Summary
Summary HPI4001 - Case 5: Pharmaceuticals as typical product innovations in healthcare
- Course
- Institution
Case 5 of the HPI4001 module
[Show more]
1 review
By: madeleine95 • 2 year ago
Seller
Follow
1998Eva
Reviews received
Content preview
Case 5: Pharmaceuticals as typical product innovations in healthcareLearning goals
1. How does a drug come into the market? What is the role of research & development?
2. What is the fourth hurdle?
3. Why is taking the fourth hurdle not a straightforward process?
4. Which factors and criteria are used in priority setting of pharmaceuticals?
5. What is coverage with evidence development (CED)?
a. What are other types of coverage options (framework by Walker)?
Keywords of the case
Clinical trials, drug development process, fourth hurdle, health technology assessment, marketing
authorisation (similar to ´licensing´), reimbursement and pricing phase, pharmaceutical market,
priority setting, risk-sharing arrangements and overage with evidence development.
Literature
- Erntoft S (2011). Pharmaceutical priority setting and the use of health economic evaluations: a
systematic literature review. Value in Health; 14(4):587-99.
- European Medicines Agency (2019). From laboratory to patient: the journey of a centrally
authorised medicine. Available from URL
https://www.ema.europa.eu/en/documents/other/laboratory-patient-journey- centrally-authorised-
medicine_en.pdf
- European Parliament. Toward a harmonised EU assessment of added therapeutic value of medicine.
2015. Available from URL
http://www.europarl.europa.eu/RegData/etudes/STUD/2015/542219/IPOL_STU(2
015)542219_EN.pdf
(Chapters 1 and 2; Chapters 3, 4 and 5 as illustration)
- Hutton, J, Trueman, P, & Henshall, C. (2007). Coverage with evidence development: an examination
of conceptual and policy issues. International Journal of Technology Assessment in Health Care,
23(4), 425-432.
- Taylor RS, Drummond MF, Salkeld G, Sullivan SD. (2004). Inclusion of cost effectiveness in licensing
requirements of new drugs: the fourth hurdle. BMJ. 2004; 329(7472): 972–975.
- Rawlins MD (2012). Crossing the fourth hurdle. British Journal of Clinical Pharmacology.73(6):855-
60.
,- Walker S, Sculpher M, Claxton K, Palmer S (2012). Coverage with evidence development, only in
research, risk sharing, or patient access scheme? A framework for coverage decisions. Value in
Health.;15(3):570-579
1. How does a drug come into the market? What is the role of research & development?
The roles of the pharmaceutical industry:
- To develop and produce medicines and vaccines
à Drugs as a method to preserve health and save live, next to nutrition, sanitation and
medical care.
- To drive innovation in drugs
à To develop, test and produce drugs safety for human use; early years very successful:
insulin (diabetes), antibiotics, polio-vaccination.
- Economic growth factor worldwide
Challenges in drug development
- High costs: spending on pharmaceutical account for a significant proportion of total health
spending in European countries due to:
o Ageing of the population;
o Reform of drugs
o Higher demand for care
- Budget impact vs. cost-effectiveness
- Unequal access
- Lack of transparency
- What is value?
- Uncertainty; new coverage decisions
- Harmonization between reimbursement and regulatory approval
Example of the pharmaceutical success:
, From laboratory to patient
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller 1998Eva. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $4.31. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
67474 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now