	“N = 1334”
COMT inhibitors	150 to 350	“1730 (2.6)”	“157 (6.7)”	“76 (1.7)”	“21 (2.3)”
COMT inhibitors	351 to 600	“3063 (5.3)”	“414 (7.5)”	“193 (4.8)”	“40 (2.7)”
COMT inhibitors	601 to 900	“2246 (8.6)”	“611 (10.5)”	“112 (7.7)”	“48 (3.8)”
COMT inhibitors	901 to 10,000	“1802 (12.1)”	“770 (14.3)”	“47 (9.8)”	“67 (5.0)”
Dopamine agonists	150 to 350	“4500 (6.6)”	“181 (7.7)”	“379 (8.7)”	“124 (13.5)”
Dopamine agonists	351 to 600	“8115 (14.0)”	“789 (14.2)”	“693 (17.1)”	“276 (18.5)”
Dopamine agonists	601 to 900	“6377 (25.8)”	“1234 (21.3)”	“555 (38.0)”	“348 (27.7)”
Dopamine agonists	901 to 10,000	“4743 (31.9)”	“1749 (32.6)”	“210 (43.8)”	“431 (32.3)”
MAO-B inhibitors	150 to 350	“2411 (3.6)”	“99 (4.2)”	“213 (4.9)”	“188 (20.5)”
MAO-B inhibitors	351 to 600	“5468 (9.4)”	“536 (9.6)”	“312 (7.7)”	“350 (24.0)”
MAO-B inhibitors	601 to 900	“3067 (11.7)”	“720 (12.4)”	“180 (12.3)”	“268 (21.3)”
MAO-B inhibitors	901 to 10,000	“1445 (9.7)”	“689 (12.8)”	“55 (11.5)”	“271 (20.3)”
Amantadine	150 to 350	“770 (1.1)”	“39 (1.7)”	“56 (1.3)”	“43 (4.7)”
Amantadine	351 to 600	“2457 (4.2)”	“209 (3.8)”	“157 (3.8)”	“99 (6.7)”
Amantadine	601 to 900	“2155 (8.3)”	“485 (8.3)”	“195 (13.6)”	“152 (12.1)”
Amantadine	901 to 10,000	“2049 (13.8)”	“838 (15.6)”	“88 (18.3)”	“212 (15.9)”

Average daily dose of carbidopa-levodopa among Medicare fee-for-service beneficiaries, 2017 to 2019

“Patients using ER carbidopa–levodopa had the highest mean dose (1140 mg, although this is roughly equivalent to approximately 570 mg of non-ER levodopa, aligning with the other formulations due to reduced bioavailability)” (opens the source at this quote in a new tab)
“All other formulations had mean doses between 480 and 585 mg.” (opens the source at this quote in a new tab)

Formulation	Quoted number of patients	Quoted mean ± SD daily dose (mg)	Quoted median daily dose (mg)
Overall	“201,241”	“510.99 ± 365.93”	“400.0”
Immediate-release carbidopa-levodopa	“166,788”	“480.39 ± 334.94”	“400.0”
Immediate-release plus controlled-release carbidopa-levodopa	“19,086”	“585.52 ± 359.21”	“500.0”
Controlled-release carbidopa-levodopa	“10,369”	“551.92 ± 296.38”	“520.0”
Extended-release carbidopa-levodopa	“4998”	“1140.26”, “± 709.51”	“980.0”

Adherence and persistence after initiation of levodopa or a dopamine agonist, United States Medicaid claims

“Our study sample of 805 Medicaid patients had an average age of 54.1 years, with 52.0% being female. Levodopa was the predominant PD medication at initiation (75.4%).” (opens the source at this quote in a new tab)
“Persistence was determined by identifying the last consecutive medication day of the initiating medication during the post-index period, without a gap in therapy of 60 days or greater. Given that we allowed for a 60-day runout period to determine a gap in therapy, persistence was assessed through day 305 of the post-index period.” (opens the source at this quote in a new tab)
“Slightly more than half (51.4%, adjusted) of levodopa patients continued use of the medication, without a gap of 60 days or greater, while only 40.6% (adjusted) of DA patients were persistent in medication use (p = 0.008) (Table 1).” (opens the source at this quote in a new tab)

Measure	Quoted adjusted value, levodopa	Quoted adjusted value, dopamine agonist	Quoted p value
Mean proportion of days covered (SD)	“0.621 (0.322)”	“0.546 (0.343)”	“0.007”
Adherent patients (proportion of days covered of 0.80 or higher)	“41.4%”	“33.8%”	“0.060”
Mean persistent days (SD)	“209.5 (114.2)”	“185.4 (117.8)”	“0.011”
Persistent patients	“51.4%”	“40.6%”	“0.008”

