Document for Paediatric Liver Transplants in India (Strategy Case)

Contents

Overview: ........................................................................................................................................... 3
Strategy............................................................................................................................................... 3
Approach ............................................................................................................................................ 4
Possible stakeholders and partnerships ............................................................................................ 7
Interventions at different stages ....................................................................................................... 8
Monitoring parameters ...................................................................................................................... 9
Public relations strategy .................................................................................................................... 9
Sustainability .................................................................................................................................... 10
Summation ....................................................................................................................................... 10

Glossary
LT- Liver Transplant

ALF- Acute Liver Failure

CLF- Chronic Liver Failure

CSR- Corporate Social Responsibility

HNI- High Net worth Individuals

PHIL-Philanthropist

DFI- Development Finance institutions

PHC- Primary healthcare Centre/ CHC- Community Healthcare Centre

NOTTO – National Organ & Tissue transplant Organization

ROTTO- Regional Organ & Tissue transplant Organization

IEC- Information Education Communication (Material/Content)

BCC- Behaviour Change Communication

ASHA- Accredited Social Health Activist

SMs- Social mobilizers (Gram Sevak/ Sarpanch)

IAP- Indian Academy of Paediatrics

IMA- Indian medical Association

FR- Fund raising

FBNC – Facility based new born care

2
Overview:
With India’s economy and population growing at great pace it is imperative for long-term
sustainability to match this growth with proportional improvements in healthcare services.
Unfortunately there is a dearth of availability of quality medical services in both rural areas and the
socio-economically marginalised communities in urban and semi urban parts. There are various
contributing factors for this:

 Poor health infrastructure

 Unavailability of experienced healthcare professionals
 lack of functional primary and secondary healthcare centres
 Lack of knowledge about govt. incentives for insurance and treatment
 Poor operations & patient management systems
 Lack of required medicines disposables and diagnostic facilities
 Failure to consolidate different diverse stakeholders under an initiative

All these factors essentially become far more compounded when patients especially
children have developmental abnormalities and/or acute infections life-threating complications
that go undetected due to lack of expertise and care. Coupled with parents who may not have all
the monetary and social resources to contribute for the treatment of their child with the risk of
losing him/her within few weeks to months.

An estimated 200,000 patients die of liver failure or liver cancer annually in India, about
10-15% of which can be saved with a timely liver transplant. Hence about 25-30 thousand
liver transplants are needed annually in India but only about 1500 are being performed.

- Ministry of Health & Family Welfare

With this context in mind the philanthropy fund wants to campion the cause of affordable
paediatric liver transplantation in India. The vision of the philanthropist is to become a change maker
& thought-leader in this space preventing a children dying from lack of liver care and treatment by
creating an ecosystem of medical specialist hospitals; CSOs; philanthropic organizations; and others
who become partners to realise this goal.

Drawing from my experience in working with the healthcare and development sectors. I have drawn
a proposed draft plan to approach and shape this initiative.

Strategy
To achieve the goal of 100 successful paediatric transplants it is vital to understand the dynamics
between the patient; guardian; physicians; hospitals; payers & care-givers, if any and map out their
typical journey as seen below. The typical journey of the patient shows us the major challenges and
constraints that exit today but also gives us an opportunity to fully analyse and assess steps that
can be taken at each stage to improve the outcomes.

If proper guidance; information and help is available right from stage 1 many more children
can be saved and their lives can be greatly improved after transplant. It is essential to determine
that we can attain and maintain zero to nil mortality levels after transplant to achieve high success
rate and improve fund utilization. Close monitoring of the patient condition (usually done by
hospitals on weekly basis for first 4 weeks) and thereafter monthly check-ins with the family are
imperative. Most transplants in the Asian subcontinent fail due to post-operative infections by lack
of hygiene; improper medication and lack of patient compliance.

3

1] Parents bring child to
physician/post-birth
symptoms seen by the
hospital
3] Confirmation of
2] Diagnostic tests
Acute Liver Faliure
done to confirm
(ALF) or End stage liver
acute/chonic liver
disorder requiring
failure (CLF)
Transplant

6] If parents donate
they need post-opt
medical care & miss
work for 2/3 months.
Expenses increase with
complications & delay.
Cadevar may/may not
become avaliable
5] Evaluate options for
Deceased transplant OR
live transplants. Medical
expenses loom around
15L to 18L. Many lose
hope
4] Parents are distraught
& paniced as ALF gives
them just few days and
CLF few weeks. Financial
expenses & finding a
donor are major worries

The Critical challenges that need to be addressed during each stage of the patient journey have
been mentioned in Slide 4 of the presentation.

