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IOWA MEDICAID DRUG UTILIZATION REVIEW COMMISSION

100 Army Post Road – Des Moines, IA 50315 • (515) 725-1287 • Fax 1-866-626-0216 Professional Staff: Thomas Kline, D.O. Pam Smith, R.Ph. From: Pam Smith, R.Ph., DUR Project Coordinator RE: DUR Recommendation to the Department of Human Services

The members of the Iowa Medicaid Drug Utilization Review Commission met on November 4th, 2009
and voted in favor of making the following recommendations to the Department of Human Services
regarding clinical prior authorization criterion. You are receiving this letter because the DUR
Commission is interested in the opinions of the members of your organization on these issues.
1) Smoking Cessation Therapy – to be consistent with other smoking cessation therapy, PA
criteria for bupropion SR (that is FDA approved for smoking cessation) is being proposed and added to the existing varenicline PA criteria. Newly Proposed PA Criteria Prior Authorization is required for varenicline (Chantix™) or bupropion SR that is FDA approved for smoking cessation. Requests for authorization must include: 1) Diagnosis of nicotine dependence and referral to the Quitline Iowa program for counseling. 2) Confirmation of enrollment and ongoing participation in the Quitline Iowa counseling program is required for approval and continued coverage. 3) Approvals will only be granted for patients eighteen years of age and older. 4) The duration of therapy is initially limited to twelve weeks within a twelve-month period. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment will be considered with a prior authorization request. The maximum duration of approvable therapy is 24 weeks within a twelve-month period. 5) Requests for varenicline to be used in combination with bupropion SR that is FDA indicated for smoking cessation or nicotine replacement therapy will not be approved. 6) The 72-hour emergency supply rule does not apply for drugs used for the treatment of smoking cessation 2) Proton Pump Inhibitors
Current Clinical Prior Authorization Criteria Prior authorization is not required for the preferred proton pump inhibitors (PPI) for a cumulative 60-days of therapy per 12-month period. Prior authorization will be required for all non-preferred proton pump inhibitors as indicated on the Iowa Medicaid Preferred Drug List beginning the first day of therapy. Payment for a non-preferred proton pump inhibitor will be authorized only for cases in which there is documentation of previous trials and therapy failures with three preferred products. Prior authorization is required for any PPI usage longer than 60 days or more frequently than one 60-day course per 12-month period. The 12-month period is patient specific and begins 12 months before the requested date of prior authorization. Payment for usage beyond these limits will be authorized for cases in which there is a diagnosis of: 1. Specific Hypersecretory conditions (Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas). 2. Barrett’s esophagus. 3. Erosive esophagitis 4. Symptomatic gastroesophageal reflux after documentation of previous trials and therapy failure with at least one histamine H2-receptor antagonist at full therapeutic doses. 5. Recurrent peptic ulcer disease after documentation of previous trials and therapy failure with at least one histamine H2-receptor antagonist at full therapeutic doses and with documentation of either failure of Helicobacter pylori treatment or a negative Helicobacter pylori test result. Prior authorization is NOT required for Prevacid granules for oral suspension or SoluTabs for children age 12 years old or younger for the first 60 days of therapy. Prior authorization is required for Prevacid granules for oral suspension and SoluTabs for patients over 12 years of age beginning day one of therapy. Authorization for Prevacid granules for oral suspension and SoluTabs will be considered for those patients who cannot tolerate a solid oral dosage form. Proposed Clinical Prior Authorization Criteria Prior authorization is not required for the preferred proton pump inhibitors (PPI) for a cumulative 60-days of therapy per 12-month period. Prior authorization will be required for all non-preferred proton pump inhibitors as indicated on the Iowa Medicaid Preferred Drug List beginning the first day of therapy. Payment for a non-preferred proton pump inhibitor will be authorized only for cases in which there is documentation of previous trials and therapy failures with three preferred products. Prior authorization is required for any PPI usage longer than 60 days or more frequently than one 60-day course per 12-month period. The 12-month period is patient specific and begins 12 months before the requested date of prior authorization. Payment for usage beyond these limits will be authorized for cases in which there is a diagnosis of: 1. Specific Hypersecretory conditions (Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas). 2. Barrett’s esophagus. 3. Erosive esophagitis 4. Symptomatic gastroesophageal reflux after documentation of previous trials and therapy failure with at least one histamine H2-receptor antagonist at full therapeutic doses. 5. Recurrent peptic ulcer disease after documentation of previous trials and therapy failure with at least one histamine H2-receptor antagonist at full therapeutic doses and with documentation of either failure of Helicobacter pylori treatment or a negative Helicobacter pylori test result. Prior authorization is NOT required for Prevacid granules for oral suspension or SoluTabs for children age 12 8 years old or younger for the first 60 days of therapy. Prior authorization is required for Prevacid granules for oral suspension and SoluTabs for patients over 12 8 years of age beginning day one of therapy. Authorization for Prevacid granules for oral suspension and SoluTabs will be considered for those patients who cannot tolerate a solid oral dosage form. The required trials may be overridden when documented evidence is provided that the use of these agents would be medically contraindicated. 3) Ankylosing Spondylitis
Current Clinical Prior Authorization Criteria
Prior authorization is required for biologicals used for ankylosing spondylitis.
Payment will be considered following an inadequate response to a preferred NSAID.
Prior authorization is required for all non-preferred biologicals for ankylosing spondylitis as
indicated on the Iowa Medicaid Preferred Drug List beginning the first day of therapy.
Payment for non-preferred biologicals for ankylosing spondylitis will be considered only for
cases in which there is documentation of a previous trial and therapy failure with a preferred
agent.

