Saturday, June 15, 2024

G-BA Initiates Benefit Assessment for Prostate Cancer Combination Treatment Talazoparib and Enzalutamide

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The German Federal Joint Committee (G-BA) has initiated a benefit assessment process for Talazoparib (marketed as Talzenna) in combination with Enzalutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This evaluation is part of the mandatory process for new therapeutic indications under § 35a of the German Social Code Book V (SGB V).

The assessment process began on February 15, 2024. The benefit assessment was published, and the written statement procedure commenced on May 15, 2024. Stakeholders have until June 5, 2024, to submit their written statements. The final decision is expected in early August 2024. The status of the procedure is currently open for statements. Talazoparib, marketed under the trade name Talzenna, is used in combination with Enzalutamide for the treatment of adult patients with prostate cancer where chemotherapy is not clinically indicated.

Benefit Assessment for Prostate Cancer: Comparator Therapies for Talazoparib and Enzalutamide

This benefit assessment focuses on two patient populations:

Comparator therapies for adults with mCRPC who have not received prior mCRPC therapy and for whom chemotherapy is not clinically indicated:

  • Abiraterone acetate with Prednisone or Prednisolone
  • Enzalutamide
  • Olaparib monotherapy or in combination with Abiraterone acetate and Prednisone or Prednisolone (for patients with BRCA mutations)

Comparator therapies for adults with prostate cancer who have received prior mCRPC therapy and for whom chemotherapy is not clinically indicated:

  • Abiraterone acetate with Prednisone or Prednisolone
  • Enzalutamide
  • Olaparib monotherapy or in combination with Abiraterone acetate and Prednisone or Prednisolone (considering previous therapies and BRCA1/2 mutation status)

The information regarding the comparator therapies is based on the recognized state of medical knowledge at the time of consultation and may be subject to change if new evidence necessitates a review. The benefit assessment was published on May 15, 2024, by the Institute for Quality and Efficiency in Health Care (IQWiG). The assessment document is available for download in PDF format.

Prostate Cancer

G-BA Invites Stakeholder Input on Talazoparib and Enzalutamide Benefit Assessment

Stakeholders are invited to submit their statements electronically via the G-BA’s portal or by email, using the specified templates and adhering to the guidelines provided. The deadline for submitting written statements is June 5, 2024, with a public hearing scheduled for June 24, 2024, conducted via video conference. Registration for the hearing is open until June 17, 2024. The G-BA’s decision on the benefit assessment will be made within three months, incorporating the submitted statements and evidence.

The benefit assessment under 35a SGB V is crucial for determining the added value of new pharmaceuticals and their suitability for coverage under the German statutory health insurance system. Talazoparib’s evaluation, in combination with Enzalutamide, aims to establish whether this combination provides a significant therapeutic benefit for patients with prostate cancer compared to existing standard treatments. The process ensures that new treatments are rigorously evaluated for their clinical effectiveness, safety, and economic impact, thereby guiding reimbursement decisions and optimizing patient care.

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Resource: Gemeinsame Bundesausschuss, May 15, 2024

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