Drug Utilization Review (DUR) Meeting

May 8, 2013

Members present
Allyson Schlichte, Pharm. D., MBA, Ling Xu, Pharm. D.
DHS staff present
Mary Beth Reinke, Pharm. D., Sara Drake, RPh, Liz Schiller
Other attendants: Larry Dent, Pharm.D., Xerox
Public comments
None
Minnesota Collaborative Consultation Service Update:
New business
Fee-for-service Medicaid recipients under the age of eighteen years on four or more
psychotropic drugs for a 60-day period will be requiring a psychiatric consultation.
While this criteria has been approved at previous meetings, Dr. Reinke presented the
psychotropic drug classification with specific drugs that will per excluded or included
from the American Hospital Formulary Service (AHFS) drug classification which served
as the basis. This is also the drug classification that will be used for outcome
assessment of psychiatric consultation service.
Finalized drug categories include:
ADHD drugs stimulants
ADHD drugs clonidine and guanfacine
ADHD drugs atomoxetine (Listed under AHFS 28:92 CNS Agents, Miscellaneous).
Anticonvulsant drugs:
Group I. Eight anticonvulsants were included, that is, those that could be used
as bipolar mood stabilizers which include carbamazepine, gabapentin,
lamotrigine, oxcarbazepine, topiramate, divalproex sodium, valproate sodium,
and valproic acid.
Do not count as a bipolar mood stabilizer if there is a diagnosis of seizures
within the last two years of medical claims.
o DUR Board approved.

Do not count if the recipient receives an anticonvulsant that is used only to

treat seizures and a bipolar mood stabilizer (will assume that is used to treat
seizures).
FFS claims analysis showed that 48% of recipients will have these drugs
counted as a psychotropic.

Group II. Anticonvulsants used exclusively to treat seizures, those being

fosphenytoin, phenytoin, ethosuximide, methsuximide, ezogabine (Potiga),
felbamate, lacosamide (Vimpat), levetiracetam (Keppra), rufinamide
(Banzel), vigabatrin (Sabril), zonisamide, and tiagabine (Gabitril), were
excluded.
Antidepressants TCA and tetracyclics
Antidepressants SSRI
Antidepressants SNRI
Antidepressants Other
Antipsychotics FGA (typical)
Antipsychotics SGA (atypical)
Phenobarbital
Benzodiazepines
Logic similar to bipolar mood stabilizer anticonvulsants, barbiturates and
benzodiazepines applied the same exclusion logic if seizures.
Do not count as psychotropic drug if there is a diagnosis of seizures within
the last two years of medical claims.
o DUR Board approved.
FFS claims analysis showed that 34% of recipients will have these drugs
counted as a psychotropic.
Other anxiolytics/sedatives/hypnotics
Antimanic drugs (lithium)
Additional drugs were included because of high utilization in children less than eighteen
years of age based on FFS paid prescription claims from 1-1-2012 to 3-31-2013. These
drugs will be reported but not counted.
Miscellaneous propranolol
Miscellaneous prazosin
Miscellaneous propranolol
Miscellaneous hydroxyzine
Drugs used to treat antipsychotic side effects will be reported. SGA were initially
marketed as having fewer extrapyridamal side effects (EPS) adverse drugs effects as
an advantage over first generation antipsychotics. However, claims data shows that a
number of children taking SGA drugs are also these drugs often prescribed for EPS.
o Benztropine
o Trihexyphenidyl

DUR Board Meeting on May 8, 2013

o Amantadine
Dr. Reinke stated that recipients with third party liability (TPL) where the TPL pays 60%
or greater of the prescription claim, then age edits are by-passed. The 60% by-pass
occurs in 66% of TPL claims which accounts for 17.5% of recipients. Therefore, this
factor must be accounted for in the outcomes analysis. Dr. Reinke suggested three
groups, recipients that did not hit on the edits, recipients that did hit on the age edits
with TPL, and recipients that did hit on the age edits with TPL. Dr. Xu suggested that
recipients that did not hit on the edits also be broken into a with-TPL and no TPL
group.
RetroDUR
I.

