Clinical Publications

Cost-Effectiveness of Third-Generation HMEs

January 7, 2026

Clinical Publications of Interest 2026-01

This issue delves into third-generation HMEs, which have been shown to offer better functionality over previous generations. With previous cost-effectiveness studies primarily targeting second-generation HMEs, this is the first study investigating the cost-effectiveness of the third-generation HMEs. The primary outcomes suggest that while third-generation HMEs carry greater healthcare costs, they are more cost-effective and reduce health complications more than second-generation HMEs and no HMEs.

Oridate N, Smedby T, Ruzza C, Roth M, Mehta M, Akachi Y, et al. Cost-effectiveness analysis of third-generation heat and moisture exchangers in patients who underwent laryngectomy in Japan. Cost Eff Resour Alloc. 2025;23(1):54

The new generation of HME offers better humidification and breathability than second-generation counterparts

  • Heat and moisture exchangers (HMEs) serve to compensate for the loss of function of the upper respiratory tract caused by total laryngectomy (TL), improving pulmonary health, as well as physiological and psychosocial wellbeing. They offer humidification, breathing resistance and heating of incoming air.
  • Between second-generation (Provox XtraMoist, Provox XtraFlow) and third-generation (Provox Life Series: Provox Life Go, Night, Home, Energy and Protect) HMEs, the functionality of the latter shows greater improvements in breathability and humidification (1-3).
  • Previous studies show that TL patients using third-generation HMEs had a higher CASA-Q score (ie. lower frequency and severity of cough and sputum production) compared to those using second-generation HMEs. Additionally, EQ-5D-centred studies indicated that they also exhibited less depression and anxiety (1, 3, 4).
  • No studies have yet investigated the cost-effectiveness of third-generation HMEs.

Objectives of the study

  1. To carry out a cost-effectiveness analysis of third-generation HMEs compared to second-generation and no HMEs in simulated TL patients
  2. To conduct a health outcome comparison following use of third-generation, second-generation and no HMEs in simulated TL patients. Health outcomes included quality-adjusted life year (QALY), skin irritation, mucus plug events and pulmonary infections

Third-generation HMEs have been available in the Japanese market since November 2024, with insurance coverage allowing for broad adoption of the HMEs. This study considered the perspective of the Japanese public healthcare payer.

A Markov model spanning a 10-year period was used to simulate a TL patient group

  • The study employed a Markov model with a 10-year horizon, with cycles of 1 year, the time period being chosen based on average age and survival of TL patients. The model simulated 1000 patients, with an average age of 67 years.
  • Five health states reflecting differences in health-related quality of life were chosen: no or mild sputum impact; moderate sputum impact; severe sputum impact; recurrent cancer; death.
  • No studies have yet investigated the cost-effectiveness of third-generation HMEs. The calculations were made based on patient-level data from a randomized cross-over study by Longobardi et al. 2022 (1).
  • A combination of literature reviews, clinical trials, manufacturer-provided information and validation by key opinion leaders was used for establishing Japanese-specific parameters, costs associated with each health state, and the study outcomes.
  • To note, due to a lack of Japan-specific data, this study only included costs of devices and costs associated with pulmonary infection, mucus plug events and skin irritation. It did not include other costs associated with follow-up visits, medication use or disease progression.

The cost-effectiveness analysis compared the intervention (third-generation HMEs) to second-generation HMEs and no HMEs.

Primary outcomes:

  • Incremental costs
  • Incremental quality-adjusted life year (QALY)
  • Incremental cost-effectiveness ratio (ICER)

Secondary outcomes:

  • Pulmonary infection
  • Mucus plug events
  • Skin irritation

The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) per QALY

  • Within the study, the main indication of cost-effectiveness was summed up by ICER per QALY.
  • QALY measures consider a patient’s quality and quantity of life in a given health state (1 QALY = 1 year of life in perfect health; 1 year with a health condition that reduces QoL to half = 0.5 QALY). The study considered factors affecting a patient’s quality of life, such as skin irritation, mucus plug events and pulmonary infection.
  • The ICER quantified the extra cost associated with each additional unit of QALY (calculated by cost of treatment A/ QALYs from treatment A). This ratio was compared to Japan’s informal willingness-to-pay (WTP) threshold (the maximum amount society is willing to pay for 1 extra QALY) of ¥5,000,000 per QALY.
  • Robustness of the study results were confirmed with a probabilistic sensitivity analysis.

