Prior Auth Protocol

FDA Approved Indications:

Renagel: To control serum phosphorus in patients with Chronic Kidney Disease (CKD) on dialysis
Renvela: To control serum phosphorous in patients with Chronic Kidney Disease (CKD) on dialysis

Health Net Approved Indications and Usage Guidelines:

Patient is on dialysis

AND

Serum phosphorus is > 5.5 mg/dL - for initial requests only

AND

Any ONE of the following criteria:
- Failure or clinically significant adverse effect to calcium-based phosphate binding agents (i.e. calcium carbonate or calcium acetate)
- Hypercalcemia as evidenced by serum calcium level > 10.2 mg/dL
- Serum levels of calcium x phosphate product > 55 mg²/dL²
- History of severe vascular and/or soft-tissue calcifications

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) Bone Metabolism and Disease guidelines recommend successful treatment of Stage 5 Chronic Kidney Disease with the following parameters:

Parameter
Target Concentration
Serum calcium (corrected)
8.4 - 9.5 mg/dL
Serum phosphorus
3.5 - 5.5 mg/dL
Calcium-phosphorus product (Ca x P)
< 55 mg²/dL²

Aluminum-based phosphate binders are typically used as short-term therapy (4 weeks) and for one course only, when potent phosphate binding is required (> 7.0 mg/dL). It is not considered first line therapy due to the risk of aluminum toxicity (adynamic bone diseases, osteomalacia, anemia, constipation, and encephalopathy).
Renagel and Renvela are contraindicated in patients with bowel obstruction.
There are published data about the use of Renagel in patients with CKD not on dialysis, but it is not FDA approved for use in this population.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Calcium-based phosphate binder calcium carbonate (OTC) (Coverage of OTC agents will vary with plan formulary and benefit design)	1 tablet PO BID to TID with meals; titrate to response	Total elemental calcium should not exceed 1,500 mg/day
calcium acetate (PhosLo^R)	Initial 2 gelcaps PO TID with meals; titrate to phosphorus < 6 mg/dL and calcium < 9.5 mg/dL	Total elemental calcium should not exceed 1,500 mg/day
Fosrenol^R(lanthanum carbonate)	Initial 250 to 500 mg PO TID with meals; titrate every 2 - 3 wks to target serum phosphate level. Dosing range 1500 to 3000 mg/day	Maximum dose studied was 4500 mg

Calcium-based phosphate binder

calcium carbonate (OTC)**

**(Coverage of OTC agents will vary with plan formulary and benefit design)

1 tablet PO BID to TID with meals;
titrate to response

Total elemental calcium should not exceed 1,500 mg/day

calcium acetate (PhosLo^R)

Initial
2 gelcaps PO TID with meals;
titrate to phosphorus < 6 mg/dL and calcium < 9.5 mg/dL

Total elemental calcium should not exceed 1,500 mg/day

Fosrenol^R(lanthanum carbonate)

Initial
250 to 500 mg PO TID with meals;
titrate every 2 - 3 wks to target serum phosphate level.
Dosing range
1500 to 3000 mg/day

Maximum dose studied was 4500 mg

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Renagel

*Starting dose based on serum phosphorus level*
If serum phosphorus is:	Renagel 800 mg tablet	Renagel 400 mg tablet
> 5.5 and < 7.5 mg/dL	1 tab PO TID w/meals	2 tabs PO TID w/meals
> 7.5 and < 9 mg/dL	2 tabs PO TID w/meals	3 tabs PO TID w/meals
> 9 mg/dL	2 tabs PO TID w/meals	4 tabs PO TID w/meals
Starting dose for patients switching from calcium acetate to Renagel
Calcium Acetate 667 mg (gelcaps per meal)	Renagel 800 mg (Tablets per meal)	Renagel 400 mg (Tablets per meal)
1 gelcap	1 tablet PO	2 tablets PO
2 gelcaps	2 tablets PO	3 tablets PO
3 gelcaps	3 tablets PO	5 tablets PO

Titrate dosage to serum phosphorus level < 5.5 mg/dL
Maximum average daily Renagel dose studied was 13 gms.

Length of benefit

Renvela

*Starting dose based on serum phosphorus level*
If serum phosphorus is:	Renvela 800 mg Tablet		Renvela Powder
> 5.5 and < 7.5 mg/dL	1 tab PO TID w/meals		0.8g PO TID w/meals
> 7.5 mg/dL	2 tabs PO TID w/meals		1.6g PO TID w/meals
Starting dose for patients switching from calcium acetate to Renvela
Calcium Acetate 667 mg (gelcaps per meal)		Renvela 800 mg (Tablets per meal)		Renvela Powder (dose per meal)
1 gelcap		1 tablet PO		0.8g PO
2 gelcaps		2 tablets PO		1.6g PO
3 gelcaps		3 tablets PO		2.4g PO

The highest daily dose of Renvela studied was
14 grams in CKD patients on dialysis.

Length of Benefit

Product Availability:

RenagelTablet: 400 mg, 800 mg

Renvela Tablet: 800 mg, Powder for Oral Suspension: 0.8 g and 2.4 g packet

References:

Renagel [Prescribing Information] Cambridge, MA: Genzyme Corporation; May 2011.
Renvela [Prescribing Information] Cambridge, MA: Genzyme Corporation; May 2011.
National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J of Kidney Dis. 42:S1-S201, 2003 (suppl 3).
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 3, 2015.
MedicinesComplete [online]. London: Pharmaceutical Press. Available at: http://www.medicinescomplete.com. Accessed June 30, 2014.

Parameter	Target Concentration
Serum calcium (corrected)	8.4 - 9.5 mg/dL
Serum phosphorus	3.5 - 5.5 mg/dL
Calcium-phosphorus product (Ca x P)	< 55 mg²/dL²