Transcript Idaho Medicaid Drug Utilization Review Program

20 October 2011
Follow-up to Previous Reviews
 Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Pharmacy Provider Profiling
 Colchicine DUR
 Ketorolac DUR
2
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Pharmacy Provider Profiling
 Patients were selected if they had more than one tramadol
fill, at least a 30 day overlap with the SSRI or SNRI, and had
both a tramadol and an antidepressant claim within the
most recent six weeks of data.
 Letters along with the Serotonin Syndrome Informational
sheet were sent to 182 pharmacies about 552 patients on
7/18/2011.
 As of 9/27/2011, 45 responses have been received (25%
response rate.)
3
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 Note that providers may choose more than one selection per response.
 Reviewed and do not believe adjustment is needed
 Reviewed and have or will modify the treatment
19
10
 I have previously discussed with the provider
and their response was
 I attempted to modify the therapy, but the patient
response was not favorable
3
1
4
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 Note that providers may choose more than one selection per response.
 Information clinically useful: plan to monitor
 I will use this information in the care of future pts
 No longer my patient
 Somewhat useful to my practice
 Extremely useful to my practice
 Very useful to my practice
21
30
10
8
8
23
5
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 “We are not a providing pharmacy for this patient.”
 “The patient has been on concurrent therapy for several years with no apparent serotonic
toxicity”
 “Patients had a trial of Tramadol and other interacting meds since discontinued. Good
reminder to watch for multiple offending drugs. This often gets over quickly on DURs.”
 “John is no longer on tramadol. Only on it for a week.”
 “I have previously discussed with the provider and their response was dosages not high
enough to cause serotonin syndrome.”
 “Patient and family counseled on serotonin syndrome. Patient has not filled medication
since April (only need if pain).”
 “Patient was taking Tramadol temporarily and hasn’t filled since. I have contacted
providers several instances when they are adding Tramadol and they are currently taking
2 other serotonergic drugs. They always state they aren’t concerned about it.”
6
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 “Patient has addiction programs by past hydrocodone and has not responded to past
antidepressant treatment. He has been on this therapy for 9 years, continue with current
therapy.”
 “Testing”
 “Patient moved from this area Aug 15, 2011.”
 “Both medications are prescribed by the same provider. Patient was counseled.”
 “We explained the signs and symptoms of SS to the patient or caregiver if they get the
symptoms they are to contact their prescriber. Our computer flags drugs.”
 “Dr. switched Rx to Hydrocodone/APAP”
 “Tramadol was changed to other pain relievers in May 2011. The patient is not
symptomatic”
 “Neither patient is currently taking tramadol at this time. The problem I find is the
doctors are reluctant to change medication when you call them about a serotonin
syndrome reaction. But refer to question 6.”
7
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 “7 of 12 required contact with the doctor”
 “Patients are counseled to be aware of symptoms of Serotonin Syndrome. When taking
more than one medication. Monitoring patient aware of interaction patient has been
taking both Serotonergic drugs without problems. Will continue to remind patients of
possible interaction with each refill. Helpful reminder reviewed with our pharmacist on
staff also made copies of your hand out for educational purposes to give to patient at
patient counseling.”
 “Serotonin Syndrome is rare and I would rather have her take Tramadol than
hydrocodone. I appreciate the service you are offering, however I do not think Serotonin
Syndrome is common enough to warrant Medicaid contacting pharmacies. This one
interaction would keep you busy for a very long time. Thank You.”
 “I have counseled patient and she has been stable on both meds. She is aware of
serotonin syndrome. Will f/u again.”
8
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 “Patient has had concomitant therapy since August 16 2010 and has not reported the
symptoms of serotonin syndrome.”
