THE PRESCRIBER e-LETTER September 2012, Volume 5, Issue 4 MassHealth Anti-Platelet Agents Acute coronary syndrome (ACS) is a disorder that results from the disruption of an atherosclerotic plaque that causes the formation of a thrombus, which can partially or completely occlude myocardial arteries. ACS can be presented as unstable angina (UA), non- ST elevation myocardial infarction (NSTEMI), or ST- elevation myocardial infarction (STEMI). Currently, there are four marketed platelet P2Y12 receptor-blocking agents including Brilinta (ticagrelor), Effient (prasugrel), Plavix (clopidogrel), and ticlopidine, that are Food and Drug Administration (FDA)- approved for the treatment of ACS. The use of ticlopidine is limited by bone marrow toxicity and has largely been replaced by clopidogrel. Clopidogrel is FDA-approved for the treatment of UA, NSTEMI, and STEMI, and became available as a generic in May 2012. Prasugrel is FDA-approved for the treatment of UA, NSTEMI, and STEMI in patients who are undergoing percutaneous coronary intervention (PCI). Ticagrelor is the newest antiplatelet agent FDA- approved to reduce the rate of thrombotic cardiovascular events in patients with ACS, including UA, NSTEMI, and STEMI. Unlike clopidogrel and prasugrel, which bind irreversibly, ticagrelor binds reversibly to the P2Y12 receptor on the surface of platelets. Due to a relatively short half-life, ticagrelor is dosed twice daily while clopidogrel and prasugrel are dosed once daily. Ticagrelor has a more rapid onset and more pronounced platelet inhibition than clopidogrel. <> Medication Brilinta (ticagrelor) Cost/30 Days of Maintenance Therapy $241.80 Medication Effient (prasugrel) Cost/30 Days of Maintenance Therapy $201.00 Medication Plavix# (clopidogrel) Cost/30 Days of Maintenance Therapy $6.60 Medication ticlopidine Cost/30 Days of Maintenance Therapy $101.40 <> # 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 equivalent. Short-Acting Narcotic Initiative Opioid analgesics are among the most effective medications for the treatment of pain, which affects at least 75 million Americans each year. During the last two decades, there have been large increases in opioid prescribing for the management of both cancer and non-cancer pain in the United States. A review of available pain guidelines from the American Pain Society (APS), American Academy of Pain Medicine, World Health Organization, American Society of Interventional Pain Physicians, and the American College of Physicians/APS practice guideline on the treatment of lower back pain found that the use of duplicate short-acting opiates in the treatment of malignant or non-malignant pain is not recommended. In order to ensure short-acting opiates are used appropriately, in February 2011 MassHealth began to require prior authorization (PA) for the use of duplicate short-acting opiates for periods lasting longer than two months. For the purposes of this pain initiative, tramadol was included as a short-acting agent not to be used in combination with short-acting opiates due to its mu-receptor affinity and opiate-like properties, for periods of greater than two months. A recently conducted quality assurance analysis examined the requests received for duplicate short-acting opioids (including tramadol). This analysis found that most pharmacy claims submitted and denied as a result of the PA requirement were for combinations of short-acting opioids that included tramadol. Because tramadol has serotonin and norepinephrine reuptake inhibitor effects that may result in synergistic analgesia and also as a result of the lower affinity for the mu-receptor seen with tramadol compared to morphine, tramadol has been removed from the list of agents included in the duplicate short-acting opioid initiative. The Prescriber e-Letter is an 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. <> The Prescriber e-Letter September 2012, Volume 5, Issue 4 Recent MassHealth Drug List Updates <> Drug/Drug Class beclomethasone nasal aerosol (Qnasl) Addition/Deletion/Change Addition; requires PA Rationale Beclomethasone nasal aerosol is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents ?12 years of age. Due to the high cost of this agent and the availability of less costly alternatives, including fluticasone propionate, flunisolide 0.025% spray, and flunisolide 29 mcg spray, this agent requires PA. Drug/Drug Class clopidogrel Addition/Deletion/Change Addition; does not require PA Rationale Clopidogrel is the new “A” rated generic to Plavix. This agent does not require PA. Drug/Drug