Depression

Class Edit Summary* Status Drug PR PR-QL PR-AL ST M EX‡ Preferred Generics P budeprion   X       P bupropion, bupropion SR   X       P citalopram   X       P fluoxetine   X       P fluvoxamine   X       P maprotiline   X       P paroxetine   X       Preferred brands P Effexor XR® (venlafaxine SR) X     X X P Paxil CR® (paroxetine SR)       X X P Wellbutrin XL® (bupropion SR)       X X Non-preferred brands NP Desyrel® (trazodone)     X X NP Remeron® (mirtazapine)       X X Formulary Excluded brands FE Celexa® (citalopram)   X   X X FE Cymbalta® (duloxetine) X X   X X FE Effexor® (venlafaxine)   X   X X FE Lexapro® (escitalopram)   X   X X FE Paxil® (paroxetine)   X   X X FE Pexeva® (paroxetine)   X   X X FE Prozac® (fluoxetine)   X   X X FE Prozac® Weekly (fluoxetine)   X   X X FE Rapiflux® (fluoxetine)   X   X X FE Serzone® (nefazodone)       X X FE Wellbutrin® (bupropion)   X   X X FE Wellbutrin SR® (bupropion SR)   X   X X FE Zoloft® (sertraline)   X   X X *P = Preferred; FE = Formulary Excluded; NP = Non-preferred 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 epsdrugstore 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 (i.e., 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 Precertification Criteria Under some plans, including plans that use an open or closed formulary, certain antidepressants are subject to Precertification as specifically described below. Cymbalta and Effexor XR may be subject to Precertification. If Precertification requirements apply, Aetna considers Cymbalta and Effexor XR to be medically necessary for those members who meet the following Precertification criteria: A documented diagnosis of one of the following: Cymbalta: major depressive disorder OR diabetic peripheral neuropathic pain Effexor XR: major depressive disorder, generalized anxiety disorder (including long-term treatment), social anxiety disorder (social phobia), OR perimenopausal hot flashes Budeprion, bupropion, bupropion SR, citalopram, fluoxetine, fluvoxamine, maprotiline, paroxetine, Celexa, Cymbalta, Effexor, Lexapro, Luvox, Paxil, Pexeva, Prozac, Prozac Weekly, Rapiflux, Wellbutrin, Wellbutrin SR, and Zoloft may be subject to quantity limits. According to the manufacturers, these antidepressants can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below; for Cymbalta, the member must also fulfill criteria A above. Drug Maximum DAILY Dose per Package Insert Doses per day Dosage Strengths Quantity Limits bupropion Wellbutrin 450 mg Three 75 mg, 100 mg Up to 180 tablets in 30 days bupropion SR Wellbutrin SR budeprion 400 mg One or two 100, 150, 200 mg Up to 60 tablets in 30 days citalopram Celexa 40 mg One 10, 20, 40 mg Up to 30 tablets in 30 days Cymbalta 60 mg One or two 20 mg, 30 mg Up to 60 capsules in 30 days Cymbalta 60 mg One or two 60 mg Up to 30 capsules in 30 days Effexor 375 mg Two or three 25mg, 100 mg Up to 90 tablets in 30 days Effexor 375 mg Two or three 37.5 mg Up to 120 tablets in 30 days Effexor 375 mg Two or three 50 mg Up to 180 tablets in 30 days Effexor 375 mg Two or three 75 mg Up to 150 tablets in 30 days fluoxetine Prozac 80 mg One or two 10 mg Up to 30 tablets or capsules in 30 days fluoxetine Prozac 80 mg One or two 40 mg Up to 60 capsules in 30 days fluoxetine Prozac 80 mg One or two 20 mg capsules Up to 120 capsules in 30 days fluoxetine Rapiflux 80 mg One or two 20 mg tablets Up to 30 tablets in 30 days fluoxetine Prozac 80 mg One or two Liquid 20 mg/5ml Up to 300 ml in 30 days (10ml/day) Prozac Weekly 90 mg One weekly 90 mg Up to 4 capsules in 28 days fluvoxamine 300 mg One or two 25 mg, 50 mg Up to 30 tablets in 30 days fluvoxamine 300 mg One or two 100 mg Up to 90 tablets in 30 days Lexapro 20 mg One 5, 10, 20 mg Up to 30 tablets in 30 days Lexapro 20 mg One Solution 5mg/5ml Up to 600 ml in 30 days maprotiline 225 mg One, or can be divided 25 mg Up to 30 tablets in 30 days maprotiline 225 mg One, or can be divided 50 mg Up to 60 tablets in 30 days maprotiline 225 mg One, or can be divided 75 mg Up to 90 tablets in 30 days paroxetine Paxil, Pexeva 60 mg One 10 mg, 20 mg Up to 30 tablets in 30 days paroxetine Paxil, Pexeva 60 mg One 30 mg, 40 mg Up to 60 tablets in 30 days paroxetine Paxil, Pexeva 60 mg One Suspension 10mg/5ml Up to 900 ml in 30 days Zoloft 200 mg One 25 mg Up to 30 tablets in 30 days Zoloft 200 mg One 50mg Up to 45 tablets in 30 days Zoloft 200 mg One 100 mg Up to 60 tablets in 30 days Zoloft 200 mg One Liquid 20mg/ml Up to 300 ml in 30 days For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of these antidepressants for those members who meet ANY of the following criteria: Member requires a dose including half tablets OR Member's dose is being titrated by physician (3 month limit) OR Member has had intolerance to drug administered as a single daily dose OR Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose. Step-Therapy Criteria Under some plans, including plans that use an open or closed formulary, Celexa, Cymbalta, Desyrel, Effexor, Effexor XR, Lexapro, nefazodone, Paxil, Paxil CR, Pexeva, Prozac, Prozac Weekly, Rapiflux, Remeron, Serzone, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zoloft are subject to Step-Therapy. Aetna considers these drugs to be medically necessary for those members who meet the following Step-Therapy criteria: A documented trial of one (1) month of one (1) of bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone - alternatives on the Preferred Drug List. If it is medically necessary for a member to be initially treated 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). Medical Exception Criteria Desyrel, Effexor XR, Paxil CR, Remeron, and Wellbutrin XL currently are listed on the Aetna Step-Therapy List.