HTA Flashcards
An arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject
to specified conditions. These arrangements can use a
variety of mechanisms to address uncertainty about the
performance of technologies or to manage the adoption
of technologies in order to maximize their effective use,
or limit their budget impact.
Managed Entry Agreement (MEA)
Initiative in which a payer provides temporary or interim funding for a particular
technology or service to facilitate the collection of information needed to reduce
specific uncertainties around a coverage decision.
Access with Evidence Development (AED)
Schemes where coverage is
granted conditional on the initiation of a program of data
collection.
Conditional Coverage
Continuation
of coverage for individual patients is conditioned upon
meeting short-term treatment goals.
Conditional Treatment Continuation (CTC)
A binary
coverage decision is conditioned upon the collection of
additional population level evidence to support
continued, expanded, or withdrawal of coverage.
Coverage with Evidence Development (CED)
Coverage conditional on
individual participation in research (i.e. only patients
participating in the scientific study are covered)
Only in Research (OIR)
Coverage conditional on a scheme
to conduct a study that informs the use of the medical
product in the payer patient population.
Only with Research
An agreement where the
manufacturer provides rebates, refunds, or price
adjustments if the product fails to meet the agreed
outcome target.
Outcomes Guarantees
_____-are special ways pharmaceutical companies can
propose to enable patients to gain access to high costs
medicines.____is the name for managed entry
agreements in the United Kingdom. They are proposed
by a pharmaceutical company and agreed between the
Department of Health and the pharmaceutical company;
as other managed entry agreements they can take
different forms (e.g. financial or performance-based
agreement).
Patient Access Scheme (PAS)
Schemes where the
reimbursement level is tied to the impact on clinical
decision making or practice patterns.
Pattern or Process Care
Agreement between a payer
and a pharmaceutical, device or diagnostic manufacturer
where the price level and/or revenue received is related to
the future performance of the product in either a research or
a real world environment. One category of managed-entry
agreements, in contrast to the financial agreements.
Performance Based Agreement
Schemes between healthcare payers and medical
product manufacturers in which the price, level, or nature of
reimbursement are tied to future measures of clinical or
intermediate endpoints ultimately related to patient quality or
quantity of life; appear to have arisen out of a desire to
provide patients with access to novel and potentially
beneficial healthcare technologies under conditions of
significant uncertainty and cost pressures.
Performance Based Health Outcome Reimbursement
Schemes
Schemes where
the reimbursement level for covered products is tied to
the measure of clinical outcomes in the real world.
Performance-Linked Reimbursement
Agreements which focus on
controlling financial expenditure with pharmaceutical
companies refunding over budget situations.
Price Volume Agreement
greements concluded by
payers and pharmaceutical companies to diminish the
impact on the payer’s budget of new and existing
medicines brought about by either the uncertainty of the
value of the medicine and/or the need to work within
finite budgets.
A contract between two parties who agree to engage in a
transaction in which there are uncertainties concerning
its final value. Nevertheless, one party, the company,
has sufficient confidence in its claims of either
effectiveness or efficiency that it is ready to accept a
reward or a penalty depending on the observed
performance of its product.
Risk Sharing Schemes (RSS)
When a medicine or medical device is prescribed outside
its licensed indication, to treat a condition or disease for
which it is not specifically authorised.
OFF-LABEL PRESCRIBING
In such
processes, the price is determined through competitive
bidding: the pharmaceutical company that offers the
lowest, or best, price for a specific medicine / group of
medicines will be awarded the tender. The tendered
medicines will be included in reimbursement (often a
reference product, impacting the prices/reimbursement
status of similar medicines); the tendered price is likely
to serve as reimbursement price.
Auction-like Policies (Auction-like Systems)
Pricing procedure which calculates a
‘reasonable’ price for a product based on the production
costs, promotional expenses, research & development,
administration costs, overheads and profit.
Cost-plus Pricing
Differential pricing is the strategy of
selling the same product to different customers at
different prices. In the case of (reimbursable) medicine
prices would vary among the countries according to their
ability to pay. It was not introduced in the European
countries due to the wide-spread practice of external
price reference and the existence of parallel trade.
Differential pricing
Dispensing of pharmaceuticals via
internet or posting services.
Distance Selling
A system that aims to identify, filter and
prioritise new and emerging health technologies, or new
uses of existing interventions; to assess or predict their
impact on health, health services and/or society; and to
disseminate information
Early Awareness and Alert (EAA) System (Early Warning
System)
a process to remove technologies that are not relevant to the early
awareness and alert system from a list of technologies originating from the identification process
Filter
a process to determine the significance of, or order for dealing with, filtered technologies according to their relative importance to the aims of the early awareness and alert system.