Clinical Criteria Update

All the following RetroDUR clinical criteria changes for March and April 2013 were
accepted by the DUR Board.
A. New drug: mipomerson Kynamro is indicated for the treatment of homozygous
familial hypercholesterolemia (HoFH).
Age:
Criteria: less than eighteen years of age
Increase ADE:
Criteria:
a) Hepatic impairment in the past two years.
b) Hepatic monitoring in the past 180 days
c) Lipid monitoring in the past 180 days
d) Quantity limit of four doses (one dose every seven days). Since
administered subcutaneous, would be processed as a medical
claim.
B. Geriatric-related issues: thirty-four updates were not reviewed as drugs covered
under Medicare Part D.
C. New drug: canagliflozin Invokana is indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus.
Age:
Criteria: less than eighteen years of age
Increase ADE:
Criteria:
a) Moderate to severe renal impairment in the past two years or are
receiving dialysis
b) Renal monitoring in the past 365 days
D. Migraine
Underuse of preventive therapies was updated using Evidenced-based guideline
update: Pharmacologic treatment for episodic migraine prevention in adults.
Neurology 2012;78:1337-1345 and Evidenced-based guideline update: NSAIDs
and complimentary treatments for episodic migraine prevention in adults.
Neurology 2012;78:1346-1353.

DUR Board Meeting on May 8, 2013

E. New drug for MS, Dimethyl Fumurate (Tecfidera) = new agent for the treatment
of MS added to existing Rules which include medication compliance if therapy
discontinued, underutilization, and appropriate lab monitoring which is CBC
evaluated in the last 365 days or six months of starting.
II.

Population-based interventions

FFY 2012 Summary

A summary of the four population-based interventions for FFY 2012 was reported.
A. Antidepressant management showed a 61% reduction of clinical indicators and
an estimated annual cost avoidance of $74,677.
B. Chronic nonmalignant pain management resulted in 62% of clinical indicators
and an estimated cost avoidance of $139,060.
C. Hyperlipidemia management produced a 46% reduction in clinical indicators with
an estimated cost avoidance of $15,329.
D. Drugs of abuse which was mailed September 28, 2012 did not have outcomes
available yet.
MN GI Disorders Population based Proposal (to be mailed 1st quarter, 2014)
The purpose is to promote safe, cost-effective use of anti-secretory agents in the
management of gastrointestinal disorders, including peptic ulcer disease (PUD) and
gastroesophageal reflux disease (GERD).
Setting and population:
All patients receiving a proton pump inhibitor (PPI) or H2 receptor antagonist (H2RA).

Performance Indicator #1: Extended Duration of H2RA or PPI Therapy with

Unknown Diagnosis (N=836)
Rationale:
Anti-secretory therapy is indicated for 8 weeks or less in the majority of patients with
PUD with maintenance therapy used in patients with a high-risk of ulcer recurrence
(e.g. recurrent or H. pylori negative ulcers, or patients with a history of ulcer
complications such as bleeding or perforation). Due to the high rate of placebo
response and variable efficacy of drug regimens for other GI diagnoses like non-ulcer
dyspepsia, periodic reevaluation of anti-secretory therapy and trial off medication, if
appropriate, should be considered.
Criteria:
Candidates (denominator): Patients receiving an H2RA or PPI without a
diagnosis of PUD or any condition requiring longer lengths of therapy.
Exception criteria (numerator): Candidates receiving H2RAs or PPIs for greater
than 12 weeks.

DUR Board Meeting on May 8, 2013

DUR Board recommendation: accept.

