Drug Pricing Pressure to Escalate Further?

On February 09, 2018, NITI Aayog released its “Healthy States, Progressive India” Report. The study ranked the States based on ‘health index’. Kerala, Punjab and Tamil Nadu featured as top three in terms of overall performance in 2015-16. However, the interstate variation of ‘health indices’ was quite significant, with the highest being 76.55 (Kerala) and the lowest in Uttar Pradesh with 33.69, during the same period.

Importantly, the report also noted: “About one-third of the States have registered a decline in their performance in 2016 as compared to 2015, stressing the need to pursue domain-specific, targeted interventions.” It’s worth noting, the reported decline in performance was registered despite several promises of the Government in this space, during immediately preceding years.

Apparently, as a corrective measure to this effect, the world’s largest government-funded health care program – the ‘National Health Protection Scheme (HPS)’ of India was announced in the Union Budget Proposal, on February 01, 2018. HPS is expected to provide insurance cover of up to ₹500,000 to 100 million poor and vulnerable families, covering around 500 million population in the country.

As enshrined in the National Health Policy 2017 (NHP 2017), HPS too seeks to ensure improved access and affordability of quality secondary and tertiary care services with a significant reduction in Out of Pocket Expenditure (OOPE) on health care, for the common citizens in the country.

Such a massive public health care program as HPS, is obviously expected to use a transparent drug procurement and logistics framework. This, in turn, would necessitate tough price negotiations with the pharma manufacturers for the purchase of medicines, leading to significant reduction in drug prices. This is already happening in some States, like Tamil Nadu.

High OOPE on health:

According to the December 2016 report of the Union Ministry of Health and Family Welfare, of the total 64.2 percent OOPE in 2013-14, 53.46 percent was spent on medicines and 9.95 percent was spent on diagnostics, in India. 82.29 percent of the total OOP medicines expenditure and 67 percent of total OOP diagnostic expenditure was for outpatient treatment. Of the total OOPE, 15.96 percent was on traditional medicines/ AYUSH, of which equal proportion was spent on outpatient and inpatient care.

In an interview, published on December 18, 2017, the Chairman of the Insurance Regulatory and Development Authority of India (IRDAI), reportedly, also said, OOPE makes up about 62 percent of all health care costs in India, causing impoverishment of many patients. In a comparative yardstick, OOPE is about 20 percent in the U.S. and the U.K. and 20-25 percent in BRICS countries. Thus, there is a need to significantly bring it down in India, he said.

Curiously, the ‘Health in India’ report, which draws data from the 71st round of the National Sample Survey conducted from January to June 2014, presents a somewhat different picture. It reportedly says, of the total OOPE, 72 percent in rural and 68 percent in urban areas was towards buying medicines for non-hospitalized treatment. The Health in India report shows, in rural India, 25 percent patients relied on “borrowings” for hospitalization, and 68 percent on household income and other savings. In urban India, 18 percent patients had to borrow while admitted in hospital, and 75 percent relied on income or savings – the report further added.

Containing OOPE – a dire necessity:

Be that as it may, OOPE for health in India and, especially, on drugs, is indeed very high, by any measure. To contain this burden on the general population in the private market, the Government had introduced, since quite some time, a balancing mechanism through various Drug Price Control Orders (DPCO).

Similarly, to contain its own health care expenditure, as HPS comes into force, the Government is expected to choose a digitalized and transparent drug procurement process. This would, almost certainly, prompt tough price negotiations for the purchase of medicines, as well.

Thus, HPS may further add to the current discomfort of the pharma players in this area, as they mostly want free pricing of drugs that will only be regulated by market forces. Unfortunately, market forces do not work for drugs. I explained it in an article, published in this blog on April 27, 2015, titled “Does Free Market Economy Work For Branded Generic Drugs In India?

Industry lobbying for free pricing of drugs and devices:

It is well known that pharma industry, supported by other businesses dependent on it, including a section of the media, is still against such a move by the Indian policy makers, for various reasons. The primary one being, such pressure on drug prices would stifle  innovation, impacting patient access to the best possible health care.

Pharma Multination Corporations (MNC) appear to be in the forefront of this ‘innovation’ bandwagon to score a brownie point in this area, as many say. This is an ongoing process for them. Even recently, in the report titled, ‘2017 Accomplishments’, the US-India Business Council’s (USIBC) made a strong assertion in this regard, quite expectedly, though.