Approach
The overall strategic approach for success would depend on understanding the:

 causes & urgency for the transplant;

 medical & socio-economic due diligence;
 assessment of the best available funding options;
 exploring the possibility of leveraging government funds;
 verifying the financial stability of post-operative support (long-term medication/weekly
check-ups/ recovery for donor / enough savings till work can be resumed)
 Following risk mitigation practices

A uniform approach to solving this problem will require for a standardised process to be created.
The layout of the process is outlined below. It would be important to note that given that each
medical case is unique and unforeseen factors/expenses may arises in few cases. The process
should have the inherit flexibility to allow for slight modification.

Empanelment & on boarding: Since LT is a highly specialised and technical procedure it is

mandatory to select the most suitable hospital; surgeon; donor organ; and post-operative care
process. There a few leading hospitals that enjoy a very high success rate in Paediatric LTs and
have been pioneers in the field with turn-around time for emergency operations (required in
case of ALF or BSD donations) of just 24 hours or less. Some of the hospitals featured in the top
list are:

 Fortis Delhi & Bangalore

 Apollo New Delhi Chennai Bangalore Hyderabad
 Aster Mendacity
 Sir Ramachandra Medical centre Delhi & Sir Ganga Ram Hospital Delhi

4
 2.Completing the 4.EVALUTE ALL EXPENSE
1.EMPANELMEMENT & funding options
MEDICAL DUE 3. CASE SELECTION -
& ONBOARDING of avaliable
DELIGENCE. 2nd & Chronic Vs Acute &
hospitals/partner/NG
3rd opinion in case of Type of transplant Live Payers-Hospital & Pt
Os/ advisory medical
ambiguity wrt Vs Cadevar CSR- THE PHILANTHROPY
experts
etiology & risk FUND + Milaap & ORS

5.LEGAL & SOCIAL DUE

DELIGENCE. Verify no 7. POST -OPERATIVE
6. RAISE FUNDS via OBSERVATION till 8. For Live Donor TL- Visit
complications occur to check on both the Donor
before translpant partners for the patient returns to and Receipient. MANAGE
Prepare budget procedure and meet normalcy. Medical COMPLICATIONS IF ANY.
account for the FR goal checkups & diagnostic Donors resume work
complications tests

9. DOCUMENT THE CASE

PROGRESS. Sucess
stories/Case study. Long-
term monitoring -
6/12/18/24 months.
DONOR REPORTING.

The criteria for selection of hospitals besides the success rate of surgeries should include the
presence of a multi-disciplinary medical team; patient-donor education; post-operative care; and the
cost of the diagnosis procedure and follow-ups especially for patients from marginalised
communities should be subsidised.

In addition to selection of the right hospital it is vital to select the correct NGO/CSO partner as
counselling; patient and donor education; are important parts of the entire process throughout the
LT process. In rural and semi-urban areas Government enabled ASHA workers and Village SMs can
also be involved as they already have a good grasp over the social setting in that local area.
Moreover theses can be with the family during the entire pre-natal period (few weeks before the
delivery to 4-6 weeks after the mother gives birth). This helps in patient education; precautions &
compliance; vaccinations for mother-child; and early detection of systems

Payers or Funders need to be emplaned and on boarded in parallel. The partnership process with
DFIs/ Insurers/CSR funders takes a good amount of time sometimes 3-4 months. Keeping this fact in
mind the enplanement processes need to run simultaneously to save time.

Medical Due diligence & Case Selection: Since the treatment will vary greatly dependent on the
cause and urgency as seen in the presentation. We can start by analysing the research medical data
we have on the most common causes of liver failure in children and learnings from the 32 operations
undertaken by THE PHILANTHROPY FUND so far and the medical literature as well. Some useful
insights that indicate that few causes lead to the ALF acute liver failure while others to CLF chronic
liver failure.
In Acute liver failure the window available to get a donor and complete all the diagnostic and legal
paperwork ahead of the transplant is just 2-4 weeks. The prognosis of the patients is also less
optimistic in such patients.
In Chronic cases the hospital and supporting donors have more time to plan an elective surgery;
find a donor; gather finances etc. But in either case a delay in transplant can further worsen the
condition of the child/patient to a point where other organ systems like the kidneys heart and
other GI organs start deteriorating making the patient illegible for transplant altogether increasing
the risk of mortality exponentially.