 “Not currently on this combination.”
 “We do counsel on the possibility of SS.”
 “Long standing regimen.”
 “She has been consulted on the risk. She has been on Tramadol since April 2010.
Cymbalta since 11/2010 without incident.”
 “One patient no longer on Cymbalta. Other uses infrequently.”
 “Thank you very much for bringing this to my attention. I will speak with the provider
directly and report his or her response back to you.”
 “To continue current regimen.”
 “I have reviewed the information and plan to follow up with the prescriber concerning
the treatment regimen for the specified patient.”
9
Tramadol with SSRIs or SNRIs
Potential for Serotonin Syndrome
Response detail as of 9/27/2011
 “She has been using this for awhile with no problem. I will let prescriber know of the
issue again.”
 “I have previously discussed with Doctor and he has been watching the patient sees no
indication of symptoms of Serotonin Syndrome. He is aware and watching.”
 “Continue therapy.”
 “Counsel patient and combine with current med. Patient received full interaction
consult.”
 “Provider was notified about possible problems. No response.”
 “Watch for symptoms, patients are not taking Tramadol all the time. Thanks.”
10
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
11
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.
 Use of Colcrys®
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
12
Colcrys’® Place in Therapy
 Utilization Overview
Number of
Recipients
Number of
Claims
Average
Cost/Claim
Allopurinol
172
432
$6.62
Colcrys®
16
29
$259.78
Probenecid
7
13
$25.26
Probenecidcolchicine
0
0
$0.00
Uloric®
9
25
$167.62
All information based on Idaho Medicaid Pharmacy Data 2nd Quarter 2011 (4/1/11-6/30/11).
13
Colcrys® - Summary
 72.2% (13/18) of the Prior Authorization requests
received were approved.
 Continue to require Prior Authorization for Colcrys®
with the current therapeutic criteria (listed on next
slide)
 Off-label use for treatment of chronic constipation was
discovered
 Turned off Auto Pay rule which approved Colcrys® at
point of sale if there was a paid colchicine claim in the
past 90 days.
14
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
15
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.
16
Ketorolac DUR
 Patients were selected for evaluation if there was a
paid claim for ketorolac > 40mg total daily dose or > 5
days duration over the 3 month period 3/1/20115/31/2011.
 A total of 29 patient profiles were evaluated
 Letters were sent to 9 prescribers about 9 patients on
6/20/2011.
 As of 9/26/2011, 4 responses have been received (44%
response rate)
17
Ketorolac DUR
 Criteria Paragraph
 During a retrospective drug utilization review, it was noted that your
patient, (Patient Name), received at least one prescription of more than 20
tablets and/or received multiple consecutive fills of ketorolac. The
recommended maximum daily dose of oral ketorolac is 40mg per day (10mg
tablet four times daily). Ketorolac is FDA approved for the short term (up
to 5 days) management of moderately severe acute pain that requires
analgesia at the opioid level and only as continuation treatment following
IV or IM dosing of ketorolac. The total combined duration of use of
injectable and oral ketorolac should not exceed 5 days. Increasing the dose
beyond the recommended daily maximum of 40mg will not provide better
efficacy, but will increase the risk of developing serious adverse events.
Ketorolac has black box warnings addressing the following risks:
Gastrointestinal, Cardiovascular, Renal, Risk of Bleeding, Risk During
Labor and Delivery, Concomitant Use with NSAIDs, and in Special
Populations.
18
Ketorolac DUR
Response detail as of 9/26/2011
 Note that providers may choose more than one selection per response.
 Information clinically useful: plan to monitor
 I will use this information for care of future patients.
 No longer my patient
 My patient, but I did not prescribe this
 My patient, but I have not seen him/her recently
 Somewhat useful to my practice
2
2
1
1
1
1
 “The meds were being given in the ER and PCP I believe”
 “Will discuss Kadian and the use of other pain meds as an option for
care”
19
Ketorolac DUR - Summary
 Maximum quantity per day reduced from 10 to 4
tablets on 5/24/2011
 DUR letter sent on 6/20/2011 to 9 prescribers with 4
responses as of 9/26/2011
20
Auto Refill Practices
