19 April 2012
Follow-up to Previous Reviews
 Citalopram High Dose
 Transdermal Testosterone Intervention
 Colchicine DUR
 Ketorolac DUR
2
Citalopram High Dose DUR
 FDA Drug Safety Communication: Abnormal heart
rhythms associated with high doses of Celexa
(citalopram hydrobromide)
 On August 24, 2011, the Food and Drug Administration
(FDA) released a Safety Announcement addressing the
high dose of citalopram and potential adverse effects it
can have on the heart. The maximum daily dose is now
recommended to be 40 mg per day when it was
previously 60 mg per day.
 A review of Idaho Medicaid Recipients showed that
during the previous 3 months 234 recipients had
received doses greater than 40 mg per day.
3
Citalopram High Dose DUR
 Letters were sent out about 235 patients on 10/6/2011 to
186 prescribers with a list of their patients along with
the FDA Safety Announcement and Survey Response
Form. (see Letter and Announcement in Packet)
 As of 4/11/2012, 60 responses have been received (32%
response rate)
 1 additional response since last DUR Meeting
4
Citalopram High Dose DUR:
Response Detail as of 4/11/2012
 Note that providers may choose more than one
selection per response.
 Will use this information for care of future patients
 Reviewed info and have modified or plan to modify treatment
 Found Info clinically useful and plan to monitor patients
 Reviewed info and do not believe adjustment is necessary
 Will change dose
 Very useful to my practice
 Extremely useful to my practice
 Somewhat useful to my practice
 Not useful to my practice
29
28
22
19
19
18
15
10
6
5
Citalopram High Dose DUR:
Response Detail as of 4/11/2012
 Note that providers may choose more than one
selection per response.
 Previously saw this patient, but no longer in my care
5
 Attempted to modify the therapy, but the patient response
was not favorable
 Will discontinue medication
 Patient is under my care, but I am not prescriber for this med
 I am not the provider for this patient
5
3
2
1
6
Citalopram High Dose DUR:
Response Detail as of 4/11/2012 (one additional
comment from last meeting)
 “Pt is no longer on this. It was changed to Effexor when she was
hospitalized, thanks.”
7
Citalopram High Dose DUR
 Recommendations
 Decrease the maximum daily dose to the FDA
recommended 40mg.
 Require a quantity override Prior Authorization for any
claims with a dose greater than 40mg per day.
8
Citalopram High Dose DUR
 2 patients currently receiving 60mg daily
 Both times pharmacy overrode with:



TD – Therapeutic Duplication
M0 – Prescriber consulted
1G – Filled, prescriber approval
 Idaho Medicaid Pharmacy Clinical Call Center has
been receiving PA requests for 60mg stating patient is
stable on current regimen with no mention of
awareness of the new FDA Safety announcement.
These requests are being denied.
 Example of recent PA request (see packet)
9
Citalopram High Dose DUR
 On March 28, 2012 the FDA sent out a revised Drug Safety
Communication with updated recommendations:
 Recognition that although citalopram use should be avoided, if possible, in patients
with certain conditions because of the risk of QT prolongation, ECG monitoring
and/or electrolyte monitoring is recommended if citalopram must be used in such
patients.
 Patients with congenital long QT syndrome are at particular risk of Torsade de
Pointes, ventricular tachycardia, and sudden death when given drugs that prolong
the QT interval. Nevertheless, the labeling recommendation for patients with
congenital long QT syndrome has been changed from “contraindicated” to “not
recommended,” because it is recognized that there may be some patients with this
condition who could benefit from a low dose of citalopram and who lack viable
alternatives.
 The maximum recommended dose of citalopram is 20 mg per day for patients over
the age of 60.
 Citalopram is recommended to be discontinued in patients who are found to have
persistent QTc measurements greater than 500 ms.
10
Citalopram High Dose DUR
 Report ran looking at data from 1/1/2012 to 3/25/2012
and there were 76 recipients receiving 40mg of
citalopram daily who were over the age of 60.
 Should a new RetroDur activity be done on this patient
population?
11
Transdermal Testosterone
Intervention
 The Idaho Medicaid Pharmacy and Therapeutics
Committee recommended that therapeutic criteria be
set up on this class of medication including
testosterone levels as part of the criteria.
 RetroDur activity was completed and new criteria was
implemented based on these recommendations.
12
Transdermal Testosterone
Intervention
 48 prescribers with 52 recipients were identified and letters





along with the educational handout and PA form were sent
out to the prescribers. (see packet)
As of 4/11/2012, 24 completed PA forms (46%) were sent in
and 1 returned saying they were not the prescriber.
As of 4/11/2012, 3 new PA requests have come in which were
not part of the DUR Intervention.
18 out of the 27 PA requests (67%) were approved.
5 recipients are no longer on therapy
22 recipients will have claim deny on next fill at pharmacy.
13
Colchicine DUR
 Historical Perspective
 In June 2006, the FDA announced a new drug safety initiative
to remove unapproved drugs from the market, including a
final guidance entitled “Marketed Unapproved DrugsCompliance Policy Guide (CPG)”.


