Drug: ACCUTANE - Magellan Health Services || TennCare Portal

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GASTROINTESTINAL AGENTS PREFERRED N/A NEW: DICLEGIS NON-PREFERRED DICLEGIS ® (doxylamine succinate/pyridoxine) Prior Authorization Criteria Diclegis will be approved for pregnant females. COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION Quantity Limits Diclegis ® 4/day COMMITTEE VOTE: APPROVED DISAPPROVED APPROVED with MODIFICATION References 1. Facts and Comparisons on-line. Version 4.0; Wolters Kluwer Health, Inc.; 2013. Accessed July, 2013. 2. Thompson MICROMEDEX on-line © 1974-2013. Accessed July, 2013. 3. Magellan Medicaid Administration. Diclegis New Drug Update. May, 2013. 4. Koren G, Clark S, Hankins GDV, et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010; 203(6):571.e1-7. Available at: http://download.journals.elsevierhealth.com/pdfs/journals/0002- 9378/PIIS0002937810009142.main-abr.pdfjid=ymob. Accessed May 29, 2013. 5. American College of Obstetricians and Gynecologists. Nausea and vomiting of pregnancy. ACOG Practice Bulletin No. 52. Obstet Gynecol. 2004; 103:803-15. Available at: http://www.molinahealthcare.com/medicaid/providers/mo/pdf/acog%20nausea%20%20vo miting%20pregnancy.pdfE=true. Accessed May 29, 2013. Page 8 of 14 August 13, 2013 Tennessee PAC
OPHTHALMIC AGENTS NEW: CYSTARAN BACKGROUND Cystinosis is a rare genetic metabolic disease affecting an estimated 2,000 individuals worldwide. Cystinosis causes accumulation of the amino acid in multiple organs of the body and without specific treatment patients typically develop end stage renal disease around the age of nine years. Excess cystine damages cells and commonly results in crystalline cystine formation that builds up in many tissues and organs causing significant issues. Eyes and kidneys are particularly vulnerable to cystine accumulation and damage; however, muscles, thyroid, pancreas and testes may also be affected. Cysteamine decreases the amount of cystine in the lysosomes of patients with cystinosis. Exogenous cysteamine enters the cell and converts cystine to cysteine and a cysteinecysteamine complex. Both cysteine and the cysteine-cysteamine complex are more readily transported out of the lysosome than cystine, resulting in a long-term depletion of lysosomal cystine. Ophthalmic cysteamine is indicated for use in the treatment of corneal cystine crystal accumulation in patients with the genetic disease cystinosis. In ophthalmic cysteamine clinical trials, the most commonly reported adverse reactions (≥ ten percent) reported by patients were sensitivity to light, redness, eye pain/irritation, headache and visual field defects. o o There are no reported contraindications to ophthalmic cysteamine. Instances of benign intracranial hypertension (or pseudotumor cerebri) have been reported in patients receiving oral cysteamine therapy. These effects were resolved with the addition of diuretic therapy. Reports have also been received for patients using ophthalmic cysteamine, however it should be noted these patients were concomitantly receiving oral cysteamine therapy. o As this product is intended for topical ophthalmic therapy, no drug interactions have been reported. The clinical efficacy of cysteamine ophthalmic solution was evaluated in three controlled clinical trials consisting of approximately 300 patients diagnosed with cystinosis. Individuals were measured for their baseline Corneal Cystine Crystal Score (CCCS) prior to the initiation of cysteamine ophthalmic therapy. The primary efficacy end point for the trials was the response rate of eyes that demonstrated a reduction of at least one unit in the photo-rated CCCS at some time point during the study when the baseline CCCS for the individual was ≥1, or a lack of an increase of more than one unit in CCCS throughout the study for individuals whose pre-treatment baseline CCCS was
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Drug: ACCUTANE - Magellan Health Services || TennCare Portal

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