The report articulated, as part of advocacy around price controls, USIBC had sent a letter to the National Pharmaceutical Pricing Authority (NPPA), detailing American industry concerns on setting up ceiling prices for drugs and medical devices. USIBC, reportedly has also sent a letter, expressing its concern on the “serious problems for US companies that sell these products in the Indian market.” Advocacy initiatives of this kind, reportedly included the then Foreign Secretary, Minister of Commerce and Industries of India, and the Prime Minister’s Principal Secretary, as well.

Pricing pressure getting more intense, even in the US:

Curiously, a similar and equally interesting scenario is rapidly developing alongside in the largest pharma free-market economy in the world – the United States. On January 30, 2018, during his State of the Union address, President Donald Trump said that he wants his administration “to make fixing the injustice of high drug prices one of our top priorities.”

Likewise, as reported by Bloomberg on February 09, 2018, President Trump’s Health and Human Services Secretary – Alex Azar reaffirmed that he plans to take up the President’s promises to do something about pharmaceutical prices to reduce patients’ out-of-pocket spending. He assured, “The president is firmly committed in this space.” Incidentally, Alex Azar is a former executive at drug maker Eli Lilly & Co.

HPS needs efficient public procurement and logistics mechanisms:

As the cost of drugs and devices contribute so much to the total OOPE on health, together with ensuring patients’ easy access to convenient to reach primary, secondary and tertiary health care facilities – access to drugs, devices and diagnostics for the target population of HPS must also increase, effectively. Thus, bulk procurement and distribution of these, free of cost, at the designated health centers, assumes paramount importance for its success. Consequently, the trust of the HPS beneficiaries will keep ascending.

The Public Health Foundation of India (PHFI) too, had aptly asserted, any inefficiency due to poor governance, lack of transparency and inequities in public health financing and delivery would greatly impede access to medicines and diagnostics for those who would need these most.

Admitting its importance, the NHP 2017 noted: “Quality of public procurement and logistics is a major challenge in ensuring access to free drugs and diagnostics through public facilities. An essential prerequisite that is needed to address the challenge of providing free drugs through the public sector, is a well-developed public procurement system.”

Thus, putting in place an effective framework and process for this purpose, at both the central and the state government levels, as the situation would warrant, requires to be a key priority focus area of the HPS implementation process. There doesn’t seem to be any other viable choice, either.

Any need to ‘reinvent the wheel’?

The answer is, of course, ‘no’. Perhaps, to attain similar goals, the Government had established the fully autonomous Central Medical Services Society (CMSS) as a Central Procurement Agency (CPA). This was intended to streamline drug procurement and distribution system of the Ministry of Health and Family Welfare of India. Accordingly, the Gazette Notification on the formation of CMSS said that it:

  • Will be responsible for procuring health sector goods in a transparent and cost-effective manner and distributing them to the States/UTs by setting up an IT enabled supply chain infrastructure including warehouses in 50 locations.
  • Will ensure uninterrupted supply of health-sector goods to the State Government, which will then maintain the flow to the government health facilities, such as district hospitals, primary health centers and community health centers.
  • All decisions on procurement will be taken by the CMSS without any reference to the Ministry of Health and Family Welfare.
  • The Ministry will be responsible only for policy decisions concerning procurement and for monitoring its performance.
  • The CMSS will also assist the State Governments to set up similar organizations in states to reform their procurement.

Currently, CMSS carries out procurement for following ‘Disease Control and Welfare Programs’ of the Union Ministry of Health & Family Welfare:

  • Revised National Tuberculosis Control Program (RNTCP)
  • National Vector Borne Disease Control Program (NVBDCP)
  • Family Welfare Program (FWP)
  • National Aids Control Organization (NACO)

The scope of services of CMSS includes tendering, bid Evaluation, procurement decision, concluding rate agreement, placing purchase orders, receiving in stores, sampling and testing, releasing payment to suppliers and keeping stocks of drugs available in warehouses for distribution to state program offices.

So far as State Governments are concerned, a World Bank article says, the Tamil Nadu Medical Services Corporation (TNMSC) had successfully demonstrated a cost-effective model. This IT enabled system is an integral part in the supply chain infrastructure to support the management decisions, and adequate attention to quality in drug procurement.

