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):

Value Based healthcare system involves

-Payer & HTA
-Provider & Hospital
-Rx & Dx Manufacturer


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


What are some Market trends with current healthcare system?

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


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


Examples of influential HTAs

NICE in england


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


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


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


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


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


Stakeholders when it comes to Real world evidence generation

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


What is the triple aim?

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


Market Trends--Coverage with evidence development( CED)

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


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


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


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


Market trends--Pharma/Payer Partnerships

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


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