5
 Also one of the leading causes of transplant failure is not treating the underlying aetiology
correctly. Whenever the underlying cause is unclear or there is a vast difference in treatment
modalities proposed by 2 hospitals a third opinion should be taken. Selecting the correct case for
LT at the correct time (if patients wait too long to get a transplant secondary infections in the
peritoneum can greatly hamper the chances for LT)

Expenses & Budgeting – After the medical DD and case selection the expenses for that particular case
will become evident. It is important not to ignore the costs incurred due to pre and post-operative diagnostic
procedures; medication; travel; lost donor wages during recovery; other miscellaneous expenses like travel
& food. In case the family member is not a donor match then waiting for a cadaver donor can take long
requiring few more pre-operative procedures to prevent infections. Also it is good to account expenses for
common complications that may occur. The average indicative costs for LT are given below. The actual
costs will vary depending on the patient medical condition hospital & surgeon fees and post-operative
care required. The rates for multiple surgeries under THE PHILANTHROPY FUND can be negotiated and
further discounted.

Pre and Post-operative Diagnostics *INR 200000

Liver Transplant operation *INR 1500000-1800000
Post-operative medication *INR 15000-20000 (1st year)
Expenses towards Common Complication *INR 50000 - 150000
Lost wages/Salary until Donor recovers *INR 5000-10000
Lost jobs/wages for care-giver * INR 5000-10000
*All costs are indicative. Actual cost
will vary
Source- Sir Ganga ram hospital Delhi. Misc.
costs additional

Legal & Social due Diligence and Raising funds: Before proceeding to start crowdfunding campaigns
and sharing donor details it is mandatory to finish the legal and social DD. Legal – resident status;
location; income sources and salaries; BPL status- All these will be vital to understand qualifications
for any government subsidies/insurance and health schemes and also to make a strong case for
public donation. Social DD- the family size; donor & care-giver; support system during recovery;
access to sanitation & hygiene measure; presence of PHC/CHC/ clinic & hospitals.

Raising funds via multiple stakeholders requires a lot of co-ordination. The FR partners –
Crowdfunding platforms/ NGOs for leveraging govt. schemes/ DFIs/ Subsidies negotiated extended
via stakeholders (Hospital; surgeon; pharma Cos)/ CSR funds from foundations & HNIs. Need to be
updated about on-ground progress and changes while trying to maximising the amount of funds
raised. The process requires a high amount of transparency and trust making the prior steps of DD
and case selection very very critical.

Post-procedure check-ins: Post the LT operation the patient and donor are placed in the ICU for 48-
72 hours after which the donor is transferred to the ward and patients can need specialised
monitoring & care in the ICU/NICU up to a week. Donor is usually discharged from the hospital after
a week and can resume his daily activity in 8 to 10 days. To resume his full work most require 2-3
months. The recipients can be discharged after 3-4 weeks from the hospital. After the discharge
there are weekly check-ups up to 4-5 weeks followed by monthly check-ups. During this post-
operative period it becomes essential to maintain hygiene to avoid infections; maintain precautions

6
& nutrition; comply with medication & vaccination schedules. A social health worker/ NGO member
can be assigned to make sure all the above post-operative steps are being met by regular visits to
the family and facilitate to eliminate any roadblocks during this period.

Monitoring & Documentation: Close patient & donor (if live donor) monitoring are required to
communicate the progress to the donors & payers. It is also important to document good practices
and case specific inputs that will help to strengthen and modify our strategic approach. Process
Documents in the long run help of standardise practices and techniques that leading to quick turn-
around time when seeking partnerships; funding; and also hiring more staff. Case studies help to
highlight the achievement challenges and learning encountered by various stakeholder throughout
the process. Both of these should be shared with the donors/funders along with the note of
appreciation & thanks from the patient family to build-on the partnership. These become excellent
resources for PR campaigns and patient education as well.

Possible stakeholders and partnerships –

Indian
Treritary Pedicatric Asso.
Transplant
Medical PHCs/ CHCs Hospitals (Urban
Areas)
of India & IAP &
IMA
registry &
NOTTO/ROTTO

Private
Government development
Players-
Payers Schemes &
Insurance
Insurance &
Patient/Family financial
institution
Subsidy

THE Hospital* Rate

Funders PHILANTHROP
Y FUND
Subsidy &
Post-opt Care
Crowdfunding CSR/HNI/Phil

Novel
IEC & BCC Pre & Post-opt LT impact Innovations &
NGO/SEs campaigns visits assessment Leverage Govt
Funds

Rural- Network
Social Past cases -
Survivers &
Network of
transplant
Network of
of ASHA/Block
Health
Care-givers
Networks Campions successes officers/Mid-
wives

Multi-sectoral partnerships & networks are required to make the process robust and achieve
desired outcomes. The possible partners can be seen in the diagram above are self-explanatory.

