Prostate Cancer Notes & Notable – New Claims Data!

Don DeStefano, Vice President of Life Science Sales at Health Market SciencePartnership with Health Market Science provides access to claims data for Prostate Cancer.

(For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Drug Market Info is pleased to announce a partnership with Health Market Science (HMS), a specialty healthcare data company. HMS uses proprietary technology to systematically collect, analyze and publish accurate and current information from the most comprehensive U.S. provider database and the largest practitioner-level medical claims database in the U.S. Only HMS can track activity at the ‘claims’ level.

Drug Market Info will now be including Health Market Science data as another analytical tool for assessing the oncology market in our new 2013 Prostate Cancer Market Info™ report.

Don DeStefano is Vice President of Life Science Sales at HMS and a longtime friend. His career spans more than 20 years in the healthcare industry encompassing leadership roles in Sales, Market Research, and Account Management. During this time, Don has partnered with numerous healthcare clients to successfully meet their data management and information needs. Don has this to say about the value of this comprehensive claims database.

Could you begin by telling us about HMS?

Health Market Science helps solve business challenges with healthcare provider information. HMS uses big data technology and domain expertise to build solutions that help our clients improve operational efficiencies and maximize market opportunities. These solutions are based on our proprietary data, which includes more than 6 million HCPs and 400,000+ unique healthcare organizations and their affiliations, as well as the largest medical claims database in the United States.

What does HMS offer that other databases or suppliers do not?

We offer our Provider MasterFile™, the most accurate and comprehensive source of provider reference data, and the vast coverage of our medical claims warehouse. Escalating regulations as well as fierce competition are driving the need for the more comprehensive market intelligence that HMS provides. Understanding where physicians spend most of their time can improve sales and marketing strategies for life sciences organizations. Our Provider Master File contains millions of data points on all U.S. healthcare practitioners including physicians, advanced nurse practitioners, dentists, veterinarians, and physician assistants. Attributes for each HCP include ranked demographic data as well as essential credential information. The integration of our Provider MasterFile with our vast PxDx® medical claims data warehouse drives improved assessment and quantification of market share and opportunities and takes organizational intelligence to the next level.

How can the HMS data be used with pharmaceutical audit data (Rx’s and sales) to better understand markets?

Many companies look at the prescription volume shipped to an account. HMS takes this one step further and combines that information with our medical claims data enabling us to identify the provider associated with each account and the corresponding volume of patients. This increased market visibility offers more insight than prescription data alone.

Drug Market Info is now including HMS “claims” level data in the new 2013 Prostate Cancer Market Info™ report. What perspective will HMS data provide that is missing now in understanding the prostate cancer market?

With HMS data, an enhanced quantitative perspective of the prostate cancer market provides another analytical view, especially since there is a lack of available prescription data due to the nature of therapy (injectables and infused drugs). HMS provided data to Drug Market info for the new 2013 Prostate Cancer Market Info™ report that shows which settings prostate cancer patients go to for treatment, as well as the volume of patients who had a PSA Test, and the reason for the PSA Test.

How can companies use HMS data to their best advantage?

The value of medical claims data is that it provides quantitative data for non-retail brands such as oncology and specialty drugs. Companies can use it to target high-value physicians and where they practice, determine market size, sales force sizing and alignment, and to segment practitioners for non-personal promotions.

Can you provide a couple of examples of how clients actually use your data?

Absolutely.

Example #1

A top medical device company was looking to maximize sales force efforts for a pain management device in order to meet revenue goals. They had been targeting and segmenting physicians using internal sales data and territory insight accumulated by a seasoned sales force.

HMS delivered precise physician and organization data including projected patient volumes and the corresponding decile ranks. This gave them the ability to:

  • Sort by volume and hone in on the settings with higher sales potential, such as acute care hospitals and ambulatory surgery centers
  • Understand which physicians had privileges at an acute care hospital, along with a breakdown of which specialties were performing the targeted procedure
  • Understand which messages and tactics were needed based on the MD being targeted

As a result, the company learned who their physician targets were, the settings where they practice, and they were able to prioritize based on volume to more effectively deploy the sales resources against high-value targets.

Within 60 days, the company’s sales force:

  • Generated a 278% return on investment (ROI)
  • Generated an additional $500,000 in opportunities

Example #2

A biotech firm was looking to gain market share after the FDA withdrew indication approval for a well-known tumor-starving drug in the treatment of metastatic breast cancer (MBC). They needed to understand the indication-specific utilization of the competitive product in order to target the relevant physicians who had been using that product.

HMS provided the total volume of patients with a diagnosis of MBC at the physician level and the oncologist’s chemotherapy utilization at the product level – specifically the drug recently taken off label for the treatment of MBC patients. The biotech firm could now:

  • Understand which oncologists were treating MBC patients with a specific drug/ treatment of interest
  • Rank the oncologists by patient volume and product utilization
  • Prioritize sales and marketing resource efforts
  • Tailor the promotional message

In summary, Health Market Science and Drug Market Info are pleased to be partnering to provide an enhanced analytical view of the prostate cancer market.

Cystic Fibrosis Notes and Notable: Jeanne Barnett on Patient Communities – What They Do and How They Help

Jeanne Barnett, founder of CysticFibrosis.comDrug Market Info presents Cystic Fibrosis Notes & Notable, an interview series with leading voices in the struggle against Cystic Fibrosis. (For more data on Cystic Fibrosis, see the Drug Market Info Cystic Fibrosis Fact Sheet)

Today we present our interview with Jeanne Barnett, a teacher, web developer and patient advocate who established CysticFibrosis.com. She established CysticFibrosis.com in 1996 through a company called Medrise. Medrise develops solutions for online media, market research and health resources for various audiences.

