EVALUATION REPORT
September 2014
TREATMENT OF
POOR CANCER PATIENTS
IN KHYBER PAKHTUNKHWA
ADP# 169 / Code# 110584
GOVERNMENT OF KHYBER PAKHTUNKHWA
DIRECTORATE GENERAL MONITORING AND EVALUATION
PLANNING AND DEVELOPMENT DEPARTMENT
www.MandE.gkp.pk
Acronyms
ADP
Annual Development Program
CDS
Comprehensive Development Strategy
CML
Chronic Myeloid Leukemia
FATA
Federally Administered Tribal Areas
FISH
Fluorescence In Situ Hybridisation
GDP
Gross Domestic Product
GIST
Gastro Intestinal Stromal Tumor
HMC
Hayatabad Medical Complex
KP
Khyber Pakhtunkhwa
M&E
Monitoring & Evaluation
MDGs
Millennium Development Goals
MOU
Memorandum of Understanding
NGOs
Non-Governmental Organizations
OPD
Out Patient Department
PC-I
Planning Commission Document
PCNA
Post Crisis Needs Assessment
PCR
Polymerase Chain Reaction
PKR
Pak Rupees
SOP
Standard Operating Procedure
i
Table of Contents
Acronyms ......................................................................................................................................... i
Executive Summary ....................................................................................................................... iii
Introduction ..................................................................................................................................... 1
Program Summary .......................................................................................................................... 1
Project Description.......................................................................................................................... 2
Project Objectives ........................................................................................................................... 2
Memorandum of Understanding (MOU) ........................................................................................ 3
Medication / Treatment of poor Cancer Patients ............................................................................ 4
Project Executors ............................................................................................................................ 5
Year wise Patients Registration ...................................................................................................... 5
Financial Phasing ............................................................................................................................ 5
Methodology ................................................................................................................................... 6
Literature Review............................................................................................................................ 6
a.
PC-1 of the Program ..........................................................................................................6
b.
Comprehensive Development Strategy .............................................................................7
c.
Budget Estimates for Service Delivery (2012-15) ............................................................7
d.
Monitoring and Evaluation Framework ............................................................................7
Data Collection ............................................................................................................................... 8
Key Informant Interviews ............................................................................................................... 8
Interviews were based on the following set of questions ............................................................... 8
Patient Data and Record.................................................................................................................. 8
Project Outputs.............................................................................................................................. 10
Outcomes / Impact ........................................................................................................................ 10
Analysis & Recommendations ...................................................................................................... 10
Conclusion .................................................................................................................................... 11
ii
Executive Summary
Khyber Pakhtunkhwa confronts huge public health challenges due to the prevalence of
different disease like Cancer, Tuberculosis and Hepatitis etc. The province is mindful of the
threat and has taken significant remedial measure to overcome problems faced to the general
community especially to the poor/vulnerable public of the province. The Government of Khyber
Pakhtunkhwa approved a project (Treatment of Poor Cancer Patients in Khyber Pakhtunkhwa
under Serial No 169, Code.110584). The project is mainly focused on Chronic Myeloid
Leukemia (CML) and GIST (Gastro Intestinal Stromal Tumor).
Chronic Myeloid Leukemia (CML) is a form of Blood cancer that generally affects the
age group of 45–55 years internationally but in Pakistan the age group affected is 35-45 years
thus by affecting the working class of the nation hence hampering the economic status and
therefore contributes to poverty, treatment of cancer is expensive. There were estimated 1000
patients of CML in Khyber Pakhtunkhwa with expected diagnosis of 200 new patients every
year. The concerned authority has already achieved the target of 800 CML and GIST patients
and the registered patients with the Hayatabad Medical Complex under the project are 855 as on
2nd September 2014 of both type of cancer disease. The cost of one patient per year is around 1.4
million PKR.
The total budget allocated for the project was 578.340 million for 3 years i.e. July 2011 to
June 2014. Against the allocated budget, 476.00 million was utilized and the remaining 102.340
million is still saving with the department and available in the HMC non-lapsable account. All
the expenditures are based on procurement of medicines as per set criteria of the PC-I and MOU
signed with Novartis Pharma Pakistan Ltd.
