february 16, 2017 - idaho medicaid pharmacy program | … pain reliever for most state medicaid...

February 16, 2017

1

Ongoing Reviews

Narcotic Prescribing Improvement Project

Top 150 Utilizers

Top 150 Narcotic Utilizers 2013-2016 and Treatment of Opioid Induced Constipation

Methadone

Buprenorphine and benzodiazepine concomitant use

Opioid and benzodiazepine concomitant use

Hepatitis C Update

Foster kids

Second-Generation Antipsychotic Use in children < 6 years old2

February 16, 2017

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Medicaid DUR

February 16, 2017

4

Opioid Induced Constipation

Frequent use of opioids can lead to constipation

Increased amount of time for stool to travel through the gastric system

Decrease longitudinal propulsive peristalsis in the intestines

Opioids can cause gastroparesis

Opioids reduce digestive secretions and decrease the urge to defecate

Additional factors

Inadequate fiber/fluid intake

Lack of physical activity

Diabetes, spinal cord compression, excessive calcium, or kidney problems 5


Idaho Medicaid was asked about the frequency of emergency room visits for abdominal pain due to opioid induced constipation.

Difficult to gather medical billing information and data to determine if emergency room visits for abdominal pain are related to opioid induced constipation.

Pharmacy data can determine prescribing patterns for medications to treat or prevent opioid induced constipation.

Obtained the top 150 narcotic utilizers and determined the number of patients and claims for the treatment/prevention of opioid induced constipation.

6


Review of top 150 narcotic utilizers

Total number of patients prescribed an agent for constipation

21 patients

Male= 7 Female=14

6 patients were prescribed more than 1 agent.

7


8


Conclusions

Majority of patients from the top 150 narcotic utilizers are not treated for opioid induced constipation.

21 patients (14%) have active prescription history for agents to treat constipation.

Multiple factors can be involved in constipation including diet, exercise, and comorbid illnesses.

Limitations to data collection for Medical admissions to the emergency room and diagnosis to determine opioid induced constipation prevalence in Medicaid population.

9

Ongoing Review

February 16, 2017

10

MethadoneGrowing Public Health Concern

More than 16,500 people in the United States die each year from opioid-related prescription drug overdoses.

Methadone is responsible for nearly 1/3 of these deaths but accounts for only 2% of opioid pain reliever prescription.

Centers for Disease Control and Prevention. “Opioids Drive Continued Increase in Drug Overdose Deaths” (2013). http://www.cdc.gov/media/relases/2013/p0220_drug_overdose_deaths.html.

11

MethadonePreferred pain reliever for most state Medicaid programs.

Idaho Medicaid removed Methadone preferred status October 2015.

Prior authorization required.

Informed methadone providers of implementation of methadone prior authorization and requested tapering off of methadone.

12

MethadoneMethadone Prior Authorization Request Forms

Methadone, Initial Request

States initial criteria for review:

Failure of all alternative long acting narcotic agents.

Electrocardiogram (QTc interval documentation).

Pain score and functionality documentation.

Other active concurrent opioids (immediate release).

Documentation of failure/intolerance to non-opioid or opioid agents.

13

Methadone Methadone, Reauthorization

Emphasizes monitoring and recommends dose tapering: Electrocardiogram (QTc interval annual review).

Doses greater than 40 mg/day will require documentation of medical necessity and clinical reason why dose reduction cannot be employed.

History of failure/intolerance to non-opioid or other opioid agents.

Only prescribers who are familiar with methadone’s titration and risks, or those who are able to consult with a pain specialist or clinical pharmacist, should prescribe or make changes to methadone treatment.

Work in progress.

14

MethadoneReview of Methadone drug utilization after changing to non-preferred agent.

Calendar Quarters Reviewed:

4th Quarter 2015 (Oct-Dec)

2nd Quarter of 2016 (Apr-Jun)

3rd Quarter of 2016 (Jul-Sept)

4th Quarter of 2016 (Oct-Dec)

15

Methadone

16

Methadone

17

Methadone

18

MethadonePatients taking more than 40 mg/day

Average #tablets/day=7

Range: 5-17 tablets/day (50 mg-160 mg/day)

Morphine Equivalents Daily (MED)*

30 mg-240

40 mg=320

50 mg=500

60 mg=600

70 mg=840

130 mg=1560*Opioid Dose Calculator: http://www.agencymeddirectors.wa.gov/opioiddosing.asp

(Washington State Agency Medical Directors' Group)19

MethadoneIn conclusion:

Methadone utilization has decreased since incorporation of non-preferred status and prior authorization requirements.