CysticFibrosis.com spawned a new model of information exchange, at least in part because cystic fibrosis (CF) patients are often quarantined from each other to avoid bacterial infection. However, CF patients also undergo very complex, time-consuming treatments, which can be greatly improved through interaction with others. CysticFibrosis.com has provided the CF community with a way to connect to each other and has evolved into a vibrant online social network. Jeanne also advises and coaches companies on how to engage with the CysticFibrosis.com e-patient community.

We caught up with Jeanne recently to learn more about this one-of-a-kind resource. Here is what Jeanne has to say about CysticFibrosis.com:

You have a very interesting background in online media. How did you get involved with cystic fibrosis?

The site was originally designed because my partner had CF. It became instantly busy as patients reached out, understood and empathized with each other. As I reviewed the site in this early stage, I began to realize it was becoming layered with stories and facts about the disease itself. I was so taken by the huge unmet need that I decided to commit for the long haul.

CysticFibrosis.com has evolved into patients from all over the world sharing their experiences with drugs, delivery systems, the devices and equipment they are using, exercise regimens, alternative medicine, diet, treatment protocols as well as their specific CF mutations. Members have a deep-rooted need for belonging and knowing more in order to have hope in the future.

How many members are in the online community and where are patients located?

We have 14,000 members who have filled out profiles, many including optional genetic mutation information; over 11,000 are in the US and close to 700 in the UK. Overall, we have 121 countries and territories represented.

CF Community

Who exactly is the community composed of…is it mostly patients, caregivers or others?

We have 40% patients, 45% caregivers and 15% others.

Do you need to be member to access the site and what does membership entail?

You don’t have to be a member to read the messages. The site is free to all and about 2,000 viewers access it every day. Membership entails filling out a form with some optional questions about research and mutations. Once you are a member, you can receive our newsletters and you can post on the site.

Is the community open to industry and what’s the best way for a company with CF products to interact?

Our site facilitates and is an agent for CF patients. In addition, we have good relationships with many pharmaceutical companies and device manufacturers. The best way for a company to interact is to address patients’ needs and answer questions patients have. Companies have done this in the past with general helpful videos. Patients have also signed up for clinical trials through our site. Companies can ask questions of our community and we have excellent response rates to our surveys, usually 500 members in 3 days.

What do you view as the primary benefit of cysticfibrosis.com for the CF community?

CysticFibrosis.com saves lives. I have heard this in testimonials many times. Perhaps, people have lost hope. By sharing experiences, people find new ways to cope with a challenging condition. Or it may be that patients have never heard of a particular treatment or how important exercise and diet are to their well-being. Our community serves as a backup means of support and caring.

What drives your members to continue returning and contributing?

This is a complex disease and members learn something new every day. Patients can easily be on 17 drugs at a time and use three or more medical devices. There are always updates, new products, and clinical trials on the forefront. Besides an abundance of empathy, there is a lot of knowledge about the disease. CysticFibrosis.com is easily found on the web and may be one of the first places a new patient or caregiver finds on a Google search.

What predominant themes or issues have emerged since you started the site?

Patients talk about medications, delivery systems, activities of daily living, how to sanitize and clean equipment (always an ongoing question) because manufacturer’s directions may be inconsistent with established patient procedures.

Even when people branch out on their own, starting a site or blog, they stay tethered to our community.

Do you routinely survey the CF community? How do you like to work with companies that have products for CF patients?

Yes, we routinely survey, and the community always responds to surveys. Patients like to contribute important information. In this way they can stay informed and learn what is on the horizon in the way of drugs, devices, and healthier living. I suggest always allowing this community to comment on surveys. We have so much to learn from them!

They are the experts (In The Outliers, Malcolm Gladwell defines an expert as someone who has studied a topic for 10,000 hours). These patients are way over that and converse on so many levels about their disease and living with it.

How do you see CysticFibrosis.com evolving?

We have set up patient retail in the last few months on our Medrise.com site. This is a store where patients with cystic fibrosis can find many of the products and devices they use every day, as well as interact with manufacturers of CF products. We are also in the process of initiating a Pilot study to learn about Home Spirometry and CF patients.

Concerning genetics and the Human Genome Project, Cystic Fibrosis patients are aware of their mutations. They often self group by mutation, accordingly on our site. We are moving to help them form guilds based on their mutations. From there, they can map their genomes, compare and contrast disease progression, discuss their treatments with each other and their Health Care Providers and work directly with researchers.

Leading Researcher Expounds on Faster FDA Approvals – Notes & Notable on Oncology Drug Approvals

Christopher-Paul Milne, DVM, MPH, JDDrug Market Info presents Notes & Notable, an interview series with leading voices in the field. Today we present our interview about Oncology drugs with Dr. Christopher-Paul Milne, DVM, MPH, JD. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Dr. Milne is Director of Research at Tufts Center for the Study of Drug Development (TCSDD), Research Assistant Professor at Tufts University Medical School, a member of the Editorial Board of the Food & Drug Law Journal, and an Honorary Fellow at the University of Edinburgh. He joined TCSDD in 1998 to address legal and regulatory issues and current research interests include: tracking new regulatory and research initiatives such as regulatory science, comparative effectiveness research, translational medicine and personalized medicine.

Here is what Dr. Milne has to say about his study recently completed by the Tufts Center for the Study of Drug Development, “Oncology Drugs Get Faster Approvals than Non-Oncology Drugs in U.S., But the Opposite is True in the EU”:

Why is there a shorter approval time for oncology drugs in the U.S. versus the European Union?

There is a different philosophy at FDA. It embraced expedited review for cancer earlier than the European Marketing Authority (EMA) and is more comfortable and facile with it. FDA isn’t relying so much on predictivity of animal data but rather is focused on new, more flexible weighting of the evidence. This approach utilizes a target population medicine concept which favors benefit (efficacy) over potential risk. However, unknown levels of risk are still difficult to quantify pre-approval, because of the small number of patients tested pre-approval.

