Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement; Public Hearing
Comments by the Global Healthy Living Foundation
“Patients’ Perspectives on Febuxostat and the Importance of Education”
January 11th , 2019
We have no disclosures to make regarding this comment. The Global Healthy Living Foundation accepts grants and charitable contributions from pharmaceutical companies, government, private foundations and individuals.
We would like to thank the FDA for this opportunity to provide comments. The Global Healthy Living Foundation is a 20-year-old 501(c)(3) patient advocacy organization representing chronically ill patients and their caregivers across the U.S., Western Europe, Australia and South America. We work to improve the quality of life for people living with chronic disease by making sure their voices are heard and advocating for improved access to care at the community level.
Our patients are suffering from chronic conditions including arthritis, psoriasis, osteoporosis, chronic pain, cardiovascular disease, gout and migraine, and many of them have been living with these conditions for years. Also, many of these patients have comorbid diseases requiring extra care and non-traditional treatment.
Many patients in our community make use of febuxostat to effectively treat their gout when the first-line treatment fails to work or is more harmful to them. They also experience significant out of pocket expenses as a result of step therapy policies that create a longer wait time to achieve the adequate treatment needed and this, in turn, puts the financial burden onto the patient forcing the patient to start on therapy that is not deemed helpful by their healthcare provider. Febuxostat has the potential to drastically reduce the disease burden by treating patients with high uric acid levels, or comorbid diseases that cause other therapies to be harmful for the patient.
A patient’s right to know is also a GHLF priority. We would like to highlight that although the conclusions in the CARES publication states an increase in cardiovascular risk in patients with gout, the following additional data should be highlighted: ” a larger proportion of patients in the febuxostat group than in the allopurinol group had serum urate levels of less than 5.0 mg per deciliter (300 μmol per liter) for the entire trial.” Meaning that there was a significant decrease in serum urate levels from febuxostat since all patients accepted into the trial had a “serum urate level of at least 7.0 mg per deciliter (420 μmol per liter), or of at least 6.0 mg per deciliter (360 μmol per liter) with inadequately controlled gout, after a 1-to-3-week washout period from previous gout therapies.” 1
Also, the hazard ratio of Febuxostat to Allopurinol was very low being 1.03 and there were discrepancies as stated in the document, “for cardiovascular mortality; there was an interaction for NSAID use and the absence of use of low-dose aspirin (unadjusted P<0.05 for both comparisons)”.1
The benefit of febuxostat is great to patients that, because of comorbid diseases (kidney disease) or lack of positive outcome to allopurinol are in need of another option to lower their serum urate levels. Febuxostat is a potent xanthine oxidase inhibitor, and has minimal effects on other enzymes involved in purine and pyrimidine metabolism, and is metabolized mainly by glucuronide formation and oxidation in the liver, therefore, not affecting the kidneys. This is beneficial to many patients who cannot afford the side effects of allopurinol which can be severe or life-threatening and occur more often in patients with renal insufficiency. 2
Finally, GHLF feels that the responsibility for helping to build confidence around additional therapies also lies with the payers. They should be working with physicians, patients, and patient groups to help them understand that these alternatives are not only just as effective at managing diseases but will also reduce the cost to patients. GHLF looks forward to partnering with all stakeholders to continue patient education.
Thank you again for the opportunity to provide comment on this issue. If you have any additional questions, please contact me.
Daniel Hernandez, MD
Medical Advocacy Liaison
Global Healthy Living Foundation
1. “Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout | NEJM.” New England Journal of Medicine, www.nejm.org/doi/full/10.1056/NEJMoa1710895
2. “Febuxostat Compared with Allopurinol in Patients with Hyperuricemia and Gout | NEJM.” New England Journal of Medicine, www.nejm.org/doi/full/10.1056/NEJMoa050373