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2023 FALL SEM > Health Econ Final Exam > Flashcards

Health Econ Final Exam Flashcards

1
Q

Does the FDA grant patents or exclusivity?

A

Exclusivity

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2
Q

Can FDA market exclusivity exist in the absence of a patent?

A

Yes

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3
Q

Is FDA exclusivity usually longer or shorter than patent protection?

A

Shorter

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4
Q

Can the FDA approve a single drug with two different brand names for two different purposes? If yes, give me an example! If not tell me why not!

A

Yes
Example: Ozempic for type 2 diabetes and Wegovy for weight loss

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5
Q

When drugs that are all small molecules go generic what will be the effect?

A

There will be enormous savings to both the domestic and global economies

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6
Q

Small molecules have caused a lot of ________ upfront that can be burdensome but once they go off patent and become generic they are extremely profitable.

A

Spending

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7
Q

_________ are dramatically taking over the biology market

A

Biosimilars

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8
Q

Small molecules can be _________________ to be almost the same as the original drug

A

Reverse engineered

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9
Q

What is a biosimilar?

A

A biologic medication highly similar to a biologic medication that has already been approved by the FDA. The two have no clinically meaningful differences from the reference product.

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10
Q

Which one has significantly higher research and development costs and risks: biosimilars or generics?

A

Biosimilars

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11
Q

Is it normal and expected for both biosimilars and original biologics to have minor differences between batches of the same medication?

A

Yes

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12
Q

Biosimilars are often __________ than their FDA approved biologic

A

Less expensive

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13
Q

What are the cons of biosimilars?

A

They may not have identical efficacy and safety as their FDA approved counterparts

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14
Q

Why are biosimilars so expensive compared to generics?

A

Due to their complexity, development process, administration route, competition, and market demand

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15
Q

The first time we passed a biosimilars act was with the _____

A

ACA

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16
Q

Biosimilars were introduced to the market within the last ________

A

Decade

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17
Q

Within the market the US is dominating in _______ but not necessarily ________

A

Profits, total revenues

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18
Q

What is a blockbuster drug?

A

A very popular drug that generates annual sales of $1 billion or more for the company that sells it

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19
Q

What is the significance of blockbusters in the pharmaceutical industry?

A

Because drug development is so costly and most launches are duds, the industry as a whole relies on blockbusters - drugs with annual global revenues of $1 billion or more - to cover the flops and keep the entire enterprise afloat.

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20
Q

Do blockbusters dominate the prescription drug market?

A

Yes bc the revenue is so important and foundational to the system

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21
Q

Speciality pharma drives the costs ______ while generic drugs and loss of exclusivity drive costs ______

A

Higher, lower

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22
Q

The industry is trifucated! Tell me how!

A

Generics are biggest in number but smallest in dollars
Speciality pharma is small in number but majority of dollars
Small molecule brand drugs are large in numbers but less so in dollars

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23
Q

What did the Kefauver-Harris Act of 1962 do?

A

Required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects through eliminating the 180 day loophole

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24
Q

What did the Prescrisption drug user fee act do?

A

Authorizes FDA to collect user fees from persons that submit certain human drug applications for review

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25
Q

What did the PDUFA reauthorization Act do?

A

Enabled the agency to reduce to 15 months the 30-month average time that used to be required for a drug review before PDUFA

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26
Q

How often does Congress re-authorize the PDUFA?

A

Every 5 years

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27
Q

What is the FDA’s Emergency Use Authorization?

A

Allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases

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28
Q

What is the only country other than the US that does direct to consumer advertising of drugs?

A

New Zealand

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29
Q

What does DTCA stand for?

A

Direct to consumer advertising

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30
Q

Do the ads used in direct to consumer advertising have to be submitted to the FDA in advance?

A

No but many are with the goal of soliciting advice and maintaining mutual respect

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31
Q

What is the impact of direct to consumer advertising on pharmaceutical prices and demand?

A

DTCA can raise the demand for existing drugs, utilization, and price shifts

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32
Q

What is compassionate use also known as?

A

Expanded access

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33
Q

What is expanded access/compassionate use?

A

A potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available

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34
Q

What led to the development of emergency use authorization?

A

HIV/AIDS epidemic

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35
Q

What was the idea that led to the development of compassionate use/expanded care?

A

Idea that the FDA process was good but didn’t always service people who really needed drugs or were dying

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36
Q

Through compassionate use manufacturers may provide unapproved drugs to patients who meet specific criteria if ________

A

No other therapies are available

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37
Q

What does the 21st century cures act allow for?

A

Less rigorous pre-approval testing in order to achieve faster drug approvals

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38
Q

What drugs is the 21st century cures act particularly important for and why?

