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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

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Review of authorization criteria in pdl drug classes

Review of authorization criteria in PDL drug classes

Nicole N. Nguyen, PharmD

Senior Clinical Pharmacist

Health Care Services

September 24, 2014


Newer sedative hypnotics
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.


The dur board approved the modified medicaid sedative hypnotic policy as follows
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)


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.


Sleep consultations
Sleep consultations at a HCA-approved sleep center for clients receiving more than 6 months of continuous nightly treatment with:

  • 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.


Motion newer sedative hypnotics
Motion – Newer Sedative at a HCA-approved sleep center for clients receiving more than 6 months of continuous nightly treatment with: 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.


Nsaids cox 2 inhibitors
NSAIDs/COX-2 at a HCA-approved sleep center for clients receiving more than 6 months of continuous nightly treatment with: inhibitors

Criteria originally developed and approved by DUEC in 1999.

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.


Dur board recommendation
DUR board recommendation: at a HCA-approved sleep center for clients receiving more than 6 months of continuous nightly treatment with:

  • 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.



Black box warning
Black Box Warning recommendations

  • 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.


Warnings and precautions
Warnings and precautions: recommendations

  • 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.


Motion nsaid cox 2
Motion – NSAID/COX-2 recommendations

  • 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.


Proton pump inhibitors
Proton Pump Inhibitors recommendations

  • 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.


  • 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).



Motion ppi
Motion - PPI with anticoagulants, NSAIDs, bisphosphonates, or prednisone

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.


Laba ics combination inhalers
LABA/ICS Combination Inhalers with anticoagulants, NSAIDs, bisphosphonates, or prednisone

  • 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


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.



Initiating asthma treatment with laba ics
Initiating asthma treatment with LABA/ICS persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

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


Step up in treatment
Step up in treatment persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

  • Step up as needed after checking adherence, environmental control and comorbid conditions.

  • From Step 2 with preferred treatment of low-dose ICS


Step down in treatment
Step down in treatment persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

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


Asthma pa reviews
Asthma PA Reviews persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

  • 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.


COPD persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

  • FEV1/FVC <0.70

  • Risk Assessment for COPD

    • (A) or (B) patient groups are low risk

    • (C) or (D) patient groups are high risk


Assessment includes
Assessment includes: persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

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)


Laba ics recommendations
LABA/ICS recommendations persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

  • 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)


Pa review
PA review persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

  • Approval based on spirometry or exacerbation history.

  • If spirometry not available: SABA use/symptoms, oxygen, exacerbations, oral corticosteroid use.


Questions
Questions? persistent asthma for Steps 3 -6 (moderate to severe persistent asthma)

More Information:

http://www.hca.wa.gov/medicaid/billing/pages/prescription_drug_program.aspx

or

http://www.hca.wa.gov/medicaid/pharmacy/Pages/index.aspx

Nicole N. Nguyen PharmD, Senior Clinical Pharmacist

Health Care Services

[email protected]

Tel: 360-725-1757


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