On the Medical Side in addition to empanelment of the treating hospitals there needs to be a
partnership with Primary and Secondary healthcare centres that are usually the first POC (point of
contact) for the rural population and become referral hospitals. Timely management of patient
symptoms at this juncture can save critical time for LT and reduce expenses & chances of
complications. Moreover in the Long term they can become centres for IEC and BCC campaigns for
liver care & donation. Before coming to a GI/Transplant specialist the child and parent are mostly in-
touch with their family doctor/ GP (general practioner) or paediatrician. Partnerships with IAP;
Paediatric association of India and IMA will help strengthen the THE PHILANTHROPY FUND network
resources and innovations taking place in child health. Also LT case referrals can increase with
reduced turn-around time. Partnerships with ROTTO/NOTTO are important to understand and gauge
the availability of deceased donors. Also they are connection channels to avail government subsidies
& financial help.

7
Payer-Provider relationship is very clearly defined in the western countries where the payer is mostly
the insurance company for government health aid agencies. But In India where the population is
largely uninsured and unaware the payer-provider model isn’t well defined. In addition to
contributions coming from the patient family; hospitals and crowdfunding campaigns (that may/may
not achieve their FR goals). CSR funds from private sector industries like –pharmaceutical
companies; medical device corporations; diagnostic companies can be leveraged. Certain companies
like Religare who are both in the patient insurance and diagnostic space can offer LT patient subsidy
schemes. A lot of pharma companies as part of their CSR initiative provide free and subsidies drugs
to patients in need each year. Such opportunities can be capitalised to reduce the burden on the
patient family since the medication expense rise each year post-operatively. Moreover DFIs like
NABARD offer loans at low interest rates for low-income family and sectors. Often they also
underwrite such loans. Possibility of a tie-up with such institutions can be explored where the
patient family can play such low-interest loans over many years.

Non-profits/ Social health workers are important part of the HC matrix. Their on-ground reach is
imperative to realise last mile impacts. Their services are important for IEC BCC campaigns Post-
operative checks and monitoring. Many SEs working on novel techniques to reduce the transplant
burden (difference between donors & demand for organs) by levering technology & government
policies.

Lastly support groups and social networks can help in a great way to reduce stress and panic for the
family in such difficult situations. Peer to peer learning and sharing of experiences improves patient
understanding and compliance reducing the burden on hospitals and care-givers to some extent.
Many a time survivors becomes champions and beckons of hope of the suffering patient and his/her
family.

Interventions at different stages

The patient education should ideally begin before child birth about preventive care – sanitation &
vaccination against Hepatitis. Avoiding the high doses/ use of medication such as
acetomorphin/paracetamol that can lead to ALF. In case the child has already contacted liver disease
via one of the many causes – early detection & managing symptoms can prevent further worsening
of the condition and complications. HC social workers (ASHA) /Parents should be trained via IEC
materials & BCC programs on early signs of jaundice (the first sign of liver disease)

Early referrals by Primary physicians/ PHCs to hospitals for cases of Liver disease especially in
neonates & infants can be lifesaving. Rapid assessments kits for testing hepatitis infection can be
made available as subsidised costs at paediatric clinics & diagnostic labs. Partnerships with
companies in the space can be very beneficial to make this happen.
Test blood
before C-
Prenatal Maintain section
education & Perinatal hygiene & surgery
FBNC examination sanitation (HBV HCV)

Vaccination Prevent Consume

jaundice clean food &
while water (HAV
pregnancy HEV)
After the confirmation of ALF or CLF due diligence procedure should be run in parallel to make the
recipient data available for FR efforts. For correct budgetary estimation it is important to include loss
of wages; miscellaneous costs and account for any complication leading to prolonged hospital stay.

8
Partnerships with Payers & Funders as seen above should already be in place so that the monetary
requirements can be met in time. Networks of NGOs/CSOs should start interacting with the patient
family as soon as the case of ALF/CLF is confirmed. The different interventions at each stage can be
seen in the slide 15 of the presentation.

Monitoring parameters
Since transplant cases and surgeries require multi-disciplinary medical teams and multiple
stakeholders to come together different monitoring parameters for each stakeholder are required.

First and foremost the post-surgery parameters are checked on a monthly basis up to 6 months since
this time is extremely crucial as the new liver adjusts to the body and the body adjusts to the new
liver. Chances of infection and/or rejection are high during this time. Even the donor who has
undergone a major operation requires care and compliance to aid full recovery. Medical values of PT
and INR are the most dependable indications for prognosis.

