Step Therapy Policy Number: 5.01.524 Last Review: 10/2015 Origination: 11/2005 Next Review: 10/2016 Policy BCBSKC will provide coverage for brand name non-steroidal anti-inflammatory drugs (NSAIDs) including COX II inhibitors, angiotensin II receptor blockers (ARBs), cholesterol-reducing statin medications, cholesterol-reducing fibrates, antidepressant medications, nasal steroids, sedative hypnotics, brand name doxycyclines, topical anti-acne agents, topical corticosteroids and proton pump inhibitors (PPIs), rapid-acting insulin, metformin when the following criteria are met. When Policy Topic is covered If a claim for a therapeutically equivalent (TE) generic medication is found within the previous 120 days, the brand name drug will be allowed to process. If no claim is found, a message will be returned to the pharmacy stating Prior Generic Therapy Required. The prescriber may change the prescription to a generic alternative or request prior authorization based on other medical appropriateness rationale. In some cases, an automatic prior authorization will be granted if the patient meets criteria as outlined below. Brand Name (NSAIDs) and COX II Inhibitors Members initiating therapy with a brand name NSAID or COX II inhibitor will be required to try at least two generic NSAIDs first. The claims system will also be set to look back for any of the following criteria and allow automatic prior authorization for a COX II drug: Patient age > 65 years, Past history of peptic ulcer disease, GI bleed or other GI disorder as evidenced by prescription for H2 or PPI, Patient has prescription history for warfarin or other anticoagulant, Patient is on current long term corticosteroid therapy, Patient has diagnosis of RA as evidenced by prescription history of any DMARD. Angiotensin Receptor Blockers (ARBs) Members initiating therapy with a brand name ARB, or renin inhibitor will be required to try one generic ARB first. The claims system will also be set to look back for any claims for a diabetic medication. If a diabetic medication is found, the brand name product will be allowed to process. Coverage criteria for prior authorization of an ARB or renin inhibitor includes: Patients post MI and already stabilized on brand name, Renal transplant patients already stabilized on brand name, Other patients already stabilized on brand name product and interruption of therapy would have adverse effect will be authorized. Cholesterol-reducing statin and fibrate medications
Members initiating therapy with a brand name statin drug will be required to try one TE generic product first. Members initiating therapy with a brand name fenofibrate drug will be required to try one TE generic product first. The statin medications are limited to one tablet or capsule per day. Antidepressant medications Members initiating therapy with a brand name antidepressant drug will be required to try one TE generic product first. Nasal Steroids Members initiating therapy with a brand name nasal steroid will be required to try one TE generic product first. Nasal steroids are subject to quantity limitations. Please see Nasal Steroids policy for further detail. Sedative Hypnotics Members initiating therapy with a brand name sedative hypnotic, such as Ambien CR, Lunesta, or Sonata will be required to try one TE generic product first. Brand Name Doxycyclines for Acne and Rosacea (Adoxa, Doryx, Oracea, etc.) Members must try and fail a generic doxycycline product first. Proton Pump Inhibitors (PPIs) Brand name PPI are subject to the following double step: Step 1: members must try and fail generic omeprazole or lansoprazole Step 2: members must try and fail Nexium before changing to another branded PPI PPIs are limited to one tablet or capsule per day. Topical Acne Products and Kits Members must try and fail a generic prescription topical anti-acne product first. Topical Corticosteroids Members must try and fail two generic prescription topical corticosteroids first. Rapid-Acting Insulins Members must try and fail a Tier 2 product (Humalog) prior to a Tier 3 (Apidra, Novolog.) Brand Name metformin Members must try and fail a generic metformin product first.