Proposed Clinical Prior Authorizaiton Criteria
Prior authorization is required for biologicals used for ankylosing spondylitis.
Payment will be considered following an inadequate response to a preferred NSAID. Payment
will be considered following inadequate responses to at least two non-steroidal anti-
inflammatories (NSAIDs) at maximum therapeutic doses unless there are documented adverse
responses or contraindications to NSAID use. These trials should be at least three months in
duration. Patients with symptoms of peripheral arthritis must also have failed a 30-day
treatment trial with at least one conventional disease modifying antirheumatic drug
(DMARD), unless there is a documented adverse response or contraindication to DMARD
use. DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate,
leflunomide, d-penicillamine, azathioprine, oral gold, intramuscular gold.
Prior authorization is required for all non-preferred biologicals for ankylosing spondylitis as
indicated on the Iowa Medicaid Preferred Drug List beginning the first day of therapy.
Payment for non-preferred biologicals for ankylosing spondylitis will be considered only for
cases in which there is documentation of a previous trial and therapy failure with a preferred
agent.

4) Short Acting Narcotics
Newly Proposed Clinical Prior Authorizaiton Criteria Prior authorization is required for all non-preferred short acting narcotics. Payment will be considered for cases in which there is documentation of previous trial(s) and therapy failures with three (3) chemically distinct preferred short acting narcotics (based on narcotic ingredient only) at therapeutic doses, unless evidence is provided that the use of these products would be medically contraindicated. Prior to the formal recommendation of these clinical prior authorization criterion going to the Department of Human Services, the DUR Commission is interested in the opinions of the members of your organization. Any comments regarding these proposed changes may be forwarded to me and will be shared with the DUR Commission Members. My contact information is listed below. Please have comments/feedback submitted to me on or before November 30, 2009. Sincerely, Pamela Smith, R.Ph. Drug Utilization Review Project Coordinator Iowa Medicaid Enterprise 100 Army Post Road Des Moines, IA 50315 515.725.1287 – voice 515.725.1010 – fax - email

Source: http://www.ioma.org/DUR%20Recommendations_Nov_09.pdf