Third-generation HMEs proved more costly, yet more cost-effective than both second-generation and no HMEs

  • Overall, third-generation HMEs had a greater effect and total healthcare spending per patient.
  • The extra cost of third-generation HMEs compared to second-generation HMEs was ¥883,447 with 0.38 extra QALYs. This came to an incremental ICER of ¥2,350,010 per QALY gained. The extra cost of third-generation HMEs compared to no HMEs was ¥1887504 with 0.4 extra QALYs. This came to an incremental ICER of ¥4,708,917 per QALY gained.
  • Both resulting ICERs were lower than the WTP threshold of ¥5,000,000 per QALY, indicating that the health benefit per yen spent is of good economic value.

Users of third-generation HMEs experience fewer adverse health outcomes

  • Third-generation HME users experienced fewer adverse effects (skin irritation, mucus plug events, pulmonary infections) than second-generation HME users.
  • Compared to TL patients who didn’t use a HME, third-generation HME users had fewer mucus plugs events and pulmonary infections, but they experienced more skin irritation. This is attributable to the fact that they used HME adhesives, which the HME-free patients did not.

Transition probabilities highlight the importance of maintaining a good health status and not shifting into a worse state

  • The transition probabilities were the most influential factor in cost-effectiveness.
  • This suggests that small changes in a patient’s wellbeing have a big impact on cost-effectiveness. Maintaining or returning to better health status, with low probability of transitioning into worse health statuses may potentially lead to lower costs long-term, and better health outcomes.

Key Takeaways

  1. Third-generation HMEs prove to be more cost-effective than second-generation or no HMEs. Despite being more costly per patient, third-generation HMEs are good value for money for the health benefits and reduce complications. This is supported by the incremental ICER values being below Japan’s WTP threshold.
  2. Third-generation HMEs reduce the number of pulmonary infections and mucus plug events compared to second-generation HMEs and no HMEs.
  3. Skin irritation was lower with third-generation HMEs compared to second-generation HMEs but higher compared to no HMEs. This is an expected result as HME users wear adhesives which can contribute to skin irritation. However, this is outweighed by the benefits of third-generation HMEs in terms of reducing the frequency of other adverse events, and overall better cost-effectiveness.
  4. The model used validated tools (CASA-Q and EQ-5D), input from key opinion leaders and real-world data, making it highly relevant for clinical practice. However, due to differences in countries’ healthcare systems, the model’s input assumptions, and a lack of Japan-specific data making inclusion of all HME-associated costs infeasible, caution should be taken in cross-country comparisons of cost-effectiveness.
  5. Transition probabilities between health states were the most influential factor in cost-effectiveness. Third-generation HME use reduces the probability of transitioning into worse health states and increases the probability of staying in or returning to better health states, leading to better health outcomes and potentially lower long-term costs. This highlights the importance of early and consistent use of effective HMEs to prevent moving to a worse state and understanding that preventing complications like mucus plugs or infection has both a clinical and economic value.

References

    1. Longobardi Y, Galli J, Di Cesare T, D'Alatri L, Settimi S, Mele D, et al. Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers. Otolaryngol Head Neck Surg. 2022;167(6):929–40.
    2. Almajali O, Balk M, Rupp R, Allner M, Sievert M, Iro H, et al. The Effects of a "New Generation" of Heat and Moisture Exchangers in Laryngectomized Patients with Previous Heat and Moisture Changer Experience. Ear Nose Throat J. 2023:1455613231200769.
    3. Ward EC, Hancock K, Boxall J, Burns CL, Spurgin AL, Lehn B, et al. Post-laryngectomy pulmonary and related symptom changes following adoption of an optimal day-and-night heat and moisture exchanger (HME) regimen. Head Neck. 2023;45(4):939–51.
    4. Parrilla C, Minni A, Bogaardt H, Macri GF, Battista M, Roukos R, et al. Pulmonary Rehabilitation After Total Laryngectomy: A Multicenter Time-Series Clinical Trial Evaluating the Provox XtraHME in HME-Naive Patients. Ann Otol Rhinol Laryngol. 2015;124(9):706–13.

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