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2015 Three Tier Formulary Reference Guide A list of medications that may lower your patients’ costs TABLE OF CONTENTS INTRODUCTION . ii Product Selection Criteria . ii Member Copayment Contributions . ii Pharmacy and Therapeutics (P&T) Committee . iii Generic Substitution . iii DESI Drugs . iv Legend . iv Prior Authorization (PA) . v Prior Authorization Drug List . v Drugs with Quantity Limitations (QL) . vi Step Therapy (ST) . vii Drugs with Step Therapy . vii Specialty Pharmacy Products . viii Excluded Drugs - Alternatives . x 2015 Preventive Drug List . xi Affordable Care Act Requirements . xiii Editor's Note . xiv Pharmacy Appeals . xiv Notice . xiv Clinical References . xv THERAPEUTIC CHAPTER INDEX . .1 BLUECROSS BLUESHIELD OF TENNESSEE THREE TIER FORMULARY . .4 INDEX . .58 i INTRODUCTION BlueCross BlueShield of Tennessee is pleased to provide a Three Tier Formulary. This formulary was reviewed and approved by the BlueCross Pharmacy and Therapeutics (P&T) Committee and can assist practitioners in selecting drugs for members whose drug benefits are administered through BlueCross BlueShield of Tennessee. Product Selection Criteria The BlueCross P&T Committee considers U.S. Food and Drug Administration (FDA) approved drugs for inclusion in the formulary. The evaluation includes a literature review, and expert opinion may be sought. Formal reviews are prepared and typically address the following information: • Effectiveness • Contraindications • Safety • Pharmacokinetics • Comparison studies • Patient administration/compliance considerations • Approved indications • Medical outcome and pharmacoeconomic studies • Adverse effects • Cost When a new drug is considered for formulary inclusion, an attempt will be made to examine the drug relative to similar drugs currently on formulary. Drugs reviewed by the P&T Committee are typically assigned to either Tier 2 or Tier 3, considering cost and clinical usefulness of the product. In addition, entire therapeutic classes are periodically reviewed. The class review process may result in a tier change for a specific drug(s). All the material in the Three Tier Formulary is provided as a reference for drug therapy selection. The final choice of specific drug selection for an individual member rests solely with the prescriber. Member Copayment Contributions Each therapeutic group is designated by disease state or drug class. Drug lists are a part of each therapeutic group. They show an assigned copay tier for each drug, reflecting the level of member share of the prescription cost. Please note that some restrictions and exclusions may apply due to a plan's specific benefit design. For example, smoking deterrents, e.g., nicotine patches, are excluded from coverage for some plans. In addition, over-the-counter (OTC) products are not covered, with the exception of insulin and glucose monitoring products. Investigational drugs are excluded from plans. The Three Tier Formulary is separated in the following manner: Tier 1: Lowest member copayment: Includes generic prescription drugs. Tier 2: Reduced member copayment: Includes selected branded products that are more cost-effective than similar drugs within a common drug class. All Tier 2 drugs are shown in this formulary. Tier 3: Highest member copayment: Includes branded products listed in this formulary not selected for Tier 2 and all covered branded products not listed. In many cases there is a reasonable alternative drug in Tier 1 or Tier 2 for the Tier 3 products. ii To assist in the understanding of how the tiers are assigned, the following guidelines apply: • All generic products, whether shown or not, are in Tier 1. • The equivalent brand product for a listed generic is in Tier 3. • Extended-release and delayed-release products are listed separately from the immediate-release form of the same drug. These modified release forms may appear in a different tier or an excluded benefit. • Drugs shown in a drug list include dosage forms and strengths appropriate to that therapeutic category. A drug name representing different dosage forms and uses, and therefore shown in different categories, may have different copays or an excluded benefit. • Oral liquids and suppositories will be in the same tier as the immediate-release entry. Some member groups are served in a dual copay plan. This formulary may be used as a guide for their drug selection. These members' copay plan is separated in the following manner: • Lowest copay: all generic drugs • Highest copay: all branded products Pharmacy and Therapeutics (P&T) Committee The BlueCross P&T Committee consists of pharmacists and physicians, some of whom are community practitioners. The decisions of