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Pharmacy Clinical Policy Bulletins

Subject: Osteoporosis

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P fortical (calcitonin salmon nasal spray)          
P Actonel® (risedronate)   X      
P Actonel with Calcium® (risedronate /calcium carbonate tablets)   X      
P Evista® (raloxifene)          
P Fosamax® (alendronate)   X      
P Fosamax Plus D™ (alendronate70mg/ vitamin D 2800mg)   X      
FE Boniva® (ibandronate)   X     X
FE Didronel® (etidronate)         X
FE Miacalcin® (calcitonin salmon nasal spray)         X
FE Skelid® (tiludronate)         X

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy ‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

  1. Precertification Criteria

    Under some plans, including plans that use an open or closed formulary, Actonel, Actonel with Calcium, Boniva, Fosamax and Fosamax Plus D are subject to precertification. If precertification requirements apply Aetna considers Actonel, Actonel with Calcium, Boniva, Fosamax and Fosamax Plus D to be medically necessary for those members who meet any of the following precertification criteria:

      A. Quantity limits:

    According to the manufacturer, the osteoporosis drugs Actonel, Actonel with Calcium, Fosamax and Fosamax Plus D are dosed once weekly. Boniva 150mg is dosed once monthly and Boniva 2.5mg is dosed once daily. A quantity of each drug will be considered medically necessary as indicated in the table below:


    Drug Dosing Interval Dosage Strength Quantity Limits
    Actonel Once weekly 35 mg Up to 4 tablets in 28 days
    Actonel with Calcium Once weekly 35 mg Up to 1 package(4 tablets)* in 28 days
    Boniva Once monthly 150 mg Up to 3 tablets in 90 days
    Boniva Once daily 2.5 mg Up to 30 tablets in 30 days
    Fosamax Once weekly 35 mg 70 mg Up to 4 tablets in 28 days
    Fosamax Once weekly 70 mg/75 ml oral solution Up to 4 doses (75 ml each) per 28 day
    Fosamax Plus D Once weekly 70 mg/ 2800 mg Up to 4 tablets in 28 days
    * Package contains 4 Actonel 35mg (once weekly) tablets and twenty-four 1250mg calcium carbonate tablets

    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of osteoporosis drugs Actonel and Fosamax will be considered medically necessary for those members who meet the following criterion:

    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.

  2. Medical Exception Criteria

    Boniva, Didronel, Skelid and Miacalcin Nasal are currently listed on the Aetna Formulary Exclusions List.* Therefore, Boniva, Didronel, Skelid and Miacalcin Nasal are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Boniva, Didronel, Skelid and Miacalcin Nasal to be medically necessary for those members who meet any of the following criteria:

    1. A documented:

      • Intolerance to two preferred alternatives indicated for the member's condition OR
      • Contraindication to two preferred alternatives indicated for the member's condition OR
      • Allergy to two preferred alternatives indicated for the member's condition OR
      • Failure of an adequate trial of one month each of two preferred alternatives indicated for the member's condition

*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

Place of Service:

    Outpatient

The above policy is based on the following references:

  1. Product Information Insert. Actonel ® Tablets, Proctor and Gamble, Cincinnati, OH May 2003.
  2. Actonel internet site accessed 07-20-04 at http://actonel.com/index.jsp
  3. Harris ST, Nelson B, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. VERT (NA) Study Group. JAMA 1999; 282: 1344-1352.
  4. Reginster J, Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group (MN) Osteoporos Int 2000; 11(1): 83-91.
  5. McClung MR, Geusens P, Miller PD, Zippel H. Bensen WG, Roux C. Effect of Risedronate on the Risk of Hip Fracture in Elderly Women. N Engl J Med 2001; 344-333-40.
  6. Lindsay R, Adachi JD, Emkey RD, et al. Once-a-week risedronate is as effective as daily (5mg). Presented at the 65th Annual Scientific Meeting of the American College of Rheumatology, San Francisco, CA, November 2001.
  7. Fogelman, I, Moreland L, Woodsan G et al. Gastrointestinal side effects and endoscopic findings similar between risedronate and placebo-treated patients. Osteoporosis Int 2000; 11(2): S179.
  8. Hoskings D, Bockman R, Glowinkski J, et al. Similar gastrointestinal side effects and endoscopic findings between risedronate and placebo-treated patients. J Bone Miner Res 2000 Sep; 15(1): S428
  9. Woodson G. Once-weekly risedronate therapy. Osteoporosis Int 2000; 11:550.
  10. Lindsay R, Adachi JD, Emkey RD, et al. Once-a-week risedronate is as effective as daily (5mg). Presented at the 65th Annual Scientific Meeting of the American College of Rheumatology, San Francisco, CA, November 2001.
  11. Brown JP, Kendler DL, McClung MR, et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int 2002;71:103-11.
  12. Baker DE. Alendronate and risedronate: what you need to know about their upper gastrointestinal tract toxicity. Rev Gastroenterol Disord 2002;2:20-33.
  13. Cryer B, Bauer DC. Oral bisphosphonates and upper gastrointestinal tract problems: what is the evidence? Mayo Clin Proc 2002;77:1031-43.
  14. Product Information Insert. Fosamax ® Tablets, Merck & Company., Inc., Whitehouse Station, NJ April 2004
  15. Fosamax internet site accessed 07-20-04 at http://fosamax.com/alendronate_sodium/fosamax/hcp/index.jsp?US_healthcare=yes
  16. Black D, Cummings S, Karpf D et al. Randomised Trial of Effect of Alendronate on Risk of Fracture in Women with Existing Vertebral Fractures. Lancet. 1996; 348: 1535-1541
  17. Cummings S, Black, Black D. Effect of Alendronate on Risk of Fracture in Women With Low Bone Density but Without Vertebral Fractures. Results from the Fracture Interventiion Trial. JAMA. 1998; 280: 2077-2082.
  18. McClung M, Alendronate Prevents Postmenopausal Bone Loss in Women Without Osteoporosis. A Double-Blind, Randomized, Controlled Trial.
  19. Alendronate Osteoporosis Prevention Study Group Ann Intern Med. 1998; 128(4): 253-61.
  20. Anon. Results of Head to Head Efficacy Study of Osteoporosis Drugs Unveiled-Fosamax, the only once weekly osteoporosis medication approved in Canada, shown to be more effective than Risendronate. World Congress of Osteoporosis in Lisbon, Portugal, 2002
  21. Schnitzer T, Therapeutic equivalence of alendronate 70mg once weekly and alendronate 10mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging(Milano) 2000; 12(1): 1-12.
  22. Bone, HG Weekly Administration of Alendronate: Rationale and Plan for Clinical Assessment. Clin Ther 2000; 22(1): 15-28
  23. Sharp, Miriam et.al. ADIS Drug Evaluation: Alendronate An Update of its Use in Osteoporosis. Drugs 2001: 61(7): 999-1039.
  24. Hosking D, Adami S, Felsenberg D, et al. Comparison of change in bone resorption and bone mineral density with once-weekly alendronate and daily risedronate: a randomised, placebo-controlled study. Curr Med Res Opin 2003 (abstract)
  25. Greenspan S, Field-Munves E, Tonino R, et al. Tolerability of once-weekly alendronate in patients with osteoporosis: a randomized, double-blind, placebo-controlled study. Mayo Clin Proc 2002;77:1044-52.
  26. Lanza F, Sahba B, Schwartz H, et al. The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly: a placebo-controlled endoscopy study. Am J Gastroenterol 2002;97:58-64
  27. Product Information Insert Didronel ® Tablets, Proctor and Gamble, Cincinnati, OH June 2001.
  28. Cortet B, Comparative Efficacy and Safety Study of Etidronate and Alendronate in Postmenopausal Osteoporosis. Effect of Adding Hormone Replacement Therapy. Joint Bone Spine 2001; 68(5): 410-5.
  29. Siris E, Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone J Clin Endocrinol Metab 1996; 81(3): 961-7.
  30. Miller PD, Brown JP, Siris ES, Hoseyni MS, Axelrod DW, Bekker PJ, A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget's disease of bone. Paget's Risedronate/Etidronate Study Group. Am J Med 1999; 106(5): 513-20.
  31. Product Information Insert Skelid Tablets, Sanofi-Synthelabo Inc. New York, NY June 1998.

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.

January 1, 2006