• How Innovative Alternate Payment Models Are Bringing Change In Healthcare?

    How Innovative Alternate Payment Models Are Bringing Change In Healthcare?

    Drug prices in the US are the highest in the world, which necessitate new or alternate payment approaches. For instance, the new treatments for hepatitis C virus (HCV) infection are highly effective and very expensive at the same time, at least from the view of many payers, physicians, and patients. Even 5 years after these drugs were introduced, only 15% of the estimated population of more than 3 million HCV patients in the US have been treated. This can also be due to budgetary constraints of the state Medicaid programs. (1)

    In the example stated above, the ideal way to treat the HCV infection would be at the population level, treating every patient possible, at a possible speed. Since the medicine is shifting towards value-based care day by day, it is essential for patients and physicians to have flexible, innovative, and practical payment models that would facilitate better outcomes. As a result, many industry stakeholders are predicting the introduction of new alternate payment models (APMs) that are in being developed currently and will possibly be rolled out later this year. Moreover, the Centers for Medicare and Medicaid Innovation (CMMI) is responsible for the assessment of alternative payment models (APMs), such as bundled payment models that would reduce program expenditures under Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) in order to increase quality and efficiency. (2) In addition, with the support of increasing evidence and momentum, APMs are the precise solution to today’s cost and quality challenge in healthcare. They promise to bend the healthcare cost curve to achieve a sustainable, long-standing future for Medicare and reasonably priced private coverage. (3)

    Having said that, Medicaid programs in several US states have limited access to treatment. For instance, Louisiana State only treated 384 HCV patients last year (2017-18) out of an estimated 35,000 Medicaid beneficiaries carrying the virus. Consequently, the Centers for Medicare and Medicaid Services (CMS) warned the states about possible violation of statutory Medicaid requirements owing to restricted access to hepatitis C treatments. (4)

    However, as a solution, Louisiana State is soon adopting the ‘Netflix Model’ that involves a licensing deal, to expand access to treatment. As per this model, instead of paying for each prescription individually, the State would pay the drug company a subscription fee for medication for several years in exchange for unlimited access to treatment, just like the consumers paying a monthly fee to stream unlimited television shows and movies. (4,5) This ‘Netflix Model’, when applied to health care, makes a lot of sense. This is because the pharmaceuticals R&D costs can be high, but the manufacturing costs, much like software, are often low. Netflix content is essentially purchased through a monthly license, where the consumers are not charged a fee every time to view a show. The basic idea here is to incentivise the content creator, not limiting the ability to watch since marginal costs are low. (4)

    Similar to the ‘Netflix Model’, researchers have also proposed drug-licensing models for health care that promise increased drug use without altering patients’ out-of-pocket spending, health plans’ costs, or drug companies’ profits. These models are based on an idea of buying annual drug licenses to ensure unrestricted access to a clinically optimal number of prescriptions over the course of a year. (6) Furthermore, new efforts are in progress in Massachusetts to figure out ways to pay for the potential million dollar price tag for an experimental one-time therapy designed to treat the devastating, rare disease of spinal muscular atrophy and its underlying genetic cause. Even in this case, similar to the ‘Netflix Model’, the health insurers are considering to pay for the treatment over several years, which if succeeded, could hopefully prove to be a viable model for the entire US. (7) Here, Novartis’s AveXis unit, the manufacturer of the gene therapy Zolgensma, has suggested a price tag of up to $5 million, and is in talks to participate.

    Evidence from literature has shown such subscription models to improve outcomes and save money at the same time. Subscriptions can better balance the public health interest in gaining rapid, extensive and inexpensive access to these drugs than traditional fee-per-dose reimbursement. This can further ensure that manufacturers’ generate enough revenues to justify the drugs’ development costs. (4-6)

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    References 

    1. Trusheim MR, Cassidy WM, Bach PB. Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model”. JAMA 2018; 320(19):1977-1978.
    2. Landi H. Are New APMs from CMMI Coming Soon? Industry Stakeholders Forecast Bold Moves from the CMS Innovation Center in 2019. 
    3. Leavitt MO. Alternative payment models in healthcare are a must. January, 2017. 
    4. Goldman DP. When we find a cure, price it like Netflix to ensure access. September, 2018.
    5. Johnson CY. Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs. January, 2019. 
    6. Goldman DP, Jena AB, Philipson T, et al. Drug licenses: A new model for pharmaceutical pricing. Health Affairs 2008; 27(1).
    7. Court E. A revolutionary drug that could treat a rare and devastating disease is prohibitively expensive. But one state has a plan to pay for its potential $5 million price tag. January, 2019. 

