Posts Tagged outcomes research

Achieving Market Access in India – Are You Hitting the Mark? An Interview with Marksman Healthcare Solutions CEO Dr. Amit Dang

modern indiaIt’s well-accepted that the Indian pharmaceuticals market cannot be ignored.  India will be one of the top 10 sales markets by 2020, fueled by the rapid growth in its population and economy.  Commensurately, India is experiencing expansion within its middle-class population, who are increasingly able to afford western medicines. Like the rest of the world, the demographics of India’s population are ageing, and it is anticipated that demand for drugs within the cardiovascular, central nervous system, and other chronic diseases such as diabetes will escalate. The total market is expected to rise to a value of approximately US$50 billion by 2020 (Source: PwC).

According to McKinsey & Company’s report “India Pharma 2020: Propelling Access and Acceptance, Realising True Potential”, several characteristics make the India pharma market unique, including the domination of branded generics (70-80% of the retail market), strong position of local players in formulation development capabilities, low price points, and intense competition.  And while India may be ranked 10th globally in terms of sales, it is within the top 3 in terms of volume.

Dr. Amit Dang, M.D.

Dr. Amit Dang, M.D.

The India pharma marketplace is ripe with challenges and opportunities.  The legislative arena is complex, the competitive field is challenging and intense, and the value messaging to decision-makers and payers is multi-faceted.  We spoke with Dr. Amit Dang, MD, Founder and CEO of MarksMan Healthcare Solutions based in India to get insight into this unique market.  MarksMan Healthcare Solutions is an international knowledge-based Health Economics and Outcomes Research (HEOR) consulting firm focused on the value of real-world data to maximize the opportunities for pharma and medical device products during a decision making process.  Marksman HealthCare Solutions comprises a team of medical professionals, evidence analysts, experienced medical writers, economic modelers, HEOR consultants and project managers who provide cost-effective solutions to achieve optimal access for products in the India marketplace.

My interview with Dr. Dang is below.

[HealthEconomics.Com] Please describe the India healthcare system, including overall health expenditures, percent of GDP, universal vs private payer healthcare provision, out-of-pocket spending, and major public and private stakeholders.

[Dr. Dang] India has a dual system of health care: a public tax-based sector where the health care providers are salaried by the government, and a private free-of-service based sector where the money is paid out-of-pocket by individual households.

MarksMan Healthcare SolutionsThe public health system in India consists of state-owned health care facilities ranging from sub-centres and PHCs (public health centres) at the peripheral level to specialty hospitals at district and state levels to super-specialty referral hospitals such as AIIMS (All India Institutes of Medical Sciences), government-run medical college hospitals and specialty care hospitals. Some of these institutions are controlled by the central government, and some by the state governments. The public healthcare in India comes under the aegis of the Ministry of Health and Family Welfare, which doles out national health schemes from time-to-time. Preventive healthcare, maternal and child health services and nutritional services in India are largely provided by the public sector.

The private healthcare sector is structured similarly, but is more concentrated in larger cities and towns than in the periphery. Though the private healthcare sector is significantly more expensive, it is generally viewed to be more popular than the public healthcare sector. The reasons for this include poorer quality, excessive crowding, an unfortunate disregard to hygiene and lack of qualified staff in public hospitals. Because of the government’s failure to deliver quality care, there has been a rapid expansion in the private sector. It is estimated that the private sector accounts for 93% of all hospitals (which was only 8% in 1947), 64% of all beds, and 80%-85% of all doctors.

allopathyThe majority of the institutions providing healthcare in India practice allopathy (i.e., the “usual” practice of medicine, vs. the homeopathic practice), but the traditional systems of medicine (including Ayurveda, Homoeopathy, Unani, and Naturopathy) are also popular, especially in the periphery.

The total health expenditure (% of GDP) in India was 3.87 as of 2011, out of which public and private sector expenditure (% of GDP) was 1.20 and 2.67 respectively. The comparable rates for public health are 1.5% in Sri Lanka, 2.7% in China, and 3% in Thailand.

The public health expenditure consists of recurrent and capital spending from government (central and local) budgets, external borrowings and grants (including donations from international agencies and nongovernmental organizations), and social (or compulsory) health insurance funds. Private health expenditure includes direct household (out-of-pocket) spending, private insurance, charitable donations, and direct service payments by private corporations.

In 2010, out-of-pocket expenses account for 78% of the total healthcare expenditure. This is among the highest in the world, and are much higher than other countries (Thailand: 25%, China: 44%, and Sri Lanka: 55%). Many families are driven below poverty line every year by large medical expenses.

To summarize, most Indians seeking health care have two options: a public health system that is almost entirely free but of poor quality, and a largely unregulated private health system that provides quality healthcare service but is highly expensive, and often indulges in inappropriate or unnecessary diagnostic or treatment modalities.

[HealthEconomics.Com] How is the India reimbursement and pricing environment different or the same as the United States and Europe?

[Dr. Dang] In the US and Europe, most medicines payments are made by the state or health insurance institutions. In contrast, in India most pharmaceutical expenditure is out-of-pocket. This creates a different dynamic for policy enforcement. USA and Europe have clear-cut guidelines for reimbursement and pricing. However, such guidelines are lacking in the Indian set-up.

[HealthEconomics.Com] What are the major pharmaceutical regulations in India as it pertains to pharmaceutical pricing and reimbursement? Who are the major organizations or regulatory bodies that are involved in setting prices and determining reimbursement?

[Dr. Dang] As said before, there is no clear-cut guidelines pertaining to reimbursement and pricing in India. However, in this context, two autonomous authorities function independently of each other: the NPPA and the IRDA.

NPPA LOGOThe National Pharmaceutical Pricing Authority (NPPA) is the government organization which is responsible for setting and revising the prices and to enforce the availability of drugs and formulations in India. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels. The organization is also responsible for recovering amounts overcharged by manufacturers for the controlled drugs from the consumers.

The Insurance Regulatory and Development Authority (IRDA) is a state-controlled, autonomous apex statutory body which regulates and develops the insurance industry in India. The IRDA is responsible for regulating reimbursements pertaining to the health insurance sector.

The state-controlled insurance schemes such as Central Government Health Scheme (CGHS) and Employees State Insurance Corporation (ESIC) have independent reimbursement plans and do not fall under the purview of the IRDA.

[HealthEconomics.Com] What are the major hurdles or goals to reach when obtaining favorable pricing for one’s drug product?  Does this differ for certain drugs like orphan products?

[Dr. Dang] As such there is no concept of favorable drug pricing in India as the drug pricing is governed by the Drug (Prices Control) Order (DPCO). Recently, with the objective to improvise and endow with the basic health care and availability of basic medicines at an affordable price across the country, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, notified the Drug (Prices Control) Order 2013 (“DPCO 2013”) in May 2013, which may fluctuate the pricing of 348 essential medicines. The DPCO 2013 provides formula for the calculation of ceiling price of a scheduled formulation as follows:

  • Firstly, the Average Price to Retailer of the scheduled formulation i.e. P(s) would be calculated as below:

AVERAGE PRICE TO RETAILER, P(S) = (Sum of prices to retailer of all the brands and generic versions of the medicine having market share more than or equal to one percent of the total market turnover on the basis of moving annual turnover of that medicine) / (Total number of such brands and generic versions of the medicine having market share more than or equal to one percent of total market turnover on the basis of moving annual turnover for that medicine.)

  • Thereafter, the ceiling price of the scheduled formulation i.e. P(c) would be calculated as below:

P(c) = P(s). (1+M/100), where P(s) = Average Price to Retailer for the same strength and dosage of the medicine as calculated in step 1 above. M = % Margin to retailer and its value =16

Currently, drug developers in India are receiving no formal incentives from the Government and hence are more focused on developing affordable drugs for more common diseases such as oral insulin, statins for preventing or slowing the progression of cardiovascular disease, vaccines and antibiotics for a number of preventable infectious diseases, etc. Hence, patients with rare diseases in India have to rely on imported drugs from western countries which makes these treatments (even when available) unaffordable. Some Indian Organizations like Organization for Rare Diseases India (ORDI) aim to work between the Government of India and the Pharma/Biotech/Diagnostic industry to enact an Orphan Drugs Act (ODA) that will create incentives for orphan drug developers. Further, a Government frame work is required that is conducive in enabling the manufacturing of orphan drugs in India.

