8 - Drugs & introduction to pandemics Flashcards
what are the three main categories of investment for pharmaceutical companies?
- R&D
- multinational and international marketing
- on-patent drugs and generics
what is the difference between on-patent drugs and generic drugs?
- On-patent: New drugs that are developed are protected by patent rights (only the original company can produce the drug, and is thus very expensive).
- Generic: Once the patent ends, other companies can take over, which results in a reduced cost of the drug in the industry.
what are the major determinants of drug prices?
1 - Substitute products → How many other products could be used as treatment?
2 - Associate drugs/therapies → What other treatment must be used in conjunction with the drug?
3 - Competitors → How many competitors are there in the market for this drug?
4 - Regulatory environment → The price of the drug depends on the company’s estimated demand for the product.
Explain Japan’s direct pricing system
- national health insurance
- central social insurance medical council is a committee which decides the price of each treatment individually
- Use the comparator + premium or the cost-calculation method to aid in the price determination system
what is the difference betweent comparator-premium and cost-calculation in determining prices of drugs?
Comparator + premium: Look at the cost of drugs in the market and if the new drug is more effective, can add to the price
Cost-calculation: Directly ask the pharma company how much money they spent → If there is no comparator, companies will often inflate this price.
what are orphan drugs?
they are drugs for very rare forms of diseases. although expensive to sell, there is a very little profit margin for pharma companies so are severely underdeveloped. Furthermore, there are uncertainties about the size of health benefits they can provide as well as the long-term benefits (very small QALY)
Is it unfair to patients with orphan disease if orphan drug is rejected?
McCabe, Claxton, Tsuchiya: No.
why are antibiotics often under-researched?
- Expensive research and development → continual research, but not much profit so companies don’t want to produce and develop
- Fragile supply chain
- antimicrobial resistance = major issue
distinguish between outbreak, epidemic and pandemic
Outbreak (small area, sudden rise of cases in limited space)
Epidemic (broader scale, could be international, but smaller scale)
Pandemic (global scale)
what is the common ground restriction?
“Ethical claims and recommendation in the specific context of pandemic response should be acceptable by two or more major ethical theories”
→ Want the restrictions to represent the overall population and not hold bias from one belief system
list 5 previous pandemics
Influenza→ Spanish Flu (1918)
Influenza→ Asian Flu (1957-1958)
HIV/AIDS (1981-ongoing)
H1N1 influenza/Swine Flu (2009)
COVID-19 (2019-ongoing)
compare and contrast pharmaceutical pricing in England vs Japan
In Japan, the pharmaceutical pricing system is based on a cost-calculation method with little consideration for the size of health benefits. Prices are initially set high and may be opportunistically reduced based on sales volumes. This approach lacks explicit consideration of cost-effectiveness and health benefits, leading to potential vulnerability to manipulation and unpredictable pricing.
In contrast, England employs a more explicit commitment to cost-effectiveness and the possibility of rationing drugs based on their cost-effectiveness. The National Institute for Health and Care Excellence (NICE) considers the relationship between health benefits and costs, encouraging drug manufacturers to offer practical discounts to meet cost-effectiveness thresholds. This approach aligns the interests of manufacturers and broader society more effectively.
what is the main argument in Christopher McCabe, Karl Claxton, Aki Tsuchiy paper “Orphan durgs and the NHS: should we value rarity?”
- the appraisal framework already supports the use of lower evidential standards for orphan drugs
-cost of production and the value of innovation cannot justify special treatment for OD - args abt the measurement and valuation of health outcomes apply equally to OD and drugs for more common conditions
- valying health outcomes more highly for rate conditions is incompatible with other equity principles and theories of justice
- cost effectiveness of an OD should be treated in the same way as for other technologies
what is a commonly used thought experiemnt about OD and funding?
Thought experiment: Then the real choice posed by orphan status is between treating 1 person with J or 10 people with K. To argue that the patient with J should get treatment implies that that health gain of people with J should be valued 10 times higher than that of people with K
what is the tradeoff of financing OD for rare diseases selon McCabe, Claxton, Tsuchiya?
Special status for orphan drugs in resource alloca- tion will avoid difficult and unpopular decisions, but it may impose substantial and increasing costs on the healthcare system. The costs will be borne by other, unknown patients, with more common diseases who will be unable to access effective and cost effective treatment as a result.