Overall activities of the projects during the PC-I life span were found satisfactory and all
the record related to the project was as per government financial rules. Some patients were
interviewed and they showed quite satisfaction on their treatment. Provision for further
registration of needy patients is also a positive approach which has been observed by the
evaluation team.
iii
Introduction
Pakistan became a sovereign state in 1947 and its present projected population is
estimated at 181 million, spread over an area of 852392 Sq-km. The population growth rate is
2.5 %, life expectancy is about 63 year and the average literacy rate is 50 %. Per capita income is
136,412.34 PKR. Health expenditure (public sector) is 0.08 % while total health sector
investment is 3.9 % of GDP.
Chronic Myeloid Leukemia (CML) is a form of Blood cancer that generally affects the
age group of 45–55 years internationally but in Pakistan the age group affected is 35-45 years
thus by affecting the working class of the nation hence hampering the economic status and
therefore contributes to poverty, treatment of cancer is expensive. There were estimated 1000
patients of CML in Khyber Pakhtunkhwa with expected diagnosis of 200 new patients every
year. The concerned authority has already achieved the target of 800 CML and GIST patients
and the registered patients with the Hayatabad Medical Complex under the project are 855 as on
2nd September 2014 of both type of cancer disease. The cost of one patient per year is around 1.4
million PKR.
Program Summary
Information contained in the PC-I is summarized as under:
Name of Sector
Health Department
Co-Partner
Novartis Pharma Pakistan Ltd
Title of Project
KP CML Project, ADP No. 169/Code No. 110584
Total Cost
578.340 Million
Date of Approval
13-10-2011 (PDWP)
Nature of Service
Provision of Free Medicines to Poor Cancer Patients in
Khyber Pakhtunkhwa
Beneficiaries
Patients Suffering from CML and GIST Cancer
Date of Completion
30th June 2014
Total Expenditure
571.000 Million
Total Registered Patients
855 as on 2nd September, 2014
1
Medicine Provided
CML and GSIT Patients at Hayatabad
Medical Complex referred to center of excellence
Total Duration
8 years (3 years Government part and remaining 5 years
Novartis part)
Evaluation Team
Mohammad Ayaz (Director Evaluation, M&E) /
Kamran Ali Khan (A.D Evaluation, M&E), P&D Department
Visit Date
03-09-2014
Project Description
The project “Treatment of Poor Cancer Patients” was approved with a total cost of
Rs. 578.340 Million in the PDWP meeting held on 13-10-2011. The scheme was fully
operational since November 2011 with the provision of free medicine to 800 (Eight Hundred)
poor cancer patients specifically suffering from Chronic Myeloid Leukemia (CML) and Gastro
Intestinal Stromal Tumor (GIST) across Khyber Pakhtunkhwa. The activity has been running in
the province for the last 03 years in partnership with Novartis Pharma Pakistan Limited and
Government of Khyber Pakhtunkhwa.
The project envisaged Public – Private partnership between the Government of Khyber
Pakhtunkhwa and Novartis Pharma Pakistan Ltd to provide free access to the medicine (Glivec/
Imatinib Mesylate ) to patients suffering from the disease. With the old treatment, the average
life expectancy was 34 years while the newer treatment /Imatinib has resulted in prolonging the
lives of most of the patients by 8 years if taken properly as prescribed. This drug is out of reach
of most of the patients in Khyber Pakhtunkhwa due to its high cost. Now with partnership of
Novartis, the manufacturer of this drug, the medicine has been provided to cancer patients at a
fraction of the cost to the government.
The project is effectively helping these patients not only in their health but also convert
them in a working class people thus alleviating poverty.
Project Objectives
An integrated partnership based approach in health sector to establish an efficient,
equitable and effective cancer management program which will ensure acceptable, accessible
and affordable health care services for blood cancer patients in Khyber Pakhtunkhwa including
FATA.
2
This public private partnership in health sector will help people and communities to
improve their health status and is in line with MDGs by providing a health care system which is
fair, responsive and pro-poor thereby contributing to poverty reduction thus stepping forward to
a better health service for cancer patients. Other aspects of the project objectives are;
 To provide free access to health care to patients belonging to all walks of life.