Other physical parameters include the ability to return to a normal daily routine both the patient
and donor and their ease of movement with absence of any inflammation or infection.

Behaviourally and mentally the patient should be sound and returned to previous levels of social
integration cognition and comprehension in absence of any complications

Financial Parameters that can be observed are donors return to the work force eligibility and
redemption of government grants and repayments of medical loans if any

The monitoring NGO/Social organization should regular follow-up with the patient family via phone
and visits to make sure they are complying with the doctors’ prescriptions and report the progress
back to the donors. The NGO personnel can be trained to understand what are common problems or
complications which can occur and how to notice them during their visits.

Question template to monitor each parameter can be prepared and handed over to them for the
necessary data collection. Monitoring criteria can be seen in the slide 16 of the presentation

Public relations strategy

Since LT for children is a niche area for intervention THE PHILANTHROPY FUND will get a first-
movers advantage to enter this space. The non-profit can establish itself as a pioneer and thought-
leader in this field by leading efforts on the ground for this cause and also by outreach efforts and
industry participation.

Attending medical conferences and roundtables on organ transplants/ liver disease/paediatric

health will increase brand awareness about THE PHILANTHROPY FUND and aid interaction with
different players in this field – experts/medical hospitals/ MedTech/pharma/MDT/NGOs in this
sector etc.

The reports on THE PHILANTHROPY FUND on-ground learnings from execution and case studies
should be published for peer to peer learning and will be excellent marketing resources.

One should take advantage of the opportunity of media campaigns that run during specific days like
organ donation/liver heath etc. and organise events and discussions on those days.
Leveraging the social media channels can help create a connection with the existing and past
patients and also showcase the work being accomplished. Since the time people spend on their
phone and social media is increasing exponentially visual content –videos/IEC digital posters will
grab a lot of attention.

9
Lastly public discussions and brainstorming sessions on the important cause to increase organ
donation in India can be lead and broadcasted for public participation.
Slide 22 has more details about PR events & strategies.

Sustainability
To make the initiative economically & socially sustainable their needs to be efforts to create a
network payers & funders that not only raise money just for individual operations but also create a
corpus that can be utilised in case there is a shortage at a later stage. Some portion of funds need to
be contributed to this corpus each time to maintain a supply of funds and account for increase in
expenditure caused by rejections/complications.

Leveraging of government funds is imperative to service more patients and post-operative

maintenance. The national organ transplant program has a budget of 150 crores these funds are
specifically meant for the needy Indian citizens who require a transplant. THE PHILANTHROPY FUND
should help leverage some of these funds for its patients.

Network of LT survivors should be created to provide peer to peer learning and support and few of
them should be encouraged to campion this cause. Similar networks and support groups for care-
givers can go a long way to strengthen the initiative.

Non-monetary & monetary incentives to the ASHA workers/NGO/health volunteers can help them
feel appreciated for being part of a HUGE change that has the potential to save many lives and
provide a second chance to many struggling individuals. This will create a feeling of belonging and
will further help sustainability. Slide 23 has more details.

Summation

In conclusion the Paediatric liver transplantation initiative by THE PHILANTHROPY FUND can be
successfully implemented using the above mentioned strategies. Coordination with multiple
stakeholders and partners & execution will lie at the heart of this success.

It is also important to note that in India there is a heavy burden (difference between demand &
supply) as far as organ donations go. As we aim to increase the supply by facilitation of live donors
better matching using novel advanced techniques like hepatocyte transplants (refer slide 18 to 21)
we must also look to decrease demand. This can be done by reducing the number of children that
need transplants or have ESLD (end stage liver disease).

Except developmental disorders and few genetic causes the other causes like Hepatitis infections
Herpes Simplex infections Wrong medication or complications at birth can be greatly reduced by
specific preventive education and other prompt curative efforts like HAV HBV vaccination camps.
The RoI if measured per case can be far more in the long term.

Hence some efforts can be initiated towards this aspect as well. Another effort can be directed to
make a common platform for all stakeholders to interact and assist. This will break the individual
silos and sporadic efforts will be replaced by a consolidated push.

References

 National Institute of health (NIH) & NCBI US

10
  Directorate general of health services India
 National Organ transplant program India
 Cleveland Clinic US
 National health services UK
 Organs India (under NOTTO)
 Kings College hospital UK
 Top Doctors UK
 Research Articles and presentations from Jaslok hospital; VS general hospital; London school
of medicine.
 Media ( TOI/ZEE/BBC) Interviews of Head of departments & LT specialists from various
hospitals
----------------------------------------------------------------------------------------------------------------
From
--Dr Richa Singh BDS PGFM

11