WHO | World Health Organization - Priority setting: the ...€¦ · Universal Health Coverage (UHC): Priority setting within and across the ... Department of Health Systems Governance

Department of Health Systems Governance and Financing1 |

Dr Jeremy Lauer

Health Systems Governance and Financing

Priority setting: the case of new drugs

Parallel session:

Universal Health Coverage, costing and prioritization


Priority SettingPriority Setting

Asks: What's the best that can be done? (includes all

kinds of benefit attributable to the health system – see

next slide).

Is indifferent to what has already been done (so past

history is not 'baked in').

Thus, not done at the margin (in economic terms, all

constraints relaxed).


Priority setting and UHCPriority setting and UHC

Universal Health Coverage (UHC): Priority setting within and across the

3 dimensions of the 'UHC cube':

1. Which population groups should be covered first. WHO?

2. Cover more services for the people already covered (and/or increase quality).

WHAT (i.e. which services)?

3. Reduce out of pocket payments further for people currently covered with a set of

services. HOW MUCH does it cost?

Real choices involve a combination of dimensions.


UHC cubeUHC cube


Decision makingDecision making

Asks "What is the 'next' thing to do?" Or, What do we do now?

Depends on what's already been done (past history is be 'baked in').

Done at the margin.


Strategic planningStrategic planning

Intermediate between Priority setting and Decision-making.

Asks, "Given a set of Priorities and a set of Activities, how

can we make our activities look more like our priorities?"

Looks at time in 'bite-size chunks' (usually 3-10 years).

Can be thought of as Decision making that takes account

of priorities in forming objectives.

Multiple constraints addressed (incl. Affordability).


OneHealth Tool for strategic planningOneHealth Tool for strategic planning

Uses results from Priority Setting exercise to set objectives.

Allows decision makers (DMs) to quantify:

– Impact of their national plans on population health

– Cost of the national plans

– (Does not currently have a Hepatitis B/C module.)

Allows DMs to confirm presence of the necessary:

• financial resources

• health workers and

• health system infrastructure etc.


That's the Theory….

Now comes the hard part: Practice.


New medicines availabilityNew medicines availability

Highly effective, highly costly new medicine => 'cost effective' new

treatment.

Should it be introduced?

Depends on:

– What else it displacing? (not good if it displaces more CE activities => going

backwards…)

– Is it affordable? (will it absorb all available public funding)?

– Availability of health system platform for delivery and follow up?

– Etc.


ConclusionsConclusions

Keep in mind: Medicines price is a variable, not a constant.

Assuming priority etc. has been established, …

it's useful to ask: At what price will the new therapy become

– as cost effective as existing alternatives?

– as cost effective as what is displaced?


Health system implicationsHealth system implications

New medicines have important implications for basic health services,

which may be weak and under-developed.

More cost-effective interventions in such settings include:

– strengthening early detection and

– effective treatment.

Same implications for many new therapies:

– Cost effective but not affordable.


Cost-effectiveness of cervical cancer interventions Afro-D

CVC-1

CVC-2

CVC-3

CVC-4

CVC-5

CVC-7

CVC-8

CVC-9

CVC-10

CVC-11 CVC-12

CVC-15CVC-16

CVC-17

CVC-18

CVC-29

CVC-28

CVC-27

CVC-30CVC-22

CVC-21

CVC-30CVC-24

CVC-6CVC-13 CVC-14

CVC-19

10,000

100,000

1,000,000

10,000,000

10 100 1,000 10,000

DALYs averted per year per one million population (log scale)

Co

st

pe

r ye

ar

pe

r o

ne

mil

lio

n p

op

ula

tio

n (

I$, lo

g s

ca

le)

(I$ 1 per capita)

current scenario (I$ 4179)

vaccination 1 (I$ 114/DALY)

treatment (I$ 209/DALY)

VIA 40 (I$ 434/DALY)

vaccination 2 (I$ 288/DALY)

VIA, PA 35, 40, 45 (~I$675/DALY)

HPV 35, 40, 45 (I$1445/DALY) vaccination + treatment (I$233)

5-year PAP + treatment (I$637)

1-year PAP + treatment (I$1664)1-year PAP (I$4220)

I$ 1000/DALY

I$ 10/DALY

I$ 100/DALY

~current vaccine price

Price analysis: HPV vaccinePrice analysis: HPV vaccine


The endThe end

Thank you!

