Review of authorization criteria in PDL drug classes Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services September 24, 2014

Newer Sedative Hypnotics August 15, 2007 DUR board review Presentation on pharmacologic treatment of chronic insomnia by sleep specialist Ralph Pascually MD, and medical consultant Steven Hammond MD. 2

The DUR board approved the modified Medicaid sedative hypnotic policy as follows: Medicaid will cover the following hypnotic drugs without PA within the following limits: Ramelteon: 30 tablets/30 days for maximum 90 days continuous use Zolpidem, zaleplon and eszopiclone: 30 tablets/30 days for first fill, then 10 tablets/30 days (PRN use) 3

Sleep consultation with a board certified sleep specialist at a HCA-approved sleep center for clients receiving more than 6 months of continuous nightly treatment with: zolpidem zaleplon eszopiclone Ramelteon Continuous nightly use may be necessary in some clients, but may not be appropriate for others. 4

Sleep consultations If sleep consultation is required, Medicaid will send a letter to the prescribing provider and the client asking the prescriber to refer the client to a sleep center specialist to evaluate the need for continuous nightly insomnia drugs. Specialist will send the prescriber and Medicaid their recommendation which may include treatment with cognitive behavior therapy. 5

Motion – Newer Sedative Hypnotics Medicaid is requesting the board consider confirmation/ re-approval of existing criteria. Suggested motion: I move that Medicaid continue to limit ramelteon to 90 days continuous use at one tablet per day, and other products in the Newer Sedative Hypnotic class to an initial fill of 30 tablets for 30 days, and 10 tablets per 30 days thereafter. Exceptions may be made on a case by case basis, but clients requiring more than 6 months continuous nightly treatment are required to have a sleep consultation with a board certified sleep specialist at a HCA-approved sleep center. 6

NSAIDs/COX-2 inhibitors Criteria originally developed and approved by DUEC in February 12, 2003 PDL drug class review of NSAIDs and COX-2 inhibitors. At the time: Medicaid had all NSAIDs on expedited authorization (EA) with criteria that patient must not have a history of GI ulcer or bleed. COX-2 inhibitors were on EA with criteria of FDA approved indications and dosing. 7

DUR board recommendation: Clients must have tried and failed or be found intolerant to at least two preferred NSAIDs Generics NSAIDS are to be preferred Patient must not have history of GI ulcer or bleed for a NSAID Criteria added for COX-2 inhibitors, patient must not have a history of GI ulcer or bleed Recommendation made again June 2004 review. 8

June 2004 DUR board reviewed this class again with the same recommendations COX-2 requirement to not have a history of cardiovascular disease 9

Black Box Warning For All NSAIDS including COX-2 inhibitors and topical NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. 10

Warnings and precautions: NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a history of peptic ulcer disease or GI bleeding have a greater than 10-fold increased risk of developing a GI bleed. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. 11

Motion – NSAID/COX-2 Medicaid is requesting the board consider confirmation/ re-approval of existing criteria. Suggested motion: I move that Medicaid require the trial of at least two preferred NSAIDs prior to allowing a non-preferred product. Use of NSAIDs should not be approved for any patient with any history of GI ulcer or GI bleed. Use of COX-2 inhibitors should be limited according to their FDA labeled indication and dosing, and not be allowed for any patient with a history of cardiovascular disease. 12

Proton Pump Inhibitors Prior authorization required after 90 days of continuous use of a single PPI. FDA labeling and Drugdex review: GERD and gastric ulcer treatment 4 -8 weeks duration of treatment. Erosive esophagitis, duodenal ulcer maintenance have studies up to 12 months of treatment. NSAID associated ulcer risk reduction up to 6 months. Barrett’s esophagitis and hypersecretory conditions have no limit or studies for 3+ years. 13

