Pharmacy Outcomes Exam 3

Describe contexts where measurement of health-related quality of life is relevant

-HRQoL is a measurable health outcome

-HRQoL can be used to evaluate drugs in clinical trials, provider performance, and the progress of patients receiving drug therapy

HRQoL assessment is useful when

-drug therapy is palliative vs curative

-Drug is effective but also toxic

-Drug is used long term to prevent complications of asymptomatic disease

-Several drugs are available with differing adverse effects profiles

Differentiate between generic qol instruments

focuses on general health status

allow comparisons, applicable to multiple conditions, reliability/validity established

Broadly applicable

Summarizes range of concepts

May detect unanticipated effects

May not be responsive to changes in health, may not be relevant for specific populations, results may be difficult to interpret

Examples include sickness impact profile and EQ-5D

Differentiate between disease-specific quality of life instruments

focuses on specific aspects of the disease under study

More relevant for specific populations

More responsive to changes in health

Cannot compare across populations

Less likely to detect unanticipated effects

List health-related quality of life domains measured by common generic instruments (SF36, EQ5D)

1. Physical functioning

2. Bodily Pain

3. Role limitations due to physical health issues

4. Role limitations due to personal or emotional health issues

5. Emotional well-being

6. Social functioning

7. Energy/fatigue

8. General health perceptions

Define reliability of a QoL instrument

Consistency, an instrument must be reliable in order to be valid

-aspects of reliability:

✓ Stability

✓ Internal consistency

✓ Equivalence (inter-rater reliability)

Stability

extent to which the same results are obtained on repeated administration (test-retest correlation)

Internal consistency

Do subparts measure the same domain? (Cronbach alpha)

Equivalence

Do two people given the same rules of measurement record the same results?

Define validity of a QoL instrument

the degree to which an instrument measures the construct it is supposed to measure; even if it is reliable, may not be valid

Content validity

Is the content of the measure representative of all aspects of the construct?

Criterion validity

Is it useful as a predictor?

Construct validity

How does this instrument compare to other ways of measuring the same construct?

Differentiate between utility and health status measures: UTILITIES

+reflect preferences for health

+allow morbidity and mortality to be combined in a single weighted measure (i.e. QALY)

-cognitively complex, not as sensitive to small clinical changes

Differentiate between utility and health status measures: HRQoL MEASURES

+used to differentiate between patients with different diseases

+used to predict future outcomes

+used to measure a change in health status over time

- May not incorporate mortality, duration of survival, or patient preference

Define patient-reported outcomes

Defined as ‘the measurement of any aspect of a patient’s health status that comes directly from the patient’

➢ Individual symptoms (e.g. pain)

➢ Overall impact of disease (e.g. asthma)

➢ Feelings about disease (e.g. worry )

Describe steps to conduct decision analysis

-Identify the specific decision: perspective, competing options, period of time

-Specify alternative

-Draw the decision analysis structure

-Specify possible costs, outcomes, and probabilities

-Perform calculation

-Conduct a sensitivity analysis

List advantages and disadvantages of decision analyses method

Advantages:

Simple and transparent

Excellent for clarifying alternative treatment pathways

Disadvantages:

Difficult to incorporate disease recurrence for chronic conditions

Describe contexts where use of Markov modeling is appropriate

❑ High complexity of real health consequences

❑ Need to look at long-term outcomes over multiple years

❑ Patients 'transition' from one health state to the other over time

❑ Researchers use Markov modeling to evaluate complex chronic disease states

Describe types of retrospective databases available for outcomes research

-electronic health records (EHRs)

-national health

survey data

-health insurance claims records

Suggest a database for clinical/pharmacoeconomic research questions based on the knowledge of data/variables available in commonly used databases: HEALTH SURVEYS

❑ Detailed information from patients and providers

❑ Nationwide representation ( US non-institutionalized population)

❑ Include HRQoL data (SF-12, EQ5D)

Suggest a database for clinical/pharmacoeconomic research questions based on the knowledge of data/variables available in commonly used databases: SEER

The Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI): collects and publishes cancer incidence and survival data covering ~ 30 percent of the US population

