Pharmacoeconomics and

Management in Pharmacy VI

2013 [UNIT PH 3340] 1

[John Vella B.Pharm.(Hons.) M.Sc.(Pharmacoeconomics)]

2013

[UNIT PH 3340] 2

News review

[John Vella B.Pharm.(Hons.) M.Sc.(Pharmacoeconomics)]

J. Vella [PH 3340]

Reverse interpretation? (i)

3

J. Vella [PH 3340]

Reverse interpretation? (ii)

• Most times declining birth rates are viewed as the initial

stages of a drop in productive population demographics and

economic stagnation

• In Japan, this is being considered in an alternative manner

• Japan has the world's oldest population, with a median age

of 46 years, an average lifespan of 84, and a quarter of the

population over 65

4

J. Vella [PH 3340]

Reverse interpretation? (iii)

• Proponents of this hypothesis argue that less children mean

less spending on education and care

• A declining population will also lead to more land area and

arable land per capita, resulting in a higher quality of living

• This in turn will reduce the drain on global resources

• This interpretation may or may not be correct, but it is

certainly an innovative way of considering the issue at hand

5

J. Vella [PH 3340]

Who is right? (i)

6

J. Vella [PH 3340]

Who is right? (ii)

• Global pharmaceutical firms are pressuring the United

States to act against India

• Local companies produce up to a dozen new varieties of

cheap generic drugs for still on-patent medicines

• An Indian government committee is reviewing patented

drugs of foreign firms to see if so-called compulsory

licences, which in effect break exclusivity rights, can be

issued for some of them to bring down costs

7

J. Vella [PH 3340]

Who is right? (iii)

• On the one hand, big pharma claims a violation of property

rights and lost earnings

• On the other side, developing countries are faced with a

humanitarian crisis due to growing populations, an increase

in NCD’s and expensive pharmaceutical care costs

• US companies are going for an aggressive stance, asking

the US government to downgrade the status of the Indian

continent

8

J. Vella [PH 3340]

Who is right? (iv)

• The solution is, as in most cases, a middle of the road approach

• An effort must be made to find mutually acceptable terms

• In the case of developing countries big pharma must accept that the

production of pharmaceuticals is not solely a financial issue, but also

comprises a human and ethical aspect

• Prices must be set in accordance to the COL and affordability of each

world region to enable equitable access 9

J. Vella [PH 3340]

Covert intentions(i)

10

J. Vella [PH 3340]

Covert intentions(ii)

• Pharmaceutical companies are guilty of creating markets for

their products!

• They influence KOL’s and these in turn create self-help and

awareness groups around common ailments to generate

public need

• This is a financial cost to society in general and a

psychological burden on the patient for no medical or

justifiable reason

11

J. Vella [PH 3340]

Covert intentions(iii)

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J. Vella [PH 3340]

Covert intentions(iv)

• “The drug companies learned a while back that the best way

to sell drugs was to sell diagnoses… selling the diagnosis is

a way of opening up the new market. New diagnoses are as

dangerous as new drugs, at least in psychiatry.”~ Dr Allen

Frances, chair of DSM IV task force - Selling Sickness

conference, 2011.

13

J. Vella [PH 3340]

Covert intentions(v)

14

J. Vella [PH 3340]

A year later!

• A quick review of the electoral ideas floated by both parties

prior to last year’s general election in March 2013

• It is of interest to establish whether any of the proposals

have come to fruition or generated momentum for change

• On the plus side one notes the publication of a White Paper

on health care and medicines access, although no concrete

changes have yet to be made 15

J. Vella [PH 3340]

Campaign 2013 pledges (i)

• Home delivery for POYC medicines for the over 70s

• Commendable as an idea

• One must quantify how many people (40,000?), how

often(every 8 weeks or more due to OOS & warfarin), how

long each visit would take(20-30min) and who would

deliver(legally only a pharmacist can dispense)

• So far no detail and vague intentions to effect in 2015

16

J. Vella [PH 3340]

Campaign 2013 pledges (ii)

• Reimbursement for OOS medication

• In some forms it has been quoted as reimbursement for the

patient, in others as a free service to the patient with the

retail pharmacy being reimbursed

• As with the first concept no firm workings

• This might yet emerge as a workable paradigm, with a twist

17

J. Vella [PH 3340]

Will it add up?