 To invest in the prevention and cure of non-communicable diseases which share half the
burden of health related problems (Pakistan Health Policy).
 To remove disparity in the health care among the rich and the poor by providing quality
health care and free access to treatment to all.
 To foster public-private partnership for the benefit of the public (development of global
partnership for the development of the people- MDG).
Memorandum of Understanding (MOU)
A proposal was submitted by Novartis Pharma Pakistan Ltd. to the Government of
Khyber Pakhtunkhwa, for providing Imatinib (Glivec) to CML patients by entering into a joint
venture. Meetings were held between the Government representatives and Novartis to chalk out a
mechanism to enable patient’s access to this drug with minimal cost to the Government. Health
Social Welfare, Planning & Development Department, Hospital Administration, Oncologists
from Hayatabad Medical Complex and IRNUM were included in the stakeholders who were
engaged in the negotiation process and approved the overall mechanism of partnership.
Memorandum of Understanding (MOU) was signed between Government of Khyber
Pakhtunkhwa represented by the Health Department and the Novartis Pharma Pakistan Limited
registered under the law of Islamic Republic of Pakistan for 08 years (03 years Government part
and 05 years Novartis part).
Government support 02 months therapy for 03 years and Novartis supports remaining 10
months, whereby 800 patients get maximum benefits with this treatment. After 03 years in the
project, Novartis supports the complete cost of the patients on annual basis for the next 05 years.
At the end of 08 years, the total project for Glivec cost around 9.139 Billion PKR in which the
Government bears 6.3 % of the total cost (Rs. 571.200 Million) and the company bear 93.8 %
cost of the project (Rs. 8.568 Billion). This project enables most of the blood cancer patients to
live a prolong healthy life and also to become a better contributing member of the society and
not a burden.
3
Medication / Treatment of poor Cancer Patients
Cost of anti-cancer medicine marketed since the past 15 years has increased
tremendously. Most of the developing countries do not have insurance system or social support
system to provide access to these medicines. Purchases of medicine therefore are out of pocket
expense for most patients. This usually results in premature discontinuation of therapy due to
inability on part of patients to purchase these medicines. Most patients are therefore not able to
benefit from newer better treatment regimes. A great need therefore exists for partnership
between Government, Non-Governmental Organizations (NGOs) and pharmaceutical industry to
collaborate for providing access to patients for such expensive treatment.
Glivec was introduced in 2001 for treatment of Chronic Myeloid Leukemia (CML) due to
high cytogenetic response rate and increase in survival of CML patients. Currently it is used as
one of the first line therapies for CML patients world-wide. In Pakistan, with a low per capita
income, the drug is not within the purchasing power of most patients. Glivec is the proprietary
drug of Novartis in Pakistan. Manufacturer of Glivec, Novartis started a patient assistance
program in order to make the drug accessible to CML patients in Pakistan. Patients had to
partially pay for the medicine (1-2 months therapy) while the rest of the cost was borne by
Novartis. However, due to reason cited above, majority of patients could not benefit from this
special assistance program as they were not in a position to purchase this medicine even at
reduced cost of Rs.2,40,000/=per year. Thus our patients were deprived of an essential medicine
to restore their health and prolong their lives.
The advantages of the Glivec are;
 Target the molecular cause of the disease
 Improve quality of life
 Has 85 % proven 8 years overall survival
 Is the proprietary item of Novartis in Pakistan.
Cost per patient treatment is approximately 1.4 Million PKR for Glivec. Estimated
survival of the patient as a result of this treatment is more than 8 years on Glivec. The project is
not only providing the treatment needed for CML patients but also lessen the burden on the
Government treasury.
Cancer treatment has always been expensive and seemed to be non-productive due to a
perception of short term survival and compromised quality of life to the patients. With the recent
advent of targeted therapies in the last decade, the treatment paradigm has been shifted to
improve survival hence quality of life. Treatment of CML was a challenge a decade ago and
4
patients couldn’t live longer due to limited treatment options. Glivec being one of the targeted
therapy has revolutionized the management of CML treatment.