Total providers, total patients, and total claims have decreased.

No change noted with percentage of patients on greater than 40 mg/day of methadone.

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Methadone Questions/Comments??

21

February 16, 2017

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23

Suboxone Package Insert

Buprenorphine in combination with benzodiazepines or other CNS depressants including alcohol has been associated with significant respiratory depression and death.

Patients should be warned of the potential of self-administration of benzodiazepines or other depressants while under treatment with Suboxone.


24

Payment block went in to effect 1/6/16 requiring prior authorization for payment for either buprenorphine or benzodiazepine with overlapping days of service.


25

PMP Interconnect Search

Nineteen States now on the list (must select each individual state to search) –including Idaho

Alaska Massachusetts North Dakota

Arizona Michigan Ohio

Colorado Minnesota Rhode Island

Illinois Mississippi South Carolina

Indiana Nevada Texas

Kansas New Mexico Utah


26

New Federal Regulations Increase Limit Rule to 275 Buprenorphine Patients

Effective Date: 8/08/2016


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Physicians who have prescribed buprenorphine to 100 patients for at least one year can now apply to increase their patient limits to 275 under new federal regulations.

To be considered for the higher limit, complete the Online Request for Patient Limit Increase. SAMHSA reviews applications within 45 days of receipt.

Document Citation: 81 FR 44711

http://buprenorphine.samhsa.gov/pls/bwns/waiver


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FOR IMMEDIATE RELEASENovember 16, 2016

Contact: HHS Press [email protected]

HHS takes additional steps to expand access to opioid treatment The U.S. Department of Health and Human Services (HHS) is taking additional steps to

address the U.S. opioid epidemic by further expanding access to medication-assisted treatment (MAT) for opioid use disorders.

Administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), today’s announcement enables nurse practitioners (NPs) and physician assistants (PAs) to immediately begin taking the 24 hours of required training to prescribe the opioid use disorder treatment, buprenorphine.

mailto:[email protected]


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NPs and PAs who complete the required training and seek to prescribe buprenorphine for up to 30 patients will be able to apply to do so beginning in early 2017. Previously, only physicians could prescribe buprenorphine. Once NPs and PAs receive their waiver they can begin prescribing buprenorphine immediately.

HHS also is announcing its intent to initiate rulemaking to allow NPs and PAs who have prescribed at the 30 patient limit for one year, to apply for a waiver to prescribe buprenorphine for up to 100 patients.


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NPs and PAs prescribing buprenorphine for treatment of opioid abuse in Idaho

What still needs to happen:

The new language has to be added to the federal controlled substances act (DEA).

There is no time estimate yet on when this will happen.

Personal communication – Idaho Board of Pharmacy – January 19, 2017


31

200 201 210 223 222 211 212 223241 251 265 265 267

301

342

26 27 23 2036 31 20 31 35 40 46 32 28 21

40

0

50

100

150

200

250

300

350

400

2/1/13 -4/30/13

6/1/13 -8/31/13

9/1/13 -11/30/13

12/1/13 -2/28/14

3/1/14 -5/31/14

6/1/14 -8/31/14

9/1/14 -11/30/14

12/1/14 -2/28/15

3/1/15 -5/31/15

4/1/15 -8/31/15

9/1/15 -11/30/2015

12/1/15 -2/29/16

3/1/16 -5/31/16

6/1/16 -8/31/16

9/1/16 -11/30/16

Total # of participants on oral buprenorphine

Participants who paid cash for an opioid while on oral buprenorphine


32

251 265265 267

301342

57 65 5955 55 60

40 46 32 28 2140

20 19 10 7 120

100

200

300

400

6/1/15 - 8/31/15 9/1/15 - 11/30/15 12/1/15 - 2/29/16 3/1/16 - 5/31/16 6/1/16 - 8/31/16 9/1/16 - 11/30/16

buprenorphine patients

concomitant benzo while on buprenorphine

cash paying opioids while on buprenorphine

cash paying opioids AND concomitant benzo while on buprenorphine


33

24

11

4

21

0

5

10

15

20

25

30

Buprenorphine and benzodiazepine September 2016 – November 2016

Buprenorphine prescriber justified ongoing benzo usage

Buprenorphine prescriber is weaning benzo or has discontinued benzo

Patient no longer on buprenorphine but continuing benzo

Paying cash for benzo while on buprenorphine (see detail next slide)


34

15

1

5

0

2

4

6

8

10

12

14

16

Detail on patients paying cash for benzo while on buprenorphine but no PA submitted

MD aware/ok with it

Patient told to discontinue benzo

Procedural (1 - 4 tablets), 1x fill


35

Questions/Comments ??