FDA and EMA appear to approach cancer differently. What is different about the EU review process?

Cancer is a complex disease, not only scientifically but also politically. Choices have to be made about how to address both aspects. The European environment for making decisions in both spheres adds an additional level of complexity.

Were you surprised from your research that oncology drug review times in the U.S. are 10 months shorter than other drugs?

Yes and no. We were not surprised that cancer was faster, but we were surprised that it was so much faster! We have recently done an analysis of FDA review divisions which confirmed what we already knew about cancer “exceptionalism”. The oncology review division has an edge over other divisions.

Since fast track and accelerated approval status do not seem to affect oncology drug approval time, how should companies view this?

Fast track and accelerated approval do help. Typically, the more special programs you can get your R&D project approved for, the more scientific interaction with the agency and prioritization it can benefit from – that’s what Fast Track provides. At the same time, Accelerated Approval, for example, allows FDA to more readily approve a drug on the basis of efficacy for surrogate endpoints that are just predictive (sometimes by a few years) of actual efficacy.

In the case of cancer, companies also have other factors working in their favor. On the payer side of the equation, payers see value in reimbursing medicines for cancer that are “conditionally” approved for what may not seem like dramatic outcomes in terms of cure or long extensions of survival time. This is not done in other therapeutic areas.

Total drug development time for oncology and non-oncology drugs decreased by half a year in the last decade. Can you elaborate on the process improvements that occurred?

In addition to the FDA’s approach on flexible weighting discussed in Question 1, I would also add that an organized and long-standing advocacy movement for cancer has helped. This has extended to addressing development problems such as patient recruitment.

In addition, there is an integral and balanced relationship between private and public sector resources that are devoted to this endeavor. The National Cancer Institute, academia and industry partner in so many ways and this makes the evidence compelling and more objectively framed when it comes time for FDA review. And last, strong cancer advocacy among a very active network of cancer medical specialists helps in this regard (for example with availability for Advisory Committee Meetings).

What do you think the FDA is doing right as far as reviewing and approving oncology drugs?

Obviously…just about everything. For some specifics, you could look at our recent paper on FDA review divisions (CP Milne and KI Kaitin. FDA Review Divisions: Performance Level and the Impact of Drug Sponsors Clinical Pharmacology & Therapeutics 2012; 91:393-404.).

What advice would you give to companies developing oncology drugs?

Look at the unmet medical needs that are developing in cancer. Forty percent of cancers are preventable, largely by vaccines that prevent the underlying infection, such as Hepatitis C in liver cancer or papilloma virus in cervical cancer. Yet of the 40 indications in the late-stage pipeline for cancer-preventing vaccines, only 10 are for diseases likely to have major health impacts in the emerging markets over the next 5-10 years.

The late-stage pipeline does not seem primed to meet the needs that will hit the practice environment in the next 5-10 years, let alone further down the road.

There are a number of products in the late-stage pipeline for the six major types of cancer. However, there are at least another six cancers that I have looked at with few and sometimes no late-stage products in the pipeline. These cancers will be among the top 3 cancers in the emerging and next wave markets by 2020 according to World Health Organization data.

There are also unmet medical needs in the mature market. Survivor syndromes, such as those in the evolving area of cardio-oncology, indicate that the occurrence of cardiac after-effects of surviving cancer treatment are increasingly recognized and require management. Also, breakthrough or hard-to-manage pain greatly affects quality of life in cancer patients who otherwise manage the cancer well.

On the down side, tumor heterogeneity and increasing competition in the targeted medicine market means developers will have to spend more just to keep pace with their current success. When you look at market projections for the next five years, cancer usually still comes out on top in the U.S. and world market for total market size in dollar volume. But cancer is often not even among the top 5 therapeutic areas in terms of compounded annual growth.

Psoriatic Arthritis Notes and Notable: Dr. M. Elaine Husni on PsA vs RA – Why More Clinical Trials Are Needed

Staff Photograph taken in StudioDrug Market Info presents Psoriatic Arthritis Notes & Notable, an interview series with leading voices in the struggle against Psoriatic Arthritis, or PsA. (For more data on Psoriatic Arthritis, see the Drug Market Info Psoriatic Arthritis Fact Sheet)

Today we present our interview with M. Elaine Husni, MD, MPH. Dr. Husni is the Department Vice Chair of Rheumatology and Director, Arthritis and Musculoskeletal Treatment Center at the Cleveland Clinic. The Department of Rheumatic and Immunologic Diseases at Cleveland Clinic is ranked second in the nation by U.S. News & World Report. Dr. Husni is also Assistant Professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and current Director of Musculoskeletal Outcomes research and the fellow’s research committee for the Rheumatology Department.

Dr. Husni is a member of the medical and scientific committee for the Arthritis Foundation and a recipient of the Clinical Investigator Award and Physician Scientist Development Award from the American College of Rheumatology for her research on health outcomes among patients with rheumatoid arthritis and psoriatic arthritis. She is involved in a number of rheumatology clinical trials at Cleveland Clinic and serves on the Executive Committee of the PRECISION trial.

Here is what Dr. Husni has to say about Psoriatic Arthritis:

In your opinion, why are there fewer clinical trials for psoriatic arthritis (PsA) compared to rheumatoid arthritis (RA)?

The pathogenesis of RA has been more extensively studied than PsA leading to more specific therapeutic targets. In addition, there is a perception that RA tends to carry a greater personal and societal disease burden than psoriatic arthritis. I believe that PsA research is growing and we will see more clinical trials in the near future as the mechanism of this disease is better elucidated.

