Searching for the silver lining

Ever since the United Nations General Assembly designated October 1 as International Day of Older Persons in 1990 and similarly observed 1999 as International Year of Older Persons, policy makers across the world have been preparing for what is being called a ‘social transformation’.

Utkarsh Palnitkar, Partner & National Head, Pharma & Life Sciences, KPMG India, points out that while the global population is projected to increase 3.7 times from 1950 to 2050, the number of those aged 60 and over will increase by a factor of nearly 10. Among the elderly, the portion of those aged 80 and over, is projected to increase by a factor of 26.

Consider the numbers in India. Extrapolating from the 2001 census, the proportion of India’s population above 60 years, which was just 7.4 per cent in 2001, will balloon to over 300 million, representing a whopping 17 per cent by 2051. “We will have the problems of the West with none of the resources to tackle them,” rues Ranjit Shahani, Vice Chairman and Managing Director, Novartis India and President OPPI, citing changing lifestyles, smaller families and the break-up of the joint family system as the major reasons for this situation.

“We will have the problems of the West with none of the resources to tackle them.” Ranjit Shahani Vice Chairman & Managing Director, Novartis India and President OPPI

India has awoken quite late to this reality. In 2010, it was ranked at the bottom of the Economist Intelligence Unit’s “Quality of Death” Index, a first ever attempt devised to measure how different countries provided for end-of-life care. While it was understandable that a developed nation like the UK topped the index, the survey commissioned by the Lien Foundation, a Singaporean philanthropic organisation, was a damning indictment.

Developed nations have had longer to deal with such issues as their demographic profiles started ageing two decades back. However, the speed of ageing in developing nations has taken most policy makers by surprise. A WHO background note to World Health Day (WHD) 2012, which focused on ageing issues, made the point that while it took more than a century for France’s 65+ population to double from 7 to 14 per cent, it will take countries like Brazil and China less than a quarter of a century to reach the same growth.

“From a quality of life perspective, geriatric care comprises more than medicines.” Utkarsh Palnitkar Partner & National Head Pharma & Life Sciences, KPMG in India

To compound this situation, each country has unique problems. As Palnitkar says, “The needs of geriatric patients vary with the geographical location and lifestyle of the larger demographic. In India 63 per cent of men over 50, smoke, compared to ~11 per cent in Ghana. In China, 51 per cent of women over 50 have high blood pressure, compared with 27 per cent in India.

Within countries too certain regions will need more attention. A June 2011 report from the Ministry of Statistics & Programme Implementation, Government of India, titled ‘Situation Analysis Of The Elderly in India’, highlights that ageing will be uneven across states. By 2026, North India population would be younger compared to the South. Similarly, by this year, Kerala will have highest educated working people with average age hovering above (median age) 35 years whereas Uttar Pradesh will have uneducated and less educated working population with average age below 30 years. Although projections indicate that India’s population above 60 years will be double in size between 2001 and 2026, the elders will account for 12.17 per cent of overall population in 2026. Being a vast country India may face a different set of problems in the rural and urban areas.

Palnitkar also underlines that women in India are far worse impacted especially in rural areas – due to limited accessibility of healthcare and lack of support from family members. Statistically, around 75 per cent of the elderly live in rural areas of which over 48 per cent are women and of this, 55 per cent are widows. Nearly three out of five single older women are not self dependent.

While the rights of the elderly are enshrined in Articles 41 and 47 of the Constitution of India, the National Policy on Older Persons was announced in 1999. Further, legislative measures like the Senior Citizen Act, 2007 also protect the rights of senior citizens by stating that a family has to take care of their elderly. The Ministry of Health and Family Welfare (MoH&FW) has also launched the National Programme for Health Care of Elderly (NPHCE) in the XI Five Year Plan in 100 districts with plans to scale it up to the entire country.

Customising geriatric care

As policy makers add legislative layers to cover the social issues faced by the elderly, other sectors too are changing their approach to address this sector. Palnitkar says that there is a need to customise the healthcare/pharma landscape to meet the needs of this strata of society.

Geriatric medicines – medicines used in the treatment of disorders that impact the elderly majorly (orthopaedic disorders, CVS and CNS problems, auditory and visual impairment etc) – form a major component of geriatric care. According to him, a decade ago the global market was growing at a CAGR of 10-14 per cent and estimated close to $57 billion. Assuming a similar growth trajectory the market for geriatric drugs today is likely to be worth $125- 150 billion.

