台灣健保規範下:探討24個月的藥物限制對於轉移性賀爾蒙敏感性攝護腺癌的治療及影響

李一宏 林益聖 歐宴泉 翁瑋駿 黃立華 許兆畬 童敏哲

童綜合醫院 外科部 泌尿科

Exploring Healthcare Policies: A Comprehensive Analysis of the 24-Month Medication Restrictions for mHSPC

Yi Hong Li, Yi Sheng Lin, Yen Chuan Ou, Wei Chun Weng,

Li Hua Huang, Chao Yu Hsu, Min Che Tung

Division of Urology, Department of Surgery,

Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan

Purpose:

The current standard treatment of metastatic hormone-sensitive prostate cancer (mHSPC) are Abiraterone, Apalutamide, or Enzalutamide as category 1 in National Comprehensive Cancer Network guidelines. However, the Taiwan NHI has a 24-month restriction due to economic considerations. We would like to study how the policies influence the clinical practice and patients ‘ outcomes during and after discontinuing these medications.

Materials and Methods:

Even though every novel hormonal agent (NHA) is available in Taiwan, the NHI only approved the indication of Abiraterone since 2020/05 and Apalutamide 2021/03 in high risk mHSPC.

We retrospective analyzed our patients diagnosed mHSPC in our single intuition. Patients characteristics, initial PSA, pathology reports of TRUS biopsy, palliative surgical treatment, duration and modification on NHA, and following sequential PSA were recorded. We defined PSA rise ≥2 ng/dL, clinical or radiographic progression as PSA progression.  

Results:

There are 17 patients included with 14 patients received Abiraterone due to earlier approved. 14 patients showed no PSA progression till the last follow up time. However, there was no difference on pathological parameters between PSA progression and stable.

In these 14 patients, 9 patients remained PSA stable after discontinuing and following received LHRH plus ADT. 5 patients remained using NHA with dose reduction to 1 to 2 tabs per day due to PSA decreased to undetectable. Notable, the 5 patients’ PSA were noted not gradually dropped to undetectable but immediately after NHA used within 1 month. The other 3 patients suffered from progression to mCRPC and received chemotherapy or radium-223 therapy. 1 of the 3 patients had no PSA progression in our criteria immediately after discontinuing but meet the criteria on the 6th month. There are 4 patients not diagnosed mHSPC initially but all remained PSA undetectable after discontinuing NHA.

Conclusions:

Under the healthcare policy, patient may not meet guideline concordance treatment. We showed our experience on real-world modification on medication dosage, especially for patients with dramatic response after  NHA used, it can be an alternative. However, we did not find the difference in response group. Otherwise, the greatest duration on holding medication is 8 months. A longer term follow up may elucidate the pros and cons.