How do clinical trial endpoints differ for psoriatic arthritis and rheumatoid arthritis?

The main difference is that RA trials measure predominant joint involvement, function, serum markers of inflammation, and quality of life. PsA has all the above, but also includes a skin measurement score. Therefore, PsA endpoints generally incorporate both the skin and joints, whereas RA is the joint only.

Is it more difficult to prove efficacy and safety for PsA than RA?

No, probably not. Proving safety and efficacy is the hallmark of scientific research and disease investigation. Similar methods can and should be used for PsA and RA. In patients with PsA, efficacy trials may be a bit more challenging due to the incorporation of multi-system outcomes for both skin and joints.

What do you feel is needed for more companies to undertake trials for PSA?

This is a great question. From a basic science perspective, we need to increase our understanding of the pathophysiology of PsA and improve animal models of PsA disease. As we continue to investigate the etiology of PsA at the molecular and cellular level we must also expand investigation of the role of genetics and gene-environmental interactions. Understanding the biological, genetic and environmental relationships which exist can lead to targeted therapeutics which treat or maybe even cure the disease.

How is first line therapy for PsA patients generally determined?

In general, overall disease activity is assessed. I always consider the severity of the patient’s disease (number of joints involved, inflammatory markers, and function) and how it globally impacts their life. Furthermore, their level of joint involvement and their skin disease activity will determine the treatment plan, with the goal being to impact both with the fewest side effects.

Are most of your PsA patients on combined therapy with methotrexate and the biologics?

The majority of PsA patients may be on combination therapy, but many are on monotherapy as well. Combination therapy is a more common treatment path for patients with RA. In psoriasis and PsA, many patients start with one agent and remain on one agent as the literature does not support combination therapy as strongly as in RA.

What are the similarities and differences regarding how patients with rheumatoid arthritis versus psoriatic arthritis respond to methotrexate and biologics?

There are probably more similarities than differences. DMARDs (disease modifying anti-rheumatologic drugs) such as methotrexate and biologics, are widely used to treat both RA and PsA. The American College of Rheumatology (ACR) has published recommendations and guidelines for use of these agents. Treatment response is generally efficacious with some patients experiencing months or years of stable disease or remission without disease progression. This is the goal of therapy: to halt disease progression, lengthen periods of remission and prevent joint destruction. There are many more DMARDs that are FDA approved for RA compared to DMARDs for PsA.

What are the most troublesome side effects for PsA patients with both of these therapies?

The most troublesome side effects of drugs like methotrexate and biologics are the increased risk of serious infection as these drugs reset the immune system. What is also important to understand is that patients with PsA tend to have a “hyperactive” immune system which can be improved with the use of DMARDs. Most anti-TNF therapies are well tolerated. Side effects exist, but are rare and if diagnosed early, good outcomes are still possible.

The use of medications like methotrexate and biologics require close monitoring and regular visits to the rheumatologist in order to minimize these side effects.

Is there one biologic that you feel works better for PsA than the others?

No. Anti-TNF therapies have similar effects on the disease; however, a particular patient may respond better to one over another. There are limited head-to-head trials comparing anti-TNF therapies.

How do PsA patients feel about being on biologic therapy long-term?

Biologics are generally used to treat moderate to severe PsA when other treatments have failed. Biologics have been shown to slow disease progression by targeting specific components of the immune system. As with most immune-targeting treatment, the risk of infection (including tuberculosis) is highest in the first six months of therapy. Careful monitoring for signs of infection, cardiovascular disease, and even malignancy is required to minimize side effects of these drugs.

Are drug holidays ever an option and how long should a holiday last?

There is no good clinical data supporting “drug holidays” in PsA. A drug holiday is not a practice which I encourage my patients to consider, but many patients do stop drugs on their own. I encourage patients to let me know if they are planning a “drug holiday” so they can be monitored more frequently to avoid permanent joint damage.

What, if any, long-term effects have you noted with use of the biologics for PsA?

Recent reports have shown that biologics slow disease progression, especially when all other treatments have failed. Permanent, irreversible joint damage and life altering physical disability can be halted or prevented by the proper use and monitoring of biologic agents. Efficacy may wane with long-term use of biologics, but more studies are needed to understand this. If efficacy of a biologic does wane, there is always the option of adding a topical, utilizing phototherapy or introducing an oral agent like methotrexate.

Psoriasis Notes and Notable – Dr. Steven Feldman on Biologics, Topicals, Adherence and Treatment

Feldman, Steven 1107ADrug Market Info presents Psoriasis Notes & Notable, an interview series with leading voices in the struggle against Psoriasis. (For more data on Psoriasis, see the Drug Market Info Psoriasis Fact Sheet)

Today we present our interview with Steven R. Feldman, M.D., Ph.D., a professor of dermatology, pathology and public health sciences at Wake Forest University Baptist Medical Center. His research studies into patients’ compliance with their topical treatments helped transform how dermatologists understand and use topical medications over the course of a chronic disease like psoriasis. Dr. Feldman’s work has been published in over 500 articles in peer-reviewed journals. He is the author of Practical Ways to Improve Patients’ Treatment Outcomes (Informa) and he founded http://www.DrScore.com. He is a long-time volunteer with the National Psoriasis Foundation and in many respects, Dr. Feldman is the “derm patients are always looking for.” Here is what Dr. Feldman has to say about the Biologics, Adherence and Treatment of Psoriasis:

You have been prominently involved with psoriasis and PsA for a number of years. Currently, what are the biggest hurdles you face in treating psoriasis?

Hurdles in treating psoriasis are a little different than they used to be. We now have treatments that are extraordinarily effective. One of the biggest hurdles I have is getting patients to use their medication, particularly the topical medications. Using biologics is even a hurdle, too.

