Lecture 21 - Role of government in Biotechnology Flashcards
What is the overview of the Therapeutics R&D Value Chain
Discovery > development > market
What is the flow for Discovery in Therapeutics R&D Value Chain
Gene»_space;(deciding where to look(academia)» Protein (target) > Screen»_space;(Select commercial opportunity(academia, MNC, SME))» lead»_space;(Create case for investment (MNC, SME and sometimes acedemia)» Candidate
What is the flow for Development in Therapeutics R&D Value Chain
Phase I (FTIH)»_space;(early development (SME MNC))» Phase II (POC) > Phase III( Late development (MNC)
What is the flow for market in Therapeutics R&D Value Chain
File»_space;(commercialisation)» Launch
Health Products from a buyer’s perspective
- 2 key MARKET ACCESS BARRIERS - regulatory and pricing
- Products are often NON DISCRETIONARY
- Products sell into highly COMPLEX markets with many STAKEHOLDERS
- The product is IP claim and label claim
- Leads to UNCONVENTIONAL business models
Examples of Government support for Biotech
- Education and training
- Supporting PFROs (Publicly Funded Research Organisations)
- Buying health products and services
- Translation Funding (MRFF)
- Accelerators/ incubators
- Tax incentives
- Advisory programmes - capability, networks, effectiveness - often offer matched funded grants
- Regulatory policy
- Sector Capability
- Enhance collaboration with PFRO
What are the examples of Supporting PFROs (Publicly Funded Research Organisations)
o Universities
o CSIRO
o MRIs
What are the examples of Research Infrastructure support
Expensive Kit: Synchrotron/ ANSTO
-Expensive to run
Capability (crystallography, tissue banks, GMP etc)
What are the examples for Buying health products and services
o PBS o MBS o PL o NDIA/ ADHA o Other health funds
What are the examples for Translation Funding (MRFF)
o AC
o Medical Research Future Fund: BTF, Biotech Bridge, Horizons,
o Challenge based programs Biotech Horizons
What are the examples for Tax incentives
o R&D Tax incentive for business (esp. refundable part)
o Tax incentives for Early Stage Investors
o (Philanthropy)
What are the examples for Advisory programmes - capability, networks, effectiveness - often offer matched funded grants
o AusIndustry - Business Management (also IC and AC)
o Austrade
o TGA Assist
o IP Australia patent hub
o Special purpose initiatives (eg. Biotech bridge)
What are the examples for Regulatory policy
o Comp Meds and GMP
o CTN/ CTX
o Patent system
What are the examples for Sector Capability
o Clinical Trial Initiatives
o Growth Centers
What are the examples for Enhance collaboration with PFRO
o Innovation Connections
o Cooperative Research Centres and CRC-Ps
o ARC Linkage
What are the Top 5 Trends for Biotech
- Big data analytics
- Growth in use of personalised medicine
- Digitisation of healthcare
- Automation of healthcare delivery
- Move to value-based care
What tiers of Value-derived compensation: move from fee-for-service to increasingly outcome-based models
FFS-Payment Not Linked to Quality > FFS - Payment Linked to Quality > Alternative payment Models (based on FFS architecture) > Population- based Payment
Meaning of FFS-Payment Not Linked to Quality
Reimbursement is solely represented by volume of patient care, and it is not characterised by care quality or outcome
Meaning of FFS - Payment Linked to Quality
% of total reimbursement is proportional to the quality of care delivery
Meaning of Alternative payment Models (based on FFS architecture)
- % of total reimbursement is linked to efficient care delivery.
- Payment is largely based on volume but opportunities to share care-efficiency-led saving or 2-sided risk exist.
Meaning of Population- based Payment
Reimbursement is not linked to yearly care volume , rather, providers are awarded for offering quality services to beneficiaries for a longer period of time(generally more than 1 year)
What is Accountable care organizations(ACOs)
-An ACO is a network of providers (physicians, hospitals, etc.) that give coordinated, high quality care to Medicare beneficiaries.
Example of value based care delivery models introduced the US in Bundled payments
In this model, the amount to be paid to treat a specific condition is calculated based on historical prices
What is a bundled payment
an episode-based payment wherein a single payment is made for an entire episode of care which may include several procedures and different settings of care. Here, the providers are collectively reimbursed for the expected costs to treat a specific condition.
What is the risk for bundled payment
If the providers provide care at a higher cost than that determined under bundled payment, they incur losses
What is the risk in ACOs
Providers may have to repay Medicare if they fail to provide value-based care to Medicare beneficiaries
What does the model tell us about ACOs
the providers in the network share savings if the ACO is able to deliver high-quality care in a cost-effective manner by preventing unnecessary and redundant services
What does the model tell us about bundled payment
the amount to be paid to treat a specific condition is calculated based on historical prices
