The facts continue to show that, when it comes to prescription drug costs, the country is heading in the right direction. But this doesn’t mean there aren’t patients who have a hard time affording the medicines they need. In fact, we know:
Many patients with commercial insurance have experienced a 50% increase in out-of-pocket costs for brand name medicines since 2014;
The growth in patients’ out-of-pocket costs generally has outpaced the growth in what insurers are spending on health care; and
The insurance industry often claims that these and other schemes are necessary to help keep premiums lower for everyone else. But a new analysis shows that is not the case.
Milliman released the results of a study – commissioned by BIO – that looks at the effects of a California law limiting how much insurers could require patients to pay out of pocket for prescription drugs. The law caps patients’ co-pays at $250 per month for each prescription. Milliman examined how the law impacted premiums for health plans offered through the state’s insurance marketplace.
In a piece published by Managed Care Magazine, the team at Milliman summarizes the results of the study, and they are encouraging to say the least:
California insurers expected that the cap on co-pays would only increase premiums by 1%;
The co-pay cap helps patients better manage their drug costs throughout the year, avoiding the financial shock many experience when a new benefit year begins;
Insurers in California did not expect the utilization or use of prescription drugs to increase because of the co-pay law, which suggests total spending on medicines would remain stable; and
These results should apply to employer-sponsored health plans offered through the workplace, which is where the vast majority of Americans receive their health care.
These findings show that instead of shifting more costs onto the sickest patients, insurers should be limiting what patients pay out of pocket for medicines and that they can do so without increasing health care costs for everyone else. We know there are positive steps insurers can take right now to do just that. Two insurance companies have promised to pass along to patients the rebates the companies receive from drugmakers to help lower the cost of medicines, and one insurer even stated this commonsense approach would have a “negligible” impact on premiums.
But more needs to be done and more insurance companies need to follow suit. If they won’t, then policymakers need to ask the insurance industry why people are paying more for less coverage, get some real answers and demand better.
The United States Patent and Trademark Office (PTO) is currently considering a rules change that, if enacted, would significantly improve how it conducts patent challenge proceedings. This is a policy change that BIO has long advocated for.
This week BIO submitted comments to the PTO in support of the proposed revisions to the standard for construing disputed claim terms in inter partes reviews, post-grant reviews, and covered business method reviews (“post-grant proceedings”).
Labeling of GMOs has been in the news a lot lately. Actually, the issue has been in the news a lot for several years now. People say they have a right to know what’s in their food and how their food is grown. The question is: Why GMOs? Why not other breeding methods like mutagenesis, crossbreeding, or polyploidy? None of them are “natural.” All of them made with man’s intervention. All of them involved changes to DNA. Why now? GMOs have been on the market in the United States for more than 20 years now – why is there a big push for labeling GMOs now?
Young man in supermarket comparing bottles of oil, rear view, close-up
Most importantly, should you care if GMOs are labeled? Should you be worried? Should you avoid GMOs, once you start seeing them being labeled? A new study shows that GMO labels reduce peoples fear of GMOs. But does it matter?
GMO Answers volunteer expert Connie Diekman, M.ED., RD, CSSD, LD, FAND, has written a new op-ed in the Kansas City Star that tells what you really need to know about GMOs and labels.
GMO crops have been around since the 1990s. As outlined in the Academy of Nutrition and Dietetics’ review “Advanced Technology in Food Production,” they are grown by farmers in the U.S. and in 28 nations around the globe. The process involves introducing desirable traits in plants, either by selective breeding of healthy strains or by crossbreeding related species.
And
In 2016, the National Academies of Science released a review of more than 1,000 research publications, which concluded that there was no difference between GMO and non-GMO crops in regards to nutritional value or impact on human health. As a registered dietitian, I found strong confirmation in that review of the benefits and safety of these products.
Further, a 2018 systemic review paper in The Journal of The Academy of Nutrition and Dietetics looked at GE, or genetically engineered, foods – a specialized subset whose genes have been modified using technology – and found their allergenic potential is no different from that of conventional foods.
So while you’re reading these stories about GMO labeling, seeing posts on social media about the issue, remember to stick to the facts and not fall prey to hyperbole and scare tactics.
To learn more about GMOs, visit the GMO Answers website to explore and submit your own questions about the technology.
Next week is the 2018 BIO World Congress on Industrial Biotechnology in Philadelphia. This year’s conference features robust programming for anyone working in industrial biotechnology, including four plenary sessions, 28 breakout sessions across seven tracks, 10 GreenTech Investor Sessions and more than 50 company and technical presentations.