Biologics have certainly had a profound impact on more severely affected patients. What are the major advantages and disadvantages of biologics for psoriasis?

The major advantage of biologics is they are more effective than the treatments we had previously. Safety (compared to methotrexate or cyclosporine) is an advantage, too. The major disadvantage is the cost. Biologics seem quite safe although there can be some risk of infection associated with them.

In your opinion, have biologics increased patient adherence to psoriasis therapy?

Adherence is the critical issue in psoriasis treatment. Biologics have improved things but patients being patients, they do not take their biologics as regularly as prescribed. We have looked at patient adherence to self-administered biologic treatment using electronic monitors and found that people take their medication quite irregularly. I worry that this will potentially result in loss of effectiveness. Stelara®, which is given once every three months in the office, negates the adherence to self-administration hurdle of other biologics.

How do you feel about patients taking drug holidays and does this affect long-term efficacy?

With etanercept I don’t worry too much about drug holidays, as I think antibodies that reduce effectiveness of the drug are not likely to occur. I worry more with Humira® and certainly infliximab – if a holiday results in an antibody, it may reduce long-term efficacy of those drugs. To be clear, these are my general impressions and not strongly supported by clinical data as far as I’m aware.

Now that biologics have been used for longer periods, is waning efficacy a problem that you see often and how is it managed?

Efficacy does wane in some patients but then others maintain good control of the disease for very long periods of time. When efficacy of a biologic does wane I can add topicals or phototherapy or perhaps methotrexate or switch to another biologic if needed.

What percent of patients refuse to go on a biologic therapy? What treatment approach is recommended for these patients?

When patients don’t want to go on a biologic therapy because they are concerned about the risks, I try to put those risks in perspective by relating them to common risks that people have anyway like getting in a car and driving on the highway. For patients who do not want to go on a biologic, using oral therapies like acitretin (along with phototherapy), methotrexate or sometimes even cyclosporine provides adequate control of the disease for many people.

Is there a need for topical therapy among those on biologics and what proportion of psoriasis patients on biologics also need to use topicals?

Most patients on biologics still have some limited psoriasis remaining which would be amenable to topical therapy. But when patients have very severe disease and they move to more mild disease, they may be happy without complete clearing. It is my general sense that most of my patients on biologics probably use their topical therapy very little if at all.

What improvements have been made in topical therapies and what is still needed?

A major improvement in topical therapy has been the development of vehicles that are less messy. Combination products have been an advance too. These changes have made it easier for patients to be adherent to treatment so results are much better. Another improvement in topical therapy in my practice has just been my approach and things I do to develop and foster a strong physician/patient relationship and things that help the patients use their medicine better. Finally a disappointment has been the recent increase in the price of generic topical therapy creating more of a hurdle for patients.

What are the most significant features for any psoriasis therapy to have to increase patient adherence?

Important features for psoriasis therapy to improve adherence include affordability, simplicity, perception of safety, and meeting patients’ preferences. As of yet I don’t think the perfect psoriasis treatment has been developed.

What do pharmaceutical/biotech companies need to keep in mind when developing drugs for psoriasis?

I would like to see as many new psoriasis products developed as possible so I have the maximum number of options for my patients. I think realistically pharmaceutical and biotech companies need to keep in mind that the move of topical therapies to generic status, development of biosimilars, and changes in our healthcare system will likely reduce the market for expensive new products over time.

Prostate Cancer Notes and Notable – Dr. Judd W Moul: Part 2 – Sequencing and Prostate Cancer Treatment

Moul 2Drug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today we present Part 2 of our interview with Judd W Moul, MD,  Director of the Duke Prostate Center, Professor of Surgery, Duke University School of Medicine and the James H. Semans, MD Professor of Surgery at the Duke Cancer Institute. (Click here for Part 1 of the interview, focusing on new prostate cancer drugs Zytiga and Xtandi.) Dr. Moul is an international authority on prostate cancer and outcomes/database research. His clinical interests include minimally invasive nerve-sparing radical prostatectomy, multidisciplinary management of prostate cancer, and clinical trials in prostate disease. He was director of the Center for Prostate Disease Research, a Congress-mandated research program of the Department of Defense. He received national acclaim for creating a prostate disease research database that houses information on more than 20,000 prostate cancer patients treated at nine collaborating institutions. In 2009, he was selected as a recipient of the “National Physician of the Year” award, presented by Castle Connolly, publisher of the America’s Top Doctors series.

Here are some Notes from Dr. Moul on “Sequencing” and treating prostate cancer:

How do you currently select which therapy to use for men with prostate cancer who are castrate-resistant, but not yet symptomatic for metastatic disease?

There is only one FDA-approved new agent for this population and it is Provenge® (sipuleucel-T) immunotherapy. Provenge is specifically approved for asymptomatic or minimally symptomatic metastatic CRPC. It is best used for men who have mets (metastases) but are not yet on narcotics for cancer-related pain and who have early CRPC. New data suggest it is best for men who have a lower PSA level, such as less than about 25 ng/ml. At the Duke Cancer Institute (DCI), we have used Provenge extensively and like to sequence it as the first novel treatment for CRPC before chemotherapy and early in the course of metastatic CRPC.

Zytiga® is now being reviewed as a treatment for prostate cancer in patients who have not received chemotherapy. The FDA should finish in mid-December. What are your thoughts – will it get approved? Does it improve survival?

I certainly do not want to speculate on FDA decisions. However, Zytiga is clearly very active in the setting of CRPC prior to docetaxel-based chemotherapy. The drug resulted in an improvement in progression-free survival and significant delay to chemotherapy compared to placebo. Survival was also improved, but just missed being statistically significant at the current analysis. With regard to survival, the current P-value for significance was just higher than the standard benchmark of P= 0.05. As more patients are followed for survival, this result may become statistically significant. However, with more novel agents being used in these patients, this may be part of the reason that the survival endpoint was not completely met.