[HealthEconomics.Com] What is the need and acceptance for Health Economics and Outcomes Research (HEOR) on attaining optimal reimbursement?

[Dr. Dang] As per the DPCO 2013, the price to retailer of a new drug, not available in domestic market, will be fixed by the Government of India on the principles of “Pharmacoeconomics” of the new drug, on the recommendation of a Standing Committee of Experts. As HEOR is still in infancy in India, this can be considered as a silver lining in the dark cloud as Government of India is willing to accept principle of pharmacoeconomics for optimal reimbursement on newer drug therapies.

[HealthEconomics.Com] Are risk-sharing arrangements or other methods used to attain market access?

[Dr. Dang] Risk-sharing agreements, under which payers and pharma manufacturers agree to link payment for drugs to health outcomes achieved, rather than the volume of products usedoffer an appealing payment model for pharmaceuticals. In future, the risk sharing concept may be in place. The Government is willing to accept the principles of pharmacoeconomics as per the DPCO 2013.

[HealthEconomics.Com] Is real-world evidence research or are observational studies important in the India marketplace?

[Dr. Dang] Real-world evidence (RWE) infuses clinical and commercial decisions with the insights and scientific proof points crucial to success in today’s healthcare environment. The Indian market is catching up with the principle of health economics and outcomes research (HEOR), thereby demonstrating the value of real-world insights in healthcare decision making.

[HealthEconomics.Com] Is there use of electronic medical records or insurance claims analyses or economic modelling to attain market access? 

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The Tata Memorial Centre

[Dr. Dang] The use of electronic medical records is gradually developing in India. There are government-sponsored HMIS (Health Management Information System) projects in some of the Indian states which have come up in the last decade. Electronic recording of patients’ information is being practiced in some major corporate hospitals, but these cater to only to a small percent of the country’s population. The Tata Memorial Centre, the national comprehensive cancer centre for the prevention, treatment, education and research in Cancer, which is recognised as one of the leading cancer centres in this part of the world has recently started using e-medical records. As for the insurance claims analysis, though the concept of health insurance has been in India since 1950s, it has picked up only since the past decade. As a result, at this point, we can say that the use of electronic medical records and insurance claims are rarely, if at all, used for economic modelling.

[HealthEconomics.Com] What do you predict for the future of HEOR/Pricing in India in 5 years and 10 years?

[Dr. Dang] The field of HEOR is still in its infancy in India. The most important reason for this is that the health insurance was not considered to be important. However, India’s landscape of health insurance, which was dominated by CGHS and ESIC, has undergone tremendous changes since 2007 with the launch of several new health insurance schemes in the country, largely initiated by central and state governments. The percentage of population covered by a health insurance scheme has accelerated from about 75 million people covered (roughly about 16 million family beneficiaries) in 2007, to an estimated 302 million people in2010, about one-fourth of the population.

With the rising cost of health care in India, and with increase in awareness among the general public, the health insurance sector is expected to grow significantly in the next 5 to 10 years. As a direct result, HEOR is going to play a very vital role in India.

[HealthEconomics.Com] How does your company, MarksMan Healthcare Solutions, approach this challenge?  Who are some of your clients and what are some of your successful projects?

[Dr. Dang] MarksMan Healthcare Solutions, established in April 2014, is a budding HEOR consultancy operating in India. Our greatest strength is that we are one amongst the very few HEOR consultancies of Indian origin and operating in India. By virtue of this unique positioning, we aim to offer localised support and strategic working partnership to the established HEOR consultancies based in US/ UK/ Canada, and to grow to be the pioneers in the field of HEOR in India over the next 5-7 years. We have experienced HEOR consultants, health economists and medical writing professionals in our team and are currently in the expansion mode. We offer services including comparative effectiveness research, health economic evaluation, HTA (Health technology assessment) submission and global value dossiers. We also intend to be an active element of ISPOR Indian chapter and HealthNetIndia, and work in close collaboration with other related agencies as well. We also aim to provide high-quality training and to do talent development in the fields of HEOR and pharmacoeconomics, which are still in their infancy stages in India. Our vision is to play a vital role in establishing the complete spectrum of HEOR studies in India, and in that process, contribute to improve the healthcare system in India.