Notice that any illegally marketed product is subject to FDA
enforcement at any time
Clarified that the FDA intends to use a risk-based approach to
enforcement
 July 29, 2009: Colcrys® approved for Familial Mediterranean
Fever (FMF)
 July 30, 2009: Colcrys® approved for Acute Gout Flares
 October 16, 2009: Colcrys® approved for Chronic Gout
14
Colchicine DUR
 October 1, 2010: FDA sent out a notice that it intends to
initiate enforcement action against any marketed and
listed unapproved single-ingredient oral colchicine
product that is manufactured on or after November 15,
2010, or that is shipped on or after December 30, 2010.
Colcrys®
colchicine
May 2010
May 2011
No Rx’s
8 Rx’s
$241.82/46 tabs
42 Rx’s (7 different NDCs)
$23.25/46 tabs
No Rx’s
15
Therapeutic Criteria for Colcrys®
Acute Gout
1.
•
Contra-indication and/or failure to NSAIDS or
corticosteroids
2. Chronic Gout
•
Adjunct to allopurinol AND contra-indication or
failure to NSAIDS
16
Colcrys’® Utilization
 Utilization Overview
Date
Number of
Recipients
Number of
Claims
4/1/11-6/30/11
Colcrys®
16
29
1/1/12-3/31/12
Colcrys®
15
23
17
Therapeutic Criteria for Colcrys®
 The Idaho Medicaid Pharmacy & Therapeutics
Committee has recommended that no PA be required
for acute cases.
 Pharmacies do have the ability to use a 3 day
emergency override if the prescription falls under the
appropriate criteria.
18
Ketorolac DUR
 Historical Perspective:
 Discovered that in the drug profiles the Maximum
Quantity was set at 10 tablets per day.
 The Maximum Quantity was immediately changed to 4
tablets per day as recommended by the package insert.
 Report was generated to see how many patients have
actually received doses higher than the recommended
amount and based on this report it was felt that a
Retrospective DUR would be appropriate.
19
Ketorolac DUR
 Maximum quantity per day reduced from 10 to 4
tablets on 5/24/2011
 Utilization Overview:
Date Span
Total # of claims
Total # of claims
>4 per day
2/23/11-5/23/11
ketorolac
249
39
5/24/11-8/24/11
ketorolac
213
0
1/1/12-3/31/12
ketorolac
239
0
 DUR letter sent on 6/20/2011 to 9 prescribers
 3 patient profiles provided in packet to review
20
Current Interventions/Outcomes
Studies
 P&T Committee Narcotic Analgesic Studies
 Ophthalmic Antibiotic/Steroid Combinations
 Atopic Dermatitis
 Senator Grassley Letter
 Protease inhibitors and statins
 Synagis 2010-2011 Season
21
Intermittent Report
22
Profile Review
 Generated profiles for the top 150 recipients by total
narcotic claim count from the recipients who had at
least one narcotic claim in each of the 24 months of
the period ending December 2011
 Time Period: May 1, 2011 through December 31, 2011
 Evaluated thus far 90. Cancer Diagnosis found in 3.
 All profiles were hand reviewed by Idaho Medicaid
Pharmacists
 Diagnoses were hand searched from electronic records
since medical diagnosis codes were unavailable in
RetroDUR database
23
Review Focus










Years of opioid use
Number of different opioids used
Daily morphine equivalents
Number of different prescribers
Other concurrent potentially addictive drugs
Diagnosis or indication for chronic opioid use
Average days between refills
History of abuse diagnosis
Currently in lock-in program?
Additional opioid use outside of Medicaid
24
Length of Time for Continuous Opioid
Use
Number of Years on Opioids
20
18
16
14
Average = 9.8 years
12
Number of
Participants 10
8
6
4
2
0
1
Records only back to 1998
2
3
4
5
6
7
8
9
10
11
12
13
14
Years
25
Number of Different Opioids
 Includes different drugs or dosage forms
 May or may not be concurrent, but over course of therapy
35
30
Average = 2.6
25
Number of
Participants
20
15
10
5
0
1
2
3
4
5
6
7
8
9
Number of Different Opioids
26
Daily Morphine Equivalents
Lowest = 10 mg
Highest = 1080 mg
Daily Morphine Equivalents
1000-1100
900-999
800-899
700-799
Average= 202 mg
equivalents
600-699
Daily Morphine
500-599
Equivalents
(mg)
400-499
300-399
200-299
100 - 199
0-99
0
5
10
15
20
25
30
35
Number of Participants
27
Number of Prescribers per Participant
50
45
40
Average number of prescribers per participants is 2
35
30
Participants 25
20
15
10
5
0
1
2
3
4
5
6
7
8
9
10
11
12
Number of Prescribers
28
Other Concurrent Potentially Addictive Drugs
None
Benzodiazepines Only (up to 3)
Muscle relaxants only
1
2
2 1
18
Sedative Hypnotics Only
17
Benzodiazepines plus muscle relaxants
11
24
7
Benzodiazepines plus sedative hypnotics
5
Sedative Hypnotics plus muscle relaxants
Benzodiazepines plus a stimulant
For this count temazepam was classified as a sedative hypnotic and
diazepam as a benzodiazepine
Benzodiazapines plus a stimulant plus a
sedative hypnotic
Benzodiazepines plus muscle relaxants plus
sedative hypnotics
29
Diagnosis/Indications
Most patients had multiples diagnoses
Diagnosis
