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Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Provider Synergies, an affiliate of Magellan Medicaid Administration Phone: 1-800-932-6648 Fax: 1-800-932-6651 NOTE: Fax requests receive a response within 24 hours. For urgent requests, please call. Not all medications listed are covered by all DMAS programs. Check individual program coverage. For program drug coverage information, visit the following: http://www.VirginiaMedicaidPharmacyServices.com All new products included in a PDL class are automatically non-preferred until reviewed by the P&T Committee Within these categories, drugs that are not listed are subject to Service Authorization This is not an all inclusive list. Not all classes are part of the PDL Routine PDL criteria guidelines will be considered as followed below to receive a Service Authorization. 1. Is there any reason the patient cannot be changed to a medication not requiring service approval within the same class? Acceptable reasons include: o Allergy to medications not requiring service approval o Contraindication to or drug-to-drug interaction with medications not requiring service approval o History of unacceptable/toxic side effects to medications not requiring service approval o Patient’s condition is clinically unstable; changing to a medication not requiring service approval might cause deterioration of the patient’s condition. Document clinically compelling information 2. The requested medication may be approved if both of the following are true: 1. If there has been a therapeutic failure of no less than a one-month trial of at least one medication within the same class not requiring service approval 2. The requested medications corresponding generic (if a generic is available and covered by the State) has been attempted and failed or is contraindicated. If the guidelines differ they will be listed along side the class with specific Service Authorization requirements. All changes from last posting will be highlighted in Yellow 1 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Analgesics Non-Steroidal Anti-Inflammatory Drug diclofenac potassium diclofenac sodium fenoprofen ibuprofen ketorolac meloxicam naproxen naproxen sodium piroxicam sulindac Anaprox® Anaprox DS® Ansaid® Arthrotec® Cataflam® Celebrex®* Clinoril® Daypro® diflunisal Dolobid® etodolac etodolac SR Feldene® flurbiprofen Indocin® Indocin SR® indomethacin indomethacin SR and rectal ketoprofen ketoprofen ER Lodine® Lodine XL® meclofenamate mefenamic Mobic® Motrin® nabumetone Nalfon® Naprelan® Naprosyn® Orudis® Oruvail® oxaprozin Ponstel® Prevacid Naprapac® Relafen® Sprix® nasal spray Tolectin DS® Toradol® tolmetin sodium Vimovo® Voltaren® Voltaren XR® Zipsor® LENGTH OF AUTHORIZATIONS: 1 year Routine PDL edit with exceptions noted below Avinza® Butrans® Embeda® Exalgo® fentanyl MS Contin® Opana® ER Oramorph SR® oxycodone-long acting Oxycontin® LENGTH OF AUTHORIZATIONS: 6 months Step edit –Trial and failure of 2 different short acting narcotics The Step-Therapy is not required for those patients that have been stabilized on Long Acting Narcotics or need relief of moderate to severe pain requiring around-theclock opioid therapy, for an extended period of time. Still subject to PDL criteria edit. PDL edit -If patient has failed a preferred narcotic or there is any reason the patient cannot be changed to a medication not requiring service approval. A one-month trial of at least two medications within the same class not requiring SA *Step edit required for Celebrex History of a trial of a minimum of two (2) different nonCOX2 NSAIDs within the past year OR have concurrent use of anticoagulants (warfarin/ heparin), methotrexate, oral corticosteroids OR history of previous GI bleed or conditions associated with GI toxicity risk factors (i.e., PUD, GERD, etc.) OR specific indication for Celebrex®, which medications not requiring service approval are not indicated. Long Acting Narcotics Duragesic® Kadian® morphine sulfate tablet SA® 2 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Short Acting Narcotics Narcotic Lozenges fentanyl citrate Short-Acting Narcotics codeine codeine/APAP codeine/APAP/caff/butal codeine/ASA codeine/ASA/caff/butal hydrocodone/APAP hydrocodone/ ASA hydrocodone/ ibuprofen hydromorphone meperidine morphine IR nalbuphine oxycodone/APAP oxycodone/ASA oxycodone IR tramadol HCL tramadol HCL/APAP Non-Preferred Agents Actiq® Fentora® Onsolis® All Brands require a SA Abstral® oxymorphone HCl RyzoltTM tramadol ER Ultracet® Ultram® Ultram ER® Zolvit® SA Criteria LENGTH OF AUTHORIZATIONS: Routine PDL edit Clinical edit for narcotic lozenges ONLY. Both of the following need to be true: The patient has a diagnosis of cancer AND the patient is already receiving and tolerant of opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking transdermal fentanyl 25 mcg/h, morphine 60 mg/day or more, oxycodone 30 mg/day, oral hydromorphone 8 mg/day, or an equianalgesic dose of another opioid for one week or longer. Barbiturate & Non-Salicylates Analgesic Combinations Phrenilin Forte® acetaminophen-butalbital ® Sedapap® Bupap ® Cephadyn Opioid Dependency buprenorphine SL Suboxone® Suboxone®film 3 months Subutex® 3 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents Topical Agents and Anesthetics *Flector® patch *Voltaren® gel **Lidoderm® patch *Pennsaid® topical solution SA Criteria LENGTH OF AUTHORIZATIONS: Routine PDL edit 1 year *Clinical Criteria for Flector®, Voltaren gel®, and Pennsaid®: Approval is based on patient failing the oral generic of the desired product and at least one other preferred NSAID (to equal a total of at least two preferred). For example, a patient who failed ibuprofen or naproxen will still need to try oral generic diclofenac for approval of Flector. Pennsaid topical solution can only be approved for the FDA approved indication of osteoarthritis of the knee. Quantity limit for Flector® Patch of 30 units per RX **Clinical Criteria for Lidoderm® Patch: Lidoderm® patches can be approved for relief of pain associated with post-herpetic neuralgia. Antibiotic-Anti-Infective Oral Antifungals for Onychomycosis Grifulvin V® tablets Griseofulvin oral ® suspension Gris-Peg® terbinafine itraconazole Lamisil® Lamisil ® granules Sporanox capsules® Sporanox solution® LENGTH OF AUTHORIZATIONS:Duration of the prescription (up to 6 months) Routine PDL edit Sporanox Indications: Aspergillosis, Candidiasis (oral or esophageal), Histoplasmosis, Blastomycosis, empiric treatment of febrile neutropenia Lamisil ® granules Indication