When Policy Topic is not covered Brand name non-steroidal anti-inflammatory drugs (NSAIDs) including COX II inhibitors, angiotensin II receptor blockers (ARBs), cholesterol-reducing statin medications, cholesterol-reducing fibrates, antidepressant medications, nasal steroids, sedative hypnotics, brand name doxycyclines, topical antiacne agents, topical corticosteroids and proton pump inhibitors (PPIs), rapid-acting insulin, metformin are considered not medically necessary when the above criteria is not met Considerations This Blue Cross and Blue Shield of Kansas City policy statement was developed using available resources such as, but not limited to: Hayes Medical Technology Directory, Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers Description of Procedure or Service The step therapy policy is designed to encourage members to use a therapeutically equivalent (TE) generic alternative before initiating a brand name product. Payment for brand name drugs in certain therapeutic classes is restricted unless the patient has tried and failed a TE generic product or if they meet other medical criteria as outlined in this policy. This program is administered at the point of dispensing and involves a retrospective review of the member s pharmacy claims for prior use of TE generics or other prior authorization criteria. If any of the criteria is met an authorization is automatically provided for coverage of the brand name drug. If the criteria for approval are not met a prior authorization request must be submitted to the clinical pharmacy department for review. Rationale ARBs In patients with essential hypertension, high cardiovascular risk factors, recent MI, HF or nephropathy there are no data to suggest that one ARB is superior to another for efficacy and safety. Additionally, there is inadequate data to determine whether there is a difference between the ARBs with respect to demographics (age, racial groups, or sex), in combination with other medications, or in hypertensive patients with other comorbidities. Brand Name NSAIDs and COX II Inhibitors NSAIDs and COX-IIs are anti-inflammatory drugs that work by inhibiting the synthesis of the prostaglandin cyclooxygenase which is responsible for pain. COX-IIs are more specific for inhibition of the cyclooxygenase 2 enzyme. These agents do no inhibit the cyclooxygenase -1 enzyme, like other non-specific NSAIDs, which is believed to be linked to adverse effects on the GI system. NSAIDs and COX-II inhibitors have similar clinical efficacy at equipotent doses for the treatment of acute and chronic pain although individual response to different products may vary among patients. No one product can be distinguished from another product on a consistent basis. Controlled clinical trial data are not available to accurately evaluate whether certain patients will derive greater pain relief from one product compared to another. All COX-IIs and the non-specific NSAIDs contain a warning about the potential increase in risk for serious adverse CV events. In addition, it has been determined that the overall benefit of COX-IIs in reducing the risk of serious GI bleeding remains uncertain. To date, the only COX-II that has demonstrated a reduced risk for serious GI bleeding is Vioxx (no longer being marketed). This was in comparison to naproxen. Cholesterol-reducing statin and fenofibrate medications
Numerous generic alternatives are now available including, but not limited to: atorvastatin, lovastatin, pravastatin, and simvastatin. The majority of patients treated with Lipitor take a 10mg dose for which a generic statin therapy would produce equal lipid lowering effects. The brand to generic conversion of statin users was studied by Kaiser Permanente and presented to the American Heart Association. The study was done from April 1, 2002 to March 31, 2003. The study included 33318 patients who were converted from brand name Zocor (now available as a generic) to lovastatin. The results showed the mean LDL-C was lowered from 110.9 to 108.4 mg/dl (P <.001) following the conversion to lovastatin. The percentage of patients with serum ALT levels greater than 3 times the upper limit of normal (ULN) was similar before (0.7%) and after (0.6%) conversion from simvastatin to lovastatin. Creatine kinase elevations greater then 10 times the ULN occurred at similar rates before and after the conversion. The study concluded that appropriately selected patients can be safely and effectively converted from a brand name to a generic statin medication. The fenofibrates are all indicated as adjunct to diet to reduce low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B, and to increase high-density lipoprotein cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Tricor was the original fenofibrate introduced to the market in 1998. Since its introduction, it has been reformulated so that it possesses greater bioavailability and thus a lower dosing requirement. Other products have been approved that are bioequivalent to the