Class colistin/neomycin/thonzonium/hydrocortisone (Coly-Mycin S) Addition/Deletion/Change Change in PA status; requires PA Rationale Colistin/neomycin/thonzonium/hydrocortisone is used for the treatment of otitis externa and may also be used for the treatment of otitis media. Due to the availability of the less costly alternative neomycin/polymyxin/hydrocortisone, this agent requires PA. Drug/Drug Class colistin/neomycin/thonzonium/hydrocortisone (Cortisporin-TC) Addition/Deletion/Change Change in PA status; requires PA Rationale Colistin/neomycin/thonzonium/hydrocortisone is used for the treatment of otitis externa and may also be used for the treatment of otitis media. Due to the availability of the less costly alternative neomycin/polymyxin/hydrocortisone, this agent requires PA. Drug/Drug Class desoximetasone cream, gel, and ointment (Topicort) Addition/Deletion/Change Change in PA status; requires PA Rationale Desoximetasone (cream, gel, and ointment) is a high potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the availability of less costly alternatives, including amcinonide, betamethasone dipropionate, fluocinolone acetonide, and triamcinolone, this agent requires PA. Drug/Drug Class diflorasone cream/emollient (Apexicon-E) Addition/Deletion/Change Change in PA status; requires PA Rationale Diflorasone cream/emollient is a very high potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the availability of less costly alternatives, including augmented betamethasone, clobetasol propionate, diflorasone diacetate, and halobetasol, this agent requires PA. Drug/Drug Class dorzolamide/timolol, preservative free (Cosopt PF) Addition/Deletion/Change Addition; requires PA Rationale Dorzolamide/timolol, preservative free, is a carbonic anhydrase inhibitor combined with a beta-blocking agent indicated for the reduction of elevated intraocular pressure in patients with open-angel glaucoma or ocular hypertension who have an insufficient response to beta-blockers. Due to the availability of the less costly generic dorzolamide/timolol, this agent requires PA. Drug/Drug Class fentanyl sublingual spray (Subsys) Addition/Deletion/Change Addition; requires PA Rationale Fentanyl sublingual spray is FDA approved for the management of breakthrough pain in adult cancer patients who are already receiving and who are tolerant to around-the- clock opioid therapy for their underlying persistent cancer pain. Due to the availability of less costly alternatives, including hydromorphone, immediate release morphine, immediate release oxycodone, and fentanyl lozenges, this agent requires PA. <> Please send any suggestions or comments to PrescriberELetter@state.ma.us. <> The Prescriber e-Letter September 2012, Volume 5, Issue 4 Recent MassHealth Drug List Updates <> Drug/Drug Class fluocinolone body oil, scalp oil (Derma-Smoothe FS) Addition/Deletion/Change Change in PA status; does not require PA Rationale Fluocinolone (body oil and scalp oil) is a low potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the low comparative price of this agent to other generic topical corticosteroids, it no longer requires PA. Drug/Drug Class fluticasone furoate nasal spray (Veramyst) Addition/Deletion/Change Change in PA status; requires PA for members ? 4 years of age and for quantities > 1 inhaler/month Rationale Fluticasone furoate nasal spray is FDA approved for the treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children at least two years of age. A recent quality assurance analysis demonstrated appropriate utilization of this agent within the MassHealth population. As a result, fluticasone furoate nasal spray (Veramyst) now only requires PA for members ? 4 years of age and for requests to use more than one inhaler per month. Drug/Drug Class hydrocortisone acetate/aloe vera cream, gel, and lotion Addition/Deletion/Change Change in PA status; does not require PA Rationale Hydrocortisone acetate/aloe vera (cream, gel, and lotion) is a low potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the low comparative price of this agent to other generic topical corticosteroids, it no longer requires PA. Drug/Drug Class hydrocortisone solution (Texacort) Addition/Deletion/Change Change in PA status; requires PA Rationale Hydrocortisone solution is a low potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the availability of less costly alternatives, including alclometasone, desonide, fluocinolone acetonide, and hydrocortisone, this agent requires PA. Drug/Drug Class ingenol (Picato) Addition/Deletion/Change