Prioritise
The systematic identification of health technologies that are new, emerging or becoming obsolete and that have the potential to effect health, health services and/or society
Horizon Scanning
(e.g. early awareness and alert
(EAA) systems) aim to support decision-making and the adoption and use of innovative technologies to the benefit of patients and health services.
Horizon scanning systems
Formation of an alliance of several
purchasers to negotiate product price based on increased
volume. This includes bulk procurement through a tender
system, at a national or regional level.
Group Purchasing
The procurement of certain products or services is done by a single purchasing body for several
healthcare providers (e.g. hospitals, regions, countries)
Joint Procurement
Requirements for prescribers (e.g. physicians) to prescribe medicines by its INN, i.e. the active ingredient
name instead of the brand name. INN prescribing may be allowed (indicative INN prescribing) or required (mandatory/obligatory INN prescribing)
International Non-proprietary Name Prescribing (INN Prescribing)
This term is used in a different way in different countries: e.g. in some countries it is the maximum
amount which is reimbursed (cf. reference price system), in others it is the maximum share that is refunded by third party payers expressed as percentage of the reimbursement
basis.
Maximum Price
List of medicines that cannot be prescribed at the expense of a third party payer.
Negative List
List of medicines that may be
prescribed at the expense of a third party payer. This is one
form of a reimbursement list.
Positive List (Formulary)
The maximum amount (e.g. a certain percentage of income) that an insured person has to pay for all covered health care services for a defined period (often a year).
Out-of Pocket Maximum (Annual Ceiling)
Pricing system, where medicine
prices are set on a regulatory basis (e.g. law, enactment, decree).
Statutory Pricing
Pricing policy, where pharmaceutical
companies determine the price of the medicine they
launch.
Free Pricing
A comprehensive strategy to select,
communicate and achieve adherence to essential
medicines recommendations in out-patient care in a
metropolitan healthcare region of Stockholm
Wise List
The concept of value-based pricing
has gained momentum, though there is no widely
accepted definition of value. In general, it is meant that
countries set prices for new medicines and/or decide on
reimbursement based on the therapeutic value which
medicine offers, usually assessed through health
technology assessment (HTA) or economic evaluation.
Value Based Pricing
A definition of quality that assesses
the quality of provision, processes or outcomes against
the monetary cost of making the provision, undertaking
the process or achieving the outcomes.
Value For Money
A prospectively planned process, starting with
the early authorization of a medicine in a restricted
patient population, followed by iterative phases of
evidence gathering and adaptations of the marketing
authorization to expand access to the medicine to
broader patient populations. As a holistic approach,
adaptive licensing requires the involvement of all
stakeholders who have a role in determining patient
access, including the European Medicines Agency, the
industry, health technology assessment (HTA) bodies,
organizations issuing clinical treatment guidelines and
patient organizations
Adaptive Licensing (Progressive Licensing, Staggered
Approval):
Policy undertaken around the launch of a medicine on the market. Related to the entry
of new medicines, this might be specific arrangements (e.g. managed-entry
agreements, HTA) during the pricing and reimbursement decision process. Peri-launch
activities address, among other things, issues of access and affordability
Peri-Launch Activity
Policy undertaken before the launch of a medicine on the market. Pre-launch activities
provide policy-makers with a forward-looking perspective on new medicines in
development. This includes a review of their potential specific clinical and treatment
outcomes and health system impact (in terms of cost and benefit to patients). Prelaunch activities also anticipate the budget impact of a treatment for its proposed
indication, as well as understanding which patients stand to benefit most from the
treatment. Governments and payers are thus directly involved as these activities assist
them in taking a longer-term strategic approach in development of health care
systems and facilitating access to interventions. Pre-launch activities further include horizon scanning to identify potential new medicines meeting health care priorities
and planning for their potential use
including physician and prescriber education; development of patient registries; and
demand forecasting. An extensive evaluation of medicines prior to marketing (in some
contexts broadly termed ‘critical drug evaluation’) is also part of the pre-launch
activities.
Pre-Launch Activity
Collections of secondary (clinical) data
on diagnosis, follow-up and treatment related to patients
with a specific diagnosis, condition, or procedure. Patient
registries are relevant for quality assurance,
documentation and for future analyses, and are a post-
launch policy option to optimise the entry of new
medicines.
