What’s New with Atypical Antipsychotics? MassHealth currently requires prior authorization (PA) for the use of multiple concurrent antipsychotic medications and for antipsychotic medication prescriptions in excess of established quantity limits. In addition, after careful consideration, MassHealth will require PA for asenapine (Saphris), iloperidone (Fanapt), and paliperidone (Invega), because these medications have not shown substantial evidence of superiority over currently available medications. The following changes to the MassHealth Drug List became effective for prescriptions dispensed on or after March 1, 2010. 1. Asenapine (Saphris) and iloperidone (Fanapt) require PA. Authorization for the medications will be based on the outcome of a therapeutic trial of a generic atypical antipsychotic and two other antipsychotics. 2. Paliperidone (Invega) tablets require PA for MassHealth members who are not currently taking Invega. PA is not required for MassHealth members who are currently taking Invega tablets on a continuous basis. Authorization will be based on the outcome of a therapeutic trial to a generic atypical antipsychotic and two other antipsychotics. 3. Paliperidone palmitate (Invega Sustenna) does not require PA. Risperdal Consta will continue to be available without PA. This decision is based upon the expectation that good clinical practice will have demonstrated that oral paliperidone or oral risperidone, respectively, is effective for the member and that the member has shown the need for the long acting dosage form. Quantity limits will be imposed to prevent inadvertent excessive dosing. Requires PA Avg. Monthly Price asenapine (Saphris) $519.75 iloperidone (Fanapt) $551.25 paliperidone (Invega) $363.85-563.36 Available without PA Oral Formulations aripiprazole (Abilify) $424.33-$603.06 clozapine (Clozaril)# $139.25-$194.05 olanzapine (Zyprexa) $233.27-$819.00 quetiapine (Seroquel) $76.95-$386.86 quetiapine (Seroquel XR) $114.03-$350.25 risperidone (Risperdal)# $31.20-$58.74 ziprasidone (Geodon) $198.86-$478.37 Long-Acting Injectables paliperidone palmitate (Invega Sustenna) $767.81-$1,006.98 risperidone (Risperdal Consta) $250.81-$1,037.61 # This is a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic. Need Some Sleep? In response to provider feedback subsequent to a recent low-dose Seroquel mailing, it was suggested that MassHealth alleviate the restrictions on hypnotic agents in an effort to reduce use of off-label low-dose Seroquel for insomnia. Because of this, MassHealth will increase the quantity limits for the benzodiazepine hypnotics (i.e., estazolam, flurazepam, triazolam, and temazepam 15 mg and 30 mg) and the non-benzodiazepine medications, including zolpidem. The following changes to the MassHealth Drug List became effective for prescriptions dispensed on or after February 4, 2010. 1. The quantity limits for zolpidem 10 mg; estazolam; flurazepam; triazolam; and temazepam 15 mg and 30 mg, increased from 10 units per month to 30 units per month available without PA. 2. The quantity limit for zolpidem 5 mg increased from 10 units per month to 45 units per month. The extra 15 units per month will allow for dose titration. Requires PA Avg. Monthly Price eszopiclone (Lunesta) $159.94-$175.77 quazepam (Doral) $115.92 ramelteon (Rozerem) $125.78 temazepam (Restoril 7.5 mg, 22.5 mg) $439.37 zolpidem SL (Edluar) $126.00 zolpidem (Ambien CR) $156.86 Available without PA estazolam (ProSom)# ? 30 units/month $5.53-$13.50 flurazepam (Dalmane)# ? 30 units/month $3.54-$4.12 temazepam (Restoril)# 15 mg and 30 mg ? 30 units/month $3.95-$4.75 triazolam (Halcion)# ? 30 units/month $9.49-$10.26 zolpidem (Ambien)# 5 mg ? 45 units/month $3.11 zolpidem (Ambien)# 10 mg ? 30 units/month $2.83 # This is a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic. Prescriber E-Letter is a quarterly update designed to enhance the transparency and efficiency of the MassHealth drug prior-authorization (PA) process and the MassHealth Drug List. Each issue will highlight key clinical information and updates to the MassHealth Drug List. The Prescriber E-Letter was prepared by the MassHealth Drug Utilization Review Program and the MassHealth Pharmacy Program. Recent MassHealth Drug List Updates Drug/Drug Class Addition/Deletion/Change Rationale acetohexamide Deletion Acetohexamide has been removed from the drug list because it has been discontinued by the manufacturer. acyclovir (Zovirax) cream and ointment Change in PA status; PA required There are more cost-effective alternatives available for the management of the same clinical condition. Clinical trials have shown that oral therapy is more effective than topical for the treatment of genital herpes. Generic oral