Number of Participants
(incidence)
lumbago: unspecified disorder of back; back pain
62
chronic pain; chronic pain syndrome; other chronic pain
58
intevertebral disc disorder; lumbar disc degeneration; cervical disc degeneration; cervicalgia; sciatica; disc
degeneration; spondylosis
29
knee injury; shoulder injury; pain in limb; lower leg pain; neck injury; hip and thigh injury; wrist injury
29
hand joint pain; osteoarthritis; rheumatoid arthritis; pain in joint of ankle and foot; ankylosing spondylitis;
other disorders of synovium tendon and bursa
headache; migraine
28
6
disorders of muscle ligament and fascia; other disease of bone and cartilage; myalgia
5
abdominal pain, generalized pain
4
multiple sclerosis
3
peripheral neuropathy; diabetic peripheral neuropathy
2
Unknown
2
30
Average Days Prior to Refill
45
40
35
30
25
Participants
20
15
10
5
0
1
2
3
4
5
6
7
8
9
10
11
12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Average Days Prior to Refill
31
Other Information Gathered
 Number on Medicaid Pharmacy Lock-In
 3 currently on lock-in
 1 previously on lock-in, released 1/2011
 Non-Medicaid Opioid Fills
 From Board of Pharmacy Reports
 30 of the 87 patients had fills not paid for by Medicaid
 Extra number of doses ranged from 2 to 1719
32
Summary of Narcotic Study- 1
 87 of the top 150 were evaluated for time period of
5/2011 through 12/2011
 The average patient evaluated had been receiving
narcotic analgesics f0r 9.8 years
 Each patient was on an average of 2.6 different narcotic
analgesics
 Daily total morphine equivalents ranged from 10 mg to
1080 mg with average being 202 mg
 The patients saw an average of 2 different prescribers
for their narcotic prescriptions
33
Summary - 2
 Most patients were on concurrent potentially addictive
drugs
 Most common were benzodiazepines with or without
muscle relaxants or sedative hypnotics
 The most common diagnoses were lumbago/back pain
and chronic pain syndrome
 Three patients were currently on pharmacy lock-in
 34 % of the patients had opioid prescriptions paid
outside of Medicaid pharmacy benefit with extra doses
up to 1719 for the 8 month period
34
Next Steps
35
Ophthalmic Antibiotic/Steroid
Combinations
 The P&T Committee requested a DUR to evaluate whether the
prescribing physicians were specialists (ophthalmologists),
primary care, or ER prescribers. Also included in the review will
be the age of the recipients.
36
Ophthalmic Antibiotic/Steroid
Combinations
 Ophthalmic Antibiotic/Steroid Combinations by
Provider Type (see packet)
Ophthalmic Antibiotic/Steroid Combo Claims 1/1/2011 – 3/19/2012
Age Range
Recipients
Claims
0 – 9 yrs old
540
621
10 – 18 yrs old
443
478
> 18 yrs old
471
619
Totals
1454
1718
37
Ophthalmic Antibiotic/Steroid
Combinations
Ophthalmic Antibiotic/Steroid Products
GSN
Brand
Generic
Form
# of claims
7986
Tobradex
tobra/dex
Susp
783
48547
Maxitrol
neo/polymyx b/dex
Susp
423
48546
Maxitrol
neo/polymyx b/dex
Oint
202
7985
Tobradex
tobra/dex
Oint
121
58620
Zylet
tobra/lotepred
Susp
84
7964
Cortisporin
neo/polymyx b/hc
Susp
77
66617
Tobradex
tobra/dex
Susp
23
48543
Cortisporin
neo/bacitrac zn/polymyx b/hc
Oint
4
7985
Pred-G
gent/prednisolone
Susp
1
38
Next Steps
39
Atopic Dermatitis
 The P&T Committee requested a DUR on this drug class to
include patterns of use, presence or absence of step up therapy
from steroids, specialty of prescribers and geographic region
differences of prescribing patterns. The DUR should include an
educational piece on risks of these agents compared to risks from
steroids since many practitioners seem to be using these agents
to spare patients from steroid exposure.
40
Atopic Dermatitis
 Atopic Dermatitis (AD) is a chronic relapsing, pruritic,
inflammatory skin condition that most commonly
affects children.
 60-65% of patients develop AD before age 1
 85-90% of patients have developed signs of their disease
by age 5.
 Lifetime prevalence is estimated between 10-20% in
children and 1-3% in adults.
 It is estimated that close to $2.6 billion is spent yearly on
the disease in the United States.
41
Atopic Dermatitis
 The cause of AD appears to be a result of interactions
between genetics, environment, skin barrier defects,
and the immune system.
 AD persists on average 4.4 years in children and 18.2
years in adults.
 The disease typically improves as children get older;
however, up to 40% does not and recurs into adulthood.
 Triggers may include aeroallergens, climate, emotional
stress, hormones, food, irritants, and microbes.
42
Atopic Dermatitis
 Treatment
 Emollients are considered mainstay of maintenance therapy
 Topical corticosteroids are the standard of care which other
treatments are compared and are considered first-line treatments
for flare-ups.


Local side effects include striae, atrophy, and telangiectasia.