Twelve-month persistence and adherence with dopamine agonist monotherapy, United States commercial and Medicare Advantage claims

“Discontinuation was defined as a treatment gap of ≥60 days.” (opens the source at this quote in a new tab)
“A total of 283 (44.1 %) of the patients discontinued their index therapy, while 359 (55.9 %) persisted for 12 months after initiation without any change.” (opens the source at this quote in a new tab)
“The mean (SD) PDC for the overall 642 patients was 0.66 (0.3). A total of 324 (50.5 %) of patients were PDC adherent to treatment as defined by PDC ≥0.80 (Table 5).” (opens the source at this quote in a new tab)

ICER potential budget impact analysis: prices evaluated

“We used the placeholder price and the threshold prices (at $50,000, $100,000, $150,000, and $200,000 per evLY gained) for tavapadon in these estimates.” (opens the source at this quote in a new tab)
“Because tavapadon had not yet received regulatory approval, a placeholder price of $15,000 per year (as reported by IPD Analytics) was used as the intervention acquisition cost in both models. In Model 1, levodopa was costed at the median generic wholesale acquisition cost (WAC) from RED BOOK ($289 per year), consistent with ICER Reference Case guidance for generic agents.” (opens the source at this quote in a new tab)

ICER cost-effectiveness models: dosing regimens costed for tavapadon and comparators

“For Model 1, levodopa utilization was informed by the NMA, with the annual carbidopa/levodopa acquisition cost reflecting one 25 mg/100 mg tablet taken eight times daily. For Model 2, a market-basket approach reflected the mix of dopamine agonists used in practice, with annual acquisition costs based on ropinirole HCl 3 mg three times daily, pramipexole dihydrochloride IR 1 mg three times daily, and rotigotine 2 mg/24-hour transdermal patch once daily.” (opens the source at this quote in a new tab)

Intervention	Quoted dosing	Quoted annual drug cost
Tavapadon	“5–15 mg once daily”	“$15,000 (placeholder)”
Levodopa (Model 1)	“Carbidopa/levodopa 25/100 mg, 8×/day”	“$289”
Dopamine agonist market basket (Model 2)	“Ropinirole 3 mg TID; pramipexole 1 mg TID; rotigotine 2 mg/24-hr patch”	“$3,588 (weighted)”
Monotherapy market basket (Model 2)	“65% Carbidopa/levodopa 25/100 mg, 8×/day; 35% on DA market basket (Ropinirole 3 mg TID; pramipexole 1 mg TID; rotigotine 2 mg/24-hr patch)”	“$1,444”

Rasagiline: recommended dose in the prescribing information

“When AZILECT is prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start AZILECT at the recommended dose of 1 mg administered orally once daily.” (opens the source at this quote in a new tab)
“In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of AZILECT is 0.5 mg once daily. If the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily.” (opens the source at this quote in a new tab)

Selegiline: recommended dose in the prescribing information

“The recommended regimen for the administration of selegiline hydrochloride is 10 mg per day administered as divided doses of 5 mg each taken at breakfast and lunch.” (opens the source at this quote in a new tab)

Safinamide: recommended dose in the prescribing information

“The recommended starting dosage of XADAGO is 50 mg administered orally once daily (at the same time of day), without regard to meals. After two weeks, the dosage may be increased to 100 mg once daily, based on individual need and tolerability.” (opens the source at this quote in a new tab)

Entacapone: recommended dose and number of daily doses in the prescribing information

“The recommended dose of entacapone is one 200 mg tablet administered concomitantly with each levodopa and carbidopa dose to a maximum of 8 times daily (200 mg x 8 = 1,600 mg per day).” (opens the source at this quote in a new tab)
“patients were randomized to receive placebo or entacapone 200 mg administered concomitantly with each dose of levodopa and carbidopa (up to 10 times daily, but averaging 4 doses to 6 doses per day)” (opens the source at this quote in a new tab)

Opicapone: recommended dose in the prescribing information

“The recommended dosage of ONGENTYS is 50 mg administered orally once daily at bedtime.” (opens the source at this quote in a new tab)

Istradefylline: recommended dose in the prescribing information

“The recommended dosage of NOURIANZ is 20 mg administered orally once daily. The dosage may be increased to a maximum of 40 mg once daily, based on individual need and tolerability.” (opens the source at this quote in a new tab)

Amantadine extended-release capsules: recommended dose in the prescribing information

“The initial daily dosage of GOCOVRI is 137 mg, administered orally once daily at bedtime. After one week, increase to the recommended dosage of 274 mg (two 137 mg capsules) once daily at bedtime.” (opens the source at this quote in a new tab)