acyclovir and oral valacyclovir are available without PA. aliskiren/valsartan (Valturna) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic ACE inhibitors. amlodipine/telmisartan (Twynsta) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic amlodipine and generic ACE inhibitors. antipsychotics Starting March 1st, 2010 Change in PA status: requires PA paliperidone (Invega) tablets Starting March 1st, 2010 Additions; requiring PA asenapine (Saphris) iloperidone (Fanapt) There are more cost-effective alternatives available for the management of the same clinical condition, including generic risperidone, which is available without PA. benzodiazepine hypnotics Change in PA status: requires PA estazolam (>30 units/month) flurazepam (Dalmane) (>30 units/month) temazepam (Restoril) 15 mg and 30 mg (>30 units/month) triazolam (>30 units/month) The generic hypnotic benzodiazepines will no longer require a PA for prescriptions that are less than 30 units/month. It is anticipated that this change will lead to decreased use of off-label low-dose Seroquel for insomnia. non-benzodiazepine hypnotics Starting February 4th, 2010 Change in PA status: requires PA zolpidem (Ambien) 5 mg (>45 units/month) zolpidem (Ambien) 10 mg (>30 units/month) The quantity limit on zolpidem 10 mg tablet has been increased from 10 units per month to 30 units per month, and 45 units per month for the 5 mg tablet. It is anticipated that this change will lead to decreased use of off-label low-dose Seroquel for insomnia. benzoyl peroxide foam (Benzefoam) Addition; requires PA There are more cost-effective alternatives available for the management of the same clinical condition. All single-entity generic topical anti-acne products are available for members aged 21 years and under without PA. Recent MassHealth Drug List Updates are continued on the next page. The Prescriber e-Letter April 2010, Volume 3, Issue 2 Recent MassHealth Drug List Updates (cont.) Drug/Drug Class Addition/Deletion/Change Rationale bepotastine besilate (Bepreve) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including over-the-counter antihistamine products, as well as ketotifen (OTC). brimonidine (Alphagan) Deletion Alphagan has been discontinued by the manufacturer. A generic version of brimonidine is available without PA. butalbital-containing products Deletion butalbital/ acetaminophen (Axocet) butalbital/ acetaminophen/ caffeine (Farbital) butalbital/ aspirin/ caffeine (Fiorpap) butalbital/ aspirin/ caffeine (Fiortal) These products have been removed from the drug list because they have been discontinued by the manufacturer. canakinumab (Ilaris) Addition; requires PA This medication is FDA approved for the treatment of cryopyrin- associated periodic (CAP) syndrome. It will require PA to ensure appropriate use. cromolyn (Intal inhaler) Deletion Intal inhaler has been removed from the drug list because it has been discontinued by the manufacturer. cyclosporine products Change in PA status; PA required cyclosporine, modified (Neoral) cyclosporine (Sandimmune) The FDA approved generic formulation of Sandimmune and Neoral is now available without PA. PA will be required for members who are newly starting on the brand products. For members who are currently stable on the brand product, PA will not be required. dexamethasone intravitreal implant (Ozurdex) Addition; MassHealth does not pay for this drug to be dispensed through a retail pharmacy Only available through the health- care professional who administers the drug MassHealth has determined that this product will be paid for only when obtained through a health-care professional. diclofenac products Addition; requires PA diclofenac (Zipsor) Change in PA status; PA required diclofenac extended-release (Voltaren XR) For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic immediate-release diclofenac. dihydroergotamine (Migranal) Change in PA status; PA required Ergot alkaloid use has diminished with the introduction of selective serotonin agonists. Consensus guidelines now recommend their use as a second- or third-line agent after trials of triptans; therefore, this medication requires PA. Recent MassHealth Drug List Updates are continued on the next page. Recent MassHealth Drug List Updates (cont.) Drug/Drug Class Addition/Deletion/Change Rationale entacapone (Comtan) Change in PA status; PA required Due to an increase in off-label use, this medication will now require PA. Members currently on this medication for Parkinson’s disease should not be affected. etodolac extended-release Change in PA status; PA required For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic immediate-release etodolac. fenofibric acid (Fibricor) Addition; requires PA For the management