Systemic side effects including hypothalamic-pituitary-adrenal axis
suppression, reduced linear growth in children, and bone density
changes in adults are the most worrisome. There is no conclusive
evidence that appropriately used topical steroids cause significant
systemic adverse effects.
 Topical corticosteroids should be used for the shortest duration
possible to control the flare-up.
43
Atopic Dermatitis
 Treatment
 Sedating antihistamines are useful when patients have sleep
disturbances and concomitant allergic conditions.
 Antibiotics should be reserved for patients with acutely infected
lesions.
 Topical calcineurin inhibitors should be second-line treatments for
flare-ups and maintenance.


Local side effects include skin burning and irritation. Patients should
also be counseled on proper sun protection.
Black Box Warning – discussed on next slide
44
Atopic Dermatitis
45
Atopic Dermatitis
 In March 2010, the FDA issued a public health advisory about the
potential cancer risk associated with the use of Elidel
(pimecrolimus) and Protopic (tacrolimus) products applied to
the skin.
 This was based off of information from animal studies, case reports
in a small amount of patients, and how the drugs work.

The FDA recommends that healthcare providers, patients, and
caregivers consider the following:
 Use these products only as second-line agents as short term and
intermittent treatment.
 Avoid the use in children under the age of 2.
 Use for a short period of time, not continuously.
 Children and adults with a weakened or compromised immune
system should not use these products.
 Use the minimum amount of the products needed to control the
patient’s symptoms.
46
Atopic Dermatitis
 References
. Retrieved
March 22, 2012.
 Hanifin, J.M., Cooper, K.D., Ho, V.C., Kang, S., et al. Guidelines of care for atopic
dermatitis. Journal of the American Academy of Dermatology. 2004;50:391-404.
 Peterson, J.D., Chan, L.S., A Comprehensive Management Guide for Atopic
Dermatitis. Dermatology Nursing. 2006;18(6):531-542.
 Buys, L.M., Treatment Options for Atopic Dermatitis. Am Fam Physician. 2007;Feb
15;75(4):523-528.
Retrieved March 16, 2012.
Retrieved March 16, 2012.
 Elidel [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp.; July 2010.
 Protopic [package insert]. Deerfield, IL; Astellas Pharma US, Inc.; November 2011.
47
Atopic Dermatitis
 Topical Immunomodulators 2011 Table (see packet)
 Topical Immunomodulators 2011 Sorted by City Table
(see packet)
48
Atopic Dermatitis
Region Map
Region
# of
prescribers
# of 2011 claims for
topical
immunomodulators
1
17
38
2
23
68
3
30
90
4
55
186
5
30
90
6
29
110
7
40
187
Out of State
18
31
None noted
2
10
49
Atopic Dermatitis
Claims Data from 2011
Brand Strength Form
# of Recipients
Age Range
# of Paid Claims
Protopic 0.03% Oint.
76
0 – 71
125
Protopic 0.1% Oint.
39
2 – 60
90
Elidel 1% Cream
348
2 – 67
595
Totals
463
0-71
810
50
Atopic Dermatitis
# of recipients with
calcineurin inhibitor
claims
< 2 yrs old
2
112
194
# of claims per age group
150
2 - 6 yrs old
7 - 15 yrs old
>= 16 yrs old
< 2 yrs old
2
209
363
236
2 - 6 yrs old
7 - 15 yrs old
>= 16 yrs old
51
Atopic Dermatitis
Claims Data from 2011
Corticosteroid Totals
# of Recipients
Age Range
# of Paid Claims
299
0 – 71
1,661
52
Atopic Dermatitis
# of recipients of
calcineurin inhibitors with
previous corticosteroids
# of claims per age group of
corticosteroids
2
65
128
18
104
< 2 yrs old
2 - 6 yrs old
396
744
< 2 yrs old
503
2 - 6 yrs old
7 - 15 yrs old
7 -15 yrs old
>= 16 yrs old
>= 16 yrs old
53
Next Steps
54
55
Grassley Letter 2010
Premise
 Federal and State governments spend $317 billion
annually on Medicaid programs
 As ranking member of Senate Committee on Finance he
is obligated to ensure that taxpayer dollars are
appropriately spent on federal health care
 Medicaid suffers from systemic weaknesses that lead to
fraud, waste, and abuse resulting in higher costs and less
health care to those who are in need
 Purpose of letter: request information on outliers,
how Idaho monitors and actions taken
56
2010 Drugs In Review
 Abilify
 Geodon
 Seroquel
 Zyprexa
 Risperdal
 OxyContin
 Roxicodone
 Xanax
57
Data Requested
 List of top ten Medicaid prescribers for listed drugs
 For each prescriber
 His/her prescriber identifier
 Number of prescriptions written per drug per year
 Total amount billed to Medicaid per drug, separated for
each year
Note: no information requested on number of Medicaid
eligibles or total number of prescriptions for each drug
58
Results
 See Handout number 1
 Reported from Medicaid data unit, no pharmacy input
59
Grassley Letter January 23,
2012
Premise
 Follow-up from previous letter
 Pain management and mental health drugs have
addictive properties and potential for fraud and abuse
by prescribers and patients is extremely high
 High prescribing rates of mental health drugs
 Pain management clinics are hotbeds for black market
painkillers
 American people pay the price for over-prescription,
abuse, and fraud
60
His Extensive Review of our
Data
 Concern about oversight and enforcement of Medicaid
abuse in our state
 The data we provided is “ quite shocking”
 The top prescriber of OxyContin wrote nearly double
the amount of scripts of next provider and 8 times more
than another top 10 prescriber
 Antipsychotic top prescribers wrote double or triple the
others in the top 10
61
Responses to Questions 1 and 2
1.
