Background
Chronic kidney disease (CKD) is a recognised healthcare problem across the world and afflicts 8 – 10 % of the population globally. The proportion of CKD cases is even higher in developing countries. In India, this number is estimated at 8-17% of the total population – propelled by an increased number of elderly people, changing lifestyle and other NCD risk factors. CKD is associated with increased risk of complications and mortality at all stages in its natural course. About 10-20% of those with CKD are expected to develop End Stage Renal Disease (ESRD) and will need some form of Renal Replacement Therapy (RRT). Over 2 million people worldwide receive treatment with dialysis or a kidney transplant, yet this number represents less than half of persons who need treatment to stay alive.
About 2.2 Lakh new patients of ESRD get added in India every year, resulting in an additional demand for 3.4 Crore dialysis sessions. Outcomes and “time on therapy” are poor now, but will get better with improving living conditions, better awareness, higher incomes, and reimbursement. This will put pressure on the dialysis infrastructure – and demand much more capacity creation.
Peritoneal dialysis (PD) can, in part, relieve some of this pressure. PD can be done at home and can be cheaper than HD when scale is reached. PD does not need much infrastructure or technical manpower. It has been adopted as the preferred modality by many countries - Thailand, Hong Kong, New Zealand, and Australia, being the latest examples. Other countries like USA are pushing to increase the share of patients on peritoneal dialysis.
On 7th April 2016, the Ministry of Health and Family Welfare, Govt. of India, launched programme guidelines for hemodialysis under the Pradhan Mantri National Dialysis Programme (PMNDP) for implementation at District Level. Subsequently, the initiative was expanded to Peritoneal Dialysis to provide respite and better quality of life to kidney patients, particularly those who live in remote areas. An estimated 70-80% of kidney patients who start dialysis are forced to drop out due to a variety of reasons. While resource limitations are a prominent cause, access to dialysis centres and care-giver availability are huge problems too. Dialysis is hard to access for large number of patients living in remote rural areas and the introduction of home-based Peritoneal Dialysis will benefit these individuals by allowing greater flexibility and freedom in their treatment schedule.
According to the recently published Global Kidney Health Atlas, 63 out of the 124 countries surveyed provided free PD from public funds – compared to 52 that provided free HD. It is important for doctors and patients to make their Dialysis modality choice after a careful evaluation of all available options. Sadly, many patients today are not even offered PD before beginning dialysis.
According to current estimates, there are only 6,500 patients on PD in India. There are multiple reasons for low utilisation of PD - including the high cost of PD supplies, physician and provider bias, financial incentives, and higher professional earnings to physicians from HD, need for provider organisations to utilise existing HD capacity and lack of familiarity amongst physicians making them uncomfortable with the therapy. There is a widespread but
unfounded belief that PD is associated with higher complication rates, in particular,
infection. It is felt that patients from low socio-economic group are not suitable for the self-management that PD warrants. Experience in PD first countries across the world bely these theories. Adoption of PD in India will need each one of these factors to be addressed and mitigated
Factors that will drive greater PD utilisation
- Building the clinical case for PD. Doctor support, patient and care-giver education, PD infra in key hospitals, tele-medicine
- Attracting large scale manufacturing of PD in India – and making the therapy more affordable
- Building the clinical support – training, quality, social worker involvement, clinical protocols, condition monitoring, complications management
1. Building the clinical / health economic case for PD
PD is the therapy of choice for remote dialysis patients, as a bridge to transplant, for independent patients seeking quality of life and for those with cardio-vascular insufficiencies. Moreover, 60 % of ESRD patients are suited for either dialysis form – HD being the choice of most treating physicians. It is necessary to put a formal program in place to counter-act the considerable negativity associated with PD - through education, demonstrated clinical evidence and outcomes. Some measures are elaborated below:
- Partnering with the ISN (Indian Society of Nephrology) and PDSI(Peritoneal Dialysis Society of India) to develop a PD clinical evidence series – clinical papers and outcomes from PD first countries; comparison of DALY adjusted for initial clinical condition, Quality of Life. Programs run by PD companies prove that, stripped of financial constraints and supply issues, patients can live many years on PD with a better quality of life.
- Partnering with the ISN and PDSI on continuing Medical Education: Bringing strong PD practitioners alongside promising ones to help cross-learning of the nuances
- Make it mandatory for all centres participating in government programs to offer PD along with HD. Reserving even 10 % of patients for PD will serve to ensure that HD centres are committed to the therapy; physicians are encouraged to learn and incorporate PD into their practice; and large-scale manufacture will reduce cost
- Equating physician incentives on HD and PD – to build objectivity and eliminate any financial biases that could affect therapy choice.