Some pharmacies are instituting Auto Refill policies
which allow them to automatically dispense refills
based on days since last fill
 Issues
 Potential for stockpiling
 Potential for continued fill of discontinued medications
 Increase cost/waste
 Please see Survey in Packet
21
Auto Refill Practices
 Fax blast of survey went out to 318 pharmacies on July
8, 2011.
 As of 10/3/2011 a total of 78 surveys have been returned
(25% response rate)
22
Auto Refill Practices – Results
 Does your pharmacy participate in an Auto Refill
process?
27
Yes
No
51
23
Auto Refill Practices – Results
 Do you exclude Auto Refill for any specific third
party payers? If so which? ____See attached sheet for comments______
5
Yes
No
32
24
Auto Refill Practices – Results
 How are specific patients included in the Auto
Refill process?
25
20
15
10
5
20
10
2
0
All patients are automatically enrolled in Auto Refill
All patients are offered Auto Refill as a service option
A patient must specifically request Auto refill
All patients are included unless they specifically "opt out" of the program
25
Auto Refill Practices – Results
 Which medications does your pharmacy include in
your Auto Refill?
25
22
20
15
10
5
5
2
0
All Medications
Maintenance medications only
Our Pharmacy has a specific list of medications or therapeutic classes (see attached
sheet)
26
Auto Refill Practices – Results
 Which medications does your pharmacy include in your
Auto Refill?
 Our Pharmacy has a list of excluded medications (please list),
otherwise all are included in auto refill program 12 responses see
attached sheet
 Does your system automatically flag all medications or does each
RX have to be individually flagged? 22 responses see attached sheet
 Do you have a systematic method to discontinue an Auto Refill to
prevent duplication of therapy when drugs or doses change?
20 responses see attached sheet
 How many days remain on the prescription when your
system Auto fills the medication? 46 responses average 5 days
27
Auto Refill Practices – Results
 Does your system alert the patient that the
prescription is ready for pick up? If so, how?
30
25
25
19
20
9
Yes
25
No
17
15
10
3
5
0
Phone
Text
Email
Other (see attached sheet)
28
Auto Refill Practices – Results
 How long does the medication sit on the shelf before it is
returned to stock?
 39 responses with an average of 13 days
 How does your store handle medications not picked up?
40
33
30
20
7
10
11
0
Phone call to patient
Mail out
Other
29
Auto Refill Practices – Results
 Do you find the Auto Refill process beneficial for
patients?
6
Yes
No
24
30
Auto Refill Practices – Results
 Do you find the Auto Refill process potentially
dangerous for patients?
13
Yes
17
No
31
Auto Refill Practices – Results
 Do you find the Auto Refill process has increased
compliance by the patient?
7
Yes
No
18
32
Auto Refill Practices – Results
 Do you have any other comments related to the
Auto Refill process?
 24 responses see attached sheet
 Comments/Questions/Recommendations?
33
Hepatitis C DUR
 Rationale for choosing this topic
 Multiple ribavirin products are available at very different
costs.
 There is currently no therapeutic criteria required for
ribavirin, so prescriptions pay at the pharmacy with
prior authorization not needed.
34
Hepatitis C DUR – approximate cost of therapy
for one month of therapy
Ribavirin
200mg
capsules
Ribavirin
200mg tablets
Ribasphere (400
and 600mg tablets)
Ribapak
400mg twice daily
$160
$120
$880
$1114
600mg in am and
400mg in pm
$200
$150
$1105
$1273
600mg twice daily
$240
$180
$1320
$1678
35
Hepatitis C DUR
 FDA Approved Indication
 Treatment of chronic hepatitis C in combination with
interferon.
 Profiles Selected for Review
 Patients who had at least one paid claim for oral
ribavirin between 5/01/2011 and 7/31/2011. N=29
 Patient Demographics
 16 female, 13 male
 Average age 46 yrs (Range 31-59)
36
Hepatitis C DUR
 Diagnosis for Hepatitis C in Electronic Profile
 Yes – 28 patients
 No – 1 patient (but called prescriber and this patient
does have hepatitis C)
 Concomitant Therapy with Interferon
 Defined as at least one fill for interferon between
5/01/2011 and 7/31/2011. Yes – all 29 patients
 7 of these patients are also on either Incivek or Victrelis
for triple therapy.
37
Hepatitis C DUR
 Medication Possession Ratio (MPR)
 Definition:
Total Days Supply of Dispensed Medication
Total Days of Therapy
 Example






