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Cost-effectiveness analysis of augmentation therapy for severe alpha1-antitrypsin deficiency.

Thomas R Gildea1, Kenneth M Shermock, Mendel E Singer

  • 1Department of Pulmonary and Critical Care Medicine, The Cleveland Clinic Foundation, OH 44195, USA.

American Journal of Respiratory and Critical Care Medicine
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Augmentation therapy (Aug) for severe alpha1-antitrypsin deficiency is not cost-effective. Significant cost reductions are needed for Aug for life to be considered viable compared to no Aug or Aug until FEV1 decline.

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Area of Science:

  • Pulmonary Medicine
  • Health Economics
  • Genetics

Background:

  • Alpha1-antitrypsin deficiency is a genetic disorder leading to severe lung disease.
  • Augmentation therapy (Aug) is a treatment option for severe alpha1-antitrypsin deficiency.
  • The cost-effectiveness of Aug remains a critical consideration for clinical practice.

Purpose of the Study:

  • To evaluate the cost-effectiveness of different augmentation therapy (Aug) strategies for severe alpha1-antitrypsin deficiency.
  • To compare no Aug, Aug for life, and Aug until FEV1 decline.
  • To determine the incremental cost-effectiveness ratios (ICERs) for each strategy.

Main Methods:

  • A Markov-based decision model was developed.
  • A hypothetical cohort of 46-year-old patients with FEV1 49% predicted was simulated using Monte Carlo methods.
  • Five health states were defined: FEV1 50-79%, FEV1 35-49%, FEV1 <35%, lung transplantation, and death.

Main Results:

  • Aug for life yielded 7.19 QALYs at $895,243; Aug until FEV1 <35% yielded 6.64 QALYs at $511,930; no Aug yielded 4.62 QALYs at $92,091.
  • ICERs were $207,841/QALY for Aug until FEV1 <35% and $312,511/QALY for Aug for life.
  • Sensitivity analyses showed Aug for life ICERs consistently exceeded $100,000/QALY.

Conclusions:

  • Augmentation therapy for severe alpha1-antitrypsin deficiency is relatively less cost-effective compared to other health interventions.
  • The cost of Aug would need to decrease from $54,765 to $4,900 for the 'Aug for life' strategy to be cost-effective.
  • Further development of more clinically and cost-effective therapies for alpha1-antitrypsin deficiency is warranted.