International HTA Processes, Pricing & Reimbursement at Hochschule Fresenius | Flashcards & Summaries

Select your language

Suggested languages for you:
Log In Start studying!

Lernmaterialien für International HTA Processes, Pricing & Reimbursement an der Hochschule Fresenius

Greife auf kostenlose Karteikarten, Zusammenfassungen, Übungsaufgaben und Altklausuren für deinen International HTA Processes, Pricing & Reimbursement Kurs an der Hochschule Fresenius zu.

TESTE DEIN WISSEN

What does Adaptive Licensing (AL) mean?

Lösung anzeigen
TESTE DEIN WISSEN

Definition: A prospectively planned, adaptive approach to bringing drugs to market.

  • Starting point: Authorisation for most likely a “niche” indication
  • Gradual evidence gathering and license adaptations for the authorised indication and the potential further therapeutic uses
  • Using the regulatory processes within the existing EU legal framework, including scientific advice (with participation of HTA bodies and/or payers and/or other stakeholders)

Criteria for candidate selection

  • An iterative development plan (start in a well-defined subpopulation and expand)
  • Real World Data (safety and efficacy) can be acquired to supplement clinical trials
  • Input of all stakeholders, particularly HTAs, is fundamental
    • Unmet medical need is an important feature that allows full use of regulatory tools
Lösung ausblenden
TESTE DEIN WISSEN

Medicines Adaptive Pathways to Patients

Lösung anzeigen
TESTE DEIN WISSEN

Objective

  • The aim of adaptive pathways is to bring potentially beneficial treatments to patients with unmet medical needs
    • Adaptive pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine

How does it work?

  • Manufacturer with right of request; EMA decides
  • Scientific Advice with/without HTA/Payers
  • Accelerated or conditional market authorisation
  • Conditional marketing authorisation: Phase II  positive Benefit-Risk Assessment for defiened patient population, Phase III-Data or/and RWD later
  • Imposed conditions might cover overall performance of a product in clinical practice, safety aspects
Lösung ausblenden
TESTE DEIN WISSEN

Benefits of adaptive licensing

Lösung anzeigen
TESTE DEIN WISSEN
  • Earlier access for patients
  • Increases efficiency of drug development process
  • Helps to bridge the „valley of death“ funding gab for small and medium sized enterprises (SME)
  • Can provide better evidence of value and potential for cost savings in the health care system
Lösung ausblenden
TESTE DEIN WISSEN

Challenges of adaptive licensing

Lösung anzeigen
TESTE DEIN WISSEN
  • Selection criteria for „substantial advance“ for patients in areas of serious unmet medical need?
  • Risk management – Agreement from patients, doctors, payers? Strict prescribing practice in initial period?
  • Reimbursement – Full reimbursement from beginning? Criteria for revision?
  • Confirmatory data – What is collected? How long? Who pays?
  • Sequence of indications?
  • What to do if benefits are not confirmed?
  • Data exclusivity – impact on return on investment (since counting down from initial marketing authorisation without full reimbursement)
Lösung ausblenden
TESTE DEIN WISSEN

GBA`s Task on Pharmaceuticals

Lösung anzeigen
TESTE DEIN WISSEN
  • AMNOG
  • Exclusion of prescription drugs
  • Reference price setting
  • OTC exemption list
  • Therapeutic advice
  • Off-label use
  • Second opinion
Lösung ausblenden
TESTE DEIN WISSEN

Responsibilities and objectives of IQWiG

Lösung anzeigen
TESTE DEIN WISSEN
  • Quality and efficiency are two deciding factors for a good and effective health care system. To achieve this aim, it is important to examine objectively the advantages and disadvantages of medical interventions for patients
  • Since 2004 this has been the responsibility of the Institute for Quality and Efficiency in Health Care (IQWiG for short). The Institute produces independent, evidence-based reports, e.g. on:
    • drugs
    • non-drug interventions (e.g. surgical procedures)
    • diagnostic tests and screening tests
    • clinical practice guidelines (CPGs) and disease management programmes (DMPs)
  • In addition, IQWiG provides easily understandable health information for the general public
Lösung ausblenden
TESTE DEIN WISSEN

EU Commission and MS set up Joint Actions

Joint Action 1

Joint Action 2

Joint Action 3

Lösung anzeigen
TESTE DEIN WISSEN

 

Joint Action 1 2010 - 2012 

“The broad intent of EUnetHTA JA1 was to take forward the prior developments of the EUnetHTA Project and bring them to a level that enables a genuine collaboration that is implemented in practice.”


Joint Action 2 2012 - 2015 

“The general objective of the EUnetHTA Joint Action 2 on HTA is to strengthen the practical application of tools and approaches to cross-border HTA collaboration.”


Joint Action 3 2016 - 2021 

“Joint Action 3 aims to define and implement a sustainable model for the scientific and technical cooperation on Health Technology Assessment (HTA) in Europe. The voluntary cooperation within and between national and regional HTA Bodies is essential in this joint action.”