Not to be missed, however, are several sponsored workshops designed to assist attendees of the 2018 BIO World Congress in taking advantage of invaluable opportunities to advance their companies. From learning about finance programs available to help companies develop and commercialize their products to an overview of new technologies revolutionizing the industry, you won’t want to miss any of the sponsored workshops.
The four sponsored workshops will take place Wednesday, July 18, from 10:15 – 11:30 a.m. and include:
A Thriving Bioeconomy: USDA’s Role, Outreach and Finance Programs
Sponsored by USDA Rural Development
A thriving bioeconomy requires research, commercialization, programs and policy to bring biobased products to market. Included in USDA’s Rural Development efforts are research and development, technology transfer-marketing and verification, commercialization and government procurement programs. Additionally, USDA’s grant and guaranteed loan programs finance construction and development of commercial-scale biorefineries and manufacturing facilities and advancement of new and emerging technologies for the production of advanced biofuels, renewable chemicals, and biobased products. At this workshop, you’ll learn about the various opportunities available through USDA to help your company advance in the biobased economy.
Renewable Chemicals and Biofuels Processes Use of Sartorius ambr ® 250 Platform and Umetrics Software for Process Optimization, Scale-Up and Advanced Analytics
Sponsored by Sartorius Stedim
Process development and optimization in industrial biotechnology requires technical solutions which reduce timelines, increase efficiency, and raise likelihood of success. Sartorius’ (booth #317) ambr®15 and ambr®250 fermenters as well as Umetrics Suite of software for advanced analytics has been widely applied to speed up process development and implement advanced data analytics in manufacturing. Ginkgo Bioworks will detail case studies involving process optimization and scale up from ambr® to 50kL, minimizing developing timelines including an example of taking a shake flask process to economically viable titers in 2 months, scale down from 400kL to 15 and 250mL scale in order perform strain screening experiments, and demonstrating similar performance to 2.5L benchtops when modeling a commercially available process using an insoluble media. This workshop provides an overview of the technology through product reviews, customer case studies and visions for the future. It wraps up with a Q&A session.
Successful Deals on How to Structure and Close Biobased Economy Financing
Sponsored by Faegre Baker Daniels, Kilpatrick Townsend & Stockton LLP, and New Energy Risk
In this workshop, expert panelists will review the strategies on the first commercial bioeconomy transactions financially closed in 2017 and 2018. Our panelists and moderators constitute the principal investment bankers, lenders, investors and attorneys that structured, funded and/or closed each of these transactions involving biojet, renewable chemicals, biobased products, and renewable diesel projects throughout the country. Each of the transactions were financially closed under different and very sophisticated project financing structures which bodes well for successfully executing new technologies emerging in the respective biobased economy industries now and in the future.
USDA BioPreferred® Program Stakeholder Meeting
Sponsored by USDA BioPreferred Program
During this workshop, you’ll hear from representatives from BIO member companies as they share information about the role of high-value bioproducts in the global bioeconomy, learn about the benefits of working with the BioPreferred program and get the opportunity to provide suggestions and feedback for improvements to the BioPreferred program.
For more information about sponsored workshops, click here. For more information about the 2018 BIO World Congress, click here.
Today, 83 percent of children with cancer survive, compared to just 58 percent in the mid-1970s. Hepatitis C, a once-incurable disease, now has a cure rate of more than 90 percent, thanks to new treatments. And HIV/AIDS – once a death sentence – is now a manageable, chronic condition. This is the power of biopharmaceutical innovation, and it’s been truly remarkable to witness.
This progress would be impossible without the help and leadership of the Food and Drug Administration (FDA) – the hard-working public servants who review, approve, and are ultimately responsible for breakthrough medicines coming to the market in a safe and timely manner. Yet, a recent story by ProPublica takes a cheap shot at the Agency’s personnel, alleging that they are “fast-tracking expensive drugs” to support their budget for scientific reviews – a misleading claim that could not be further from the truth.
A more balanced approach would have highlighted the numerous advances in medicine that have been facilitated by FDA’s work and have resulted in lives saved and quality of life improved for millions of patients, rather than presenting negatives as the norm. A few months saved during FDA review can quite literally mean the difference between life and death for many – though the rigorous evaluation process is still required. Further, the story fails to note that prescription drug user fees also support significant and important post-market safety activities of FDA, including contributing substantially to the use of the Sentinel database. This database includes real-world data from tens of millions of patients and provides crucial insights into how those drugs are working once they reach the larger population, as well as safety issues that could not be detected in clinical trials that may need further exploration.
