The Prescriber e-Letter MassHealth Pharmacy Program April 2011, Volume 4, Issue 2 Quantity Limits on Proton Pump Inhibitors Proton pump inhibitors (PPIs) are FDA-approved for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers, H. pylori eradication, and hypersecretory conditions such as Zollinger-Ellison syndrome. The recommended dosing for symptomatic GERD is one unit per day for each agent. In the cases of hypersecretory conditions, significantly higher dosing has been shown to be efficacious. Given these considerations, MassHealth has determined that all PPIs will have a quantity limit restriction of 1 unit per day with the exception of omeprazole 20 mg, where the quantity limit is 4 units per day. Quantity limits will not apply to children <12 years old or for members with certain diagnoses, with the exception of omeprazole 10 mg and 40 mg. The quantity limit restrictions on PPI agents outlined below were implemented on February 28, 2011. 1 Available without PA QL omeprazole 10 mg (Prilosec) # 30 units omeprazole 20 mg (Prilosec) # 120 units lansoprazole (Prevacid) capsules, solutabs # for members <2 years old No QL Requires PA QL rabeprazole (Aciphex) tablets dexlansoprazole (Dexilant) capsules esomeprazole (Nexium) capsules, packets lansoprazole (Prevacid) OTC omeprazole (Prilosec) 40 mg capsules * omeprazole (Prilosec) suspension, OTC * pantoprazole (Protonix) 20 mg tablet, suspension, IV * omeprazole/bicarbonate (Zegerid) capsules, * suspension, OTC 30 units lansoprazole (Prevacid) capsules *, solutabs * for members ?2 years old 30 units pantoprazole 40 mg (Protonix) tablet * 60 units # This is a brand-name drug with FDA “A”-rated generic equivalent. PA is required for the brand, unless a particular form of that drug does not have an FDA “A”-rated generic. * Both brand and generic require PA New MassHealth Drug List Web Site Since the implementation of the MassHealth Drug List Web site nearly a decade ago, the MassHealth Pharmacy Program has delivered comprehensive, up-to-date information on the drug list for providers and their patients through a static Web site. This Web site has recently been redesigned to improve the search capacity for health care providers, while maintaining a similar look and feel to the original design. These changes are intended to streamline the medication choice process. The Web site now has the functionality to search for individual drugs by brand and generic drug names, over-the-counter (OTC) generic drug names, prior authorization (PA) requirements, and therapeutic classes. These new search functions will allow for more efficient identification of the coverage status of medications. In addition, the new Web site improves access to important Drug List topics by using subject tabs located along the top of the Drug List Web site. These subject tabs include therapeutic class tables, prior authorization forms, and archives of previous MassHealth Drug Lists. Electronically fillable prior authorization forms will be accessible on the Web site to ensure for more efficient and improved patient care if the provider decides a PA medication is desired for their patients. Archives of previous MassHealth Drug Lists are available for download from the Web site, allowing for prescribers to review changes that have been made to the drug list within the past five quarters. The MassHealth Drug List Web site will continue to be a valuable resource containing a list of commonly prescribed drugs, drug coverage status, therapeutic class tables, and prior authorization forms. The MassHealth Pharmacy Program will continue to improve the MassHealth Drug List Web site in order to address the needs of MassHealth providers. 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. Drug/Drug Class Addition/Deletion/Change Rationale ophthalmic antibiotic/ corticosteroid combination products Change in PA status: sulfacetamide/prednisolone (Blephamide) neomycin/polymyxin B/prednisolone (Poly-Pred) prednisolone/gentamycin (Pred-G) tobramycin/dexamethasone ophthalmic ointment (Tobradex) loteprednol/tobramycin (Zylet) Branded Blephamide, Poly-Pred, Pred-G, Tobradex, and Zylet require prior authorization. There are more cost-effective alternatives available for the management of the same clinical condition, including generic ophthalmic antibiotic/corticosteroid combination products, which are available without PA. acetaminophen- containing products Change in PA status: requires PA >4 grams/day The FDA recommends limiting the maximum daily dose of acetaminophen to 4 grams/day. Therefore, a prior authorization is required for acetaminophen doses >4 grams/day. aliskiren/amlodipine (Tekamlo) Addition; requires PA Tekamlo is indicated for the treatment of hypertension. There are more cost-effective alternatives available for the management of the same clinical condition, including generic amlodipine, ACE inhibitors, and ARBs, which are available without PA. alpha1-proteinase inhibitor, human (Glassia) Addition; does not require PA Glassia is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor, also known as alpha1-antitrypsin deficiency. argatroban Change in PA status: H symbol - inpatient use only Argatroban is indicated for prophylaxis or treatment of thrombosis in patients with heparin- induced thrombocytopenia in a heath care setting. Argatroban is available only in an inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through a retail pharmacy or a physician's office. benzoyl peroxide (Pacnex Cleansing Pads) Addition; requires PA Pacnex Cleansing Pads are indicated for the topical treatment of acne vulgaris. There are more cost- effective alternatives available for the management of the same clinical condition, including generic benzoyl peroxide products, which are available without PA for members ? 