COST-EFFECTIVENESS OF HPV VACCINATION IN PREVENTION OF CERVICAL CANCER IN MALAYSIA

Dr. Sharifa Ezat Wan Puteh

Department of Community Health Faculty of Medicine UKMMC

Researchers
Researchers Prof Dato Syed Aljunid Sharifa Ezat Wan Puteh Fuad Ismail Aniza Ismail Seri Suniza Ahmad Zailani Hatta Sharifah Noor Akmal Nurismah Md Isa Paul Ng Murali Ganesalingam Vicknesh Visvalingam Mymoon Alias Majdah Mohd Rushdan Mohd Noor Institutions UKMMC Hospital Kuala Lumpur Hospital Sultanah Bahiyah Alor Star Kedah Hospital Kuantan, Pahang Hospital Kangar, Perlis Hospital Seremban, Negeri Sembilan Ministry of Health Malaysia

Cervical Cancer
Serious health problem 9 mil. women develop disease each year world wide. Developing countries with no preexisting screening or poor coverage.
Much higher compared to developed countries with established screening programs (UK 11.5/100000)

2nd most commonest cancer in Malaysia after breast cancer. Strong relationship with the Human Papilloma virus (HPV) 16, 18.
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Cervical Cancer Incidence By Age, Peninsular Malaysia (Per 100,000)

CR

Incidence of CC by Age

ETHNICITY

80 70 60 50 40 30 20 10 0
Age 0-9 10-19 20-29 30-39 40-49 50-59 60-69 70+

% of Cervical Cancer Cases

CHINESE

56.4

MALAYS

32.8

INDIANS

10.8

2003 2006
Total Nos. of Cases Per Year = 1,557 (NCR 2003)
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HPV Vaccine
Two types 1. Quadrivalent Vaccine HPV Types 6, 11, 16, 18 Cervical, Vulva, Vagina Cancer and Genital Warts 2. Bivalent Vaccine HPV Types 16,18 Cervical Cancer Only

Objectives
SPECIFIC OBJECTIVES To determine the cost of treatment and womens quality of life
according to age and disease progression.

To compare the CEA 3 programs i.e. Pap smear program, HPV vaccination program and the combined strategy (HPV vaccination with screening program).
Robustness of the economic model using sensitivity analysis.
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STUDY HYPOTHESIS
Burden of Cervical Cancer is substantial to the Malaysian economy. Cost of treatment of cervical cancer patients will increase with age and severity. Combined strategy (HPV vaccination combined Pap smear program) is the most cost-effective option.

Cost-Effectiveness Model
Costs
Cost of Vaccination Program Cost of Pap Smear Program Cost of Managing Positive Pap Smear Cost of Adverse Events of Vaccination

Outcomes
Quality Adjusted Life Years (QALYS)

Cost-Effectiveness Ratio (Cost/QALYs)

Negative: Cost Saving Less than 1 GDP : Highly Cost Effective Between 1 to 3 GDP : Cost Effective More than 3 GDP : Not Cost Effective
Per capita GDP 2006: RM 20,911 (WHO)
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METHODOLOGY

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Study Design
Economic Evaluation Design Tools 1. Quality Of Life from SF-36 questionnaires.
Physical composite summary scores (PCS) Mental composite summary scores (MCS) Quality Adjusted Life Years saved(QALYs)= QOL x life expectancy (years) saved

2. Costing Data (patients & providers). Duration: 2006-2008. Respondents= 502 patients
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Costing Data
1. Expert group discussion, develop treatment algorithms, management cost for cervical cancers by severity pathways.
- Activity Based Costing.

2. Step down costing for the Providers Cost Using case mix UKMMC cost per day admission and cost per day of outpatient. Programs Cost-2 data and published literatures. 3. Micro costing questionnaire for Patients cost. direct interview with respondents with cervical cancers. Modelling of vaccinated women, using QOL (secondary data Azman et al 2004) and normal life expectancy of women (Statistics Dept 2006). Patients sampled universally- inclusion and exclusion criteria.
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RESULTS
Socio demographic data and QOL

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Prevalence by Disease Stage

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Percent

20

30.88%
10

28.29%

9.56%
0

6.97%

7.57%

4.98%

7.17%

4.58%

CIN 1

CIN 2

CIN 3

ASCUS Stage 1 Stage 2 Stage 3 Stage 4

Disease by Stages

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Age and Ethnicity

Mean age=53.0 (SD 11.23) years

50.0%

40.0%

Percent

30.0%

45.82%
20.0%

37.25%

10.0%

15.14% 1.79%
0.0%

Malay

Chinese
Etnicity

Indians

Others

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Respondents Income
Patients Income Median RM 525 (IQR 300-1000) /month.
70.0% 50.0% 60.0%

Partners income Median RM 500 (IQR 0-1150).

50.0%

40.0%

Percent

40.0%

30.0%

61.95%

Percent

30.0%

48.61%
20.0%

20.0%

10.0%

20.32% 9.96%

2.79% 2.59% 0.4% 1.99%

10.0%

18.53% 11.35% 7.17% 6.37%

RM 20002499

0.0%

1.79% 6.18%
RM 25002999 RM 3000 and above

Income RM0-499

RM 500999

RM 1000- RM 1500- RM 2000- RM 2500- RM 3000 1499 1999 2499 2999 and above

0.0% Partners RM 500-999 Income RM0499 RM 10001499 RM 15001999

Patients' Income

Range of Partners Income

Household Income/ month: RM 800 (IQR 400-1525).