A

Drugs with much smaller patient populations - Some people wanted more money for opioid treatment, others wanted for NIH treatment, or stronger regulations around electronic health records, etc

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39
Q

What are the benefits of the Orphan Drug Act?

A

Provided incentives such as tax credits, marketing exclusivity, fee waivers, and the opportunity to apply for grants to support clinical trials

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40
Q

What was the problem with the orphan drug act?

A

Despite the fact that it made more medications available it did not always make them accessible bc of crazy high costs

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41
Q

What did the FDA Amendments Act do?

A

1) Increased the FDA’s power to require manufacturers to conduct postapproval studies by giving it authority to impose monetary penalties for noncompliance.
2) Required that information on the design of all clinical trials be recorded in a public database soon after a trial’s inception
3) Set in motion rulemaking to require that summary results also be included in the database within 12 months after the trial’s primary completion date.
4) Mandated the implementation of risk evaluation and mitigation strategies (REMS) which can require physician certification, mandatory risk communications, or laboratory testing when specific high-risk medications are used

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42
Q

Is the distribution of drugs concentrated or spread out?

A

Concentrated because small companies came together and are under big umbrellas like Walgreens, CVS, and rite aid

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43
Q

Do a lot of prescription drugs have generic competition?

A

Yes

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44
Q

Are generic drugs cheap or expensive?

A

Cheap

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45
Q

Often copays are _______ than the actual cost of the generic drug

A

Greater

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46
Q

Biologics are starting to move off of patents and are becoming _____. What will this cause?

A

Generics - it will cause some real competition

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47
Q

Do branded drugs have competition? Why or why not?

A

No they do not because of their patents

48
Q

What is a branded generic?

A

A drug that once had a patent and now does not

49
Q

What is an example of a branded generic?

A

Motrin

50
Q

What is the purpose of patents?

A

Protection of intellectual property

51
Q

Are patents a domestic or global idea?

A

They are a domestic idea - we need to have official trade agreements in order to respect each other

52
Q

What were the goals of the HW act?

A

Foster innovation, increase consumer access, and assured competition after a finite period of time

53
Q

Pre Aca how long was the period of generic exclusivity?

A

180 days

54
Q

What are some facts about drugs with over the counter status?

A

Benefits outweigh the risks, potential for misuse and abuse is low, consumers can use for self-diagnosed conditions, and health practitioners are not needed for the safe and effective use of the product

55
Q

What does the title of physician grant you?

A

Value and certain skillset but not necessarily the right to practice anywhere

56
Q

What does a physician need to practice?

A

A degree, certification by a national authority, state licensure, and DEA number

57
Q

What does IMG stand for?

A

International medical graduate

58
Q

What is an IMG?

A

A US physician who received a basic medical degree or qualification from a medical school located outside the United States and Canada

59
Q

What does CMS stand for?

A

Centers for medicare and medicaid services

60
Q

What is the goal of CMS by 2030?

A

To cover 100% of beneficiaries in value based care

61
Q

What does our economic model enable us to invest in heavily?

A

Primary and preventative care to prevent downstream adverse effects

62
Q

What are some requirments for success in VBC?

A

Investment of time and resources, desire to shift away from profit maximization, comittment to integration and flexibility, and external partnerships

63
Q

What is value based care down risk?

A

Physicians receive allotted funds per patient and retain a defined portion of the surplus generated. However, if they spend more than they’re given, they are responsible for a defined portion of the deficit.

64
Q

What do all value based care payment models focus on?

A

Removing costs over the long-term through population health management and other programs that incentivize providers for delivering quality care.

65
Q

What are duals?

A

People who qualify for both Medicare and Medicaid

66
Q

Why do duals have a special name?

A

They are expensive beneficiaries who use a lot of institutional care

67
Q

Who did Medicaid start for?

A

Kids, families, and pregnant women

68
Q

Since the ACA the expansion covers people who are ____% of the federal poverty level

A

138%

69
Q

The federal government matches each state’s Medicaid spending at a set rate that varies by state. What is this rate called?

A

FMAP

70
Q

Before ACA who was not covered by Medicaid?

A

Households with no children

71
Q

Medicaid is funded by a mix of ____ and ____ money

A

State and federal

72
Q

Medicaid is administered by _____

A

The state

73
Q

Beneficiaries with Medicaid pay almost nothing. They do not pay ____ or ____

A

Premiums or deductibles

74
Q

Medicaid is known as a ______

A

Lab for different ways to administer healthcare

75
Q

If a state needs to rebalance it’s budget for Medicaid it most likely to cut money from ______

A

Education

76
Q

As a Medicaid beneficiary are prescription drugs covered?

A

Yes 100%

77
Q

If the state wants to cover something that the federal government doesn’t want them to cover then the federal government _____

A

Doesn’t give them an FMAP for that service

78
Q

What is managed medicare also known as?

