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Drug Regulatory Affairs > Pricing and Reimbursement > Flashcards

Pricing and Reimbursement Flashcards

1
Q

Pricing of Medicinal Products, how it is regulated?

A

Pricing and Reimbursement is a national topic

Differences between conuntries

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2
Q

What the main differencex between US and EU with pricing?

A

in EU, the first year the pharmaceutical companies can fix their prices, afterwards there is a negotiation
US: PC can fix their prices

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3
Q

what are the main objective for the pricing Strategies?

A

Drug Uniqueness
Competition
Drug effectivenes

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4
Q

Whats the meaining of the Drug Uniqueness?

A

How many other drugs are already available to treat the same condition

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5
Q

Competition?

A

new drugs have addedd benefits overr competing drugs (addeitional benefits–> hgher prices)

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6
Q

Drug Effectiveness

A

change the current practice of medcine
cut down on expensive surgeries/hospital
can extend or ven save lives

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7
Q

What is the issue with Pricing?

A

Too high–> Unwilling to reimburse for ir or to prescribe it

Too low–>Physicians may conclude that it offers a discounted from of therapy

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8
Q

What institutions are invlved in pricing in Germany

A

Federal Joint Committee (G-Ba)

Institue for Quality and Efficiency in Helath Care (IQWiG)

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9
Q

What are the responsibility of the Federal Joint Committee (G-BA) (part 1)

A
  • charge of deciding on the coverage of health, goods and services
  • establishing practice guidelines
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10
Q

What are the responsibility of the Federal Joint Committee (G-BA) (part 2)

A
  • Representatives of the umbrella association of physicians, dentist, hospitals and health
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11
Q

IQWiG?

A
  • Independent body in charge of evaluating the quality and efficiency of health services products
  • Performs the evidence-based assessment–> no reimbursement decisions making
  • missions: clinical effectiveness and cost-beneits assessment
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12
Q

which drugs are reimbursed?

A

prescriptions drugs, unless included in an exclusion ist meaintained by the G-BA

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13
Q

Which drugs are meationed in the exclusion list?

A 
Lifestyle medicinal products
Smoking cessation
Alcohol abstinence
Contraceptives
Hair growth enhancers
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14
Q

Which are Non-Rx medicinall products?

A

Over the counter drugs

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15
Q

Which drugs are in exception list

A
  • Children under 12 years
    Young people under 18 with development disabilities
  • Calcium compounds as well as vitamins D (treatment o manifest osteoporosis
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16
Q

Calcium compounds as well as vitamins D treatment for?

A

treatment of manifest osteoporosis

only simultaneously with steroid therapy

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17
Q
  1. how is the pricing and reimbursement in germany regulated?
A

Usually manufacturers are free to set their price (the final price depends on a benefits assessment)

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18
Q
  1. What happend after the first year?
A

Prices of innovative drugs are mainly negotiated

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19
Q

how the decision made?

A

Prodcuts with positive benefits assessment

Products considered therapeutically equivalent (Clustered)

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20
Q

Prodcuts with positive benefits assessment?

A

Price will be negotiated

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21
Q

Products considered therapeutically equivalent (Clustered)

A

Reference price cluster

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22
Q

What is the responsibility of the Pharmaceutical Market Restrucuturing Act

A

Legal basis for benefit assessment

Imposes a systematic and formal assessment of the added therapeutic benefits

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23
Q

What are the their objectives of the AMNOG?

A

Encoraging innovation

Ensuring efficient use of resources

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24
Q
  1. Wat is the Benefits Assessment Procedure?
A
  1. Marketing Approcal (Cp, DCP, MRP and NP)
  2. Set the price freely for the first year–>at the same time submission of a dossier to the G-BA, showing that you have an innovative drug.
25
Q
  1. Wat is the Benefits Assessment Procedure?
A
  1. The G-Ba starts with the evaluation, the handle it over to the IQWIC
    (supportive agency, evaluation of added therapetical benefit)
26
Q
  1. Wat is the Benefits Assessment Procedure?
A
  1. The G-BA published the official decision.
27
Q

what are the possible desicion of the G-BA?