is tinea capitis and the recipient must be over 4 years of age. 4 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Oral Cephalosporins Non-Preferred Agents Second Generation Cephalosporins Ceftin® tablets / suspension cefaclor cefuroxime axetil suspension capsule/ER/suspension cefprozil capsule/suspension Cefzil® tablets / suspension cefuroxime tablets Raniclor® Third Generation Cephalosporins Cedax® capsule/suspension cefdinir capsule/suspension ® cefditoren pivoxil Spectracef cefpodoxime proxetil capsule/suspension Suprax® suspension/tablets Omnicef® SA Criteria LENGTH OF AUTHORIZATIONS: date of service only; no refills Potential reasons for SA are: Infection caused by an organism resistant to medications not requiring service approval OR a therapeutic failure to no less than a three-day trial of one medication within the same class not requiring service approval OR the patient is completing a course of therapy with a medication requiring a service authorization, which was initiated in the hospital. Oral Macrolides Macrolides & Ketolides azithromycin packet/suspension/tablet clarithromycin tablet/suspension E.E.S. ®* EryC®* Eryped®* erythrocin stearate erythromycin base erythromycin ethylsuccinate erythromycin estolate suspension erythromycin stearate erythromycin / sulfisoxazole Biaxin®tablet/ suspension/XL® clarithromycin ER Dynabac® Ery-tab® Ketek®** PCE® Zithromax® tablet/suspension ZMAX suspension® LENGTH OF AUTHORIZATIONS: date of service only; no refills Potential reasons for SA are: Infection caused by an organism resistant to medications not requiring service approval OR a therapeutic failure to no less than a three-day trial of one medication within the same class not requiring service approval OR the patient is completing a course of therapy with a medication requiring a service authorization, which was initiated in the hospital. *Generics not available in some strengths/dosage forms **To receive a SA for Ketek®, a specific Ketek SA request form must be completed and faxed or mailed to Magellan Medicaid Administration with the physician's signature. 5 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Oral Quinolones Non-Preferred Agents Second Generation Quinolones Cipro® IR/ XR Cipro® suspension ciprofloxacin suspension/ER ciprofloxacin tablet Floxin Maxaquin® Noroxin® ofloxacin Proquin XR® SA Criteria LENGTH OF AUTHORIZATIONS: date of service only; no refills Potential reasons for SA are: Infection caused by an organism resistant to medications not requiring service approval OR a therapeutic failure to no less than a three-day trial of one medication within the same class not requiring service approval OR the patient is completing a course of therapy with a medication requiring a service authorization, which was initiated in the hospital. Third Generation Quinolones Factive® Avelox® ® Levaquin® tablet/suspension Avelox ABC PACK Proquin XR® Zagam® Otic Quinolones Ciprodex® ofloxacin Cetraxal® Cipro HC® Floxin® LENGTH OF AUTHORIZATION Date of service only; no refills Routine PDL edit Altabax® * Bactroban® cream and ointment CentanyTM Centany AT® Kit LENGTH OF AUTHORIZATIONS: Date of service only; no refills Routine PDL edit *Has a 15 gram per 34 day quantity limit famciclovir valacyclovir Zovirax® suspension/tablet LENGTH OF AUTHORIZATIONS: Routine PDL edit Topical mupirocin ointment Antivirals Herpes acyclovir suspension/tablets Famvir ® Valtrex ® 6 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Influenza Non-Preferred Agents SA Criteria amantadine tablet/capsule/syrup Relenza Disk® rimantadine Tamiflu® capsule/suspension Flumadine® syrup/tablet LENGTH OF AUTHORIZATIONS: For diagnosis of influenza, the authorization is for the date of service only; no refills Routine PDL edit Interferon for Hepatitis C Pegasys® Pegasys Conv.Pack® Peg-Intron® Peg-Intron Redipen® LENGTH OF AUTHORIZATIONS: All products require a Clinical SA Clinical SA for initial 16 week SA: Initial approval periods limited to 16-weeks and viral titer obtained at week 12 of therapy. Clinical SA for established HCV reactors: 1) Therapy is approvable for a total of 24 weeks in patients that are HCV genotypes 2 or 3 who have achieved a virologic response (either undetectable HCV RNA [<50 IU/mL] or at least a 2-log drop in HCV RNA titer from baseline) at 12 weeks of treatment. 2) Therapy is approvable for total of 48 weeks in HCV genotype 1 or 4 patients who have achieved a virologic response (either undetectable HCV RNA [<50 IU/mL] or at least a 2-log drop in HCV RNA titer from baseline) at 12 weeks of treatment. 3) If patient fails to achieve a virologic response by 12 weeks, further treatment is not indicated. Topical: Herpes Abreva OTC® Zovirax® ointment Denavir® Xerese® cream Zovirax® cream LENGTH OF AUTHORIZATIONS: Routine PDL edit 7 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Cardiac Anticoagulants Low Molecular Weight Heparin includes FactorXA Inhibitor enoxaparin Arixtra ® Innohep ® Fragmin ® ® Lovenox Oral Anticoagulants warfarin Coumadin® Jantoven® Pradaxa®* LENGTH OF AUTHORIZATION: 1 year Routine PDL edit *Oral Anticoagulants Clinical edit Pradaxa® will be approved if all of the following are true: Diagnosis of non valvular atrial fibrillation; AND Patient has at least one risk factor: o History of stroke, TIA, or systemic embolism; OR o Age ≥ 75 years; OR o Diabetes mellitus; OR o History of left ventricular dysfunction or heart failure; OR o Age ≥65 years with the presence of one of the following: diabetes mellitus, coronary artery disease (CAD), or hypertension; OR o Patient does not have access to warfarin management. ACE Inhibitors, Angiotensin Receptors Blockers, Beta-Blockers ACE Inhibitors benazepril captopril enalapril lisinopril Accupril® Aceon® Altace®capsule/table Capoten® Fosinopril Lotensin® Mavik® moexipril Monopril® perindopril Prinivil® quinapril ramipril trandolapril Univasc® Vasotec® Zestril® LENGTH OF AUTHORIZATION: Routine PDL edit 8 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents ACE Inhibitors + Diuretic Combinations Accuretic® benazepril/HCTZ captopril/HCTZ Capozide® enalapril/HCTZ fosinopril/HCTZ lisinopril/HCTZ Lotensin HCT® moexipril/HCTZ Monopril HCT® Prinzide® quinapril/HCTZ Quinaretic® SA Criteria Uniretic® Univasc® Vaseretic® Zestoretic® ACE Inhibitors + Calcium Channel Blocker Combinations amlodipine/benazepril (5/50 ;10/40) amlodipine/benazepril Lexxel® (2.5/10, 5/10, 5/20 & 10/20) ® Lotrel (5/40 and 10/40) Lotrel® (2.5/10, 5/10, 5/20 & 10/20) Tarka Teczem® trandolapril/verapamil hydrochloride ER Angiotensin Receptor Blockers