What action, if any, has your agency taken with respect to the
prescribers identified to the Committee?
A.
2.
No action has been taken.
If there has been no action taken with respect to these prescribers,
please explain why not.
A. The number of prescriptions written by these prescribers only shows
that these prescribers have relatively higher prescribing of these
specific agents compared to other prescribers. It does not necessarily
indicate overprescribing or inappropriate prescribing. These numbers
must be looked at in context of several factors including total
prescriptions for a particular drug in Medicaid overall and the patient
mix seen by the specific prescriber. Specialists for mental health or
pain management will have more of those patients using those drugs
than general practitioners. Almost all of prescribers in both the
mental health and pain classes of medication seen here have the
majority if not all of their patients fitting that category.
62
Responses to Questions 3 and 4
3.
Please identify which of the providers identified to the Committee
remain eligible to bill the Medicaid Program.
A.
4.
All of the providers except for O0391, PA 724, M5597, CNS15A and
MD00046330 remain eligible to bill the Idaho Medicaid Program.
M5597 is incarcerated for Medicaid billing fraud (not related to drug
prescribing) and all of the others listed above have left the state.
Please provide the 2010 and 2011 numbers for the top prescribers of
these same drugs.
A. Attached. Please note that the analysis for 2010 and 2011 includes
Risperdal Consta, generic Roxicodone (oxycodone), and generic Xanax
(alprazolam) which were not included in the 2008 and 2009 report.
63
Results
 See Handout #2
64
Responses to Questions 5 and 6
5. Has each of these prescribers been cross-checked for
complaints or misconduct with the state medical board or
the National Practitioner Data Bank? If not, do you plan to
do so?
A. Our claims adjudication system does use the National Data
Bank for prescribers and no irregularities have come to our
attention. We have not checked with the state medical board
and would not do so unless we determined that prescribing
was inappropriate.
6. Have any of the prescribers identified to this Committee
been referred to your state medical board?
A. Not by Idaho Medicaid.
65
Responses to Questions 7 and 8
7. Is there any system set up in you state to identify and monitor
excessive prescription writing? If not, why not?
A. This would come under the responsibility of the state board of
pharmacy and resources would have to be designated and funded.
8. Have you received any training or guidance from the Centers for
Medicare and Medicaid Studies to help identify potential issues with
prescription drugs?
A. No
66
Responses to Questions 9 and
10
9. Does your state maintain a database of all prescribed controlled-substance? If
so, what entities have access to it?
A. Idaho does have a prescription monitoring program. The program is overseen
by the Idaho Board of Pharmacy. Information is available to prescribers,
pharmacies, and law enforcement. Idaho Medicaid has this information
available for review of participants and providers. The Medicaid Pharmacy
Program uses this information for its lock-in program.
10. Does your state have any point-of-sale restrictions related to maximum units,
prior authorization, therapeutic duplication, or early refill?
A. Yes. All individual medications in the Idaho Medicaid drug database have been
reviewed and have hard edits on dose/day and maximum units per month as
well as age restrictions. We have over 100 drugs requiring prior authorization
for preferred drug status, therapeutic use, age, and/ or quantity. We utilize
point of sale prospective drug utilization review edits for therapeutic
duplication and early refill.
67
Response to Question 11
11. Were any of these top ten prescribers identified in the federalmandated Drug Utilization Review or CMS-base retrospective reviews?
A. The Idaho Medicaid Drug Utilization Review Board has looked at or is
currently looking at appropriate use of both narcotic analgesics and
atypical antipsychotics. In these reviews, we identify specific patients so if
one of those patients identified had one of these prescribers as their
prescriber they would have received an educational intervention.
In 2010 the Board looked at the following:



Narcotic use studies looking at multiple short or long-acting agents in
one patient.
Narcotic use study identifying patients receiving continuous narcotic
pain treatment with short acting agents without addition of long-acting
agents.
Narcotic use study of continued opioid use with dependency and/or
abuse diagnosis.
68
Response to Question 11
(cont.)
Currently the DUR Board is doing a very detailed study on narcotic
analgesics that includes the following data. If deemed necessary, they will
also use information from the Board of Pharmacy Prescription Drug
Monitoring Program, legal/arrest databases and hospital discharge
medication records.
Patient Profiling












Number of patients on monthly (chronic) narcotics
Number of different agents used by individual patients
Total (cumulative) monthly doses of all concurrent narcotics
Number of prescribers per patient
Analysis of multiple scripts from multiple providers
Other addictive drugs prescribed concurrently
Diagnosis/indication for narcotic use and data backing that diagnosis
Patients with no relevant diagnosis for medication
Evaluation for evidence of illicit drug use
Relationships of long-acting narcotic use and break through narcotics use (lack of
long acting and/or break through narcotics given continuously)
Hospital and ER admissions for overdose
Prescription fill history, including early refills
69
Response to Question 11 (cont)
Provider Profiling
• Prescribing pattern for non-pain clinic prescribers
Currently the DUR Board is working with the Program Integrity unit to
look at use of injectable atypical antipsychotics and ensuring what is paid
for by Medicaid is actually administered.
