Recent studies by the National Comprehensive Cancer Network [NCCN] and the American Society of Clinical Oncology (ASCO) predict a large workforce shortage among oncology physicians.  According to ASCO, while the number of oncologists is expected to increase 20 percent by 2020, patient demand is expected to grow by 48 percent. According to Practical Clinical Exchange, an organization that provides educational opportunities to meet the needs of nurse practitioners (NPs) and physician assistants (PAs), NPs and PAs may be the answer to this upcoming shortage.

The ASCO study results showed that physicians who work with NPs or PAs in their practice saw 10 percent more patients per week. This was true with NPs or PAs who performed advanced patient care activities—defined as assisting with new patient consults, ordering routine chemotherapy, or performing invasive procedures. With only 56 percent of clinical oncologists working with NPs and PAs, the potential to expand capacity simply by adding an NP or PA to the mix is great.

According to Practical Clinical Exchange, the roles of NPs and PAs may be underutilized in oncology practice. Researcher Maura Polansky, MS, PA-C, and colleagues write in the November issue of the Journal of Oncology Practice that ASCO may be understating the current roles of these clinicians. Polansky found that PAs were writing chemotherapy orders and prescriptions, as well as performing invasive procedures at a much higher rate than reported by ASCO. Additionally, they found that oncology PAs participated in clinical trials at a rate four times as high as reported by ASCO.

Polansky also pointed out that to effectively increase the use of NPs and PAs in oncology, more of these clinicians should be attracted to work in oncology. Considering the limited exposure to oncology in their formal training, oncology continuing education and training opportunities tailored to these clinicians is essential for NPs and PAs to perform advanced patient care activities, fully practice to their potential, and best improve the efficiency of oncology practices.

The survey is also useful in documenting the importance of physician assistance in enhancing the role of drug therapy and assuring appropriate use.  Incorporating this emerging stakeholder in advocacy work linked to oncology product launches is important but must be handled with discretion – oncologists remain the essential front line in what can only be described as an increasingly complex treatment environment, where the choices facing clinicians and patients are many.

For more information on this survey, please visit the American Society of Clinical Oncology.

Under the Labour government, the time that it took for a patient suspected of having cancer to be referred from a GP to a specialist was set at two weeks maximum, and the Party promised in its April 2010 election manifesto to further reduce this to one week.

Despite the coalition government’s ring-fencing of healthcare (and pledge to increase it, in “real terms”, by 0.4%), the Spending Review’s retention of the old target is no great surprise. The Tories made no indication of matching Labour’s cancer diagnosis promise in their election manifesto, and, back in July, House of Commons Leader Sir George Young announced that the two-week waiting time was “clinically justified”. Nor is it a surprise to hear Andrew Lansley, the coalition Health Secretary, complain that Labour had never actually identified how the one-week target would be paid for or provided in the first place.

What does seem a tad incongruous is Lansley’s comment on Sunday that the coalition government is “fully committed to improving early diagnosis for people with cancer. Up to 10,000 lives a year could be saved if England’s survival rates were brought up to the best levels in Europe…”

With, according to a 2009 government report*, only 15 of England’s 152 healthcare trusts matching the highest survival rates in Europe for patients suffering from the three most common forms cancer (colorectal, lung and breast), it’s clear that the country was lagging significantly behind Europe even when Labour was tripling the NHS budget and promising swifter diagnosis for cancer patients. On the report’s publication, the then-Health Secretary Andy Burnham said: “I hope the publication of this data combined with the Prime Minister’s pledge to give patients key diagnostic tests within one week of seeing their GP will save thousands more lives.”

Considering the strong arguments that swifter diagnoses at this vital early stage make a huge difference to cancer survival rates, perhaps the one cut the coalition government should be making is to cancer testing times.

*Cancer Reform Strategy, UK Department of Health, December 2009.

