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[Roflumilast in combination with long-acting bronchodilators in the management of patients with severe and very severe COPD. A cost-effectiveness analysis for Germany].
Dtsch Med Wochenschr. 2013 Jan; 138(4):119-25.DM

Abstract

OBJECTIVE

To calculate the cost-effectiveness of roflumilast in combination with a long-acting beta agonist (LABA) versus LABA as a monotherapy in patients with severe and very severe COPD in Germany.

METHODS

The cost-effectiveness of Roflumilast plus LABA vs. LABA as monotherapy was calculated by a long-term model (Markov). The effectiveness data are based on the clinical trials AURA and HERMES (M2-124 and M2-125). Roflumilast plus LABA compared to LABA monotherapy reduced the exacerbation rate by 20.7 % (95 % CI, -31,-9) and improved post-bronchodilator FEV1 by 46 ml (2). These data were used to calculate the mean life expectancy of the COPD cohort (start age: 64 years). Costs for the treatment of exacerbations in the inpatient setting and the outpatient setting were included in the model. Endpoints were incremental costs per avoided exacerbation and per quality adjusted life year (QALY). The input variables were addressed in sensitivity analyses. German data on epidemiology and management of COPD were to populate the model and the cost-effectiveness was analyzed from the perspective of German statutory health insurance (SHI).

RESULTS

The model predicts a mean life expectancy of 8.1 years for patients with roflumilast plus LABA and 7.8 years for patients with LABA alone. This corresponds with a gain of 0.26 life years or 0.23 QALYs. Within this time span patients receiving roflumilast plus LABA experienced 2.43 exacerbations less than the comparator group. The incremental cost for roflumilast plus LABA is €1,852 per exacerbation avoided and €19,457 per QALY gained.

CONCLUSION

The model calculation indicates that the cost-effectiveness of roflumilast as an add-on to LABA in patients with severe and very severe COPD is comparable to the cost-effectiveness of established and reimbursed treatment options in Germany. Analogue consideration of the cost-effectiveness of the treatment options LAMA, LABA and ICS are advisable.

Authors+Show Affiliations

Institut und Poliklinik für Arbeits-, Sozial- und Umweltmedizin, München. Dennis.Nowak@med.uni-muenchen.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

English Abstract
Journal Article
Randomized Controlled Trial

Language

ger

PubMed ID

23322425

Citation

Nowak, D, et al. "[Roflumilast in Combination With Long-acting Bronchodilators in the Management of Patients With Severe and Very Severe COPD. a Cost-effectiveness Analysis for Germany]." Deutsche Medizinische Wochenschrift (1946), vol. 138, no. 4, 2013, pp. 119-25.
Nowak D, Ehlken B, Kotchie R, et al. [Roflumilast in combination with long-acting bronchodilators in the management of patients with severe and very severe COPD. A cost-effectiveness analysis for Germany]. Dtsch Med Wochenschr. 2013;138(4):119-25.
Nowak, D., Ehlken, B., Kotchie, R., Wecht, S., & Magnussen, H. (2013). [Roflumilast in combination with long-acting bronchodilators in the management of patients with severe and very severe COPD. A cost-effectiveness analysis for Germany]. Deutsche Medizinische Wochenschrift (1946), 138(4), 119-25. https://doi.org/10.1055/s-0032-1327416
Nowak D, et al. [Roflumilast in Combination With Long-acting Bronchodilators in the Management of Patients With Severe and Very Severe COPD. a Cost-effectiveness Analysis for Germany]. Dtsch Med Wochenschr. 2013;138(4):119-25. PubMed PMID: 23322425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Roflumilast in combination with long-acting bronchodilators in the management of patients with severe and very severe COPD. A cost-effectiveness analysis for Germany]. AU - Nowak,D, AU - Ehlken,B, AU - Kotchie,R, AU - Wecht,S, AU - Magnussen,H, Y1 - 2013/01/15/ PY - 2013/1/17/entrez PY - 2013/1/17/pubmed PY - 2013/5/1/medline SP - 119 EP - 25 JF - Deutsche medizinische Wochenschrift (1946) JO - Dtsch. Med. Wochenschr. VL - 138 IS - 4 N2 - OBJECTIVE: To calculate the cost-effectiveness of roflumilast in combination with a long-acting beta agonist (LABA) versus LABA as a monotherapy in patients with severe and very severe COPD in Germany. METHODS: The cost-effectiveness of Roflumilast plus LABA vs. LABA as monotherapy was calculated by a long-term model (Markov). The effectiveness data are based on the clinical trials AURA and HERMES (M2-124 and M2-125). Roflumilast plus LABA compared to LABA monotherapy reduced the exacerbation rate by 20.7 % (95 % CI, -31,-9) and improved post-bronchodilator FEV1 by 46 ml (2). These data were used to calculate the mean life expectancy of the COPD cohort (start age: 64 years). Costs for the treatment of exacerbations in the inpatient setting and the outpatient setting were included in the model. Endpoints were incremental costs per avoided exacerbation and per quality adjusted life year (QALY). The input variables were addressed in sensitivity analyses. German data on epidemiology and management of COPD were to populate the model and the cost-effectiveness was analyzed from the perspective of German statutory health insurance (SHI). RESULTS: The model predicts a mean life expectancy of 8.1 years for patients with roflumilast plus LABA and 7.8 years for patients with LABA alone. This corresponds with a gain of 0.26 life years or 0.23 QALYs. Within this time span patients receiving roflumilast plus LABA experienced 2.43 exacerbations less than the comparator group. The incremental cost for roflumilast plus LABA is €1,852 per exacerbation avoided and €19,457 per QALY gained. CONCLUSION: The model calculation indicates that the cost-effectiveness of roflumilast as an add-on to LABA in patients with severe and very severe COPD is comparable to the cost-effectiveness of established and reimbursed treatment options in Germany. Analogue consideration of the cost-effectiveness of the treatment options LAMA, LABA and ICS are advisable. SN - 1439-4413 UR - https://www.unboundmedicine.com/medline/citation/23322425/[Roflumilast_in_combination_with_long_acting_bronchodilators_in_the_management_of_patients_with_severe_and_very_severe_COPD__A_cost_effectiveness_analysis_for_Germany]_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0032-1327416 DB - PRIME DP - Unbound Medicine ER -