Atacand® Diovan® * losartan Avapro® Benicar® Cozaar® Edarbi® Micardis® Teveten® Angiotensin Receptor Blockers + Diuretic Combinations Atacand HCT® Hyzaar® Diovan HCT®* Micardis HCT® losartan/HCTZ Avalide® Teveten HCT® Benicar HCT® *Step edit requires a trial and failure of losartan *Step edit requires a trial and failure of losartan/HCTZ 9 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Angiotensin Receptor Blockers + Calcium Channel Blocker Combinations Azor® N/A Exforge® Exforge®HCT Tribenzor® Direct Renin Inhibitors (includes combination) Amturnide™ Twynsta® N/A ® Tekturna Valturna® ® Tekturna HCT Beta Blockers Betapace® Kerlone® acebutaolol ® Betapace AF Levatol® atenolol betaxolol Lopressor® bisoprolol fumarate ® Blockadren metoprolol carvedilol Bystolic® succinate labetalol Cartrol® Normodyne® metoprolol tartrate ® Coreg propranolol LA nadolol Coreg CR® Sectral® pindolol ® Corgard Tenormin® propranolol solution/tablet ® ® Inderal Toprol XL® Sorine ® Inderal LA Trandate® sotalol AF ® Innopran XL Visken® sotalol HCL Zebeta® timolol maleate Beta Blockers + Diuretic Combinations Corzide® atenolol/chlorthalidone Inderide® bisoprolol/HCTZ Lopressor HCT® metoprolol/HCTZ nadolol/bendroflumethiazide Tenoretic® Timolide® propranolol/HCTZ Ziac® 10 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Calcium Channel Blockers: Dihydropyridine CCB &Non-Dihydropyride CCB Dihydropyridine Calcium Channel Blockers Adalat ® Afeditab CR® Adalat CC® amlodipine ® Cardene® Dynacirc CR Cardene SR® felodipine ER Dynacirc® nicardipine ® Dynacirc CR® Nifediac CC ® isradipine Nifedical XL nisoldipine nifedipine Norvasc® nifedipine ER Procardia® nifedipine SA Procardia XL® Plendil® Sular® Non-Dihydropyridine Calcium Channel Blockers Calan® Cartia XT® ® Calan SR® Diltia XT Cardizem® diltiazem Cardizem CD® diltiazem ER q 24hr Cardizem LA® diltiazem ER q 12hr Cardizem SR diltiazem XR Covera HS® Taztia XT® Dilacor XR® verapamil diltiazem SR q 12hr verapamil SA Isoptin SR® verapamil 24hr pellets Tiazac® Verelan® Verelan PM® LENGTH OF AUTHORIZATIONS: Routine PDL edit 1 year There are two main classes of Calcium Channel Blockers (each with different actions on the peripheral vasculature and cardiac tissue): o o 11 Dihydropyridine Calcium Channel Blockers (DHPCCB) Non-Dihydropyridine Calcium Channel Blockers (NDHPCCB) Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Lipotropics Non-Preferred Agents HMG CoA Reductase Inhibitors and Combinations (Statins) Advicor® lovastatin Altoprev® pravastatin Lescol® Lescol XL® Mevacor® Pravachol® HMG CoA Reductase Inhibitors and Combinations (High Potency Statins) Crestor® simvastatin Lipitor® Livalo® Vytorin® Zocor® Fibric Acid Derivatives fenofibrate Lopid® Antara® ® Fenoglide Tricor® gemfibrozil ® Lipofen Triglide® ® Lofibra Trilipix™ Niacin Derivatives Niacor® Niaspan® Niacin Derivatives & HMG CoA Reductase Inhibitors (Statins) Combination Simcor®* CAI Zetia® Omega 3 Fatty Acid Agent **Lovaza® SA Criteria LENGTH OF AUTHORIZATIONS: 1 year 1) Therapeutic failure to no less than three-month trial of at least one medication not requiring service approval. * Requires a history of either a niacin or simvastatin product within the past 365 days **Lovaza® o Step edit is the trial and failure of any other lipotropic. o A SA may also be approved without any specific preferred medication trial, if they have documented very high triglycerides of (≥ 500 mg/dL) in adult patients. 12 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Bile Acid Sequestrants cholestyramine powder/powder Light Colestid® granules/packet/tablet Colestipol HCl granules/packet/tablet Prevalite® Questran® powder/powder Light Welchol ® packet/tablet Phosphodiesterase 5 Inhibitors for Pulmonary Arterial Hypertension Adcirca TM Revatio® Revatio injection® LENGTH OF AUTHORIZATIONS: 1 year 1) Diagnosis of Pulmonary Hypertension in patients >18 years is required. 2) The requested medication may be approved if both of the following are true: o The prescribing physician is a pulmonary specialist or cardiologist and will be followed by the prescribing physician. 3) Must have a rationale for not taking the oral Revatio to receive a SA for the injectable Revatio. 4) Contraindications where the SA should not be approved: o Concurrent use of nitrates (e.g., nitroglycerin) o Hypersensitivity to product Platelet Inhibitors Aggrenox® dipyridamole Effient® Plavix® ticlopidine HCL Persantine® LENGTH OF AUTHORIZATION: Routine PDL edit 13 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Central Nervous System Non-Ergot Dopamine Receptor Agonist pramipexole ropinirole HCl Mirapex® Mirapex ER® Requip® Requip Dose Pack® Requip®XR LENGTH OF AUTHORIZATIONS: Routine PDL edit 1 year ADDITIONAL INFORMATION TO AID IN THE FINAL DECISION o If requested for treatment of Parkinson’s, may approve without the necessary trial of a preferred agent if the patient has swallowing issues that causes them to be unable to use a preferred product OR if the request is for continuation of established therapy. o If requested for treatment of restless legs, forward request to a pharmacist to be denied. o An indication that is unique to a non-preferred agent and is supported by peer-reviewed literature or an FDAapproved indication, or Age specific indication, or Medical co-morbidity, unique patient circumstance, other medical complications, or Clinically unacceptable risk with a change in therapy to preferred agent. Sedative / Hypnotic Sedative Hypnotics (Benzodiazepine) Dalmane® chloral hydrate syrup Doral® estazolam Halcion® flurazepam Prosom® temazepam Restoril® triazolam LENGTH OF AUTHORIZATIONS: Length of the prescription (up to 3 months) Routine PDL edit 1) To receive a non preferred benzodiazepine there must 14 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents Sedative Hypnotics (Non-Benzodiazepine) See step edit Ambien® Rozerem® Ambien CR® zolpidem EdluarTM Lunesta® Somnote® Sonata® Zaleplon® Zolpimist TM oral spray SA Criteria have been a therapeutic failure to no less than a onemonth trial of at least one benzodiazepine not requiring service approval. 