After 90 days of continuous PPI, the prescriber is faxed requesting diagnosis, date of diagnosis, and if and when ranitidine was tried. Prescriber to provide any additional info to support ongoing use. Approved for Barrett’s esophagitis, hypersecretory conditions, erosive esophagitis, duodenal ulcer maintenance, and for GERD if has tried a step down to ranitidine in past 2 years or has risk factor (i.e NSAID use, comorbid condition). 14

Auto-approved (programmed step therapy) for concurrent use with anticoagulants, NSAIDs, bisphosphonates, or prednisone 15

Motion - PPI Suggested motion: I move that Medicaid limit the use of proton pump inhibitors to 90 days continuous use unless the client has a diagnosis of Barrett’s esophagitis, hypersecretory condition, erosive esophagitis, duodenal ulcer, or other appropriate comorbid conditon. Continuous use may be approved when used concurrently with anticoagulants, NSAIDs, bisphosphonates, or prednisone. For a diagnosis of GERD, patients should be required to try a step down to ranitidine at least every two years. Patients whose symptoms are not adequately controlled on ranitidine may be approved for continuous use up to two years. 16

LABA/ICS Combination Inhalers Asthma criteria is based on the Guidelines for the Diagnosis and Management of Asthma, National Heart Lung and Blood institute Expert Panel Report 3 COPD criteria is based on the Global Initiative for Chronic Obstuctive Lung Disease’s Global Strategy for the Diagnosis, Management and Prevention of COPD 17

Step-wise (Steps 1 -6) approach for managing asthma, recommended steps to initiate treatment at: Intermittent asthma: Step 1 Mild persistent asthma: Step 2 Moderate persistent asthma: Step 3 Severe persistent asthma: Step 4 or 5 Consultation for Step 4 or higher is required and is recommended to consider for step 3. 18

ICS/LABA included as preferred treatment option for persistent asthma for Steps 3 -6 (moderate to severe persistent asthma) 19

Initiating asthma treatment with LABA/ICS Moderate persistent asthma Daily symptoms Nighttime awakenings > 1x/week, but not nightly Daily use of SABA for symptom control (not forEIB prevention Some limitation of normal activity FEV1 >60% but < 80% predicted and FEV1/FVC reduced 5% Exacerbations ≥ 2/year 20

Step up in treatment Step up as needed after checking adherence, environmental control and comorbid conditions. From Step 2 with preferred treatment of low-dose ICS 21

Step down in treatment Step down if possible and asthma is well controlled at least 3 months. Symptoms ≤ 2 days/week Nighttime awakenings ≤ 2x/month SABA ≤ 2 days/week FEV1 >80% predicted/personal best Exacerbations 0 -1/year ACT ≥ 20 22

Asthma PA Reviews Prefer spirometry, but will use frequency of SABA use, frequency of symptoms and history of exacerbations and oral corticosteroid use to assess severity if not available. Approve step up from ICS Consider step down trial only if normal spirometry, SABA use not daily, no exacerbations, no daily symptoms and has not recently tried a step down. 23

COPD FEV1/FVC <0.70 Risk Assessment for COPD (A) or (B) patient groups are low risk (C) or (D) patient groups are high risk 24

Assessment includes: Spirometry low risk FEV≥1 ≥ 50% (A) or (B) high risk FEV1 < 50% (C) or (D) Exacerbations ≤ 1/yr and no hospitalization (A) or (B) ≥ 2/yr, or ≤ 1/yr with hospitalization (C) or (D) Symptoms (CAT or CCQ questionnaires) less symptoms (A) or (C) more symptoms (B) or (D) 25

LABA/ICS recommendations Recommended as a first choice option for patient group (C) or (D) LABA/ICS or ICS are not recommended for patient group (A) or (B) 26

PA review Approval based on spirometry or exacerbation history. If spirometry not available: SABA use/symptoms, oxygen, exacerbations, oral corticosteroid use. 27

Questions? More Information: or Nicole N. Nguyen PharmD, Senior Clinical Pharmacist Health Care Services Tel: