Study supports illegal darbepoetin marketing claim

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Takeaway

 

  • Use of erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA) decreased between 2002 and 2010. 
  • Per-patient dosing of darbepoetin (Aranesp), but not epoetin (Mircera), increased between 2003 and 2010. 
  • Monthly per-patient costs decreased 3% for epoetin and increased 30% for darbepoetin.

 

Why this matters

  • In 2004, 2007, and 2008, US FDA committees warned of risks of ESAs for CIA. 
  • In 2015, the manufacturer of darbepoetin paid a litigation settlement of $72 million relating to allegations of marketing darbepoetin at doses greater than those approved by the FDA. 
  • The are the first data on epoetin vs darbepoetin use for CIA.

Study design

  • Study evaluated 3689 patients with CIA.
  • Funding: American Cancer Society.

Key results

  • 35% patients had at least 1 ESA prescription.
  • In 2003, epoetin and darbepoetin use rates were 22% and 28%.
  • In 2010, rates were 3.4% and 7.1%, respectively.
  • In 2003 vs 2010, the mean per patient, per administration dosing for epoetin was 40,983 vs 47,753 IU, whereas for darbepoetin it was 191 vs 369 μg.
  • In 2003 and 2010, cost of monthly dose of epoetin was 1030 and 932 USD, and for darbepoetin, it was 981 and 1352 USD.

Limitations

  • Degree of anemia in patients may be different.

Coauthored with Deepa Koli, MPharm