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Pharmacy Clinical Policy Bulletins

Subject: Ulcerative Colitis Agents

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P mesalamine enema          
P prednisolone          
P prednisone          
P sulfasalazine   X      
P Asacol® (mesalamine oral)   X      
P Canasa® (mesalamine supp.)   X      
P Rowasa® (mesalamine enema)          
NP Azulfidine® (sulfasalazine)   X      
FE Colazal® (balsalazide)   X   X X
FE Dipentum® (olsalazine)   X     X
FE Entocort EC® (budesonide oral)         X
FE Pentasa® (mesalamine oral)   X   X 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, Asacol, Azulfidine, Canasa, Colazal, Dipentum, Pentasa, and sulfasalazine are subject to precertification. If precertification requirements apply Aetna considers Asacol, Azulfidine, Canasa, Colazal, Dipentum, Pentasa, and sulfasalazine to be medically necessary for those members who meet the following precertification criteria:

      A. Quantity limits:

    According to the Ulcerative Colitis Practice Guidelines from the American College Gastroenterology (ACG), these agents may be dosed up to a maximum dose as indicated below. A quantity of each drug will be considered medically necessary as indicated in the table below.


      Drug Maximum Daily Dose Dosage Strength Quantity Limits
      Asacol 4.8 grams 400 mg Up to 360 tablets in 30 days (12/day)
      Azulfidine 6 grams 500 mg Up to 360 tablets in 30 days (12/day)
      Canasa 1500 mgs 500 mg Up to 90 suppositories in 30 days (3/day)
      Canasa 1500 mgs 1000 mg Up to 60 suppositories in 30 days (2/day)
      Colazal 6.75 grams 750 mg Up to 270 capsules in 30 days (9/day)
      Dipentum 3 grams 250 mg Up to 360 capsules in 30 days (12/day)
      Pentasa 4.8 grams 250 mg Up to 600 capsules in 30 days (20/day)
      sulfasalazine 6 grams 500 mg Up to 360 tablets in 30 days (12/day)

    For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of ulcerative colitis agents will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member's dose is being titrated by physician (3-month limit) OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.

  2. Step-Therapy Criteria

    Under some plans, including plans that use an open or closed formulary, Colazal and Pentasa are subject to step-therapy. Aetna considers Colazal and Pentasa to be medically necessary for those members who meet the following step-therapy criterion:

    A documented trial of one month of one of sulfasalazine OR Asacol - alternatives on the Preferred Drug List.

    If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below)

  3. Medical Exception Criteria

    Colazal, Dipentum, Entocort EC, and Pentasa are currently listed on the Aetna Formulary Exclusions List.* 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 Colazal, Dipentum, Entocort EC, and Pentasa to be medically necessary for those members who meet ANY of the following criteria:

      A documented

      • Contraindication to one preferred alternative agent indicated for the member's condition OR
      • Intolerance to one preferred alternative agent indicated for the member's condition OR
      • Allergy to one preferred alternative agent indicated for the member's condition OR
      • Failure of an adequate trial of one month of one preferred alternative agent indicated for the member's condition OR
      • Members has Crohn's disease located in the small (top) intestine (Pentasa-only)


    Notes:
      For treatment of active ulcerative colitis with Colazal, the usual dose in adults is three 750mg capsules to be taken three times a day for a total daily dose of 6.75 gms (9 capsules) for a duration of 8 weeks. Some patients in the clinical trials required treatment for up to 12 weeks. Safety and effectiveness of Colazal beyond 12 weeks has not been established.

      Entocort EC is indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. It is said to be "locally active" in the colon. The active ingredient in Entocort EC is released in the intestines and is then quickly and extensively metabolized, preventing the majority of the drug from entering the systemic circulation. This leads to fewer systemic side effects (compared with other corticosteroids, such as prednisolone) and improved tolerability.

      The recommended adult dosage for Entocort EC is 9 mg taken once daily in the morning for up to 8 weeks. For recurring episodes of active Crohn's Disease, a repeat 8 week course of Entocort EC can be given. Treatment with Entocort EC capsules can be tapered to 6 mg daily for 2 weeks prior to complete cessation. Patients have been switched from oral prednisolone to Entocort EC with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating Entocort EC treatment
*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:

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  15. Hanauer SB, Krawitt EL, Robinson M, et al. Long-term management of Crohn's disease with mesalamine capsules (Pentasa). Am J Gastroenterol 1993;88:1343-51.
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  18. Lochs H, Mayer M, Fleig WE, et al. Prophylaxis of postoperative relapse in Crohn's disease with mesalamine: European Cooperative Crohn's Disease Study VI. Gastroenterology 2000;118:264-73.
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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