Sunday, August 14, 2016

On Serious Healthcare, Some Bizarre Decisions

On Serious Healthcare Some Bizarre Decisions

On August 04, 2016, it was widely reported by the media that the Union Minister of Chemicals and Fertilizers – Mr. Anant Kumar, would launch a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, on August 29, 2016.
This is an app developed by the National Informatics Centre, for android smartphones ‘that will enable patients to check the prices of essential medicines on-the-go’. It will be an extension of NPPA’s “Pharma Jan Samadhan” web-portal facility. The Indian price regulator believes that wide use of this app would successfully reduce the instances of overcharging the consumers by the pharma companies and retail chemists, especially for lifesaving, and other expensive medicines. 
India’s drug pricing watchdog is planning to introduce this app to enable the patients check the prices of essential medicines on-the-go, and expects that this measure will hold drug companies and medicine retail outlets more accountable to patients.
In the test version of the app, which has since been released for stakeholder feedback, patients can search for the ceiling price of all medicines under the National List of Essential Medicines (NLEM), on the basis of its generic name and the state they’re buying it from.
The Chairman of NPPA, reportedly, further said, “Consumers can use the app before paying for a medicine to ensure that they get the right price. At present, whatever action we take against the companies, including recoveries, the consumer does not get back the overcharged amount he or she has paid.”
Good intent with a basic flaw:
The intent of the Government in this regard is indeed laudable. However, the initiative seems to underscore the blissful ignorance of the prevailing ground realities in India.
The media report highlights that with this app, the patients can search for the ceiling price of all medicines featuring in the NLEM on the basis of their generic names.
Whereas, the ground reality to make any meaningful use of this app is quite different. This is primarily because, in the Indian Pharmaceutical Market (IPM), over 90 percent of drugs are branded generics. An overwhelming majority of the doctors, as well, follow this trend while writing prescriptions for their patients, in general. For any single ingredients or Fixed Dose Combination (FDC) formulation, there are as many as even 30 to 40 brands, if not more. 
In that case, when the prescriptions given to patients are mostly for branded generic drugs, how would that person possibly get to know their generic names, to be able to check their ceiling prices with the help of the new “Search Medicine Price” app?
Not just a solitary example: 
This is just not a solitary instance of ignorance of the Government decision makers on the realities prevailing in the country.
With an admirable intent of making drugs more affordable for increased access, especially, to all those patients incurring out-of-pocket health expenditure, the Government has been taking several such measures, and is also trying to create a hype around these. Unfortunately, most of these efforts, miss the core objective of increasing access to drugs at the right price, by miles. 
Another recent example: 
This particular example, in my view, is even more bizarre.
It happened on February 29, 2016, the day when the Union Budget proposal for the financial year 2016-17 was presented before the Parliament of India.
In this budget proposal, the Union Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’3,000 Stores under PMJAY will be opened during 2016-17.
Many consider this scheme as a repackaged old health care initiative, only adding the new words ‘Pradhan Mantri’ to it.
Just to recapitulate, Jan-Aushadhi is an ongoing campaign launched by the Department of Pharmaceuticals in 2008, in association with Central Pharma Public Sector Undertakings (PSU), to provide quality medicines at affordable prices to the masses.
Under this scheme, Jan Aushadhi Stores (JAS) are being set up to provide generic drugs, which are available at lesser prices, but are equivalent in quality and efficacy as expensive branded drugs.
The Department of Pharmaceuticals had initially proposed to open at least one JAS in each of the 630 districts of the country, so that the benefit of “quality medicines at affordable prices” is available to at least one place in each district of India.
If the initiative becomes successful, based on its inherent merit and the cooperation of all stakeholders, the scheme was to be extended to sub divisional levels as well as major towns and village centers by 2012. However, after 5 years, i.e. up to February, 2013, only 147 JAS were opened, and out of those only 84 JASs are functional. 
More recently, according to a June 02, 2015 report, “under the new business plan approved in August 2013, a target of opening 3,000 Jan Aushadhi stores during the 12th plan period i.e. from 2013-14 to 2016-17 was fixed. As per the Standing Committee on Chemicals and Fertilizers report in March 2015, till date only 170 JAS have been opened, of which only 99 are functional.”
Tardy progress:
The tardy progress of the scheme was largely attributed to:
  • A lackluster approach of State governments
  • Poor adherence to prescription of generic drugs by doctors,
  • Managerial/ implementation failures of CPSU/ BPPI.
  • Only 85 medicines spread across 11 therapeutic categories were supplied to the stores and the mean availability of these drugs was found to be 33.45 percent, with wide variations across therapeutic categories. 
There is no doubt, however, the intent of ‘Pradhan Mantri Jan-Aushadhi Scheme’ of 2016 is as laudable as the earlier “Jan-Aushadhi Scheme”, launched by the Department of Pharmaceuticals in 2008, was at that time. But, the moot question that comes at the top of mind:  Is it robust enough to work effectively in the present situation? 
Why it may not fetch the desired outcome?
Besides strong support from the State Governments, and other factors as enlisted above, making......
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Sunday, August 7, 2016

NCDs: Any Wolf Around, in Sheep’s Clothing? 

NCDs: Any Wolf Around, in Sheep’s Clothing? 

Noncommunicable Diseases (NCDs), such as, cancer, cardiovascular disease, diabetes and chronic respiratory disease, are now the leading cause of death in the world, accounting for 63 percent of annual deaths. Over 80 percent of NCDs occur in lower or middle income countries.
Moreover, wide prevalence of NCDs and inadequate patients’ access to related drugs have a profound negative impact on the economic progress of any country. According to various reports, the increase of around just one year of a country’s average life expectancy, could increase its GDP growth by around four percent.
Since long, the global drug industry has been contributing immensely to discover and bring to the market various amazing medicines to effectively treat a spectrum of NCDs. It is still happening, but with a stark different impact on the majority of the patients, across the world. 
There are many important aspects to NCDs, such as, public and private initiatives in their prevention, continuous screening, proper diagnosis, providing most effective treatment, and population’s lifestyle management for more effective disease control. However, in this article, I shall focus only on modern drug pricing, as one of the key barriers for patients’ access to modern drugs for the treatment of these ailments.
Saying something, and doing something else:
In this context, some large pharma lobby groups pontificate that the drug industry recognizes the economic and social impact of NCDs. Many of them also try to widely publicize, that they are working with various stakeholders, such as, the Governments, other payers and patients’ groups, as an active solution partner in lessening this burden. 
Yes, some of them do actively support some programs, mostly to prevent, screen and diagnose these chronic ailments. There are also instances when they try to showcase some of their occasional and complicated, so called ‘patient access’ programs.
Interestingly, a global major even wanted to reap a rich harvest by highlighting one such initiatives to win a patent litigation in the Supreme Court of India. As many would know, the Apex Court of the country did not take cognizance of its real value to patients, as projected by the concerned company, while dictating its final judgement on the Glivec case.
To many independent experts, these could most probably be part of a grand façade to justify the high drug prices, which most of the patients can’t afford, and also is an attempt to manage their fast eroding overall public image. On the other hand, they ‘religiously’ continue to keep increasing the drug prices arbitrarily, including those of NCDs. I shall dwell on it below.
Impeding patient access to modern drugs:
Despite all these developments, the issue of general affordability of most effective available drugs, even by the payers, such as, many Governments and the health insurance companies, are seriously impeding the patient access to these medicines.
Such exorbitant treatment costs with modern and more effective drugs is creating almost an impregnable barrier for access to these medicines, mostly for those patients incurring Out-of-Pocket (OoP) expenditure on health care. In a situation like this, where the volume sales do not increase significantly, to maintain the business growth the manufacturers of these drugs further hike up their product prices to a jaw dropping level, as perceived by both the patients and the payers.
This overall pricing environment is now posing a major challenge to many even in many developed countries of the world, including the United States.
Even the sky is not the limit:
Today, for a drug price increase not even the sky is the limit. Recently, the Census Bureau, Commerce Department of the United States (US) announced May 2016 sales of merchant wholesalers of various industries in the country. According to this report, the total pharma sales by manufacturers to pharmacies, hospitals, and others in the distribution chain reflected a buoyant increase of a hefty 11.3 percent from a year ago, especially when most other sectors showed sluggishness in growth.
The obvious question, therefore, that comes up, are the Americans now consuming more pharmaceutical products than in the past? The answer, however, is negative, though not very surprising to many.
In that case, is this increase in growth coming primarily from price increases of drugs, which are mostly used for the treatment of chronic ailments? The answer now will be an affirmative one. 
How much price increase is enough?
This question becomes quite relevant, when a large section of even Americans starts raising their voices against high drug price, as it is adversely impacting their access to those drugs............
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