Eye disease biotech Oyster Point Pharma files for a $85 million IPO

Oyster Point Pharma, a clinical stage biotech focused on developing therapies for ocular diseases, filed on Friday with the SEC to raise up to $85 million in an initial public offering.

The Princeton, NJ-based company was founded in 2015. It plans to list on the Nasdaq under the symbol OYST. J.P. Morgan, Cowen and Piper Jaffray are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: OYST

https://www.renaissancecapital.com/IPO-Center/News/65316/Eye-disease-biotech-Oyster-Point-Pharma-files-for-a-$85-million-IPO

Relatively Small Weight Loss Can Put Diabetes Into Remission

British researchers have good news for people with type 2 diabetes — you don’t need to lose a ton of weight to make a difference in your health.
In fact, they found that losing just 10% of your body weight during the first five years you have the disease can lead to remission of type 2 diabetes. That weight loss would be 18 pounds for someone who weighs 180 pounds.
It doesn’t matter what diet helps you lose the weight. And it doesn’t matter how slow or how quickly those pounds come off, the investigators found.

“Even small amounts of weight loss can help you achieve remission. Extreme dieting and exercising are not necessary,” said study author Dr. Hajira Dambha-Miller, a general practice physician and clinical lecturer at the University of Cambridge School of Clinical Medicine, in the United Kingdom.
“Type 2 diabetes should no longer be seen as a lifelong disease,” she added. The disease can essentially be cured if you lose weight and keep it off, according to Dambha-Miller.
The researchers said that type 2 diabetes affects 400 million people around the world. It’s typically considered a chronic, progressive disease. But significant weight loss through extreme dieting (less than 700 calories a day) can bring about remission in almost 90% of people with type 2 diabetes, the study authors noted. Weight-loss surgery also tends to bring on remission.
Intensive exercise coupled with a modest weight loss of 7% or less of body weight brought on remission in almost 12% of people in one study, according to the new report.
But maybe bringing on remission didn’t need to be so hard, the researchers surmised.
“The existing evidence for achieving remission suggests extreme levels of exercise and rather restrictive diets. This is simply not realistic or achievable for my patients, especially in the longer term,” Dambha-Miller said.
“It is also demotivating for my patients when they are unable to achieve large amounts of weight loss. Accordingly, we decided to look at modest weight loss over a longer period in a real-world population without any crazy diet or exercise requirements,” she explained.
For the new study, the researchers followed the health of almost 900 people newly diagnosed with type 2 diabetes for five years. The study participants, aged 40 to 69, provided information on weight, activity levels, diet and alcohol consumption.
Thirty percent of the group had achieved type 2 diabetes remission at the five-year follow-up. Those who had achieved a 10% weight loss were 77% more likely to be in remission after five years, the findings showed.
There was no specific intervention in the study. “This means there were no mandatory exercise or dietary requirements. All our participants did different things and still managed to lose weight and beat diabetes into remission,” Dambha-Miller said.
She said that experts don’t know exactly how losing weight helps, but they hypothesize that as people lose weight, the beta cells in the pancreas that produce insulin start to work again. That means the body can properly use sugar from foods instead of letting it build up in the blood.
Dr. Berhane Seyoum, chief of endocrinology at Detroit Medical Center and Wayne State University in Michigan, wasn’t involved in the current research, but said the findings are encouraging.
“People with type 2 diabetes can be encouraged to lose weight, and it doesn’t matter how. They can do whatever is convenient for them. Controlling diabetes keeps you healthy, gives you more energy and makes you feel better,” he said.
Seyoum also noted that any amount of weight loss can help the body use insulin better and will help with diabetes management.
The study was published online recently in the journal Diabetic Medicine.
More information
Read more about weight loss and diabetes from the American Diabetes Association.

SOURCES: Hajira Dambha-Miller, M.R.C.G.P., Ph.D., general practitioner and clinical lecturer, the University of Cambridge School of Clinical Medicine, United Kingdom; Berhane Seyoum, M.D., chief, endocrinology, Detroit Medical Center and Wayne State University, Detroit; Sept. 30, 2019, Diabetic Medicine, online

https://consumer.healthday.com/diabetes-information-10/type-ii-diabetes-news-183/just-a-little-weight-loss-can-put-diabetes-into-remission-750906.html

Tricare Drug Costs to Increase More Than 40% in 2020

Prescription drug costs for Tricare users are set to rise Jan. 1, some by as much as 42%.
Effective Jan. 1, 2020, a 90-day supply of generic drugs received through the program’s Express Scripts mail-order pharmacy will increase from $7 to $10. Co-pays on brand-name drugs received through the mail will go from $24 to $29; the price rises from $53 to $60 for non-formulary drugs.