All major pharma companies already have a sizeable geriatric care focus. Palnitkar points out that for established disorders like diabetes, Alzheimer’s etc – companies like Pfizer, J&J, and Novartis etc have well established portfolios. GSK is investing heavily in translational research in the field of Alzheimer’s which while a developed world disorder still impacts a huge fraction of geriatric patients. Astrazeneca too is building a strong portfolio in diabetes. Merck and Pfizer are established players in the field of geriatrics.

Giving a further glimpse into the Novartis pipeline, Shahani mentions that while his company’s pharmaceuticals division alone has 138 projects in clinical development, some of this research, which is at an advanced stage of clinical trials, are in areas that are of particular concern for the elderly for e.g. for L-dopa-induced dyskinesia in Parkinson’s disease, Alzheimer’s disease and choroidal neovascularisation macular edema.

Regulatory guidelines like the geriatric medicines strategy of the European Medicines Agency (EMA) which were released in February 2011, have served to focus attention on the many challenges involved in the treatment of older patients. These range from co-morbidities, lack of clinical trial data on the elderly population due to the ethical issues of involving this population in trials as well as challenges of drug-drug interactions and non-compliance issues.

Palnitkar says companies are aligning their research focus to develop drugs and drug delivery systems specifically to treat geriatric patients. Companies are also carrying out trials and studies to determine the best drugs for the treatment of geriatric disorders and endorsing their prescription over other drugs in the category.

Speaking about the impact of the EMA’s guidelines Palnitkar says, “The EMA’s guidelines have enhanced the use and import of the “Summary of product characteristics (SmPC) and package leaflet which accompanies the medication on purchase. Both the SmPC and package leaflet aim to provide users with clear and concise information on drug use.”

Considering the complexities involved in the elderly, Shahani reasons, “There is a need to work in close proximity with the regulators and also plan the approach based on emerging safety data like periodic safety update reports (PSURs). Innovative clinical trial designs ensure that important pharmacodynamics parameters like drug-drug interactions are appropriately covered.”

Analysing drug research in this area, Palnitkar says it is focused on drugs whose mode of action is more “regeneration” rather than “halt progression”. Companies are also focussing on innovation in drug delivery to increase compliance, palatability and other physicochemical properties more suited to the geriatric population. Some of the thrust areas that are of focus are geriatric endocrinology, urology, CVS and rheumatology.

More than medicines

But Palnitkar cautions that from a quality of life (QOL) perspective, geriatric care comprises more than medicines, with management of health as a priority rather than the mere treatment of the disorder. Elderly patients may not necessarily need medical treatment but mental stimulation and activities to keep them occupied, therefore he advocates that players investing in this space should consider these factors while building a comprehensive care model.

For example, he points out that since the elderly face a number of issues associated with drug use – non-compliance/skipping doses being a major one – healthcare companies in the US and Europe have designed tools/devices which serve to remind patients when it’s time to take the medicine. He suggests that Indian companies may want to explore this space too. Beyond pure play pharma products, health supplements to boost mind activity, increase physical vigour, depression management etc are all being explored by companies focusing on the neutraceutical segment.

“The challenge for India, as for all countries all over the world, is not just to add further years to life but to add life to years.” Dr Nata Menabde WHO representative to India

The WHO’s take on the ageing crisis, is to look at this ‘major social transformation’ as both ‘a complex challenge and a great opportunity.’ As Dr Nata Menabde, WHO representative to India said in her message on World Health Day 2012, “The challenge for India, as for all countries all over the world, is not just to add further years to life but to add life to years.”

India has made a start on this front with laws like the Senior Citizens Act, 2007 striving to address the issue in holistic terms. But as Palnitkar points out, “India has not achieved much in terms of geriatric care. The traditional tertiary set-ups are currently not prepared for the coming challenges of the increasing elderly population because of the sheer size and diverse needs of this ageing generation. These challenges include both physical and mental health care needs – with the latter issue even more largely neglected than the former. The Indian system of care is not patient centric and importance is being given to treatment rather than management.”

Shahani too lauds measures like the National Programme for Healthcare of the Elderly and the Senior Citizen’s Act as steps in the right direction but cautions that we need to ensure that these do not remain on paper but are implemented in letter and spirit.

If the pharma industry claims a lion’s share of the credit for increasing lifespans across the globe, it is indeed but fitting that the sector plays as major a role in improving the quality of life as well. But social models of care are better equipped to take care of the elderly than medical models reiterates Palnitkar, advising that companies should endorse this approach when dealing with this segment of the market. “Elderly care is a function of synergy between community, government and the private sector fuelled mostly by the family of the patient,” he concludes.

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