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 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.)

3

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

4

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

5

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.”

6

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.”

7

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.”

8

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.”

9

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.”

10

11

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

12

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

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

13

All information based on Idaho Medicaid Pharmacy Data 2nd Quarter 2011 (4/1/11-6/30/11).

14

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.

15

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

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.

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 3/1/2011-5/31/2011.

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)

17

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.

18

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”

19

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

20

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

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?

23

27

51

YesNo

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

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

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)

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?

28

25

9

YesNo

Series10

5

10

15

20

25

3025

1917

3

Phone Text Email Other (see attached sheet)

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

Auto Refill Practices – Results Do you find the Auto Refill process

beneficial for patients?

30

24

6

YesNo

Auto Refill Practices – Results Do you find the Auto Refill process

potentially dangerous for patients?

31

17

13YesNo

Auto Refill Practices – Results Do you find the Auto Refill process has

increased compliance by the patient?

32

18

7

YesNo

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 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.

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 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)

36

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.

37

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

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)

39

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)

40

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.

41

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.

42

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

43

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).

44

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

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 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.

47

Hepatitis C DUR

SummaryNot recommending prior authorization for

generic ribavirinRecommend continuing to require prior

authorization for Incivek and Victrelis

48

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)

49

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

f P

ati

en

ts

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

51

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

52

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

# o

f p

ati

en

ts

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.

54

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

55

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

56

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

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.

58

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

59

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

60

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

61

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

# o

f p

ati

en

ts

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

# o

f p

ati

en

ts

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.

64

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

65

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.

66

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

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

Oral Terbutaline Utilization

19

7

1 1

Prescribers

OB/GYNFamily PracticeLegal MedicineNP (works in OB?GYN office)

69

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

70

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

71

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.

72

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

73

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.

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 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)

76

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

77

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

78

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.

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 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

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

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

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 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

87

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

88

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

89

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

90

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 

91

Drug to Pregnancy Encounters

92

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

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

93

DUR Fall NewsletterCopy of Summer Newsletter in packetBrainstorm for new topics

94

Medicaid Update

95