Suggest a database for clinical/pharmacoeconomic research questions based on the knowledge of data/variables available in commonly used databases: INSURANCE CLAIMS

❑ Used for reimbursement purposes

❑ Records from healthcare organizations and providers:

✓ Physicians, nurse practitioners

✓ Hospitals, outpatient clinics, laboratories

✓ Pharmacies

Advantages of use of insurance claims for database research questions

• Large number of patients

• Inexpensive

• Most are reliable (adjudicated and paid claims)

• Standard variables collected

• Less lag time

Suggest a database for clinical/pharmacoeconomic research questions based on the knowledge of data/variables available in commonly used databases: EMR

❑ More detailed than other databases

❑ More complete picture of care (lab values, patient information documented by provider)

Compare and contrast findings generated via studies using retrospective databases vs RCTs: RETROSPECTIVE

1. Clear explanation of the database (types of patients covered Medicaid, Medicare, VA or private insurer)

2. Clear explanation of patient selection criteria (e.g., study of adherence to oral hypoglycemics- at least two ICD9 for diabetes , at least two Rx fills)

3. Patient eligibility for coverage (were patients included only if eligible for the entire study period?)

4. Sensitivity analyses may often provide additional insights (all healthcare costs vs diabetes-related costs only)

retrospective databases vs RCTs advantages

❑ ↑generalizability

❑ Large samples

❑ Inexpensive

❑ Change criteria & reanalyze - sensitivity analyses

retrospective databases vs RCTs disadvantages

❑ Selection bias

❑ Incomplete data

❑ Miscoding /upcoding (ICD9 and CPT)

❑ Duplicate records

❑ Missing data

❑ Out-of-range data

❑ Changes in coding (ICD10)

Pharmacy services

-PK monitoring

-Patient education to improve med taking behaviors

-Drug use monitoring and review to ensure appropriate use of medication

Features of pharmacy services

• Focus on patient needs

• Easy & simple in implementation

• Focused on enhancing use of preventive care (regular outpatient visits, treatment adherence)

• Care coordination

• Incentives to all participants (providers, patients, payers)

Outcomes of pharmacy services

Pharmacy services including MTM may improve medication adherence and medication appropriateness

Describe sources of economic value for pharmacy services

✓ Reductions in ER/inpatient care use through improvements in ambulatory care and medication use

✓ Economic outcomes are dependent on high degree of care coordination between pharmacists and other healthcare team members

Define deprescribing and discuss outcomes of deprescribing in older adults

‘Deprescribing is the planned and supervised process of dose reduction or stopping of medication that might be causing harm or no longer be of benefit. Deprescribing is part of good prescribing – backing off when doses are too high, or stopping medications that are no longer needed.’

Medication discontinuation in nursing home residents:

❑ Reduced number of inappropriate medications

❑ Reduced all-cause mortality

❑ Reduced number of falls

Define AMCP Value dossier

• AMCP Dossier-standardized set of clinical & economic evidence prepared by manufacturers and presented to health plans to assist formulary decision making

Examples of performance-based coverage agreements between pharmaceutical companies and payers

agreements between payers and product manufacturers in which price, level and nature of reimbursement are tied to future measures of clinical & surrogate endpoints that are related to patients' longevity and/or quality of life

Rationale:

✓ Efficiency (value for money)

✓ Improved Outcomes

✓ Cost control

What does PLC exclude?

Price/volume/discount/market share agreements

Regional examples of PLC

Harvard Pilgrim health plan: Several performance-based agreements to date Examples:

❑ Heart failure (HF) treatment (Entresto) - if no reductions in HF hospitalizations are achieved, Novartis reimburses part of the medication costs.

❑ Cholesterol-lowering treatment (Repatha)- if no reductions in CV events are achieved, Amgen reimburses health plan for all treatment costs

Discuss the difference between performance-based coverage agreements and commercial agreements (market share, volume-based discounts)

-Performance based agreements prioritize outcomes and quality of care with payments tied to achieving metrics such as patient outcomes or cost savings; Excludes Price/volume/discount/market share agreements

-Commercial agreements focus on market share, volume, and cost and commonly used discounts or rebates based on sales volume or achieving market share targets