HTA

Question 1

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.

Answer 1

Managed Entry Agreement (MEA)

Question 2

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.

Answer 2

Access with Evidence Development (AED)

Question 3

Schemes where coverage is
granted conditional on the initiation of a program of data
collection.

Answer 3

Conditional Coverage

Question 4

Continuation
of coverage for individual patients is conditioned upon
meeting short-term treatment goals.

Answer 4

Conditional Treatment Continuation (CTC)

Question 5

A binary
coverage decision is conditioned upon the collection of
additional population level evidence to support
continued, expanded, or withdrawal of coverage.

Answer 5

Coverage with Evidence Development (CED)

Question 6

Coverage conditional on
individual participation in research (i.e. only patients
participating in the scientific study are covered)

Answer 6

Only in Research (OIR)

Question 7

Coverage conditional on a scheme
to conduct a study that informs the use of the medical
product in the payer patient population.

Answer 7

Only with Research

Question 8

An agreement where the
manufacturer provides rebates, refunds, or price
adjustments if the product fails to meet the agreed
outcome target.

Answer 8

Outcomes Guarantees

Question 9

_____-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).

Answer 9

Patient Access Scheme (PAS)

Question 10

Schemes where the
reimbursement level is tied to the impact on clinical
decision making or practice patterns.

Answer 10

Pattern or Process Care

Question 11

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.

Answer 11

Performance Based Agreement

Question 12

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.

Answer 12

Performance Based Health Outcome Reimbursement
Schemes

Question 13

Schemes where
the reimbursement level for covered products is tied to
the measure of clinical outcomes in the real world.

Answer 13

Performance-Linked Reimbursement

Question 14

Agreements which focus on
controlling financial expenditure with pharmaceutical
companies refunding over budget situations.

Answer 14

Price Volume Agreement

Question 15

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.

Answer 15

Risk Sharing Schemes (RSS)

Question 16

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.

Answer 16

OFF-LABEL PRESCRIBING

Question 17

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.

Answer 17

Auction-like Policies (Auction-like Systems)

Question 18

Pricing procedure which calculates a
‘reasonable’ price for a product based on the production
costs, promotional expenses, research & development,
administration costs, overheads and profit.

Answer 18

Cost-plus Pricing

Question 19

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.

Answer 19

Differential pricing

Question 20

Dispensing of pharmaceuticals via
internet or posting services.

Answer 20

Distance Selling

Question 21

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

Answer 21

Early Awareness and Alert (EAA) System (Early Warning
System)

Question 22

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

Answer 22

Filter

Question 23

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.

Answer 23

Prioritise

Question 24

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

Answer 24

Horizon Scanning

Question 25

(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.

Answer 25

Horizon scanning systems

Question 26

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.

Answer 26

Group Purchasing

Question 27

The procurement of certain products or services is done by a single purchasing body for several healthcare providers (e.g. hospitals, regions, countries)

Answer 27

Joint Procurement

Question 28

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)

Answer 28

International Non-proprietary Name Prescribing (INN Prescribing)

Question 29

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.

Answer 29

Maximum Price

Question 30

List of medicines that cannot be prescribed at the expense of a third party payer.

Answer 30

Negative List

Question 31

List of medicines that may be prescribed at the expense of a third party payer. This is one form of a reimbursement list.

Answer 31

Positive List (Formulary)

Question 32

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).

Answer 32

Out-of Pocket Maximum (Annual Ceiling)

Question 33

Pricing system, where medicine prices are set on a regulatory basis (e.g. law, enactment, decree).

Answer 33

Statutory Pricing

Question 34

Pricing policy, where pharmaceutical companies determine the price of the medicine they launch.

Answer 34

Free Pricing

Question 35

A comprehensive strategy to select, communicate and achieve adherence to essential medicines recommendations in out-patient care in a metropolitan healthcare region of Stockholm

Answer 35

Wise List

Question 36

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.

Answer 36

Value Based Pricing

Question 37

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.

Answer 37

Value For Money

Question 38

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

Answer 38

Adaptive Licensing (Progressive Licensing, Staggered Approval):

Question 39

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

Answer 39

Peri-Launch Activity

Question 40

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.

Answer 40

Pre-Launch Activity

Question 41

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.

Answer 41

Patient Registry

Question 42

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.

Answer 42

POST-LAUNCH ACTIVITY

Question 43

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.

Answer 43

premium-priced medicine

Question 44

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.

Answer 44

Price Review

Question 45

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

Answer 45

Reimbursement Review

Question 46

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.

Answer 46

EXTERNAL PRICE REFERENCING (INTERNATIONAL PRICE COMPARISON, EXTERNAL REFERENCE PRICING, EPR, ERP, IPR)

Question 47

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.

Answer 47

INTERNAL PRICE REFERENCING

Question 48

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.

Answer 48

Reference Group

Question 49

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).

Answer 49

Reference Price System (RPS)

Question 50

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.

Answer 50

Fixed Co-payment

Question 51

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.

Answer 51

Prescription Fee (Prescription Charge)

Question 52

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.

Answer 52

Percentage co-payment

Question 53

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

Answer 53

DeductiblE

Question 54

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

Answer 54

Cost-sharing

Question 55

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.

Answer 55

Co-payment

Question 56

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.

Answer 56

Claw-back

Question 57

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.

Answer 57

Pay-back (Payback)