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
INTEGRIS Formulary July 2017 Foreword FORMULARY EXCLUDED THERAPEUTIC DRUG This document represents the efforts of the MedImpact Healthcare Systems THERAPEUTIC DRUGS CLASS Pharmacy and Therapeutics (P & T) and Formulary Committees to provide ALTERNATIVES physicians and pharmacists with a method to evaluate the safety, efficacy and cost- clindamycin/tretinoin, ACNE AGENTS, effectiveness of commercially available drug products. A structured approach to the VELTIN drug selection process is essential in ensuring continuing patient access to rational ZIANA TOPICAL drug therapies. The ultimate goal of the MedPerform Formulary is to provide a morphine sulfate ER process and framework to support the dynamic evolution of this document to guide tablets, oxycodone ANALGESICS, KADIAN prescribing decisions that reflect the most current clinical consensus associated ER, NUCYNTA, NARCOTICS with drug therapy decisions. NUCYNTA ER ANALGESICS, This is accomplished through the auspices of the MedImpact P & T and Formulary BELBUCA BUTRANS PATCH Committees. These committees meet quarterly and more often as warranted to NARCOTICS ensure clinical relevancy of the Formulary. To accommodate changes to this ABSTRAL, document, updates are made accessible as necessary. FENTORA, fentanyl citrate ANALGESICS, LAZANDA, lozenge NARCOTICS As you use this Formulary, you are encouraged to review the information and ONSOLIS, provide your input and comments to the MedImpact P & T and Formulary SUBSYS Committees. immediate-release GRALISE ANTICONVULSANTS The MedImpact P & T
Scripps Health Formulary July 2016 Foreword Pharmacy and Therapeutics Committee. MedImpact approves such multi- This document represents the efforts of the MedImpact Healthcare Systems source drugs for addition to the MAC list based on the following criteria: Pharmacy and Therapeutics (P & T) and Formulary Committees to provide physicians A multi-source drug product manufactured by at least one (1) nationally and pharmacists with a method to evaluate the safety, efficacy and cost-effectiveness marketed company. of commercially available drug products. A structured approach to the drug selection At least one (1) of the generic manufacturer’s products must have an “A” process is essential in ensuring continuing patient access to rational drug therapies. rating or the generic product has been determined to be unassociated with The ultimate goal of the Portfolio Formulary is to provide a process and framework to efficacy, safety or bioequivalency concerns by the MedImpact P & T support the dynamic evolution of this document to guide prescribing decisions that Committee. reflect the most current clinical consensus associated with drug therapy decisions. Drug product will be approved for generic substitution by the MedImpact P & T Committee. This is accomplished through the auspices of the MedImpact P & T and Formulary Committees. These committees meet quarterly and more often as warranted to ensure This list is reviewed and updated periodically based on the clinical literature and clinical relevancy of the Formulary. To accommodate changes to this document, pharmacokinetic characteristics of currently available versions of these drug updates are made accessible as necessary. products. As you use this Formulary, you are encouraged to review the information and provide If a member or physician requests a brand name product in lieu of an approved your input and comments to the MedImpact P & T and Formulary Committees.