Project Executors
Following Doctors, Nurses and Staff were available in the Department of Oncology,
Hayatabad Medical Complex (HMC), Peshawar.
S. No
Name
Designation
1.
Prof. Dr. Abid Jamil
Head Of Oncology
2.
Dr. Sadaf Chiragh
Senior Medical Officer Oncology
3.
Dr. Bushra
Medical Officer Oncology
4.
Miss. Alishba
Nurse Oncology
5.
Mr. Abdul Wahab
Data & Registration Officer
6.
Miss. Kulsoom Qureshi
Dispensing Officer Oncology
7.
Mr. Ikram
Assistant Oncology
8.
Mr. Shah-e-Rome
Dispensing Assistant Oncology
Year wise Patients Registration
In the three years project life i.e. 2011-12 to 2013-14, a total of 855 patients were
registered till 2nd September, 2014 that exceeded the budgeted number of participants of 800
patients.
S. No
Financial Year
No. of Patients
1
2011-12
419
2
2012-13
654
3
2013-14
855
Financial Phasing
Following expenditure was done on the procurement of the Drugs during the following
Financial Years.
S.No
Financial Year
1
2011-12
Allocation
192.780
Expenditure
Balance
142.8 Million
49.98
5
2
2012-13
192.780
142.8 Million
49.98
3
2013-14
192.780
190.400 Million
2.380
Total
2011-2014
578.340
476.000
102.340
The concern authority informed the M&E team that they have no concern in procurement
of the medicine. As per MOU, Government supports 2 months therapy for 03 years and Novartis
supports remaining 10 months which indicates that for 03 years patient received medicine from
Government procured medicine for 06 months and rest of the 30 months, the patients received
medicine from the Novartis stock moreover the Novartis is also responsible to provide medicine
for the next 05 years as per agreement. All the procurement was made by the Health Department
while Head of Oncology Department HMC, only received the stock and gave them to the
patients.
Methodology
Keeping in view the importance of poor cancer patient treatment in the province, the
Chief of Health Section, Planning and Development Department requested the Directorate
General M&E vide his office letter NO.C/HLT/P&D/PDWP/2014-15/731-35 dated 20th August
2014 to evaluate the project. The Evaluation cell conducted the evaluation which clearly
indicates the impact & effectiveness of the program.
Furthermore, the evaluation was carried out through meeting, interviews of the patients
and scrutiny of relevant record of the activities held throughout the program. Basically the
physical activities were assessed in comparison with planned activities under PC-I.
Literature Review
Relevant documents and publications that provided the basic context of the program were
thoroughly reviewed that are as follow:
a. PC-1 of the Program
PC-I of the scheme was approved for 03 years and the agreement signed with co-partner
i.e. Novartis for 08 years just because of treatment duration and the company will facilitate the
patients for next 05 year after completion of the project to fulfill the required tenure of treatment.
Moreover, as per agreement, the government gave medicine to patients for 02 month free of cost
while rest of 10 months, Novartis is responsible to provide the medicine free of cost to each and
every patient registered under the project beside extra 05 year treatment as per registration.
6
b. Comprehensive Development Strategy
Khyber Pakhtunkhwa Comprehensive Development Strategy (CDS) 2010-17 is defined
in the Health Sector Plan reveals that Comprehensive Development Strategy aims to improve
access to high quality, responsive health care delivery system through acceptable and affordable
mechanism. In this regard, Government of Khyber Pakhtunkhwa took initiative for the treatment
of poor cancer patients. Keeping in view the treatment of cancer is not affordable and very
expensive therefore, approved an ADP project with the support of Novartis Pharma Pakistan Ltd
to facilitate the poor community of the society.
c. Budget Estimates for Service Delivery (2012-15)
Budget estimates for service delivery were published in June, 2012. The document
mentions many improvements in the financial management system introduced in the province,
including an M&E Framework for the surveillance of service delivery around Output-Based
Budgets, presenting Budget Strategy Paper before the provincial cabinet and communicating
medium-term ceilings to line departments.