• However the current budget will not suffice

• As at least 10% of medicines are OOS at any one point one

could argue that the budget for medicinals would at least

need to expand by the same proportion

• Based on the assumption that the state would pay the same

price it pays at public tender

• Viability depends on total inventory, prescribing and

entitlement control 18

J. Vella [PH 3340]

Multiple conditions cost more!

• A recent study from Robert Wood Johnson consulting

• 28% of US citizens suffer from two or more chronic disease

states

• 58% of Medicare expenditure is on individuals with five or

more comorbidities

• Per capita cost rises rapidly with increasing no of chronic

conditions

19

J. Vella [PH 3340]

Incidence of chronic conditions

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J. Vella [PH 3340]

Per capita cost/no of disease states

21

J. Vella [PH 3340]

Local data

• No comparable study available

• Data from five years of POYC could be put to good use

• The great likelihood that results would mirror the previous

study mentioned

• A high incidence of diabetes, hypertension and obesity

leading to metabolic syndrome

22

J. Vella [PH 3340]

Strange but true

23

J. Vella [PH 3340]

Doctors are different

• 754 physicians surveyed in the United States

• 64% of doctors surveyed had an advanced directive

• The general public had 24%

• The mentality seems to indicate the futility of fighting a lost

battle

• Doctors actually consume less healthcare resources at end

of life

24

J. Vella [PH 3340]

Patient-centred finance

25

J. Vella [PH 3340]

Reality check

• Most patients, in the US or Malta, have no idea of the cost of

their treatments unless they are out-of-pocket costs

• This article suggest that patients should be brought into the

picture, and informed that shopping around for cheaper

interventions will lead to lower insurance premiums

26

J. Vella [PH 3340]

As long as its free!

• This is also relevant locally, where the privately insured are

not price-sensitive

• There are certain elements who have suggested including

the cost of free medications along with the prescriptions

• This could introduce a sense of financial responsibility from

the patient’s perspective

27

J. Vella [PH 3340]

The MMR – autism scare

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J. Vella [PH 3340]

A spike in new infections

29

J. Vella [PH 3340]

Credibility is vital!

• The MMR scandal was a setback to vaccination campaigns

worldwide

• A study published in the Lancet in 1998 supported the

hypothesis that the MMR vaccine could be the cause of

autism in young children

• This led to thousands of parents refusing the state required

procedure

30

J. Vella [PH 3340]

Effects can be far-reaching

• Rates of reported disease rose, especially in the UK

• It was only last year that the journal withdrew the article and

published a full retraction

• This proves the importance of verification and the

reproducibility of methodology and sensitivity analyses

31

J. Vella [PH 3340]

Study defects

• The study turned out to have only 12 subjects

• Five already had developmental issues

• Pre-selection bias was present

• Results were doctored

• No ethical approval was sought or granted

32

J. Vella [PH 3340]

Fall out

• "This case reveals major flaws in pre and post-publication

peer review. Allegations of research misconduct must be

independently investigated in the public interest. But it's still

too easy for institutions to avoid external scrutiny, and

editors can fail to adequately distance themselves from work

they have published and then defended.“

• Dr. Fiona Godlee, Editor in Chief, BMJ (Brtitish Medical Journal)

33

J. Vella [PH 3340]

The moral of the story

• Always check facts before quoting

• Never sensationalise when the plain truth will do

• Never put personal gain before public health and safety

• Confer and consult with peers and experts in a particular

field before publishing work with far reaching consequences

34

J. Vella [PH 3340]

Established medium

35

J. Vella [PH 3340]

Clear title and objective

36

J. Vella [PH 3340]

Credentials of authors and no

37

J. Vella [PH 3340]

Abstract is direct and not vague

38

J. Vella [PH 3340]

The results

• Screening is not cost-effective in the general population or in

the elderly or even those sub-groups suffering from

hypertension

• The cost is comparable to other interventions when

considering patients with diabetes in specific sub-groups

39

J. Vella [PH 3340]

Are biphosphonates worth it?