British Journal ofOphthalmology 1992; 76: 681-684 681 MINI REVIEW Br J Ophthalmol: first published as 10.1136/bjo.76.11.681 on 1 November 1992. Downloaded from Pharmacokinetics of ophthalmic corticosteroids Corticosteroids have been used by ophthalmologists with an identical vehicle, the aqueous humour concentrations of increasing frequency over the past 30 years, with the these steroids are almost identical.'9 None the less it is concomitant development of a diverse range of drop, essential when considering such empirical data, to recall that ointment, subconjunctival, and oral preparations. Though the systemic anti-inflammatory effect of both betamethasone the clinical benefits and side effects of such corticosteroid and dexamethasone is five to seven times that of predniso- preparations have been well documented, their basic lone.39"' The local anti-inflammatory potency of ocular pharmacokinetics in the human eye have yet to be fully steroids has yet to be fully investigated and whilst early work established. Indeed most of our pharmacokinetic knowledge suggested that prednisolone acetate 1% had the greatest anti- of these drugs has been elucidated by extrapolation of data inflammatory effect in experimental keratitis,'7 later studies obtained from rabbit experiments.1-26 These results can be demonstrated that fluorometholone acetate in a 1% formu- significantly disparate from human data because of the lation was equally efficacious in the same model.26 However, thinner rabbit cornea, lower rabbit blink rate, effect of prednisolone
m n a d v s g o PRODUCT v1 2015 CATALOGUE h p b e q f i t w c l r z www.tapi.com PRODUCT CATALOGUE v1 2015 US CEP EU Japan Korea DMF DMF DMF DMF ABIRATERONE a ACYCLOVIR x x x AFATINIB ALCLOMETASONE DIPROPIONATE x x ALENDRONATE SODIUM x x x ALLOPURINOL x x x x AMCINONIDE x x x AMITRIPTYLINE HCL x x x x x AMLODIPINE BESYLATE x x x ANASTROZOLE x x x ANIDULAFUNGIN APIXABAN APREMILAST ARIPIPRAZOLE x x ARIPIPRAZOLE LAUROXIL ATORVASTATIN CALCIUM* x x x x ATOSIBAN ACETATE ATRACURIUM BESYLATE x x x AZACITIDINE x x AZITHROMYCIN x x x x AZTREONAM x BECLOMETHASONE DIPROPIONATE x x x x b BETAMETHASONE ACETATE x x x BETAMETHASONE BASE x x x BETAMETHASONE DIPROPIONATE x x x x BETAMETHASONE VALERATE x x x x BICALUTAMIDE x x BIMATOPROST x x BIVALIRUDIN x x BLEOMYCIN SULFATE x x BORTEZOMIB x x x * TAPI can provide several different polymorphs or processes of this product. To obtain complete DMF files of a specific product's polymorph or process, please contact your account manager. For the most updated product list please go to "Products" at www.tapi.com Additional DMFs or Tech Files are available upon request All subject to the disclaimer on page 15 PRODUCT CATALOGUE v1 2015 US CEP EU Japan Korea DMF DMF DMF DMF BROMOCRIPTINE MESYLATE x x b BUDESONIDE x x x x BUPRENORPHINE BASE x x BUPRENORPHINE HCL x x x BUTORPHANOL TARTRATE x x CABAZITAXEL x CABERGOLINE x x x x c CALCIPOTRIENE (CALCIPOTRIOL)* x x x CALCITRIOL x x x CANDESARTAN CILEXETIL x CAPECITABINE x x CARBIDOPA x x x x CARBOPLATIN x x x x CARFILZOMIB CARVEDILOL BASE x x x x x CARVEDILOL PHOSPHATE x CASPOFUNGIN ACETATE x x CERITINIB CHLORMADINONE ACETATE x x CICLOSPORIN x x x x x CILOSTAZOL x x x x CINACALCET HCL x x CISATRACURIUM BESYLATE x x CISPLATIN x x x CLARITHROMYCIN x x x x x CLOBETASOL PROPIONATE x x x x x CLONAZEPAM x CLOPIDOGREL BISULFATE x x x x CYPROTERONE ACETATE x x d DABIGATRAN ETEXILATE x DARIFENACIN HBR x x * TAPI can provide several different polymorphs or processes of this product.
