20 October 2011. Follow-up to Previous Reviews Tramadol with SSRIs or SNRIs Potential for Serotonin...
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Idaho Medicaid Drug Utilization Review Program
20 October 2011
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Follow-up to Previous Reviews
Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Pharmacy Provider Profiling
Colchicine DUR
Ketorolac DUR
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Tramadol with SSRIs or SNRIsPotential for Serotonin SyndromePharmacy Provider ProfilingPatients 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.)
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Tramadol with SSRIs or SNRIsPotential for Serotonin Syndrome Response detail as of 9/27/2011Note that providers may choose more than one selection
per response.Reviewed and do not believe adjustment is needed
19Reviewed and have or will modify the treatment 10 I have previously discussed with the provider
and their response was 3 I attempted to modify the therapy, but the patient
response was not favorable 1
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Tramadol with SSRIs or SNRIsPotential for Serotonin Syndrome Response detail as of 9/27/2011Note that providers may choose more than one selection
per response. Information clinically useful: plan to monitor 21 I will use this information in the care of future pts
30No longer my patient 10Somewhat useful to my practice 8Extremely useful to my practice 8Very useful to my practice 23
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Tramadol with SSRIs or SNRIsPotential 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.”
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Tramadol with SSRIs or SNRIsPotential 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.”
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Tramadol with SSRIs or SNRIsPotential 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.”
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Tramadol with SSRIs or SNRIsPotential 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.”
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Tramadol with SSRIs or SNRIsPotential 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.”
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Colchicine DURHistorical 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 Drugs-Compliance 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 enforcementJuly 29, 2009: Colcrys® approved for Familial
Mediterranean Fever (FMF)July 30, 2009: Colcrys® approved for Acute Gout FlaresOctober 16, 2009: Colcrys® approved for Chronic Gout
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Colchicine DUROctober 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®May 2010 May 2011
Colcrys® No Rx’s 8 Rx’s$241.82/46
tabs
colchicine 42 Rx’s (7 different NDCs)
$23.25/46 tabs
No Rx’s
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Utilization OverviewNumber of Recipients
Number of Claims
Average Cost/Claim
Allopurinol 172 432 $6.62
Colcrys® 16 29 $259.78
Probenecid 7 13 $25.26
Probenecid-colchicine
0 0 $0.00
Uloric® 9 25 $167.62
Colcrys’® Place in Therapy
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All information based on Idaho Medicaid Pharmacy Data 2nd Quarter 2011 (4/1/11-6/30/11).
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Colcrys® - Summary72.2% (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.
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Therapeutic Criteria for Colcrys®
1. Acute Gout• Contra-indication and/or failure to NSAIDS or
corticosteroids
2. Chronic Gout• Adjunct to allopurinol AND contra-indication
or failure to NSAIDS
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Ketorolac DURHistorical 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.
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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 3/1/2011-5/31/2011.
A total of 29 patient profiles were evaluatedLetters 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)
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Ketorolac DURCriteria 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.
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Ketorolac DURResponse detail as of 9/26/2011Note that providers may choose more than one selection
per response. Information clinically useful: plan to monitor
2 I will use this information for care of future patients.
2No longer my patient
1My patient, but I did not prescribe this
1My patient, but I have not seen him/her recently
1Somewhat useful to my practice
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”
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Ketorolac DUR - SummaryMaximum 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
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Auto Refill PracticesSome pharmacies are instituting Auto Refill
policies which allow them to automatically dispense refills based on days since last fill
IssuesPotential for stockpilingPotential for continued fill of discontinued
medicationsIncrease cost/waste
Please see Survey in Packet
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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)
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Auto Refill Practices – Results Does your pharmacy participate in an
Auto Refill process?
23
27
51
YesNo
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Auto Refill Practices – Results Do you exclude Auto Refill for any specific
third party payers? If so which? ____See attached sheet for comments______
24
5
32
YesNo
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Auto Refill Practices – Results How are specific patients included in the
Auto Refill process?
25
Series10
5
10
15
20
2520
10
2
All patients are automatically enrolled in Auto Re-fillAll patients are offered Auto Refill as a service optionA patient must specifically request Auto refillAll patients are included unless they specifically "opt out" of the program
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Auto Refill Practices – Results Which medications does your pharmacy
include in your Auto Refill?
26
Series10
5
10
15
20
25
5
22
2
All Medications
Maintenance medications only
Our Pharmacy has a specific list of medications or therapeutic classes (see attached sheet)
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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
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Auto Refill Practices – Results Does your system alert the patient that
the prescription is ready for pick up? If so, how?
28
25
9
YesNo
Series10
5
10
15
20
25
3025
1917
3
Phone Text Email Other (see attached sheet)
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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?
29
Series10
10203040 33
7 11
Phone call to patientMail outOther
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Auto Refill Practices – Results Do you find the Auto Refill process
beneficial for patients?
30
24
6
YesNo
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Auto Refill Practices – Results Do you find the Auto Refill process
potentially dangerous for patients?