Patient Registry
Policy undertaken after the launch of a medicine on the
market. Related to the entry of new medicines, post-launch
activities include:
– monitoring the effectiveness and safety of new medicines in clinical
practice and ensuring that patients with the greatest clinical need and
those most likely to benefit from treatment can access the medicine,
– systematic detailed analysis of medicine usage data.
* Systems that facilitate data management include:
– electronic accessible patient registries that collect key clinical data
– e-prescription for reviewing prescribing practices to ensure these are
consistent with agreed best practice outlines in guidelines and any
prescribing restrictions.
* Standardizing data requirements and integration of different
data sets across the health system, as well as close
monitoring and evaluation, can allow for improvements in the
use of medicines.
POST-LAUNCH ACTIVITY
one whose acquisition cost is greater than €10,000 per patient
for a yearly therapy for the public payer and which is replacing an existing medicine (whose costs public payers were already paying). Few countries in Europe seem to have a country-specific definition of what is a high-cost medicine.
premium-priced medicine
Evaluation of the price of all, or groups of, medicines, typically in comparison to the
prices of the same medicines in other countries, in order to account for developments
such as the market entry of medicines and price changes in other countries and
exchange rate evolutions. Price reviews may, or may not, be performed in combination
with reimbursement reviews. Price reviews can be done systematically (e.g. once a
year) or out-of-schedule.
Price Review
Evaluation process of a reimbursement decision (i.e. decision about the
reimbursement status and reimbursement rates of medicines), which may, or may
not, include the price. Reimbursement reviews can be done systematically (e.g. once a
year) for all reimbursed medicines or a group (e.g. specific indication), or out-ofschedule
Reimbursement Review
The practice of using the price(s) of a medicine in one or several countries in order to
derive a benchmark or reference price for the purposes of setting or negotiating the
price of the product in a given country.
EXTERNAL PRICE REFERENCING
(INTERNATIONAL PRICE COMPARISON,
EXTERNAL REFERENCE PRICING,
EPR, ERP, IPR)
The practice of using the price(s) of identical medicines ( ATC 5 level) or similar
products ( ATC 4 level) or even with therapeutically equivalent treatment (not
necessarily a medicine) in a country in order to derive a benchmark or reference price
for the purposes of setting or negotiating the price or reimbursement of the product in
a given country.
INTERNAL PRICE REFERENCING
A group of medicines of the same active ingredient ( ATC 5), in a given therapeutic
class ( ATC 4) or clustered based on a broader definition but still considered
interchangeable. These clusters of medicines form the basis for establishing a
reference price system.
Reference Group
A reimbursement policy in which identical medicines ( ATC 5 level) or similar
medicines ( ATC 4 level) are clustered ( reference group). The third party payer
funds a maximum amount (= reference price), while the patient must pay the
difference between the reference price and the actual pharmacy retail price of the
medicine, in addition to any co-payments (e.g. prescription fees, or percentage
co-payment rates).
Reference Price System (RPS)
An out-of pocket payment in the form of a fixed amount (like for example a
prescription fee) to be paid for a service, a medicine or a medical device.
Fixed Co-payment
A fixed amount for
each prescription item dispensed on the expense of a third-
party payer to be payable by the patient, i.e. a form of fixed
co-payment.
Prescription Fee (Prescription Charge)
Cost-sharing in the form of a set
proportion of the cost of a service or product. The patient
pays a certain fixed proportion of the cost of a service or
product, with the third-party payer paying the remaining
proportion.
Percentage co-payment
Initial expense up to a fixed amount which must
be paid out-of pocket for a service or over a defined period of
time by an insured person; then all or a percentage of the rest of the cost is covered by a third-party payer
DeductiblE
a provision of health insurance or third-
party payment that requires the individual who is covered
to pay part of the cost of health care received. This is
distinct from the payment of a health insurance premium,
contribution or tax which is paid whether health care is
received or not
Cost-sharing
nsured patient’s contribution towards the
cost of a medical service covered by the insurer. Can be
expressed as a percentage of the total cost of the
service or as a fixed amount. Co-payment is a form of
out-of pocket payment. Co-payments might be designed
in different formats. With regard to co-payment applied to
the medicines, commonly applied variants in European
countries are prescription fees, percentage
reimbursement / co-payment rates and, but to a less
extent, deductibles.
Co-payment
A funding element in a reimbursement
system allowing third party payers to recoup (part of the)
discounts/ rebates granted by various stakeholders, e.g.
wholesalers and pharmacists.
Claw-back
A financial mechanism that
requires manufacturers, or other health care
stakeholders, to refund a part of their revenue to a payer
(i.e. third party payer) if sales exceed a previously
defined level.
Pay-back (Payback)
