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That is the finding from a recent paper by myself and co-authors Joanna MacEwan, Syvart Dennen, Rebecca Kee, Farzad Ali, and Katharine Batt. An excerpt from the paper is below:
Between 2000 and 2016, deaths per 100,000 population across the 15 most common tumor types declined by 24%. Additionally, 10.2 new indications were approved per year across the 15 most common tumor types. Cancer drug approvals were associated with statistically significant deaths averted in 2016 for colorectal cancer (4,991, p = 0.004), lung cancer (33,825, p < 0.001), breast cancer (11,502, p < 0.001), non-Hodgkin’s lymphoma (6,636, p < 0.001), leukemia (4,011, p < 0.001), melanoma (1,714, p < 0.001), gastric cancer (758, p = 0.019), and renal cancer (739, p < 0.001). Between 2000 and 2016, new cancer treatments were correlated with 1,291,769 (p < 0.001) total deaths prevented across the 15 most common tumor types.
Do read the whole article here.
Great news on progress for a COVID-19 vaccine from Pfizer. From their press release:
The Phase 3 clinical trial of BNT162b2 began on July 27. Pfizer expects to produce o produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. Note that since this is a two-dose regimen, this would be sufficient capacity for 25 million people this year and 650 million people next year.
That is the key question explored in a recent article from The Economist titled “Masked up, ready to battle bugs“. As individuals in developing nations leave crowded cities for fear of COVID, they may be at more risk for malaria due to the presence of more standing water (which attracts malarial mosquitos) used for irrigation in rural areas. Additionally, COVID has disrupted supply chains for the distribution of mosquito nets. COVID-19 also makes treating malaria more complicated.
Governments in rich countries have pushed a consistent message for COVID-19. If you children have a fever, keep them at home. “That message would be an unmitigated disaster in countries with high malaria transmission, because a child with a fever can die from malaria in 24 hours,” says Melanie Renshaw of the African Leaders Malaria Alliance….Such a child must quickly be tested for malaria and, if the test is positive, be given anti-malarial drugs.
One can clearly see how the COVID-19 pandemic affects not only people who suffer from the disease, but also affects the treatment of other conditions–like malaria. The interplay of COVID-19 with other diseases is an area which requires more studies and more solutions.
Poor, elderly individuals who may qualify for both Medicaid (for being poor) and Medicare (for being elderly, blind, disabled or have ESRD). In these cases, Medicaid serves as a supplemental insurer, covering Medicare coinsurance and deductibles. The generosity of this supplemental coverage for so-called ‘dual-eligibles’ varies across states.
These differences in Medicaid payments arise from two sources of policy variation. First, states differ in their adoption of so-called “lesser-of” policies, which are provisions for Medicaid to pay the lower of (a) Medicare’s cost sharing, or (b) the difference between the Medicaid fee schedule and Medicare’s payment for a service (net of cost sharing).1 Second, Medicaid fee schedules, which vary across states and over time, affect the amount of cost sharing that Medicaid will pay providers in lesser-of states.
In lesser-of states with low Medicaid fee schedules, providers can be paid substantially less when rendering services to duals vs other Medicare beneficiaries, who either pay Medicare’s cost sharing out of pocket or have private supplemental (ie, Medigap) insurance to
cover these expenses.
Unsurprisingly, providers are not as excited to provide care for dual-eligibles when they get paid less money for providing the same services they provide to Medicare beneficiaries (see Mitchell et al 2004, Haber et al. 2014, Zheng et al. 2017).
To measure variation in state Medicaid policies regarding dual eligibles, a paper by Roberts et al. (2020) describes the process of creating a database of these policies. The sources of the database were (i) state Medicaid plans and amendments filed with CMS; (ii) state laws from LexisNexis; (iii) and Medicaid provider manuals, program bulletins, and related online policy documents. Then the authors created a payment index using a nationally representative sample of claims data for evaluation and management services HCPCS codes. The database is publicly available here.
Based on these data, the share of states with <80% coverage of Medicare coinsurance and deductibles has grown over time, from 24 states in 2004 to 29 states in 2018. Further, the number of states that provide full reimbursement fell from 11 in 2004 to 7 in 2018.
