Your browser doesn't support javascript.
loading
Is health-related quality of life sufficiently addressed in trials for breast cancer treatments? An assessment based on reimbursement opinions from the French health technology assessment body, 2009-2023.
Kyheng, Maéva; Tonoli, Hélène; Supah, Nicolas; Riou França, Lionel; Massol, Jacques.
Afiliación
  • Kyheng M; Aixial Group, 8 cours André Philip - 6ème étage, Villeurbanne 69100, France. Electronic address: maeva.kyheng@aixial.com.
  • Tonoli H; Aixial Group, 8 cours André Philip - 6ème étage, Villeurbanne 69100, France. Electronic address: helene.tonoli@aixial.com.
  • Supah N; Aixial Group, 221 bis avenue Jean Jaurès, Boulogne-Billancourt 92100, France. Electronic address: nicolas.supah@aixial.com.
  • Riou França L; Aixial Group, 221 bis avenue Jean Jaurès, Boulogne-Billancourt 92100, France. Electronic address: lionel.rioufranca@aixial.com.
  • Massol J; Consultant at Aixial Group, 221 bis avenue Jean Jaurès, Boulogne-Billancourt 92100, France. Electronic address: jacques.massol.ext@aixial.com.
J Cancer Policy ; 42: 100504, 2024 Sep 10.
Article en En | MEDLINE | ID: mdl-39260453
ABSTRACT

BACKGROUND:

Breast cancer treatments can impact the patients' health-related quality of life (HR-QoL). This criterion is relevant for drug reimbursement decisions. We wanted to assess the usage of HR-QoL in health technology assessments (HTA).

METHODS:

All HAS (Haute Autorité de Santé, the French HTA body) opinions published between January 1, 2009 and March 31, 2023 for the reimbursement of breast cancer drugs were analysed.

RESULTS:

51 distinct appraisals were found during the period, corresponding to 45 product-specific indications, of which 36 (80 %) including clinical studies in which HR-QoL was an endpoint. HAS explicitly rejected HR-QoL data in 25 out of 36 (69 %) indications with such data. Rejections are justified by methodological weaknesses, including lack of adjustment for type I error inflation (n=21 indications), open-label treatment (n=7), lack of a pre-specified clinically relevant HR-QoL threshold (n=6) or missing data (n=6). Regardless of rejection status, HR-QoL results were not mentioned as a determinant of value assessment in 3/36 (8 %) instances (2/25 for rejected data).

CONCLUSIONS:

HR-QoL data are inconsistently present in HTA assessments of new breast cancer drugs. Their methodological quality often hinders their use in determining the drug's value. POLICY

SUMMARY:

A rigorous and acceptable comparative experimental framework is expected for HR-QoL assessments. More detail on the precise impact of the absence or presence of HR-QoL data in the determination of the drug's added value could help understanding how this dimension is influential in the assessments.
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Cancer Policy Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Cancer Policy Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido