Lecture 10: Pharmacopeia applications to health services research Flashcards

1
Q

Value Based healthcare system involves

A
  • Patient
  • Policymaker
  • Payer & HTA
  • Provider & Hospital
  • Laboratory
  • Rx & Dx Manufacturer
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2
Q

Why do we dial up cost containment?

A
  • Increasing focus on the small portion of patients driving healthcare spending due to them having chronic diseases for example.
  • Most expensive 20% of patients account for 80% of total US healthcare costs
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3
Q

What are some Market trends with current healthcare system?

A

-Rapid spending growth (spending has reached an all time high, especially in the US)

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4
Q

Health Technology assessment (HTA)

A

-these can impact a product’s market access and must be understood in order to make strategic decisions about product development, launch and lifecycle management

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5
Q

Examples of influential HTAs

A

CMS, PCORI AND AHRQ IN THE US

NICE in england

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6
Q

PCORIs priorities

A
  • assessment of options for prevention, diagnosis and treatment
  • improving health care systems
  • communication and dissemination research
  • addressing disparities
  • accelerating patient-centered outcomes research and methodological research
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7
Q

Comparative effectiveness research (AHRQ)

A

AHRQ compares cost-effectiveness of biologic medications, procedures and preventive measures and the overarching purpose of the program is to give clinicians and patients the info they need to make decisions

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8
Q

Comparative effectiveness research (product lifecycle)

A

Early in an asset’s life, CER can guide development strategy and pricing. Later it can help identify new indications and subpopulations

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9
Q

Comparative effectiveness research (drivers)

A

Shifting priorities and needs of key stakeholders such as:
-Value vs. standard of care
-Effectiveness in real world setting
-Regulatory acceleration
-Safety concerns
Drives demand for more robust evidence using:
-Observational data analysis
-Larger populations for longer FU
-Holistic view of treatment, cost and outcomes

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10
Q

Comparative effectiveness research (barriers)

A

Roadblocks in this study and anticipated road blocks:

  • differing drug copays, which can impact results
  • masking drug identities to patients
  • coordinating logistics among hundreds of insurance plans for studies involving patients of all ages
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11
Q

Stakeholders when it comes to Real world evidence generation

A
  • Patients
  • Providers
  • Payers
  • Regulators
  • Industry
  • Industry–> Regulators–>Payers–>Providers–>Patients
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12
Q

What is the triple aim?

A
  • better health for individuals
  • lower costs
  • better health for populations
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13
Q

Market Trends–Coverage with evidence development( CED)

A

Benefits
-expedited approval process
-potential synergies with personalized medicine
-utilize patient data and real world results
Challenges
-only applied to Part B drugs
-treatment coverage only within confines of a clinical trial
-not appropriate for all technologies and products

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14
Q

Market Trends–Accountable Care Organizations (ACOs)

A

Alternative to fee-for-service model of health care payment designed to encourage quality of care while reducing the unnecessary use of resources

  • Benefits: encourage quality of performance, high cost savings potential, patients free to seek care from any healthcare provider of their choosing
  • Concerns: small savings result in pilot programs, anti-trust issues, higher prices for insurers as hospitals and physicians consolidate to become more powerful negotiators
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15
Q

Market Trends–Value based Insurance Design (VBID)

A
  • reduces the shared payments of high value drugs for consumers, but there are multiple boundaries standing in its way
  • engaging stockholders is the toughest part of this
  • other challenges are: obtaining and integrating data, keeping momentum going, getting employees to use the new benefits, understanding health care reform and communicating success
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16
Q

Market Trends–Parallel Review/Regulator/Payer convergence

A
  • US FDA and CMS launched parallel review for concurrent review of medical devices for FDA approval and medicare coverage
  • this will reduce administrative burden, provide faster access to new technologies, provide feedback to companies about study design and endpoints needed to justify reimbursements
17
Q

Market trends–Pharma/Payer Partnerships

A

-they do this to understand real-world value of innovative products

18
Q

Risk Sharing Agreements

A
  • Finance Based (based on budget caps, discounts or restrictions)
  • Outcome Based (based on pre-specified outcomes)
  • Demand for risk-sharing is greatest when clinical outcomes (and endpoints) are uncertain. The key to successful risk-sharing agreements are pre-specified endpoints