One limitation of the data used for this evaluation is that it ignores managed care. Medicaid managed care organizations (MCOs) and MCOs are have grown–relative to Medicaid fee-for-service–over time.
Lesser-of policies function similarly under Medicaid managed care, except that Medicaid MCOs pay the lesser-of (a) the difference between their negotiated provider rates and Medicare’s payment amount, and (b) Medicare’s cost sharing. However, to the extent payment rates negotiated by Medicaid MCOs differ from those in fee-for-service Medicaid, our payment index will not accurately reflect provider payments for duals enrolled in Medicaid MCOs.
Further, the analysis also does not include Medicare Advantage beneficiaries. In 2018, Medicare Advantage plans covered 33% of dual-eligibles with full Medicaid.
Nevertheless, the creation of this dataset to track changes in Medicaid dual-eligible generosity is certainly a useful contribution to the literature.
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Dasgupta et al. (2020) compares individual behavior in the COVID-19 pandemic with the 1665 London plague outbreak based on the descriptions by Daniel Defoe in A Journal of the Year of the Plague. The historical comparison is interesting throughout and merits a full read. Some excerpts are below.
On the failure to recognize the disease’s severity:
Given their relative disbelief in the severity of the outbreak, in the early days people in every country or borough of London believed that there really was no cause for concern. Those in London believed it might affect other parts and maybe it existed in the outskirts but had not arrived in the city. For Covid often people believed it to be no more fatal than the flu or an infection that was present elsewhere. As a result, they did not take adequate measures to protect themselves.
In both COVID-19 and the London plague, consumer hoarded goods. In the case of COVID-19, it was food, masks and toilet paper; in the London plague hoarding household goods was common. The hoarding is due to the uncertain nature of the duration of the pandemic. In addition:
…sellers too react to such episodes in very predictable ways. A very pointed instance of hoarding that Defoe describes in the book is when trying to escape the city to Lincolnshire, he witnesses an acute shortage of horses for hire even though most people were not moving around the city. There are other instances where he talks about theft—for instance of an unnecessary item like women’s hats from an unguarded warehouse in London, as well as frequent descriptions of food shortages. Similar instances of opportunistic market behavior can be found in the current pandemic…a seller in Florida was offering 15 N95 face masks on Amazon for $3,799, milk was being sold at $10 per gallon in a convenience store in Massachusetts, and of course the most curious of case where toilet rolls were vanishing from stores and being offered at exorbitant prices
With prices fluctuating frequently during a pandemic, opportunism is common.
Increased faith in “miraculous cures” also commonly occurs.
As Defoe notes “…they were as mad upon their running after quacks and mountebanks, and every practicing old woman, for medicines and remedies.” Models of herding behavior of the type developed by Banerjee (1992) and Bikhchandani, Hirshleifer, and Welch (1992) can be used to explain such behavior. Imagine that each person receives a private signal about the effectiveness of the miracle cure. However, if they observe other people believing in such a cure (since there is no known cure), an individual might ignore their private signal and follow the herd…Waiting to learn about the effectiveness of a cure during a pandemic can be costly (strategic delay), and this in itself can lead to herding.
On the positive side, necessity is the mother of invention. While remote working, teleconference, and contactless technology grew out of COVID-19, innovation also occured during the time of the plague.
Defoe notes the example of a waterman who took up the job of delivering water when he realized that there was a huge demand for such basic necessities stuck in the anchored ships in the nearby docks, which in turn provided him “… a great sum, as things go now with poor men”
Do read the entire article as there are many more interesting examples.
Wouldn’t be great if we could find a treatment to improve longevity? Not just a treatment for a specific disease but one that could dramatically improve longevity for a large percentage of human kind. While there is a lot of longevity research going on and much progress has been made. There are some challenges. Milan Cvitkovic writes about these challenges in his blog post “(How) should we pursue human longevity?” One issue is regulatory.
Before it can conquer death, a longevity treatment will have to conquer the U.S. FDA’s clinical trial process. The FDA doesn’t consider aging to be a medical indication (a.k.a. a valid reason for treatment). This means longevity companies have to choose an existing age-related indication (e.g. Alzheimer’s) to demonstrate efficacy of their treatment on. How to do this well is a key consideration for any longevity biotech.