From your experience, would most prostate cancer patients rather take Zytiga than go on chemotherapy?

I think the message to patients is that all of these new agents are important and I do not like to pit one drug against another. Some patients will prefer to start an oral therapy before further chemotherapy. However, currently Zytiga is only FDA approved for men who have progressed on docetaxel-based chemotherapy and some men may want to march on with further chemotherapy and would go on to Jevtana®. Other men may desire a break from chemotherapy and will prefer Zytiga before moving on to Jevtana. It is up to us as prostate cancer doctors to educate our patients about all the new options and to prepare and educate patients that they may need all these new drugs given in a sequential fashion.

What about Provenge, where do you think it fits?

As noted above, Provenge is a novel cellular immunotherapy custom-made for each patient and can be administered over about 4 weeks with three separate leukophoresis procedures followed several days later by re-infusion of activated product. In two separate phase III clinical trials, the survival benefit was 4.1 to 4.5 months compared to a placebo control group. However, two-thirds of the control patients received a frozen cellular immunotherapy similar to Provenge at the time they progressed on placebo. Recent secondary analyses have suggested a greater survival benefit for men who had lower PSA values (less than about 25 ng/ml) and perhaps that a comparison of Provenge to true placebo patients may result in a greater survival benefit than the reported survival benefit of 4.1 months. I think Provenge fits in the earliest phase of metastatic CRPC while patients have a robust immune system and it should be given ideally at least 3-6 months before the patient is expected to need chemotherapy or steroids.

With all of these new treatment options, how will doctors decide which drugs to use and where?

This is the key question to our field now that we have four new agents available in the last several years for use in advanced prostate cancer. If we follow the current (Sept 2012) FDA-approvals and use these drugs fully on label, then the sequence might look like this:

1. Provenge; 2. Docetaxel; 3. Zytiga or Jevtana or Xtandi® depending on the physician and patient preference. Also, denosumab (Xgeva®), a new RANK-Ligand inhibitor given at 120 mg subcutaneously every month, is also FDA-approved to prevent skeletal events in men with advanced prostate cancer. It can be used as soon as a man is diagnosed with bony-metastatic prostate cancer or can be reserved for those with CRPC at a similar time as the patient is eligible for Provenge.

There is a lot of talk about “sequencing.” What does it mean for prostate cancer treatment?

As noted in some of the earlier questions, it is using the new agents in the correct order for the individual patient. We are very excited that the “toolbox” has more tools to help us treat our patients with advanced prostate cancer. However, we are not certain which order to use all the new riches at our disposal.

What are your patients saying about all the new drugs? What is still needed?

My patients have renewed optimism about their prospects even when they develop metastatic prostate cancer. However, they are also concerned that the government via the US Preventative Services Task Force (USPSTF) has recommended that doctors stop using the PSA test to screen for prostate cancer. If we truly go back to the “Pre-PSA Era” we will go back to a time when 20-25% of men present initially with metastatic prostate cancer. Currently, in the PSA-Era this had fallen to only about 2%. We may see more patients who are candidates for these new agents because we are no longer picking up cancer early.

In my opinion, we still need to look for the disease earlier especially in younger men where a diagnosis of metastatic prostate cancer is still a death sentence despite all the new drugs. However, we do need to do a better job to fine tune testing in older men to avoid overtreatment. We also need better disease markers for early and advanced disease – PSA is good, but we need even better disease markers. We also need a better way to image inside the prostate so we can better define early stage tumors for individual patients.

Prostate Cancer Notes and Notable – Dr. Judd W Moul: Part 1 – A Leading Clinician’s View on Zytiga® and Xtandi®

MoulDrug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today’s interview is with Judd W Moul, MD,  Director of the Duke Prostate Center, Professor of Surgery, Duke University School of Medicine and the James H. Semans, MD Professor of Surgery at the Duke Cancer Institute. Dr. Moul is an international authority on prostate cancer and outcomes/database research. His clinical interests include minimally invasive nerve-sparing radical prostatectomy, multidisciplinary management of prostate cancer, and clinical trials in prostate disease. He was director of the Center for Prostate Disease Research, a Congress-mandated research program of the Department of Defense. He received national acclaim for creating a prostate disease research database that houses information on more than 20,000 prostate cancer patients treated at nine collaborating institutions. In 2009, he was selected as a recipient of the “National Physician of the Year” award, presented by Castle Connolly, publisher of the America’s Top Doctors series.

Here are some Notes from Dr. Moul on Xtandti® (Medivation), Zytiga® (Johnson & Johnson)  and treating prostate cancer:

What do you think about Xtandi, the new drug from Astellas/Medivation? Could you have predicted that it would be approved three months early?

We have been hearing about this new drug now for the past 2-3 years. We were first introduced to it as “MDV-3100” and more recently by its new generic name, “enzalutamide.” What is brand new for me is the catchy trade name of “Xtandi.” I am very excited about this new oral antiandrogen because of its triple mechanism of action against the androgen receptor and its impressive survival advantage over placebo in castrate-resistant prostate cancers (CRPC) that have progressed after chemotherapy. I was not really too surprised when it was approved early because it showed impressive survival gains with an excellent safety profile.

Where will Xtandi fit into the treatment regimen for Prostate Cancer?