Performance Indicator #2: Extended Duration of PPI Therapy in Patients with PUD
(N=45)
Rationale: PPIs effectively heal peptic ulcers in 4 to 8 weeks and are not generally
indicated for maintenance therapy in PUD, except for refractory cases. Currently
H.pylori testing is recommended in all patients with a history of, or active PUD. Treating
patients testing positive for H.pylori has been shown to decrease ulcer recurrence
greater than acid suppression alone.
Criteria:
Candidates (denominator): Patients receiving a PPI for greater than 12 weeks
within the last 16 weeks of claims history.
Exception criteria (numerator): Candidates receiving a PPI for greater than 12
weeks without history of PUD, diagnosis of H.pylori, and/or treatment for H.pylori.
DUR Board recommendation: include Table 1. American College of Gastroenterology
Recommended Treatment Regimens for H.Pylori Infection from this proposal.
Performance Indicator #3: Duplicate Anti-Secretory Therapy (N=37)
Rationale: Within-class (H2RA or PPI) duplicate therapy increases cost without
increasing efficacy. Patients may have continued therapy when therapy is changed
from a PPI to H2RA (or vice versa) due to misunderstanding directions. A minority of
patients who continue to have nighttime symptoms despite PPI therapy may benefit
from this combination (daytime PPI and nighttime H2RA), but there is no evidence of
improved long-term efficacy. When multiple prescribers are involved, coordination of
care issues may need to be resolved. Additionally, combination therapy with a PPI and
H2RA is not routinely recommended.
Criteria:
Candidates (denominator): Patients receiving an H2RA or PPI within in the last
60 days of claims history.
Exception criteria (numerator): Candidates receiving more than one drug within
each class; candidates receiving both a PPI and H2RA from >1 prescriber.
DUR Board recommendation: accept. Dr. Allyson Schlichte stated that a patient may
be on both when a prescriber is trying to get a patient off a PPI.
Increase ADE with NSAID therapy in patients with PUD. Indicators 4, 5, and 6 (N=160)

DUR Board Meeting on May 8, 2013

Performance Indicator #4: Increased Risk of Adverse Drug Event: Concomitant

H2RA and NSAID Therapy in Patients with PUD
Rationale: NSAID use is one of the critical factors underlying recurrent or
refractory ulceration. Every effort should be made to reduce or eliminate NSAID
use in patients with PUD. Additionally, H2RAs are not recommended for the
prevention of NSAID-induced ulcers.
Criteria:
Candidates (denominator): Patients who received a NSAID and an H2RA
concurrently within the last 60 days of claims history unless they received
misoprostol, PPI/NSAID combination product, or a COX-2 inhibitor from
the same prescriber.
Exception criteria (numerator): Candidates with a history of PUD receiving
an H2RA.
DUR Board recommendation: include a table showing the American College of
Gastroenterology guidelines for prevention of NSAID-related ulcer complications
and cardiovascular risk in the mailing to prescribers. Dr. Allyson Schlichte
described the cross table having low or high CV risk as rows and low, moderate,
or high GI risk as columns.
Performance Indicator #5: Increased Risk of Adverse Drug Event: Concomitant
Anti-Secretory Agent and NSAID Therapy in Patients with PUD from Multiple
Prescribers
Rationale: NSAID use is one of the critical factors underlying recurrent or
refractory ulceration. Every effort should be made to reduce or eliminate NSAID
use in patients with PUD. When multiple prescribers are involved, coordination of
care issues may need to be resolved.
Criteria:
Candidates (denominator): Patients who received a NSAID and antisecretory agent concurrently within the last 60 days of claims history.
Exception criteria (numerator): Candidates with history of PUD receiving a
PPI or H2RA from a different prescriber than the NSAID prescriber.
DUR Board recommendation: accept.
Performance Indicator #6: Increased Risk of Adverse Drug Event: Concomitant
H2RA and NSAID Therapy in Patients at High Risk for a NSAID-Induced Ulcer
Rationale: NSAID use is an important factor in the development of PUD.
Several factors have been identified that place patients with NSAID use at risk for
GI complications. Every effort should be made to reduce or eliminate NSAID use