Next, the success of the Prescription Drug User Fee Act (PDUFA) program is hard to understate. As Dr. Janet Woodcock testified before Congress last year, “Before PDUFA’s enactment in 1992, Americans’ access to innovative, new medicines lagged behind other countries. FDA’s premarket review process was understaffed, unpredictable, and slow. The Agency lacked sufficient staff to perform timely reviews or develop procedures and standards to assure a more rigorous, consistent, and predictable process.”
PDUFA has provided FDA the ability to hire more highly qualified scientific and medical staff, to be sure. However, the increase in staff numbers is only one reason that FDA is able to efficiently and effectively evaluate and make available to patients innovative medicines that are safe and beneficial.
For example, developers of new medicines are able, because of PDUFA, to meet earlier with the Agency, to discuss potential roadblocks, such as possible safety concerns, how best to measure whether the proposed new drug is effective, and how to design clinical trials that have the best chance of answering the key question of whether the potential benefits of a proposed drug outweigh its potential risks. These discussions help lead to more efficient development programs that are most likely to provide meaningful and valid data. This has led to a significantly greater chance that an FDA decision about an application can be made in the first review cycle – saving FDA time, company time, and patient lives. However, neither PDUFA funds, nor meetings with FDA, nor the desire of patients, guarantees success or FDA approval. Every drug approved must meet the FDA gold standards for safety and efficacy. Drug development is risky business – an astonishingly small percentage of investigational drugs make it to the finish line. In fact, the overall likelihood of approval for an investigational new drug starting Phase I trials remains about 10 percent overall, and only 5 percent for oncology drugs, even with PDUFA’s successes.
PDUFA funds also provide FDA with the ability to meet with the public, including academic experts, physicians and other healthcare providers, consumers, and patients, to discuss creative approaches to developing new drugs. For example, meetings with the public are occurring to discuss the appropriate use of surrogate endpoints, the evaluation and validation of biomarkers, the use of real-world evidence, and the development of computer models and use of artificial intelligence to identify the most promising approaches to study an investigational medicine’s potential safety and effectiveness. Such public meetings generally have not been within FDA’s budget capability, so it is PDUFA funds that are allowing these robust and important public discussions to occur. This influx of funding has allowed the Agency to meet with patients and their advocates and caregivers, and to listen to patients’ first-hand views of their disease. To hear what patients need, to hear what patients expect, and to determine how best to address this need are crucial aspects of the FDA’s mission.
The ProPublica piece also takes an unfair swipe at expedited approval pathways, the goal of which is to help deliver safe and effective therapies to patients suffering from serious diseases. For instance, the Accelerated Approval program allows for review of a drug based on non-traditional endpoints if it is aimed at treating a serious condition and would fill an unmet medical need. It is a designation that is only judiciously granted. An approval under this designation can be based on a surrogate or intermediary clinical endpoint, but also requires confirmatory studies to prove the product’s clinical benefit.
Other expedited programs, such as Breakthrough Therapy Designation, simply confer additional Agency resources to an application, to help the most efficient development of products for significant unmet needs and where evidence indicates the potential to provide substantial improvement over current care, including for diseases for which there is no therapy and patients for whom there is little or no hope.
Like biotechnology companies, FDA must stand at the cutting edge of science to meet the needs of patients. It seems as though nearly every month – or even more quickly – we see new technologies and true breakthroughs coming through the pipeline. And these high-quality and remarkable technologies are changing the face of medicine. Transformative new technologies such as CAR-T cell therapies for blood cancers, gene therapies for genetic diseases, and next generation immuno-oncology drugs represent real breakthroughs for patients that will change the way we treat disease forever. The developers of such transformative technologies provide strong evidence of safety and efficacy.
We all owe patients a careful and efficient FDA review that will ensure these breakthroughs reach them as quickly as possible.
In an opinion piece published at CNBC.com, Tahir Amin – co-founder of I-MAK – blames the U.S. patent system for our country’s “high drug prices.” The author commits many of the same errors we see regularly from critics of the biotech industry.
For example, he ignores the fact that the trend on prescription drug costs is actually heading in the right direction. Not surprisingly, he also neglects to mention that insurance companies have continued to shift more prescription drug costs onto patients through higher deductibles and co-insurance requirements.
Setting aside Amin’s flawed approach to prescription drug pricing, his views on the patent system and the prescription drug ecosystem are severely skewed and perhaps more dangerous to the future of biomedical innovation.
Patent “evergreening” is a red herring. Amin and others claim that brand name drugmakers are gaming the system by receiving additional patent protection for frivolous add-on inventions. But the facts tell a different story. According to academic studies, there are on average only 2.5 “secondary” patents per drug, and more than 75% of these secondary patents were filed before the drug received FDA approval. These are not “new patents on old drugs” as critics want us to believe. What’s more, these patents usually relate to valuable clinical improvements, such as supplying a drug in a special dosage form to patients with special needs.