Enzalutamide will initially be used in men who have castrate-resistant prostate cancer (CRPC) and who have progressed after docetaxel-based chemotherapy. In other words, these are men who have metastatic (spread) prostate cancer who have stopped responding to traditional hormonal medications- the LHRH agonists/antagonists and the traditional oral antiandrogens, and also after docetaxel-based chemotherapy. The most common clinical scenario will be those men who have a rising PSA level and or progression of their metastatic disease while being managed with traditional hormones, such as leuprolide acetate and docetaxel chemotherapy. At this point, the managing physician would continue the leuprolide-type LHRH agent but discontinue other cancer drugs, including the chemotherapy, and start the man on Xtandi.

What about Zytiga? Is it effective for patients where cancer has metastasized (with few or no symptoms) following androgen-deprivation therapy? Is this a difficult patient group to treat?

Zytiga, or abiraterone, is another novel hormonal medication that was FDA-approved in April 2011 for men with CRPC. It is also effective and showed a significant survival benefit in men who had stopped responding to docetaxel-based chemotherapy. We now have three FDA-approved new medications in the “Post-docetaxel space” in CRPC: cabazitaxel (Jevtana®); abiraterone (Zytiga) and now enzalutamide (Xtandi). Jevtana (25 mg M-squared IV given every three weeks with low-dose oral steroids) is a taxane systemic chemotherapy that was approved in June 2010 and was the first novel drug to show a survival benefit in post docetaxel CRPC. The median survival benefit was about 3 months and it received accelerated FDA approval due to it being the first agent to show improved survival in this group of patients.

Zytiga is an oral agent taken at a dose of 1000 mg daily (four 250 mg tablets taken once daily along with low-dose oral prednisone 5 mg twice daily). The biggest challenge now will be to learn how to properly sequence these three novel agents for maximal patient benefit. Furthermore, both Zytiga and Xtandi are both effective in men who are pre-chemotherapy CRPC and are both likely to be approved in the next year or so in the pre-chemo space. The clinical trials of all three of these agents were done independent of the other two so we still have to learn how to use these drugs together and in the best order for our patients.

What have you heard from patients about Zytiga? What about side effects or any other patient-related issues?

Zytiga is well-tolerated; however, does have to be given with low-dose prednisone. It may cause hypokalemia (low serum potassium levels) so doctors need to measure a serum potassium level before starting the drug and need to monitor levels periodically. It can also cause fluid retention and hypertension so oncologists and urologists need to be aware and monitor appropriately. In the post-docetaxel setting where it is currently FDA-approved, the low-dose steroids are not generally an issue and patients are being monitored by oncologists and their staff pretty often. However, when Zytiga becomes FDA-approved in the pre-chemotherapy setting where men are generally healthier and may not be monitored as often, doctors will need to be a little more vigilant with monitoring patients on Zytiga.

Also, in the pre-chemotherapy setting, patients are generally under the care of urologists and not oncologists. Among urologists, we are working hard to further train a subset of urologists to use these new agents who will be very comfortable managing men in this new era. As far as patients, what I have heard is that virtually all patients are excited about the new options where we have more to offer them and the prospects of making advanced prostate cancer more and more of a chronic disease.

With all of these new treatment options, how will doctors decide which drugs to use and where?

This is the key question to our field now that we have four new agents available in the last several years for use in advanced prostate cancer. If we follow the current (Sept 2012) FDA-approvals and use these drugs fully on label, then the sequence might look like this:

1. Provenge®; 2. Docetaxel; 3. Zytiga or Jevtana or Xtandi depending on the physician and patient preference. Also, denosumab (Xgeva®), a new RANK-Ligand inhibitor given at 120 mg subcutaneously every month, is also FDA-approved to prevent skeletal events in men with advanced prostate cancer. It can be used as soon as a man is diagnosed with bony-metastatic prostate cancer or can be reserved for those with CRPC at a similar time as the patient is eligible for Provenge.

Mary Beth Cicero: Why I’m Walking in the Great Strides Walk for Cystic Fibrosis May 20

May is Cystic Fibrosis Awareness Month and one of the largest national fundraising events takes place this Sunday. It is the Great Strides Walk, which is taking place in over 200 cities this Saturday and Sunday, May 19-20. (Click to find out more about Great Strides, including walk locations.)

I will actually be walking twice! Last year when Drug Market Info was looking for CF patients to interview for our Cystic Fibrosis Market Info report, I contacted my good friend Sue (whom I hadn’t seen in years) but knew her daughter had CF. We ended up interviewing her and a number of her friends from western Massachusetts and were completely touched by their stories.

Our interviews with these patients and caregivers took place last November and they mentioned the Great Strides Walk to me. I promised them that I would be there and so here it is May and I am on my way to both Northampton and Shelburne Falls Mass. I will be supporting Team Paige and Audrey’s Angels.

I am so excited because I will be meeting some of the patients and mothers we interviewed that contributed so many insights to our Cystic Fibrosis Market Info report. I truly hope that the patients’ perspectives they shared will influence companies to either undertake further drug development on Cystic Fibrosis or take their needs into account. (You can get the facts on Cystic Fibrosis here.)

I am particularly excited to meet in person one of the patients we talked with that has had 2 lung transplants—she touched my heart and I can’t wait to meet her! When I asked her about her goals in life she said she didn’t have any. Her mother interjected that she doesn’t know how long she will live and doesn’t like to think about the future. Of course, I jumped in and said, “Why don’t you want to be the first person to have 3 lung transplants!” I am hoping that won’t have to happen and that she will thrive and be happy.

She did mention that she always wanted to go skydiving. Even though I want to make her happy… I am drawing the line at skydiving! However, I am going to take her zip lining and I am happy to report that Bob Coughlin (President of Mass BIO, read our Notes & Notable interview with Bob Coughlin) who has a son with CF is not as “chicken” as me and has graciously agreed to take her sky diving.

To all of you out there with CF and to those who love you, as well as all of the drug researchers trying to cure this disease—I salute you and will be proudly walking alongside of you on Sunday.