31
17
13YesNo
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Auto Refill Practices – Results Do you find the Auto Refill process has
increased compliance by the patient?
32
18
7
YesNo
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Auto Refill Practices – Results Do you have any other comments related
to the Auto Refill process?24 responses see attached sheet
Comments/Questions/Recommendations?
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Hepatitis C DURRationale 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.
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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
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Hepatitis C DURFDA Approved Indication
Treatment of chronic hepatitis C in combination with interferon.
Profiles Selected for ReviewPatients who had at least one paid claim for
oral ribavirin between 5/01/2011 and 7/31/2011. N=29
Patient Demographics16 female, 13 maleAverage age 46 yrs (Range 31-59)
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Hepatitis C DURDiagnosis for Hepatitis C in Electronic Profile
Yes – 28 patientsNo – 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.
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Hepatitis C DURMedication 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
1.038
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Hepatitis C DURRibavirin 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)
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Hepatitis C DURInterferon 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)
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Hepatitis C DURRecommendations
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.
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Hepatitis C DURPotential 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.
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Hepatitis C DURCost 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
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Hepatitis C DUR
Incivek and VictrelisNew 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).
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Hepatitis C DURIncivek – 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
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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.
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Hepatitis C DURPrior 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 Victrelis15 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.
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Hepatitis C DUR
SummaryNot recommending prior authorization for
generic ribavirinRecommend continuing to require prior
authorization for Incivek and Victrelis
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Transdermal Testosterone DURRationale for this DUR Project
P&T Committee recommended implementing therapeutic criteria, including serum testosterone levels, for the Transdermal Testosterone drug class
Patient SelectionPatients 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)
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Transdermal Testosterone DURPatient Demographics
50
Series105
10152025303540
10
17
23
37
28
8
18-20 21-30 31-40 41-50 51-60 61-70
Age
# o
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Transdermal Testosterone DURProduct Selection
Preferred agents Androgel n=91 Androderm Patches n=31
Non-preferred agents Testim Gel n=1 Fortesta Gel n=0 Axiron Underarm Solution n=0
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Transdermal Testosterone DURPatient Diagnoses
ICD-9 257.x hypogonadismICD-9 259.9 unspecified endocrine
disorderICD-9 302.7x low libidoICD-9 607.84 erectile dysfunction
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Transdermal Testosterone DURPatient Diagnoses
53
Series10
10203040506070
50
2 38
60
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
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Transdermal Testosterone DURPotential Cost Savings
$133,447 paid in claims for the study periodIf 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.
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Transdermal Testosterone DURDiagnosis 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
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Transdermal Testosterone DURMore specific symptoms and signs of
androgen deficiency in menAs 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
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Transdermal Testosterone DURLess specific symptoms and signs of
androgen deficiency in menAs 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
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Transdermal Testosterone DURDiagnosis of androgen deficiency in men
Consistent symptoms and signsUnequivocally 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.
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Transdermal Testosterone DURContra-indications to therapy with
testosteroneBreast or prostate cancerPalpable 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 apneaSevere lower urinary tract symptomsUncontrolled or poorly controlled heart failure
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Transdermal Testosterone DUR
Follow-Up Laboratory Determination in 3-6 monthsAchieve testosterone level during treatment in
the mid-normal range; test 3-6 months after therapy has started
Then Annual MonitoringAssess whether symptoms have responded to
treatmentAssess whether patient is suffering any adverse
effectsAssess adherence to therapy
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Transdermal Testosterone DUR
Duration of TherapyFor 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
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Transdermal Testosterone DURNumber of Prescriptions
62
Series105
101520253035 32
11 11
2 14
1 1 1 1
1 2 3 4 5 6 7 8 9 10 11 12
# of fills
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Transdermal Testosterone DURDuration with respect to diagnosis
63
hypogonadism low libido or ED No applicable diagnosis
02468
101214161820
1 2 3 4 5 6 7 8 9 10 11 12
# of fills
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Transdermal Testosterone DURRecommendations
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.
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Transdermal Testosterone DURRecommendations, continued
Initial approval would be for six monthsThen 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
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Transdermal Testosterone DURProposed 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.
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Oral Terbutaline UtilizationFDA Drug Safety Communication: New
warnings against use of terbutaline to treat preterm laborOn 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
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Oral Terbutaline UtilizationReview of the data included female patients
between the ages of 10-55, n=28.Female patients < 10 years or > 55 years: 1 -
62 year oldNo male patients
23/28 patients had a pregnancy diagnosis in the electronic profile.Average age 27 years (range 19-37)1 fill – 222 fills – 53 fills – 1Average fill was for 35 tablets (range 3-90) 68
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Oral Terbutaline Utilization
19
7
1 1
Prescribers
OB/GYNFamily PracticeLegal MedicineNP (works in OB?GYN office)
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Oral Terbutaline Utilization
6
5
2
2
For multiple patients per office
OB/GYN BoiseOB/GYN Idaho FallsOB/GYN Twin FallsOB/GYN Coeur d'Alene
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Oral Terbutaline UtilizationAll 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 FallsNo address available for one office
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Oral Terbutaline UtilizationBased 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.