40

J. Vella [PH 3340]

Costly treatment

• This study evidences the fact that continuing treatment for

longer than 5 years has no beneficial effect

• The short term effect is debatable as the significant

reduction in fractures occurs only in high risk patients and

does not take into consideration other factors such as

mobility, mental health or medication determinants

41

J. Vella [PH 3340]

Recent study on anti-psychotics

42

J. Vella [PH 3340]

Results (i)

• Increased mortality rate with high doses of medication

• This should change our approach to prescribing and restrict

it to only to cases of clear need, especially in the elderly

• 75,445 subjects in the study

• Risk highest for haloperidol and lowest for quietapine

43

J. Vella [PH 3340]

Results (ii)

• The effects were strongest at the beginning of treatment, did

not vary after dose adjustment and were seen for all causes

of death examined

• Atypicals had a higher mortality risk from respiratory disease

and stroke

• The use of haloperidol cannot be justified in the elderly

especially those with dementia

44

J. Vella [PH 3340]

Kaiser Permanente investment in EHR

45

J. Vella [PH 3340]

Massive capital involved

• $4 billion so far

• A complex learning curve to integrate all the units within the

healthcare algorithm

• Already savings of 50% in diabetic hospitalisation

• A patient-centric focus to enable the end user

• Main problems are inter-operability and mobility

46

J. Vella [PH 3340]

User unfriendly!

47

J. Vella [PH 3340]

Continued!

• EHR’s have suffered problems

• Time consuming, clunky, non-intuitive, and more often than

not impractical

• Newer systems are having to observe the health

professional at arm’s length and evolve code to lighten

workload not increase it

• Key is inter-disciplinary co-operation in product development

48

J. Vella [PH 3340]

Local implications

• This approach should have been applied to the development

of the present POYC software

• The end-user should have been directly involved in the

framing of the process algorithm and also in the practical day

to day functionality

• The system is limited in scope and does not empower the

dispenser or prescriber; the system proposed in the

recent(Dec 2013) White Paper would address these issues

49

J. Vella [PH 3340]

Education leads to better health!

50

J. Vella [PH 3340]

Strange but true

• A higher level of education leads to better awareness for

one’s individual health and also of the surrounding family

• Investment in education thus leads to a better quality of life

and lower expenditures in the long term

• Only possible to appreciate with a holistic approach to

healthcare administration an d policy

51

J. Vella [PH 3340]

Again!

52

J. Vella [PH 3340]

Malta, health & education

• These have a direct bearing on the local situation

• As the following slide demonstrates we have incredibly low

levels of education

• Hence our health education and lifestyle approach suffers

• This can be clearly seen in the levels of smoking, obesity

and physical inactivity

53

J. Vella [PH 3340]

Shocking data!

54

Inequities vs. Inequalities vs.

Disparities in Health

A quick guide to the terms and a framework

for understanding differences in health

J. Vella [PH 3340]

Health Disparities

• Health disparities - population-specific differences in the

presence of disease, health outcomes, or access to health

care (HRSA definition)

• Key is that there are differences between populations in

measures of health (e.g. access to care, health outcomes,

rates of chronic disease)

J. Vella [PH 3340]

How to eliminate health disparities?

Commonwealth Fund (www.cmwf.org) recommends the following steps in developing policies to eliminate racial and ethnic disparities:

• Consistent racial and ethnic data collection by health care providers.

• Effective evaluation of disparities-reduction programs.

• Minimum standards for culturally and linguistically competent health services.

• Greater minority representation within the health care workforce.

• Establishment or enhancement of government offices of minority health.

• Expanded access to services for all ethnic and racial groups.

• Involvement of all health system representatives in minority health improvement efforts.

J. Vella [PH 3340]

Health inequalities

• Equivalent to health disparities

• Again, the issue is that there is a difference between the

health status of one population compared to another

population

J. Vella [PH 3340]

Global inequalities

59

J. Vella [PH 3340]

Health Equity

• Health equity = absence of systematic disparities in health (or in the

major social determinants of health) between groups with different

social advantage/disadvantage (e.g. wealth, power, prestige).

-Braveman, Gruskin (2003)

• Thus, health inequities are the presence of such differences, or the

presence of disparity in the health status of a population or socio-

economic group

J. Vella [PH 3340]

What causes health inequities?