Generic drug prescriptions filled at retail pharmacies will see the cost rise from $11 to $13 for a 30-day supply, while the same supply of brand-name medications will increase from $28 to $33. Non-formulary drugs — those not on Tricare’s list of fully covered medications — will go up from $53 to $60.
Prescriptions filled on base will continue to be free.

The price increases, while normal in the civilian world, are fairly new to Tricare. They were mandated by Congress as part of the 2018 National Defense Authorization Act in an effort to bring the amount users pay into line with the actual costs of prescription drugs, which have been skyrocketing in recent years.
Per that law, these annual increases will continue until at least 2027.
Out-of-network pharmacy costs are also increasing. Users who buy drugs at those pharmacies or overseas must first meet their annual deductible, which varies by Tricare plan.
Tricare Prime users pay a 50 percent cost share for the drug after their point-of-service fee. All other users, except active-duty troops, will pay 20 percent of the total cost or $29, whichever is higher, for drugs on the formulary. They will pay 20 percent of the cost or $60, whichever is higher, for off-formulary drugs. Active-duty troops will be reimbursed for any out-of-network pharmacy fees.
https://www.military.com/daily-news/2019/10/03/tricare-drug-costs-increase-more-40-2020.html

Rite Aid’s Turnaround Hinges On Health Plans, Not Amazon

Rite Aid’s relationships with health insurance plans appear to be a priority to turning around the drugstore chain rather than another attempt at a merger.

Though it’s early in the reign of Heyward Donigan, the new Rite Aid chief executive officer is sending signals that putting the drugstore chain and its pharmacists in a good spot with health insurers is critical to the company’s survival.
It’s in sharp contrast to the dream of some longtime Rite Aid shareholders who have held on to the stock hoping the pharmacy chain will become a potential acquisition target of the online retailer Amazon, which has talked about getting deeper into healthcare and the prescription business.
But selling Rite Aid didn’t go so well under Donigan’s predecessor, John Standley, who departed after two failed mergers and a plummeting stock price that drew the ire of shareholders.
“Given my background, it’s going to be obvious that health plans are going to be a key focus for this company,” Donigan told analysts on the company’s fiscal second quarter earnings call last week.
Donigan touted her past executive roles at Premera Blue Cross, ValueOptions and Sapphire Digital. And she said she will draw on that work with health insurers, medical providers and pharmacies to build and grew Rite Aid, which has watched its sales deteriorate.
“The partnership between us and health plans in the regions that we serve is going to be crucial to our future,” Donigan told analysts. “And I think we can really add a tremendous amount of value to their future.”

While she’s been CEO for less than two months, she wants to leverage Rite Aid’s thousands of pharmacists as a way to provide more healthcare services.
“Pharmacists are the ultimate physician extender, if you think about it,” Donigan said. “Our pharmacists touch probably more members on a daily basis and engage more consumers on a daily basis than any other provider in America.”
Rite Aid also plans on highlighting its pharmacy benefit manager, EnvisionRx Options, when negotiating deals with employers and health insurance companies.
Rite Aid’s PBM will remain a part of the company at a time when larger PBMs are now owned by health insurance companies, executives told analysts last week. Last year, Cigna bought the PBM Express Scripts while Anthem this year is rolling out its own PBM, IngenioRx and the nation’s largest health insurer, UnitedHealth Group, owns OptumRx.
“Our progress in attaining more lives in the health plan business is because of our position as an independent pharmacy services alternative offering of flexible models,” Ben Bulkley, who was named CEO of Rite Aid’s EnvisionRxOptions earlier this year. “Clients and prospects indeed share their support for EnvisionRx as an essential option in the marketplace.”
https://www.forbes.com/sites/brucejapsen/2019/09/30/rite-aids-turn-around-hinges-on-health-plans-not-amazon/#280c7fc6d06a

The Real Impact Of Drug Price Legislation On Biopharmaceutical R & D

As outcry around drug prices rages, arguments continue to surface that limiting corporate revenues via price controls will have little impact on biopharmaceutical innovation. The latest salvo comes from academics at Rutgers Law School. In an article published by STAT, the authors claim that the industry grossly overstates the impact of price controls, likening the industry to Aesop’s boy who cried wolf.