2) To receive a preferred non benzodiazepine there must have been a therapeutic failure to no less than a onemonth trial of a benzodiazepine (step edit) 3) To receive a non preferred non benzodiazepine there must have been a therapeutic failure to no less than a one-month trial of first a benzodiazepine (step edit) and second a therapeutic failure to not less than a one-month trial of Rozerem® For patients age 65 and older, Rozerem®, Ambien® or Lunesta may be approved after a trial of trazodone (duration = at least one month). It is not necessary for patient’s ≥ 65 to try a benzodiazepine if they have had a trial of trazodone. Antimigraine Agents Maxalt ® MLT Relpax® sumatriptan succinate cartridge, nasal, pen, tablet, vial Amerge® Axert® Cambia® Frova® Imitrex® cartridge, nasal, pen kit, tablet, vial Maxalt® naratriptan Treximet Zomig® tablets, nasal spray, ZMT LENGTH OF AUTHORIZATIONS: Routine PDL edit 6 months CLINICAL CONSIDERATIONS: Service Authorization will not be given for prophylactic therapy of migraine headache unless the patient has exhausted or has contraindications to all other ―controller‖ migraine medications (i.e., beta-blockers, calcium channel blockers, etc) and the physician and patient are aware of the adverse risk potential. 15 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents Skeletal Muscle Relaxants baclofen carisoprodol carisoprodol/ASA carisoprodol/ASA/codeine chlorzoxazone cyclobenzaprine HCL dantrolene sodium methocarbamol tizanidine Amrix® Dantrium® Fexmid® Flexeril® metaxalone Norflex® orphenadrine citrate orphenadrine/ASA/caffeine Parafon Forte DSC® Robaxin® Skelaxin® Soma® Zanaflex® SA Criteria LENGTH OF AUTHORIZATIONS: 1 year for chronic conditions Duration of prescription (up to 3 months) for acute conditions Routine PDL edit ADDITIONAL INFORMATION TO AID IN FINAL DECISION 1) If there is a specific indication for a medication requiring service approval, for which medications not requiring service approval are not indicated, then may approve the requested medication. This medication should be reviewed for need at each request for reauthorization. 2) Chronic Conditions: Multiple Sclerosis Spasticity Cerebral Palsy Muscle rigidity as a result of spinal cord/ brain injury or disease 3) Acute Conditions: Muscle spasm associated with acute painful musculoskeletal conditions (ex. Generalized back, neck, or shoulder pain and muscle spasms attributed to trauma) Smoking Cessation bupropion SR Chantix® Chantix® Tab DS PK Nicotrol® Inhaler Nicotrol ®NS nicotine gum nicotine lozenge nicotine patch Commit ®Lozenge Nicoderm CQ® Patch Nicorette Gum Zyban LENGTH OF AUTHORIZATIONS: Routine PDL edit 16 6 months Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents Stimulants/ADHD Medications Amphetamine Products amphetamine salts combo dextroamphetamine Vyvanse® Methylphenidate Products Concerta® Focalin XR® All methylphenidate generic IR tablets Adderall® Adderall XR®(see criteria) amphetamine salts combo XR Desoxyn® Dexedrine® dextroamphetamine SR Dextrostat® methamphetamine Daytrana™ transdermal dexmethylphenidate Focalin® Metadate CD® Metadate ER® Methylin ER® Methylin chew® Methylin solution® methylphenidate oral solution methylphenidate SR Procentra solution® Ritalin® Ritalin LA® Ritalin SR® SA Criteria LENGTH OF AUTHORIZATION: Routine PDL edit 1 year 1) If the patient requires a service authorized medication based on a specific medical need that is not covered by the FDA indications of one of the preferred medications, a SA will be granted for a non-preferred medication. 2) This should be reviewed for need at each request for reauthorization. Adderall XR®If a trial & failure of a preferred product occurs and the physician requests Adderall XR® or amphetamine salts combo XR. The brand Adderall XR®- is preferred over the generic. Clinical Criteria for Nuvigil/Provigil: Length of Authorization: 1 year for Sleep Apnea and Narcolepsy; 6 months for Shift work sleep disorder. Approvable diagnosis’ include: o Sleep Apnea: Requires documentation/confirmation via sleep study. Requires documentation that C-PAP has been maximized. o Narcolepsy: Documentation of diagnosis via sleep study. o Shift Work Sleep disorder: ONLY APPROVABLE FOR 6 MONTHS, work schedule must be verified and documented. Shift work is defined as working the all night shift. Minimum age of 16 Provigil® (modafanil) Minimum age of 17 Nuvigil (armodafinil) 17 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Miscellaneous Products Strattera® Non-Preferred Agents SA Criteria Intuniv® Kapvay® SR 12H Nuvigil TM Provigil® Dermatologic Dermatologic Agents Combo Benzoyl Peroxide & Clindamycin Benzaclin® benzoyl peroxide Benzaclin ®CareKit clindamycin Clindamycin 1%/Benzoyl Peroxide 5% Duac CS® Duac® gel Topical Retinoids/Combinations adapalene 0.1% cream Differin® cream 0.1% adapalene 0.1% topical gel Differin® gel 0.1% & 0.3% Altinac® Retin®-A Micro ® atralin Retin -A Micro Pump Differin® 0.1% topical lotion tretinoin Epiduo® Retin-®A Tazorac® Tretin®-X Ziana® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year 1. Failure to respond to a therapeutic trial of at least two weeks of one preferred medication ADDITIONAL INFORMATION TO AID IN THE FINAL DECISION o Topical retinoids will reject for 21 and older - this can not be overridden. o Renova and other products considered to have only a cosmetic indication are not covered by Virginia Medicaid. o If the patient is completing a course of therapy with a medication requiring service approval, which was initiated in the hospital or other similar location, or if the patient has just become Medicaid eligible and is already on a course of treatment with a medication requiring service approval, then the requested medication may be approve. 18 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Topical Agents for Psoriasis calcipotriene Dovonex® Psoriatic® Non-Preferred Agents SA Criteria Anthralin Calcitrene® Dovonex® Scalp Micanol® Taclonex® Taclonex® Scalp Vectical® Endocrine and Metabolic Agents Androgenic Agents (Testosterone – Topical) Androderm Androgel Axiron solution Fortesta Testim LENGTH OF AUTHORIZATION: 1 year Failure to respond to a therapeutic trial of at least one week of one non-service authorized medication Contraceptives LENGTH OF AUTHORIZATION: Oral Contraceptives Apri Junel Fe Loestrin Lo-Ovral-28 Micronor Nor-Q-D Nortrel Ortho-Cyclen Ortho-Novum Ortho Tri-Cyclen Ortho Tri-Cyclen Lo Ovcon-50 Portia Sprintec Tri-Sprintec Yasmin 28 Yaz All other oral contraceptives 1 year If there is a specific indication for a medication requiring service approval, for which medications not requiring service approval are not indicated, then may approve the requested medication. 19 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Etonogestrel/Ethinyl Estradiol Vaginal Ring NuvaRing® Norelgestromin/Ethinyl Estradiol Transdermal Ortho Evra® Diabetes Hypoglycemics: Injectable Amylin Analogs Symlin® LENGTH OF AUTHORIZATION: 1 year Clinical edit 1. The recipient must have a history of at least a 90 day trial of insulin. 