of hyperlipidemia, there are more cost- effective alternatives available without PA, including generic fenofibrate and gemfibrozil. fentanyl buccal film (Onsolis) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic methadone (<120 mg/day), morphine IR (<360 mg/day), and oxycodone IR (<240 mg/day). guanfacine extended-release (Intuniv) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic immediate-release guanfacine. human papillomavirus bivalent vaccine (Cervarix) Addition; requires PA This vaccination is active against two strains of human papillomavirus while another product, Gardasil, is active against four strains of HPV. Current national guidelines recommend HPV vaccination but do not specify any particular product. MassHealth has placed this vaccine on the drug list requiring PA in order to ensure appropriate use. indomethacin extended- release Change in PA status; PA required For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic immediate-release indomethacin. ketoprofen ocular products Deletion ketoprofen (Orudis, Oruvail, and ketoprofen OTC) Orudis, Oruvail, and OTC ketoprofen have been removed from the drug list because they have been discontinued by the manufacturer. ketoprofen extended-release Change in PA status; PA required For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic immediate-release ketoprofen. ketorolac ophthalmic solution (Acuvail) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic ketorolac 0.5%, diclofenac 0.1%, and flurbiprofen 0.03%. ketotifen (OTC) Addition to OTC list Generic ketotifen has been added to the MassHealth OTC list and is available without PA. lansoprazole/naproxen (Prevacid NapraPAC) Deletion Prevacid NapraPAC has been removed from the drug list because it has been discontinued by the manufacturer. Generic naproxen and omeprazole are available without PA levocabastine (Livostin) Deletion Livostin has been removed from the drug list because it has been discontinued by the manufacturer. Recent MassHealth Drug List Updates are continued on the next page. The Prescriber e-Letter April 2010, Volume 3, Issue 2 Recent MassHealth Drug List Updates (cont.) Drug/Drug Class Addition/Deletion/Change Rationale morphine/naltrexone (Embeda) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic methadone (<120 mg/day), morphine IR (<360 mg/day), and oxycodone IR (<240 mg/day). Clinical studies have not shown that Embeda has less abuse potential then other forms of oral morphine. metoclopramide, orally disintegrating tablet (Metozolv ODT) Addition; requires PA For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic metoclopramide tablets. mupirocin (Bactroban) nasal ointment Change in PA status; PA required For the management of the same clinical condition, there are more cost-effective alternatives available without PA, including generic mupirocin ointment. omeprazole (Zegerid) Deletion Zegerid has been removed from the drug list because it no longer participates in the federal rebate program. Generic omeprazole is available without PA. phenytoin products Change in PA status; PA required (Dilantin) capsule, kapseal, suspension (Phenytek) Brand Dilantin products will now require PA. FDA-approved generic formulations are available on the drug list without PA. For members who are currently stable on the brand product, PA will not be required. ramipril Change in PA status: does not require PA Generic ramipril is now available without PA. treprostinil (Tyvaso) Addition; does not require PA Treprostinil is indicated for the treatment of pulmonary artery hypertension. Due to the difficulty of the management of this condition and a novel route of administration, this medication does not require PA. triptans Change in PA status: requires PA almotriptan (Axert) zolmitriptan (Zomig) sumatriptan injection sumatriptan tablet (>9 units/month) The available triptans have demonstrated similar efficacy and safety. Generic sumatriptan is the most cost-effective agent and does not require PA if prescribed for less than nine units per month. All brand name triptans will require PA. Sumatriptan injections also require PA due to their higher cost compared to the generic oral formulation. ustekinumab (Stelara) Addition; requires PA Ustekinumab is a new monoclonal antibody that blocks the IL-2 receptor and inhibits the progression of psoriasis. Ustekinumab, like other biologics on the MassHealth drug list, will require PA to ensure appropriate use. vigabatrin (Sabril) Addition; requires PA In order to encourage appropriate use and minimize the risk of serious adverse events, this medication will require PA. Please send any suggestions or comments to: PrescriberELetter@state.ma.us. The Prescriber e-Letter April 2010, Volume 3, Issue 2