The Pharmacy and Therapeutics Committee is also instituting appropriate
use guidelines for atypical antipsychotics which will involve prior
authorization review of those prescriptions not meeting the guideline
criteria.
70
Response to Questions #12
12. Does your state have any programs in place to educate providers about
the prescription of antipsychotics to children and adolescents?
A. The Idaho Medicaid Pharmacy program utilizes an Academic Detailing
(Educational Outreach) program to meet one on one with high use
prescribers of mental health medication. The Medicaid pharmacy
program is also participating in a project with other areas of Health and
Welfare and various community organizations to improve the use of
psychotropic drugs in Foster kids. It is anticipated that this will include
appropriate consent for treatment, prior authorization when necessary and
a set up of red flags to identify potential inappropriate prescribing.
71
Protease inhibitors and statins
 On March 1, 2012 the U.S. Food and Drug
Administration (FDA) issued a safety communication
in regards to interactions between protease inhibitors
and statins. (see packet)
 Idaho had one patient on both a protease inhibitor and
a statin. His course of Incivek will be complete soon
and he has been non-compliant on his lovastatin (fills
9/11/11, 10/10/11, and 1/6/12) so it was decided not to
send any correspondence to the prescriber.
72
Impact of using the 2009 revised American Academy of
Pediatrics (AAP) recommendations for infants with
gestational age between 32 to 35 weeks.
 The AAP Committee on Infectious Disease updated the recommendations for
the use of palivizumab for the prevention of respiratory syncytial virus
infections August 2009
2006 Red Book
Recommendations
2009 Red Book
Recommendations
32-35 weeks gestation
32 weeks, 0 days - 34 weeks, 6 days
Less than 6 months of age at the start
of the RSV season
Less than 3 months of age at the start
of the RSV season
Receive 5 doses for prophylaxis per
season
Receive prophylaxis until 90 days of
age or a maximum of 3 doses
Must have 2 of 5 risk factors
Either of 2 specific risk factors
73
2006 Red Book
Risk Factors
2009 Red Book
Risk Factors
Child care attendance
Child care attendance with
infants and young toddlers
School aged siblings
Sibling(s) less than 5 years of age
Exposure to environmental air
pollutants
Congenital abnormalities of the
airways
Severe neuromuscular disease
74
Information from the American Academy of Pediatrics
regarding update to previous recommendations.
 Optimal balance of benefit and cost from this expensive intervention.
 Based on the availability of additional data regarding seasonality of
RSV disease as well as the limitations in available data on risk factors
for identifying children at increased risk of serious RSV lower
respiratory tract disease.
 Cost Considerations of immunoprophylaxis with 5 monthly doses of
palivizumab is an effective, though costly, intervention that reduces
hospitalization rates by 39% to 82% among high-risk infants. The
primary benefit of immunoprophylaxis is a decrease in the rate of RSVassociated hospitalization. No prospective, randomized clinical trial
has demonstrated a significant decrease in the rate of mortality
attributable to RSV or in the rate of recurrent wheezing following RSV
infection among infants who receive prophylaxis. Economic analyses
fail to demonstrate overall savings in health care dollars because of the
high cost if all at risk infants receive prophylaxis.
75
Incidence of RSV Hospitalization by Treatment Group per
prescribing information
MedImmune revision date July 2010
Trial
Trial 1
Impact-RSV
Trial 2 CHD
Placebo
Synagis
N
500
1002
Hospitalization
53 (10.6%)
48 (4.8%)
N
648
639
Hospitalization
63 (9.7%)
34 (5.3%)
Difference
Between
Groups
Relative
Reduction
p-Value
5.8%
55%
<0.001
4.4%
45%
0.003
76
History of Synagis Season Prior
Authorization Requests
Total Requests
Received
Percentage
Denied
2007
452
31%
2008
509
30%
2009
472
35%
2010
445
39%
Criteria change did not cause fewer prior authorization request
submissions.
77
Review Criteria:
 Specifically looked at 56 infants between 32 weeks, 0
days to 35 weeks gestational age and < 6 months
chronological age as of December 1, 2010.
 Filtered denials based on infants that met criteria per
the previous 2006 Red Book recommendations but did
not met criteria per the updated 2009 Red Book
recommendations.
78
Case studies:
One infant was hospitalized
 Baby 1: DOB 11/3/2010 with the gestational age box 32-34
weeks, 6 days checked. No other information was provided
as well as no discharge summary. The electronic claims
profile was not indicative of any risk factors. RSV positive
with hospitalization February 2011.
 Using either the 2006 or the 2009 Red Book
recommendations the infant would not have met criteria
because no risk factors were provided.
79
Two infants were RSV positive
without hospitalization
 Baby 2 and 3: Twins with DOB 8/7/2010 with gestational age
checked 32-34 weeks, 6 days. Synagis denied because infants
> 90 days old upon start of RSV season using 12/1/2010. RSV
positive 3/2/11 and 3/8/11 without hospital or emergency
department admission.