2. Symlin is only indicated as adjunct therapy with insulin. 3. Recipient meeting ALL of the following criteria may be approved: Diagnosis of Type 1 or 2 diabetes On insulin therapy Failure to achieve adequate glycemic control (HbA1c ≤ 6.5%) Diabetes Hypoglycemics: Injectable Incretin Mimetics Byetta® Victoza® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year ADDITIONAL INFORMATION TO AID IN FINAL DECISION If there is a specific indication for a medication requiring service approval, for which medications not requiring service approval are not indicated, then may approve the requested medication. Diabetes Hypoglycemics: Injectable Insulins Long-Acting Insulins Lantus vial Levemir pen and vial Rapid-Acting Insulins Humalog® cartridge, Kwikpen, and vial Novolog® cartridge, Flexpen Syringe, and vial Lantus Solostar and cartridge LENGTH OF AUTHORIZATION: Routine PDL edit 1. Apidra cartridge, Solostar, and vial 20 1 year Therapeutic failure of one non-service authorized medication. For approval of a non-preferred insulin, the patient must have a failure on the equivalent preferred product if one is available (ex. Approval of Humalog® would require a failure on Novolog®). Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Insulin Mix Humalog Mix 75/25 vial Humalog Mix 50/50 vial Humalog Mix 50-50 Kwikpen Humalog Mix 75-25 Kwikpen Novolog Mix 70/30 pen and vial Humulin 70/30 pen and vial Novolin 70/30 vial Insulin N Humulin N pen and vial Novolin N vial Insulin R Humulin R vial Novolin R vial 2. Pens/cartridges should only be approved if there is a physical reason (such as dexterity problems, vision impairment) vials cannot be used. Approvals should not be granted based on issues of convenience or compliance. Will be approved for individuals meeting the following criteria: o Recipient or caregiver has poor eyesight such that dosing errors may occur o Recipient or caregiver has problems with manual dexterity which may result in dosing errors (i.e. Parkinson’s disease, rheumatoid arthritis in the finger/hand joints, multiple sclerosis) o Recipient is under 18 years of age Additional information to aid in the final decision: If Humalog® is authorized and the patient is to mix with Humulin® (any formulation), then approve the Humulin® medication(s). Diabetes Oral Hypoglycemics Oral Hypoglycemics Alpha-Glucosidase Inhibitors Precose® acarbose ® Glyset Oral Hypoglycemics Biguanides Fortamet® metformin Glucophage® metformin ER Glucophage ®XR Glutmetza® Riomet® suspension Oral Hypoglycemics Biguanide Combination Products Glucovance® Avandamet® Metaglip® glipizide/metformin glyburide/metformin LENGTH OF AUTHORIZATION: Routine PDL edit 21 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Oral Hypoglycemics DPP-IV Inhibitors and Combination Kombiglyze XRTM Janumet® ® TradjentaTM Januvia TM Onglyza Oral Hypoglycemics Meglitinides nateglinide Starlix® Prandin® PrandiMetTM Oral Hypoglycemics Thiazolidinediones Actoplus Met® Actos 15mg®, 30mg, and 45 Avandaryl® mg ® Duetact® Avandamet ® Avandia Oral Hypoglycemics Second Generation Sulfonylureas Amaryl® glimepiride Diabeta® glipizide Glucotrol® glipizide ER Glucotrol XL® glyburide Glynase® glyburide micronized Micronase® Antihyperuricemics allopurinol Probenecid® Probenecid and Colchicine *Colcrys® Uloric® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year *Clinical Criteria for: Colcrys™ Approve if one of the following is true: Diagnosis of Familial Mediterranean Fever; OR For Acute Gout Flare: o Trial and failure of one of the following: NSAID (i.e., indomethacin, naproxen, ibuprofen, sulindac, ketoprofen) OR Corticosteroid 22 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Growth Hormone Genotropin® Nutropin AQ® NuSpinTM Non-Preferred Agents Humatrope® cartridge and vial Norditropin cartridge® Norditropin FlexPro® Norditropin Nordiflex® Nutropin® Nutropin AQ® cartridge and vial Omnitrope® Saizen® cartridge and vial Serostim® Tev-Tropin® Zorbtive® SA Criteria All Growth Hormones requires a clinical SA PEDIATRICS LENGTH OF AUTHORIZATION (pediatrics): 1 year PEDIATRICS (18 years of age and under) Clinical Criteria for Approval: 1. Prescriber is an endocrinologist, nephrologists, infectious disease specialist or HIV specialist or one has been consulted on this case, 2. The patient has open epiphysis and one of the following diagnoses o Turner Syndrome o Prader-Willi Syndrome o Renal insufficiency o Small for gestational age (SGA) - including Russell-Silver variant and patient is < 2 years old o Idiopathic Short Stature (for request for renewal only (a) information is required to be approved) o Growth hormone deficiency (physician should provide the required information below) o Newborn with hypoglycemia and a diagnosis of hypopituitarism or panhypopituitarism. 3. Height is more than 2 SD (standard deviations) below average for the population mean height for age and sex, and a height velocity measured over one year to be 1 SD below the mean for chronological age, or for children over two years of age, a decrease in height SD of more than 0.5 over one year; AND 4. Growth hormone response of less than 10ng/ml to at least two provocative stimuli of growth hormone release: insulin, levodopa, L-Arginine, clonidine, or glucagon 23 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Requests for Renewal (pediatrics): a. For renewal, a response must be documented. Patient must demonstrate improved/normalized growth velocity. (Growth velocity has increased by at least 2 cm in the first year and is greater than 2.5 cm per year), AND b. Patient height is less than 5’ 6" for males or 5' 1" for females, and is more than 1 standard deviation (2") below mid-parental height (unless parental height is diminished due to medical or nutritional reasons). ADULTS Growth Hormones LENGTH OF AUTHORIZATION: 1 year (Serostim® – 3 months * see below) ADULTS (> 18 years of age) Clinical Criteria for Approval: Prescriber is an endocrinologist and has: Diagnosis of growth hormone deficiency confirmed by growth hormone stimulation tests and rule-out of other hormonal deficiency, as follows: growth hormone response of fewer than five nanograms per mL to at least two provocative stimuli of growth hormone release: insulin, levodopa, L-Arginine, clonidine or glucagon when measured by polyclonal antibody (RIA) or fewer than 2.5 nanograms per mL when measured by monoclonal antibody (IRMA); Cause of growth hormone deficiency is Adult Onset Growth Hormone Deficiency (AO-GHD), alone or with multiple hormone deficiencies, such as hypopituitarism, as a result of hypothalamic or pituitary disease, radiation therapy, surgery or trauma Other hormonal deficiencies (thyroid, cortisol or sex steroids) have been ruled out or stimulation testing would not produce a clinical response such as in a diagnosis of panhypopituitarism. 