original Tricor and have since become available as generics. Antidepressant medications Antidepressants do not differ significantly in their ability to treat depression. Excluding the tricyclic antidepressants (TCAs), these drugs also do not differ significantly in their incidence of adverse events. Therefore, the initial choice of antidepressant medication should be based, in part, on cost. Multiple generic antidepressants are now available while brand name antidepressants are still extensively used. Antidepressants currently available as a generic include, but are not limited to: bupropion, citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline. Nasal Steroids Nasal steroid products are considered equal in safety and efficacy for the treatment of nasal allergy symptoms. There is currently no evidence to support the use of one nasal steroid over another in the treatment of allergic rhinitis. Sedative Hypnotics There are currently two generic options to effectively treat insomnia related to sleep initiation. Therefore, the initial choice of a sedative hypnotic should partly be based on cost. Brand Name Doxycyclines for Acne / Rosacea (Adoxa, Doryx, Oracea, etc.) There are currently multiple generic doxycycline options that can be used to effectively treat acne or rosacea. Therefore, the initial choice of a doxycycline product to treat acne or rosacea should partly be based on cost. Proton Pump Inhibitors (PPIs) There is currently no evidence to support the use of one PPI over another in the treatment of GERD, gastric ulcers, hypersecretory conditions, etc. There are also multiple generic PPI options. Therefore, the initial choice of a PPI product to treat acid related gastritis should partly be based on cost. Topical Anti-Acne Cleansers, Products and Kits
Topical anti-acne products are, in general, approved by the FDA for the treatment of acne vulgaris. Guidelines do not prefer any of the specific brand name agents to their generically similar products. Because multiple prescription topical anti-acne agents have generically similar alternatives, a step therapy program has been put in place to encourage the use of generics. Topical Corticosteroids There are currently multiple topical corticosteroids that are available generically. They are, in general, all approved by the FDA for symptomatic relief of inflammation and/or pruritus associated with acute and chronic corticosteroid responsive skin disorders (dermatoses). References 1. http://www.factsandcomparisons.com/efacts.asp. Accessed on 12/15/04. 2. Hamada T, Watanabe M, Kaneda T, et al. Evaluation of changes in sympathetic nerve activity and heart rate in essential hypertensive patients induced by amlodipine and nifedipine. J Hypertens. 1998;16:111-118. 3. Conlin PR, Williams GH. Use of calcium channel blockers in hypertension. Adv Intern Med. 1998;43:533-562. 4. Hoegholm A, Wiinberg N, Rasmussen E, et al. Office and ambulatory blood pressure: a comparison between amlodipine and felodipine ER. Danish Multicentre Group. J Hum Hypertens. 1995;9:611-616. 5. Ostergren J, Isaksson H, Brodin U, et al. Effect of amlodipine versus felodipine extended release on 24-hour ambulatory blood pressure in hypertension. Am J Hypertens. 1998;11:690-696. 6. Covera-HS extended-release tablets controlled-onset [package insert]. Chicago, IL: Pharmacia; July 2003. 7. Verelan PM extended-release capsules controlled-onset [package insert]. Milwaukee, WI: Schwarz Pharma; May 2004. 8. Calan SR sustained-release caplets [package insert]. North Chicago, IL: Abbott Laboratories; July 2003. 9. Verapamil (DRUGDEX System Drug Evaluation). In: Klasco RK (Ed): DrugKnowledge System (electronic version). Thomson MICROMEDEX, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com. Accessed on 01/13/05. 10. Conlin PR, Williams GH. Use of calcium channel blockers in hypertension. Adv Intern Med. 1998;43:533-562. 11. Diovan [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corporation; November 2003. 12. Avapro [package insert]. New York, NY: Sanofi-Synthelabo; August 2002. 13. Cozaar [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; August 2003. 14. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. The JNC 7 Report. JAMA. 2003;289:2560-2572. 15. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851-860. 16. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345:861-869. 17. American Diabetes Association. Position Statement. Diabetic nephropathy. Diabetes Care. 2004;27(Suppl 1):S79-S83. 18. Pearson TA, Blair SN, Daniels SR, et al. AHA guidelines for primary prevention of cardiovascular disease and stroke: 2002 update. Consensus panel guide to comprehensive risk reduction for adult patients without coronary or other atherosclerotic vascular diseases. Circulation. 2002;106:388-391. 19. Dickstein K, Kjekshus J, et al. Effect of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomized trial. Lancet. 2002;360(9348):752-760. 20. Celebrex capsules [package insert]. New York, NJ: Pfizer, Inc.; January 2004.
21. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis-2002 update. Arthritis Rheum. 2002;46:328-346. 22. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. The CLASS study: a randomized controlled trial. JAMA. 2000;284:1247-1255. 23. FDA issues public health advisory on Vioxx as its manufacturer voluntarily withdraws the product. Accessed on October 5, 2004 at http://www.fda.gov/bbs/topics/news/2004/new01122.html 24. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med. 1998;105(1B):31S-38S. 25. Gabriel SE, Jaakkimainen L, Bombardier C. Risk of serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs. A meta-analysis. Ann Intern Med. 1991;115:787-796. 26. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet. 1994;343:769-772. 27. Griffin MR, Piper JM, Daugherty JR, et al. Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons. Ann Intern Med. 1991;114:257-263. 28. Henry D, Dobson A, Turner C. Variability in the risk of major gastrointestinal complications from nonaspirin nonsteroidal anti-inflammatory drugs. Gastroenterol. 1993;105:1078-1088. 29. Hernandez-Diaz S, Garcia Rodriguez LA. Association between nonsteroidal anti-inflammatory drugs and upper gastrointestinal tract bleeding/perforation. An overview of epidemiologic studies published in the 1990s. Arch Intern Med. 2000;160:2093-2099. 30. Cheetham T, et al. Successful Conversion of Patients with Hypercholesterolemia From a Brand Name to a Generic Cholesterol-Lowering Drug. The American Journal of Managed Care. September 2005; 546-552. 31. Is Effexor more effective for depression than an SSRI? Med Lett. 2004;46 (1176):15-16. 32. Ekselius L, von Knorring L, Eberhard G. A double-blind multicenter trial comparing sertraline and citalopram in patients with major depression treated in general practice [abstract]. Int Clin Psychopharmacol. 1997;12(6):323-31. 33. Kroenke K, West SL, Swindle R, et al. Similar effectiveness of paroxetine, fluoxetine, and sertraline in primary care: a randomized trial. JAMA. 2001; 286(23):2947-55. 34. Bennie EH, Mullin JM, Martindale JJ. A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression. J Clin Psychiatry. 1995;56(6):229-37. 35. Fava M, Hoog SL, Judge RA, et al. Acute efficacy of fluoxetine versus sertraline and paroxetine in major depressive disorder including effects of baseline insomnia. J Clin Psychopharmacol. 2002;22(2):137-47. 36. Thase ME, Haight BR, Richard N, et al. Remission rates following antidepressant therapy with bupropion or selective serotonin reuptake inhibitors: a meta-analysis of original data from 7 randomized controlled trials. J Clin Psychiatry. 2005;66(8):974-81. 37. Gillessen A, et al. "40 mg pantoprazole and 40 mg esomeprazole are equivalent in the healing of esophageal lesions and relief from gastroesophageal reflux disease-related symptoms". J Clin Gastroenterol. 2004;38(4):332-40. 38. Schoten T, et al. "Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms." Aliment Pharmacol Ther. 2003;18(6):587-94. 39. Vakil N. "Review article: esomeprazole, 40mg once daily, compared with lansoprazole, 30 mg once daily, in healing and symptom resolution of erosive oesophagitis." Aliment Pharmacol Ther. 2003;17(suppl 1):21-3. 40. Korner T, et al. "Comparable efficacy of pantoprazole and omeprazole in patients with moderate to severe reflux esophagitis. Results of a multinational study." Digestion 2003;67(1-2):6-13.
41. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004. 42. Beck IT, Champion MC, Lemire S, et al. The Second Canadian Consensus Conference of the Management of Patients with Gastroesophageal Reflux Disease. Can J Gastroentrerol 1997: 11 (Suppl B) 7B - 20B. 43. Jaspersen, D et al. A comparison of omeprazole, lansoprazole, and pantoprazole in the maintenance treatment of severe reflux oesophagitis. Aliment Pharmacol Ther 12:49-52, 1998. 44. Oregon Health Services Commission Subcommittee Report ARBs, March 2006 Available at http://www.oregon.gov/das/ohppr/hrc/docs/aiira_hrc.pdf. Accessed May 15, 2007. Billing Coding/Physician Documentation Information NA The above listed medications are a pharmacy benefit only. Additional Policy Key Words 5.01.524 Policy Implementation/Update Information 11/2005 New Policy titled Step Therapy 11/2006 Policy revised to include cholesterol-reducing statin medications and antidepressant medications 09/2007 Policy revised to include renin inhibitors in the ACE/ARB step therapy criteria. 11/2008 No policy statement changes. 09/2009 Policy revised to include nasal steroids and sedative hypnotics. 08/2010 Policy revised to include brand name doxycyclines for acne and proton pump inhibitors 10/2013 Policy revised to remove CCB step and ACE step since these programs were retired. 10/2014 No policy statement changes 10/2015 Added Rapid-acting insulin and brand metformin State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.