 


 

For further information on the India HEOR and market access arena, as well as strategic tools to achieve optimal product value messaging, please contact Dr. Amit Dang, M.D., Founder and CEO, MarksMan Healthcare Solutions, http://marksmanhealthcare.com/, +91-7738389300.

If you or your organization would like to be interviewed for the tHEORetically Speaking blog, please contact HealthEconomics.Com at info@healtheconomics.com or contact Dr. Patti Peeples directly at patti@healtheconomics.com.

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Secrets of Success: How EPI-Q Does Real-World Research Really Well

dilbert cartoon

colin-powell-calloutNothing beats experience.  Well, maybe a list of secrets learned from that experience, compiled directly from an expert!  And that’s what you’ll get here, in today’s blog post.

I recently conducted a podcast with Dr. Mark Jewell, President of EPI-Q, about his Secrets to Success in designing and conducting real-world evidence (RWE) research studies for the pharmaceutical and healthcare industry.

 

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Why EPI-Q?  Two main reasons:

  1. EPI-Q has conducted hundreds, if not thousands, of healthcare studies representing tens of thousands of patients over the past two decades.
  2. EPI-Q has worked with an incredible diversity of providers and patient-care environments in these studies, thus gaining extensive insight into how to conduct research in various arenas.

EPI-Q’s RWE studies have produced results which have been widely published not only in peer-reviewed literature, but these results have gained world-wide attention and have influenced health policy.  Their study results have been discussed on CNN, CBS NewsUS News and World Report, among others.

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A summary of my interview with Dr. Jewell is below, or you may listen to the podcast here to benefit from his “in the trenches” experience with successfully conducting real-world research.

patti-image[Patti Peeples (PP), CEO and Founder, HealthEconomics.Com]  There is a lot of buzz around generating meaningful evidence from real world studies. Based on your experience, what are some important considerations before initiating a study using real world data?

mark-image[Mark Jewell (MJ), President, EPI-Q]  In short, the most basic questions or issues must be addressed up-front.   These include:

 

  • What is the level of evidence required?
  • When are results needed?
  • Who is the internal audience within the client sponsor?
  • Who is the external audience?
  • What business objectives are you trying to accomplish?

Then, one needs to delve deeper and this is where we typically uncover the real challenges – the major “learnings”, so to speak.  For example, as researchers, we:

  • Clarify study objectives;
  • Seek collective buy-in from internal key stakeholders;
  • Identify specific audience segments for the results; and,
  • Further elucidate exactly what will resonate with these individual audiences.

Through this process, we begin to operationalize exactly how to answer these questions, allowing the development of the specific methodology for the study.

[PP]  What processes have you used when working in a therapeutic area or a product that currently is of low awareness or interest to the payer or your target audience?

[MJ]  We have absolutely encountered this challenge, and we’ve approached it in a few innovative ways!  A case study is a good way to explain this.

We had a client with a product for insomnia.  The Phase III clinical trial data were quite promising from a clinical perspective; however, payers had indicated that insomnia was a disease state lacking in importance to them.  Insomnia was just not on their horizon, although it was a prevalent condition.

In addition to low awareness and interest, a complicating factor was that the definition of insomnia was varied. This resulted in wide-ranging estimates of prevalence in the published literature.

The combination of these awareness and disease state definition issues suggested that a typical RWE study would not generate evidence that would result in favorable positioning for the company’s product.  However, we still needed to create a product value message that was meaningful to relevant stakeholders.

Our solution was multi-fold.  We first began with evaluating the type of data that could be used to accurately establish burden of illness for insomnia to various customer groups, including a newly-identified audience – the employer.  Through this process, we determined that employer-relevant data such as absenteeism and presenteeism associated with insomnia would not be typically available in traditional claims databases.

