Script Notes Third Quarter 2006 The Pharmacy and Therapeutics Newsletter for Keystone Mercy Health Plan Participating Providers In This Issue: Treatment of Mild to Moderate Asthma........... 1 Formulary Update........... 2 Product Update............. 3 Zocor, Zoloft, and Proscar Available as Generic Products.. 3 Safety Alerts............... 4 References................. 5 Script Notes Has a New Look! We have made some changes to our format to help make Script Notes easier to read. Please let us know what you think by emailing : andrew.maiorini@performrx.com. Treatment of Mild to Moderate Asthma Statistics from the American Lung Association showed that, by far, most people with asthma (88% or 16.6 million people in the United States) have a diagnosis of mild to moderate asthma. Many of these patients can be controlled on inhaled cortico-steroids, which is the standard of treatment. A 2005 Public Health advisory published by the FDA stated that products containing Long Acting Beta Agonists (LABAs) should not be used as a first line treatment for asthma. LABAs should be added to a treatment plan only if other medicines, including low-or-medium-dose inhaled corticosteroids, do not control asthma. Corticosteroid agents on Keystone Mercy Formulary include: Qvar (beclomethasone), Asmanex (mometasone), Azmacort (triamcinolone) and Flovent (fluticasone). A large placebo-controlled U.S. study, the Salmeterol Multi-Center Asthma Research Trial (SMART), compared the safety of salmeterol or placebo added to usual asthma therapy. The data showed an increase in asthma-related deaths in patients receiving salmeterol: 13 deaths out of 13,176 patients treated for 28 weeks on salmeterol 3 deaths out of 13,179 on placebo Advair (fluticasone/salmeterol xinafoate) is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta2-agonists. In July 2006, a new agent Symbicort (budesonide and formoterol) was approved. It contains a corticosteroid and long-acting beta2-agonist. 88% or 16.6 million people in the United States have a diagnosis of mild to moderate asthma. According to a study, The Treatment of Asthma Study XXII, inhaled corticosteroids are prescribed in fewer than one out of three patients as initial therapy for mild-persistent asthma. A step-therapy approach should be used when initiating therapy with a newly diagnosed member based on his or her symptoms and the severity and frequency of the symptoms. As a provider, you can influence the health outcomes of our members. Please review their asthma therapy, calculate compliance, and, from time to time, review inhaler technique with members. These steps can assure appropriate therapy and increase positive outcomes. For more information about Script Notes, or questions about our formulary please visit our website: www.keystonemercy.com. 1
Formulary Update: Additions to the Keystone Mercy Drug Formulary Drug Additions to Formulary Effective Date Alphagan P June 2006 Diovan HCT 320/12.5 June 2006 Diovan HCT 320/25 June 2006 Asmanex Twisthaler June 2006 Alphagan P 0.1% (brimonidine tartrate) Indication: For lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Made by Allergan, Inc., Alphagan P, 0.1% ophthalmic solution (brimonidine tartrate) was approved by the FDA in August 2005. The approval was based on study data showing that the 0.1% and 0.2% (Alphagan) formulations were similarly effective for reducing IOP. The product s increased bioavailability allows a further decrease in drug exposure compared with the previously approved and equally effective 0.15% formulation. All product formulations of Alphagan P are formulary agents for Keystone Mercy Health Plan members. Diovan HCT 320/12.5 and Diovan HCT 320/25 Indication: These two new higher-dose formulations of Diovan HCT are now available for patients with hypertension. Diovan HCT contains the angiotensin receptor blocker valsartan and the diuretic hydrochlorothiazide (HCTZ). Many patients need a combination of two therapies to achieve blood pressure goals. The higher doses provided significantly greater reductions in blood pressure compared with either agent alone. Giving this combination also reduced the incidence of low blood potassium, which is associated with HCTZ. Dosing: The tablets are already available in combinations of 80/12.5, 160/12.5, and 160/25 mg. Asmanex Twisthaler (mometasone) Indication: For the maintenance of asthma as prophylactic therapy in patients 12 years of age and older. Asmanex is also indicated for asthma patients that require oral corticosteroid therapy, where adding Asmanex may reduce or eliminate the need for oral corticosteroids. Asmanex is administered by inhalation route. Mometasone is a corticosteroid that demonstrates potent anti-inflammatory activity. The systemic availability of mometasone when inhaled has been determined to be less than 1%. Currently inhaled corticosteroids are a first line treatment in patients with persistent mild to moderate asthma. The inhalation device provides a dose of 220 mcg per actuation. Dosing: The recommended dosing frequency is once or twice daily. Once daily dosing is unique to this product when compared to other dry powder corticosteroid inhalers. It is recommended that when dosing once daily, Asmanex should be taken in the evening. The starting dose depends on the patient s previous therapy and degree of asthma severity. Recommended Dosages Starting Maximum Previous Therapy Dose Daily Dose Bronchodilators only 220 mcg 440 mcg once daily Inhaled corticosteroids 220 mcg 440 mcg once daily Oral corticosteroids 440 mcg 880 mcg twice daily The efficacy and safety of Asmanex at various dosing regimens has been demonstrated in multiple clinical trials involving 1,941 patients with asthma aged 12 years and older. Asmanex is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Asmanex Twisthaler is a device for inhalation of dry powder mometasone. Each actuation delivers 220 mcg. There are four different sizes each providing a different number of total actuations: 14, 30, 60, and 120. 2
Formulary Update: Removed From Formulary: Generic Equivalent of Percodan (Oxycodone and Aspirin) The generic equivalent of Percodan (Oxycodone and Aspirin 325/4.5 mg) has been removed from the formulary. The generic equivalent of Percocet (Oxycodone and Acetaminophen 5/325mg) is offered as a therapeutic alternative. If you feel that generic Percocet is not an appropriate alternative for a patient, you will need to submit a Prior Authorization Request for generic Percodan. Product Updates Please be aware the information discussed in this section is to provide the reader with product updates only. It is not indicative of what is currently or will be on Keystone Mercy s formulary. There have been a few new product releases for the treatment of asthma within the last year. Asmanex Twisthaler inhaled corticosteroid Indicated for asthmatic patients who are 12 years or older Dosed once daily in the evening Available in three different 220 mcg unit dose inhalers: 30 inhalation units, 60 inhalation units, and 120 inhalation units Common adverse events are headache, allergic rhinitis, pharyngitis, and upper respiratory infections Orapred ODT oral disintergrating prednisolone tablet Used to treat exacerbations of asthma in pediatric patients Doses based on weight of the pediatric patient in single or divided doses Tablets available in 10 mg, 15 mg, and 30 mg of the prednisolone base Adverse reactions in clinical trials included: facial edema, pharyngolaryngeal pain, blood in stool, eye irritation, and eyelid edema Tablets should not be cut, split or broken Advair HFA combination product of fluticasone and salmeterol Can be administered twice daily in patients who are 12 years of age or older Available in the following combination doses of Fluticasone and Salmeterol: 45/21mcg, 115/21mcg, and 230/21mcg Common side effects are headaches, upper respiratory tract infections, throat irritation, and dizziness Carries the black box warning in regards to an increase in asthma-related deaths Requires a MedGuide for outpatient use Zocor, Zoloft, and Proscar Available as Generic Products This year several widely used blockbuster medications now have generic alternatives available on the market. Whenever possible, Keystone Mercy strives to increase generic utilization to reduce the cost of medication management for the plan and our members. Simvastatin (generic for brand Zocor ) became available in many pharmacies in June of 2006. Simvastatin is the second most frequently prescribed statin on the market today. Statin medications are most often prescribed for patients with hyperlipidemia, a common risk factor for cardiovascular disease. The generic manufacturers Ranbaxy