Billy Wynne of the Healthcare Lighthouse blog hosts the latest edition of the Health Wonk Review. And, in a new first–literally–a post from Wright on Health is batting in the leadoff spot–just in time for the baseball playoffs to get started!
Monthly Archives: September 2014
He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors to air scrubbing systems at his infamous Chicago wine parties. And his mustache rules his twitter feed. In 2013 he was awarded the Star of Distinction, the highest civil award by the Government of Pakistan, for his inventions that are making significant impact in developing countries. He has written over 50 books, well over 100 research papers, and hundreds more articles in the field of science, philosophy, rhetoric, poetry and religion, drawing thousands of hits per day on his blog. Dr. Sarfaraz Niazi might just be the most interesting man in the world, but he is certainly the most interesting man pursuing biosimilars in the United States.
Throughout his career his driving principle has been to make things simpler. He did this while at Abbott Labs, as a former tenured professor at the University of Illinois at Chicago (UIC), in developing countries, and presently in his independent career at Therapeutic Proteins International, LLC (TPI) where he is working on biosimilars – or “copies” of current biologic pharmaceuticals that are about to lose their patents. Although only 17 biosimilars have been approved to date worldwide, though none in US, Dr. Niazi and TPI have nine in the pipeline to transform the entire market. According to photographer Steve Huff, Dr. Niazi is, “An amazing man, in fact the most interesting man in the world!”
Flexibility Is Key To Innovation
When asked his advice to other inventors in a recent interview, Dr. Niazi explained his philosophy that, “You should never get enamored by your thoughts. If the idea does not solve a problem or move the quality of life farther, there are many more things to be invented.” With that mentality, he is filing two products this year alone, similar to Amgen Inc.’s $6 billion molecule white blood count product, due to its expiring patent in the cancer market. Next year, the two molecules he plans to take to market are similar to AbbVie’s expiring $12 billion product Humira.
With movement like that, it’s no wonder Dr. Niazi claims that the U.S. Food and Drug Administration (FDA) is his “friend.”Nevertheless, he notes extreme complications with the rolling submission model, which can cost up to $4 million per submission in fees alone. Additionally, the four levels of the FDA’s “analytical similarity” benchmarking can be troublesome if one has a new biologic entity. This benchmarking, however, allows scientists and the FDA to work together in a predictable, step-wise fashion to move products to market quickly that have fingerprint-like similarity to existing US-licensed biologic products.
Dr. Niazi’s strategy is to create an analytical and clinical equivalent to biologics with expiring patents, which is preferred even over a Phase 3 clinical trial. By doing this, the cost of production is reduced drastically and the speed of development increases by 2-3 times. Dr. Niazi estimates an overall reduction in production costs for his biosimilars of up to 50% or higher compared to market competitors.
By being flexible, his products are proving to be bio-revolutionary.
Can The United States Catch Up?
Additionally, thanks to the Affordable Care Act (ACA), a shorter licensing path for lower-cost versions of cell-derived drugs is now possible, giving inventors like Dr. Niazi another pathway for approval and distribution.
While he claims that the ACA will not reduce health costs, he does believe that independent shocks to the health market will. By this, he believes that making biosimilars easier, faster, cheaper and better translates directly into his mission of making all things simpler. Further, cost-effectiveness in the US and European Union (EU) can directly convert into worldwide distribution and scalability that is safe.
Although a friend of the FDA, Dr. Niazi is not hesitant to note the tough decisions US-based companies face to stay in the states. Having FDA approval carries weight around the world, but the financial and regulatory burden can be great for inventors and business owners. In contrast, he asserts that the EU has moved ahead of the rest of the world, with the most established and advanced regulatory framework for the authorization and marketing of biosimilars, which has since been adopted by the World Health Organization (WHO).
Additionally, Dr. Niazi says that it is difficult to raise money in the US. Venture capitalists and corporate investors are less likely to take risk and have notoriously poor track records with the health sector
Investing In The Windy City
In 2003, the TPI founder committed that his work and company would stay in Chicago. He believed that from creation to manufacturing and testing to going to market, that TPI would excel in the Midwest due to Chicago’s health care ecosystem, experts and manufacturers.