This led us to establish a relationship with key opinion leaders (KOL) and other relevant stakeholders whokol-pullout could assist us with several challenges, including:

  • Refining the definition of the disease;
  • Assessing the epidemiology of insomnia using robust data; and,
  • More fully quantifying the burden of insomnia from various perspectives.

One KOL served as the principal investigator (PI) and assisted with identifying potential claims databases that would allow us to quantify many of our economic outcomes.  In addition, these KOLs would eventually serve as allies and experts in the transmission of the study results to relevant external groups, an activity I’ll describe in more detail later in the interview.

Through this process of establishing the research objectives from various perspectives, we also identified the need to quantify the disease burden utilizing patient-reported outcomes (PRO), including absenteeism and productivity-related effects.  Therefore, our research protocol utilized a combined strategy whereby we used a claims database plus PROs obtained through interviews with a segment of the population to provide a complete picture of the burden of illness associated with insomnia.

Lastly, we encountered another challenge in this particular study, this one relating to study data control.  We found that the owners of the claims database that we had originally identified wanted to maintain control of their data and the study results.  However, this did not fit with the original objectives as identified by the sponsor.  We handled this by engaging our PI who collaborated with us to define the study objectives, design, and database identification.  This PI helped achieve a solution that allowed both access to the data and a mutually acceptable control of results.

I like to describe this insomnia case study because I believe it highlights the many roles that can be played by a KOL/thought-leader in real-world evidence studies.  In addition, this research project showcases how to identify what data are important, processes we went through to obtain the data and how long it takes to get it, as well as it describes the different partners that an organization needs to work with in order to address relevant stakeholder issues during the study and after the results are available.

(Editor Note:  For access to EPI-Q’s publications and other work related to insomnia, visit here.)

 

[PP]   What are some lessons learned when EPI-Q has worked with some of the newer organization types such as Accountable Care Organizations (ACOs) or Integrated Delivery Networks (IDNs)? 

[MJ]   There are many advantages to working with ACOs and IDNs, and particular types of data (such as hospital readmissions, among others) resonate strongly with payers.  So, these relationships with ACOs and IDNs, and the utilization of their data for research, are very useful.

But there are some important factors to consider when working with these groups because their main job is patient care, not research or data provision.  These issues have a direct effect on timing and budget. For example, they may not have an Investigational Review Board (IRB), and we’ve found that we may need to liaise with many different types of individuals in order to build relationships to achieve political support to conduct the research, access the data, identify processes, etc.  Instead of the IRB, a Medical Director of a therapeutic area may be in charge, or someone in Quality Management or Improvement handles such studies.  On occasion, they may have a senior level individual in charge of Research, and we need to work with this group.

These relationships with the internal groups just mentioned are very important as you navigate the organization’s Legal Department.  Legal may have standards of practice as they relate to clinical research studies (such as obtaining informed consent), but these are not necessary or appropriate for observational research, for example.  With internal relationships already established with individuals like those I identified, then it is easier to negotiate research protocols within the organization.  We’ve also encountered the need to present the study to an initial committee (before it goes to an IRB), and this preliminary review assesses if the study has scientific merit of it’s appropriate or relevant for the ACO or IDN.

These groups are extremely important from a strategic perspective, but it is essential to understand that working with ACOs or IDNs may affect study timing and budget (as already mentioned), but it may also directly affect research methodology.  Nevertheless, working with these groups is increasingly essential for our industry.

[PP]   When you look across the vast array of data sources available, what qualifying criteria do you use for your research studies?

[MJ]   We start, of course, with the individual objectives of the study.  Then we assess whether the data source is representative of the study or target population, is it sufficient in size to provide enough study patients, is there sufficient quality to the data, does it have the appropriate and necessary data elements, and can we have the desired control over the data.  Again, let me use a case study to showcase some real-life examples that can be encountered when selecting the best data source.

In one example, we had a client that desired to evaluate treatment outcome differences between their product and a competitor in the relatively rare chronic kidney disease population.  As we investigated data sources, it was essential that the database have a sufficient number of patients with the identified disease (and with patients taking the identified treatments), and the data source needed to provide generalizability and sufficient internal validity.  We found no single database that fulfilled these basic criteria.