A

Medicare Advantage

79
Q

What does Medicaid Advantage / managed medicare offer?

A

You get a set plan that you do not get to choose - if u decide you want managed care then they give u whatever they think you should have

80
Q

Name some characteristics of Managed care

A

Choice of the state but federal government is running the plans, and very tightly managed

81
Q

What is the minimum mandated FMAP?

A

50%

82
Q

What is the maximum FMAP a state can receive?

A

83%

83
Q

Who is SCHIP for?

A

Kids who were not poor enough to be on Medicaid

84
Q

Can drugs have multiple patents?

A

Yes - they can different patents for proteins, paperwork, managemnet, machinery etc

85
Q

If we don’t have patents or exclusivity then we will not have ___________

A

Competition in the market

86
Q

What are the 3 segments of the market?

A

Really expensive speciality pharma drugs, small molecules that are still patent protected and generics

87
Q

Will speciality pharma drugs ever be cheap?

A

No - they are 50% of total dollar spending but only 2.5% of patients use them

88
Q

Less than ______ percent of drugs submitted get approved

A

25%

89
Q

The physicians and nursing labor markets are ____ controlled and _____like

A

Tightly, guild

90
Q

Why is the physicians and labor market guild like?

A

Goal of protecting the standard of care while allowing people to specialize and not have competition in their respective fields

91
Q

Are nurse practitioners primary care providers or primary care physicians?

A

Primary care providers

92
Q

What are residency spots dependent on?

A

Balancing of supply and demand and quality of teaching capability

93
Q

How does residency match work?

A

Places will determine what they were willing to pay and then take the amount of residents who are within that boundary

94
Q

What are most adverse events due to?

A

Life, allergies etc but NOT MALPRACTICE

95
Q

Top paid physician specialties

A

Plastic surgeons, dermatologists, ortho, neuro

96
Q

Lowest paid physician specialties

A

Public health, primary care, and preventative medicine

97
Q

As more people come into higher paying jobs within the physician market what could be a possible problem?

A

At a certain point they begin to work less so you have to find the balance between paying people for their work and paying them to the point they feel they no longer have to work anymore

98
Q

What do most physician models emphasize and why?

A

Fee for service care and volume because they often get reimbursed for quantity

99
Q

What is defensive medicine?

A

The practice of recommending a diagnostic test or medical treatment that is not necessarily the best option for the patient, but mainly serves to protect the physician against the patient as potential plaintiff

100
Q

Why is defensive medicine expensive?

A

You may order more tests and treatments bc you’re so aware and paranoid that something will go wrong bc of the risk you took

101
Q

Is YNHH tied to yale?

A

No - it is a teaching hospital that interacts with Northeast practice plan and Yale medical practice group (Yale Med)

102
Q

What are Yale University’s health services?

A

Staff model HMO - med school and student center

103
Q

Why are there hurdles to practice?

A

Everyone has a scope and want to define it in a way to do as much as possible and prevent competition from others

104
Q

Most grad school and medical programs are funded by ________

A

CMS & Medicare Part A

105
Q

What do residents do for the healthcare system?

A

Add value and labor - even though they are not doctors they can do administrative work to promote efficiency and also shadow and learn

106
Q

Why do physician salaries vary (non-cynical view)?

A

Intensity of training, intensity of work, length or training/workday, utility of practice, requirements for practice - special skills reduce the available pool

107
Q

Why do physician salaries vary (cynical view)?

A

Reimbursement scheme compensates for services and some specialities can increase volume and therefore profit

108
Q

What is supplier-induced demand?

A

When a provider of healthcare stimulates or produces more demand for their offering than would otherwise exist in the market - the physician influences a patient’s demand for care against the best interest of the patient (asymmetric info)

109
Q

What is resource-based relative work?

A

If you pay me on the time I commit to work then I do I will work slower - ultimately decreased fee for service payments for services

110
Q

Are medical malpractice and medical error the same thing?

A

No - malpractice has to have harm and provable negligence

111
Q

What are academic medical centers?

A

Typically refers to a medical school and a university affiliated hospital

112
Q

YNHH is not an __________ without Yale University

A

Academic medical center

113
Q

What do med schools provide to the academic medical center?

A

Research and education

114
Q

How do hospitals fund graduate medical education?

A

They pass through dollars from Medicare

115
Q

What are OTC drugs?

A

Drugs that once required a prescription and now don’t

116
Q

What are economic damages?

A

Medical bills, lost income, property damage, loss of earning capacity, vocational rehabilitation, household services, and out-of-pocket costs.

117
Q

What are non-economic damages?

A

Pain and suffering

2023 FALL SEM (4 decks)

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