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Healthcare Expenditure (Percentage Spent on Health)

100.0%

80.0%

Percent

60.0%

90.04%
40.0%

20.0%

4.98%
0.0% % spent on health care <10% 10-19%

2.59%
20-29%

0.6%
30-39%

0.2%
40-49%

1.59%
50-59%

% Spent on Health Care

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Life Expectancy by Disease Severity

Life Expectancy Vaccinated Women
33.98

Life Expectancy Cervical Cancers

27.72 24.23 20.54

28.36 26.59 25.59 26.25

14.25 10.98

15.18
13.51 12.65 11.48

Preinvasive Diseases

Stage 1A1

Stage 1A2

Stage 1B-2A

Stage 2B-4A

Stage 4B

Total
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Difference p<0.05

QUALITY OF LIFE

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90 80 70 60 50 40 30 20 10 0
Physical Functioning (PF) Role limitation-physical (REP) Bodily Pain (BP) General health (GH) Vitality (VT) Social Functioning (SF) Role limitationemotional (REE)

QOL between Cervical Cancers & Normal Women

Mental Health (MH)

Normal Women Population

Cervical Cancers

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QOL by Disease Severity

60.00 50.00 40.00 30.00 20.00 10.00 0.00 PCS MCS

PCS difference significant p<0.0001;

MCS not significant p=0.267

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QOL by Age
50.00 45.00 40.00 35.00 30.00 25.00 20.00 15.00 10.00 5.00 0.00

PCS MCS
Less than 25 years old

PCS difference significant p<0.0001;

MCS not significant p=0.22

25-34 years

35-44 years

45-54 years

55-64 years

65 years and above

Total
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Clinical Pathways Cost

Cost/Case/Year by Age

25,222 20,741 17,333

25,561 21,250

3,260 1,743

Less than 25 years old

25-34 years

35-44 years

45-54 years

55-64 years

65 years and above

Total

Mean cost difference significant p<0.0001

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Comparison of Costs by Activities

Activities UK ( Million) % Malaysia (RM Million) 22.0 %

Cost of Screening Cost of Managing Pre-invasive Disease Cost of managing new invasive cancer cases Cost of managing existing cases

104.3

56.2

34.5

18.6

1.4

33.3

17.9

167

68

13.5

7.3

55

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Total

185.6

100

245.4

100

Brown RE, Breugelmans JG, Theodoratou D, Benard S. Costs of Detection and Treatment of Cervical Cancer, Cervical Dysplasia 24 and Genital Warts in the UK. Current Medical Research and Options. 2006; 22 (4):663. 24 Sharifa Ezat et al. 2008.Economic Burden of Cervical Cancer in Malaysia. Medical Journal of Indonesia. 17(4):272-280.

COSTING and CEA

Three program strategies1. Pap smear 2. HPV Vaccinations 3. Combined (Vaccination & Pap smear)
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Parameters in CE Model
Quadrivalent Vaccine
Sensitivity Analysis Cost/dose RM 300-RM 400 No booster required i.e. Vaccine efficacy sustained Side effects not serious

Cost and outcomes were discounted 3% for 10 years. Incidence Cx Cancer based on 19.7/100,000 female population (year 2003).
Female population based on Msia population statistics year 2006.

Pap smear population coverage

40, 70 and 80%

Mandatory Vaccinations
Administered at 15 years old Plus catch up period from 9-26 years old.
Coverage 70% only.
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Scenarios for Cost Effectiveness

Scenario Base Case Best Case Worst Case Pap Smear Coverage
40% 70% 40%

Price of Vaccine/dose
RM 300 RM 300 RM 400

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CEA of Three Programs

Cost (RM)/ Pap Smear QALYs Only

Base Case Best Case Worst Case

1,215 1,100
1,215

HPV Vaccination only 35,347 35,347

46,530

Combined

11,290 7,713
14,590

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Incremental Cost Effectiveness Ratio (ICER)

Strategy Cost (RM) Effectivenes (QALYs) Incremental Cost (RM) Incremental Effectiveness (QALYs) ICER (per QALYs avoided) RM

Pap smear program 40% coverage Pap smear program 70% Coverage Combined Strategy Best Case

91,930,890

109,850

211,462,910

192,237

77,999,691

82,387

947

1,837,478,053

238,240

1,626,015,143

46,002

35,347
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Budget Impact Assessment

16,000

Millions

14,000 12,000 10,000 8,000 6,000 4,000 2,000 0

Cost per year Cost per 5 years

Cost per 10 years

Cost per 20 years

Cost per 50 years

RM (Cost)

Projected Cost if Reduced Incidence

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Conclusions
Loss of life to years is substantial in cervical cancer patients. Cost gets higher with increase severity and age. QOL lowest at older age group higher severity of disease. Physical functions more affected than Mental functions. Combined strategy is Highly Cost Effective HPV Vaccine Alone is still cost-effective at all level of Sensitivity in preventing Cervical Cancers in Malaysia More cost effective at higher Pap smear coverage and if vaccine cost is cheaper.
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THANK YOU

sh_ezat@yahoo.com sh_ezat@ppukm.ukm.my
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