It recounts the achievements in the Health sector outlining the continued functioning of
several programs i.e. Provision of Strengthening TB Control Program, Enhanced HIV/AIDS
Control Program, Hepatitis Control Program, and enhancing coverage and access of essential
health services especially for the poor vulnerable community of the province. The Government
approved a PC-I for treatment of the poor cancer patients amounting to Rs.578.340 million
during the fiscal year 2011 to 2014.
d. Monitoring and Evaluation Framework
The Government of Khyber Pakhtunkhwa has acknowledged the importance of
Monitoring and Evaluation for the policy, planning and budget process by adopting an M&E
Framework in early 2011. The Framework outlines the broad aims and structure of a
strengthened M&E system that covers four core areas:
i.
Policies, plans and priorities as set out in CDS and PCNA;
ii.
Objectives and goals of sectoral strategies;
iii. Output-Based Budgets; and
iv. Implementation of the Annual Development Program.
The framework examines the existing monitoring mechanism, draws lessons from
international best practices, determines the scope of strengthened M&E Framework, lays down
institutional responsibilities and works out an activity plan to implement the M&E Framework.
7
This evaluation study is part of the M&E Framework implementation and will help the
Government of Khyber Pakhtunkhwa to measure the impact of policies, plans and programs
being implemented in the province.
Data Collection
Data was collected from the Project Director/Focal Person stationed at department of
Oncology, Hayatabad Medical Complex, Peshawar and coordinator of the Novartis Pharma as
well as other officials.
Key Informant Interviews
Interviews were conducted with following stakeholders:
 The Program Management team
 Patients in OPD and telephonically
Interviews were based on the following set of questions
a) Were the project activities being performed as planned?
b) How satisfactory was the dispensing procedure and patient follow up?
c) Did the project reached the intended number of patients?
d) Did the project provide the necessary and budgeted medicine to the patients?
e) Did the project lead to development of comprehensive database of patients for future
follow up?
f) Was there any unexpected events?
g) Did the patients getting response on the drug provided?
h) What would be the long term impact of the work?
i) What lesson learnt for the future?
j) What outcomes should be considered if health department wants to repeat or extend
this project?
Patient Data and Record
Since December 2011, 855 patients have been enrolled in the project, 55% patients are
male while 45% patients are female. Half of patients (48%) belong to age group 31- 50 years
showing CML affects our population in most productive time of their lives. Thus by helping
8
these patients restore to normal health not only their family income remains intact but they also
contribute to the growth of the national economy. Patients from all the districts of the province
have been enrolled.
So far 855 patients have free access to medicine under this scheme. These patients are
living normal lives and are carrying out their daily routine activities without having to worry the
purchase of medicine. They visiting OPDs regularly compliance to treatment is ensured in all
patients. In addition to receiving medicine at no cost, these patients are also able to contribute to
their family income but being able to continue with their jobs.
Steps have been taken to ensure strict transparency and to prevent any pilferage that may
cause a loss to the public exchequer. All patients have a personal file in which their cytogenetic
tests, prescriptions, CNIC/Form-B, Photograph and Cell Phone numbers are attached. Upon each
visit, these patients get their prescription and tests signed by the physician and record is entered
into their files. Patients testify to receiving their medicines and at each visit, they have to bring
empty packs of used medicines before they can receive new packs. This is to ensure that patient
has consumed all the medicines as prescribed. The empty blister packs are gathered in pharmacy
and are incinerated after inspection by hospital staff after few months. Data of all the patients
and their ID etc is also available on web-based server which is updated at each OPD to ensure
that electronic data is also stored which can be accessed by authority personnel.
Patients who were either lost to follow-up or died, their treatment was switched to new
patients thereby accommodating 60 more patients in the project at no cost to the Government
since Novartis has agreed to provide them with 10 months medicines from their free treatment
part thus again saving millions of rupees to the Government.
Patient data was analyzed in detail. The data is comprehensive and can be retrieved at any
given point in time as electronically saved over web with access to only authorized personnel
managing the project.
SOPs are in place for the dispensing of medicine to each and every patient. Date, Month
and year wise data of each patient is mentioned both electronically as well as physically in files.
A random check of patient’s files revealed data in proper place with dispensing record and
hospital visits.