Presenter:

Universal Health Coverage (UHC)

Costing and Prioritization

Regional Plan of Action for the Prevention

and Control of Viral Hepatitis in the Americas

Massimo N. Ghidinelli

Pan American Health Organization/World Health Organization (PAHO/WHO)

Viral Hepatitis in the Americas

Hepatitis A Hepatitis B Hepatitis C

Estimates

for the

Americas

Antibodies to HAV

North America: 10%

Caribbean: 50%

Latin America: 70-90%

7.6 M chronic HBV infection

Latin America: 2-4%

Amazon Basin: 8%

USA, South America : <2%

13 M

Caribbean: ~0.7 M (2.1%)

North America: ~4.4M(1.3%)

Latin America: ~7.6 M (1.2%-2%)

109,000 death/year related to Hepatitis (4)

Source:

1. World Health Organization. The global prevalence of hepatitis A. Virus Infection and susceptibility: a systematic review [Internet]. Geneva: WHO; 2010

2. Franco E, Bagnato B, Marino MG, Meleleo C, Serino L, Zaratti L. Hepatitis B: Epidemiology and prevention in developing countries. World J Hepatol . 2012 Mar 27;(3):74-

80.

3. World Health Organization. Guidelines for the screening care and treatment of persons with hepatitis C infection. Geneva: WHO; 2014

4. WHO/ PAHO Mortality Information System (updated in July 2013).

5. Aparna S, Johannes Ho, Rafael T M, Gerard K, Jordis J Ott. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review

of data published between 1965 and 2013. The Lancet July, 2015

0

25

50

75

100

HAV HBV HVC HDV HEV

%

surveillance of acute hepatitis

Source: WHO. Global policy report on the prevention and control of viral hepatitis. Geneva, 2013PAHO, Situation analysis , Washington DC 2015 (Preliminary data)

American Member States with routine

surveillance for viral hepatitis

HepB Vaccine: 3d dose coverage in infants, 2013

Source: Pan American Health Organization. Hepatitis vaccine coverage map, 2013. Available at

: http://www.paho.org/hq/index.php?option=com_content&view=article&id=9730%3Ahepatitis-vac

cine-coverage-map&catid=4217%3Afgl03-hepatitis-vaccine-feature&Itemid=4329&lang=es

http://www.paho.org/hq/index.php?option=com_content&view=article&id=9730:hepatitis-vaccine-coverage-map&catid=4217:fgl03-hepatitis-vaccine-feature&Itemid=4329&lang=es

Emerging framework for elimination targets

by 2030Focus Indicator Target

(reduction from 2010 baseline)

Impact Incidence Incidence of Hepatitis B

Incidence of Hepatitis C

70-90% reduction by 2030

Impact Mortality Deaths due to Hepatitis B

Deaths due to Hepatitis C

50-70% reduction by 2030

HBV Coverage Infant vaccination

Birth dose vaccine

Hepatitis B treatment (cascade)

90% +

80%

90, 90, 90

HCV Coverage Risk of medical exposure (in and outside facility)

Harm reduction for injecting drug users

Hepatitis C treatment (cascade to cure)

75%

50%

90, 90, 90

GoalStrengthen regional public

health responses to VH

Reduction in morbidity and mortality related to

VH

Promotion of an integrated

comprehensive response

Fostering equitable access to

clinical care

Equitable access to

prevention

Strengthening lab capacity to support Dx,

surveillance & safe blood supply

Strengthening of strategic information

Regional Plan of Action for Viral Hepatitis, 2016-2019

PAHO’s Plan of Action for Prevention and Control of Viral Hepatitis

Indicator Baseline Target

1.1.1 Number of countries that have a structured and budgeted national

strategy or plan related to prevention, treatment, and control of viral

hepatitis

10 in 2015a 20

1.2.1 Number of countries with goals of elimination of hepatitis B and

Hepatitis C as public health problems

0 in 2015a 6

1.2.2 Number of countries with goals of elimination of mother-to-child

transmission of hepatitis B

1 in 2012b 5

1.3.1 Number of countries that commemorate World Hepatitis Day

through awareness campaigns or major thematic events

10 in 2015a 20

Promoting an integrated comprehensive response


Fostering equitable access to preventive care


2.1.1 Number of countries that maintain high HBV coverage (95% or above) as part of

the routine childhood vaccination schedule (below 1 year of age)