the Committee may be communicated after each meeting in the BlueCross BlueShield of Tennessee newsletter, BlueAlert, specialized mailings or on http://www.bcbst.com. Drug classification, availability, and tier placement are subject to change. Generic Substitution Generic substitution is a pharmacy action whereby a generic version is dispensed rather than the prescribed brand-name product. Products designated in the formulary drug lists by boldface type have generic availability or the brand name cited is a generic drug. Examples of the latter include Levoxyl and Avita. The generic products selected for substitution are commonly prescribed and dispensed and have gone through the FDA's review and approval process. This FDA process assures the following requirements have been met: 1. The generic drug must contain the same active ingredient(s), be the same strength and the same dosage form as the brand-name product. 2. The FDA has given the generic an "A" rating compared to the branded product indicating bioequivalence, and has determined the generic is therapeutically equivalent to the reference brand. The ratings of generic drugs are available by referring to the FDA reference, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). When the above two criteria are met, a generic can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products that have a narrow therapeutic index (NTI) can also be guided by these principles. It is not necessary for the health care provider to approach any one therapeutic class of drug products (e.g., NTI drugs) differently from any other class, when there has been a determination of therapeutic equivalence by the FDA for the drug products under consideration. Also, additional clinical tests or examinations by the physician are not needed when a therapeutically equivalent generic drug product is substituted for the brand-name product. Under most BlueCross plans, if a member requests a brand-name drug which is available generically, the member will likely pay the Tier 1 copayment cost plus the cost difference between brand and generic referred to as MAC Penalty. iii It is recommended that generic substitution not be exercised by the pharmacist with multi-source products that appear in the Orange Book and carry a "B" rating, indicating that these products cannot be considered therapeutically equivalent to other products in the group. Also, state laws or regulations may dictate the ability to practice generic substitution for selected products or categories of drugs. It is also recommended that generic substitution not be undertaken for any unrated multi-source products that might be considered narrow therapeutic index, or maintenance drugs where it is known that products from different labelers are not bioequivalent. DESI Drugs DESI drugs are those drugs first marketed between 1938 and 1962, which were approved as safe but required no showing of effectiveness for FDA product approval. The DESI program subsequently determined that most of these products may remain available. A few DESI products remain classified as "less than fully effective" while awaiting final administrative disposition. Also classified as DESI are many products listed as identical, similar, or related to actual DESI drugs. Certain plans may exclude the coverage of DESI drugs. LEGEND AGE-A Age edit is applicable. Prior Authorization for members 17 years of age and younger. AGE-B Age edit is applicable. Prior Authorization for males 30 years of age and younger; Prior Authorization required for all females. OTC Over-the-counter PA Prior Authorization required PA+ Prior Authorization required for all males 19 years of age and older; Prior Authorization required for females ages 44 years and younger QL Quantity Limitation SPRx Product is on the Specialty Drug List ST Step Therapy d DESI drug boldface Indicates generic availability ext-rel Extended-release (also known as sustained-release) delayed-rel Delayed-release (also known as enteric coated) # Some plans do not cover these medications. Check with BlueCross BlueShield of Tennessee Member Service or the Express Scripts Pharmacy Help Desk to determine coverage. † Some groups limit the quantity to 6 tablets every 30 days. ^ Gender edit is applicable. Weigh risk of birth defects or other adverse outcomes. Do not use in pregnancy. iv Prior Authorization (PA) Prior Authorization for the following drugs is required by most plans before BlueCross will pay for them. To request PA, the prescriber or agent should call or fax Express Scripts. Phone: 1-877-916-2271 Hours: 24 hours a day, 7 days a week Fax: 1-800-837-0959 The following information will be requested: 1. Patient name and cardholder I.D. number 2. Physician name and phone number