80
The following Infants were neither
hospitalized nor RSV positive:
Requests
Received
Gestational Age
5
32 weeks
23
32-34weeks , 6 days
4
33 weeks
2
33-35 weeks
12
34 weeks
10
35 weeks
81
Summary
 445 prior authorizations received and 56 of those did
not meet criteria using the new AAP guidelines (13%).
 Only one of the 56 infants was RSV positive with
hospitalization. There was no information submitted
and nothing in the electronic claims profile indicative
of high risk.
 Impact of implementing the new AAP guidelines
continues to not be significant.
82
Proposed Studies for Next Quarter:
 P&T Committee Narcotic Analgesic Studies
 Leukotrienes vs. inhaled corticosteroids in children with
asthma
 Use of Psychotropic Medications in Foster Children
 Use of Lupron
83
P&T Committee Narcotic Analgesic
Studies
 Committee Recommendation for Drug Utilization
Review of Narcotic Analgesics
 The Committee recommended a comprehensive drug utilization review of
short and long-acting narcotics. This was based on concern over the
misuse/abuse of these agents that is not addressed through the preferred
drug list. Components of the proposed review are outlined below.
 Patient Profiling
 Number of patients on monthly (chronic) narcotics
 Number of different agents used by individual patients
 Total (cumulative) monthly doses of all concurrent narcotics
 Number of prescribers per patient
 Analysis of multiple scripts from multiple providers
84
P&T Committee Narcotic Analgesic
Studies
 Patient Profiling Continued
 Other addictive drugs prescribed concurrently
 Diagnosis/indication for narcotic use and data backing that
diagnosis
 Patients with no relevant diagnosis for medication
 Evaluation for evidence of illicit drug use
 Relationships of long-acting narcotic use and breakthrough
narcotics use (lack of long acting and/or breakthrough
narcotics given continuously)
 Hospital and ER admissions for overdose
 Prescription fill history, including early refills
85
P&T Committee Narcotic Analgesic
Studies
 Provider Profiling
 Prescribing pattern for non-pain clinic prescribers
 They also suggested utilizing several data sources outside
Medicaid including outlier reports from the Board of
Pharmacy Prescription Drug Monitoring Program,
legal/arrest databases and hospital discharge medication
records.
86
P&T Committee Narcotic Analgesic
Studies
 Possible policy changes suggested for consideration after
collection and analysis of the data



Restriction of prescriptions to prescribers and pharmacies within
Idaho state borders
Stricter refill policies (90% rather than current 75% threshold)
Expansion of lock-in program
87
Leukotrienes vs. inhaled corticosteroids in
children with asthma
 Number of recipients < 18 years of age with paid claim
for leukotriene:
Date
# of recipients
7/1/2011 – 9/30/2011
3,369
1/1/2012 – 3/31/2012
3,059
 Number of recipients < 18 years of age with paid claim
for inhaled corticosteroid:
Date
# of recipients
7/1/2011 – 9/30/2011
1,595
1/1/2012 – 3/31/2012
2,156
88
Use of Psychotropic Medications in
Foster Children
 The U.S. Government Accountability Office released
the results from a study that they performed
examining the rates of psychotropic medications for
foster and nonfoster children in 2008.
 It was determined that HHS Guidance Could Help
States Improve Oversight of Psychotropic
Prescriptions.
89
Use of Psychotropic Medications in
Foster Children
 Medication Classes included in the report
 ADHD drugs
 Anti-anxiety
 Anticonvulsant
 Antidepressants
 Anti-enuretic (just desmopressin acetate)
 Antiparkinson
 Antipsychotics
 Combination anti-anxiety and antidepressant
 Hypnotic Mood stabilizer (just lithium)
 Sleep aid (just melatonin)
90
Use of Psychotropic Medications in
Foster Children
Percentage of children (017 years old) prescribed
psychotropic Medications
in named State and year
Foster Children
Nonfoster children
Ratio of foster to
nonfoster children
Florida 2008
22.0%
8.2%
2.7
Massachusetts 2008
39.1%
10.2%
3.8
Michigan 2008
21.0%
7.9%
2.7
Oregon 2008
19.7%
4.8%
4.1
Texas 2008
32.2%
7.1%
4.5
Idaho 2008
38.8%
14.8%
2.6
Idaho 2011
42.9%
14.8%
2.9
91
4/2012 Update
92
AACAP1 Practice Parameter on the Use of Psychotropic
Medication in Children and Adolescents
1.
2.
3.
4.
5.
Assessment
Development of a treatment and monitoring plan
Psychoeducation and assent/consent
Implementation of the treatment and monitoring
plan
Management of complex pharmacological
interventions including medication discontinuation
1 Journal of American Academy of Child and Adolescent Psychiatry 48:9; September 2009
93
Areas For Idaho Medicaid
Pharmacy Program to Assist
1.
2.
3.
4.
5.
6.
7.
Education of prescribers on the medications – extension of
Academic Detailing program
Educational information on the medications for persons giving
consent
Provide medication profiles to case workers
Set up guidelines with red flag systems
Develop protocols for monitoring medications
Develop and provide simple medication guides for foster
parents
Data
1.
2.
3.