24 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Zorbtive®- Diagnosis of short bowel syndrome Serostim® o Diagnosis of AIDS Wasting or cachexia o Patient has a documented failure, intolerance, or contraindication to appetite stimulants and/or other anabolic agents (both Megace® and Marinol®) *Length of Authorization (Serostim® only): 3 months initial; then 1 year. Renewal is contingent upon improvement in lean body mass or weight measurements. Requests for Renewal (adults) Renewal is contingent upon prescriber affirmation of positive response to therapy (improved body composition, reduced body fat, and increased lean body mass). Erythropoiesis Stimulating Proteins: Epogen®, Procrit® (Erythropoietin) & Aranesp® (Darbepoetin) Procrit® Aranesp® Epogen® LENGTH OF AUTHORIZATION: for duration of the prescription up to 6 months Routine PDL edit Clinical Information for Pharmacists; RENEWAL REQUESTS for patients with anemia due to chronic renal failure/end stage renal disease should be approved, even if the Hgb or Hct are above the cutoff point. Progestational Agents LENGTH OF AUTHORIZATION: Routine PDL edit medroxyprogesterone acetate (tablet only) norethindrone acetate progesterone Prometrium® Provera® 1 year Failure to respond to a therapeutic trial of at least one week of one non-service authorized medication Progestins Used For Cachexia megestrol acetate Megace® Megace® ES LENGTH OF AUTHORIZATION: Routine PDL edit 25 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Vaginal Estrogens Non-Preferred Agents Premarin Vaginal cream Vagifem Vaginal tablets Estrace Vaginal cream Estring Vaginal ring Femring Vaginal ring SA Criteria LENGTH OF AUTHORIZATION: Routine PDL edit 6 months LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Gastrointestinal Histamine-2 Receptor Antagonists (H-2 RA) famotidine ranitidine capsule, tablet, and syrup Axid® capsule and solution cimetidine tablet and syrup famotidine oral suspension nizatidine capsule and suspension Pepcid ®oral suspension and tablet Tagamet® Zantac® syrup and tablet 1. Patient’s condition is clinically unstable—patient has had an ER visit or at least two hospitalizations for asthma in the past thirty days—changing to a medication not requiring service approval might cause deterioration of the patient’s condition. 2. Approve if treatment was initiated in the hospital for the treatment of a condition such as a GI bleed. Motility Agents – GI Stimulants metoclopramide Metozolv® ODT Reglan® LENGTH OF AUTHORIZATION: Routine PDL edit 12 weeks This medication should be reviewed for need at each request for reauthorization. Black box warning placed on product for TARDIVE DYSKINESIA 2/27/2009 Proton Pump Inhibitors pantoprazole* Prevacid® OTC Prilosec® OTC Aciphex® Dexilant® lansoprazole Nexium® omeprazole RX and OTC 20mg (no SA required if age < 12yrs) omeprazole/sodium bicarbonate Prevacid® RX Prevacid® susp (no SA required if age < LENGTH OF AUTHORIZATIONS: dependent on criteria met *Step one requires a therapeutic failure of a 60-day trial of OTC Prilosec® (up to 40mg daily) or OTC Prevacid® (up to 30mg daily) to be approved for 120 days. For exceptions to this, see criteria for ―proton pump inhibitors exception‖. 26 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents 12yrs) Prevacid® solutab (no SA required if age < 12yrs) Prilosec® Rx form Prilosec® suspension Protonix® Zegerid® capsule Zegerid® OTC Zegerid® susp packet SA Criteria Step two: the other preferred medication, pantoprazole must be tried/failed Routine PDL edit Proton Pump Inhibitors exceptions If an exception is met, approve desired product and make the duration for 1 year. Step therapy requirements detailed above do not apply. Erosive Esophagitis Active GI Bleed Zollinger-Ellison Syndrome Greater than 65 years of age If Failed 120 day trial and is under the care of a Gastroenterologist and has ruled out a nonsecretory condition SPECIAL CONSIDERATION: o pantoprazole is a delayed release tablet and cannot be crushed or opened. o For tubed patients or patients with swallowing difficulties omeprazole, Prevacid®, Prevacid Solutab®, Prilosec®, Nexium® or Prevacid® granules (if oral administration) can be used. These Proton Pump Inhibitors may be opened and the intact granules may be mixed in apple sauce or orange juice and administered. Alternatively, the capsules may be opened and the granules may be dissolved in a small amount of sodium bicarbonate to form a compounded suspension for administration. The omeprazole will be the preferred agent for these circumstances and may be approved. o If there has been a therapeutic failure on omeprazole or there is a clinical contraindication to omeprazole then another non-preferred agent may be approved. o Aciphex® is an extended release tablet and should not be opened or crushed. 27 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Ulcerative Colitis Oral and Rectal Preparations (5-ASA DERIVATIVES) Ulcerative Colitis – Oral Asacol ® Apriso ® balsalazide disodium Pentasa ® sulfasalazine DR sulfasalazine IR Ulcerative Colitis – Rectal Canasa® supp. rectal mesalamine enema Asacol HD ® Azulfidine Dr ® Azulfidine IR® Azulfidine® susp Colazal® Dipentum Lialda ® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Fiv-Asa® Rowasa® Enema Rowasa® Enema Kit Rowasa® supp. rect SFRowasa® Genitourinary Alpha-Blockers and Androgen Hormone Inhibitors For Benign Prostatic Hypertrophy (BPH) LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Calcium Acetate 667MG Eliphos® Renvela® powder and tablet LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Detrol® Ditropan® Ditropan® XL Gelnique™ gel oxybutynin ER Toviaz™ LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Alpha-Blockers for BPH tamsulosin HCL Flomax ® Rapaflo® Uroxatral® Androgen Hormone Inhibitors for BPH Jalyn® Avodart ® Proscar® finasteride Phosphate Binders Fosrenol® Phoslo® Renagel® Urinary Antispasmodics Detrol® LA Enablex® oxybutynin tablet and syrup Oxytrol® transdermal Sanctura® Sanctura® XR VESIcare® 28 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria Immunological Agents Self Administered Drugs for Rheumatoid Arthritis Enbrel® Humira® Cimzia® Cimzia® SyringeKit Kineret® Simponi® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Ampyra®* Extavia® Gilenya® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Multiple Sclerosis