Chris Johnson PharmD

Mark England PharmD

36


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FDA is requiring boxed warnings for all opioid analgesics and benzodiazepines with information about the serious risks associated with concomitant use of opioids and benzodiazepines.

Part of the FDA Opioid Action Plan to combat the growing epidemic of opioid abuse, dependence and overdose in the United States.


38

Diazepam Package Insert:

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, or death. Reserve use for patients for whom alternative therapies are inadequate and limit use to lowest possible dose and shortest possible duration. Monitor for signs or symptoms of respiratory depression and sedation

Oxycodone Package Insert:

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation


39

Included in packet is the FDA Drug Safety Communication and FDB response.

ProDUR report ran for 1/2017 for DR/DR between LA/SA Opioids and Benzos and LA/SA Opioids and Sleep Drugs;Tranquilizers

5,236 claims

1,925 unique recipients


40

Utilizing Magellan Rx First IQ Data and pulling for dates of 11/1/2016 –1/31/2017:


41

Discussion on Concomitant Benzodiazepines and Opiates

How to proceed ?

February 16, 2017

4th Quarter 2016

(Calendar Year)

42

Hepatitis-C DUR

43

Hepatitis-C DUR

44

Hepatitis-C DUR

45

Hepatitis-C DUR

46

Hepatitis-C DUR

47

Hepatitis-C DUR

48

Hepatitis-C DUR

49

Hepatitis-C DUR

50

Hepatitis-C DUR

51

Hepatitis-C DUR

52

Hepatitis-C DUR

53

Hepatitis-C DUR

54

Hepatitis-C DUR

Total: $1,510,841 55

Hepatitis-C DUR Questions/Comments??

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February 16, 2017

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February 16, 2017

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Current Interventions/Outcomes Studies

Codeine and Tramadol Use in Children

Low dose quetiapine

Ophthalmic Antibiotic/Steroid Combinations

59

February 16, 2017

60

Codeine Use in Children

AAP Report Says Codeine Too Risky for Kids, Urges Restrictions on Use 9/19/16

The American Academy of Pediatrics is urging parents and health providers to stop giving codeine to children, calling for more education about its risks and restrictions on its use in patients under age 18. A new AAP clinical report in the October 2016 issue of Pediatrics, Codeine: Time to Say `No’, cites continued use of the drug in pediatric settings despite growing evidence linking the common painkiller to life-threatening or fatal breathing reactions.

61


AAP Report Says Codeine Too Risky for Kids, Urges Restrictions on Use 9/19/16

According to the AAP report, it still is commonly prescribed to children after surgical procedures such as tonsil and adenoid removal. More than 800,000 patients under age 11 were prescribed codeine between 2007 and 2011, according to one study cited in the AAP report. Otolaryngologists were the most frequent prescribers of codeine/acetaminophen liquid formulations (19.6 percent), followed by dentists (13.3 percent), pediatricians (12.7 percent) and general practice/family physicians (10.1 percent).

62


Excerpts from Codeine: Time to Say No

Codeine is a prodrug that has limited affinity for the µ-opioid receptor and no analgesic effects. After an oral dose, the majority of codeine undergoes hepatic glucuronidation or N-demethylation to inactive metabolites. The analgesic properties result from hepatic metabolism and conversion of the parent compound (codeine) to morphine and the active metabolite morphine-6-glucuronide. The conversion from codeine to morphine is regulated by the cytochrome P450 2D6 (CYP2D6) enzyme system.

63



The activity of CYP2D6 varies significantly as a function of genetic polymorphisms. Poor metabolizers initially received the greatest attention because of codeine’s lack of efficacy in such patients. As our understanding of the influence of genetic variations on pharmacokinetics has improved, attention has become more focused on individuals who are ultrarapid metabolizers secondary to gene duplications. This latter group has ≥2 copies of the CYP2D6 gene, which can result in an enzyme activity score ≥3, indicating a very high level of enzyme activity. The result in these patients is the production of large amounts of morphine that can cause respiratory depression or apnea, even after normal therapeutic doses of oral codeine.

64


Excerpts from Codeine: Time to Say NoIn the last 5 years, various organizations and regulatory bodies have promulgated warnings regarding adverse responses associated with codeine, as follows:

1. March 2011: The World Health Organization deleted codeine from its list of essential medications for children because of concerns that its “efficacy and safety were questionable in an unpredictable portion of the pediatric population.”

2. August 2012: The US Food and Drug Administration (FDA) issued a safety alert regarding the use of codeine in children after tonsillectomy, adenoidectomy, or adenotonsillectomy.

3. February 2013: An update from the FDA added a “black box warning” to the drug label of codeine and codeine-containing preparations. The warning advises health care professionals “to prescribe an alternative analgesic [to codeine] for postoperative pain control in children undergoing tonsillectomy and/or adenoidectomy.” A contraindication was added to restrict codeine use in such patients. The “Warnings/Precautions,” “Pediatric Use,” and “Patient Counseling Information” sections of the label were also updated.

65



4. June 2013: The European Medicines Agency issued a report recommending the restriction of codeine for the treatment of pain to children older than 12 years as well as a contraindication to its use in children younger than 18 years undergoing tonsillectomy and/or adenoidectomy. In addition, it recommended against codeine use in breastfeeding women.

5. June 2013: Health Canada announced that it had reviewed the safety of prescription pain and cough medications containing codeine and recommended against their use in children younger than 12 years.

6. March 2015: The European Medicines Agency completed a review of the use of codeine for cough and cold and recommended against its use in children younger than 12 years as well as children and adolescents between 12 and 18 years who have problems with breathing.

66


Paid oral codeine claims for Idaho Medicaid participants – Age < 18 years

August 1 – October 31, 2016

287 claims

274 unique patients (13 patients with two paid claims)

$3723 in paid claims to pharmacies

Safety issue – not a cost issue !!

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68

0-6 years, 2, 1%

7-11 years, 65, 24%

12-15 years, 129, 47%

16-17 years, 78, 28%

Paid claims for Idaho Medicaid participants – Age < 18 years August 1 - October 31, 2016


Focusing on children < 12 years old:

68 paid claims for 67 unique patients

58 prescribers (one prescriber with 3 paid claims and 9 prescribers with 2 paid claims)

69


14

14

10

9

8

8

2

1

1

Dentist

PA

MD-FP

NP

Surgeon

MD-ER

Ophthalmology

MD-Pediatrics

MD-Internal Medicine

Focusing on children < 12 years old

Taxonomy of Prescribers

70


71

Discussion on how to proceed

Currently codeine/acetaminophen products are a preferred agent and pay at the pharmacy with prior authorization not needed.

Possible option: Institute age limits that would require an age override prior authorization with medical necessity justification for use (e.g. under 12 years old or under 18 years old).

Tramadol Use in Children

72

Ultram (tramadol) Package Insert

The safety and efficacy of Ultram in patients under 16 years of age have not been established. The use of Ultram in the pediatric population is not recommended.

FDA Drug Safety Communication – 9/21/15

FDA Evaluating Risks of Using Tramadol in Children Aged 17 and Younger:

The FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing.


73

Mechanism of Action

Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin.

Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding.


74

Metabolism

Tramadol is extensively metabolized after oral administration by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% of the dose is excreted as metabolites. The remainder is excreted either as unidentified or as unextractable metabolites. The major metabolic pathways appear to be N- and O-demethylation and glucuronidation or sulfation in the liver. One metabolite (O-desmethyltramadol, denoted M1) is pharmacologically active in animal models. Formation of M1 is dependent on CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response.


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Pharmacogenomics

Approximately 7% of the population has reduced activity of the CYP2D6 isoenzyme of cytochrome P-450. These individuals are "poor metabolizers". Based on a population PK analysis of Phase I studies in healthy subjects, concentrations of tramadol were approximately 20% higher in "poor metabolizers" versus "extensive metabolizers", while M1 concentrations were 40% lower.


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Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products, including ULTRAM®, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).


77

Paid oral tramadol (includes tramadol/acetaminophen) claims for Idaho Medicaid participants – Age < 18 years

November 1, 2015 – October 31, 2016

1158 claims

803 unique patients

$12,688 in paid claims to pharmacies


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0-6 years, 0, 0% 7-11 years, 68, 6%

12-15 years, 554, 48%

16-17 years, 536, 46%

Paid oral tramadol (includes tramadol/acetaminophen) claims for Idaho Medicaid participants – Age < 18 years

November 1, 2015 – October 31, 2016


15

14

12

9

8

3

2

1

1

1

1

1

0

0

0

Surgeon

PA

MD-FP

MD-ER

MD-Pediatrics

OB

Urology

Dentist

Podiatry

Student

Medical Examiner

other

MD-Internal Medicine

NP

Ophthalmology

Taxonomy of Prescribers

79


80

Discussion on how to proceed

Currently tramadol and tramadol/acetaminophen are preferred agents and pay at the pharmacy with prior authorization not needed for patients ≥ 10 years of age.

Possible option: Institute age limits that would require an age override prior authorization with medical necessity justification for use (e.g. under 18 years old).

February 16, 2017

81

Low dose quetiapine

82

Per package insert:

Low dose quetiapine

83

Per package insert:

Low dose quetiapine

84

Per package insert:

Low dose quetiapine

85

Concern – Likely that low dose quetiapine (especially doses < 100mg/day) is being used off-label as a sedative-hypnotic as these doses are not therapeutic for treatment of either bipolar disease or schizophrenia.

Low dose quetiapine

86

Paid claims for quetiapine 25mg and 50mg tablets between 11/1/16 – 12/31/16

Children < 18 years

218 patients

372 claims

Adults ≥ 18 years

472 patients

819 claims

The majority of these patients are filling prescriptions for the 25mg and 50mg strengths monthly and for at least 30 tablets so these tablet strengths are NOT being used for initial dose titration.

Low dose quetiapine

87

176

42

Paid claims for quetiapine 25mg and 50mg tablets for children < 18 years between 11/1/16 – 12/31/16

Only on 25mg and 50mg tablets On 25mg and/or 50mg tablets plus larger strength tablet

Low dose quetiapine

88

48

4

78

2116

72

0

10

20

30

40

50

60

70

80

90

25mg 37.5mg 50mg 75mg 100mg 150mg 200mg

Nu

mb

er o

f p

atie

nts

Daily dose

Paid claims for quetiapine 25mg and 50mg tablets for children < 18 years between 11/1/16 – 12/31/16

Low dose quetiapine

89

Discussion on how to proceed next

Limiting 25mg and 50mg tablets to 6/month which is the maximum amount needed to titrate up to a minimally therapeutic dose per package insert dosing.

Concerns – will affect hundreds of current patients; staffing issues to handle phone calls and PA requests

Grandfather current patients ?

Send out educational DUR letter ?

February 16, 2017

90


91

Paid claims between 9/1/16 – 11/30/16

DUR review requested by P&T Committee to look at taxonomy of prescriber of pediatric patients

Concern: Risk of cataract formation, glaucoma, or worsening infection, especially with long-term use.


92

Risks Associated with Use of Ophthalmic Steroids

Prolonged use: risk for increased intraocular pressure (glaucoma) and secondary infections.

Micromedex Solutions – online database accessed 12/22/16

Cataracts can develop in patients with uveitis as a result of chronic ocular inflammation or secondary to the chronic use of steroids.

American Academy of Pediatrics

Pediatric Cataracts: An Overview

Nov 11, 2015


93

< 18 years of age, 169, 64%

>= 18 years of age, 96, 36%

Paid claims between 9/1/16 – 11/30/16


94

19

7

11

10

5

3

8

10

5

12

7

13

15

7

8

19

7

3

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

# of recipients

Age

of

reci

pie

nt

Breakdown by age


95

Patients with more than one paid claim for an ophthalmic steroid

Of the 169 paid claims for patients < 18 years, 8 patients had 2 claims each during the 9/1/16 – 11/30/16.

Reviewed these 8 patients’ profiles and none of them had more than 2 paid claims for an ophthalmic steroid looking back for 2 years.