15 in 2013c 25

2.1.2 Number of countries that have included immunization of newborns against HBV

within the first 24 hours in their vaccination programs

18 in 2013c 25

2.2.1 Number of countries that have conducted HAV epidemiological, burden of

disease, and health technology assessment, such as cost-effectiveness analyses to

inform vaccine introduction

5 in 2013d 10

2.3.1 Number of countries with measures for the prevention of hepatitis B among

health workers

13 in 2015a 26

2.4.1 Number of countries with viral hepatitis prevention and control strategies, such

as HBV vaccine targeting key populations

8 in 2015a 20


Fostering equitable access to clinical care


3.1.1 Number of countries that have developed guidelines for prevention, care, and treatment of hepatitis

B in line with latest WHO recommendations

16 in 2012b 25

3.1.2 Number of countries that have developed guidelines for screening, diagnosis, care, and treatment

of hepatitis C in line with latest WHO recommendations

6 in 2015a 15

3.1.3 Number of countries that have started offering publicly funded HBV diagnosis and treatment 11 in 2015a 20

3.1.4 Number of countries that have started offering publicly funded HCV diagnosis and treatment 6 in 2015a 10

3.1.5 Number of countries that include in their national essential medicine lists and/or formularies one or

more drugs recommended in WHO 2015 guidelines for HBV treatment

10 in 2015a 15

3.1.6 Number of countries that include in their national essential medicine lists and/or formularies one or

more drugs recommended in WHO 2014 guidelines for HCV treatment

8 in 2015a 15

3.2.1 Number of countries that have updated their antiretroviral treatment criteria, including the

recommendation of initiating antiretroviral therapy (ART) regardless of CD4 count in HIV patients with

severe HBV-related chronic liver disease

24 in 2014e 30

PAHO’s Plan of Action for Prevention and

Control of Viral Hepatitis

Strengthening strategic information


4.1.1 Number of countries that report cases of acute and

chronic hepatitis B

8 in 2015a 16

4.1.2 Number of countries that report cases of hepatitis C

infection

13 in 2015a 26

4.1.3 Number of countries conducting surveys on prevalence

of viral hepatitis B or C in general population and/or key

populations

11 in 2015a 18

4.2.1 Number of countries that have published a national

report on viral hepatitis

8 in 2015a 15

PAHO’s Plan of Action for Prevention and

Control of Viral Hepatitis Strengthening laboratory capacity to support

diagnosis, surveillance, and a safe blood supply


5.1.1 Number of countries that implement

standardized and effective technologies

for HBV patient monitoring,

10 in 2015a 20

5.1.2 Number of countries that implement

standardized and effective technologies

for HCV confirmation, genotyping, and

patient monitoring

8 in 2015a 15

5.2.1 Number of countries that screen

100% of blood transfusion units for HBV

and HCV

39 in 2014f 41

Case reporting Case based surveillance with unique

identifiers

Serologic

surveillance

Population-based studies

Sub-population studies: pregnant

women, MSM, SW, IDU, indigenous,

blood banks…

Surveillance of

outcomes

Chronic liver disease surveillance

Hepatic carcinoma incidence

Liver transplant surveillance

Mortality due to hepatic carcinoma,

cirrhosis, liver failure…

Monitoring of

response

Immunization HBV

Testing coverage

Linkage and retention in care

Treatment

Sustained virological response

Care & Treatment cascade for people with

chronic HCV infection

0

20

40

60

80

100

Chronic HCVinfection

Diagnosis+confirmation(HCV-RNA)

Linked tocare (staging)

Eligible fortreatment

Treatment forHCV

Sustainedvirologicalresponse

Regional Framework for Surveillance

and Monitoring of HBV and HCV

Cost of HCV associated diseases, 2010

5,000

55,000

105,000

155,000

205,000

Americas Asia Pacific Europe USA

Hep Encephalopathy

HCC

Liver TX

Source: A. C. El Khoury, W. K. Klimack, C. Wallace, H. Razavi. Economic burden of hepatitis C-associated diseases in the United States. Journal of Viral Hepatitis, 2012, 19,

153–160.