More optimistically, regulatory changes like dual-track clinical trials or eliminating phase 3 trials altogether might entail a massive acceleration in longevity therapeutic development. Outsourcing or decentralizing clinical trials is also an exciting option. Science 37 is one company working on this.
Increased transparency and a ‘fail fast’ mentality would also be helpful.
Between 25% and 50% of clinical trial results remain unpublished even several years after completion. This isn’t surprising: why publish your clinical data when there’s zero gain to you and even a slim chance you can repurpose the asset in the future? But this means a potential downside of moving longevity efforts from research to commercial therapeutic development is that the field will learn less overall.
A related problem is that because liquidity events can happen far before convincing clinical data, biotechs are incentivized to push their risky studies until as late as possible (ideally after the employees get their money) and to gussy them up to look better than they really are. A fail-fast-and-publish-honestly mentality would of course be better for longevity overall.
Nintil also has a very helpful “Longevity FAQ” post that is worth reading as well.
“The highest form of wisdom is kindness.”
– The Talmud, Brachot 17a
While many health technology assessment (HTA) organizations acknowledge that many new treatments reduce the burden placed on caregivers, the value that these new treatments provide is rarely incorporated into formal cost effectiveness analyses. This is the finding from Pennington (2020) based on a review of ll published technology appraisals (TAs) and highly specialized technologies (HSTs).
Twelve of 414 TAs (3%) and 4 of 8 HSTs (50%) included carer HRQL in cost-utility analyses. Eight were for multiple sclerosis, the remainder were each in a unique disease area. Twelve of the 16 appraisals modeled carer HRQL as a function of the patient’s health state, 3 modeled carer HRQL as a function of the patient’s treatment, and 1 included family quality-adjusted life year (QALY) loss. They used 5 source studies: 2 compared carer EQ-5D scores with controls, 2 measured carer utility only (1 health utilities index and 1 EQ-5D), and 1 estimated family QALY loss from a child’s death. Two used disutility estimates not from the literature. Including carer HRQL increased the incremental QALYs and decreased incremental cost-effectiveness ratios in all cases.
Blame can be shared between both HTAs and life sciences companies. On the life sciences side, evidence on the impact on treatments on caregiver burden needs to be quantified if is to be included into technology assessments. On the HTA side, caregivers should not be ignored when measuring the value of new treatments.
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This is one of the main topics explored by the interesting book Remedy and Reaction by Paul Starr. The U.S. has gotten close to national health insurance programs a number of times. One of the first times was in New York after World War I.
The one state where compulsory health insurance came close to passage was New York…In March 1919…the New York State Senate…[passed] a health-insurance bill that had the support of the recently elected Democratic governor Al Smith…
If New York had adopted a health insurance program in 1919,it might have had national ramifications. The unemploymen tinsurance program that Wisconsin adopted in 1932 helped pave the way for federal legislation in 29135. In Canada, the health insurance plan adopted in Saskatchewan in 1946 played a comparable role as a stepping stone toward a national program.
Private health insurance in the US developed out of the need to finance the high cost of hospital services. In the early 20th century, health insurance was most valuable for replacing wages and providing a funeral benefit. As the cost of medical care care grew in the late 1920s and 1930s, the value of health insurance to cover medical cost grew.
…in the late 1920s and early 1930s individual hospitals and hospital associations in Texas, California and other states created the first plans for groups of employees to buy insurance for hospital expenses. These plans, which evolved into the Blue Cross system, were run on a non-profit basis and at first covered only a small number of people…
Another reason why nationalized health insurance has not passed is that physician have generally been opposed to government health insurance.
In the late nineteenth and early twentieth centuries, legislatures enacted progressively stricter licensing laws for doctors, raising requirements for medical education; the effect of those laws was to close many medical schools and reduce the supply of physicians at a time when demand for their services was growing. Under these conditions, doctors were able to increase their fees and incomes (which was one reason why organized professional support for government health programs diminished).
Many government health insurance programs would pay physicians based on global capitation, which would likely drive down demand and wages, particularly for specialist services.
The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records (EHRs), patient registries, or mobile devices. But how has FDA used RWD in practice?
A paper by Feinberg et al. (2020) examines oncology drugs approved by the FDA between 2017 and 2019 to try to answer this question. In this time period, 40 new oncology drugs were approved.