e.g. Patient fills 30 tablets/30 days on January 1, March 1, and April 15 and then there are no more
fills.
Total days of therapy: 31 (January) + 28 (February) + 31 (March) + 30 (April) + 14 (May) = 134 days
Note: last day of therapy is May 14th as patient has 30 days of medication to use from April 15
through May 14th.
MPR = 30 (Jan fill) + 30 (Mar fill) + 30 (Apr fill) = 90
=
0.67
134 days
134
In general, MPR > 0.80 is considered good adherence to therapy. There are not specific
standards for different drug classes.
If a patient fills prescriptions early (e.g. opioids), then MPR will be greater than 1.0
38
Hepatitis C DUR
 Ribavirin MPR
 Average for all 29 patients: MPR = 0.904 (average days of
filled ribavirin = 126, average days of ribavirin therapy
142 days)
 Subtracting out 8 patients with only one fill (who
therefore had a MPR 1.0): Average MPR = 0.87 (average
days of filled ribavirin = 163, average days of ribavirin
therapy 186 days)
39
Hepatitis C DUR
 Interferon MPR
 Average for all 29 patients: MPR = 0.964 (average days of
filled interferon = 138, average days of interferon therapy
145 days)
 Subtracting out 7 patients with only one fill (who
therefore had a MPR 1.0): Average MPR = 0.96 (average
days of filled interferon = 173, average days of interferon
therapy 182 days)
40
Hepatitis C DUR
 Recommendations
 Ribavirin and interferon do not currently require prior
authorization.
 All patients treated with oral ribavirin between May 1,
2011 and July 31, 2011 have a diagnosis of chronic hepatitis
C and are on concomitant interferon therapy.
 Therefore, prior authorization for oral ribavirin with
therapeutic criteria is NOT recommended at this time.
41
Hepatitis C DUR
 Potential for Cost Savings
 Currently 26 out of 29 patients are using generic
ribavirin 200mg tablets or capsules which are the most
cost effective dosage forms.
 Three (of the 26) of these patients switched from
RibaPak to generic ribavirin during the time frame of
this study.
 Three patients are still using Ribapak or Ribasphere
(400mg or 600mg) tablets.
42
Hepatitis C DUR
 Cost Savings Example
 Patient switched from using Ribapak 600-600 (two
600mg tablets) to using six ribavirin 200mg tablets daily
[same daily dose of 600mg twice daily].
 Per 28 days of therapy:
$1566 vs. $168
 Per year of therapy:
$20,414 vs. $2190
43
Hepatitis C DUR
 Incivek and Victrelis
 New class of medications recently approved by the FDA
– Protease Inhibitors for chronic hepatitis C
 Triple combination with oral ribavirin and injectable
interferon. Improves likelihood of attaining sustained
virologic response (SVR).
44
Hepatitis C DUR
 Incivek – triple therapy with ribavirin and interferon
for 12 weeks followed by double therapy with ribavirin
and interferon for an additional 12-36 weeks
depending on viral response and prior response status.
 Victrelis – triple therapy with ribavirin and interferon
for 28-36 weeks with potential continuation of
ribavirin and interferon through week 48 depending
on viral response and prior response status
45
Hepatitis C DUR
 In treatment-naïve patients, incidence of achieving SVR
(ADVANCE study)


Triple therapy with Incivek – 79%
Standard ribavirin/interferon therapy – 46%
 In treatment-naïve patients, incidence of achieving SVR
(SPRINT-2 study)
Triple therapy with Victrelis – 66%
 Standard ribavirin/interferon therapy – 38%
 Cost of therapy per month:
 Incivek $18,560
 Victrelis $4,984

 Currently requires prior authorization as a New Drug.
 Initial approval for 12 weeks
 Will be reviewed by P&T Committee in the future.
46
Hepatitis C DUR
 Prior Authorization requests from the FDA approval date
of Victrelis (5/13/2011) and Incivek (5/23/2011) were
reviewed.
 There were 17 approved requests.
 2 for Victrelis
 15 for Incivek
 2 patients never filled any prescriptions.
 1 for Victrelis
 1 for Incivek


Neither filled a prescription for ribavirin or interferon either.
All patients that filled prescriptions for Victrelis/Incivek also filled
prescriptions for ribavirin and interferon for the same timeframe.
47
Hepatitis C DUR
 Summary
 Not recommending prior authorization for generic
ribavirin
 Recommend continuing to require prior authorization
for Incivek and Victrelis
48
Transdermal Testosterone DUR
 Rationale for this DUR Project
 P&T Committee recommended implementing
therapeutic criteria, including serum testosterone levels,
for the Transdermal Testosterone drug class
 Patient Selection
 Patients with at least one paid claim for transdermal
testosterone between June 1, 2010 and June 26, 2011
N=123 (122 male, 1 female with 1 fill)
49
Transdermal Testosterone DUR
 Patient Demographics
40
37
# of Patients
35
28
30
23
25
20
15
10
17
10
8
5
0
18-20
21-30
31-40
41-50
51-60
61-70
Age
50
Transdermal Testosterone DUR
 Product Selection
 Preferred agents


Androgel
Androderm Patches
n=91
n=31
 Non-preferred agents



Testim Gel
Fortesta Gel
Axiron Underarm Solution
n=1
n=0
n=0
51
Transdermal Testosterone DUR
 Patient Diagnoses
 ICD-9 257.x
 ICD-9 259.9
 ICD-9 302.7x
 ICD-9 607.84
hypogonadism
unspecified endocrine disorder
low libido
erectile dysfunction
52
Transdermal Testosterone DUR
 Patient Diagnoses
# of patients
80
60
60
50
40
20
2
3
8
0
hypogonadism (2 patients also had ICD-9 for low libido and 4 patients also had ICD-9 for erectile dysfunction)
unspecified endocrine disorder
low libido (without hypogonadism diagnosis)
erectile dysfunction (without hypogonadism diagnosis)
no applicable diagnosis listed in electronic profile
53
Transdermal Testosterone DUR
 Potential Cost Savings
 $133,447 paid in claims for the study period
 If only paid claims for patients with diagnosis of
hypogonadism (n=50), cost savings would be $79,200.
 Reference

Testosterone Therapy in Adult Men with Androgen Deficiency
Syndromes: An Endocrine Society Clinical Practice Guideline.
Journal of Clinical Endocrinology & Metabolism, June 2010,
Vol 95(6):2536-2559. Evidence based guideline was developed
using the Grading of Recommendations, Assessment,
Development, and Evaluation (GRADE) system to describe the
strength of recommendations and the quality of the evidence.
54
Transdermal Testosterone DUR
 Diagnosis of androgen deficiency in men
 Consistent symptoms and signs

Note: Idaho Medicaid does not authorize payment for
medications for sexual dysfunction so patient must be having
other symptoms such as losing secondary sex characteristics,
low bone mineral density, height loss
 Unequivocally low serum testosterone level
55
Transdermal Testosterone DUR
 More specific symptoms and signs of androgen
deficiency in men
 As defined by the Endocrine Society

Incomplete or delayed sexual development, eunuchoidism
Reduced sexual desire (libido) and activity
Decreased spontaneous erections
Breast discomfort, gynecomastia
Loss of body (axillary and pubic) hair, reduced shaving
Very small (especially <5ml) or shrinking testes
Inability to father children, low or zero sperm count
Height loss, low trauma fracture, low bone mineral density
Hot flushes, sweats

Idaho Medicaid does not cover for the s/s underlined








56
Transdermal Testosterone DUR
 Less specific symptoms and signs of androgen
deficiency in men
 As defined by the Endocrine Society