Addition; requires PA Rationale Ingenol is an inducer of cell death that is FDA approved for the topical treatment of actinic keratosis. Due to the high cost of this agent and the availability of less costly alternatives, including topical fluorouracil, this agent requires PA. Drug/Drug Class lamivudine/zidovudine Addition/Deletion/Change Addition; does not require PA Rationale Lamivudine/zidovudine is the new “A” rated generic to Combivir. This agent does not require PA. Drug/Drug Class lenalidomide 2.5 mg (Revlimid) Addition/Deletion/Change Addition; requires PA for quantities greater than 30 units/month Rationale Lenalidomide is a thalidomide analogue that is indicated for the treatment of multiple myeloma, in combination with dexamethasone in patients who have received at least one prior therapy as well as for the treatment of patients with transfusion- dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities. In order to ensure appropriate dosing of this product, the new 2.5 mg dosage form requires PA for > 30 units per month. Drug/Drug Class mifepristone (Korlym) Addition/Deletion/Change Addition; requires PA Rationale Mifepristone is FDA-approved to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have diabetes mellitus type 2 or glucose intolerance. Surgery remains the first-line treatment for this condition. A variety of agents that are less costly than mifepristone are available, including ketoconazole, etomidate, metyrapone, and mitotane. This agent requires PA. Please send any suggestions or comments to PrescriberELetter@state.ma.us. > The Prescriber e-Letter September 2012, Volume 5, Issue 4 Recent MassHealth Drug List Updates (cont.) Drug/Drug Class peginesatide (Omontys) Addition/Deletion/Change Addition; requires PA^ ^This agent is only available through the health-care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy. Rationale Peginesatide is an erythropoiesis-stimulating agent indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. Due to the high cost of peginesatide and the indication of use only in patients on dialysis, this agent requires PA and is only available through the health-care professional who administers the drug. MassHealth does not pay for this drug to be dispensed through a retail pharmacy. Drug/Drug Class polyethylene glycol-electrolyte solution (CoLyte with flavor packs) Addition/Deletion/Change Change in PA status; requires PA Rationale Polyethylene glycol-electrolyte solution is used for bowel preparation prior to a colonoscopy. Due to the availability of various less costly generic formulations of polyethylene glycol bowel prep products, this agent requires PA. Drug/Drug Class polyethylene glycol-electrolyte solution (GoLytely packet) Addition/Deletion/Change Change in PA status; requires PA Rationale Polyethylene glycol-electrolyte solution is used for bowel preparation prior to a colonoscopy. Due to the availability of various less costly generic formulations of polyethylene glycol bowel prep products, this agent requires PA. Drug/Drug Class tafluprost (Zioptan) Addition/Deletion/Change Addition; requires PA Rationale Tafluprost is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Due to the availability of the less costly generic latanoprost, this agent requires PA. Drug/Drug Class triamcinolone 0.05% ointment (Trianex) Addition/Deletion/Change Change in PA status; requires PA Rationale Triamcinolone 0.05% ointment is a high potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the availability of less costly alternatives, including amcinonide, betamethasone dipropionate, fluocinolone acetonide, and triamcinolone, this agent requires PA. Drug/Drug Class triamcinolone spray (Kenalog) Addition/Deletion/Change Change in PA status; requires PA Rationale Triamcinolone spray is a high potency topical corticosteroid that can be used for a variety of dermatological conditions. Due to the availability of less costly alternatives, including amcinonide, betamethasone dipropionate, fluocinolone acetonide, and triamcinolone, this agent requires PA. Drug/Drug Class zolpidem, sublingual tablet (Intermezzo) Addition/Deletion/Change Addition; requires PA Rationale Zolpidem sublingual tablets are FDA approved for as-needed use for the treatment of insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep. Due to the availability of various less costly alternatives, including various benzodiazepines, zolpidem, and zaleplon, this agent requires PA. <> Please send any suggestions or comments to PrescriberELetter@state.ma.us. <> <> September 2012, Volume 5, Issue 4