Five of the 40 made reference to RWE submitted in support of the approval. During the same time period, 71 supplemental indication approvals were identified (for 38 oncology drugs); however, drug approval packages were only available for 13. Three of the 13 made reference to RWE submitted in support of the approval. All 8 of the approvals with submitted RWE involved indications with an unmet need for effective therapies. For 5 of the 8 approvals with submitted RWE, the data represented historical controls; in 2 cases the RWE was derived from expanded access studies, and in 1 case the RWE was collected from off-label use of an approved therapy in a new patient population. The submitted RWE was rejected by FDA in 3 of the 8 approvals.
Many of the drugs using RWD were indicated for rare diseases and a variety of different real-world data sources were used.
…we found that 4 of the 5 drugs reviewed had orphan drug designation, and the fifth was for a rare subset within a larger patient population (palbociclib for male patients with breast cancer). Three of the 5 drugs (avelumab, blinatumomab, and selinexor) received accelerated approval for the indications for which RWE was submitted; all 3 had PMRs [post-marketing requirements] for confirmatory clinical trial data, with avelumab and blinatumomab both requiring new clinical trials. The types of RWE used in the regulatory submissions included EHR data, claims data, postmarketing safety reports, retrospective medical record reviews, and expanded access study data.
Efficacy was most often justified using EHR data as a historical control or expanded access studies. Sometimes the EHR data was supplemented with claims data or diagnostic test results (e.g., next-generation sequencing data).
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University of Virginia Health System (UVA Health) has gone after patients’ homes to pay for medical bills. Kaiser Health News reports:
UVA Health and other medical systems rarely force the sale of a home to claim money. Instead, they wait for families to refinance or sell, taking their cut at the settlement table. But with 6% simple interest accumulating year after year after the court judgment, as allowed by Virginia law, the final amount owed can be much more than the original charges…
Creditors such as UVA and VCU don’t need addresses to create liens. All they have to do is file a judgment in county or city land records. If debtors own any property there, title companies won’t approve a sale until the debt is paid, often with home equity.
Often owners don’t know debts exist until paralegals unearth them when homes are sold, property pros say. Old debts can create liens on newly acquired real estate.
The UVA Health approach contrasts with VCU Health–another large, state-owned medical system. VCU Health pledged in March 2020 to stop seizing patients’ wages and to remove all property liens for patients with unpaid medical bills,
From John Maynard Keynes’ Essays in Biography:
The study of economics does not seem to require any specialized gifts of an unusually high order. Is it not, intellectually regarded, a very easy subject compared with the higher branches of philosophy and pure science? Yet good, or even competent, economists are the rarest of birds. An easy subject, at which very few excel! The paradox finds its explanation, perhaps, in that the master-economist must possess a rare combination of gifts. He must reach a high standard in several different directions and must combine talents not often found together. He must be mathematician, historian, statesman, philosopher – in some degree. He must understand symbols and speak in words. He must contemplate the particular in terms of the general, and touch abstract and concrete in the same flight of thought. He must study the present in the light of the past for the purposes of the future. No part of man’s nature of his institutions must lie entirely outside his regard. He must be purposeful and disinterested in a simultaneous mood; as aloof and incorruptible as an artist, yet sometimes as near the earth as a politician.
Hat tip: Marginal Revolution.
When evaluating a new diagnostic, HTA agencies must assess two separate issues: analytical and clinical validity. Analytical validity basically indicates whether the test works; is it able to accurately predicts the presence or absence of a particular biomarker of interest. Clinical validity is whether the test matters in clinical practice. It could be the case that a test perfectly predicts a biomarker, but the presence or absence of the biomarker would not have a big impact on the treatment recommended by a physician.
Two papers in Value in Health evaluate the criteria health technology assessment (HTA) bodies use to evaluate new diagnostic tests.
Garfield et al. 2016 examines a series of case studies evaluated by Australia’s Medical Services Advisory Committee (MSAC), Canada’s CADTH, UK’s NICE and it’s Diagnostic Assessment Programme (DAP), US’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) and Palmetto’s MolDX Program, and Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG). The missions of these different HTA agencies varied:
Palmetto, for example, serves as a reimbursement gatekeeper similar to Australia’s MSAC for diagnostics, whereas NICE’s DAP assesses diagnostics in all phases of a product life cycle that could already have reimbursement.”