A

MP with no added benefit or with added benefit

28
Q

MP with no added benefit

A

G-BA: Inclusion in reference price cluster

29
Q

MP with added benefit

A

Price negotiation with GKV-SV

30
Q

What happend is there is no negotiation?

A

Arbitration

31
Q

when is a therapeutic benefit assessment necessary?

A

MP with

  • new active ingredients
  • new combination of active ingredients
  • new indication or new population group or new treatment are
32
Q

which is the exception of not performing the TB?

A

Orphan drug status

33
Q

when should the benefit dossier be submitted?

A

by the manufacuturer at the time of placing the MPon the market

34
Q

what is the content of the module 4 of the BD?

A

Quantitative additional benefit must be demostrated by clinical studies

35
Q

which is the main different between the clinical studies for approval and Pricining/reimbursement?

A

For approval is is baded on the Risk-benefits assessment

Pricing/ reimbusement is improving the supply quality with medicinal product

36
Q

how should the comparator be chosen in approval and benefit assessment studies?

A

approval studies: comparator is selected according ti the crrent state of knowledge (best available standard therapy, on member state)

benefit assessment studies: comparator must be approved in germany for the indication (described in S3 guidelines

37
Q

what are some measurabe endpoints of both approval studies and benefits assessment?

A

overall survival or surrogat endpoints

38
Q

what is surrogat endpoint?

A

laboratory values (lung function, blood pressure), which are not accpeted in the benefits assessment

39
Q

patient related endpoints ae

A

Mortality, Morbidity, side effects

40
Q

how long the is negotiation prcesse?

A

6 months

41
Q

what is the main aspect of the benefits assessment of selcting the endpoint

A

it should be patient relevant therapeutica effect

42
Q

what is different between efficacy, efficieny and effectiveness?

A

Efficacy: outcome of the clinical trials
Efficiency: gives us an ideal about if the drug worth is cost
Effectiveness: efficacy in real life

43
Q

how is advertising regulated within the EU?

A

minimum requirement regarding the advertising of the medicinal products are marmonized, each member state can extend their restrictions

44
Q

which differences should be made when it comes to advertising?

A

Advertising in general public an to health care professions

45
Q

how is advertising defined?

A

any form of door-to-door information, canvassig activity or inducement designed to promote the prescription, supply, sale or consumption or medicinal products

46
Q

what is should be excluded when advertising a MP?

A

labelling and package leaflet
answer to a specific question about a prticular medicinal product
informative announcemnets and reference material

47
Q

What are the general prohibition?

A

any advertising for MP when has not been granted a MA

any misleadning advertisinh such as with effects that it does not have

48
Q

What are the general obligation?

A

all advertising must be compliance with SPC

obhectively and without exaggeratting its properties

49
Q

which law does apply to vaccination campaigns?

A

prohibitiion of advertising of medicinal products, which are only available via prescription or contain substances defined as psychotropic and narcotic

50
Q

what are the information that ha sto be included when advertising to the genral public?

A

indication
name of the medicinal product
comman name of the API
information necessary for the correct use of the medicinal product
legible invitation to read carefully the instructions on the package leaflet

51
Q

what are some prohibition in advertisng to the genral public?

A

effects of the product are guaranteed
comparing of its effect with other product
directed exclusivley a children
recommendations

52
Q

advertising to healthcare professionals?

A

this are qualified persons to prescribe and supply medicinal products

53
Q

what are the obligations in the AHP?

A

it should include all essential information, which should be in accordance with the SPC
information should be accurate, upto-date, verifable and sufficiently complete

54
Q

where can advertising ofr HP be done?

A

pharmaceitcal newspaper

55
Q

what are the essential informations on the AHP?

A 
name of the MP
indication
information about clinical studies, regarding safety and efficacy
comparison to other MP
all information with references
56
Q

what is not included in the AHP?

A

No warnings and orecautions for the use of medicinal product

57
Q

what are the rulse of a medicinal sales representatives?

A

allowed to visit healthcare professionals
have the SPCs available
can provide free samples on an exceptiona basis to physicians

58
Q

what are the exceptionals basis for the free samples?

A

limited amount per year
only as response to a writting request
smallest package

59
Q

how are advertising monitored?

A

authority in germany

Self-monitoring

Drug Regulatory Affairs (15 decks)

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