Through a focus on creating “generic equivalents,” Dr. Niazi is proving that TPI can be wildly successful in the Midwest, and further, that in the same way generics revolutionized how people access pharmaceuticals, biosimilars can revolutionize the way those around the world access lifesaving treatments.
As his biosimilars enter the market with FDA approval, the ability of Dr. Niazi to impact the entire health sector grows because his biosimilars can be substituted for its reference product without provider or patient intervention. However, the FDA has not yet finalized these guidelines, and only 17 biosimilars have been approved internationally to date, of which none are by the FDA.
Ultimately, with numerous billion-dollar biologics coming off patent over the next six years, and the exorbitant cost for specialty drugs, the nine biosimilars TPI has in the pipeline stand to make a huge impact in the health sector. While Dr. Niazi could be doing many interesting things these days as an international man of mystery, he has devoted his research, time and energy to bringing high quality, cost-effective treatments to the US, and beyond. So long as he maintains his wine parties and poetry readings, its certain no one will complain.
When health reform made it on the agenda in 2008-9, it took almost no time to hear the old familiar line that government-run health care will mean rationing, with crowded waiting rooms and the dreaded prospect of it taking months or years to get seen by the doctor or have an important surgery performed. It didn’t matter when Brits and Canadians chimed in to say “Actually, it’s not like that here at all.” Americans succumbed to the combination of logic and fear. The logic is apparent: If more people have the ability to go to the doctor, and there isn’t suddenly a corresponding increase in doctors, then either doctors are going to have to see more patients in less time (potentially reducing quality), or patients are going to have to wait to be seen (and we don’t like to wait). Given my parenthetical explanations in the preceding sentence, do I even need to elaborate on the fear aspect?
There’s just one important question: Is that really what will happen? This is where the good folks at Harvard who do health policy and health services research are so lucky. In Massachusetts, which basically implemented ObamaCare at the state level years before ObamaCare came into being, we have a nice policy laboratory to investigate this question. That’s precisely what Karen Joynt and colleagues did, as they report in a recent article in Health Services Research.
The very short version of what they did is this: Using Medicare data, they looked to see if people with chronic diseases like diabetes and hypertension had fewer outpatient visits to the doctor after the Massachusetts health reform was enacted, compared to the number of visits they had before the reform. They also looked at some quality metrics in the same way. That is, did the patients get the treatments we know they are supposed to get? And they also looked at health care costs. The cool thing about this is that they were able to use patients in other New England states that didn’t have health reform as controls. That means that their study design is really able to attribute any changes they see in Massachusetts above and beyond what they see elsewhere in New England to the health reform in Massachusetts.
The very short version of what they found is this: There was no decrease in health care visits or health care quality in Massachusetts because of health reform, but there was an increase in costs. Now, there are some limitations to what they did, but the authors acknowledge these nicely. The biggest issue is that Massachusetts had a low rate of uninsured persons to begin with, so their health care system was less flooded with newly insured than other places–like Kentucky–might be thanks to the ACA. The other big issue is that the study only examined the Medicare population age 65 and up, so we have no idea if the under-65 disabled Medicare population and everyone else may have experienced issues getting seen by a doctor. Still, despite these limitations, the study offers a ray of hope that our health care delivery system is responsive enough to adapt to an increase in demand without making us suffer lengthy waits to be seen for outpatient care, and that the ACA may well end up doing more good than harm.
Meaningful Use Stage 2 is coming to a theater near you.
A brief history: in 2008-2009 two acts created the incentive program for implementation of EHR that resulted in the Meaningful Use requirements: HITECH (Health Information Technology for Economic and Clinical Health), and ARRA (American Recovery and Reinvestment Act). The idea was that doctors who billed Medicare and Medicaid could get financial incentives to help them install EHRs in their practices, but only if the EHR and the doctor both ensured CMS that the EHR had “meaningful use”, i.e, that it did what CMS wanted it to do. It was supposed to be a phased-in process, and stage 2 requirements are more stringent than stage 1.