ICER potential budget impact analysis: outcome measures and threshold

“Figure 7.1 illustrates the cumulative per-patient potential budget impact of tavapadon as first-line treatment compared with levodopa over the five-year time horizon, assuming 20% uptake each year.” (opens the source at this quote in a new tab)
“For 2025–2026, the five-year annualized potential budget impact threshold that should trigger policy actions to manage access and affordability is approximately $821 million per year for new drugs.” (opens the source at this quote in a new tab)

First-line treatment compared with levodopa at the placeholder price

“At the placeholder price of $15,000 per year, the average annual potential budget impact per patient treated was approximately $12,500 in year one and $20,200 in year five.” (opens the source at this quote in a new tab)
“At the placeholder price of $15,000 per year, 46% of the first-line candidate population could be treated with tavapadon before reaching the potential budget impact threshold of $821 million.” (opens the source at this quote in a new tab)

Add-on treatment compared with other dopamine agonists at the placeholder price

“Figure 7.2 illustrates the cumulative per-patient potential budget impact of tavapadon as add-on treatment with levodopa compared to other dopamine agonists over the five-year time horizon, assuming 20% uptake each year. At the placeholder price of $15,000 per year, the average annual potential budget impact per patient treated was approximately $8,600 in year one and $13,700 in year five.” (opens the source at this quote in a new tab)
“At the placeholder price of $15,000 per year, 59% of the candidate population for add-on treatment could be treated with tavapadon before reaching the potential budget impact threshold of $821 million.” (opens the source at this quote in a new tab)

Budget impact at cost-effectiveness threshold prices

“The proportion of the eligible population that could be treated before reaching the potential budget impact threshold was not estimated at threshold prices because no threshold price would make tavapadon as first-line treatment cost-effective at any of the evaluated thresholds.” (opens the source at this quote in a new tab)
“At the $50,000, $100,000, $150,000, and $200,000 per evLY threshold prices ($6,336, $6,598, $6,861, and $7,123 from the health care system perspective, and $4,501, $4,764, $5,026, and $5,289 from the modified societal perspective), 100% of the population could be treated before reaching the potential budget impact threshold.” (opens the source at this quote in a new tab)

Summary

The only budget impact analysis of tavapadon identified is the ICER potential budget impact analysis in the evidence report of 16 September 2026, which used a placeholder price of $15,000 per year because tavapadon had not yet received regulatory approval. AbbVie has published no price statement; a William Blair analyst, as reported by Benzinga on 28 September 2026, and ICER's public meeting slides of 1 October 2026 give a list price of $58,800 per year, and ICER's published budget impact results use the $15,000 placeholder. It sized an eligible United States population of 944,927 (436,786 first-line and 508,141 add-on to levodopa) and assumed that 20% would initiate treatment in each of five years. At the placeholder price, 46% of the first-line population and 59% of the add-on population could be treated before annual spending reached ICER's threshold of $821 million; at the add-on threshold prices ($4,501 to $7,123 per year), 100% could be treated. The analysis takes a health care cost perspective over five years without discounting and does not model a health plan membership. AbbVie's comments on the draft report stated that tavapadon is unlikely to displace levodopa as first-line therapy, which would reduce the first-line population the analysis includes, and that the budget-impact calculations are not presented in enough detail for independent verification. AbbVie expects a modest initial uptake because tavapadon will not be added to Medicare formularies immediately after approval. The actual budget impact will depend on the launch price and on how often tavapadon displaces generic dopamine agonists and levodopa, whose acquisition costs were $3,588 and $289 per year in the ICER models.

Manufacturer critique of the ICER economic analysis

“AbbVie unequivocally disagrees with ICER’s Draft Evidence Report conclusions regarding tavapadon.” (opens the source at this quote in a new tab)
“Evaluating tavapadon as a direct alternative to first-line oral levodopa may not reflect likely treatment patterns. As tavapadon enters the market, it is unlikely to displace levodopa as first-line therapy.” (opens the source at this quote in a new tab)
“AbbVie did not have full access to the economic model through ICER’s Model Transparency Program.” (opens the source at this quote in a new tab)
“Certain model outputs, cost inputs, terminology, and budget-impact calculations are not presented with sufficient detail to allow independent verification. This limits confidence that the reported results are fully reproducible and appropriate for use as a decision-making benchmark.” (opens the source at this quote in a new tab)

Manufacturer expectation of initial uptake

“To get to the nub of your question, we do see that the ramp will be modest at first, and I'll tell you why. It's not the profile of the medication. It's largely because based on the timing of the approval, we will not be immediately added into the Medicare formularies.” (opens the source at this quote in a new tab)