Generic medicines are coming to market at a record rate. If there is some coordinated effort by the biotech industry to block generic competition, it isn’t working.
According to representatives of the generic drug industry, 89% of all drugs dispensed in the United States are generics. As OECD health statistics show, this far exceeds the share of generics sold in other countries, such as the United Kingdom (83%), Germany (81%), Canada (73%) and France (30%).
Meanwhile, FDA Commissioner Scott Gottlieb recently praised his agency for approving the “highest ever number of generic drugs” last year (more than 1,000 generic approvals). Once generic medicines are approved, they are gaining greater market share more quickly than ever before. And according to a report in the Journal of Medical Economics, the time it takes for a generic medicine to reach the market has remained steady for the last two decades.
I-MAK wants innovation, but wants to punish innovators. How else to explain I-MAK’s attempts at filing patent challenges against the company that recently discovered the first cure for hepatitis C? Amin balks at the cost of the cure, but omits several important facts.
He cites the list price of the cure, but any honest review of the facts will show that this is almost never what the drugmaker makes or what patients pay. That’s because every day drugmakers provide significant rebates off the list price of the drug to help promote broader patient access. These savings reached an estimated $154 billion in 2017, and the question is whether insurance companies and middlemen are passing the savings along to patients.
Competition from other innovators is driving down prices, and the cure for hepatitis C is a great example. Less than two years after the first hepatitis C cure hit the market, the average discount to payers was roughly 50% due to intense market competition from other drugmakers who soon released their own innovative cures. Today, Hepatitis C patients have multiple medicines to choose from at a fraction of the cost of the first treatment and a more than 90% chance of beating the disease.
Third, and perhaps more important, the costs associated with not curing hepatitis is far greater and more devastating. Before a cure for hepatitis C hit the market, the cost of treating the disease ranged roughly between $155,000 and up to $489,000. Today, the cost of care for a patient with the disease is approximately $60,000. Thanks to biomedical innovation, a cure for a deadly disease is saving lives and saving money throughout the health care system. Yet insurers still discriminate against those who need treatment, despite the benefit it provides patients and our health care system more broadly.
Our nation develops more new medicines than the rest of the world combined (57% of all new medicines to be exact), thanks in no small part to a patent system that rewards and protects innovation. These are facts Amin appears willing to ignore, because it fits well with his organization’s mission of paying lip service to biomedical innovation while pursuing an agenda that threatens the discovery of new cures and treatments. Patients and policymakers: Beware.
On July 4th across the country people will be celebrating the United States of America’s independence and birth. Many celebrations will feature hot dogs, hamburgers and other types of meat. As the past is celebrated, however, the future of Independence Day cookouts may not be present in people’s minds.
Recent innovation in biotechnology has allowed companies to develop alternative proteins using animal stem cells. Right now, there are only a few companies working with, producing and selling this type of meat, including Impossible Foods and Memphis Meats. A third company, Finless Foods, is even looking to produce fish without the need for tackle and reel. As these companies continue to innovate – and another object of forward-thinking innovation becomes reality – let’s have a look at some of the reasons why researchers are looking at biotechnology to develop alternative proteins:
In 2050, the world’s population will reach about 9 billion people. As the population sky rockets so will the demand for protein. And in a world where the amount of land available is also decreasing (livestock already occupies 70% of the arable land), biotechnology can develop safe, consumable alternative protein that could help meet this increased demand.
Raising livestock requires a lot of water and feed and releases greenhouse gases, which is detrimental to the environment. Developing alternative proteins would provide a more environment friendly alternative to current farming techniques.
As the human population continues to grow, so does the diversity of diets. Becoming more and more popular are meat-less, vegetarian or other diets that do not allowfor the consumption of meat from animals. The introduction of alternative proteins could help meet demands for protein for an array of diets.
Alternative proteins are made in sterile environments, reducing the risk for diseases or pathogens, like Salmonella or Listeria, significantly.
But, as with any new innovation there are initial drawbacks. High production costs may be a concern for those companies producing alternative proteins, but since 2013 the cost of an alternative protein burger has dropped substantially from $325,000 to a mere $11.36. Another potential drawback is the potential to scale up protein production to meet demand. However, new procedures are beingdeveloped that can grow a lot more meat by improving cell growth.
Credit: Impossible Foods
The innovation for alternative protein is happening rapidly Thirty years from now, people may be grilling and eating alternative proteins just like they grill hotdogs and hamburgers today. But ultimately, whether or not that will happen is in the hands of the consumer. Will consumers accept the benefits and idea of eating lab-grown meat or will this innovative biotechnology become another fad that flames out?