Baseline
Trending
Monitoring the impact of the interventions
94
Guidelines, Prior Authorization,
and Red Flags
 Prior Authorization
 Diagnosis per P&T recommendations

Evidence-based indications for age
 Age and Quantity per evidence-based information
 Red Flags
 RetroDUR evaluation of patients meeting red flags
 Quarterly interventions
 Transition to timely alerts (ProDUR) and possible hard
edits requiring prior authorization
95
Possible Red Flags
 Texas
 Five (5) or more psychotropic medications prescribed
concomitantly
 Two (2) or more concomitant antidepressants
 Two (2) or more concomitant antipsychotic medications
(actual PA on 3rd)
 Two (2) or more concomitant stimulant medications (longacting plus an immediate release of same chemical entity not
considered concomitant)
 Three (3) or more concomitant mood stabilizer medications
 Psychotropic polypharmacy ( 2 or more agents) for a given
mental disorder prescribed before utilizing psychotropic
monotherapy
96
Texas Red Flags - continued
 Additionally
 Diagnosis, age, and dose limitations similar to what
Idaho does presently
 Require specialty training for diagnosis other than
ADHD, uncomplicated anxiety disorders or
uncomplicated depression
*Medication overlap and cross-titration ok when switching psychotropics
97
Possible Other Red Tags
• Two (2) or more concomitant anti-anxiety agents
• Two (2) or more concomitant sedative/hypnotic agents
 Split into separate interventions for 1 Vs 2 prescribers
for duplicate therapy for antidepressants, stimulants,
atypical antipsychotics, anti-anxiety agents,
sedative/hypnotics
98
Next Steps
99
Prospective DUR Report
 History Errors:
• DD – drug-to-drug
• PG – drug to pregnancy
• TD – therapeutic duplication
• ER – early refill
• MC – drug-to-disease
 Non-History Errors:
• PA – drug-to-age
• HD – high dose
• LD – low dose
• SX – drug-to-gender
100
Prospective DUR Report
Idaho Medicaid Program
ProDUR Message Report
March-12
ProDUR
Message
Drug To Drug
Drug To Gender
Drug To Known Disease
Drug To Pregnancy
Duplicate Therapy
Min Max
Too Soon Clinical
ALL
ProDUR
Severity
1
2
3
9
1
2
1
2
3
1
2
A
B
C
D
X
0
0
0
Message
Count
2,272
14,784
65,365
3
116
53
64,935
242,066
289,788
101
23
3
131
256
36
41
120,392
37,330
22,684
Message
Amount
$457,602.00
$2,549,305.71
$11,032,658.53
$22.47
$25,224.88
$1,287.90
$19,679,895.85
$45,599,264.18
$55,585,891.88
$3,180.77
$429.52
$70.69
$55,749.15
$21,660.28
$2,146.06
$863.47
$26,014,904.40
$7,045,362.22
$4,678,290.51
860,379
$172,753,810.47
Total Number of Claims with Messages 218,822
Average ProDUR Message Per Claim
3.93
101
DUR Winter Newsletter
 Copy of Fall Newsletter in packet
 Brainstorm for new topics (Prescriber emails???)
102
February 23-25, 2012
Scottsdale, Arizona
103
ADURS 2012
 Representatives were present from 43 states
 State Medicaid employees
 Drug Utilization Review personnel
104
ADURS 2012
 14 hours of Continuing Education
 Hepatitis C Update
 “Less Abusable” Opioids
 New Drugs
 Pipeline Drugs
 CMS Update
 Is it a “Drug” ?
105
ADURS 2012
 Round Table – Oral report by
representative from each state on DUR
projects done in the past year plus
challenges and successes.
106
ADURS 2012
 Round Table Report
 Atypical antipsychotics




Require psychiatrist to be prescriber for (a) children
less than 6 years or (b) children less than 18 years.
Signed consent form (by parents or guardians).
Baseline metabolic monitoring (blood glucose,
HgbA1c, lipid panel) and then routinely thereafter.
Letters sent to prescribers of patients less than 16
years old who are receiving two or more atypicals
concurrently .
107
ADURS 2012
 Round Table Report
 Suboxone Therapy




Maximum daily dose of 16mg with enforced
reduction to 8mg after 3-6 months.
Automatic lock-in to one pharmacy.
Approvals for only three months at a time, requiring
documentation of patient’s attendance at
counseling sessions and negative urine drug screen
for renewal.
Limiting approval to two years per lifetime.
108
ADURS 2012
 Round Table Report
 Polypharmacy – Patients receiving more than 15
medications per month for at least 3 consecutive
months.
 Methadone – No other opioids are allowed without
prior authorization
 Topical Immunomodulators – Requires trial and
failure of TWO topical corticosteroids first.
Quantity is limited to one tube per 90 days.
109
ADURS 2012
 Round Table Report
 Pain Therapy – Require pain specialist review of any
non-cancer patient receiving more than 1000
mg/day of morphine equivalents.
 Controlled Substances – Refills not allowed until
100% of time has elapsed (pharmacy can override
for weekends/holidays to allow early refill by a few
days).
 Twice daily PPI not approved unless patient has first
tried and failed once daily PPI plus a bedtime H-2
blocker.
110
Medicaid Update
111