(19) TZZ ZZ__T (11) EP 2 808 015 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 03.12.2014 Bulletin 2014/49 A61K 31/34 (2006.01) A61K 31/502 (2006.01) A61K 31/353 (2006.01) A61P 9/00 (2006.01) (21) Application number: 14002458.9 (22) Date of filing: 16.11.2005 (84) Designated Contracting States: • O’Donnell, John AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Morgantown, WV 26505 (US) HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI • Bottini, Peter Bruce SK TR Morgantown, WV 26505 (US) • Mason, Preston (30) Priority: 31.05.2005 US 141235 Morgantown, WV 26504 (US) 10.11.2005 US 272562 • Shaw, Andrew Preston 15.11.2005 US 273992 Morgantown, WV 26504 (US) (62) Document number(s) of the earlier application(s) in (74) Representative: Samson & Partner accordance with Art. 76 EPC: Widenmayerstraße 5 09015249.7 / 2 174 658 80538 München (DE) 05848185.4 / 1 890 691 Remarks: (71) Applicant: MYLAN LABORATORIES, INC This application was filed on 16-07-2014 as a Morgantown, NV 26504 (US) divisional application to the application mentioned under INID code 62. (72) Inventors: • Davis, Eric Morgantown, WV 26508 (US) (54) Compositions comprising nebivolol (57) The active ingredients of the pharmaceutical composition described consist of nebivolol, one or more ACE inhibitors and one or more ARB. EP 2 808 015 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 808 015 A1 Description [0001] This application is a continuation-in-part of application Ser.
EFFECTIVE Version Department of Vermont Health Access Updated: 02/16/17 Pharmacy Benefit Management Program /2016 Vermont Preferred Drug List and Drugs Requiring Prior Authorization (includes clinical criteria) The Commissioner for Office of Vermont Health Access shall establish a pharmacy best practices and cost control program designed to reduce the cost of providing prescription drugs, while maintaining high quality in prescription drug therapies. The program shall include: "A preferred list of covered prescription drugs that identifies preferred choices within therapeutic classes for particular diseases and conditions, including generic alternatives" From Act 127 passed in 2002 The following pages contain: • The therapeutic classes of drugs subject to the Preferred Drug List, the drugs within those categories and the criteria required for Prior Authorization (P.A.) of non-preferred drugs in those categories. • The therapeutic classes of drugs which have clinical criteria for Prior Authorization may or may not be subject to a preferred agent. • Within both of these categories there may be drugs or even drug classes that are subject to Quantity Limit Parameters. Therapeutic class criteria are listed alphabetically. Within each category the Preferred Drugs are noted in the left-hand columns. Representative non- preferred agents have been included and are listed in the right-hand column. Any drug not listed as preferred in any of the included categories requires Prior Authorization. GHS/Change Healthcare GHS/Change Healthcare GHS/Change Healthcare Sr. Account Manager: PRESCRIBER Call Center: PHARMACY Call Center: PA Requests PA Requests Michael Ouellette, RPh Tel: 1-844-679-5363; Fax: 1-844-679-5366 Tel: 1-844-679-5362 Tel: 802-922-9614 Note: Fax requests are responded to within 24 hrs.
COMMENTARY—1ST SUPPLEMENT TO USP30 - NF25 Revision proposals published in Pharmacopeial Forum often elicit public comments that are forwarded to the appropriate Expert Committee for review and response. Some revision proposals can advance to official status with necessary modifications without requiring further public review. In such cases a summary of comments received and the Expert Committee's responses are published in the Commentary section of USP website at the time the revision becomes official. For those proposals that require further revision and republication in Pharmacopeial Forum, a summary of the comments and the Committee's responses will be included in the briefing that accompanies the publication. The Commentary section is not part of the official text of the monograph and is not intended to be enforceable by regulatory authorities. Rather, it explains the basis for the Expert Committee's response to public comments. If there is a difference between the contents of the Commentary section and the official monograph, the text of the official monograph prevails. In case of a dispute or question of interpretation, the language of the official text, alone and independent of the Commentary section, shall prevail. Where appropriate, the Commentary includes a separate discussion of proposals related to international harmonization of the USP, the European Pharmacopoeia, and the Japanese Pharmacopoeia in order to highlight such proposals. The Commentary is presented in the following order: USP Monographs, Dietary Supplement Monographs, General Chapters, NF Monographs. USP MONOGRAPHS Monograph/Section: Allopurinol/Multiple sections Expert Committee: MD-GRE No. of Commenters: 2 Comment summary #1: Commenter suggested that a proposal for Related compounds, previously submitted by the commenter and published in PF 28(5), be reconsidered by the Committee.