Avonex® Avonex® Adm Pack Betaseron® Copaxone® Rebif® Gilenya is to be used as monotherapy ONLY * REQUIRED CLINICAL EDIT SA FOR AMPYRA LENGTH OF AUTHORIZATION FOR AMPYRA: Initial 8 weeks then, 1 year after successful trial Criteria: o The patient has a diagnosis of MS and a gait disorder or difficulty walking o Patient has no history of seizures o Patient’s Creatinine Clearance [CrCL] ≥ 50 mL/min. o If patient has a gait disorder, they may receive an 8 week trial of Ampyra o If after 8 week trial the physician states that the patient showed improvement or that the drug was effective (by improved Timed 25-foot Walk), the patient may receive authorization for Ampyra for one year. Atopic Dermatitis: Topical Elidel®* Protopic®* LENGTH OF AUTHORIZATION: 1 year Routine PDL edit *Requires a clinical SA A SA may only be given for an FDA approved diagnosis: o Atopic dermatitis (a type of eczema) - FDA approved: o Elidel®: mild to moderate for ages > 2 years. o Protopic® 0.03%: moderate to severe for ages > 2 29 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria o years. Protopic® 0.1%: moderate to severe for ages > 18 years. Critical information o Black box warnings are in place for both products as well a requirement for a patient guide to be given with each product dispensed. o Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments. o Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream. o Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elidel and Protopic are unknown o Children and adults with a weakened or compromised immune system should not use Elidel or Protopic. o Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer. Ophthalmic Antihistamines/Mast Cell Stabilizers Antihistamines Alaway OTC® ketotifen fumerate Zaditor® OTC drops Elestat ®drops Emadine® drop epinastine 0.05% eye drops Lastacaft® drops Optivar ® drops Patanol® drops Pataday® drops LENGTH OF AUTHORIZATION: 1 year Routine PDL edit 1. Therapeutic failure to no less than a three-day trial of one medication within the same class not requiring service approval 2. If the patient is completing a course of therapy with a medication requiring service approval, which was initiated in the hospital, then may approve the 30 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Mast Cell Stabilizers cromolyn sodium Anti-inflammatory diclofenac sodium flurbiprofen sodium ketorolac 0.4% ketorolac 0.5% Nevanac® drops suspension Non-Preferred Agents SA Criteria requested medication to complete the course of therapy. Alamast® drops Alocril® drops Alomide® drops Crolom® drops Acular® Acular LS® Acular PF® droperette Acuvail® Bromday® bromfenac 0.09% Ocufen® Voltaren® LENGTH OF AUTHORIZATION: for the date of service only; no refills Routine PDL edit AzaSite™ drop Besivance® drops Ciloxan® drops and ointment Iquix® drops levofloxacin drops Moxeza® drops Ocuflox® drops Zymaxid® drops LENGTH OF AUTHORIZATION: for the date of service only; no refills Routine PDL edit 1. 2. Therapeutic failure to no less than a three-day trial of one medication within the same class not requiring service approval. If the patient is completing a course of therapy with a medication requiring service approval, which was initiated in the hospital, then may approve the requested medication to complete the course of therapy. Antibiotics ciprofloxacin drops ofloxacin drops Quixin® drops Vigamox® drops Zymar® drops® 1. 2. 3. 31 If the infection is caused by an organism resistant to medications not requiring service approval, then may approve the requested medication. Therapeutic failure to no less than a three-day trial of one medication within the same class not requiring service approval If the patient is completing a course of therapy with a medication requiring service approval, which was initiated in the hospital, then may approve the requested medication to complete the course of therapy. Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Glaucoma Agents Non-Preferred Agents Prostaglandin Analogs Lumigan® 0.03% drops latanoprost ® Lumigan® 0.01% drops Travatan Z drops ® Xalatan® 0.005% drops Travatan 0.0004% drops Alpha 2 Adrenergic Agents brimonidine tartrate (0.15%) Alphagan P® 0.1% & 0.15% drops brimonidine 0.2% drops Iopidine® 0.5% & 1% drops Beta Blockers Betagan® 0.25% & 0.5% drops betaxolol 0.5% drops ® Istalol® 0.5% drops Betimol 0.25% &0.5% Ocupress®1% drops drops ® optipranolol 0.3% drops Betoptic-S 0.25% susp Timoptic® drops 0.25% & 0.5% drops Timoptic® XE 0.25% & 0.5% Sol-Gel carteolol 1% drops ® Combigan levobunolol 0.25% & 0.5% drops metipranolol 0.3% drops timolol maleate drops 0.25% &0.5% timolol maleate 0.5 % SolGel Carbonic Anhydrase Inhibitors Cosopt® 0.5%-2% drops Azopt® 1% drops Trusopt® 2% drops dorzolamide dorzolamide/timolol SA Criteria LENGTH OF AUTHORIZATION: Routine PDL edit 1 year LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Bone Resorption Suppression and Related Agents Bisphosphonates alendronate Fosamax® solution Actonel® Actonel® with CA Atelvia DR® Boniva® *Didronel® * Indicated only for Treatment of Paget’s disease of bone OR prevention and treatment of 32 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria etidronate Fosamax ®plus D Fosamax® heterotopic ossification following total hip replacement or spinal cord injury. Calcitonins Miacalcin® calcitonin-salmon nasal Fortical® LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Forteo® LENGTH OF AUTHORIZATION: Initial approval will be for 1 year with ONE renewal if demonstrated compliance. Maximum duration of therapy is 24 months during a patient’s lifetime. Others Evista® Forteo® (teriparatide): Indications o Treatment of osteoporosis in postmenopausal women who are at high risk for fracture o Increase of bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fractures o Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture Forteo is indicated if: o Bone mineral density of -3 or worse or o Postmenopausal women with history of non-traumatic fracture(s) or o Postmenopausal women with two or more of the following clinical risk factors: Family history of non-traumatic fracture(s) Patient history of non-traumatic fracture(s) DXA BMD T-score ≤-2.5 at any site Glucocorticoid use* (≥6 months of use at 7.5 dose of prednisolone equivalent) a. Rheumatoid Arthritis Postmenopausal women with BMD T-score ≤2.5 at any site with any of the following clinical risk factors: 33 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria a. b. c. d. More than 2 units of alcohol per day Current smoker Men w/primary or hypogonadal osteoporosis Osteoporosis associated