AMA board chair Steven Stack says that the AMA “has provided ongoing input since the inception of the EHR incentive program and has urged greater flexibility to make the program more reasonable and achievable for physicians.” This is sort of true. On March 15, 2010 AMA executive vice president and CEO Michael Maves wrote a letter to then-head of Health and Human Services Kathleen Sibelius. In it he said the following:
Last week, the American Hospital Association and the American Medical Association sent a joint letter to HHS Secretary Kathleen Sebelius asking for greater flexibility in the requirements of the meaningful use program:
“We appreciate the Department of Health and Human Services’ (HHS) decision to extend Meaningful Use Stage 1 through 2014. Physicans and hospitals have made significant investments in health information technology (IT), which is evidenced by the increasing numbers of providers who are using EHRs and attesting to Meaningful Use. We also share the administration’s commitment that no providers – or the patients they serve – are left behind as we proceed to Stage 2. However, our members, and the vendors they work with, report growing concerns that the rapidly approaching start date for Stage 2 is on a trajectory that will not provide enough time or adequate flexibility for a safe and orderly transition unless certain changes are made.”
Translation: The beatings will continue until morale improves.
The AMA has created a new framework for usability. At least, they’re calling it new. The rest of us have known this stuff for years. Things like this:
1. Poor EHR design gets in the way of face-to-face interaction with patients because physicians are forced to spend more time documenting required information of questionable value. Features such as pop-up reminders, cumbersome menus and poor user interfaces can make EHRs far more time consuming than paper charts. Amen.
2. Current technology often requires physicians to enter data or perform tasks that other team members should be empowered to complete. No kidding.
3. Transitioning patient care can be a challenge without full EHR interoperability and robust tracking. Yup.
4. Few EHR systems are built to accommodate physicians’ practice patterns and work flows, which vary depending on size, specialty and setting. Preach it!
5. Although physicians spend significant time navigating their EHR systems, many physicians say that the quality of the clinical narrative in paper charts is more succinct and reflective of the pertinent clinical information. A lack of context and overly structured data capture requirements, meanwhile, can make interpretation difficult. Yes.
6. Data “lock in” is a common problem. EHR systems should facilitate connected health care across care settings and enable both exporting data and properly incorporating data from other systems. The end result should be a coherent longitudinal patient record that is built from various sources and can be accessed in real time. Bring it to me Lord!
7. The meaningful use program requires physicians to use certified EHR technology, but many of these products have performed poorly in real-world practice settings. Ya think?
“Physicians believe it is a national imperative to reframe policy around the desired future capabilities of this technology and emphasize clinical care improvements as the primary focus,” says Dr. Stack. What would have been nice is if the AMA had pushed harder back in 2008 for regulations regarding usability and opposed regulation regarding meaningful use a little more.
While there are plenty of valid reasons to be skeptical about the Affordable Care Act, regardless of where you fall on the political spectrum, it’s hard to argue that imposing an individual mandate to purchase insurance won’t result in more people obtaining coverage. According to the results of a recent survey conducted by the Centers for Disease Control and Prevention (CDC), that’s precisely what’s happened. Based on results of the National Health Interview Survey, researchers at the CDC estimate that nearly 4 million people gained insurance coverage from January to March of 2014. Of course, we also know that people tend to procrastinate, and that consequently, there was a surge of last-minute sign-ups occurring in March. Those newly insured individuals aren’t accounted for in the CDC’s findings, and other estimates that include those individuals put the number of newly insured at between 8 and 10 million. Even then, as Jonathan Gruber is quoted saying in the New York Times, “This is really a three-year process of implementation….Trying to draw strong conclusions from one quarter of one year is impossible.” The bottom line is: The early indications are that more people have coverage, and things seem to be moving in the right direction. But let’s not get ahead of ourselves.