21 years of age. bivalirudin (Angiomax) Change in PA status: H symbol - inpatient use only Angiomax is indicated for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia in a heath care setting. Angiomax is available only in an inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through a retail pharmacy or a physician's office. Please send any suggestions or comments to: PrescriberELetter@state.ma.us 2 Drug/Drug Class Addition/Deletion/Change Rationale bromfenac (Bromday) Addition; requires PA Bromday is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. There are more cost-effective alternatives available for the management of the same clinical condition, including generic ophthalmic non-steroidal anti- inflammatory products, which are available without PA. buprenorphine/ naloxone, sublingual film (Suboxone ) Addition; requires PA Suboxone sublingual film is indicated for maintenance treatment of opioid dependence. There is no clinical advantage of Suboxone sublingual film over Suboxone sublingual tablet, which is available without PA at doses ?16 mg/day. bupropion XL (Wellbutrin XL) Change in PA status; requires PA for >30 units/month Bupropion XL no longer requires PA for ?30 units/month. Due to comparable pricing between 150 mg and 300 mg tablets, prior authorization is required for quantities >30 units/month for both dosage strengths to promote dose consolidation and to prevent inappropriate utilization. ciprofloxacin otic solution (Cetraxal) Deletion; no longer on MassHealth Drug List Cetraxal has been removed from the Drug List because it has been discontinued by the manufacturer. cyclosporine capsules (Sandimmune) Change in PA status; does not require PA Sandimmune is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The generic cyclosporine capsules have been discontinued by the manufacturer. Therefore, branded Sandimmune capsule no longer requires PA. dabigatran (Pradaxa) Addition; requires PA Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. There are more cost-effective alternatives available for the management of the same clinical condition, including generic warfarin, which is available without PA. doxepin (Silenor) Addition; requires PA Silenor is indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. There are more cost- effective alternatives available for the management of the same clinical condition, including generic doxepin, which is available without PA. doxepin 150 mg Change in PA status: requires PA Due to significant pricing difference between 75 mg and 150 mg capsules, prior authorization is required for the 150 mg capsules to promote utilization of the 75 mg capsules, which are more cost-effective. drospirenone/ethinyl estradiol/ levomefolate (Beyaz) Addition; does not require PA Beyaz is indicated for use by women to prevent pregnancy. ephedrine injection Change in PA status; does not require PA Injectable ephedrine is indicated for the treatment of acute hypotensive states, acute bronchospasm, myasthenia gravis, allergic disorders, and Adams-Stokes syndrome with complete heart block. Please send any suggestions or comments to: PrescriberELetter@state.ma.us 3 The Prescriber e-Letter April 2011, Volume 4, Issue 2 Drug/Drug Class Addition/Deletion/Change Rationale estradiol valerate and estradiol valerate/ dienogest (Natazia) Addition; does not require PA Natazia is indicated for use by women to prevent pregnancy. fibrinogen/thrombin patch (Tachosil) Addition; does not require PA Tachosil is indicated for supportive treatment in surgery for improvement of hemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient. fibrinogen/thrombin patch (Tachosil) Addition; does not require PA Tachosil is indicated for supportive treatment in surgery for improvement of hemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. fingolimod (Gilenya) Addition; requires PA Gilenya is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. There are more cost-effective alternatives available for the management of the same clinical condition, including injectable interferon beta products and Copaxone, which are available without PA. incobotulinumtoxinA (Xeomin) Addition; requires PA Xeomin is indicated for the treatment of adults with cervical dystonia and blepharospasm. Xeomin requires PA to ensure treatment is clinically appropriate. lepirudin (Refludan) Change in PA status: H symbol - inpatient use only Refludan is indicated for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia in a heath care setting. Refludan is available only in an inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through a retail pharmacy or a physician's office. norethindrone/ ethinyl estradiol/ ferrous fumarate (Lo Loestrin Fe) Addition; does not require PA Lo Loestrin Fe is indicated for use by women to prevent pregnancy. perindopril (Aceon) Change in PA status; does not require PA Perindopril is indicated for the treatment of hypertension. propoxyphene-containing products: propoxyphene (Darvon) propoxyphene napsylate (Darvon-N), propoxyphene napsylate/acetaminophen (Darvocet-N) Deletion; no longer on MassHealth Drug List Propoxyphene-containing products have been removed from the Drug List because they have been discontinued by the manufacturer. residronate, delayed release (Atelvia) Addition; requires PA Atelvia is indicated for the treatment of postmenopausal osteoporosis. There are more cost-effective alternatives available for the management of the same clinical condition, including generic alendronate, which is available without PA. Please send any suggestions or comments to: PrescriberELetter@state.ma.us 4 The Prescriber e-Letter April 2011, Volume 4, Issue 2 Drug/Drug Class Addition/Deletion/Change Rationale saxagliptin/ metformin ER (Kombiglyze XR ) Addition; requires PA Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. There are more cost-effective alternatives available for the management of the same clinical condition, including generic metformin and sulfonylureas, which are available without PA. sodium sulfate/ potassium sulfate/ magnesium sulfate (Suprep Bowel Kit) Addition; requires PA Suprep Bowel Kit is indicated for cleansing of the colon in preparation for colonoscopy in adults. There are more cost- effective alternatives available for the management of the same clinical condition, including generic PEG products, which are available without PA. tobramycin/ dexamethasone, ophthalmic suspension (Tobradex ST) Addition; requires PA Tobradex ST is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. There are more cost-effective alternatives available for the management of the same clinical condition, including generic tobramycin/dexamethasone ophthalmic suspension, which is available without PA. Please send any suggestions or comments to: PrescriberELetter@state.ma.us 5