* If it is medically necessary for a member to be initially treated with one of these medications subject to Step-Therapy, Aetna considers these drugs to be medically necessary for those members who meet the criteria specified below: Celexa, Cymbalta, Effexor, Lexapro, nefazodone, Paxil, Pexeva, Prozac, Prozac Weekly, Rapiflux, Serzone, Wellbutrin, Wellbutrin SR, and Zoloft currently are listed on the Aetna Formulary Exclusions and Step-Therapy Lists.* They, therefore, are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require Step-Therapy criteria, unless a medical exception is granted. Aetna considers these drugs to be medically necessary for those members who meet the criteria specified below: Celexa, Desyrel, nefazodone, Paxil tablets, Pexeva, Prozac, Prozac Weekly, Rapiflux, Remeron, Serzone, Wellbutrin, and Wellbutrin SR A documented: Intolerance to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Contraindication to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Allergy to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Failure of an adequate trial of one (1) month of one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone. Effexor, Lexapro, Paxil CR, Paxil suspension, Wellbutrin XL, and Zoloft - A OR B (OR C for Paxil CR) A documented: Intolerance to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Contraindication to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Allergy to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Failure of an adequate trial of one (1) month of one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone. OR Member is documented to be currently stabilized on one of these antidepressants - Effexor, Lexapro, Paxil CR, Paxil suspension, Wellbutrin XL, or Zoloft. OR Member has a documented diagnosis of premenstrual dysphoric disorder or severe PMS (evaluate per list of symptoms below) - for Paxil CR ONLY Member must have one of these symptoms in the week before menses (and symptoms improve when menses begins): Very depressed mood, feeling hopeless Marked anxiety, tension, edginess Sudden mood shifts (crying easily, extreme sensitivity) Persistent, marked irritability, anger, increased conflicts and at least 4 additional symptoms, from the list above or below: Loss of interest in usual activities work, school, socializing Difficulty concentrating and staying focused Fatigue, tiredness, loss of energy Marked appetite change, overeating, food cravings Insomnia (difficulty sleeping) or sleeping too much Feeling out of control or overwhelmed Physical symptoms such as weight gain, bloating, breast tenderness or swelling, headache, and muscle or joint aches and pains Cymbalta, Effexor XR - (A AND B) OR C A Documented diagnosis of one of the following: Cymbalta: major depressive disorder OR diabetic peripheral neuropathic pain Effexor XR: major depressive disorder, generalized anxiety disorder (including long-term treatment), social anxiety disorder (social phobia), OR perimenopausal hot flashes AND A documented: Intolerance to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Contraindication to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Allergy to one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone OR Failure of an adequate trial of one (1) month of one (1) generic preferred alternative - bupropion, bupropion SR, budeprion, citalopram, fluoxetine, fluvoxamine, paroxetine, mirtazapine, or trazodone. OR Member is documented to be currently stabilized on one of these antidepressants - Cymbalta or Effexor XR. *Information regarding epsdrugstore 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 if access to the Internet is available, providers may initiate the registration process 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 utilize our online Precertification/medical exception email request form. The aforementioned lists 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 copay levels based on a percentage of epsdrugstore 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 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 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 non-preferred drug because (i) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the non-preferred drug, and (ii) 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 non-preferred 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 non-preferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (i) the terms of epsdrugstore arrangements with participating pharmacies; (ii) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (iii) 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 non-preferred alternative. For members in Texas, additions to the 2005 Preferred Drug List will be effective no later than January 1, 2005. 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.