Laboratories (80 mg strength only) and Teva (all other strengths) have exclusivity to market the generic for a period of 180 days. Typically this exclusivity limits the degree to which the price decreases during the initial 180 days. Dr. Reddy s Laboratories, under license from Merck & Co., is also going to be marketing simvastatin during this time period. Simvastatin is currently non-formulary and requires prior authorization (PA) for Keystone Mercy Health Plan. Formulary alternatives to simvastatin, which do not require PA, include lovastatin, Lescol, Lescol XR, Altoprev, and pravastatin (generic Pravachol ). Sertraline (generic for brand Zoloft ) became available in August of 2006. Zoloft is a very popular medication belonging to the Selective Serotonin Reuptake Inhibitor (SSRI) class of antidepressants. SSRIs are used to treat depression, anxiety, Post Traumatic Stress Disorder (PTSD), as well as other behavioral health related conditions. Generic manufacturers Roxane Labs (concentrated oral solution only) and Teva will be marketing a generic formulation of sertraline. Also Greenstone LTD, a subsidiary of brand Zoloft patent holder Pfizer Inc., will also be marketing a generic version. Sertraline is currently nonformulary for Keystone Mercy Health Plan. Formulary (continued on page 5) 3
Safety Alerts: Warnings Due to outcome of Salmetrol Muliticenter Asthma Research Trial (SMART) May increase the risk of asthma-related deaths Recommend prescribing LABAs only when patients are not adequately controlled on other asthma-controlled medications... or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Long-Acting Beta2 Agonist (LABA) Inhalers Advair Diskus (salmetrol and fluticasone combination) and Servent Inhaler (salmeterol) Two of the long-acting beta2 agonist (LABA) inhalers, Advair Diskus (salmetrol and fluticasone combination) and Servent Inhaler (salmeterol), have a black box warning in place due to the outcomes of the Salmetrol Muliticenter Asthma Research Trial (SMART). This black box warning states LABAs may increase the risk of asthma-related deaths. The warning also states physicians should only prescribe LABAs when patients are not adequately controlled on other asthmacontrolled medications (e.g. low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Recently, Foradil Aerolizer (formoterol) had this black box warning put into place as well, due to a recommendation from the FDA Pulmonary and Allergy Drug Advisory panel. Another newly marketed product, Advair HFA, has also included this black box warning. Misadministration Warning Both Sprivia HandiHaler (tiotropium bromide) and Foradil Aerolizer (formoterol) have had reported cases of patients orally ingesting the inhalation capsules. Although these reported cases have had few adverse events, the misadministration does decrease the therapeutic effects of these medications. To help prevent this mishap, counsel patients on keeping inhalation capsules with the inhaler, and instruct them on how to use the inhalers. As an added precaution, place an additional warning label on the inhalation capsules indicating that it is for inhalation use only. MedGuides The FDA has required the distribution of patient medication guides called MedGuides for many prescribed medications and prescribed over-the-counter medications for outpatient use. The FDA requires a MedGuide for medications if one or more of the following apply: Patient labeling could help prevent serious adverse effects. The drug product has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients decision to use, or to continue to use, the product. The drug product is important to the patient s health, and patient adherence to directions is crucial to the drug s effectiveness. Prior to distribution, the FDA must approve all MedGuides. These MedGuides must be provided to patients with each fill and refill. A prescriber can request to not distribute the MedGuide, but a request from the patient can overrule the prescriber s request. There are over 40 medication MedGuides currently available. For a complete list of MedGuides and to print these MedGuides go to: http://www.fda.gov/cder/offices/ods/ medication_guides.htm. 4