DUR Board Meeting on May 8, 2013

in patients with risk factors for the development of NSAID-induced ulcers. These
include a history of ulcer or GI hemorrhage, age greater than 60 years, high
dosage of NSAID or use of multiple NSAIDs, and concurrent use of
corticosteroids or anticoagulants. Additionally, H2RA are not recommended for
the prevention of NSAID-induced ulcers.
Criteria:
Candidates (denominator): Patients who received an H2RA and NSAID
concurrently within the last 60 days of claims history unless they have
received misoprostol, PPI/NSAID combination product, or a COX-2
inhibitor from the same prescriber.
Exception criteria (numerator): Candidates having risk factors (listed
above) for the development of NSAID-induced ulcers that are receiving a
H2RA.
DUR Board recommendation: accept.
Performance Indicator #7: Increased Risk of Adverse Drug Event: Bisphosphonate
Therapy in Patients with GERD (N=63)
Rationale: Oral bisphosphonate therapy has been associated with dysphagia,
esophagitis, and upper esophageal ulcers and should be used with caution in patients
with upper GI disorders. Avoiding use of these medications in patients with GERD
and/or proper patient medication administration may reduce the risk of potentially
worsening symptoms associated with concomitant use.
Criteria:
Candidates (denominator): Patients who received an oral bisphosphonate within
the last 45 days of claims history.
Exception criteria (numerator): Candidates with a history of GERD in the last 2
years receiving an oral bisphosphonate.
DUR Board recommendation:
Performance Indicator #8: Increased Risk of Adverse Drug Event: Drugs Potentially
Aggravating GERD (N=2,897)
Rationale: A number of factors have been reported to worsen the symptoms of GERD,
including certain medications. Avoiding use of these medications in patients with
GERD, if possible, may reduce the risk of potentially worsening symptoms associated
with concomitant use
Criteria:
Candidates (denominator): Patients with a submitted diagnosis of GERD in the
last 2 years.

DUR Board Meeting on May 8, 2013

Exception criteria (numerator): Patients receiving a medication reported to

worsen GERD symptoms.

DUR Board recommendation: a question was raised as to the list of medications that
potentially aggravate GERD If meperidine and morphine are listed, what not OxyContin
and other narcotics? Another question was why Praxeda was not listed especially
because of the coating on the drug, it should not be used in someone with GERD.
Performance Indicator #9: Twice Daily Dosing of PPIs (N=1,040)
Rationale: Current literature does not strongly support the use of higher than standard
doses of PPIs for most indications. Additionally, the majority of efficacy studies for PPIs
utilize once daily dosing. If inadequate symptom response is obtained with once daily
dosing in patients with GERD, twice daily dosing is recommended. Twice daily dosing
is currently recommended in the treatment of H.pylori and in Zollinger Ellison syndrome
for all of the PPIs except rabeprazole, lansoprazole, and dexlansoprazole
Criteria:
Candidates (denominator): Patients receiving a proton pump inhibitor in the last
30 days.
Exception criteria (numerator): Patients receiving 2 doses of a PPI daily.
Patients receiving 2 doses of omeprazole/esomeprazole/pantoprazole with a
diagnosis of Zollinger Ellison syndrome are excluded since these PPIs are
indicated to be dosed twice daily for this indication.
DUR Board recommendation: accept.
Based on the article Recent Safety Concerns with Proton Pump Inhibitors (J Clin
Gastroenterol 2012;46:93-114), Dr. Dent discussed other possible enhancements to
Gastrointestinal Agents DUE regarding clopidogrel, fractures, and hypomagnesemia.
PPIs and hypomagnesemia: per FDA Drug Safety Communication, low
magnesium levels can be associated with long-term use of PPIs. Therefore,
should otc magnesium be suggested along with once a year monitoring.
DUR Board recommendation: Dont use as the strength of the argument is weak
and it would mean that another lab would need to be ordered.
Preferred calcium supplementation formulation was brought up by Dr. Allyson
Schlichte. An emphasis in the DUR letter would be that calcium citrate with
vitamin D is preferred over calcium carbonate formulations which are pH
dependent for absorption.
Warning about clopidogrel and PPIs.
DUR Board recommendation: dont use as the evidence is not clear.
2013 Meeting Dates
September 11, 2013
November 6, 2013

DUR Board Meeting on May 8, 2013