Decreased energy, motivation, initiative, and self-confidence
Feeling sad or blue, depressed mood, dysthymia
Poor concentration and memory
Sleep disturbance, increased sleepiness
Mild anemia (normochromic, normocytic, in the female range)
Reduced muscle bulk and strength
Increased body fat, body mass index
Diminished physical or work performance
 As these symptoms/signs are quite non-specific, need to have these
in conjunction with at least one symptom/sign from previous slide.
57
Transdermal Testosterone DUR
 Diagnosis of androgen deficiency in men
 Consistent symptoms and signs
 Unequivocally low serum testosterone levels: Defined as
a morning level below the normal range as defined by
the testing laboratory (the lower limit of normal
testosterone is approximately 280-300ng/dl but may
vary slightly between laboratories). Serum testosterone
levels exhibit a circadian variation with peak values in
the morning. Confirm low testosterone concentration
in men with an initial testosterone level in the mildly
hypogonadal range because 30% of such men may have a
normal testostosterone level on repeat measurement.
58
Transdermal Testosterone DUR
 Contra-indications to therapy with testosterone
 Breast or prostate cancer
 Palpable prostate nodule or prostate-specific antigen
(PSA) > 4ng/ml [or > 3ng/ml in African Americans or
men with first degree relative with prostate cancer]
 Hematocrit > 50%
 Untreated severe obstructive sleep apnea
 Severe lower urinary tract symptoms
 Uncontrolled or poorly controlled heart failure
59
Transdermal Testosterone DUR
 Follow-Up Laboratory Determination in 3-6 months
 Achieve testosterone level during treatment in the midnormal range; test 3-6 months after therapy has started
 Then Annual Monitoring
 Assess whether symptoms have responded to treatment
 Assess whether patient is suffering any adverse effects
 Assess adherence to therapy
60
Transdermal Testosterone DUR
 Duration of Therapy
 For patients with a start and stop date within this study
period (defined as first fill after July 1, 2010 and last fill
prior to May 26, 2011) N=65
61
Transdermal Testosterone DUR
 Number of Prescriptions
35
32
# of patients
30
25
20
15
11
11
10
5
2
1
3
4
4
1
1
1
1
0
1
2
5
6
7
8
9
10
11
12
# of fills
62
Transdermal Testosterone DUR
# of patients
 Duration with respect to diagnosis
20
18
16
14
12
10
8
6
4
2
0
hypogonadism
1
2
3
4
low libido or ED
5
6
7
# of fills
8
No applicable diagnosis
9
10
11
12
63
Transdermal Testosterone DUR
 Recommendations
 Initiate therapeutic criteria for transdermal testosterone



Diagnosis of hypogonadism
At least one non-sexual dysfunction symptom
Serum testosterone level below the lower limit of normal
range (should we require a second level if the first level is
barely under the lower limit of the normal range?)
 Contact prescribers of current patients receiving
transdermal testosterone (prescription filled within the
last 60 days?) informing them of the therapeutic criteria
and requesting documentation of the points listed
above. For study period, would be 35 Androgel patients
and 18 Androderm patients but will run more recent list.
64
Transdermal Testosterone DUR
 Recommendations, continued
 Initial approval would be for six months
 Then follow-up serum testosterone level would be
required (should be in mid-normal range).
 Subsequent approvals would be for one year.
Requirements for annual renewal would be:



Documentation that symptoms have responded to treatment
Documentation that patient is not experiencing adverse
effects
Assessment of adherence to therapy
65
Transdermal Testosterone DUR
 Proposed testosterone DUR letter paragraph:
 Your patient, NAME, has a paid pharmacy claim for a topical testosterone
agent within the last 60 days. Idaho Medicaid’s Pharmacy and
Therapeutics Committee recommended that prior authorization with
therapeutic criteria be added to the topical androgenic drug class. Idaho
Medicaid’s Drug Utilization Review (DUR) Board reviewed usage from June
2010 to June 2011 and only 41% of the patients who received a topical
testosterone agent had a documented diagnosis of hypogonadism in their
electronic profile. Effective DATE, prior authorization with therapeutic
criteria will be required for this drug class. Patients will be approved for
therapy if they have (1) diagnosis of hypogonadism, (2) documented serum
testosterone level that is below the lower limit of the normal range, and (3)
clinical signs/symptoms of hypogonadism. If you wish for your patient to
continue topical testosterone therapy, please complete the attached prior
authorization form and submit to Idaho Medicaid.
66
Oral Terbutaline Utilization
 FDA Drug Safety Communication: New warnings
against use of terbutaline to treat preterm labor
 On February 17, 2011, the Food and Drug Administration
(FDA) released a Safety Announcement addressing the
use of terbutaline for preterm labor and the potential
adverse effects it can have on the mother.
 A review of Idaho Medicaid Recipients showed that
between 5/1/2011 and 7/31/2011 there was a total of 28
female recipients between the ages of 10-55 who received
prescriptions for terbutaline.
67
Oral Terbutaline Utilization
 Review of the data included female patients between
the ages of 10-55, n=28.
 Female patients < 10 years or > 55 years: 1 - 62 year old
 No male patients
 23/28 patients had a pregnancy diagnosis in the
electronic profile.
 Average age 27 years (range 19-37)
 1 fill – 22
 2 fills – 5
 3 fills – 1
 Average fill was for 35 tablets (range 3-90)
68
Oral Terbutaline Utilization
Prescribers
1
1
OB/GYN
7
Family Practice
Legal Medicine
19
NP (works in OB?GYN
office)
69
Oral Terbutaline Utilization
For multiple patients per office
2
6
2
OB/GYN Boise
OB/GYN Idaho Falls
OB/GYN Twin Falls
OB/GYN Coeur d'Alene
5
70
Oral Terbutaline Utilization
 All others were one patient per office:
 Family Practice in Cottonwood, Emmett, Mountain
Home, Rexburg (2 different practices); Newport, WA
 OB/GYN in Boise, Montpelier, Pocatello; Logan, UT;
Pullman, WA
 Legal Medicine in Twin Falls
 No address available for one office
71
Oral Terbutaline Utilization
 Based off this manual review of profiles by the State of
Idaho Pharmacist, profiles were run for the time
period of July 1, 2011 through September 30, 2011 and
24 patients were identified.
 Letters will be generated and sent out to those
prescribers who have prescribed terbutaline along with
the FDA Safety Announcement and specific detailed
question form. (See packet)
 Currently there is no Therapeutic Criteria for oral
terbutaline, only pays within the age/quantity limits.
72
Proposed Studies for Next Quarter:
 Citalopram high dose
 Oral Terbutaline Intervention
 Injectable Atypical Antipsychotics
 P&T Committee Narcotic Analgesic Studies
 Synagis 2010-2011 Season
 Update on the impact of using the 2009 revised
American Academy of Pediatrics (AAP)
recommendations for infants with gestational age
between 32 to 35 weeks.
 Leukotrienes vs. inhaled corticosteroids in children with
asthma
73
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.
74
Citalopram High Dose DUR
 Letters were sent out 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)
 Results will be presented at the next DUR Board
Meeting.
75
Injectable Atypical Antipsychotics
Invega® Sustenna® and Risperdal® Consta®
 Indications
Agent
Indication
Invega® Sustenna®
Acute and Maintenance Treatment of Schizophrenia
Risperdal® Consta®
Treatment of Schizophrenia
Risperdal® Consta®
Mono or Adjunct therapy to Lithium or Valproate in
Bipolar I Disorder
 Utilization Overview
Agent
Recipients
Invega® Sustenna®
106
Risperdal® Consta®
148
Oral Agents
6936
Patients Receiving Both Oral and Injectable – 1st Quarter 2011
148
*Idaho Medicaid Data 4th Quarter 2010 (10/1/2010-12/31/2010)
76
Injectable Atypical Antipsychotics
Invega® Sustenna® and Risperdal® Consta®
 Responsibilities of the parties involved
 Magellan

Run reports to identify Prescribers, Pharmacies, and Patients
 Idaho Medicaid Pharmacy Unit

Analyze reports and identify where intervention is needed
 Idaho Medicaid Program Integrity

Send out letters requesting documentation of dose
administration
77
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
78
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
79
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.
80
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
81
P&T Committee Narcotic Analgesic
Studies
 Please refer to Narcotic Spreadsheet in Packet for
details.
82
Synagis Utilization Intervention
 Update using the 2010-2011 RSV season data on the
impact of using the 2009 revised American Academy
of Pediatrics (AAP) recommendations for infants with
gestational age between 32 to 35 weeks.
 Profiles will be reviewed to assess outcomes
Leukotrienes vs. inhaled corticosteroids in
children with asthma
 Number of recipients < 18 years of age with paid claim
for leukotriene from 7/1/2011 – 9/30/2011:
 3,369
 Number of recipients < 18 years of age with paid claim
for Inhaled corticosteroid from 7/1/2011 – 9/30/2011:
 1,595
 Note: We do not have diagnosis data.
84
2010 Annual DUR Report

State name abbreviation: ID
Medicaid Agency Information

Tami Eide, Pharm.D., BCPS
Magellan Medicaid Administration



Prospective DUR
Comes from First Data Bank
DUR criteria approved by DUR Board



Currently reviewing criteria
How do pharmacists handle ProDur messages?
Early Refills (Prior Authorizations)



