Pharmacy Policy Bulletin

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1 Pharmacy Policy Bulletin Title: Policy #: Age Edits Rx.01.2 Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product line, group, or contract. Some medications may be subject to precertification, age, gender or quantity restrictions. Individual member benefits must be verified. This pharmacy policy document describes the status of pharmaceutical information and/or technology at the time the document was developed. Since that time, new information relating to drug efficacy, interactions, contraindications, dosage, administration routes, safety, or FDA approval may have changed. This Pharmacy Policy will be regularly updated as scientific and medical literature becomes available. This information may include new FDA-approved indications, withdrawals, or other FDA alerts. This type of information is relevant not only when considering whether this policy should be updated, but also when applying it to current requests for coverage. Members are advised to use participating pharmacies in order to receive the highest level of benefits. Intent: Certain medications may not be appropriate for individuals in certain age groups; therefore, an age edit may be placed on a medication when there are safety concerns or inappropriate utilization issues for a particular age group. The Pharmacy and Therapeutics Committee reviews all medications that are subject to age edits. Prescribing the selected medications listed in this policy requires prior authorization for individuals in a particular age group. Authorization requires clinical pharmacist review and/or Medical Director review. An urgent, temporary, 96-hour supply of medication is available (through retail pharmacy facilitation) upon request during review for medical necessity. Refer to Policy List of Applicable Drugs for a list of medications with applicable age edits. Description: Please refer to the manufacturers' prescribing guidelines for the specific agents. Policy: The drugs in the following table are approved in the age ranges listed when there is documentation of BOTH of the following: 1. FDA approved indication 2. Use in the age group is supported by ONE of the following: a. FDA label b. Micromedex c. Published literature NOTE: Cross reference to Experimental/ Investigational Policy Black Box Warning: N/A

2 Guidelines: Refer to the specific manufacturer's prescribing information for administration and dosage details and any applicable Black Box warnings. BENEFIT APPLICATION Subject to the terms and conditions of the applicable benefit contract, the applicable drug(s) identified in this policy is (are) covered under the pharmacy benefits of the Company s products when the medical necessity criteria listed in this pharmacy policy are met. Any services that are experimental/investigational or cosmetic are benefit contract exclusions for all products of the Company. References: Accolate (zafirlukast) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; Allegra (fexofenadine HCl) [prescribing information]. Bridgewater, NJ: Aventis Pharmaceuticals; Amerge (naratriptan HCl) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Revised 10/2013. Aricept (donepezil) [prescribing information]. Teaneck, NJ: Pfizer, Inc.; Revised 08/2013. Atralin (tretinoin) [prescribing information]. Fort Worth, TX: Coria Laboratories, LTD.; Revised 09/2011. Axert (almotriptan maleate) [prescribing information]. Peapack, NJ: Pharmacia & Upjohn; Avita (tretinoin) [prescribing information]. Research Triangle Park, NC: Bertek Pharmaceuticals, Inc.; Avodart (dutasteride) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Clarinex (desloratadine) [prescribing information]. Kenilworth, NJ: Schering Corporation; Revised 04/2014. Differin (adapalene) [prescribing information]. Ft. Worth, TX: Galderma Laboratories; Exelon (rivastigmine tartrate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; Revised 10/2013. Facts & Comparisons website. [5-HT Receptor agonists monograph] Available at Facts & Comparisons website [Benzodiazepines monograph] Available at

3 Facts & Comparisons website [Flomax] Available at Accessed June 16, Facts & Comparisons website [Ziana] Available at Accessed June 16, Frova (frovatriptan succinate) [prescribing information]. San Diego, CA: Elan Phamaceuticals; Revised 10/2013. Imitrex (sumatriptan succinate) [prescribing information]. Research Triangle Park, NC:GlaxoSmithKline; Revised 11/2013. Maxalt (rizatriptan benzoate) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; Revised 01/2013. Namenda (memantine HCl) [prescribing information]. St. Louis, MO: Forest Laboratories, Inc.; Revised 10/2013. Proscar (finasteride) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; Revised 09/2013. Accessed June 18, Rapaflo (silodosin). In: Facts and Comparisons [ Indy, IN: Walter Kluwer Health Inc.. Rapaflo [package insert]. Corona, CA: Watson Pharma; November Revised 01/2013. Accessed June 16, 2014Relenza (zanamivir) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Revised 10/2013. Relpax (eletriptan) [prescribing information]. New York, NY: Roerig (Pfizer Inc.); Revised 11/2013. Accessed June 18, Retin-A (tretinoin) [prescribing information]. Skillman, NJ: Otho Dermatological; Accessed June 16, 2014 Stadol NS (butorphanol tartrate) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; Accessed June 18, Zomig (zolmitriptan) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; Revised 09/2013. Zomig NS (zolmitriptan nasal) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; Revised 09/2013. Applicable Drugs: Inclusion of a drug in this table does not imply coverage. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. Age Edit: Prior Drug Name Authorization Required (years)

4 Acne Medications Tretinoin (e.g. Atralin, Avita, Retin-A, Retin A micro, etc) Over age 35 Adapalene (Differin) Over age 35 Adapalene/ Benzoyl Peroxide (Epiduo) Over age 35 Tretinoin/ clindamycin (Ziana) Over age 35 Dapsone (Aczone) Under age 12 Tazarotene (Fabior) Over age 35 Alzheimers Drugs Donepezil (Aricept [ODT]) Under age 50 Rivastigmine (Exelon) Under age 50 Memantine (Namenda [XR]) Under age 50 Galantamine (Razadyne [ER]) Under age 50 Antimigraine Agents Eletriptan (Relpax) Under age 18 Sumatriptan (Imitrex) Under age 13 Butorphanol tartrate (Stadol NS) Under age 18 Naratriptan (Amerge) Under age 18 Rizatriptan (Maxalt) Under age 6 Zolmitriptan (Zomig) Under age 18 Antiviral

5 Zanamivir (Relenza) Under age 5 Benign Prostate Medications Dutasteride (Avodart) Under age 50 Finasteride (Proscar) Under age 50 Alfuzosin (Uroxatral) Under age 50 Tamsulosin (Flomax) Under age 50 Silodosin (Rapaflo) Under age 50 Benzodiazepines Flurazepam (Dalmane) Under age 13 Quazepam (Doral) Under age 13 Triazolam (Halcion) Under age 13 Estazolam (Prosom) Under age 13 Temazepam (Restoril) Under age 13 Lorazepam (Ativan) Under age 13 Chlordiazepoxide (Librium) Under age 13 Oxazepam (Serax) Under age 13 Clorazepate (Tranxene) Under age 9 Alprazolam (Xanax) Under age 13 Leuoktriene Inhibitors Zafirlukast (Accolate) Under age 5

6 Zileuton (Zyflo [CR]) Under age 12 Inhalers Mometasone/formoterol (Dulera) Under age 12 Gastrointestinal Agents Linaclotide (Linzess) Under age 18 Anticonvulsant Perampanel (Fycompa) Under age 12 Cross References: Policy Version Number: 7.00 P&T Approval Date: July 10, 2014 Policy Effective Date: July 01, 2014 Next Required Review Date: July 10, 2015 The Policy Bulletins on this website were developed to assist AmeriHealth in administering the provisions of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member, please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee the outcome or results of any medical services/treatments. The facility and professional providers are responsible for providing medical advice and treatment. Facility and professional providers are independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or update its Policy Bulletins AmeriHealth, Inc. All Rights Reserved.

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