“The social determinants of health are mostly responsible for health

inequities - the unfair and avoidable differences in health status seen

within and between countries. The structural roots of health inequities

lie within education, taxation, labor and housing markets, urban

planning, government regulation, health care systems, all of which

are powerful determinants of health, and ones over which individuals

have little or no direct personal control but can only be altered

through social and economic policies and political processes.”

WHO Commission on the Social Determinants of Health

J. Vella [PH 3340]

“Social Determinants of Health”

• Social-Physical-Economic-Services Determinants – Income & income inequality

– Education

– Race/ethnicity/gender & related discrimination

– Built Environment

– Stress

– Social support

– Early child experiences

– Employment

– Housing

– Transportation

– Food Environment

– Social standing

J. Vella [PH 3340]

What is the role of health care?

• Public Health Agency of Canada: “there is mounting evidence that the contribution of medicine and health care is quite limited, and that spending more on health care will not result in significant further improvements in population health. On the other hand, there are strong and growing indications that other factors such as living and working conditions are crucially important for a healthy population.”

J. Vella [PH 3340]

Estimated Deaths Attributable to Social

Factors in the US - 2000 • Low education: 245,000

• Racial segregation: 176,000

• Low social support: 162,000

• Individual level poverty: 133,000

• Income inequality: 119,000

• Area level poverty: 39,000

• In comparison: – Acute MI: 192,898

– Cerebrovascular disease: 167,661

– Lung cancer: 155,521

Estimated Deaths Attributable to Social Factors in the US. Galea S et.al. AJPH:June 16,2011;eprint.

J. Vella [PH 3340]

Oakland, CA

Life Expectancy in the Bay Area

(i)

J. Vella [PH 3340]

Life Expectancy in the Bay Area (ii)

66

• People who live in West Oakland can expect to live on average

10 years less than those who live in the Berkeley Hills.

• People who live in Bayview/Hunters Point can expect to live on

average 14 years less than their counterparts on Russian Hill

• Residents of Bay Point can expect to live on average 11 years

less than people in Orinda

J. Vella [PH 3340]

Compared to a white child born in the

Oakland hills, a black child born in West

Oakland is:

• Likely to die almost 15 years earlier

• 5x more likely to be hospitalized with diabetes

• 2x as likely to die of heart disease

• 3x more likely to die of stroke

• 2x more likely to die of cancer

• 7x more likely to be born into poverty

• 4x less likely to read at grade level by grade 4

• 4 x as likely to live in a neighborhood with high density of fast food and liquor outlets

• 5.6x more likely to drop out of school

Alameda County Department of Public Health

J. Vella [PH 3340]

Inequities in Contra Costa County

• Hospitalization rate for asthma for African American children 5x that of White children

• Latinas have a rate of births to teens more than twice that of the county overall

• Most of the homicide deaths in Contra Costa occurred among African Americans

• People living in San Pablo, Oakley, Richmond, Antioch, Brentwood and Pittsburg, as well as African Americans and men overall, are more likely to die from heart disease

J. Vella [PH 3340]

Health Equity in California

• Lowest Infant Mortality

– African Americans double

• Lowest Teenage Pregnancy

– Hispanic teens double

• Lowest Tobacco Use

– Low income population double

J. Vella [PH 3340]

How could income effect health?

Income directly shapes:

Nutrition & physical activity options

Housing quality

Neighborhood conditions

Social networks & support

Stress due to inadequate resources to face daily challenges

Medical care

Parents’ income shapes the next generation’s:

Education, which shapes their

Working conditions (physical & psychosocial) &

Income

Center on Social Disparities in Health, UCSF

J. Vella [PH 3340]

Children Raised in Poverty

• Have lower levels of educational attainment

– more likely to score lower on standardized tests, be held back a grade,

drop out of high school,

– less likely to get a college degree

– attend schools with fewer resources

– suffer from poor nutrition, chronic stress, and other health problems that

interfere with their school work

– change residences and schools frequently as their families struggle to

find affordable housing

• Have lower earnings and are more likely to live in poverty

as adults

J. Vella [PH 3340]

* BARHII

The Social Gradient in Health

J. Vella [PH 3340]

J. Vella [PH 3340]

0

5

10

15

20

25

30

35

40

45

Black, Non-Hispanic Hispanic White, Non-Hispanic

% o

f ad

ult

s ag

es 2

5+ w

ho

are

ph

ysic

ally

act

ive*

<100% FPL100%-199% FPL200-299% FPL300-399% FPL≥400% FPL

Across racial and ethnic groups, higher income*, more physically active adults

NHIS 2001-2005 Age-adjusted * Similar by education

J. Vella [PH 3340] U.S.

• California

6.1 million Californians (16.3%) incomes <FPL

2.2 million Ca children (nearly ¼) in families <FPL

J. Vella [PH 3340]

Health Impact of Resolving Racial Disparities

• 1991 to 2000

– Medical advances averted 176,633 deaths

– Equalizing the mortality rates of Whites and African Americans

would have averted 886,202 deaths

• “The prudence of investing billions in the development of new drugs and

technologies while investing only a fraction of that amount in the correction of

disparities deserves reconsideration. It is an imbalance that may claim more lives

than it saves.”

Wolff S. Satcher D., et.al. The Health Impact of Resolving Racial Disparities: An Analysis of US Mortality Data. Am J Public Health. 2004;94:2078–2081

J. Vella [PH 3340]

How could a neighborhood affect health?

Safe places to exercise

Access to healthy food

Exposure to targeted advertising of harmful

substances

Social networks & support

Norms, role models, peer pressure

Fear, anxiety, stress, despair

Violence and fear

Quality of schools

2013 [UNIT PH 3340] 78

WHO Statistics 2013 Report

[John Vella B.Pharm.(Hons.) M.Sc.(Pharmacoeconomics)]

J. Vella [PH 3340]

Fact list

79

J. Vella [PH 3340]

Full report

80

2013 [UNIT PH 3340] 81

The WHO World Report 2011

and 2013

[John Vella B.Pharm.(Hons.) M.Sc.(Pharmacoeconomics)]

J. Vella [PH 3340]

WHO

• The 2011 report focused on the MDG

• In 2013 the whole emphasis was on UHC or Universal

Health Coverage

• Reminiscent of President Obama’s quest to have universal

health insurance coverage in the United States

• In this case the unequal distribution of wealth leads to

disparities in access to health care

82

J. Vella [PH 3340]

Universal Health Coverage (i)

• “The goal of universal health coverage is to ensure that all

people obtain the health services they need without suffering

financial hardship when paying for them.”

• WHO

83

J. Vella [PH 3340]

Universal Health Coverage (ii)

• UHC requires at a minimum:

• (i) a functioning health care system

• (ii) a team of well trained health professionals

• (iii) the concepts of access and affordability

84

J. Vella [PH 3340]

Millennium Development Goals(MDG)

• In 2000, 189 nations made a promise to free people from

extreme poverty and multiple deprivations

• This pledge became the eight Millennium Development

Goals to be achieved by 2015

• In September 2010, the world recommitted itself to

accelerate progress towards these goals

85

J. Vella [PH 3340]

Eight Goals for 2015

• Eradicate extreme poverty and hunger

• Achieve universal primary education

• Promote gender equality and empower women

• Reduce child mortality

• Improve maternal health

• Combat HIV/AIDS, malaria and other diseases

• Ensure environmental sustainability

• Develop a global partnership for development

86

J. Vella [PH 3340]

Malnutrition

87

J. Vella [PH 3340]

Childhood mortality

88

J. Vella [PH 3340]

Maternal mortality

• Maternal mortality has decreased 34%

• Still around 358,000 per annum

• 99% of deaths in developing countries

• 68% of deliveries were attended by health personnel

• Only 53% of women received the recommended four ante-

natal visits

89

J. Vella [PH 3340]

Money is the key!

90

J. Vella [PH 3340]

A case for enforced generic copies?

• The % of people treated is shockingly low

• Is the cost of therapy and issue to limiting access?

• Is there a shortage of health professionals?

• Is there a need to improve third-party structures to

supplement or replace weak national infrastructures?

91

J. Vella [PH 3340]

R&D for neglected diseases (i)

92

J. Vella [PH 3340]

R&D for neglected diseases (ii)

93

• 1 billion is almost one sixth of the world’s population

• Drugs for these diseases are not a primary R&D target

• The financial rewards are not sufficient; a case for pairing

patents? Topical idea?

• The present approaches are circumvented