Zocor, Zoloft, and Proscar (continued from page 3) alternatives to sertraline include citalopram, fluoxetine, paroxetine, and Lexapro (escitalopram). Finasteride (generic for brand Proscar ) was made available in June 2006. Finasteride is a popular medication used in the treatment of Benign Prostatic Hyperplasia (BPH). Finasteride is a type II 5α-reductase inhibitor that prevents the conversion of testosterone into dihydrotestosterone (DHT). Teva will market the generic with 180-days of exclusivity. Dr. Reddy s Laboratories will also market a generic version of Proscar under a licensing agreement with brand patent holder Merck & Co. Finasteride is available on the Keystone Mercy Health Plan formulary with documented prior use of doxazosin, terazosin, or Flomax (tamsulosin). Avodart (dutasteride), also a 5α-reductase inhibitor, is another formulary option for treating BPH. References 1. Drug facts and comparisons. Alphagan P, Asmanex, Avodart, and Diovan HCT. Found at http://online.factsandcomparisons.com. Accessed September 2006. 2. Asmanex prescribing information. Schering Corporation. July 2005. 3. Avodart prescribing information. GlaxoSmithKline. May 2005. 4. Alphagan P 0.1% prescribing information. Allergan. August 2005. 5. American Lung Association. Epidemiology and Statistics Unit Research and Program Services. Trends in Morbidity and Mortality. May 2005. 6. NOP World. The Treatment of Asthma Study XXII. August 2004. 7. US Food and Drug Administration Web site. Available at http://fda.gov/cder/drug/advisory/laba.htm Accessed September 8, 2006. 8. Symbicort package insert. www.symbicort.com Accessed September 8, 2006. 9. GlaxoSmithKline. Package Insert for Advair Diskus. March 2006. 10. GlaxoSmithKline. Package Insert for Servent Diskus. March 2006. 11. O Hollaren, Mark T. Long-Acting Beta2-Agonists- Where Do We Stand? Medscape Pulmonary Medicine. 2006; 10(1). Retrieved August 16, 2006 from http://www.medscape.com/viewarticle/527629. 12. Advair Diskus, Advair HFA, Foradil, and Servent Diskus Information (Long Acting Beta Agonists). Retrieved August 16, 2006 from http://fda.gov/cder/drug/ inforpage/laba/default.htm. 13. Schering Corporation. Package Insert for Foradil Aerolizer. June 2006. 14. GlaxoSmithKline. Package Insert for Advair HFA. June 2006. 15. O Mara, Neeta Bahal. The Safety of Long-Acting Beta-2 Agonists in Patients with Asthma. Pharmacist s Letter/Prescriber s Letter 2005; 21(9): 210907. 16. Accidental Oral Administration of Capsules for Inhalation Devices. FDA Patient Safety News. Show#43, September 2005. Retrieved August 21, 2006 from http://www.accessdata.fda.gov/scripts/cdrh/ cdfdocs/psn/printer/cfm?id=362. 17. Woelfel, Joseph. Oral Administration of Capsules for Inhalation. Pharmacist s Letter/Prescriber s Letter 2005; 21(6): 210607. 18. Drug Products with Medication Guides. Pharmacist s Letter/Prescriber s Letter 2006; 22(3): 220331. 19. Medication Guides. Retrieved August 16, 2006 from http://www.fda.gov/cder/offices/ods/ medication_guides.htm. 20. Schering Corporation. Package Insert for Asmanex Twisthaler. July 2005. 21. Asmanex (Mometason Furoate Inhalation Powder). Pharmacist s Letter/Prescriber s Letter 2005; 21(9): 210906. 22. FDA Approval 2006. Retrieved August 18, 2006 from http://www.drugs.com/newdrugs.html. 23. Alliant Pharmaceuticals, Inc. Package Insert for Orapred ODT. May 2006. 24. MediMedia USA, Inc. c2006. Available from: http://www.ptcommunity.com/ptjournal/fulltext/31/6/ptj3106304.pdf. 25. Medscape Medical News, c2005. Available from: http://www.medscape.com/pharmacists. 5
Script Notes We welcome your thoughts, comments and/or suggestions. Do you have an idea for a story? Is there information we can provide to help you? All correspondence concerning Script Notes should be sent to: Andrew Maiorini, PharmD Keystone Mercy Health Plan 200 Stevens Drive Philadelphia, PA 19113 andrew.maiorini@performrx.com Editor: The Quarterly Pharmacy and Therapeutics Newsletter for Keystone Mercy Health Plan Participating Providers Denise Cubbin, PharmD Associate Vice President, Clinical Programs Contributing Editors: Mark R. Lawson, PharmD, RPh Supervisor, DUR/MTM Andrew Maiorini, PharmD Senior Clinical Pharmacist, Formulary Michelle M. Mason, PharmD Senior Clinical Pharmacist, DUR/MTM Rosellen Rajan, PharmD, Clinical Pharmacist, Formulary Margaret Shepherd, RPh Clinical Projects Pharmacist and Interim Supervisor, Formulary Jocelyn Scout, PharmD Clinical Pharmacist, Formulary 200 Stevens Drive Philadelphia, PA 19113