Lösung ausblenden
TESTE DEIN WISSEN

What is the "product" of NICE?

Lösung anzeigen
TESTE DEIN WISSEN

Aims to provide robust, transparent, evidence-based
guidance to NHS, patients and health care professionals
to:

  • reduce inconsistency in access to care
  • improve the quality of care in the UK NHS
  • promote rapid uptake of clinically and cost effective treatments
Lösung ausblenden
TESTE DEIN WISSEN

What is NICE NOT?

Lösung anzeigen
TESTE DEIN WISSEN

Is not a reimbursement authority

Does not set prices – the UK is a free pricing market therefore the
manufacturer sets the price – this is key

Does not review everything that comes to market

Lösung ausblenden
TESTE DEIN WISSEN

Core principles of all NICE guidance

Lösung anzeigen
TESTE DEIN WISSEN

1. Comprehensive evidence base
– Look at all available evidence systematically
2. Expert input
– Involve clinical experts in the specific disease area
3. Patient and carer involvement
– Involve patients and their carers in the process
4. Independent advisory committees
– Decision-making committees must remain independent of NICE
5. Genuine consultation
– Publicly consult on all guidance
6. Regular review
– Review every 3 years
7. Open and transparent process
– All in the public domain

Lösung ausblenden
TESTE DEIN WISSEN

Criteria for Topic Selection

Lösung anzeigen
TESTE DEIN WISSEN

• Is it appropriate.......
– Could it represent a future public health issue?
– Is the proposed topic an ultra-orphan disease?
• Would guidance promote best possible
improvement in public health and/or patient
care, reduce inequalities?
• Will NICE be able to add value by issuing
guidance?
• Does it have a significant budget impact?
➢ Key: Remember that NICE doesn’t review everything

Lösung ausblenden
TESTE DEIN WISSEN

First Step in NICE submission

Lösung anzeigen
TESTE DEIN WISSEN

• “Decision problem” form must be sent in around 2 weeks after
being formally invited to provide submission
• NICE sends this to the Evidence Review Group
• Ensures submission is specified appropriately
• Company attends meeting with NICE and Evidence Review
Group to discuss
• Great opportunity to ask questions, highlight key issues
and to ensure final scope is interpreted correctly

Lösung ausblenden
  • 196466 Karteikarten
  • 3545 Studierende
  • 63 Lernmaterialien

Beispielhafte Karteikarten für deinen International HTA Processes, Pricing & Reimbursement Kurs an der Hochschule Fresenius - von Kommilitonen auf StudySmarter erstellt!

Q:

What does Adaptive Licensing (AL) mean?

A:

Definition: A prospectively planned, adaptive approach to bringing drugs to market.

  • Starting point: Authorisation for most likely a “niche” indication
  • Gradual evidence gathering and license adaptations for the authorised indication and the potential further therapeutic uses
  • Using the regulatory processes within the existing EU legal framework, including scientific advice (with participation of HTA bodies and/or payers and/or other stakeholders)

Criteria for candidate selection

  • An iterative development plan (start in a well-defined subpopulation and expand)
  • Real World Data (safety and efficacy) can be acquired to supplement clinical trials
  • Input of all stakeholders, particularly HTAs, is fundamental
    • Unmet medical need is an important feature that allows full use of regulatory tools
Q:

Medicines Adaptive Pathways to Patients

A:

Objective

  • The aim of adaptive pathways is to bring potentially beneficial treatments to patients with unmet medical needs
    • Adaptive pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine

How does it work?

  • Manufacturer with right of request; EMA decides
  • Scientific Advice with/without HTA/Payers
  • Accelerated or conditional market authorisation
  • Conditional marketing authorisation: Phase II  positive Benefit-Risk Assessment for defiened patient population, Phase III-Data or/and RWD later
  • Imposed conditions might cover overall performance of a product in clinical practice, safety aspects
Q:

Benefits of adaptive licensing

A:
  • Earlier access for patients
  • Increases efficiency of drug development process
  • Helps to bridge the „valley of death“ funding gab for small and medium sized enterprises (SME)
  • Can provide better evidence of value and potential for cost savings in the health care system
Q:

Challenges of adaptive licensing

A:
  • Selection criteria for „substantial advance“ for patients in areas of serious unmet medical need?
  • Risk management – Agreement from patients, doctors, payers? Strict prescribing practice in initial period?
  • Reimbursement – Full reimbursement from beginning? Criteria for revision?
  • Confirmatory data – What is collected? How long? Who pays?
  • Sequence of indications?
  • What to do if benefits are not confirmed?
  • Data exclusivity – impact on return on investment (since counting down from initial marketing authorisation without full reimbursement)
Q:

GBA`s Task on Pharmaceuticals

A:
  • AMNOG
  • Exclusion of prescription drugs
  • Reference price setting
  • OTC exemption list
  • Therapeutic advice
  • Off-label use
  • Second opinion
Mehr Karteikarten anzeigen
Q:

Responsibilities and objectives of IQWiG

A:
  • Quality and efficiency are two deciding factors for a good and effective health care system. To achieve this aim, it is important to examine objectively the advantages and disadvantages of medical interventions for patients
  • Since 2004 this has been the responsibility of the Institute for Quality and Efficiency in Health Care (IQWiG for short). The Institute produces independent, evidence-based reports, e.g. on:
    • drugs
    • non-drug interventions (e.g. surgical procedures)
    • diagnostic tests and screening tests
    • clinical practice guidelines (CPGs) and disease management programmes (DMPs)
  • In addition, IQWiG provides easily understandable health information for the general public
Q:

EU Commission and MS set up Joint Actions

Joint Action 1

Joint Action 2

Joint Action 3

A:

 

Joint Action 1 2010 - 2012 

“The broad intent of EUnetHTA JA1 was to take forward the prior developments of the EUnetHTA Project and bring them to a level that enables a genuine collaboration that is implemented in practice.”


Joint Action 2 2012 - 2015 

“The general objective of the EUnetHTA Joint Action 2 on HTA is to strengthen the practical application of tools and approaches to cross-border HTA collaboration.”


Joint Action 3 2016 - 2021 

“Joint Action 3 aims to define and implement a sustainable model for the scientific and technical cooperation on Health Technology Assessment (HTA) in Europe. The voluntary cooperation within and between national and regional HTA Bodies is essential in this joint action.”

Q:

What is the "product" of NICE?

A:

Aims to provide robust, transparent, evidence-based
guidance to NHS, patients and health care professionals
to:

  • reduce inconsistency in access to care
  • improve the quality of care in the UK NHS
  • promote rapid uptake of clinically and cost effective treatments
Q:

What is NICE NOT?

A:

Is not a reimbursement authority

Does not set prices – the UK is a free pricing market therefore the
manufacturer sets the price – this is key

Does not review everything that comes to market

Q:

Core principles of all NICE guidance

A:

1. Comprehensive evidence base
– Look at all available evidence systematically
2. Expert input
– Involve clinical experts in the specific disease area
3. Patient and carer involvement
– Involve patients and their carers in the process
4. Independent advisory committees
– Decision-making committees must remain independent of NICE
5. Genuine consultation
– Publicly consult on all guidance
6. Regular review
– Review every 3 years
7. Open and transparent process
– All in the public domain

Q:

Criteria for Topic Selection

A:

• Is it appropriate.......
– Could it represent a future public health issue?
– Is the proposed topic an ultra-orphan disease?
• Would guidance promote best possible
improvement in public health and/or patient
care, reduce inequalities?
• Will NICE be able to add value by issuing
guidance?
• Does it have a significant budget impact?
➢ Key: Remember that NICE doesn’t review everything

Q:

First Step in NICE submission

A:

• “Decision problem” form must be sent in around 2 weeks after
being formally invited to provide submission
• NICE sends this to the Evidence Review Group
• Ensures submission is specified appropriately
• Company attends meeting with NICE and Evidence Review
Group to discuss
• Great opportunity to ask questions, highlight key issues
and to ensure final scope is interpreted correctly

International HTA Processes, Pricing & Reimbursement

Erstelle und finde Lernmaterialien auf StudySmarter.

Greife kostenlos auf tausende geteilte Karteikarten, Zusammenfassungen, Altklausuren und mehr zu.

Jetzt loslegen

Das sind die beliebtesten StudySmarter Kurse für deinen Studiengang International HTA Processes, Pricing & Reimbursement an der Hochschule Fresenius

Für deinen Studiengang International HTA Processes, Pricing & Reimbursement an der Hochschule Fresenius gibt es bereits viele Kurse, die von deinen Kommilitonen auf StudySmarter erstellt wurden. Karteikarten, Zusammenfassungen, Altklausuren, Übungsaufgaben und mehr warten auf dich!

Das sind die beliebtesten International HTA Processes, Pricing & Reimbursement Kurse im gesamten StudySmarter Universum

International Product Management

Hochschule Mannheim

Zum Kurs
International IT- Projectmanagement

Universität Bamberg

Zum Kurs
International Human Ressource Management

Duale Hochschule Baden-Württemberg

Zum Kurs
International Marketing Management

FOM Hochschule für Oekonomie & Management

Zum Kurs

Die all-in-one Lernapp für Studierende

Greife auf Millionen geteilter Lernmaterialien der StudySmarter Community zu
Kostenlos anmelden International HTA Processes, Pricing & Reimbursement
Erstelle Karteikarten und Zusammenfassungen mit den StudySmarter Tools
Kostenlos loslegen International HTA Processes, Pricing & Reimbursement