96

Prescribed by ophthalmologist/optometrist, 7,

87%

Prescribed by surgeon, 1, 13%

Patients with more than one paid claim for an ophthalmic steroid


97

108

18 159 6 5 3 5

0

20

40

60

80

100

120

# o

f p

resc

rib

ers

Taxonomy of prescribers


98

Discussion

Majority of prescriptions were done by ophthalmologist/optometrists.

Can limit to one fill/60 days (or any other number of days) without prior authorization required.

Study Proposals for Upcoming Quarters:

99

Multiple dosage forms of quetiapine prescribed concomitantly

Paroxetine Use in Children

Temazepam – No Longer a Preferred Sedative


100

The P&T Committee in November 2016 expressed concern about the usage of paroxetine in children < 18 years old due to both lack of efficacy and incidence of side effects.


101

FDA Statement Regarding Anti-Depressant Paxil for Children

June 19, 2003

Three well-controlled trials in pediatric patients with MDD failed to show that the drug was more effective than placebo.

The Food and Drug Administration (FDA) said today it is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 treated with the drug Paxil for major depressive disorder (MDD).


102


June 19, 2003

The FDA is recommending that Paxil not be used in children and adolescents for the treatment of MDD. There is currently no evidence that Paxil is effective in children or adolescents with MDD, and Paxil is not currently approved for use in children and adolescents. Other approved treatment options are available for depression in children.

The UK Department of Health issued a Press Release on June 10, 2003 stating that paroxetine (brand name Seroxat in the UK) must not be used to treat children and teenagers under the age of 18 years for depressive illness because UK authorities have concluded that there is an increase in the rate of self harm and potentially suicidal behavior in this age group, when paroxetine is used for depressive illness.


103


June 19, 2003

FDA advises that caretakers of pediatric patients already receiving treatment with Paxil for MDD talk to their doctor before stopping use of the drug. Patients should not discontinue use of Paxil without first consulting their physicians, and it is important that Paxil not be abruptly discontinued.


104

Current package insert for Paxil:

Pediatric Use: Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with PAXIL, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of PAXIL in a child or adolescent must balance the potential risks with the clinical need.


105

Current package insert for Paxil:

In placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with PAXIL and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.


106

Currently prior authorization is not required for patients > 6 years old.

Paid claims for paroxetine (both immediate release and extended release) in children < 18 years between 7/1/16 – 12/31/16: 86 patients identified.


107

10

2

5 56

16

2625

0

5

10

15

20

25

30

9 10 11 12 13 14 15 16 17

# o

f p

atie

nts

Age of patient

Breakdown by age (n=86)


108

Of the 86 patients with paid claims between 7/1/16 – 12/31/16, only 46 of them had paid claims between 11/1/16 – 12/31/16 showing a discontinuation rate of 47%.


109

Next steps for next quarter:

1. Change minimum age at which prior authorization is not needed for new patients as paroxetine immediate release is a preferred antidepressant to 18 years

2. Send out DUR letter to current patients on paroxetine who are < 18 years

a) Include educational information on efficacy and safety concerns

b) Who to include – e.g. exclude patients that are already 17 ?

c) Timeframe to implement change for current patients – e.g. 60 days to respond to DUR letter


110

Per Idaho Medicaid’s Pharmacy & Therapeutics Committee recommendation, temazepam 15mg and 30mg capsules have switched from preferred to non-preferred status effective 1-18-17. The other strengths of temazepam are already non-preferred.

The current preferred agents are zolpidem immediate release (unchanged for years) and Rozerem (ramelteon). The P&T Committee wanted to have a non-controlled sedative available as a preferred agent that would not require prior authorization.


111

Current patients who have a paid claim between 9-1-16 and 12-31-16 were identified:

398 unique recipients with 1203 paid claims

Many patients are filling their prescription monthly with 30 capsules monthly being the most common quantity.


112

Next steps for next quarter:

Send out DUR letter to current temazepam patients

Emphasize concerns about safety and efficacy of a long-term benzodiazepine, especially if the patient is concurrently on an opioid.

Prescriber will need to fill out a prior authorization form if they want the patient to continue on temazepam, including medical necessity justification, reason an alternative sedative cannot be used, and screening for substance abuse.

How long should we grandfather current patients ?

Prospective DUR Report

113

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

Prospective DUR Report

114

DUR Board Meeting February 16, 2017

115

Next Meeting April 20, 2017

116

february 16, 2017 - idaho medicaid pharmacy program | … pain reliever for most state medicaid...

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