ADHERENCE: Focus on Hepatitis C

Medication Use CrisisSponsored by the VA Medication Reconciliation Initiative

In conjunction with VHA Program Offices, DoD and IHS

Pam Belperio, PharmD, BCPS National Public Health Clinical PharmacistOffice of Public Health/Population Health

Jennifer Kryskalla, PharmD, BCPSPGY2 Pharmacy Resident

VA Sierra Pacific Network (VISN 21)

ADHERENCE: Focus on Hepatitis C

VETERANS ADMINISTRATION PATIENT CARE SERVICES

Background• Hepatitis C diagnosis:

– 5.4% of Veterans in VA care– 1.6% of general US population

• Majority infected during Vietnam era– Cirrhosis develops over 20-30 years– 1-5% die from liver cancer or cirrhosis

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• Remove the virus from the blood = CURE

• Prevent further damage to the liver

• Reduce chance of liver cancer

• Decrease the possibility of other Hep C complications

What is the reason to use medications in Hepatitis C?

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• Drugs are taken for a limited period of time• Two new drugs approved in 2011: Direct

Acting Antivirals (DAAs)• Once chronically infected with hepatitis C the

only way to get rid of it is with medication• New drugs offer cure rates of up to 40%-

80% in combination– Peginterferon + Ribavirin + DAA

(boceprevir or telaprevir)

How is Hepatitis C treated?

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Drug Specific Factors Affecting Adherence to DAAs

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Boceprevir Telaprevir

Pill burden: 12/day Pill burden: 6/day

Three times a day (specifically every 7-9 hours)

Three times a day (specifically every 7-9 hours)

Must be taken with food Must be taken with high fat food

Dysgeusia Rash/puritis

Burdensome Adverse Effects (98% of pts will experience

Burdensome Adverse Effects (98% of pts will experience


Consequence of Inappropriate Dosing = Resistance and Treatment Failure

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Time

Drug

Con

cent

ratio

n

IC 90

IC 50

Area of Potential

Replication

Inadequate drug levels will lead to viral breakthrough

Missed Dose

Inadequate Dose

Cmax

Cmin


Complicated Course:Boceprevir Therapy Algorithm

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VETERANS ADMINISTRATION PATIENT CARE SERVICES 8


Barriers to Adherence• Low level of health literacy/numeracy• Cognitive impairment• Psychosocial Issues (homeless, depression, low social

support)• Polypharmacy• Active Substance Use/Abuse• Stigma• Difficulty taking medications (swallowing pills, schedules)• Complex regimens (pill burden, frequency, food

requirements) • Adverse drug effects

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A Problem as Old as Medicine Itself…

“Keep watch also on the fault of patients which makes them lie about taking of things prescribed”

» Hippocrates circa 500 B.C

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Non-AdherenceHospitalization Risk

**

*

*** *

*

*

*

0

5

10

15

20

25

30

351-19

20-39

40-59

60-79

80-100

Hosp

italiz

ation

Risk

(%)

% Adherence

Sokol MC, McGuigan KA, Verbrugge RR, et al. Impact of medication adherence on hospitalization risk and health care cost. Med Care. 2005 43:521-30

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Methods of Estimating Adherence

• Directly observing therapy

• Measures of drug levels/biological markers in blood

• Record opening of a pill bottle electronically

• Patient interviews

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Calculations Used to Estimate Adherence

Proportion (%) of dayscovered (PDC)

Medication possessionratio (MPR)

Continuous measure ofmedication gaps (CMG)

X100Total days' supplyTotal study period days

Days' supply: Study period days

Total days of treatment gapsTotal days to end of obs. period

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Development of a Novel Medication Possession Ratio (MPR)

• Complex Running calculation

• Accounts for both stockpiling and gaps in therapy

• Resets when necessary

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MPR Example

Sum of Day’s Supply Received Sum of Day’s Elapsed =MPR

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MPR Example

Sum of Day’s Supply Received Sum of Day’s Elapsed

Past 2 Years

=MPR

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MPR Example


Past 2 Years

Rx release date + days supplyRx release date + days supply

=MPR

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MPR Example


Past 2 Years


=MPR

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MPR ExampleSum of Day’s Supply Received

Sum of Day’s ElapsedPast 2 Years


=MPR

Rx release date + days supply

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MPR Validation• VISN 21

• Prescriptions for all diabetes, hypertension and hyperlipidemia medication

• Laboratory results – Before starting the medication– Last result while on medication

• MPR associated with lab result

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Hypertension and Diabetes Outcomes using MPR


Uses for MPR

• Provides an accurate way to measure adherence with respect to outcomes

• This calculation can be used by providers to estimate a patients adherence

• Help identify adherence rate required to maximize benefit of medication

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Adherence important for DAAs• Adherence strictly

measured in Clinical Trials– Patients allowed a 7-9

hour dosing window– Lower SVR if outside

of dosing interval – Lower SVR if dose or

treatment duration <80%

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Boceprevir Adherence and Response


NationNumber

with Boceprevir

MPR < 0.80

MPR 0.80-0.94

MPR ≥ 0.95

Number with

TelaprevirMPR < 0.80

MPR 0.80-0.94

MPR ≥ 0.95

1,682 6% 14% 80% 381 8% 18% 74%

MPR Report from VA HCV Clinical Case Registry (CCR)

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VISN Number with Boceprevir MPR < 0.80 MPR 0.80-

0.94MPR ≥

0.95Number with

TelaprevirMPR < 0.80

MPR 0.80-0.94 MPR ≥ 0.95

1 104 <1% 18% 81% 42 10% 12% 79%2 13 0% 23% 77% 1 0% 0% 100%3 53 0% 13% 87% 17 0% 24% 76%4 117 7% 15% 78% 11 9% 18% 73%5 35 29% 11% 60% 14 7% 43% 50%6 85 0% 15% 85% 25 0% 12% 88%7 81 6% 10% 84% 13 15% 8% 77%8 150 2% 5% 93% 2 0% 0% 100%9 125 8% 14% 78% 20 20% 50% 30%

10 25 12% 12% 76% 9 0% 0% 100%11 47 4% 6% 89% 22 0% 9% 91%12 73 1% 11% 88% 14 21% 14% 64%15 81 2% 20% 78% 28 0% 39% 61%16 165 5% 10% 85% 21 24% 10% 67%17 49 2% 6% 92% 2 0% 50% 50%18 74 4% 7% 89% 1 0% 100% 0%19 39 8% 28% 64% 25 4% 0% 96%20 45 7% 20% 73% 27 0% 7% 93%21 168 6% 27% 67% 30 13% 23% 63%22 81 6% 14% 80% 17 6% 18% 76%23 75 20% 19% 61% 40 10% 18% 73%


HEPATITIS C INTERACTIVE REPORT

Hepatitis C DAA Dashboard Report

VISN 21 Dashboard

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Interactive Report

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Step 1: Select a site

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Step 2: Select a drug

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Step 3: Select therapy status

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Main Report

Scroll to the right for more information

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Main Report- Continued

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Drill down for more data

Click “+” to the left of the patient’s name34

Monitoring safety & efficacy

Scroll to the right for more information

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Monitoring safety & efficacy

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Monitoring medication adherence

Adherence• Calculated Medication Possession Ratio (MPR)• MPR < 90% is shown as red

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Days OverdueCalculated using last fill date and days supplied

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Patient Instructions included- show dose reductions39


HEPATITIS C INTERACTIVE REPORT

Hepatitis C Clinical Case Registry (CCR)


VA HCV Clinical Case Registry (CCR)

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Clinical Reports• BMI by Range• Clinic Follow-up • Combined Meds and Labs • Current Inpatient List• Diagnoses • Liver Score by Range

• MELD, MELD-Na, APRI, FIB-4• Patient Medication History • Procedures • Registry Lab Tests By Range • Registry Medications• Renal Function by Range

Administrative Reports• General Utilization and

Demographics• Inpatient Utilization• Lab Utilization• List of Registry Patients • Outpatient Utilization• Pharmacy Prescription

Utilization • Radiology Utilization

Hepatitis C CCR Reports


Description of Clinical Reports Useful for Managing Treatment• Clinic Follow-up

– Identify pts seen/not seen in specified date range; provides date last seen• Diagnoses

– Identify Pts with particular diagnoses• List of Registry Patients

– all patients confirmed in the registry• Patient Medication History

– fill dates, type (original/refill), method of pick-up, days supply for selected pts • Procedures

– MRI, US, biopsy…• Registry Lab Tests By Range

– Find pts who fall within a specified lab result range (HCV RNA >100)• Registry Medications

– Pts receiving registry medications (summary =count by medication; complete= lists pts by medication combination)


Combined Medication and Lab report (CM&L)

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Configuration

Meds date range

Medication selection

Lab date range

Lab selection

Utilization date range


Answer Simple Complex QuestionsOf patients in the registry, which ones

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• Did / Did not have… (med, lab, procedure)• During date range…(ever, defined by you)

…are potentially eligible for treatment…ever had PegIFN in the past, when? (trx-experienced)…have never received PegIFN? (trx-naïve)…on treatment never had an HCV RNA PCR?…had Liver Bx in last 6 months? …who had RBV in last 3 months had Hgb <10 in last 3 months? …who had RBV and ESA in last 6 mos had Hgb >11 on most recent test?…treatment-experienced, with advanced liver disease


Clinic Follow-upIdentify pts seen/not seen in a particular clinic during a specified date range; provides date last seen; can select any clinic or group of clinics. Option to include only patients with specific diagnoses

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Pharmacy Medication History

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Registry Lab Tests By Range

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Measuring and Managing Medication: Uses of the Local Clinical Case Registry for HCV

• Identify patients on treatment• Medication review• Medication Monitoring• Patient management

– Toxicity, response

• Adherence to guidelines• Continuity of care• Screening• Treatment outcomes

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Reminder Dialog for Hepatitis C[ ] HCV Treatment Nonpharmacologic intervention[ ] Adherence Assessed [ ] Knowledge of regimen(dose,frequency,food

requirements)assessed [text box][ ] Refill records reviewed [text box]

[ ] Adherence discrepancies exist based on refill records [ ] Patient verbally confirms remaining supplies which

correlate with current wk of tx [ ] Adherence discrepancies exist based on pt supplies [ ] Report of missed doses [text box] [ ] Other adherence issues identified:[textbox][ ] Medication Education Provided: [text box][ ] Medication reconciliation performed [ ] Copy provided for patient [ ] Non-VA medication updated in CPRS [ ] OTC medications documented [text box]

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Intranet Site for Providers: vaww.hepatitis.va.gov

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Patient Website: www.hepatitis.va.gov

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Patient EngagementTable of Contents

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Targeted Patient Specific Materials


Medication Treatment Planning

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• HCV Specialists PACT communication

• Hepatitis C Treatment Classes • Improving Local Care Processes

– Multidisciplinary team managing treatment– Patient Provider Communication


Medication Adherence/Management Checklist

Knows name/indication/dose/frequency Understands duration to take medication Understands risk of side effects/what to do if they occur

Understands their disease Understands treatment options Aware of benefit/risk of medication Partnered in treatment decision Agreement and able to follow treatment plan

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Strategies to Improve Adherence in Hepatitis C


• New triple therapy improves chances of success– Recognize that adherence to regimens will be challenging but is

CRUCIAL to success• MPR can be used estimate adherence• Interactive dashboard for specific patient level data• CCR offers customizable reports at the patient level and

for the population of a local facility• Reminder Dialog to document interventions related to

adherence /medication reconciliation • Targeted material to engage the patient• Communication

SummaryOptimizing Medication Management

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Questions?

Please use the Q&A Function on Live Meeting

OR

Email: [email protected]

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mailto:[email protected]

Documents

ADHERENCE: Focus on Hepatitis C