According to another report, though, the end of the third quarter may bring a slight uptick to the number of uninsured. Apparently, Uncle Sam has actually been checking on the information people submitted through Healthcare.gov when they signed up for coverage. As it turns out, the Centers for Medicare and Medicaid Services (CMS) found that nearly 1 million people had issues documenting their status as U.S. citizens. Most of these people were citizens, complied with requests to submit proper documentation, and have kept their coverage. But there are still 115,000 people who have failed to submit documentation by the government’s September 5th deadline. As I’m writing this, these people have two weeks to get their documentation in order. If they do not do so by September 30th, they will lose their coverage. On top of this, more than 350,000 other people–who are unquestionably U.S. citizens–may lose their federal subsidies that lowered the cost of their insurance, because they didn’t submit verifiable proof of income to the government. Together, this represents nearly one-half million people that could be at risk of going without insurance once again after only part of a year.
The issue is whether the discrepancies in documentation are accurate reflections of reality. If someone is an undocumented immigrant, the law is clear that they are not entitled to purchase health insurance through the exchange. Likewise, if someone makes more money than they claim, the law is clear that they are only entitled to the amount of subsidy that corresponds to their actual income. So, if the failure to provide verifiable documentation is legitimate, then by denying these individuals coverage, or eliminating their subsidy, the government is simply correcting a mistake it should not have made to begin with. That is, these people should never have qualified for coverage or a subsidy. However, we know all too well the technical issues that Healthcare.gov has experienced, and many people are claiming that they have tried to upload their documentation electronically without success. If the fault lies with a federal website that continues to experience glitches, it isn’t appropriate to deny people who are lawful residents of the U.S. and/or who have accurately reported their income to be denied coverage. Which is the case? I can only speculate, but I’d be willing to bet it’s a mixture of both. What I do know is that this is one more wrinkle in a complicated implementation process. But, to paraphrase Dr. Gruber, we’ve got at least two more years to iron things out.
It’s a good one folks. I know I say that every time, and that’s because it’s true. Go read it!
As of September 2, CVS–the ubiquitous pharmacy / convenience store–has stopped selling tobacco products, including both cigarettes and smokeless tobacco. This is a bold move from the retailer, which is also planning to rebrand itself as “CVS Health” to emphasize its place in the health care delivery chain. I personally applaud the decision, because there are simply no benefits to tobacco use in any form. And it’s also worth noting that this is a move that is financially risky for CVS. At the time that they first announced their plans to make this change, corporate leadership projected a loss of roughly $2 billion in annual revenue stemming not only from the lost sales of tobacco products, but also the sales of other incidental items that individuals in the store to purchase tobacco might have made. You can’t accuse CVS of not putting its money where its mouth is.
Does this lost revenue concern investors? It doesn’t appear so. The day after the shelves were emptied of tobacco, shares of CVS are up by nearly 1%, and over the last 52 weeks, the share price is up by nearly 43%. What has investors so confident? The answer is likely the new direction that CVS Health is taking. Yes, they are a pharmacy, but they aspire to be–and in many cases already are–much more than that. Many CVS locations also contain minute clinics where one can walk-in without an appointment and be seen by a physician assistant or nurse practitioner to receive a diagnosis–and perhaps a prescription–in a short amount of time. They are planning to have approximately 1,500 clinics in operation within the next 2 to 3 years. CVS Health also operates as a pharmacy benefits manager–you might be more familiar with the name Caremark that could be printed on your insurance card. There’s big money in that business too.
So, this looks like good news for the health of the population, and good business for CVS Health and its shareholders, but is it enough? If you’re really in the business of health care, should you be selling sugar-sweetened beverages, candy bars, and potato chips? What about household cleaning products? They can be hazardous to your health. Many of these stores also sell beer, wine, and liquor. The bottom line is: There are a lot of things one can find inside a CVS that aren’t good for your health. Perhaps none of them are as unequivocally bad for you as tobacco, but then again, you can’t buy a six-pack and a frozen pizza at your doctor’s office. So, again, I applaud CVS for their bold move to make tobacco slightly less available, and to aspire to become CVS Health, but I also wonder if they’ve gone far enough in pursuit of that goal. If they really want to be in the business of health, maybe they need to get completely out of the business of everything else.