“Big Pharma has cried Innovation Wolf every time Congress seeks to address its shenanigans. And the legislators keep coming to defend it. That has got to stop. It is past time for the industry to be called to account on using its get-out-of-jail-free innovation card to avoid reasonable legislation. As we get closer to the finish line of passing legislation addressing product hopping and other games, the cries about threats to innovation will grow louder and more urgent. But the industry’s history needs to be remembered. Consumers’ lives depend on it.”
One can argue that consumers’ lives have been saved by innumerable breakthroughs made by the biopharmaceutical industry in AIDS, cancer, infectious diseases, heart disease, etc., etc. But what about their rant about biopharma playing the “innovation card”? What’s the true impact that price controls could have on R&D?

The following account is a dramatic demonstration of what happens when R&D budgets get significantly cut. In late 2006, Pfizer learned that a potentially major new cardiovascular drug, a drug that essentially remodeled patients’ lipoprotein profiles, had no effect in prolonging the lives of people with heart disease. This drug had been expected to be a key driver of future revenues and propel Pfizer’s growth over the coming decade. These clinical results were devastating and led the CEO to decide that the company had to be “right sized” based on decreased future projected revenues. In other words, budgets across the entire company had to be cut – including that of R&D.
At the time, I was in charge of global R&D from the initial discovery stage through regulatory approval. My budget was just under $5 billion. (Pfizer’s overall corporate R&D budget was close to $8 billion, but this number included the R&D budgets of other divisions, the costs of post-marketing clinical trials, research expenses for outside investments, etc.) Going into 2007, R&D was seeking a 10% increase. That’s a pretty hefty number based on a $5 billion base. However, this increase was needed to maintain the ongoing programs, many of which were in key – and expensive – clinical trials. However, given the new reality, no budgets were being increased. Instead, R&D was told to cut its budget by 10%. So, instead of the initial vision of about $5.5 billion to run a global organization of approximately 13,000 people and a portfolio of over 100 compounds in various stages of development, we now had to figure out how to manage with $1 billion less.

I imagine the response of many would be “Big deal!” Large companies are inefficient and unwieldy. Certainly there must be plenty of fat that can be cut. Actually, for us there wasn’t. In 2000 and then again in 2004, Pfizer made major acquisitions, first Warner-Lambert Parke-Davis and then Pharmacia. In each case, to justify to shareholders the wisdom of these mergers, “synergies” had to be found; that is, the organization had to remove overlap and cut programs after vigorous prioritization processes. As a result, a lot of cost cutting had already taken place. Sure, there are always cuts that can be made. But simple changes were not going to provide $1 billion in savings.
It became pretty apparent that to meet Pfizer’s needs, R&D was going to not just drop programs but also eliminate “bricks and mortar” – research sites and the jobs of scientists who worked in these labs. Smaller sites were the obvious choices including two in France and one in Japan. But, this didn’t provide nearly enough savings. Eventually, we decided to close the legacy Parke-Davis labs in Ann Arbor, Michigan and eliminate that site’s 2,200 jobs. Coming at a time when the auto industry was experiencing its own economic issues in Michigan, this closure generated serious concerns across that state.
So, what does this have to do with proposals such as the government setting drug prices, cutting back patent life on drugs or even going so far as allowing “march in rights” to compel companies to license their patents to the government? Biopharmaceutical companies invest 15 – 20% of their top lines revenues into R&D – a number that’s higher than any other industry. Any legislation designed to cut drug prices will impact every biopharmaceutical company. Such legislation would theoretically have a meaningful impact on company revenues. Otherwise, why bother enacting such laws. Let’s say that such actions reduce a company’s revenues by 10%. Interestingly, that’s the same number I had to deal with – and look at the impact that had on cities around the world. Now, envision that on a global scale.
Certainly, innovation didn’t dry up at Pfizer when the episode described above occurred. In fact, over the years, Pfizer has rebounded pretty well. However, at the time, these closures had a dramatic impact on the R&D organization. A significant number of programs were dropped and fewer scientists were available to exploit the opportunities for new drug discovery and development. A 10% budget cut in R&D across the board for the biopharmaceutical industry would be felt not just in the U.S. but around the world. There will still be innovation – but significantly less of it. Ironically, this is a time when we should be increasing R&D given the enormous opportunities that exist for new medicines and cures. Instead, industry critics are proposing to go in the opposite direction.
By all means, let’s continue to look for ways to have affordable drugs. But some of the schemes being bandied about, if enacted, will have an “Ann Arbor” like effect in many parts of the country. It is also important to remember that over the years advances in new drugs have saved us way more in hospital costs than have been spent on drugs. New medicines may be the best levers we have in reducing overall healthcare costs.
https://www.forbes.com/sites/johnlamattina/2019/10/02/the-real-impact-of-drug-price-legislation-on-biopharmaceutical-r–d/#4d19fa722ba2

10 Steps To Make Healthcare Available To Everyone

A week ago, world leaders gathered at the United Nations and approved a new declaration on universal health coverage, committing themselves to achieving universal access to care by 2030 and reaffirming the right to health for everyone, without distinction.

While many countries have made the important step of including the right to health in their national constitutions already, too many people around the world are still unable to access high quality and affordable care.
The American tech giant Cisco Systems recently partnered with the Southeast Asia office of ACCESS Health International to explore how policymakers can use digital technologies to deliver on their promise to provide access to quality care for all. For many countries the challenge isn’t one of intention, but rather implementation. Lifestyle changes, aging populations, and the related increases in chronic diseases mean that countries trying to achieve universal health coverage must provide an increasing amount of care with the same overall pool of resources.
In the Southeast Asia region, for example, there is a remarkable level of political commitment to universal health coverage. Yet, despite this commitment, only two ASEAN countries have achieved the goal. Digital technology offers new opportunities to overcome the challenges in achieving high quality, affordable and accessible care.

While digital technology encompasses thousands of initiatives, our research focused on three main technologies with high potential and demonstrated impact – telemedicine, health information systems, and tracking and notifications. We looked at countries in the Southeast Asian region and showed how they could bring high quality and affordable access to health for all through these technologies.
Based on our research, we developed a ten-point action plan governments can follow to leverage digital technologies to achieve universal health coverage. After reading them, I encourage you all to download the full report and share widely. Universal health coverage is attainable if we and our leaders demonstrate the commitment and make good on our actions.

10-Point Action Plan
Establish head of state mandate. A head of state mandates the necessary funding and cross-ministry coordination for eHealth in national development plans.
Build the national digital infrastructure. Governments must invest in the necessary telecommunications infrastructure that underlies an eHealth strategy.
Invest in human capital. Governments and the private sector share a mutual interest in and responsibility for training medical personnel and civil servants in technology capabilities and applications.
Develop a regulatory and legal framework. Parliament or the national assembly cements a mandate for digitizing healthcare in national legislation, protecting patients and enabling innovation.
Appoint an eHealth government agency. A centralized agency is best positioned to coordinate national eHealth projects across ministries; across district, provincial, and federal levels of government; and with patient associations, medical associations, and businesses.
Define an impact measurement framework. Quality, affordability, and cost-savings metrics should be built into every digital health intervention from the early stages of planning and extending to an assessment of health outcomes.
Lead a multi-sectoral strategy. An effective eHealth strategy requires a Ministry of Health-led approach that is transparent and multi-sectoral, including a clear vision for how the government will work with the private sector and a willingness to work with non-traditional partners.
Enable private sector innovation. The government should work with and empower the private sector to innovate, share knowledge, and deliver efficient healthcare services.
Adopt a lens of equity. Technology investments and policies should strive to create equality and not focus primarily on urban areas or high-income groups.
Design for user experience. Innovators must engage and collaborate with users early on, aiding seamless clinical adoption and ensuring digital health interventions meet patients’ habits, lifestyles, and needs.
https://www.forbes.com/sites/williamhaseltine/2019/10/01/ten-steps-to-make-healthcare-available-to-everyone/#21a23a5d6d14

Walmart To Measure Doctor Quality In Local Markets

Walmart is rolling out an effort to measure the quality of community doctors who treat tens of thousands of its employees in the retailer’s latest effort to make sure its workers get the right care, in the right place and at the right time.

Because it’s Walmart, the effort is being watched closely by other employers and could have a far-reaching impact on U.S. doctors and other healthcare providers who are already being culled from employer and insurance company networks for poor quality and health outcomes. Narrow network strategies used by health plans provide enrollees an incentive to use a doctor that adheres to quality measures and is lower cost because they achieved a better outcome.
In Walmart’s case, the world’s largest retailer is launching several pilots effective Jan. 1, 2020 designed to improve quality and reduce costs in large part to eliminate unnecessary or unneeded healthcare services. The new concepts, considered in a test phase, will be an extension to the community doctor level of earlier efforts to guide patients to “Centers of Excellence” like the more specialized Mayo Clinic, Cleveland Clinic and Geisinger Health System to make sure certain heart, knee, hip and spine surgeries are done right the first time.

Walmart, which has more than 1 million employees, announced Wednesday the company will test a new “featured providers” program “that helps connect patients with local doctors who have a demonstrated history of providing the most appropriate patient care,” Walmart wrote in a column outlining the pilots. “Rather than relying on word of mouth or social media to find a provider, patients can get information based on actual data and proven results.”
Walmart is launching the “featured providers” program with a fast-growing data analytics company known as Embold Health, which says it uses data to “shine a light on top-performing doctors” from data gleaned from public and private insurers to create reports on individual doctors. Embold Health executives said its analysis “captures” whether care is appropriate, medically necessary by offering “benefits based on the latest scientific guidelines,” and cost-effective in how it is delivered.

“This data will help take the guesswork out of finding an affordable, quality local provider in eight specialties: primary care, cardiology, gastroenterology, endocrinology, obstetrics, oncology, orthopedics and pulmonology,” Walmart said in its column. “Walmart will use this data to curate a group of physicians with a track record of providing consistent quality care and then provide that to associates so they can make more informed decisions regarding their care.”
Initially, the “featured providers” program will begin in northwest Arkansas, the Florida markets of Orlando and Tampa and the Dallas/Fort Worth market in Texas, Walmart said. There will be about 60,000 employees and their family members in the featured providers pilot, Walmart said. For those who see a featured provider for care, they pay a $35 copay for a primary care visit or $75 for a specialist visit if they are enrolled in Walmart’s most popular plan though it can vary, executives said.
Walmart executives Adam Stavisky, senior vice president U.S benefits, and Lisa Woods, the retailer’s director U.S. benefits strategy and design, said they don’t plan to stop with the featured providers effort are continuing to look at ways to improve quality and hold medical care providers accountable. “(We’ve) been in the lab working on this for a longtime,” Stavisky said in a call with reporters Tuesday to discuss the new pilots.
Other employers are watching Walmart’s efforts closely as companies grow tired of paying for poor quality of care while at the same time watching their costs rise and their workers take on a greater share of the premium.
“Employers like Walmart are leading innovation within healthcare that has not been adequately responsive to the needs of purchasers and patients.” said Elizabeth Mitchell, president and chief executive of Pacific Business Group on Health, one of the nation’s largest employee healthcare business coalitions with 40 public and private employer members.
The “featured providers” program is part of a “suite of new medical benefits” Walmart said is deigned to make it easier for its workers to pick “high-quality physicians in local communities.”
Walmart’s other new health benefits for its employees that will be tested include:
* – a personal healthcare assistant, which is a concierge-like service that can help employees with billing, appointments, coordinating transportation to appointments. It will be tested in North Carolina and South Carolina.
* – expansion of its telehealth service for employees in Colorado, Minnesota and Wisconsin to include “preventive health, chronic care management, urgent care, and behavioral health for associates.”
“Through this voluntary program, patients can video chat with a doctor from the comfort of their homes, and, if they choose, access a personal online doctor . . . and an entire team to coordinate specialty care, provide nutritional and diabetic counseling and coordinate behavioral health referrals and visits billing and appointments, but also finding a quality provider, understanding a diagnosis and addressing other complex questions,” Walmart said.
https://www.forbes.com/sites/brucejapsen/2019/10/03/walmart-to-measure-doctor-quality-in-local-markets/#67391e9825d5