Patients interviews were conducted to validate the proves of dispensing and satisfaction
level. A total of 05 numbers were interviewed informally i.e. Miss. Saima, Mr. Faiz Ullah,
Mr. Yasir Qayum, Mr. Mohammad Saleem, Mr. Ghulam Rasool and Mr. Raz Mohammad
(00072), Miss. Saima Bibi (00146) Mr. Abdul Majeed (00339), Mr. Nadeem Khan (00782),
9
Mr. Mohammad Farooq (00813) through telephone, all of them were satisfied with the process of
medical follow up, medicine response and OPD days.
Dispensing diaries were evaluated and showed both Government as well as Novartis
prescription duly signed by the authorized physician. The process of medicine dispensing is quite
simple and user friendly so there was no inconvenience observed during the process.
Project Outputs
 The project enrolled more than intended number of patients.
 The dispensing procedure was well defined.
 The project provided planned medicine to deserving patients.
 The project has a comprehensive online database for record keeping and future follow
up of patients.
 There was no unexpected event reported.
Outcomes / Impact
The patients experienced significant change in quality of life and performing daily life
activities as per routines with no impairment.
Long term survival hence economic value to the society is surely the long term impact of
this project.
So far out of 855 patients, 37 patients passed away, 17 became resistant to Glivec, 5 were
other reason to leave the medicine and 49 became lost to follow up. This becomes a total of 108
patients that is 13.2 % of the total patients.
Analysis & Recommendations
During the evaluation it has been observed that initially 800 patients were required to be
registered under the project for free treatment and the department registered 855 patients till date.
On query, the project director responded that some patients are passed away and therefore the
project authority compelled the Novartis to provide free medicines to extra patients registered
under the project which is a positive step towards the beneficiary and poor cancer patient. It is
recommended that in future registration of patient may be made on need basis to provide the
facilities to all poor cancer patients in the province of Khyber Pakhtunkhwa.
During the visit it has also been observed that some tests like PCR costing Rs.18000/- per
test or fish test costing Rs.7500/- per test are required at least twice in a year for each patient to
10
check and diagnose the level of disease. Under the project no facility is available to conduct fish
test or PCR test which causing extra burden on the patient. To help the patient with huge cost
currently born by them, it is recommended that the department may arrange equipment along
with human resources to facilitate the poor cancer patient under the project to ensure on time
testing.
Awareness of poor community regarding the disease is very important and the procedure
adopted for advertisement is National Newspaper, Television and Cable Operators, while for
poor cancer patients, all these sources are very limited to bring awareness among the community.
It is recommended that proper awareness campaign may be arranged in different government
schools and different Health centers to aware the poor community in future. It is further added
that Novartis Pharma may also be encouraged to help the physician and patient awareness
program for the benefit of general public.
The performance of Focal Person/Project Director being head of the Oncology at HMC
Hayatabad is quite satisfactory and all the project activities are running smoothly under the
supervision of focal person, but no incentive has been provided to him in shape of project
allowance and mobility etc. Keeping in view his performance and dealing with maximum
number of cancer patients in his routine life, special incentive as admissible may be provided to
the Project Director/Focal Person at HMC Hayatabad for smooth running of the project
activities.
Conclusion
The need for treatment of all the eligible poor cancer patients has been addressed with
significant success. The project provided an opportunity and enables patients to take costly
medicine without price. The project specifically succeeded in achievement of the aims to provide
health care at no cost to poor cancer patients with significant improvement in the survival. The
treated patients can now live a long and productive life hence contribution to the economy of the
country.
Looking at the data of the project, it is encouraging to see that only 6.7% of the patients
have left medicine for valid reason (37 passed away; 4.6% and 7 became resistant; 2.1%). The
patients are satisfied from the treatment as they have confirmed successful outcome both in
productivity as well as carrying out their normal routine life during the interview.
Moreover the project has resulted in development of a comprehensive database for Health
Department to keep record of all patients being registered in the project as well as transparency
11
of the project. The overall result of the project found satisfactory and all activities run by the
project authority were according to the complete satisfaction as per approved scope, cost and
time frame reflected in the approved PC-I
Different Photographs taken during Evaluation visit at HMC Hayatabad.
12
13