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Proposed Studies for Next Quarter:Citalopram high doseOral Terbutaline InterventionInjectable Atypical AntipsychoticsP&T Committee Narcotic Analgesic StudiesSynagis 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
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Citalopram High Dose DURFDA 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.
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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.
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Injectable Atypical AntipsychoticsInvega® Sustenna® and Risperdal® Consta®Indications
Utilization Overview
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
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)
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Injectable Atypical AntipsychoticsInvega® Sustenna® and Risperdal® Consta®Responsibilities of the parties involved
Magellan Run reports to identify Prescribers, Pharmacies,
and PatientsIdaho Medicaid Pharmacy Unit
Analyze reports and identify where intervention is needed
Idaho Medicaid Program Integrity Send out letters requesting documentation of dose
administration
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P&T Committee Narcotic Analgesic StudiesCommittee 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 ProfilingNumber of patients on monthly (chronic) narcoticsNumber of different agents used by individual
patients Total (cumulative) monthly doses of all concurrent
narcoticsNumber of prescribers per patientAnalysis of multiple scripts from multiple providers
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P&T Committee Narcotic Analgesic StudiesPatient Profiling Continued
Other addictive drugs prescribed concurrentlyDiagnosis/indication for narcotic use and data
backing that diagnosisPatients with no relevant diagnosis for medicationEvaluation for evidence of illicit drug useRelationships of long-acting narcotic use and
breakthrough narcotics use (lack of long acting and/or breakthrough narcotics given continuously)
Hospital and ER admissions for overdosePrescription fill history, including early refills
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P&T Committee Narcotic Analgesic StudiesProvider 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.
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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
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P&T Committee Narcotic Analgesic Studies
Please refer to Narcotic Spreadsheet in Packet for details.
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Synagis Utilization InterventionUpdate 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
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Leukotrienes vs. inhaled corticosteroids in children with asthmaNumber 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
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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 Controlled85
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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
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2010 Annual DUR ReportPhysician 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 ActivitySummary Report of activities/meetings
(Attachment 4)DUR Board Involvement
Disease Management Program Medication Therapy Management
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2010 Annual DUR ReportGeneric Policy and Authorization Data
Generic Drug Substitution Policies (Attachment 5)
Generic Utilization Percentage: 70%Generic Expenditure Percentage: 17%
Program Evaluation/Cost SavingsCost Savings Estimate (Attachment 6)
Prospective DUR $4,879,377 Retrospective DUR $463,187 Total Savings $5,342,564
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2010 Annual DUR ReportFraud, 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 PracticesE-PrescribingExecutive Summary
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Prospective DUR ReportHistory 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
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Prospective DUR ReportIdaho Medicaid ProgramProDUR Message Report
Sep-11
ProDUR ProDUR Message MessageMessage Severity Count Amount
Drug To Drug 1 4,812 $710,509.70 2 11,760 $1,848,784.75 3 55,682 $8,568,836.29 Drug To Gender 1 117 $34,305.95 2 37 $2,836.30 Drug To Known Diseas 1 57,898 $7,308,213.91 2 217,811 $31,264,134.87 3 249,187 $39,299,697.37 Drug To Pregnancy 1 22 $419.72 2 6 $99.93 A 10 $174.59 B 71 $5,329.99 C 153 $12,086.68 D 34 $668.50 X 26 $1,436.76 Duplicate Therapy 0 102,499 $18,771,054.83 Min Max 0 34,089 $5,130,125.40 Too Soon Clinical 0 19,391 $3,472,743.89
ALL 753,605 $116,431,459.43 Total Number of Claims with Messages 194,477 Average ProDUR Message Per Claim 3.88
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Drug to Pregnancy Encounters
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Drug-to-Pregnancy Encounter
FDB Severity FDB DescriptionUser
SeverityUser Severity Description
1 Contraindicated or not recommended 1 Major
2 Precautions or warnings 2 ModerateA Adequate and well controlled studies have
failed to demonstrate a risk to the fetus in the 1st trimester of pregnancy, and no risk in later trimesters.
3 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.
2 Moderate
X Studies in humans or animals have shown fetal abnormalities and/or there is positive evidence of fetal abnormalities.
1 Major
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Drug to Pregnancy Encounters
Currently we report all severity levels for pregnancy and severity level 1 is set to rejectSeverity Level 1 = Major = Not Recommended in
pregnancySeverity Level 2 = Moderate = Evaluate carefully if
pregnantSeverity Level 3 = Minor = No known risk in pregnancy
Please see attached handout for specific details as it relates to specific medications
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DUR Fall NewsletterCopy of Summer Newsletter in packetBrainstorm for new topics
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Medicaid Update
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