    Written by – Ms. Tanvi Laghate

  • Facts & Fiction – Branded v/s Generic Controversy – India

    Facts & Fiction – Branded v/s Generic Controversy – India

    All branded drugs are of good quality – Fiction
    Majority of the branded drugs are of good quality – Fact

    All generic drugs are of good quality – Fiction
    Majority of the generic drugs are of good quality – Fact

    All pharma companies take pro-patient initiatives – Fiction
    Few pharma companies take pro-patient initiatives – Fact

    All doctors make their cut out of prescription – Fiction
    Majority of doctors make their cut out of prescription – Fact

    All pharmacists are qualified for their job– Fiction
    Few pharmacists are qualified for their job – Fact

    All MRs are qualified for their job– Fiction
    Few MRs are qualified for their job – Fact

    All patients look for affordability over quality – Fiction
    Majority of the patients look for affordability over quality – Fact

    Government dreams to take pro-patient initiatives – Fact
    Government’s steps to make them happen – no less than any fiction

    We all know where the double standards lie in every “Fact & fiction” mentioned above.

    Fact of irony is that inspite of India being the “Generic capital of the world”, patients are not able to afford healthcare. If it would have been all about patients:

    • Government must had central regulatory check on the quality of marketed generics
    • Pharma must not had followed unethical practices
    • Doctors must not had taken prescription cuts
    • Diagnostics must not had bribed doctors
    • Pharmacists must not had differentiated on various brands of same generic, and most importantly…

    “PATIENTS, WHO SHOULD BE IN THE CENTER OF HEALTHCARE SYSTEM, MUST HAVE KNOWN ABOUT THEIR DISEASE IN TOTALITY”

    Patient’s 3 desires in this order: – Hanno Wolfram on twitter

    1. learn what the diagnosis is
    2. learn what the disease does to them
    3. understand what to do against it

    Any patient engagement initiative has to anchor around these three patient needs!

    The million dollar question is who would like to take the responsibility first?

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  • Is India Gearing up for Patient Centric Healthcare Model?

    Is India Gearing up for Patient Centric Healthcare Model?

    Following the recent announcement by PM Narendra Modi hinting at a legal framework for doctors to prescribe generic medicines cheaper than equivalent branded generic drugs, doctors appeared to welcome the move and opined that it will benefit patients as the life-saving drugs could be obtained at much cheaper rates. (1,2)

    In reality, India being the largest supplier of generic medicines globally (20% of global export volume); the quality of the generics should not be an issue. Generic drugs dominate India’s pharmaceutical space, wherein generics account for about 70% of the market. Also, India accounts for approximately 30% (by volume) and about 10% (value) in the US$ 70-80 billion US generics market. Therefore, quality of the manufacturing has got nothing to do with branding. It is purely a manufacturer’s decision and ability enforced by law which is paid for by the customer. (3)

    However, PM Modi did attract the wrath of many following the announcement. This is because a lot of doctors questioned the accessibility and quality of the generic drugs. However, many feel this to be just an excuse, as doctors fear that this move would upset their nexus with the drug companies. (4,5) Furthermore, industry associations reaching out to the health ministry, hoping to approach the PMO to prevent the law from being passed, were opposing proposal on the grounds that the onus of decision-making (what patients should consume) would shift from doctors to chemists. This group further pointed out that the chemists are unregulated and have no ethical or commercial obligation on what they sell patients. However, the Ministry of Health and Family Welfare announced to seek only qualified candidates in the workforce. (6)

    Consequently, the health ministry has made bio-equivalence (BE) studies mandatory for all drug manufacturers before launching any generics in the market. This is primarily to guarantee the same quality and efficacy of generics as their branded counterparts. The health ministry has also issued a gazette notification to this effect. (7)

    Frankly, this move is worth applauding for, since it will ensure the quality as well as appropriate distribution of the generic drugs. This is because most of the doctors have been avoiding generic prescriptions in the name of lack of quality; while actually focusing on the incentives from the pharma marketing.iv On the other hand, in reality, prescribing generics would only benefit the patient in terms of both quality and affordability. But going by certain decisions the government has made since last couple of years, we can surely say that India has started accepting the patient-centric healthcare model.

    Big pharma players and even the smaller (generic manufacturers) ones need to think of ways to rebrand themselves. Certainly, not every company can manufacture a drug for every possible disease condition; however, the future of pharma business is predicted to go by branding based on robust ’therapy area’ leadership. For instance, Mylan Pharmaceuticals, the biggest generic drug manufacturers globally, has been manufacturing more Parkinson’s medicines than any other company in the world. (8) Furthermore, small players will have to invest money in proper and ethical ways of marketing, i.e. publishing results from BA/BE studies to prove the similar efficacy of generics with reference to their branded counterparts. (9)

    It has always been a patient-centric approach. The solution to all these complications is ‘patient empowerment’. Doctors primarily make diagnosis; they cannot polarize patients to earn their own incentives from the pharma players. Also, learned chemists/pharmacists should hopefully provide patients with cheaper generics. In the end, it is patients who must choose what is right for them.