Of the 106 US oncologists surveyed in a MDLinx survey last month, 84 percent said they had invested more time and effort into the financial planning of patients’ treatments than they ever had before. Additionally, 67 percent of those who responded reported that their patients were rationing medications and/or forgoing treatment due to financial and insurance coverage concerns.

Patient noncompliance has been a long-standing issue for the industry, and as the economy has taken a turn for the worse and healthcare has become increasingly mired in politics and policies, financial reasons for noncompliance are on the rise. “We believe that the change in the air in the US regarding medical coverage has injected an additional measure of anxiety for what is already often the most anxious time of these people’s lives,” says Aki Tomaru, CEO of M3 USA, which owns the MDLinx sites.

Now patients, particularly those with potentially terminal illnesses, must weigh their financial situation against the value of further treatment and the potential quality of life, as is evident by this account from Wisconsin-based oncologist Dr. Shahid Shekhani: “I just had a young grandmother, in her 60s, halt lung cancer treatment that would have extended her survival in order to preserve her family’s finances and her ability to leave an inheritance to her children,” he says.

“Frankly, we were shocked at the results of this poll,” said Stephen Smith, M3’s Chief Strategist. “For 20 years mortality rates for most cancers have been steadily and substantially falling. For many, the advances in diagnosis and treatment have transitioned cancer from a disease you die from, to a disease you live with. But what will be the impact if patients are unable to continue their treatments? The trend spotlighted by this poll sounds an alarm for our healthcare system. We need to take notice and find some answers.”

Confounding perceptions that oncologists are a pampered group able to set the terms of their engagement with patients—and to command high fees from compliant insurers—the survey tells a different story. Most cancer practices are working at full capacity, with a growing “triage” problem leading to variations in the quality of care for some patients, while grappling simultaneously with a troubled bottom line as payers ratchet down on costs. Significantly, that bottom line still depends heavily on reimbursement for medications—anywhere from 60 percent to 75 percent of revenues is the average per practice. Thus, the impact of health reform on the in-office specialty drugs used widely in treatment is a major uncertainty on the financial health of cancer practices going forward.

“Demand for oncology services is overwhelming the health care system and many of the professionals we surveyed see the future of cancer care as a low-margin, high-volume business in which active management of the practice will be critical to survival,” said NCCN spokesman Patricia Goldsmith. The contrast between commitment and compensation is increasingly stark. While the average working time for oncology specialists engaged in private practice is now 60 hours per week, it has been accompanied by a pronounced decline in per-patient revenues. Coping trends under way include relying more heavily on mid-level professionals to monitor care and limiting the range of non-essential services available to Medicare patients who do not have supplemental private insurance cover.

So what are the key issues that keep cancer care professionals up at night? Fears of forcing patients out of treatment due to cost and insurers who impose diminishing returns; Medicare reimbursement cuts for infusion drugs and other mainstays of treatment; alignment of private payers with Medicare around low Medicare fee-for-service rates; vanishing professional and personal time; and difficulty in attracting qualified professionals to the cancer space.

Overall, manpower shortages are an increasing reality, with the survey posting findings that indicate a 50 percent gap in surgical specialists versus current need, and more than 60 percent for specialists in gynecological cancers. The shortages are destined to grow as health reform expands the insured population. Unless this is redressed through new incentives to fix a deteriorating financial picture, it will impact everything from the quality of care available to patients to the ability of the drug industry to interact with cancer professionals.

The Indian pharmaceutical market is set to grow to $8 billion in 2010—thanks in part to an expanding middle class and the second largest workforce in the world. Generics are dominating the market at a 92 percent share, according to a study conducted by research firm RNCOS. Rather than set up shop and build brands—or even branded generic offerings—from scratch, attempting to squeeze into an already overcrowded space, acquiring an already-established company (like Piramal) is a more cost-efficient step. Abbott anticipates this move will put it at the top of the (very tall) totem pole on the subcontinent.

Piramal doesn’t yet have any proprietary drugs on the market, but it does have several candidates that have either completed or are near completion of Phase II trials. Two oncology targets are being developed with Merck as a partner; Eli Lilly is partner for two in the diabetes/metabolic arena.

The Japan-based pharma first extended an acquisition offer of $52 per share ($3.5 billion) to OSI on March 1, only to be met with a resounding “Nay” from the board, which said $52 a share was a “very significant undervalue” of the company. Proceedings then got a bit dicey after Astellas filed a suit against OSI to prevent any use of a “poison pill” rights policy, and rumors swirled about a possible acquisition by Roche instead.

Now the two have come to terms; OSI CEO Colin Goddard is pleased with the appreciation the higher offer shows, and Astellas is pleased with its shiny new oncology pipeline. The company has recently been bucking for the title of “Global Category Leader in Oncology”—which is a steep task when you don’t have any oncology drugs in development. Astellas already has cardiology, neuroscience, immunology, and infectious disease covered, as well as urology and dermatology.

OSI currently has just one drug on the market: pancreatic and non-small cell lung cancer treatment Tarceva (erlotinib). However, that one product netted the company $428 million in 2009, and three others are coming down the late-stage pipeline.

OSI has until June 2 to accept the offer (a 16-day extension from the previous deadline), though Astellas had already acquired 229,214 shares as of May 14.

Steven Paul, Lilly

Last week, Lilly announced a major restructuring plan focused around the creation of one Developmental Center of Excellence and several individual business units. The media (Pharm Exec included) focused on the news that 5,500 jobs were being cut as part of the plan. This week, we’re talking to Lilly to find out what the company’s R&D structure will look like beyond the elimination of positions.

Steven Paul, president of Lilly Research Laboratories and executive vice president of science and technology, filled Pharm Exec in on the details.

Could you clarify the role of the new Developmental Center of Excellence? Is it simply a coordination vehicle?

Its main purpose is to speed innovation to patients and to the market. Yes, it is a coordinating vehicle—we have put there the key functions for clinical development, including all the key elements such as process research development, regulatory, safety, and project management. There is going to be a single operating model at Lilly, which we piloted for the past 12 to 18 months, and that’s something we call critical chain, which is a way of seamlessly developing drugs.

Why the change?

The reason we are doing this is because we have a terrific Phase I and II pipeline—we have 64 individual molecules in development, 21 in oncology, and our goal is to get those molecules into Phase III and into the marketplace and to patients.

There are three key pillars from a technology and methodology perspective. One is critical chain methodology—a project management tool that we piloted. One hundred percent of the projects using critical chain methodology are on track, either at or ahead of their milestones, as compared to about 60 percent of our traditional development projects. We will expand this to all of our projects by the end of this year.

The other pillar is something we call advanced analytics. This is the use of clinical trial modeling and simulation, as well as adaptive, seamless design. In other words, moving from Phase I to II and from Phase II to III without stopping.

We piloted this on four projects. We literally determined the dose in Phase II—in a multi-arm study—moved the two doses that were optimal into Phase III without stopping, and continued on with the commercial development of the molecule.

This can save enormous amount of time, and you can do it on the front end. For a few molecules you could probably do it for Phase I, II, and III. Not all molecules will meet the criteria for this. It obviously requires that you have enough clinical trial material. But when you have a validated target and the molecule is behaving very well in Phase I through proof-of-concept, at that point, these kinds of trials can literally cut years off the development time of a molecule.

The third pillar of this Center of Excellence is the idea of tailored therapies. Lilly has been very successful with tailoring, but we now believe that it needs to be applied across the portfolio in a much more robust way, beginning in Phase I and not after a drug is in Phase III or on the market. Tailoring the right patient, right dose—these are essential for determining whether a drug works.

Are you altering the end points in a trial as a molecule is moving through the trial?

Not necessarily the end points. For example, because the purpose of Phase II is to pick the dose of a molecule—and to confirm efficacy and safety—you usually stop at the end of it. You look at the data, look at the best two or three doses, and move into Phase III. This way you can stop the doses that you don’t want and enroll patients into the programs that you do want.

You can also do this on the basis of tumor response. Let’s say you are in Phase II for an oncology drug that works in breast cancer. Now we know that virtually no oncology drug works for all people that have breast cancer. But let’s say you have a marker—logical or molecular—now you can determine which type of breast cancer is responding to your drug and without stopping. You literally keep enrolling patients that have that type of breast cancer.

CNS doesn’t seem to have its own business units, yet it has been a major Lilly franchise.

I think this was misinterpreted in the press release and something we are trying to clarify with the public. We are very interested in CNS, and the biggest products we have right now are CNS drugs—Zyprexa, Cymbalta, etc. But they are mature products that will lose patent protection over the next few years, beginning in 2011, so they were put into the developed markets business unit. But we have a very robust science pipeline. In fact, we have two Phase III molecules for Alzheimer’s disease. So we have not, by any means, lost interest or enthusiasm for CNS.

How are your business units different from similar models in other companies, such as J&J and Pfizer?

When we make a commercial decision on a molecule—traditionally after Phase II—at that point the molecule will move into the business unit with two exceptions. In oncology we will move all Phase I molecules into the business unit, because we often do Phase I trials for cancer in cancer patients. The other business units will pick up the molecules at the commercial decision time.

What about benchmarks? Is it all about speed to market or the number of new compounds being commercialized?

We have an unprecedented amount of molecules in early stages and mid stages, so our success as company as we transverse the patent cliffs is going to require that we speed innovation to patients. If you didn’t have enough good stuff to speed to patients, none of this will be effective. We feel we’ve got the quality molecules we need to make this work.

Is there a deadline for the restructuring plan?

This is all going to occur by January 1, 2010. We are well on our way for the Development Center of Excellence because we’ve been piloting critical chain, adaptive designs, and tailored therapies for some time. We are ready to go, and this will be rolled out at our analyst meeting in December.

Have you substantiated the number of people being laid off as opposed to positions being eliminated?

No. Frankly, we don’t have the answer to that question. We’ve done very well over the years with attrition. We’ve already reduced by 7,000 people by attrition over the last few years. We hope this predominately occurs by attrition, but obviously it might not. We don’t know the percentages, but that will all be worked out in the next few months.

Lilly broke the news Monday morning that ImClone had accepted its offer to acquire the biotech firm for $6.5 billion or $70 per share—Lilly’s largest acquisition ever.

With this purchase Lilly gains control of ImClone’s blockbuster, targeted cancer agent Erbitux, which is marketed for second- and third-line colon cancer and refractory head and neck cancer.

ImClone also has five monoclonal antibodies in clinical development—including one in Phase III and two currently moving out of Phase II trials. The acquisition will help Lilly meet the challenge of patent expiration that it will see in the next decade and bolster its 13 oncology drugs currently in development.

One sticking point will be how the deal affects ImClone’s co-marketing pact with Bristol-Myers Squibb in the United States. BMS currently pays a 39 percent distribution fee to ImClone for Erbitux and owns 17 percent of ImClone stock. In an investor call this morning, Lilly said it could not comment on the situation.

Last month, BMS offered $4.5 billion for ImClone. ImClone chairman Carl Icahn shot down the offer stating that it undervalued the company and that a second mystery suitor had made an offer for $70 per share. After more than a week of whispers and second-guessing, Lilly announced that the boards of both companies have approved a definitive merger agreement.

Lilly expects the income stream of Erbitux and the success of one additional drug to cover the cost of ImClone. The company will cover the cost with a combination of cash and debt.

Moody’s Investors Service announced this morning that it was considering the possibility of lowering Lilly’s Aa3 long-term debt rating (the company’s Prime-1 short-term rating would remain unchanged).

“The long-term success of the acquisition will be dependent on receiving expanded approvals for Erbitux as well as favorable execution of other products in ImClone’s pipeline, both of which remain uncertain at this time,” stated Michael Levesque, Moody’s senior vice president.