NICE Issues Draft Guidance on Astellas’ Xtandi and Janssen’s Zytiga for Prostate Cancer Treatment

NICE Issues Draft Guidance on Astellas’ Xtandi and Janssen’s Zytiga for Prostate Cancer Treatment

NICE issued its final draft guidance recommending enzalutamide (Xtandi, by Astellas Pharma) for prostate cancer (PC) patients who have already tried first-line treatments with no success, for those who have none to a few symptoms and for those who have not been recommended chemotherapy.

According to a press release, the Appraisal Committee decided that enzalutamide is a cost-effective, well-tolerated treatment that delays chemotherapy, improving survival. The final draft guidance for enzalutamide is now being revised by consultees, who can appeal against it. Until NICE releases its final guidance, NHS agencies can decide locally on the funding of particular treatments.

NICE is also considering preliminary recommendations that go against the support of abiraterone (Zytiga, by Janssen) as a therapy for PC that has spread after non-effective treatment, for patients who have none to mild symptoms, or for whom chemotherapy was not indicated. The Appraisal Committee recognized abiraterone’s good tolerance but did not respond positively to the evidence of long-term benefit of abiraterone, on the grounds that estimates of cost-effectiveness were substantially above what the Committee thought was reasonable.

Further Notes:

  1. Enzalutamide (Xtandi, by Astellas Pharma) is recommended — in its agreed marketing terms — as a treatment for metastatic hormone-relapsed PC in patients who have none to mild symptoms after previous therapy failed, and before chemotherapy is indicated. Additionally, the indication depends on the company providing patient access scheme discount.
  2. Abiraterone (Zytiga, by Janssen) is not yet recommended — within its agreed marketing terms — for the same position in the line of treatment for patients with no or mild symptoms or for whom therapy hasn’t been successful and cannot move to chemotherapy yet.
  3. The Appraisal Committee heard specialists claiming that when cytotoxic chemotherapy is indicated, the majority of patients would be recommended docetaxel. In the case of patients with no or mild symptoms, where chemotherapy can be delayed, supportive care including corticosteroids is recommended instead.

Preliminary recommendations for abiraterone are now available for public consultation; consultees, healthcare professionals and interested members of the public can now comment on the document and will have the Committee’s full consideration. “In this final draft guidance we recommend enzalutamide as a treatment for patients whose prostate cancer has relapsed, but for whom chemotherapy is not yet clinically indicated. There are very few treatments available for patients at this stage of prostate cancer, so this is very good news,” commented Sir Andrew Dillon, NICE Chief Executive. “The evidence submitted for abiraterone was uncertain in terms of the extent of the quality of life and survival benefit. In addition, its current cost does not appear to justify its advantages, to patients, over current standard treatment. It is obviously disappointing not to be able to recommend at this point.”

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