We determined the need to combine up to four separate databases, and beyond the challenges of combining disparate data sources, we encountered – again – the challenge of who controlled the data if portions were owned by four separate groups.  EPI-Q, as a 3rd party, acted as a mediator between these four groups and the sponsor, identifying a process for data combining and sharing, which eventually led to a successful study, and peer-reviewed presentations and publications.  Results from this chronic kidney disease RWE research can be viewed here.

Challenges like these are common in RWE study design, and this case study shows an effective means to resolve operational and study design issues, in a collaborative effective fashion.

 

[PP]   Since all databases have one or more pieces of information that are missing, incomplete, or insufficient, can you summarize some methods you’ve used to supplement these claim sources with other methods.

[MJ]   We have used claims combined with interviews collecting patient-reported outcomes (e.g., the insomnia study).  We have several examples of using a 3-prong approach, including supplementing administrative claims with electronic medical records (EMR) plus chart review, conducted on a subset of the population (to derive diagnostic test data that were not available in the claims or the EMR data).  And we have used claims data plus EMR, but did not have sufficient money for interview data or chart review, so we conducted an on-line survey with patients derived from the specific plan population (in one study) or from the US population (in another study).   A detailed case study can be viewed here.

[PP]  Health Outcomes Liaisons (HOLs) are increasingly being deployed by industry as an important group who interacts directly with payers.  How does EPI-Q work directly with HOLs in the research process to understand what customers want in the RWE studies?

[MJ]  Health Outcomes Liaisons are eager to use data from RWE studies because it allows them to talk with stakeholders in meaningful ways beyond just sales data. It facilitates a peer to peer interaction, and helps the HOL to better understand their customer (and, in some cases, the payer better understanding their own patient population) in terms of treatment and medication trends, usage patterns, as well as costs and resource utilization.

RWE data are useful for payers in terms of creating benchmarking reports, treatment reports, and publications addressing cost and quality issues, among others.  It is always imperative to work closely with the sponsor’s compliance, legal, regulatory, and other departments in terms of developing these materials for use in the field.  But there is a lot of evidence of success with the use of RWE data with major customer groups, and EPI-Q has a good deal of experience in working closely with these customer-facing groups.

[PP]   Let’s take a 20,000 foot view.  What changes have you seen in real-world evidence research over the past few decades?

[MJ]   Oh there have been many good changes!  I believe we are much more thoughtful on how RWE data are used, and we have a better understanding that real-world evidence is not a magic bullet.  We accept that there are limitations, and as such, we’ve gotten better at identifying whether and when RWE is appropriate.

We’ve also gotten much better at learning how to give life to the RWE study results on the back-end of the research project, meaning how to use RWE data and all the different groups that it can affect and influence, beyond providers and payers.  For example, RWE can be utilized with patient advocacy groups, with CMS for the Five-Star Quality Rating System, it can inform performance measures such as HEDIS, as well as being used to tie observational research results into reimbursement arrangements with payers.  These other uses of RWE are extremely important to consider early in the process, when you are setting up the study design, so that the most impact can be gained from the study results.

We’ve also improved at knowing where to conduct the studies (i.e., in what environment), such as whether ACOs or IDNs are relevant based on whether the study has important outcomes such as hospital readmission issues or the intervention under study has specific reimbursement challenges.

In terms of using RWE with advocacy groups or professional organizations, I’m not suggesting using it for undue influence, but rather working with these groups so that they are aware of the data coming out, and can utilize the data, if appropriate, for their initiatives.  The insomnia study is an example of this.  Our KOL worked closely with members of policy-making bodies so that they had the data for use in DSM-V and ICD-10 to redefine thresholds of treatment, and for crafting the definition of insomnia to determine prevalence.  We were very proud that these groups utilized our study data for policy-making purposes.

At EPI-Q, we are very excited about our two decades of experience with RWE and the future opportunities that exist for finding even more impactful uses of the data, including developing patient decision aids, shared decision-making tools, diagnostic and treatment guidelines, quality initiatives, reimbursement, and more.  You can find out more about EPI-Q and our research by visiting our website (https://www.EPI-Q.com) or contacting us by telephone at (630) 570-5505.

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