Forxiga® - Diabetes Drug Now Approved for Chronic Kidney Disease in Patients without Diabetes

Drug Review: Volume 22, Issue 2 - Download PDF

Chronic kidney disease (CKD) is a progressive disease characterized by abnormalities in kidney structure or function that is present for at least three months. In Canada, it affects 12.5% of all Canadians and 30.8% of those aged 65 years or older.  The severity of CKD is based on the estimated glomerular filtration rate (eGFR), a measurement of how well the kidneys are able to filter waste from blood. A declining eGFR increases the risk of end stage kidney disease (ESKD) requiring dialysis, all-cause mortality, and cardiovascular death. The symptoms of kidney damage as well as the side effects of treatment all negatively impact physical, emotional, and social wellbeing of the patients.

Prior to the approval of Forxiga® for this new indication, the standard of care treatment options included renin-angiotensin-aldosterone system (RAAS) inhibitors such as angiotensin-converting-enzyme inhibitors (ACEis) and angiotensin II receptor blockers (ARBs) which slow the progression of CKD. However, the risk of progression remains high and RAAS do not improve all-cause mortality. For those with diabetes, Invokana® has demonstrated and been approved to reduce the risk of ESKD.  It is in the same drug class as Forxiga, however, was only approved for use in patients with Type 2 Diabetes Mellitus (T2DM).

Forxiga® is the first medication approved to delay kidney disease progression as well as decrease all-cause mortality for patients with or without T2DM.

This is Forxiga®’s newest indication as it is already approved by Health Canada to treat T2DM and heart failure. In clinical trials, Forxiga® as an add on to the standard of care treatment was able to significantly reduce the risk of ESKD, all-cause mortality, and eGFR decline compared to standard of care alone. Forxiga® is intended to be used together with a ACEi or ARB when treatment with these medications alone is insufficient.

The annual cost of Forxiga® for this new indication is $997 and the recommended dose is 10 mg once daily. Similar to the coverage of Forxiga® for its other indications, this medication will be placed under Special Authorization for ClaimSecure groups subscribed to Managed Formularies to ensure cost-effective use. Forxiga® will be fully covered for groups subscribing to Open Formularies.

Drug Name

Forxiga®

Drug Ingredients

dapagliflozin

Annual Cost

$997

Coverage Details

Special Authorization for Managed Formularies. Fully covered for Open Formularies.

 

ClaimSecure Inc. reserves the right to amend in part, or in its entirety, its Special Authorization guidelines.

 

References:

  1. Forxiga Product Monograph. AstraZeneca Canada Inc. August 2021
  2. KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. January 2013. Available at: https://kdigo.org/guidelines/ckd-evaluation-and-management/

 

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