w/sustained systemic glucocorticoid therapy Respiratory Antihistamines: First and Second Generation First Generation Antihistamines All Brands require a SA Generic only class LENGTH OF AUTHORIZATION: Routine PDL edit Second Generation Antihistamines and Combinations Allegra® cetirizine liquid OTC/RX ® Allegra ODT® Claritin OTC ® Allegra suspension ® Claritin OTC syrup ® Allegra-D 12 hr® Claritin tablets- Reditabs Allegra-D 24 hr® OTC ® cetirizine chew and tablet OTC Claritin-D 24 hr OTC cetirizine D tablet OTC Claritin-D® 12 hr OTC Clarinex® syrup and tablet loratadine tablet (represents all OTC names) Clarinex tablet Rapids® Clarinex- D® 24 hr loratadine tab - Rapids (all Clarinex- D® 12 hr OTC names) Claritin-D® - Rx forms loratadine syrup (represents all OTC names) Claritin® - Rx forms Claritin® Chewable loratadine D 24 hr (represents all OTC names) fexofenadine fexofenadine/PSE loratadine D 12 hr (represents all OTC names) fexofenadine/PSE 60/120 ER Xyzal® Zyrtec tablet OTC/RX ® Zyrtec tab chew OTC/RX ® Zyrtec® syrup OTC Zyrtec-D® OTC/RX 34 1 year Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents Beta-Adrenergic Agents Short Acting Metered Dose Inhalers or Devices Maxair Autohaler Proair® HFA Xopenex® HFA Proventil ®HFA ® Ventolin HFA Long Acting Metered Dose Inhalers or Nebulizers Brovana® Foradil® ® Perforomist® Serevent Diskus Short Acting Nebulizers Accuneb® pediatric dosing, premixed nebs albuterol sulfate albuterol sulfate premix metaproterenol levalbuterol 0.125% Xopenex® Proventil® SA Criteria LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Therapeutic failure to no less than a two-week trial of at least one medication not requiring service approval within the same class and formulation. (i.e. nebulizers for nebulizers) COPD: Anticholinergics Atrovent HFA® Combivent® MDI ipratropium bromide solution Spiriva® Atrovent AER® Duoneb® ipratropium/albuterol nebs LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Patient’s condition is clinically unstable—patient has had an ER visit or at least two hospitalizations for asthma in the past thirty days—and changing to a medication not requiring service authorization might cause deterioration of the patient’s condition. Corticosteroids: Inhaled and Nasal Steroids Inhaled Corticosteroids: Metered Dose Inhalers Alvesco® Aerobid® ® Flovent® Aerobid M ® Flovent Rotadisk® Asmanex ® Pulmicort Flexhaler® Azmacort ® Flovent Diskus Flovent® HFA QVAR® Inhaled Corticosteroids: Nebulizer Solution Budesonide Pulmicort® Respules LENGTH OF AUTHORIZATION: 1 year Routine PDL edit 1. Patient’s condition is clinically unstable—patient has had an ER visit or at least two hospitalizations for asthma in the past thirty days—and changing to a medication not requiring service authorization might cause deterioration of the patient’s condition. 2. Therapeutic failures to no less than one-month trials of at least two medications not requiring service authorization. 3. If the patient is a child <13 years old or a patient with a significant disability, and unable to use an inhaler which does not require service approval, or is non- 35 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria compliant on an inhaler not requiring service approval because of taste, dry mouth, or infection. Inhaled Corticosteroids: Combination Products (Glucocorticoid and Beta Adrenergic) Advair® Diskus Advair® HFA Dulera® Symbicort® Nasal Steroids fluticasone Nasacort® AQ Beconase AQ® Flonase® flunisolide Nasacort® Nasarel® Nasonex® Omnaris® Rhinocort Aqua® Tri-Nasal® Veramyst® Cough and Cold Agents Drug Name Ala-Hist DM Ala-Hist LQ Cheratussin AC OTC Cheratussin DAC OTC codeine/ promethazine Diabetic Tussin EX OTC GNN brompheniramin/ phenylephrine/ dextromethor phenylephrine/diphe nhydramine guaifenesin/codeine phosphate p-ephed hcl/codeine/ guaifenesin codeine/ promethazine guaifenesin All other cough and cold product are non-preferred LENGTH OF AUTHORIZATION: Service Routine PDL edit 36 Date of Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents guaifenesin/ codeine phosphate guaifenesin/ dextromethor phan hydrobromide OTC guaifenesin/ phenylephrine HCl OTC hydrocodone/ homatropine Iophen-C NR Lohist-PEB Mytussin AC OTC Nite Time Cough OTC phenylephrine hcl/promethaz ine hcl Poly Hist DHC Poly-Tussin DHC Q-Tussin OTC Robafen-DM Clear OTC Robafen-DM OTC Non-Preferred Agents SA Criteria guaifenesin/codeine phosphate guaifenesin/ dextromethorphan hydrobromide guaifenesin/ phenylephrine HCl hydrocodone/ homatropine guaifenesin/codeine phosphate phenylephrine/ brompheniramine guaifenesin/codeine phosphate dextromethorphan hydrobromide/ doxylamine phenylephrine hcl/promethazine hcl pyrilamine/ phenylephrine/ dihydrocodeine brompheniramine/ phenylephrine/ dihydrocodeine guaifenesin guaifenesin/ dextromethorphan hydrobromide guaifenesin/ dextromethorphan 37 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria hydrobromide Robafen OTC guaifenesin Robitussin Long-Acting OTC Ryantan Pediatric Rymed OTC dextromethorphan hbr/chlor-mal Tessalon perle Tussin DM Clear OTC Tussin OTC Vicks Formula 44 D OTC phenylephrine/ chlor-tan dexchlorphenir/ phenylephrine benzonatate guaifenesin/ dextromethorphan hydrobromide guaifenesin dextromethorphan/ phenylephrine Intranasal Antihistamines Astelin® Astepro® 0.1% and 0.15% Patanase® azelastine 0.1% LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Patient’s condition is clinically unstable—patient has had an ER visit or at least two hospitalizations for asthma in the past thirty days—changing to a medication not requiring service authorization might cause deterioration of the patient’s condition. 1. Therapeutic failures to no less than one-month trials of at least two medications not requiring service authorization 2. If the patient is a child <13 years old or a patient with a significant disability, and unable to use an inhaler which does not require service approval, or is noncompliant on an inhaler not requiring service approval because of taste, dry mouth, infection The requested medications corresponding generic (if a 38 Virginia Medicaid Preferred Drug List With Service Authorization Criteria Effective July 1, 2011 Preferred Agents Non-Preferred Agents SA Criteria generic is available) has been attempted and failed or is contraindicated. Leukotriene Receptor Antagonists Accolate® Singulair® zafirlukast Zyflo CR™ LENGTH OF AUTHORIZATION: Routine PDL edit 1 year LENGTH OF AUTHORIZATION: Routine PDL edit 1 year Self Injectable Epinephrine epinephrine Autoinjector EpiPen® EpiPen® Jr AdrenaClick® Twinject® Twinject Jr.® 39