In the US, Medicare has authorized Palmetto GBA to develop an HTA evaluating new diagnostics.
Palmetto’s MolDX Program was implemented in 2012 and conducts HTAs on both US Food and Drug Administration-approved diagnostics and LDTs. The goals of the program are 1) focusing Medicare coverage to diagnostics that demonstrate clinical validity and utility; 2) tracking utilization for reimbursement through the implementation of unique codes for each diagnostic; 3) creating a consistent and standardized approach for making coverage and pricing decisions for diagnostics; and 4) building a body of evidence demonstrating the effectiveness of diagnostics in the real-world setting by linking specific tests with clinical decision making and patient outcomes.”
Diagnostic companies face significant uncertainty when determining what evidence (if any) is needed to support an HTA submission.
For example, the National Institute for Health and Care Excellence (NICE)’s Diagnostic Assessment Programme (DAP) has well-defined requirements for assessment and the submission document is not extensive. However, “the timeline is long, taking more than 2 years in some cases.”
Another paper by Chen, Peirce and Marsh (2020) examines the criteria NICE’s DAP uses to evaluate new diagnostics and how cost-per-QALY estimates affect reimbursement. This study found:
…[among] 22 evaluations, 91 decision problems were identified for further analysis, of which 52, 15, and 24 received “recommended,” “not recommended,” and “not recommended–only in research” guidance, respectively. The overall consistency rate of the DAC [Diagnostics Advisory Committee] decisions with the £20 000/QALY threshold was 73.6%. Diagnostic technologies that were not recommended, despite an ICER less than £20 000/QALY, were associated with a larger number of decision-modifying factors favoring the comparator, versus recommended diagnostic technologies with ICERs less than £20 000/QALY. For technologies with ICERs greater than £20 000/QALY, the number of decision-modifying factors was comparable for positive and negative recommendations.
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Congratulations to Paul Milgrom and Robert Wilson for the 2020 Nobel Prize in Economics. Below is an excerpt from the press release.
Using auction theory, researchers try to understand the outcomes of different rules for bidding and final prices, the auction format. The analysis is difficult, because bidders behave strategically, based on the available information. They take into consideration both what they know themselves and what they believe other bidders to know.
Robert Wilson developed the theory for auctions of objects with a common value – a value which is uncertain beforehand but, in the end, is the same for everyone. Examples include the future value of radio frequencies or the volume of minerals in a particular area. Wilson showed why rational bidders tend to place bids below their own best estimate of the common value: they are worried about the winner’s curse – that is, about paying too much and losing out.
Paul Milgrom formulated a more general theory of auctions that not only allows common values, but also private values that vary from bidder to bidder. He analysed the bidding strategies in a number of well-known auction formats, demonstrating that a format will give the seller higher expected revenue when bidders learn more about each other’s estimated values during bidding.
Over time, societies have allocated ever more complex objects among users, such as landing slots and radio frequencies. In response, Milgrom and Wilson invented new formats for auctioning off many interrelated objects simultaneously, on behalf of a seller motivated by broad societal benefit rather than maximal revenue. In 1994, the US authorities first used one of their auction formats to sell radio frequencies to telecom operators. Since then, many other countries have followed suit.
Do the laureates have a health care connection? The answer is ‘yes’! Paul Milgrom’s most cited (non-textbook) paper is studies titled “Multitask Principal-Agent Analyses: Incentive Contracts, Asset Ownership, and Job Design.” The study discusses how to set up contracts one some components of quality can be observed by the principal but some cannot. It is a cautious tale on payer value-based purchasing arrangements with providers. Paul Milgrom’s co-author on the study, Bengt Holmstrom, actually won the Nobel Prize in 2016.
More commentary on the 2020 Economics Nobel prize winners can be found here:
Results from a survey titled “Coronavirus Impact and Recovery of the Small Businesses Economy“, which has collected responses from over 520,000 business owners in the US and Canada. Some general positive trends, but still over 20% of small business owners have concerns of their financial reserves running out and nearly 20% are concerned that the COVID-19 could cause the government to close businesses again.
More specifics by industry:
In short, despite some positive trends, COVID-19 has had a huge negative financial impact on many small businesses.
