- Date 10 June 2020
- Documents : 5
- Economic analysis
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ERLEADA
Reason for request
New indication
Favourable opinion for reimbursement in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
What therapeutic improvement?
Like ZYTIGA (abiraterone acetate), ERLEADA (apalutamide), in combination with ADT, provides a therapeutic improvement compared to ADT alone, in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
Role in the care pathway?
The first-line treatment of metastatic hormone-sensitive prostate cancer is based on androgen deprivation therapy (ADT), in combination with docetaxel in patients eligible for chemotherapy, or on ADT plus abiraterone acetate in combination with prednisone or prednisolone. Both these strategies had demonstrated an improvement in overall survival compared to ADT alone.
Role of ERLEADA (apalutamide) in the care pathway:
ERLEADA administered in combination with ADT represents a new first-line option in the treatment of patients with metastatic hormone-sensitive prostate cancer.
In the absence of comparative data, the role of ERLEADA versus docetaxel or abiraterone acetate (in combination with prednisone or prednisolone) remains to be determined.
According to the experts, the choice of treatment should take into account the patient’s age, comorbidities, the patient’s informed choice and the safety profile of each medicinal product.
Clinical Benefit
| Substantial |
The clinical benefit of ERLEADA is substantial in this MA indication extension. |
Clinical Added Value
| moderate |
Considering:
and despite:
the Committee considers that, like ZYTIGA (abiraterone acetate), ERLEADA (apalutamide) in combination with ADT, provides a moderate clinical added value (CAV III) versus ADT alone, in the indication “in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)”. |
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