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We found this of interest because it has benchmark statistics on the use of specialty injectables worldwide. Specialty is an international issue and has reached mainstream treatment for many chronic conditions including cancers, rheumatoid arthritis, blood disorders, etc.
World’s established centers of biotech activity reach aggregate profitability for first time
“Biotech companies have long confounded predictions on their ability to survive difficult economic conditions and 2009 was no different,” said Glen Giovannetti, Ernst & Young’s Global Biotechnology Leader. “Companies will continue to face a challenging funding environment for the foreseeable future. The firms best poised for success are those that can seize the opportunities latent in the near-universal need for increased efficiency — from capital efficiency to new approaches to R&D and creative models for funding and partnering.”
Key financial results:
“The European biotech community showed great fortitude in meeting the challenges of the economic downturn, with only a small reduction in the number of public companies,” said Jürg Zürcher, Ernst & Young’s Biotechnology Leader for Europe,
Adapting to the “new normal”
Biotech companies are now operating in a new normal, where access to capital will remain difficult. With less available capital, venture capitalists are being more selective and reserving funds for existing portfolio investments. Some funding is being directed to finance R&D assets or projects, with potentially faster returns, instead of starting new companies. IPO investors are primarily seeking more mature, de-risked investments, and IPOs are pricing below companies’ expectations. Other public funding is increasingly concentrated in a smaller number of companies. Big pharmaceutical companies still need to acquire promising products for their pipelines, but recent mega-mergers and efforts to exit therapeutic categories have reduced the number of potential buyers for any given biotech asset.
The biggest opportunities in this new normal will come from increasing efficiency: more efficient ways to fund innovation and achieve returns for investors, better outcomes for every dollar of health care spending, and more efficient R&D and operations at drug companies. The Beyond borders report identifies five guiding principles for biotech companies operating in the new normal:
Key regional findings:
Canada/Australia
About Ernst & Young’s
Ernst & Young’s Global Life Sciences Center brings together a worldwide team of professionals to help life sciences companies address their challenges at every stage of development. From the emerging biotech or medtech firm to the well-established, global pharmaceutical company, our industry teams bring deep experience in providing assurance, tax, transaction and advisory services. The Center works to anticipate market trends, identify implications and develop points of view on relevant industry issues. Whether it’s forming innovative alliances, improving operations, new regulations or exploring new markets, we can give you a clear perspective on how to drive value in an increasingly complex, competitive and risk-driven environment. It’s how Ernst & Young makes a difference.
For more information, please visit www.ey.com/lifesciences or email globallifesciences.center@ey.com.
About Ernst & Young
Ernst & Young is a global leader in assurance, tax, transaction and advisory services. Worldwide, our 144,000 people are united by our shared values and an unwavering commitment to quality. We make a difference by helping our people, our clients and our wider communities achieve their potential.
Ernst & Young refers to the global organization of member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a
This news release has been issued by EYGM Limited, a member of the global Ernst & Young organization that also does not provide any services to clients.
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
We found this article to be of particular interest, because it describes a program that actually works. We have advocated for a long time that drugs are not the answer to every problem, and too many drugs are harmful. Antibiotics are a case in point. This article was also referenced in our Pharmacy Benefit News, Issue 132.
Look closer, however, at a microscopic level, and this place is pristine. There is no sign of a dangerous and contagious staph infection that killed tens of thousands of patients in the most sophisticated hospitals of Europe, North America and
The reason: Norwegians stopped taking so many drugs.
Twenty-five years ago, Norwegians were also losing their lives to this bacteria. But
Now a spate of new studies from around the world prove that
``It's a very sad situation that in some places so many are dying from this, because we have shown here in Norway that Methicillin-resistant Staphylococcus aureus [MRSA] can be controlled, and with not too much effort,'' said Jan Hendrik-Binder, Oslo's MRSA medical advisor. ``But you have to take it seriously, you have to give it attention and you must not give up.''
The World Health Organization says antibiotic resistance is one of the leading public health threats on the planet. A six-month investigation by The Associated Press found overuse and misuse of medicines has led to mutations in once curable diseases like tuberculosis and malaria, making them harder and in some cases impossible to treat.
Now, in
ANTIBIOTICS MISSING
Dr. John Birger Haug shuffles down Aker's scuffed corridors, patting the pocket of his baggy white scrubs. ``My bible,'' the infectious disease specialist says, pulling out a little red Antibiotic Guide that details this country's impressive MRSA solution.
It's what's missing from this book -- an array of antibiotics -- that makes it so remarkable.
``There are times I must show these golden rules to our doctors and tell them they cannot prescribe something, but our patients do not suffer more and our nation, as a result, is mostly infection free,'' he says.
• Norwegian doctors prescribe fewer antibiotics than any other country, so people do not have a chance to develop resistance to them.
• Patients with MRSA are isolated and medical staff who test positive stay home.
• Doctors track each case of MRSA by its individual strain, interviewing patients about where they've been and who they've been with, testing anyone who has been in contact with them.
``We don't throw antibiotics at every person with a fever,'' says Haug. ``We tell them to hang on, wait and see, and we give them a Tylenol to feel better.''
Dr. John Jernigan at the U.S. Centers for Disease Control and Prevention said they incorporate some of Norway's solutions in varying degrees, and his agency ``requires hospitals to move the needle, to show improvement, and if they don't show improvement they need to do more.''
And if they don't?
``Nobody is accountable to our recommendations,'' he said, ``but I assume hospitals and institutions are interested in doing the right thing.''
Around the world, various medical providers have successfully adapted
In 2001, the CDC approached a Veterans Affairs hospital in
The program has now been expanded to all 153 VA hospitals, resulting in a 50 percent drop in MRSA bloodstream infections, said Dr. Robert Muder, chief of infectious diseases at the VA Pittsburgh Healthcare System.
``It's kind of a no-brainer,'' he said. ``You save people pain, you save people the work of taking care of them, you save money, you save lives and you can export what you learn to other hospital-acquired infections.''
``So, how do you pay for it?'' Muder asked. ``Well, we just don't pay for MRSA infections, that's all.''
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
The new 2010 National Drug Control Policy may affect all healthcare professionals—in other words, increase our work loads. Pharmacies may be required to increase and/or add to their record keeping. Pharmacists may be held legally and criminally responsible for additional issues. Non-licensed pharmacy personnel may be held to a higher standard; which as we all know is another way of saying increased salaries. Other healthcare providers and personnel may also be similarly affected.
We recommend that all healthcare professionals monitor developments in the new drug policy closely. Changes in all systems and procedures may be necessary and budgets may be adversely affected.
Source: APhA Legislative and Regulatory Update - May 19, 2010
On May 11, President Obama and Director R. Gil Kerlikowske of the Office of National Drug Control Policy (ONDCP) announced the release of the Obama Administration's first National Drug Control Strategy. The goal of the 2010 Strategy is to use a comprehensive approach to reduce drug use and its consequences through a balanced policy of prevention, treatment, recovery, enforcement, and international cooperation. The Strategy was developed with input from law enforcement, health care professionals and associations, drug treatment providers and corrections professionals, individuals in recovery, parents and support groups.
The Strategy focuses on the following key objectives:
APhA provided comments to ONDCP in September 2009 and is pleased that ONCDP referenced APhA and pharmacy in the report. Specifically, the following action steps are of interest of pharmacy:
For additional information, read press statements, highlights, and the complete report on the 2010 Strategy Web site.
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
Some of our clients have asked about the rationale for the Walgreens/CVS-Caremark issue. Clearly money is the primary rationale. However, the National Community Pharmacist Association (NCPA) is providing some other rationale from their viewpoint. We thought that you would find this of interest.
NCPA eNews Weekly | June 15, 2010
Two days after Walgreens announced that it would not participate in any future CVS Caremark network plans, CVS Caremark responded by terminating Walgreens' participation in all its network effective July 9. The giant chain pharmacy/PBM/ mail order conglomerate said it would drop Walgreens from its Medicare Part D network effective Jan. 1, 2011.
When Walgreens announced its decision June 7, it cited many of the same problems experienced by independent pharmacies and prompted NCPA 18 months ago to launch a campaign for a Federal Trade Commission investigation of CVS Caremark's business and patient privacy protection practices. Last November, CVS Caremark disclosed that it was under FTC investigation. In addition, 24 states are probing the company created by the merger of the pharmacy chain with a PBM/mail order firm. NCPA members have had a number of meetings with FTC officials about their experiences since the 2007 merger.
Those experiences largely mirror those cited by Walgreens:
CVS Caremark limits patient choice by requiring patients in Maintenance Choice and other plans to use CVS retail pharmacies or Caremark mail order facilities.
CVS Caremark provides little or no information when a CVS Caremark prescription drug plan is transferred to a different and differently-priced CVS Caremark pharmacy network, or when CVS Caremark acquires a new prescription drug plan as a client."
CVS Caremark reimbursement rates are unpredictable and payments for certain drugs often don't reflect the market."
"If a large, publicly traded chain with the clout of Walgreens finds the business practices of CVS Caremark untenable, then it's easy to understand how much greater the problems have been for independent community pharmacists and their patients," commented Joseph H. Harmison, PD, NCPA president. "The concerns expressed by Walgreens echo and further validate the concerns expressed by independent community pharmacists and their patients."
"Unfortunately, for most independent pharmacies, simply telling CVS Caremark 'no' isn't a viable business option," Harmison continued. "The evidence is piling up and hopefully corrective action will be taken that either erects substantial walls between CVS and Caremark or rescinds the merger so that the market can operate equitably without one company abusing the system for its enrichment at the expense of patients and fair competition among pharmacies."
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
The PhRMA argument is that the
Eisai has become the latest drugmaker to cut prices in an effort to push sales in emerging markets. On the heels of similar moves by GlaxoSmithKline and Sanofi-Aventis, the Japanese company is cutting prices on its Alzheimer's remedy Aricept in at least six Asian countries.
The idea is to ratchet up demand by opening the door to less prosperous patients, says Eisai's Yasushi Okada, who heads up operations in Asia, Oceania and the
Okada tells the news service that he expects growth in sales volume to outweigh the price cuts, delivering overall sales growth. And that's the aim of GSK and Sanofi as well. GSK has announced major price cuts in emerging markets, with prices tiered according to the target population.
In some GSK markets, prices will be less than two-thirds of those in
Okada wouldn't say just how much Eisai plans to cut the price tags on Aricept. In the coming quarters, however, we'll be able to see how the cuts affect sales in those markets. For 2008, Aricept's global revenues amounted to $3 billion; the company loses patent protection in the
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
The following article is of interest to us because it shows that lobbying interests have a significant impact on the results of health care legislation. Although this is not surprising, the amount of money spent to move legislation to a particular interest group is huge. Perhaps the new emphasis on social networks will change the economics of lobbying and allow smaller interests to make an impact as large as PhRMA and other lobbyists. Time will tell.
When President Barack Obama declared in his first address to Congress that health care reform “must not wait,” he sparked a lobbying spree that kept medical stakeholders hustling while fattening the bottom lines of
Medical interests alone shelled out more than $876 million in lobbying expenses during the 15 months beginning in January 2009 and ending in March, when Congress passed the sweeping overhaul.
Those stakeholders, including the drug industry, doctors, hospitals and manufacturers of medical products, were responsible for one out of every five dollars doled out on lobbying during that period, according to a CQ MoneyLine analysis of lobbying disclosure reports filed with Congress.
While health care has historically been an issue that has drawn intense lobbying, even some veterans of Capitol Hill expressed astonishment at the big bucks lavished during the 15-month slog.
“That is an astounding amount of money,” said Ralph Neas, president of the National Coalition on Health Care, which pushed for passage of the overhaul. Neas, who began his career in
But there was much at stake for medical interests as lawmakers put together the bill, which will affect millions of Americans and their employers in the years ahead.
“This is the most important domestic legislation in at least 45 years,” Neas said, referring to the creation of Medicare and Medicaid in the mid-1960s.
Tony Podesta, president of the Podesta Group, which ranked second among K Street firms in fees paid to work on health care reform during this period, said lobbying on the issue is far from over.
Podesta said his firm was still picking up clients with a stake in how the measure is implemented and in any corrections Congress might make. Even companies that are not directly involved in health care are affected by the new law, which includes corporate tax changes related to retirees’ health benefits, sets up insurance exchanges and mandates all individuals purchase health insurance.
“We just did a briefing for non-health care clients on the bill,” Podesta said. “We had really good attendance.”
Prescription for Reform
Within the health care industry, drug companies racked up the biggest lobbying tab, spending $253 million. They were followed by hospitals, which spent $108 million, and doctors and surgeons, who spent $59 million.
Thomas Mann, a political scholar at the Brookings Institution, said one difference between this health care push and the last time the issue came up, during the
“A good percentage of that lobbying budget was spent on behalf of reform,” Mann said.
Indeed, the drug companies, led by the Pharmaceutical Research and Manufacturers of America, early on reached a deal with Democrats that involved providing tens of billions of dollars in drug subsidies for seniors. In return, name-brand drug companies protected their right to exclusively market groundbreaking biologic drugs over a 12-year period.
The hospital associations also reached a deal with the Democrats to provide $155 billion over 10 years to defray costs for uninsured Americans. The American Medical Association, with a $26.2 million lobbying budget for the stretch, endorsed the legislation, although many medical specialists opposed the overhaul efforts.
Smaller health care interests also joined in on the lobbying. Medical laboratories spent $1.5 million, and acupuncture advocates paid $34,000 to sway lawmakers to include the ancient treatment in the reforms.
Health insurance companies criticized the legislation as not doing enough to control costs. The industry’s chief lobby,
Rolling in Capital
The health care industry’s lobbying easily outpaced other sectors with interests on Capitol Hill, including energy and natural resources, finance and insurance, and communications and technology, the CQ MoneyLine analysis found.
Even as other sectors scaled back during the recent economic downturn, health companies continued to pump big bucks into influencing Congress.
During 2009, health care lobby spending peaked in the fourth quarter, when both the House and Senate approved their separate versions of the legislation.
At the beginning of this year, health care spending dipped as prospects of passage seemed doomed after the Jan. 19 election of Republican Sen. Scott Brown (
However, Democrats regrouped, and two months later Congress approved the sweeping health care bill along party lines.
The health care industry was not alone in its interest in the legislation.
During the 15-month stretch, about 2,700 clients, ranging from big-box stores such as Wal-Mart to high-tech firms such as Microsoft, listed health care as one of their lobbying issues, the analysis found.
The U.S. Chamber of Commerce spent $148 million on lobbying activities during this period, much of it on an aggressive media campaign to defeat the Democratic health plan.
Companies and trade associations that named health care as one of their priorities paid $333 million to outside firms to advocate on the issue. As big as they are, the health care lobbying expenditures do not reflect the millions of dollars spent by many outside groups on grass-roots and television ads both for and against the health care bill.
“The real winners in the health care debate were the lobbyists who were laughing all the way to the bank, even in a tough economy,” said Steve Ellis, vice president of Taxpayers for Common Sense.
‘Drinking From a Fire Hose’
For
The law firm Holland & Knight, which ranked ninth among firms in health care fees, fortuitously purchased in early 2009 a small shop that specialized in health care.
“We’ve been drinking from a fire hose,” said firm partner Rich Gold, noting Holland & Knight’s $4.7 million in health care lobbying fees over the past 15 months. He said business has slowed since the bill was signed, but he expects it to pick up as clients seek information about the new law. He said the firm had already prepared webinars for medical device companies and hospitals explaining the new law.
“It’s been a while since we’ve seen something of this scope and magnitude,” said Linda Tarplin, a founding partner of Tarplin, Downs & Young. Her firm ranked 10th among lobbying shops in health care business during the five-quarter period, collecting $4.5 million in revenues.
But Tarplin also noted that her firm, which is different than the others on the top 10 because it specializes exclusively in health care, finds health care issues “are always important and will remain front and center as the new health care reform law is implemented.”
Serdar Tumgoren contributed to this report.
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
The issue of TZD (e.g., Avandia, Actos) and their link to bone fractures has been discussed for several years. It seems to be a class issue, meaning that no drug in the category is exempt, although some may produce more fractures than others. A recent utilization study by Henry Ford Health System further emphasizes this problem. Below are excerpts published by Healthcare Daily Data Byte in regards to this issue.
A
"Fractures are just one of a growing number of problems associated with these medications. Henry Ford and other researchers have previously found that this class of medications also can increase risk of congestive heart failure hospitalization," says study senior author L. Keoki Williams, M.D., M.P.H., center for health services research and department of internal medicine at
Research Study Source: http://www.henryfordhealth.org/body.cfm?xyzpdqabc=0&id=46335&action=detail&ref=1056
Craig S. Stern, PharmD, MBA
President
Pro Pharma Pharmaceutical Consultants, Inc.
The following table identifies benchmark utilization for Medicare Part D. The data is from SDI and applicable to 2009. The data may be useful to compare plan utilization /1000 for the MMA Part D book of business. We would be interested if others have compared their numbers to these and found agreement/lack of agreement.
Note: There is no way to vet or validate this information, but we have no reason to believe that it is inexact. The Total column is directly from SDI and does not appear to sum all of the values in each row.