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    References

    1. Chatterji S. Modi says govt will bring law to push doctors to prescribe generic medicines. Hindustan Times. April, 2017.
    2. PTI. PM Narendra Modi Hints At Rules For Doctors To Prescribe Generic Drugs. NDTV India.  April, 2017.
    3. Pharmaceutical Exports From India. India Brand Equity Foundation (IBEF). October, 2017.
    4. Pardasani S. Health for all: Not just Prime Minister’s call. Mumbai Mirror. April, 2017. Available at:
    5. Kaul R. Doctors welcome move to prescribe generic drugs, say accessibility may be an issue. Hindustan Times. April, 2017.
    6. Rajagopal D. `Chemists, and Not Doctors, Could Decide Brand of Drug Use’. The Economic Times. April, 2017.
    7. Thacker T. Health ministry warns on rushed implementation of generics plan. livemint. August, 2017.
    8. Mylan Receives FDA Approval for Generic Version of Parkinson’s Treatment Parcopa® ODT.
    9. Phukan RS. Generic drugs in India: More awareness required. November, 2014.
  • Cost Effectivity or Affordability: What Should be Prioritized in India?

    Cost Effectivity or Affordability: What Should be Prioritized in India?

    Rapidly rising cost in healthcare is an increasing cause of concern across the world. Indian healthcare is also experiencing a change, with increasing focus on better quality of medical care services.

    As per the available information, the healthcare spending per capita per annum in India has been observed to be about $109, with total healthcare spending in the range of 4.9% of the country’s GDP. Most of the spending occurs from the private sector with public sector contributing to a mere $ 19 per capita per annum. Concurrently, the average spending per capita per annum in the United States during the same time frame has been found to be approximately $4271 whilst for the United Kingdom, the spending is $ 1675. These figures clearly indicate that healthcare in India is fairly cheaper, a strong reason for a growing medical tourism market in the country. However, when compared with paying power parity and affordability, the cost of medical care is escalating. It is worthwhile to note that as per World Bank estimates, more than 44% of Indian population earns less than one dollar a day.

    In India, a silent crisis in access to essential medicines confronts most patients who seek treatment of acute and chronic diseases. Close to 40% of Indians live on less than US $1 per day and most of them pay Out-Of-Pocket (OOP) for using healthcare. OOP spending in India is over four times higher than public spending on healthcare. Unexpected illness can have a catastrophic effect on the family of the ill person: direct out-of pocket payments could push 2.2%% of all healthcare users and one-fourth of all hospitalized patients, into poverty in a year.

    In addition, most Indians pay for medicines – a key factor that can contribute to the impoverishing effect of OOP payments for healthcare. According to the World Health Organization (WHO), an estimated 649 million people in India do not have regular access to essential medicines. Public provision of these medicines is poor; the median availability of 30 essential medicines in six states in India varied between 0% and 30%. Patients are forced to buy medicines from the private market, a compulsion that often spells calamity for those who can ill afford the twin burdens of sickness and healthcare costs.

    Drug regulatory agencies all over the world approve medicines for use in their countries on the basis of an evidence-based process which evaluates the data on their efficacy (obtained through randomized controlled trials) and safety. In India, in light of the public health problems that we face, the widespread poverty and high OOP expenditure incurred by patients, the drug regulatory authorities have an additional responsibility: to ensure that the medicines being approved for manufacture serve the public health needs of the country and are cost-effective. Moreover, patients value quality, safety and cost-effectiveness of a medicine; it matters little to them whether the medicine is branded or unbranded and whether it is promoted through the retailer or the doctor.

    India and its pharmaceutical industry have acquitted themselves very creditably on the global platform. Indian generics account for about 40% of the anti-retroviral medicines provided globally. Worldwide, these low-cost high-quality medicines are a lifeline to millions of people. There are an estimated 10,563 manufacturers in India, and more than 65,000 formulations. These numbers look impressive but the paradox is that, at home, large portions of the population lack access to even the most essential drugs. The limited funds available are frequently spent on ineffective or unnecessary medications. The money spent on overpriced medicines is very often also a waste of precious resources. Since these medicines outnumber those which are cost-effective, they directly impact the availability of and access to essential medicines.

    To address the anarchy of drug prices which is impoverishing people, we need a comprehensive cost-based system, and not the market-based system of price regulation. The drug approval system in India needs to be overhauled on the lines suggested by the recent parliamentary committee which looked into the functioning of the CDSCO. The process of drug approval needs to be rigorous, evidence-based, transparent, and in line with the interests of public health in India. The present predicament, of poverty of access to medicines amidst a plenty of overpriced, non-essential medicines which worsen poverty, should not be allowed to continue to imperil the lives and health of Indians.

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