A. C. El Khoury, W. K. Klimack, C. Wallace, H. Razavi: Economic burden of hepatitis C-associated diseases: Europe, Asia Pacific, and the Americas. Journal of

Medical Economics Vol. 15, No. 5, 2012, 887–896

Hepatitis C – Treatment costs (12 weeks)

010,00020,00030,00040,00050,00060,00070,00080,00090,000

100,000

12 weeks

Source: University of Washington. Hepatitis C online, http://www.hepatitisc.uw.edu/page/treatment/drugs

http://www.hepatitisc.uw.edu/page/treatment/drugs

Total estimated cost to fully vaccinate

a child against Hepatitis B in the Americas

Vaccine Schedule

Doses/

child

Cost/

dose Wastage Total costHepatitis B* 1+0 (infant dose) 1 0.26$ 1.05 0.27$

DPT-Hepatitis B-Hib (Pentavalent)* 3+0 (2, 4 and 6 mo) 3 2.27$ 1.05 7.15$

VACCINE ONLY 7.42$

with CIF, syringe and safety box** 4 3.28$ 13.12$

with all other delivery costs** 4 6.20$ 24.80$

OTHER ONLY 37.92$

TOTAL COST PER CHILD (Vaccine, supply, delivery, other) 45.34$ * Vaccine price/dose represents PAHO RF prices for 2015

** CIF, syringe, safety box and delivery costs data based on facility-based costing exercise in Honduras (Janusz et al. 2015)

(birth dose)

Hepatitis B – Cost estimates (30 days)

Medicine Generic* R&D *

Entecavir $209.00 - $224.00 $380.00 -1.105,00

Tenofovir $68.00 - $99.00 $568.00 - 920.00

Source: http://www.pharmacychecker.com/

*Canada

http://www.pharmacychecker.com/

Acknowledgments

Laura Alves PAHO/VH

Mónica Alonso PAHO/VH

Alba Maria Ropero PAHO/IM

Cara Janusz PAHO/IM

Homie Razavi CDA

Presenter:

Universal health coverage,

costing and priorization

Marcelo C. Moscoso Naveira, MD MPHGeneral Coordinator of Viral HepatitisMinistry of Health of Brazil

Brazil & The Unified Health System

• 1988 Constitution: Unified Health System (SUS)

• Health: “a citizen’s right and an obligation of the state”

– Universal access to health services

– Equality of access to health care

– Integrality and continuity of care

• Decentralization

• Social Participation

The Process

• Multiple levels of care

• Improvements + Sustainability

• Priorities defined by epidemiological data

– Hepatitis B: 1989

– Hepatitis C: 2002

• Constant monitoring and evaluation

Steps

• “Mais Médicos”

• Rapid Tests

• Entecavir

• Boceprevir/Telaprevir

• Daclatasvir

• Simeprevir

• Sofosbuvir

PEG-IFN, 3TC, TDF

National Program for Viral HepatitisSocial Mobilization

Right to Vote

Hep B Vaccine

Harm ReductionFamily Health Strategy

Blood Safety

Epidemiology & UHC

Hepatitis B cases, Brazil 2008-14 Hepatitis C cases, Brazil 2008-14

Trends & UHC

VH hospitalizations and deaths, Brazil 2008-14 HCC hospitalizations and deaths, Brazil 2008-14

0

10

20

30

40

50

60

70

80

90

100

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

11,000

2008 2009 2010 2011 2012 2013 2014

0

10

20

30

40

50

60

70

80

90

100

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2008 2009 2010 2011 2012 2013 2014

Costs & UHC

• Rapid Testing: 5 USD

– Over 5 million tests distributed in 2014

• Hepatitis B treatment (TDF/ETV): 48 – 238 USD/mo

– Approximately 50,000 treatments/year

• Hepatitis C treatment (DAAs): 9,425 – 9,625 USD

– Accumulated over 100,000 treatments since 2002

– Over 15,000 treatments in 2014

Costs & UHC

• Liver Transplant: 54,698 – 75,434 USD

– Over 1,700 transplants/year

– 8,000 new HCC/cases/year

• Family Health Strategy: R$ 5,00/per capita/mo

– less than £1

– Approximately 50 million people

Liver failure and transplant

Comorbidities

Indications for treatment

Access to treatment and fibrosis assessment

Diagnosis

Awareness

• Careful evaluation of new technologies

• Several actors, administrative responsibility

• Commitment

Big Picture

HCV Perspectives 2015 -

Sustained Virological Response (SVR)

PopulationTreatments/year

PR/PR+BOC/TEL

(2013-2015)

INTERFERON-

FREE

SOF+DAC/SIM

(2015-)40%

15.000

F3/F4 (F2)*

>90%

F3/F4 (F2),

HIV, Pr/P Tx...30.000

“Obrigado”

[email protected]

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WHO | World Health Organization - Priority setting: the ...€¦ · Universal Health Coverage (UHC): Priority setting within and across the ... Department of Health Systems Governance