CMSS follows similar processes to procure and distribute supplies to States through web-connected warehouses in State capitals. An IT vendor takes up the IT work with a quality control framework in place. Its warehouses are being equipped with necessary storing and warehousing equipment, which will distribute to the States the items that are procured by the Ministry. Since the warehouses will be connected through the IT system, it will be possible for the Society to monitor the inventory in warehouses preventing stock outs and wastage.

Many State governments have also adopted a similar reform process. However, any duplication in the drug procurement and logistics systems needs to be avoided.

Conclusion:

Hence, I reckon, CMSS can be extended to the procurement process of both the new ‘Health Protection Scheme (HPS)’ and also for the ‘Health and Wellness Centers,’ without trying to ‘reinventing the wheel.’

As stated before, this seemingly transparent drug procurement process for public use, would naturally involve tough price negotiations, leading to significant reduction, not just in drug prices, but also containing the overall HPS cost to the Government, enabling the country to experience the roll out of Universal Health Coverage (UHC) for all. From this perspective, it appears, while translating into reality, this noble Government intent of providing wider access to health care, including free medicines, overall pressure on drug prices may escalate further.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Union Budget 2018: The ‘WOW’ Moment for Indian Healthcare?

The 2018-19 Union Budget proposals, presented before the Parliament on February 01, 2018. Especially for those who take keen interest in the Indian healthcare environment, was there a ‘WOW’ moment in the budget? Some say, this long-awaited moment came with the Union Finance Minister’s (FM) announcement of the ‘Ayushman Bharat Program (ABP)’ – the “world’s largest healthcare program,” taking a major step towards the Universal Health Coverage (UHC) for all, in India.

Two other health care related major announcements made by the FM in his 2018 Union Budget proposal are:

  • 24 new government medical colleges by upgrading existing district hospitals.  This is to bridge the gap between doctor-patient ratio in the country.
  • An allocation of ₹60 million for nutritional support to all tuberculosis patients – ₹ 500 per month per patient for 10 months, during the duration of their treatment.

The ‘Ayushman Bharat Program (ABP)’:

In this article, I shall not touch upon what expectations of pharma and healthcare industries were not met with the budget, as that will no more than an academic deliberation, at this stage. I shall rather restrict my discussion to ABP, for obvious reasons. This potential game changer, covers two commendable initiatives, as follows:

1. The New Health Protection Scheme (HPS) offering health insurance coverage of ₹500,000 per family per annum, is expected to take under its wings 100 million vulnerable families, or around 500 million beneficiaries. The total budgetary allocation for this mega proposal, for which the detail contours, apparently, are yet to be fleshed out and made public.

Some Senior Government officials, though, have put across its sketchy outline during post-budget Television coverage, on last Thursday. However, many industry watchers construe HPS as an expanded version, with a different name, of the current ‘Rashtriya Swasthya Bima Yojana (RSBY)’, which provides annual coverage of just ₹30,000 for poor families.

A fund of just ₹20 billion has been earmarked for this mega project in the Union Budget 2018-19.

2. Creation of 150,000 health and wellness centers to provide ‘comprehensive health care’ – for prevention and treatment of both communicable and non-communicable diseases (NCDS), including maternal/child health services, and free essential drugs alongside diagnostic services. This will “bring healthcare closer to home”, as the FM articulated.

A sum of ₹1.2 billion (₹1200 crore) had been allocated for this project in the 2018 budget proposal. The FM also requested contributions from the private sectors through CSR, besides philanthropic entities, in adopting these centers.

The points to ponder before saying ‘WOW!’

So far so good. However, as the saying goes, the devil is in the detail. From that angle, sans any meaningful details, does it look merely as an expression of the Government’ intent? Or it is for real! This serious doubt emanates from some key considerations. Three of which, as I reckon, are as follows:

I. Is it the beginning of implementation of the much-awaited National Health Policy 2017 (NHP), where the Government had committed and expenditure for UHC around 2.5 percent of the India’s GDP? This number currently hovers around 1.4 percent –  reportedly, less than even Nepal (2.3 percent) and Sri Lanka (2 percent). There is no mention of this in the Union Budget Proposal 2018, either, how much it will now go up to. By the way, the same report, as above, of January 2018 also indicated that health costs push 39 million Indians back into poverty, every year.

  • Attaining the NHP 2017 objectives, prompts a rise of around 40 percent in the public health expenditure of the Government. Whereas, the allocated reported expenditure for health in 2018-19 at ₹52.8 billion over the revised estimate of ₹50.1 billion in 2017/18. This works out to an increase of just around 5.4 percent.
  • The allocated expenditure of ₹20 billion for ABP in 2018-19, over the last year’s (2017-18) very similar health budget for ‘National Health Mission (NRM)’, reportedly, of ₹26.70 billion, looks rather pale. The financial arithmetic doesn’t appear to add up, defying simple logic. Is the allocation enough to support the ABP for 2018-19, even if the ABP funding is shared in the ratio of 60:40 between the Central and the State Governments?
  • Diving slightly deeper, on February 02, 2018, quoting a Government official Reuters reported, the cost of providing health insurance to 100 million vulnerable families or close to about half the country’s population would require an estimated ₹110 billion (USD$ 1.72 billion) in central and state funding each year.
  • The government estimates the cost of insuring each family would be about ₹1,100 rupees (US$17.15), the above report says. Curiously, on the face of it, this huge amount appears as an ‘off balance sheet’ expenditure, as of now.
  • Intriguingly, when the ABP is still not in place, there has been, reportedly, a 2.1 percent decline in the allocation towards the NRM in 2018-19. Currently, NHM provides financial support to States to strengthen the public health system, including upgradation of existing or construction of new infrastructure. In addition, there is a 7 percent cut in the allocation for the ‘Swachh Bharat Mission’ Budget from 2017-18’s revised estimates.

II. The second question is equally critical. Just as the erstwhile State Sales Tax (now a part of GST), healthcare is also a state subject. Thus, a similar process of intensive consultation with all State Governments, as happened before the implementation of GST, to take them on board, has to be replicated for a consensus. This will include a commitment for 60:40 funding, alongside the mechanisms for effective implementation of ABP – step by step. Has that happened? Have all the States agreed to contribute 40 percent of total funding requirements in their respective states for ABP?

  • If the answer is yes – excellent! If not, when will the ABP be rolled out? Different senior government officials have indicated different dates on Television. Some said on the Independence Day this year – August 15, 2018. Some other official said on October 02, 2018 – Gandhi Jayanti of this year. Yet another responsible official said the actual implementation may, actually, take even more time. This could mean only one thing, the ABP has been announced without any fixed timeframe for its implementation.

III. The third question lies in the effectiveness of insurance-driven health care system, such as in the United States. The key question often is raised on this system: Do the health insurance companies derive more benefit out of this system rather than the patients?

  • Concurring with the experts of many other countries, India’s own – Dr. (Professor) K. Srinath Reddy, globally acclaimed cardiologist and the President, Public Health Foundation of India, reportedly is also of the opinion that “Government-funded social insurance schemes do increase access to advanced care. But they have not been shown to provide financial protection as they cover only part of the hospitalization cost and none of the expense of prolonged outpatient care which forms a higher percentage of out-of-pocket spending.”
  • Insurance-driven healthcare has been found wanting to properly balancing health insurance costs with access, quality of care and outcomes in several countries. The experience of most of those people in India who can avail the benefits of insurance-driven – the Rashtriya Swasthya Bima Yojana (RSBY) or Employee State Insurance Schemes (ESIS), are not very pleasant, either.
  • On the other hand, despite some peripheral issues, many prefer, the government run UHC, such as in Britain. These generally offer a broader health coverage to all, and most health and care related services are available free to the citizens. The UHC is fully funded by taxes there, though a private health care system exists along with it. Thus, serious apprehensions related to the depth of health care access, reach in the rural heartland, and the quality of product and services to be generally provided by the insurance-driven new HPS, continue to haunt.

Conclusion:

Considering all these aspects, renamed HPS, as it was announced by the FM on February 01, 2018, and subsequent incongruent and very tentative clarifications expressed through the media by some Senior Government officials, raises even more questions than answers.

Sans any transparent and well-laid out financial road map, detail mechanism of its operation, level of involvement and consensus reached with all the States on funding and implementation, specific timeframe for its rollout, besides addressing almost a collapsing public health-infrastructure framework in most States, the Government appears rather unprepared with HCP rollout in 2018.

Does this announcement for HCP, therefore, not reflect a bit of haste, if not an intent to achieve any other non-related objective? Thus, this edict didn’t fetch a WOW moment to me, at least for this year, or…did it?

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.