- Build a “Total System Cost” model to compare PD and HD. Equate standards of dialysis adequacy across PD and HD – and build in the hidden costs eg. travel, opportunity cost of care-giver time and other out-of-pocket expenses
2. Making it attractive for large scale manufacturing of PD in India
Manufacturing PD fluid and consumables is not a very complex operation – especially for a country like India that has established itself as a manufacturing hub for much more complex products. The components are predominantly plastic (PVC or PPE), filling is akin to large volume parenterels in aseptic conditions and the product is terminally sterilised by steam. The key task is to deliver adequate quality at a reasonable price – scale of manufacture has a very large part to play in this.
Large manufacturing plants in PD “friendly” countries have demonstrated that the cost of bags and consumables can be cut down to the extent that therapy costs are comparable to that achieved by HD. To derive these economies of scale, though, a plant must produce over a crore bags annually – i.e., cater to the requirements of 10,000 patients. In initial years, while patient numbers are being ramped up, manufacturers will struggle to utilise their installed capacity and will need to be supported through incentives such as:
- Long term supply contracts
- Production and Quality linked incentive schemes
- Capital credit
- Grants for research on better manufacturing methods and materials
- Subsidies and duty waiver on RM, PM and Capital goods that are needed to manufacture PD
- Tax benefits to extend existing large volume parental lines to accommodate PD
3. Building the clinical support infrastructure
HD has been the therapy of choice for several decades now – the collective patient experience is several hundred times that of PD. Clinical processes are mature, care standards well defined, patient review processes well charted and support systems for managing adverse events are in place. It is important that all these aspects are built in for PD too. Being a home care option, PD will need an additional layer of support from last mile PD coordinators, social workers, and caregivers. PD patients enjoy much higher degree of independence – the flip side of this a tendency to put off regular doctor visits until absolutely necessary. PD coordinators bridge this gap by engaging with patients on a more regular basis, keeping an eye for any decline in clinical condition, and feedback to the doctor. These need to be standardised, documented, and tracked for quality.
Infection is a common problem in both PD and HD – though the nature of infection is different in each. Infections in PD patients are related to the PD catheter - peritonitis and exit site infection, whereas HD are at greater risk of vascular catheter related sepsis, bloodstream infections (bacteraemia), infective endocarditis and pneumonia. Vascular catheters are associated with higher infection as compared to AV fistula. In comparative studies, hospital admission rates due to infection are twice as high for HD as for PD. Moreover, mortality due to peritonitis is much lower than the risk of death in the HD patients due to bacteraemia, sepsis and pneumonia.
Infection management has achieved great prominence in a hospital setting. It must be given the same importance in a home setting for PD. Patients and caregivers must be trained on proper techniques to minimise infection – this has been adopted very successfully elsewhere in the world.
Standardised elements of PD therapy will include
- Independent counselling centres for non-biased explanation of therapy choices
- PD rooms in HD centres – as a necessary feature to support initiation, hand hold patients through the troublesome initial phases, provide educational content and manage complications, if any
- A patient home care manual (paper and online) where patients can record daily therapy information – exchanges, fluid status, diet, exercise, and medication.
- PD Coordinator formats that will report on patient status – through scheduled video and in-person evaluations. Evaluations to include clinical condition, fluid status, compliance with therapy, nutrition status, fatigue assessment and complications that will need escalation
- Essential training tools and schedule – on 6 step hand-washing, maintaining a safe environment for exchanges, safe disposal, what to watch out for, patient helpline etc.
The PD Clinical Coordinator is an essential part of the PD ecosystem. It isn’t a specialised skill, though, and can easily be administered by a quasi-healthcare worker trained for the purpose. ASHA workers and volunteers at the field level can be trained to play the role of the social worker – and ensure more regular contact with patients. An incentive model must be worked out for last mile healthcare workers. The proliferation of Home Care and Telemedicine represents a huge opportunity – drawing on these home care networks can provide the last mile touch points for patients and build in a feedback loop through telemedicine for remote attending physicians. A network of this nature is essential to build confidence amongst doctors and scale the therapy.
Conclusion
In conclusion, as the RRT needs of the country grows, it is imperative to add PD to the basket of options available to the patient. However, bringing PD to the forefront required collaboration and concerted action by all stakeholders for the period of time it takes to embed the therapy into people’s mind and for it to become financially viable.
Acknowledgements
This paper would not have been possible without the involvement, advice and critique of Prof. Vivek Jha, Director, The George Institute for Global Health, India. Most of the data and clinical references are derived from his work on PD over the last 2 decades.
