Original Title: Pembrolizumab en cáncer de cabeza y cuello

Authors' recommendations: Moderate-quality evidence shows that pembrolizumab combined with platinum-based chemotherapy plus 5-fluorouracil or taxane with or without cetuximab versus the same scheme without pembrolizumab for unresectable or metastatic recurrent head and neck squamous-cell cancer, may potentially yield a higher net benefit by increasing overall survival with similar quality of life to that of chemotherapy. Moderatequality evidence shows that monotherapy with pembrolizumab compared with platinum-based chemotherapy plus 5-fluorouracil or taxane with or without cetuximab, may potentially yield a higher net benefit in patients with a combined positive score ≥ 1 by increasing overall survival with similar quality of life and a lower adverse event incidence. Moderate-quality evidence shows that adding pembrolizumab to concomitant chemo-radiotherapy yields an uncertain net benefit in patients with locally advanced head and neck squamous cell cancer when compared with chemotherapy with cisplatin concomitantly with radiotherapy. Clinical practice guidelines from United States, Europe and Argentina recommend using pembrolizumab in combination with chemotherapy in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer. One guideline from the United Kingdom recommends using pembrolizumab only as monotherapy in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer with a combined positive score ≥ 1, whereas one Argentine guideline recommends using it as monotherapy, but the population subgroup is not specified. None of the Latin-American health funders assessed cover pembrolizumab for head and neck squamous cell cancer. The public health system in United Kingdom only covers it as monotherapy in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer with a combined positive score ≥ 1, whereas France and Germany also cover it in combination with chemotherapy for the same population subgroup. The United States public health system covers pembrolizumab in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer, who have progressed during or after a platinumbased chemotherapy, whereas United States private health funders, Aetna and Cigna, cover it in combination with chemotherapy or as monotherapy in patients with a combined positive score ≥ 1. Pembrolizumab for head and neck squamous cell cancer is not covered by the Argentinean Mandatory Medical Plan or the Unique Reimbursement System. One economic evaluation carried out in our country from the public system perspective, does not recommend covering pembrolizumab for unresectable or metastatic recurrent head and neck squamouscell cancer, although it is considered effective. This is probably because of its negative impact on public health due to its high coverage cost. Another economic evaluation carried out in Argentina by the manufacturer of this technology and from the social security perspective considers that pembrolizumab as monotherapy or in combination with platinum-based chemotherapy and 5-fluorouracil versus chemotherapy with cetuximab, one platinum and 5-fluorouracil would be cost-effective with a willingness to pay threshold equivalent to three GDP per capita per quality-adjusted life years. Moderate-quality evidence shows that pembrolizumab combined with platinum-based chemotherapy plus 5-fluorouracil or taxane with or without cetuximab versus the same scheme without pembrolizumab for unresectable or metastatic recurrent head and neck squamous-cell cancer, may potentially yield a higher net benefit by increasing overall survival with similar quality of life to that of chemotherapy. Moderatequality evidence shows that monotherapy with pembrolizumab compared with platinum-based chemotherapy plus 5-fluorouracil or taxane with or without cetuximab, may potentially yield a higher net benefit in patients with a combined positive score ≥ 1 by increasing overall survival with similar quality of life and a lower adverse event incidence. Moderate-quality evidence shows that adding pembrolizumab to concomitant chemo-radiotherapy yields an uncertain net benefit in patients with locally advanced head and neck squamous cell cancer when compared with chemotherapy with cisplatin concomitantly with radiotherapy. Clinical practice guidelines from United States, Europe and Argentina recommend using pembrolizumab in combination with chemotherapy in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer. One guideline from the United Kingdom recommends using pembrolizumab only as monotherapy in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer with a combined positive score ≥ 1, whereas one Argentine guideline recommends using it as monotherapy, but the population subgroup is not specified. None of the Latin-American health funders assessed cover pembrolizumab for head and neck squamous cell cancer. The public health system in United Kingdom only covers it as monotherapy in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer with a combined positive score ≥ 1, whereas France and Germany also cover it in combination with chemotherapy for the same population subgroup. The United States public health system covers pembrolizumab in patients with unresectable or metastatic recurrent head and neck squamous-cell cancer, who have progressed during or after a platinumbased chemotherapy, whereas United States private health funders, Aetna and Cigna, cover it in combination with chemotherapy or as monotherapy in patients with a combined positive score ≥ 1. Pembrolizumab for head and neck squamous cell cancer is not covered by the Argentinean Mandatory Medical Plan or the Unique Reimbursement System. One economic evaluation carried out in our country from the public system perspective, does not recommend covering pembrolizumab for unresectable or metastatic recurrent head and neck squamouscell cancer, although it is considered effective. This is probably because of its negative impact on public health due to its high coverage cost. Another economic evaluation carried out in Argentina by the manufacturer of this technology and from the social security perspective considers that pembrolizumab as monotherapy or in combination with platinum-based chemotherapy and 5-fluorouracil versus chemotherapy with cetuximab, one platinum and 5-fluorouracil would be cost-effective with a willingness to pay threshold equivalent to three GDP per capita per quality-adjusted life years.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.iecs.org.ar/publicacion/?id=22894

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)