Lecture 10: Pharmacopeia applications to health services research Flashcards Preview

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Flashcards in Lecture 10: Pharmacopeia applications to health services research Deck (18):
1

Value Based healthcare system involves

-Patient
-Policymaker
-Payer & HTA
-Provider & Hospital
-Laboratory
-Rx & Dx Manufacturer

2

Why do we dial up cost containment?

-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

3

What are some Market trends with current healthcare system?

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

4

Health Technology assessment (HTA)

-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

5

Examples of influential HTAs

CMS, PCORI AND AHRQ IN THE US
NICE in england

6

PCORIs priorities

-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

7

Comparative effectiveness research (AHRQ)

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

8

Comparative effectiveness research (product lifecycle)

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

9

Comparative effectiveness research (drivers)

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

10

Comparative effectiveness research (barriers)

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

11

Stakeholders when it comes to Real world evidence generation

-Patients
-Providers
-Payers
-Regulators
-Industry
-Industry--> Regulators-->Payers-->Providers-->Patients

12

What is the triple aim?

-better health for individuals
-lower costs
-better health for populations

13

Market Trends--Coverage with evidence development( CED)

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

14

Market Trends--Accountable Care Organizations (ACOs)

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

15

Market Trends--Value based Insurance Design (VBID)

-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

16

Market Trends--Parallel Review/Regulator/Payer convergence

-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

Market trends--Pharma/Payer Partnerships

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

18

Risk Sharing Agreements

-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