Subject: Vitamin D Analogs

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	calcitriol
C	Hectorol®  (doxercalciferol)
C	Zemplar®  (paricalcitol)
NC	Calcijex®  (calcitriol)						X
NC	Rocaltrol®  (calcitriol)						X

Policy:

1. Medical Exception Criteria

Calcijex and Rocatrol are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.*  Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Calcijex and Rocatrol to be medically necessary for those members who meet the following criteria:

A.  A documented:

• Contraindication to one covered alternative Vitamin D analog indicated for the member's condition OR
• Intolerance to one covered alternative Vitamin D analog indicated for the member's condition OR
• Allergy to one covered alternative Vitamin D analog indicated for the member's condition OR
• Failure of an adequate trial of one month of one covered alternative Vitamin D analog indicated for the member's condition
  

* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
4. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
5. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
6. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
7. Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: April 14, 2005).
8. Rocaltrol Product Information.  Roche Laboratories Inc, Nutley NJ.  July 2004.
9. Hectorol Product Information.  Bone Care International, Inc., Middleton WI.  April 2004.
10. Drisdol Product Information.  Sanofi-Synthelabo, Inc., New York, NY.  December 2003.
11. Zemplar Product Information.  Abbott Laboratories, North Chicago, IL.  May 2005.
12. Coburn JW, Maung HM.  Use of active vitamin D sterols in patients with chronic kidney disease, stages 3 and 4.  Kidney Int.  2003;63(suppl 85):S49-S53.
13. Martin KJ, Gonzalez EA.  Vitamin D analogues for the management of secondary hyperparathyroidism.  Am J Kidney Dis. 2001;38(5 Suppl 5):S34-40.
14. Coburn JW, Maung HM, Elangovan L, et al.  Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4.  Am J Kidney Dis.  2004;43:877-90.
15. Barton Pai A, Lin S, Arruda JA, Lau AH.  Long-term therapy with paricalcitol for secondary hyperparathyroidism in hemodialysis patients.  Int J Artif Organs.  2003;26:484-90.
16. Slatopolsky E, Cozzolino M, Lu Y, et al.  Efficacy of 19-Nor-1,25-(OH)2D2 in the prevention and treatment of hyperparathyroid bone disease in experimental uremia.  Kidney Int.  2003;63:2020-7.
17. Spragye SM, Llach F, Amdahl M, et al.  Paricalcitol versus calcitriol in the treatment of secondary hyperparathyroidism.  Kidney Int.  2003;63:1483-90.
18. Teng M, Wolf M, Lowrie E, et al.  survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy.  N Engl J Med.  2003;349:446-56.
19. Drueke TB, McCarron DA.  Paricalcitol as compared with calcitriol in patients undergoing hemodialysis.  N Engl J Med.  2003;349:496-99.
20. Colussi G; Kida Y; Wolf M, Teng M, Thadhani R.  Paricalcitol, calcitriol, and survival of patients undergoing hemodialysis. [letters] N Engl J Med.  2003;349:1971-2.
21. Dobrez DG, Maths A, Amdahl M, et al.  Paricalcitol-treated patients experience improved hospitalization outcomes compared with calcitriol-treated patients in real-world clinical settings.  Nephrol Dial Transplant.  2004;19:1174-81.
22. Robinson DM, Scott LJ.  Paricalcitol: a review of its use in the management of secondary hyperparathyroidism.  Drugs.  2005;65:559-76.
23. Brown AJ, Dusso AS, Slatopolsky E.  Vitamin D analogues for secondary hyperparathyroidism.  Nephrol Dial Transplant.  2002;17(suppl 10):10-19.

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 10, 2006