Non-controlled as well as Controlled
85
2010 Annual DUR Report

Prospective DUR, continued





Therapeutic Duplications (Prior Authorizations)
Prospective criteria reviewed by the Board (Table 1)
Prospective DUR Review Summary (Attachment 1)
Prospective DUR Pharmacy Compliance Report
(Attachment 2)
Retrospective DUR


ISU College of Pharmacy/Magellan Medicaid
Administration
Retrospective DUR Board Approved Criteria
(Attachment 3)
86
2010 Annual DUR Report
 Physician Administered Drugs
 Deficit Reduction Act requires collection of NDC
numbers for covered outpatient physician administered
drugs. Has MMIS been designed to incorporate this
data into DUR for both Prospective and Retrospective
DUR?
 DUR Board Activity
 Summary Report of activities/meetings (Attachment 4)
 DUR Board Involvement


Disease Management Program
Medication Therapy Management
87
2010 Annual DUR Report
 Generic Policy and Authorization Data
 Generic Drug Substitution Policies (Attachment 5)
 Generic Utilization Percentage:
70%
 Generic Expenditure Percentage:
17%
 Program Evaluation/Cost Savings
 Cost Savings Estimate (Attachment 6)



Prospective DUR
Retrospective DUR
Total Savings
$4,879,377
$463,187
$5,342,564
88
2010 Annual DUR Report
 Fraud, Waste, and Abuse Detection
 Does the State have ways to identify fraud or abuse of
controlled drugs by recipients, prescribers, and/or
providers?
 Prescription Drug Monitoring Program (Attachment 7)
 Innovative Practices
 E-Prescribing
 Executive Summary
89
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
90
Prospective DUR Report
Idaho Medicaid Program
ProDUR Message Report
Sep-11
ProDUR
Message
Drug To Drug
Drug To Gender
Drug To Known Diseas
Drug To Pregnancy
Duplicate Therapy
Min Max
Too Soon Clinical
ALL
ProDUR
Severity
1
2
3
1
2
1
2
3
1
2
A
B
C
D
X
0
0
0
Message
Count
4,812
11,760
55,682
117
37
57,898
217,811
249,187
22
6
10
71
153
34
26
102,499
34,089
19,391
Message
Amount
$710,509.70
$1,848,784.75
$8,568,836.29
$34,305.95
$2,836.30
$7,308,213.91
$31,264,134.87
$39,299,697.37
$419.72
$99.93
$174.59
$5,329.99
$12,086.68
$668.50
$1,436.76
$18,771,054.83
$5,130,125.40
$3,472,743.89
753,605
$116,431,459.43
Total Number of Claims with Messages 194,477
Average ProDUR Message Per Claim
3.88
91
Drug to Pregnancy Encounters
Drug-to-Pregnancy Encounter
User
FDB Severity
FDB Description
Severity
1
Contraindicated or not recommended
1
User Severity
Description
Major
2
A
Precautions or warnings
Adequate and well controlled studies have
failed to demonstrate a risk to the fetus in
st
the 1 trimester of pregnancy, and no risk
in later trimesters.
2
3
Moderate
Minor
B
Animal studies have failed to demonstrate
a risk to fetus but there are no well
controlled studies in pregnant women.
3
Minor
C
Studies in humans or animals have shown
fetal abnormalities and/or there is positive
evidence of fetal abnormalities.
2
Moderate
D
Positive evidence of human fetal risk
based on investigation or marketing
information but potential benefits may
warrant use in pregnant women despite
potential risks.
Studies in humans or animals have shown
fetal abnormalities and/or there is positive
evidence of fetal abnormalities.
2
Moderate
1
Major
X
92
Drug to Pregnancy Encounters
 Currently we report all severity levels for pregnancy
and severity level 1 is set to reject
 Severity Level 1 = Major = Not Recommended in pregnancy
 Severity Level 2 = Moderate = Evaluate carefully if pregnant
 Severity Level 3 = Minor = No known risk in pregnancy
 Please see attached handout for specific details as it
relates to specific medications
93
DUR Fall Newsletter
 Copy of Summer Newsletter in packet
 Brainstorm for new topics
94
Medicaid Update
95