GW HTA lecture 8 HTA Policy Flashcards
Why do we need HTA in decision making?
- sustainable systems, equal systems, highest standards of quality of care (tension between these pillars)
- GOAL of HTA policy: ensuring affordable and equitable access for all patients to effective therapies in a sustainable manner
which criteria should we use for reimbursement?
- efficacy/effectiveness
- total budget impact
- number of patients
- cost-effectiveness
- health gain per patient
- disease severity
- rarity of disease
- own responsibility
- strenght of lobbies stakeholders (even with low ICER, strong lobbies can succeed to reimburse medicine)
revealed preferences
looking at what people actually do, rather than what they say they preffer or intend to do. (e.g. NICE reimbursement in UK, Spain orphan drugs)
stated preferences
Refer to what people express or say aobut their preferences when it comes to healthcare treatments or interventions
(e.g. may not deliver all decision-making factors. Additional relevance; HTA delivers information for decision making promotes trnasparency of policy making and guides researchers to collect relevant data)
Opportunity costs for HTA policy
Given the limited health care budget (or a limited WTP to pay a higher premium) it is unethical not to make a societal decision.
Problem; is a worldwide / EU problem. What we give to patient A cannot go to patient B.
Purpose of HTA
To inform and make an informed decision in order to promote equitable, efficient and high-quality health system.
Discrete choice experiment on policymaking for HTA. Study questions:
- What criteria are important in healthcare priority setting?
- To what extent are trade-offs made between criteria?
- Do policy makers consider uncertainty?
- Do policy makers take a societal perspective as advocated in the literature?
HTA proces in Europe; introduction
First registration;
- efficacy
- safety
- quality
Price/reimbursement
- efficieny
Newly registrated drugs approval pathway
- Regulatory approval by EMA or FDA (time between submission and market authorization)
- HTA and reimbursement; (Time between market authorization and first access (TTM))
- Patient access; (speed uptake/patient access)
Systems are not sustainable. How to reduce spending?
- shift from expensive to cheaper technologies
- Make insurance or patients pay a larger part
- Reduce the price of drugs
- Reduce total use of drugs
- Focus on reduction of prices
- However, also focus on unequal access in Europe
What is NL threshold ICER?
20.000-80.000 euros
NICE threshold ICER
US threshold
30.000 pounds
50.000-100.000 dollars
uncertainty in policy making
clinical uncertainty;
- effectiveness
- safety
- quality
Cost effectiveness
Budget impact
Technical uncertainty
advantages of (no cure no pay contract)
‘no cure no pay’–> value for money
application on best patient subgroups
after contract new decision possible
disadvantages of (no cure no pay)
transaction cost contract
clear outcome indicator crucial
cost of monitoring/registration
Budget impact may be very high
Solutions (short and midterm)
(patent; gives monopoly price, no transparancy, cost and profit)
- shorter market exclusivity orphan drugs
- more cooperation in international price negotiations
- Risk sharing price models: Pay for Performance
- Application of societal price algorithms; cost based car
- More drug discovery
- More stimulation of using biosimilars
- Restrict price increase for new owners license of established drugs
- facilitate pharmacy preperation
- court cases (human rights, abuse of market power)
Dutch financial arrangements
Confidential lower prices than official list prices
Saving 34%: 372/1084 mln (31 drugs)
Advantages:
- less uncertainty on budget impact
- industry can cover R&D costs
- surplus for producers & consumers
Disadvantage:
Does not adress value for money.
- negotiations and price not transparent
- GAMING?
GOAL HTA Policy
Ensuring affordable and equitable access for all patients to effective therapies in a sustainable manner.
Burden of disease 0.1 - 0.4
up to 20.000 euro per QALY
burden of disease 0.41-0.7
up to 50.000 euro per QALY
burden of disease of 0.71
up to 80.000 euro per QALY
Policy dilemma in drug reimbursement; reimburse at monopoly price
PRO: fast access, maybe health gain for those in need
CON: risk of no gain in health, waste of money
policy dilemma when not reimbursing
PRO: no risk of inefficiency spending
CON: missed opportunity for health gain
Rationale for adapting the business model of (cancer) drug pricing issues
- A free market does not work for (innovative) drugs
- Current cancer drug prices are not justified by Research and Development
- Country specific solutions did not solve the problem
- Restricted access to innovative drugs
Uncertainty in Policy making
clinical uncertainty
- safety
- effectiveness
- cost-effectiveness
- quality
budget impact (number of patients, price per patient)
technical uncertainty (model disease & treatment)
contract advantages
- ‘no cure is no pay’ –> value for money
- application on best patient sub groups
- after contract new decision possible
contract disadvantages
- transaction cost contract
- clear outcome indicator crucial
- cost of monitoring/registrating
- budget impact may be high
Proposals
- shorter market exclusivity for orphan drugs
- more international cooperation in price negotiations
- risk sharing price models, pay for performance
- application of societal price algorithms, cost-based price & acceptable profit
- more drug rediscovery
- more stimulation of using biosimilars
- restrict price increase for new owners of licenses of established drugs
- facilitate pharmacy preparation
- court cases (human rights, abuse of market power)
Financial arrangements
confidential prices lower than of official price lists
advantages:
- less uncertainty about budget impact
- industry can cover R&D costs
- Surplus for consumers and producers
Disadvantages:
- Does not adress value for money;
negotiations and price are not transparent (discounting)
GAMING!!
CORE domains HTA
Start assessment
1. Current use
2. Technical
3. Safety
4. Clinical effectiveness
Make decision
1. Cost & Economic
2. Ethical analysis
3. Organizational
4. Patient & societal
5. Legal
