Oscar Velphoro (sucroferric oxyhydroxide) (PG179) Form

Chronic kidney disease (CKD) is a progressive condition characterized by gradual loss of kidney function over time.

As CKD advances, the kidneys have difficulty eliminating waste products from the bloodstream. One of these waste products is phosphorus, an essential mineral needed for bone health, energy production, and other cellular functions.

In advanced CKD and end-stage renal disease (ESRD), impaired kidney function leads to hyperphosphatemia, or abnormally elevated blood phosphorus levels. If left uncontrolled, hyperphosphatemia can cause serious complications like abnormal bone mineralization, vascular calcification, and increased risk of cardiovascular mortality.

To manage hyperphosphatemia, patients with advanced CKD or ESRD undergoing dialysis often require phosphate-binding medications like Velphoro (sucroferric oxyhydroxide) in addition to dietary phosphate restriction and dialysis. Velphoro binds to dietary phosphorus in the gastrointestinal tract, preventing its absorption into the bloodstream and thereby reducing serum phosphorus levels.

While Velphoro (sucroferric oxyhydroxide) can help control elevated blood phosphorus levels, it does not cure CKD or restore normal kidney function. It is one component of a comprehensive treatment plan for advanced CKD and ESRD which may also include:

1. Dietary phosphorus restriction
2. Dialysis to remove excess phosphorus
3. Other phosphate binder medications

Definitions

Chronic Kidney Disease (CKD)

is a progressive condition characterized by gradual loss of kidney function over time.

Dialysis

is a treatment that filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this on their own. Two main types are hemodialysis and peritoneal dialysis.

End-Stage Renal Disease (ESRD)

is the final stage of chronic kidney disease when the kidneys can no longer function at the level needed to sustain life. Patients typically require renal replacement therapy such as dialysis or kidney transplantation.

Hemodialysis

is a type of dialysis where a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough.

Hyperphosphatemia

is abnormally elevated level of phosphate in the blood, defined as a serum phosphate concentration greater than 4.5 mg/dL in patients with ESRD.

Peritoneal Dialysis

is a type of dialysis where fluid is put into the abdomen to absorb wastes and fluid from small blood vessels.

Phosphate Binders

are medications that bind dietary phosphate in the gastrointestinal tract to reduce absorption and lower serum phosphate levels. Examples include calcium acetate, sevelamer carbonate, sevelamer hydrochloride, and lanthanum carbonate.

Serum Phosphate

is a measurement of the amount of phosphate in the blood, reported in mg/dL or mmol/L. Normal range is 2.5-4.5 mg/dL in adults. Levels higher than 4.5 mg/dL indicate hyperphosphatemia.

Medical Necessity Criteria for Initial Authorization

The Plan considers Velphoro (sucroferric oxyhydroxide) medically necessary when ALL of the following criteria are met:

1. Velphoro (sucroferric oxyhydroxide) is prescribed by or in consultation with a nephrologist; AND
2. The member is 18 years of age or older; AND
3. The member has a diagnosis of end-stage chronic kidney disease (ESRD); AND
4. The member has documented evidence of:
   • Hyperphosphatemia, characterized by a serum phosphate level greater than (>) 5.5 mg/dL); and
   • Inadequate control of serum phosphate despite adherence to dietary restrictions and dialysis; AND
5. The patient is currently undergoing hemodialysis or peritoneal dialysis; AND
6. The member is unable to use, or has tried and failed TWO of the following:
   • Calcium acetate (PhosLo); and/or
   • Lanthanum carbonate chewable tablet (Fosrenol); and/or
   • Sevelamer (Renvela, Renagel); AND

Velphoro (sucroferric oxyhydroxide) is prescribed at a dose that does not exceed 3,000 mg per day (6 tablets per day). If the above prior authorization criteria are met, Velphoro (sucroferric oxyhydroxide) will be approved for up to 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if the member has recent (within the last 3 months) clinical documentation showing:

1. Velphoro (sucroferric oxyhydroxide) continues to be prescribed by or in consultation with a nephrologist; AND
2. The member has experienced a reduction in serum phosphate levels with Velphoro treatment, validated by clinical documentation showing:
   • Serum phosphate level reduced to <5.5 mg/dL; or
   • A reduction in serum phosphorus concentration from baseline.

Experimental or Investigational / Not Medically Necessary

Velphoro (sucroferric oxyhydroxide) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Anemia
• Anemia of Chronic Disease
• Chronic Heart Failure (CHF)
• Chronic Lymphocytic Leukemia
• Colorectal Neoplasms
• Crohn's Disease (CD)
• Heart Failure
• Hip ArthropathyHip Fracture
• Hypoalbuminemia
• Inflammatory Bowel Diseases (IBD)
• Iron Deficiency (ID)
• Iron Deficiency Anaemia in Childbirth
• Iron Deficiency Anemia (IDA)
• Knee ArthropathyMultiple Myeloma (MM)
• Non-Hodgkin's Lymphoma (NHL)
• Osteoarthritis (OA)
• Perioperative Blood Conservation
• Restless Legs Syndrome (RLS)
• Ulcerative ColitisUnexplained Anemia (UAE)
• Variola Major (Smallpox)

References

1. Chen TK et al. Chronic kidney disease diagnosis and management: a review. JAMA.2019;322(13):1294-1304.
2. Ketteler M et al. Diagnosis, evaluation, prevention, and treatment of chronic kidney disease- mineral and bone disorder: synopsis of the kidney disease: improving global outcomes 2017 clinical practice guideline update. Ann Intern Med. 2018;168(6):422-430.
3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease—mineral and bone disorder (CKD-MBD). Kidney Int. 2017;7(suppl 1):1-59. doi:10.1016/j.kisu.2017.04.001
4. Kovesdy CP, Lu JL, Wall BM, et al. Changes with lanthanum carbonate, calcium acetate, and phosphorus restriction in CKD: a randomized controlled trial. Kidney Int Rep. 2018;3(4):897-904. doi:10.1016/j.ekir.2018.03.011
5. Locatelli F, Del Vecchio L. Iron-based phosphate binders: a paradigm shift in the treatment of hyperphosphatemic anemic CKD patients? J Nephrol. 2017;30(6):755-765. doi:10.1007/s40620-017-0421-y
6. Velphoro (sucroferric oxyhydroxide) [prescribing information]. Waltham, MA: Fresenius Medical Care North America; February 2020.

Clinical Guideline Revision / History Information

Original Date: 9/21/2023
Reviewed/Revised: