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Economic Impact Of Technology Interventions Streptokinase Economics Essay

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About 14 million patients in India suffer from heart attacks every year. Of these, 2.8 million patients can benefit from a clot buster drug which would save the patient's life and provide room for further treatment such as medical stents if so required. Coronary heart disease claims over a million lives every year in India. There is a need for a safe and affordable clot buster drug. At the turn of the century, clot buster drug formulations were either imported or based on imported bulk drug and formulated domestically. They were expensive, equivalent to eighteen months (tPA) to two months (Streptokinase) of per capita income at that time. Cost matters more in India unlike in countries with universal health insurance as most Indians spend out of own pocket for health expenses. Given India's prowess in generic drugs, the production capacity gap in an area of health emergency with severe consequences seems an anomaly. The gap stems from the fact that clot buster drugs are biotechnology drugs which require competencies quite different from those of the usual drugs based on chemical synthesis.

CSIR-IMTECH, Chandigarh made efforts to develop a process to produce clot buster drugs. Initial efforts were unsuccessful, in part due to the complex nature of the animal sources based protein drug. Subsequent teams picked up the challenge again, chose a simpler molecule and after some misses, could develop a process for natural streptokinase and then recombinant streptokinase, both harnessed from micro-organisms. The misses were important steps providing crucial learning for the process development. Streptokinase technology was transferred to industry partners, natural Streptokinase to Cadila Pharma and recombinant Streptokinase to Shasun Pharma. Implementing the technology on the shopfloor faced difficulties. In the case of recombinant streptokinase, regulatory approvals took time to obtain. The knowing-doing gap was bridged by closing the competency gap through sustained engagement between the CSIR-IMTECH scientists and the managers and technology staff of the licensees. Perseverance, team perseverance, allowing mistakes, dynamic learning from disciplined failure, give-and-take by both the scientists' team and the industrial practitioners' team, and a "can-do, must-do, done" mind-set were the keys to success. Leadership steering at both the Lab and the Industry with a commitment to collaborate and continual collaborating was crucial. This led the transition from the lab scale to industrial scale. The respective products were launched in 2001 and 2009.

The results are quite encouraging. Prices have dropped (by 65 percent, to less than one month of per capita income), availability has increased, access to a life-saving medicine has risen, and patients have realized a worth of over Rs. 16,000 crores due to the CSIR-IMTECH/licensees Streptokinase. The economic impact, or the additional benefit that would be lost if this CSIR-IMTECH Streptokinase technology intervention had not been there, is assessed based on medical impact of Streptokinase and using per capita income to be Rs. 2180 crores. The Lab itself accomplished net earnings valued at Rs.1.8 crores and the Industry partners together realized value addition of Rs. 17 crores.

Innovating for affordable healthcare is inclusive innovation. The benefits to patients eclipse the benefits to those who generated the technology intervention. This pursuit of innovation continues. CSIR-IMTECH has taken the science of clot-buster drugs to a level where improved Streptokinase (smarter streptokinase) molecules will have the advantages of the far more expensive animal cell line based tPA but will be much more affordable. Similarly, while access has expanded (about 120,000 standard doses), there remain millions of patients in need of this life-saving drug. More needs to be done.

Introduction

Heart attacks, strokes, respiratory and cardiac failure have a common enemy in blood clots in the bloodstream that can block blood supply to the heart muscle, any part of the brain or the lungs. The consequence of blockage is damage to the heart muscle, the brain cells, or the lung tissue which is usually irreversible and debilitating, if not fatal. Extreme consequences can arise if the treatment is not administered within a window of few hours (3-4.5 hours, Klabunde (2007), Hacke et. al. (2008)). Then, the heart or brain tissue, as the case may be, gets damaged which is mostly irreversible. Treatments range from clot-dissolving medication to surgical intervention such as angioplasty or insertion of stents and open chest bypass surgery. Clot busters, as clot dissolving drugs are called, attack the clot itself to dissolve it and restore blood supply. Angioplasty is an invasive and expensive procedure where blocked arteries are opened up using medical stents thus making more space for the blood supply to be restored. Similarly, bypass surgery is invasive and very expensive (see appendix 1). Prevention in high-risk patients (hardened and narrowed/blocked arteries) is via blood thinner drugs that reduce blood density allowing blood to flow through the reduced space. Despite preventive treatment, clots can form and occlusion in blood vessels can occur. Then, clot buster drugs are life saviours.

In India, more than a million patients die due to coronary heart disease every year (appendix 1). Until the year 2001, no domestic production of clot-busters existed. The formulations were imported: among others, the lead formulations of Streptokinase - "Kabinase" by Kabi Pharmacia, Sweden and "Streptase" by Hoechst Marion Roussel, Germany - were priced then between Rs. 3000 to Rs. 4000 per vial (Krishnan (2000)). The dominant drug in this class of drugs, Tissue Plasminogen Asctivator (tPA) cost more than Rs. 30,000 per vial. Thus, clot buster drugs were expensive and the supply was short of requirement. In terms of per capita income at that time, this amounted to eighteen months of income for tPA and about two months of income for Streptokinase. The Streptokinase market was about 21 thousand vials of standard dose of 1.5 miu [1] . Lack of affordability could have restricted access. Given Indian pharmaceutical industry's prowess in generic drugs, realized through strengths in organic chemicals' synthesis and process engineering, this raises the question about the obstacles. The Indian pharmaceutical industry was essentially based on chemical entities whereas clot buster drugs are based on biotechnology [2] which was almost non-existent in India around the turn of the century. Thus, access to affordable life-saving clot buster drugs was limited domestically. To make it affordable, it had to be produced domestically. To produce it domestically, a suitable technology had to be developed. The technology had then to be transitioned from a laboratory scale to an industrial scale.

As in the case of affordable chemical drugs, the impetus of finding solutions and creating domestic capacity also came from CSIR Labs. In the case of generic chemical drugs, the core scientists came from Labs such as the NCL, Pune, IICT, Hyderabad and CDRI, Lucknow. These scientists and their industry contemporaries developed and implemented safe and cost effective technologies in a short time span. In the case of biotechnology, processes are being developed by IMTECH, Chandigarh and IICB, Kolkata among others. A program at IMTECH tapped into finding a solution to the problem of an affordable clot buster drug. The program has roots in projects dating back to 1989. The scientists examined the prevalent clot buster drug - tissue Plasminogen Activator (tPA) - but then chose instead an alternate less complex protein Streptokinase for development.

This study examines the benefits realized from the Streptokinase project, specifically, the natural Streptokinase biotechnology drug licensed to Cadila Pharma and the recombinant Streptokinase drug technology licensed to Shasun Pharma Limited, to quantify the value creation and to assess the economic impact.

The Industry

The Indian pharmaceutical industry is among the top science based industries and focused on quality affordable drugs. It is estimated to be USD 21 billion or about Rs. 105,000 crores with exports accounting for about 40 percent (USD 8.7 billion) in 2009-10 (DOP (2011, 2012)). The industry is growing at over 10 percent per year. It is the sixth largest industry in India ranked by contribution to GDP (CSO (2011)). Globally, it ranks 3rd in terms of volume of production (10 percent of global share) and 14th largest in terms of value (1.5 percent of global share). A reason for the low value share is the lower cost of drugs in India -- 5 to 50 percent less than in developed countries. Thus, the Indian drugs and pharmaceutical industry is focused on affordable drugs.

The Indian pharmaceutical industry is diverse. The number of units is quoted at over 20,000. However, the actual number of drug manufacturing licenses issued is about 5877 (GOI (2003)) [3] . Registered factories are about 3500 (CSO (2011)), the rest being smaller unregistered units. The units are spread across India and provide depth that accounts for the 10 percent global volume share. Apart from MNCs such as Glaxo Smithkline, Pfizer, Astra Zeneca, several Indian companies Ranbaxy, Dr. Reddy's, Cipla, Lupin and others have global operations. Biotechnology based drugs have taken root and are growing. Companies such as Biocon, Serum Institute of India, Panacea Biotec, and Reliance Life Sciences have adopted biotechnology. The biotechnology industry value exceeds Rs. 20,000 crores in 2011-12 (BioSpectrum-ABLE Biotech Survey 2012).

Many Indian companies maintain the highest standards in purity, stability and international safety, health and environmental protection in production and supply of bulk drugs to buyer companies, who in turn are subject to stringent assessment by regulatory authorities in importing countries. These companies have secured regulatory approvals from USFDA, MHRA-UK, TGA-Australia, MCC-South Africa for their plants. Quality with certification is also a feature among many Indian pharmaceutical companies.

During the last decade, the industry has embraced new technologies and adapted to regulatory regimes more aligned to international regulatory regimes. New business models have emerged to cope with and thrive in this environment. All of these have a bearing on the development of a domestic clot buster drug, namely, Streptokinase.

With the advent of product patents in India from the 2005 amendment to the Patents Act, the focus has shifted from process engineering to drug discovery. Process engineering remains important. Several drugs will go off patent over the next few years and supply of cost effective quality generics would benefit the industry and the consumers. However, drug discovery is the new mantra. Drug discovery is a highly uncertain multi-million multi-year activity. For every one new drug molecule approved, the pipeline requires about twelve molecules for clinical trials' candidacy. For every molecule reaching clinical candidacy, the pipeline of molecules is three molecules based on current success rates at each stage. The total costs spiral to over USD 600 [4] million per new drug molecule in the USA over a span of a decade. Patent protection allows recovery of the investment but also makes the drug expensive. In India, the cost per new drug molecule can drop to less than USD 150 million due to lower costs (such as those of clinical trials). This lower cost is encouraging Indian drug enterprises to engage in drug discovery as they adapt to the product regime. However, even at the reduced cost in India, the drug would still be expensive and out of reach of many Indians.

Drugs' capacity building in India appears to be addressing reduction in costs and so also in the time span for drug discovery. Specialization along the chain of drug discovery via outsourcing is one emerging business model. Thus, R&D is being shaped by Contract Research Organizations (CROs), Drug Discovery & Development (DD&D) and Clinical Trials Organizations (CTO). Manufacturing is by large integrated companies as also by Contract Manufacturers. Marketing is also by Contract Marketers and co-marketing alliances (IBEF (2010), KPMG (2006)).

While regulatory changes may be the trigger for drug discovery, demand for drugs for Indian diseases is also an impetus. Chief among these are drugs for infective diseases found in India but not much in developed countries such as tuberculosis, malaria, typhoid, cholera etc. These diseases are far more prevalent in developing countries such as India where affordability is a key issue. Profits from patented multi-billion drug molecules will be tough to realize for these diseases. Thus, effective new molecules for these diseases would have to be developed within India. A major initiative underway in this regard is the Open Source Drug Discovery (OSDD) project of CSIR which seeks to harness talent across boundaries, cutting costs and hopes to reduce drug discovery time. It is open source and thus drug molecules found will be distributed without the higher price due to profits associated with patents. Costs will be cut down to the collaborative nature of the initiative. Incentives to collaborators are based on contributing to drug discovery for debilitating diseases and the recognition among peers.

Also important are drugs for the so called "lifestyle diseases" such as diabetes (about 50 million diabetics in India as per Ramachandran et. al. (2010)) and hypertension (65 million hypertension patients in India as per Gupta (2004)), both high risk factors for emergencies such as heart attacks, strokes and respiratory failure. India is estimated to have about 14 million patients that suffer from myocardial infarction or heart attacks every year, of which 80 percent patients may not be receiving proper medical care (Financial Express (2002)). About 20 percent (2.8 million) of the cardiac patients' population in India could use a clot buster drug. Only a fraction (about 200, 000 or under 10 percent) of these patients undergo bypass surgeries or angioplasty. The rest of the patients (2.6 million) could be treated with clot buster drugs administered within a window of 3-4.5 hours to the patient. Recall that there are over a million deaths every year due to coronary heart disease in India. With a growing number of diabetes and hypertension patients in India, and so increasing chances of blood vessel occlusion related deaths, having access to an affordable clot buster drug is going to be increasingly more important. An added advantage is the possibility of exports of these drugs since the diseases addressed are prevalent globally.

The Technology Gap, Development and Commercialization

A domestic clot buster drug was missing, as discussed earlier. The choice among three prevalent drugs narrowed to Streptokinase. Streptokinase is a 47kD [5] protein composed of 414 amino acids produced by several strains of beta hemolytic streptococci. It dissolves a clot occluding blood supply through a 3-step process. First, Streptokinase forms a complex with plasminogen (Pg). This 1:1 complex (the "Partner Pg") rapidly becomes proteolytically active. Second, the Partner Pg complex acts on "substrate" Pg molecules in circulation to convert them to plasmin (Pn), the active form of the pro-enzyme Pg. Plasmin is a protease that is capable of breaking apart cross-links between fibrin molecules, which provide the structural integrity of blood clots. So, third, the plasmin rapidly dissolves the pathological clot occluding blood supply to the heart muscle in case of myocardial infarction, to brain tissue in case of stroke or to the lungs in case of respiratory failure.

The Lab, Research Capacity and Technology Development

Technology development has been enabled by science research and ongoing (and predecessor) projects at CSIR-IMTECH. The focus is science and technology related to microbial products. A key area is recombinant gene technology based products. One initiative relates to developing a domestic clot buster drug. The initial attempt in late 1980s focused on the prevalent drug - tissue Plasminogen Activator (tPA) which is naturally found in the human body in small quantities. Through recombinant gene technology, a pioneer of the field, Professor Collen and his organization Genentech USA produced tPA from animal cell lines in the early 1980s. Attempts to replicate tPA production in IMTECH did not fructify partly due to the volatile external environment prevalent at that time and so the lack of enough scientists to execute the task.

During the early 1990s, subsequently, another team of scientists at IMTECH chose an alternative to tPA, namely, Streptokinase for development - due to its simpler structure and higher probability of success in developing a novel process for domestic production. The process involved two key competencies - protein science and cloning science among others. Technical problems arose again in implementing the recombinant gene technology. The scientists decided to down-shift to developing a process for producing Streptokinase from natural sources. It involves two main processes - fermentation (protein production) and purification (separating the protein from the broth, purified to an extent that it is admissible to humans). This effort was successful lending both credibility to the process and boosting the morale of the scientists concerned. The first success helped to delineate the tasks possible from the tasks not possible (appendix 2). This paved the way for producing Streptokinase using recombinant gene technology increasing yield many times over. The key process innovation was the use of 2-step chromatography for purification.

Leadership

Throughout the years of development spanning 1989 onward, the scientists at CSIR-IMTECH were supported by the science leadership and management comprising four different institute directors and two different director-generals [6] . Leadership and institutional continuity combined with scientific ingenuity and perseverance to produce first natural and then recombinant streptokinase. The agenda continues and smart Streptokinase is under development which could be a life-saving and life-enhancing product not only for India and the developing nations but also for the developed countries.

The Technology Transfer, Technology Embedding and Commercialization

The lab scale success has to be transitioned to industrial scale and commercial success. Subsequent to the transfer of know-how on fermentation and purification processes and the strain, implementation at an industrial scale also faced many hurdles. While the science was established at the Lab with lab scale production, the transition to industrial scale volumes threw up challenges (see appendix 2). As at the Lab level, informed hit and trial, learning from failure, delineating what not to do from what to do helped to transition the technology to industrial scale. Standardization of the industrial biotechnology process entailed initial training, repeated training and embedding the technology in the licensee's premises. IMTECH engaged with the licensees and remained engaged thereby providing a lot of handholding in the journey from the lab to factory production. This case is an example of disciplined failure where learning from initial failure led to a course change, technological success, commercial success, and then again picking up the more difficult task and taking it to fruition.

CSIR-IMTECH first developed a technology to produce natural Streptokinase from Streptococci. It was developed in 4 years by 1998-99, licensed and transferred in 1999-2000 and launched commercially in 2001-2002. The recombinant Streptokinase was developed in 5 years by the year 2001-2002, licensed and transferred in 2002-2003 and commercially launched in 2009-10.

Natural Streptokinase know-how was licensed to Cadila Limited for fees of Rs. 20 lakhs and royalty based on ex-factory sales for 5 years. This drug was launched as STPASE injection in year 2001-02. Subsequently, recombinant gene technology was licensed by CSIR-IMTECH to Shasun Pharmaceuticals Limited, Chennai for a fee of Rs. 1 crore and royalty payments based on ex-factory sales for 5 years. The drug was launched in July 2009 and marketed by Lupin Pharma as LUPIFLO.

Comparison with prevalent alternate treatments

Prior to adoption of Streptokinase for clot-blockade led heart attacks, the treatments were generalized and included oxygenation and intensive care (appendix 1). Subsequent to studies of randomized controlled trials establishing efficacy and superiority of Streptokinase, it was adopted widely specially in Europe. Later, other clot busting drugs were developed. Still later, open heart bypass surgery and then angioplasty using medical stents were developed. Clot buster drugs are more affordable than surgical treatments. Within the class of clot buster drugs, Streptokinase remains the most affordable. Its costs are lower since its production is micro-organism based unlike the others derived from animal cell lines.

Comparison with prevalent competing technologies - clot-busters

Clot-buster drugs in use are tissue plasminogen activator (tPA), Streptokinase, and Urokinase. Streptokinase competes with tissue plasminogen activator (tPA) which is the prevalent clot buster drug. tPA is preferred for its target (blood clot causing blockade) specificity. The advantage of tPA over Streptokinase is in the extent of systemic fibrinogenolysis generated by each. The resultant side effect of bleeding (due to suppression of clot formation by plasmin) can be higher for Streptokinase. However, studies have established that streptokinase is as effective in saving lives in mycocardial infarction as is tPA, despite the nearly ten-fold higher price of the latter. tPA is expensive enough to be inaccessible to most patients for this life threatening condition. Recombinant tPA reduced prices but the cost remains many times over that of Streptokinase. Cost of treatment is of utmost importance as most Indians health expenditure is out of own pocket. Appendix 1 clearly indicates that while the treatments for myocardial infarction vary from Streptokinase to tPA to angioplasty and bypass surgery, for a vast majority of Indians (with annual income about and below the current per capita annual income of Rs. 60,000), the treatment affordable and so possible is administering of Streptokinase. The alternative to Streptokinase would be a mix of morphine, oxygenation, intensive-care.

Comparison with prevalent manufacturers

Producers of natural Streptokinase, for several years, were only MNCs such as Behring-werke (Germany) and Lederle (USA). In India, before CSIR-IMTECH's intervention, Streptokinase was imported, Streptokinase injections were sold by MNCs - "Kabinase" by Kabi Pharmacia, Sweden and "Streptase" by Hoechst Marion Roussel, Germany - and priced then between Rs. 3000 to Rs. 4000 per vial in year 2000 (Krishnan(2000)). tPA prices varied from Rs. 30,000 per vial in year 2000-01 to about Rs. 19,000 per vial in 2010-11.

In India, CSIR-IMTECH licensee Cadila Pharmaceuticals Ltd. manufactured Streptokinase as "STPASE" at an ex-factory price of Rs. 900 per vial (standard 1.5 miu dose) in 2001-02. The recombinant Streptokinase which has the same biological properties of natural Streptokinase (but much higher yields) was produced by CSIR-IMTECH licensee Shasun Chemicals and Drugs Limited, Chennai at an ex-factory price of Rs. 465 per vial in year 2009-10. This is the bulk drug price. It is marketed as "LUPIFLO" by Lupin Pharmaceuticals Limited and as "STUKINASE" by Samarth Pharma among other formulators.

Non-CSIR licensee entry also occurred after the first CSIR licensee entered. There were three entrants, two of whom have already exited. The third entrant, Biocon, is successfully producing recombinant Streptokinase and marketing it as "Myokinase."

Data and Methodology

Lab data are obtained from CSIR-IMTECH. Industry data are obtained through questionnaires and interviews. Market data such as sales value and quantity numbers for Streptokinase formulations/brands along with data on company characteristics such as "MNC/Indian," date of launch, size of formulation - are from the IMS Health India database on Streptokinase. The data are collected at the stockist level and are representative of the Indian pharmaceuticals market with the exception of sales directly from producers/formulators to the hospitals.

Given the retrospective nature of this economic impact study, and the difficulties in collecting past data, the initial methodology proposed was a contemporaneous difference analysis between CSIR licensees and comparable enterprises. However, Streptokinase producer data could not be collected despite mailed questionnaires followed up with interviews [7] . Instead, for the industry analysis, market sales and volume data - for a panel of 20 years - are used to estimate a demand function with pooled OLS regressions. The pooled regressions permit segregation of estimates for CSIR licensees from others, and, of estimates over time [8] .

Benefits of the Technology Intervention - Creating Value

Benefits to the Lab

CSIR-IMTECH developed a technology and plugged a production capacity gap for a life-saving drug. The first of the series of streptokinase molecules established the credibility of CSIR as a solutions provider based on their science rooted program for technology. IMTECH scientists successfully integrated science and application producing more improved molecules and earned fees and royalty in the process. The total value of fees and royalty received is about Rs. 2.5 crores and the investment in terms of salaries and cost of patents is about Rs. 65 lakhs in 2011-12 prices. The internal rate of return on the Lab's cash flows for Streptokinase works out to 36 percent [9] . Thus, the technology program is quite cost effective for CSIR.

Benefits to CSIR Licensees and the Industry

The direct benefit to the licensees in terms of value addition thus far (from 2001-02 to 2011-12) is about Rs. 17 crores in 2011-12 prices, the bulk of it, Rs. 16.5 crores, arising from the first licensee - Cadila Pharma Limited. The second CSIR licensee - Shasun Limited - has limited value added from its two years of Streptokinase operations. The first molecule served as a proof-of-concept for the industry and even more as a proof-of-value creation. It was followed by another successful molecule variant and commercial success with that also.

From no producer of Streptokinase in year 2000, there are now at least three producers domestically. The third producer Biocon, a non-CSIR licensee, is among three entrants, the other two having exited already. In 2001, before entry of the first domestic producer, CSIR-IMTECH licensee Cadila Pharma, there were about four Streptokinase brands and sales value was about Rs. 6 crores with about 20 thousand vials of standard dose. The value of the Streptokinase industry is over Rs. 20 [10] crores in 2011 with about 118 thousand vials in terms of the standard dose of 1.5 miu and about thirty brands (including different vial sizes) marketed. While many factors are responsible for this value increase, demonstration of the proof- of-concept (technology works) and the proof-of-value (commercial success) by CSIR-IMTECH scientists and licensees may have been crucial. Without these, the country may still have been importing the drug at much higher prices. To that extent, the country is also saving foreign exchange.

The current market price of STPASE is reported to be about Rs. 1000 per vial and the prices of Streptokinase vials from Shasun's bulk drug vary from Rs.715 to Rs. 2300. Myokinase, the third non-CSIR entrant Biocon's product, is reportedly selling at a price of about Rs. 2000 per vial. The average market price is about Rs. 1700 per vial (standard 1.5 miu dose). Prices of streptokinase by CSIR-IMTECH licensees are among the lowest in the industry, where over 30 versions of formulations are now being marketed domestically.

Industry Competition

With increasing market competition, prices drop and sales increase. Competition can be enhanced more by entry of producers. A pioneering paper (Bresnahan and Reiss 1991) developed an empirical framework for measuring the effects of entry in concentrated markets by studying the relationship between the number of firms in the market, market size, and competition. Their analysis suggests that "competitive conduct changes quickly as the number of incumbents increases. In markets with five or fewer incumbents, almost all variation in competitive conduct occurs with the entry of the second or third firm. Surprisingly, once the market has between three and five firms, the next entrant has little effect on competitive conduct."

In the absence of data on price-cost margins, they develop another key metric - the ratio of break-even sales Sn+1/Sn where "n" refers to the last incumbent producer and "n+1" refers to the entrant. This threshold is equal to one in perfectly competitive markets where the minimum efficient scale of production is quite low relative to the market size and there are no entry barriers. In concentrated markets, the threshold of break-even sales ratio is higher than one due to substantial fixed costs as well as entry barriers. A new entrant could incur higher fixed capital cost and/or higher variable costs (such as marketing costs to establish their product and realize sales). With increasing entry, this threshold - break-even sales ratio - should decline and approach the value of one as in perfect competition.

While we do not observe price-cost margins for all three domestic producers of Streptokinase - Cadila (entry in year 2001), Biocon (entry in 2008) and Shasun (entry in 2009) - we do have information on sales [11] and company provided break-even years. Using the Bresnahan and Reiss (1991) framework, the calculation of break-even sales (quantity of vials) ratio is found to be 2.8 for the second entrant (Biocon, relative to first producer Cadila Pharma) and 1.6 for the third entrant (Shasun Pharma, relative to Biocon) [12] . This quick examination points to a decreasing value of the break-even sales ratio and fast increasing competition with just three entrants, much in line with the findings of the Bresnahan and Reiss paper.

Benefits to the People and the Economy

Price Reduction, Affordability and Access

From Rs. 3000 in 2000-01 per vial of Streptokinase, the price dropped to Rs. 900 per vial after the entry of Cadila's STPASE. After the entry of Shasun's recombinant gene technology based Streptokinase, the price dropped further. In real terms (values inflation adjusted using WPI for drugs and medicines, base-year 2004-05), prices have reduced by more than 65 percent. Streptokinase based treatment has become increasingly affordable. Among prevalent treatments of heart attacks due to blockade from blood clots, currently, affordability ranges from one month of average income [13] for Streptokinase (Rs. 5000) to eight months of average income for tPA (Rs. 40,000 onward) to ten months of average income for angioplasty (Rs.47,000 onward) to fourteen months of average income for bypass surgery (Rs. 70,000 onward). The increasing affordability of Streptokinase meant increasing accessibility to life-saving treatment in case of heart attacks due to blockade from blood clots. Supply has expanded in response to the rising demand and so access has been realized. This access has been enabled by affordability due to price reduction beginning with the first CSIR-IMTECH licensee, Cadila Pharma.. Thus, CSIR-IMTECH's streptokinase technology intervention has led to affordable access to life-saving treatment for heart attacks due to clot blockades. This is highlighted in the graphs below.

The graphs clearly indicate that there is a substantial price drop and corresponding increase in quantity. Using the IMS Health India database on Streptokinase and other clot buster drugs (that are used to treat heart attacks), regressions are performed to examine whether the graphical results are also statistically valid. The data are at stockist level, so the implicit prices computed are at stockist level and not at retail level. However, the variations in retail prices are likely to be at least as much as those at the stockist level.

Using pooled OLS [14] regressions (appendix 3: Streptokinase Market Data - Econometric Results), it is found (appendix 3, table A3.2) that there is a significant drop in price from year 2002 (captured through a dummy variable for observations from 2002 onward). There is a similar increase in average market price associated with a dummy variable from 2008 onward when there were two entrants - the third Streptokinase producer as well as a marketer of recombinant tPA in the Indian market. For the third year of entry - 2009 - when the second CSIR-IMTECH licensee began production, though there is an associated decrease in average market price, the coefficient is not significant. The significant coefficients do suggest that CSIR-IMTECH licensees' entry is associated with a decrease in the average market price for Streptokinase in India. Or, that the CSIR-IMTECH technology intervention is associated with increasing affordability.

Given the above decomposition of contributors to the decrease in average market price, it is pertinent to estimate a demand function and the price elasticity. As appendix table A3.3 clearly shows, in a regression of price on quantity, the price elasticity estimate (coefficient of lnqty or log quantity) is negative with absolute value less than one, indicating a relatively inelastic market. The income elasticity is positive and higher than one indicating that as income rises, a disproportionately higher share of the income is assigned to this product. An industry concentration variable is associated with an increase in price as expected.

Entry of CSIR-IMTECH licensees and associated formulators contributed to a decrease in the value of the price elasticity of demand, that is, an increase in the absolute value of the price elasticity. The entry year dummy variables for 2002, 2008 and 2009 are not significant and are dropped. However, the difference in behaviour of MNC pricing is seen here as well - before CSIR-IMTECH licensees' entry, the MNC quantity coefficient is positive or that it reduces the absolute value of the price elasticity. In other words, the pricing is associated with an even more price inelastic market.

So, what? If the price elasticity increases, what difference does it make? Economic theory and empirical evidence suggests that with a price elasticity of one or more, when producers decrease price, the response from consumers is to increase quantity demanded such that the overall revenues increase. This is a win-win scenario for both the consumers and the producers. Table A3.3 suggests that CSIR-IMTECH licensees/formulators entry helped to make the Streptokinase market in India more price elastic. Given that about 2.6 million patients could use a clot buster drug, about a million die of coronary heart disease, any increase in price elasticity is an incentive for producer entry. Even with the expanded production of almost 120,000 standard doses, there is a long way to go in closing this critical gap.

Computing Economic Loss Averted to surviving patients

To a patient, access to a life saving drug is invaluable, a monetary value to life may seem unthinkable. Nonetheless, values to life are computed.

To compute the economic loss averted, here, the disability adjusted life years (DALY, See Gold et. al. (2002) and Lopez and Mathers (2006)) for specific diseases for specific regions generated by the World Health Organization (WHO (2008)) are used. The DALYs provide the years of potential life lost (YLL) due to premature mortality and the years of productive life lost due to disability (YLD) for a specific disease. The DALY values differ by regions. The economic value of the lives saved by Streptokinase, directly through the licensees and indirectly through the other producers which followed the entry of CSIR licensees, is computed using the DALYs provided by the World Health Organization (WHO) for South-East Asia within which India falls.

There are three components of the computation of the economic value of lives saved. First, the number of lives saved is estimated. Based on the number of vials of streptokinase produced, the dosage of streptokinase, its success rate of saving lives (or inverse of mortality rate), the number of lives saved is obtained. For the CSIR licensees, the ex-factory sales are provided by them. Using the vial-size based sales provided in the market sales data from the IMS Health Database, these are converted to units of standard dosage of 1.5 million units or 1.5 miu of injectable Streptokinase administered for myocardial infarction (Journal Watch (1990)). To this volume of sales and the equivalent volume of Streptokinase administered (assuming no wastage), the success rate or survival rate of patients is applied. According to various studies on efficacy of streptokinase, the success rate is over 90%. However, the success rate may be lower in India - more than 81% (Xavier et. al. 2008) and about 80% as per the Delfi technique based survey results (appendix 1). Accordingly, here the survival rate for India is taken as 80%. This is applied to the volume of standard doses of Streptokinase administered to get the number of lives saved.

Second, using the ratio of (i) the DALYs and (ii) the deaths associated with ischaemic heart disease (WHO(2008)), the number of years of life lost due to ischaemic heart disease (clot blocking blood supply to the heart muscle) per patient death is computed. This is then also taken as the life years that would be saved per patient saved by Streptokinase. The life years saved per patient is 10.73 for ischaemic heart disease for the year 2004. It is assumed here that it is no worse for the subsequent years.

Third, a choice of the income aggregate saved per patient is chosen. In the absence of actual data about the income status of the patients, another income measure has to be chosen. Given informed opinion that patients hail from all income strata, median Indian income would be appropriate. However, in the absence of a median income estimate, the much more conservative measure of per capita income is used. This multiplied with the life years saved provides a lower bound on the economic loss averted by administering Streptokinase.

Economic Loss Averted

The value of economic loss averted due to lives saved by streptokinase produced by the CSIR licensees is over Rs. 16,000 crores in 2011-12 prices [15] . The number of vials of standard dose of 1.5 miu sold by Cadila by 2010-11 is about 350,000 and sold by Shasun by 2010-11 is about 160,000. As described in the previous section, the success rate of saving lives (80%) and the life-years saved per patient saved (10.73) are multiplied to the sales volume in terms of the standard dose to obtain total life-years saved.

The total value of economic loss averted due to lives saved by streptokinase produced domestically is over Rs. 19,000 crores. The difference owes to the sales by the third producer, Biocon, which entered the market in 2008 after CSIR_IMTECH licensee Cadila Pharma established the proof of value or the commercial viability of producing Streptokinase in India.

Total Value Creation

The value creation directly is Rs. 1.85 crores to the CSIR Lab, Rs. 17 crores to the CSIR licensees, and Rs. 16,000 crores to their surviving patients. Over and above this is the technology proof of concept and proof of commercial value effects led value of almost Rs. 3,000 crores or a total of nearly Rs. 20,000 crores to the people of India.

Economic Impact of CSIR-IMTECH Streptokinase Technology

Is the CSIR-IMTECH Streptokinase technology intervention with value creation of almost Rs. 20,000 crores worth it? The question is addressed in two parts.

Is the investment in the intervention worth it, i.e., do participants benefit from this programme? In terms of value creation, the outcomes from the Streptokinase technology development, transfer and commercialization are positive for each set of beneficiaries - the Lab, the industry and the Indian people. The benefits are clearly quite high. Further, the project IRR (inflation adjusted) of 29% compares favourably, say, with respect to GDP growth numbers of up to 9 percent.

Is the programme a worthwhile social investment? The CSIR-IMTECH intervention enabled and expanded access to a life-saving drug and so is clearly worthwhile. However, what would the outcomes be if this programme had not been there? Compared to the alternative (counterfactual) state, do the outcomes from this programme outweigh the outcomes from the alternative? In other words, is the difference in outcomes between this programme (Streptokinase technology development and commercialization) and the alternative state positive? Is the direct benefit positive? Are there favourable indirect benefits? Could the private sector have generated these direct (and indirect) benefits through alternatives without the CSIR-IMTECH intervention?

The Comparable Alternative to Streptokinase

To arrive at answers to these questions, the outcomes from Streptokinase commercialization and use have to be compared with the outcomes from the alternative that would exist if the CSIR-IMTECH Streptokinase intervention didn't happen.

Medically, the alternatives to Streptokinase were coronary bypass surgery (from 1960 onward), coronary angioplasty (from 1977 onward), and other thrombolytic drugs such as tPA (from 1987 onward). In practice, in India, all of these treatments have been available and over time, the hospitals offering these treatments have been increasing. However, the cost of treatment of the above treatments varies considerably. As noted earlier, currently, the cost of treatment ranges from one month of average income for Streptokinase (Rs. 5000) to eight months of average income for tPA (Rs. 40,000 onward) to ten months of average income for angioplasty (Rs.47,000 onward) to fourteen months of average income for bypass surgery (Rs. 70,000 onward).

Economically, the "market" for treatment of heart attacks arising from blockade due to heart attacks seems segmented by purchasing power or affordability! To test our assumption, we performed an exercise to get informed opinion of cardiologists. Mini Delphi Technique was used to approach some cardiologists in public and private hospitals across India. Results presented in Appendix 1 support our assumption that the alternative to Streptokinase based treatment would be the even cheaper (generalized) treatments prevalent prior to the introduction of Streptokinase, namely, use of Morphine, Oxygenation etc. If the patients could afford tPA or coronary surgery, they would in all likelihood take that treatment. Patients who take Streptokinase do so as the other treatments are out-of-reach economically.

Economic Impact: The Difference in value creation due to CSIR-IMTECH Streptokinase Technology Intervention

Several studies of randomized controlled trials (RCT) using Streptokinase and alternative treatments have been performed (for example ISIS and GUSTO studies). We use the medical impact from a relevant RCT study as the basis for the economic impact assessment. A study with long term survival rates is considered to be relevant since the value creation calculations use the long term survival as given by WHO's DALY for ischaemic heart disease for India. The cardiologists and researchers we consulted also validated the use of RCT studies on Streptokinase for the Indian population. In other words, the studies' results are considered to be valid for India.

The ISIS-2 study by Baigent et. al. (1998) studies long term survival among patients with acute myocardial infarction or heart attacks in a randomized comparison of Streptokinase, oral Aspirin, both, or neither. The study was conducted in 417 hospitals located across 16 countries and studying over 17,000 patients. We use the results for Streptokinase versus none that led the study to conclude that the early survival advantage produced by Streptokinase persists for many years after treatment.

According to the RCT study by Baigent et. al. (1998), the difference in survival rates in the long term is 28 per 1000 patients or a difference of 2.8 percent. This corresponds to a direct value difference of over Rs. 580 crores in 2011-12 prices due to over 14,000 additional lives saved by Streptokinase produced by CSIR-IMTECH licensees. Further, adding the value from induced entry of the third producer in India, the total impact is another Rs. 98 crores and additional 2,000 lives saved thus far.

This medical and economic impact will be realized every year. Based only on the latest year production [16] (and no further increase), the present value of the economic differential in the years to come is another Rs. 1600 [17] crores. Medically, this translates to an additional 2200 lives saved every year going forward. The direct economic impact is therefore a total of Rs. 2180 crores. Adding the impact arising from induced entry, the present value of future years would be Rs. 500 crores at current production levels with an additional 700 lives saved every year. The indirect impact is valued at Rs. 600 crores. Thus, the total economic impact is almost Rs. 2800 crores.

Thus, if there were no Streptokinase technology intervention by CSIR-IMTECH, over sixteen thousand lives and Rs. 680 crores would have been lost. An additional Rs.2100 crores will accrue in the years to come.

Science continued and Technology improved

As already noted (see section "Comparison with Competing Technologies"), Streptokinase induces rapid plasminogen activation in the blood stream. The plasmin thus produced could trigger unwanted proteolytic degradation of clotting factors, that is, systemic fibrinogenolysis, and so unwanted bleeding and other serious side effects in some patients. A clot buster drug with minimal side effects will have the ability to dissolve the pathological blood clot without plasminogen activation through the circulatory system. This highly coveted and premium property in any clot buster drug was developed in the third generation clot specific streptokinase by IMTECH scientists. The clot specific streptokinase circulates in an active state without significantly activating the blood plasminogen. When it encounters and binds to the pathological blood clot, it is activated and generates plasmin in the vicinity of the clot. The plasmin cleaves the fibrin clots without generalized proteolysis. This reduces the risk of unwanted bleeding greatly.

A further coveted property is the prevention of re-occlusion or blockade due to renewed clotting, a major problem limiting present day clot busters. The fourth generation streptokinase comprises thrombolytic molecules with target specificity and has the property of thrombin inactivation in situ (that is, at the site of vascular injury) to thwart re-occlusion. It also has an enhanced half-life so that lower doses can be given in a single shot bolus.

Both these third generation and fourth generation molecules of Streptokinase are licensed to Nostrum Pharmaceuticals Inc., USA for USD 150 million or about Rs. 750 crores on milestone linked payments. The clot specific streptokinase took 8 years to develop from 1997-2004 and was transferred in 2006-07. It is expected to be launched in 2013. The thrombotic clot specific streptokinase took 9 years to develop and was transferred in 2010-11.

Concluding Remarks

This study highlights the beneficial role played by CSIR-IMTECH Streptokinase technology intervention in enabling affordable access to a life-saving drug. The Lab's net earnings are Rs. 1.85 crores with the project IRR being 36 percent. The licensees are generating value every year with Rs. 17 crores realized. The patients have realized immense value of over Rs. 16,000 crores. Thus, based on (public and private) benefits realized on initial public investment, this can said to be a profitable and valuable public-private partnership (PPP) exercise. Including the indirect induced entry related benefits takes the total to almost Rs. 20,000 crores. As a social program also, the economic impact generated thus far is Rs. 680 crores with accrual of an additional Rs. 2100 crores.

Among the key issues highlighted, one pertains to managing the transition from the lab scale to industrial scale. This up-scaling was managed by sustaining engagement with the licensees by the key scientists and training and retraining the technical personnel on the shopfloor. Beyond development and transfer of technology, handholding by the Lab during commercialization was fruitful in closing the "knowing-doing gap."

While much progress has been achieved, there are still over 2.4 million patients (2.6 million patients less latest production of streptokinase) who could benefit from access to a safe and affordable clot buster drug. CSIR-IMTECH scientists are hard at work to improve Streptokinase as a drug, with properties equivalent to tPA. Efforts are also required to deepen the public-private partnership model here (Public Lab-Private Licensee) and perhaps experiment with other models as well.

Caveats

On the methodology, there is entry of new producers. There is also exit and re-entry, or variable participation, in the Streptokinase market. The exit and re-entry of producers does not appear to be random. Thus, the data seem apt for selection based econometric analysis. However, the non-participation years have no data available on the producers/formulators other than fixed characteristics such as MNC/Indian. Similarly, upward bias can be expected on the price elasticity estimates. Instrumentation using GMM techniques is difficult owing to the short length of the panel. Using an instrument variable from the supply side such as plant level TFP (Foster et. al. 2008) is also not feasible given lack of data on the producers. Efforts are required to collect appropriate data for economic impact assessment.

Acknowledgments

We would like to thank Dr. TS Balganesh, CSIR for crucial discussions on the methodology to assess impact on patients and on the economics of drug discovery and development. We also thank Dr. Sudeep Kumar, CSIR for invaluable support in identifying sources of information and obtaining the same. We thank the CSIR Licensees - Cadila Pharma and Shasun Pharma - for sharing data and information with us. We would like to thank Dr. Kiram Mazumdar, Dr. Sriram Akundi, Dr. Sandeep Kamath and Rajesh Venugopalan of Biocon for valuable inputs. . We also thank Anjan Das, Mallikarjun Javali and Mayank Tiwari of Technology Unit, CII, New Delhi for arranging interviews with several Streptokinase producers/formulators. We also thank Dr. Rajendra Soni, IMTECH, CSIR for providing technology related data and helping to obtain market data. We also acknowledge team-IPU, CSIR for providing data on patents. The authors also thank Team-DGTC (Gauri Deshpande, Zahoor Ahmad Wani, Nitin Gupta, Govind Kumar, Tarak Dey) CSIR for their untiring administrative and logistics support.

Author Contributions

Wrote the report: Manisha G. Singh; Appendix 1: Nisha Chandran; Appendix 2: Samir Brahmchari, Girish Sahni, Manisha Singh; Technology description and details: Girish Sahni; Project Conceptualization: Samir K. Brahmchari; Project Design: Manisha Singh; Project Management: Dipankar Basu, Zakir Thomas, Manisha Singh.

References

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Appendix 1: Streptokinase and other Clot-buster Drugs

Affordability and Drug Market Segmentation

ABSTRACT

Cardiovascular diseases have become the leading cause of deaths worldwide [18] . The knowledge about these diseases is abundant as are the spectrum of treatments available for it. The study below looks at the crucial factors involved in deciding which of the available life saving treatments for Ischemic Heart Diseases would be eventually administered. Based on the Lancet- 2008 CREATE study [19] , it was shown that 64.5% patients of the higher income group received Streptokinase while only 52.3% of the lower income group received Streptokinase. As of 2012 nearly 90% public hospitals administer Streptokinase. Costs of treatment with Streptokinase, tPA and with surgical treatments indicate market segmentation. The key driver seems to be affordability, leaving Streptokinase in its own segment.

Streptokinase

It is known that the earliest treatment for Myocardial Infarctions (MIs) included Morphine, Oxygenation and in the 1950s came Aspirin [20] . These however have not been seen as treatments rather as therapies. It was not until 1977 [21] , nearly 35 years after its discovery, that Streptokinase found recognition as an effective "cure" as a clot-buster. Various Streptococci species are known to secrete a protein called as Streptokinase, which is capable of binding to human plasminogen thereby allowing the conversion of Plasminogen to Plasmin [22] . This discovery has found potential use as a thrombolytic in cases of Myocardial Infarctions (MIs), pulmonary embolisms and strokes.Tissue Plasminogen Activator (t-PA) and Recombinant t-PA treatments were also discovered and used as clot busters in the treatment of Acute Ischemic Stroke. Figure1 shows a time evolution of thrombolytics used for MIs.

C:\Users\vikramjit.mandal\Pictures\Picture167.png

Fig 1 : Milestones in the evolution of MI treatments

OVERVIEW OF THROMBOLYTIC AGENTS [23] 

Thrombolytic Agent

Source

Mechanism of Action

Efficacy

(30 day mortality)

Side Effects

rt-PA

Produce through recombinant DNA technology

t-PA is responsible for the conversion of inactive plasminogen to active preotease plasmin

Mortality at three months was 17 percent in the t-PA group and 21 percent in the placebo group [24] 

Hemorrhage

Bleeding

Urokinase

Produced by the kidney

Direct acting plasminogen activator

Easy bruising

Bleeding

Seizures

Pancreatitis

Streptokinase

Group C β haemolytic streptococci

Performs fibrinolysis by converting plasminogen to plasmin

Vascular Mortality at 5 weeks was 9.2% in Streptokinase group and 12% for those treated with placebo [25] .

Cerebral Hemorrhage

Low blood pressure

Allergic Reactions

Anaphylaxis

THE NEED FOR AFFORDABLE HEALTHCARE

As of 2010, in India Coronary Heart Diseases has become the leading cause of death, followed by Lung diseases and Diarrhoeal disease, killing nearly 1.5 million people per year thereby accounting for nearly 14 percent of the causes for death [26] in the country.

Between 2005 and 2015, India is projected to cumulatively lose USD 236.6 billion because of heart disease, stroke, and diabetes, shaving 1% off the GDP. In 2000, in the age group of 35 to 64, India lost 9.2 million years of productive life (PYLLs).

CHD Mortality in India

In 2010, CHD was the leading cause of death in India, thereby accounting for :

• 13.88% of total number of deaths

• 7.43 per 1000 death rate

• 165.79 age-standardized deaths per 100,000

OBJECTIVE

Given the statistics the study aims to throw light on the market segmentation in the treatments available to patients of CVDs and how Streptokinase has become an affordable mode of treatment.

METHODOLOGY

A literature survey and a Mini-Delphi [

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