Prostate Cancer Notes and Notable – Dr. Tomasz Beer, co-author of Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials

Dr. Tomasz Beer, interviewed for Drug Market Info Prostate Cancer Notes and NotableDrug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today’s interview is again with Dr. Tomasz Beer, M.C., F.A.C.P.. (Click here for yesterdays interview focusing on Prostate Cancer) Dr. Beer is a medical oncologist who leads a research and clinical trial program at Oregon Health & Science University Knight Cancer Institute, and who specializes in the treatment of prostate cancer. Dr. Beer devoted a good portion of the past year to writing a book about cancer clinical trials together with Larry Axmaker, Ed.D, a cancer survivor and clinical trial participant. The book is entitled  Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials. Dr. Beer co-authored this book because he wanted to contribute to the fight against cancer. Here are his comments…

Please tell us a little about your new book and who should read it?

“Cancer Clinical Trials” is written for people living with cancer, their families and loved ones. We hope to make clinical trials and the experimental therapies they offer much less intimidating and by doing so, help people make the best decisions for their cancer care. We delve into all facets of clinical trials, from design and principles, to strategies for finding and choosing a trial to issues of insurance coverage and many other practical aspects.

We have found the book is also of interest to physicians in training, nurses, and other health professionals who interact with patients and need to know the fundamentals of experimental cancer therapy. It may also be of interest to pharmaceutical companies who want to understand how to approach clinical trial recruitment.

What prompted you to write this book?

For 15 years now, I have been deeply involved in clinical trials. I have talked to thousands of cancer patients about hundreds of clinical trials. Despite the fact that we spend a lot of time with each potential participant, I frequently had the nagging feeling that we could never quite do a good enough job sharing all the knowledge I wanted to share with my patients. The book was the only way to get this done.

What do you think is the most important message (or most unique point) in the book?

The book is meant to be an A to Z guide to clinical trials, from what they are, to how to decide if a clinical trial is right for one’s cancer care plan, to many practical aspects of

taking part in a clinical trial. There are many different messages I would want to highlight. If there is one, I would say that in cancer care, there is a need for improvement and advances throughout the continuum of cancer care.

Clinical trials are not just for folks who have no other options. Even when a well-established standard treatment is available, there is often room for improvement. Every person diagnosed with cancer should be knowledgeable about clinical trials so they can make truly informed decisions about their care.

What makes patients willing (or not) to participate in a clinical trial? Does the type of trial make a difference?

I think a trial needs to make sense for a particular situation. First and foremost, it has to be a well-designed trial that asks a sensible question. It has to offer a sensible alternative to the other options. There has to be some potential advantage, for example more effective therapy or less toxic therapy. What that translates into varies greatly by situation.

In prostate cancer, for example, there are situations where the disease is growing slowly and we would ordinarily just watch it. Very low risk interventions may be attractive here. There are also situations where the disease is very aggressive and other treatments aren’t working. More risk might be appropriate in that setting.

What do patients need to be aware of before they decide to enter a trial?

The single most important thing is to be knowledgeable about one’s disease and standard treatment options. Only then can one put a clinical trial option in perspective. We have a whole list of tips on our blog. I encourage readers to take a look at: http://www.cancer-clinical-trials.com/2012/04/practical-tips-on-choosing-clinical.html.

Would the book be beneficial for a company conducting clinical trials?

Absolutely. Participation in clinical trials remains disappointingly low. For companies working hard to move a drug forward, this results in far greater cost. From the time it takes to get a trial done, to the number of sites needed to complete a study, the low participation of people living with cancer is a major challenge to the pharmaceutical industry. We expect that the book will provide cancer patients the knowledge they need to confidently consider a clinical trial for their cancer care and therefore increase trial participation. We think every oncology office that conducts clinical trials should have this book available to their patients as a critical educational resource.

The book may also help with subject retention. Early drop out of research subjects is another challenge for clinical trials. When this happens for good reasons, such as dangerous side effects, that is unavoidable. We believe sometimes it also happens because patients don’t have enough knowledge about how to navigate the responsibilities of being a study participant. The book can help.

Is there anything that would help companies conducting clinical trials?

We think that making the book available at trial sites so that patients can approach their care decisions with strong knowledge about clinical trials will increase trial accrual. Folks already participating in a trial will also feel more secure in being a study subject armed with the knowledge the book provides. Our clinical trial system is incredibly inefficient and dismal participation of cancer patients in clinical trials is a key contributor. We are convinced that accessible knowledge about clinical trials will help substantially.

Dr. Tomasz Beer, author of Cancer Clinical Trials, interviewed for Drug Market Info Prostate Cancer Notes and Notable

Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials by Tomasz M Beer, MD and Larry Axmaker, Ed.D
Pub. Date: April 2012/Price: $16.95
ISBN 13: 978-0-9823219-7-3/Trade Paperback: 192 pages

Where can Cancer Clinical Trials be purchased?

The easiest way is to go to Amazon.com and type in “cancer clinical trials” or “Tomasz Beer.” The book shows right up. You can also go to the book’s Amazon page. For bulk purchases, a discounted price may be available from our publisher. More information can be found on the authors’ blog and at the publisher’s website.

Prostate Cancer Notes and Notable – Dr. Tomasz Beer, Chair for Prostate Cancer Research Deputy Director, OHSU Knight Cancer Institute

Dr. Tomasz Beer, interviewed for Drug Market Info Prostate Cancer Notes and NotableDrug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today’s interview is with Dr. Tomasz Beer, M.C., F.A.C.P.,  a medical oncologist who holds the Grover C. Bagby Endowed Chair for Prostate Cancer Research and leads a research and clinical trial program at Oregon Health and Science University Knight Cancer Institute, and who specializes in the treatment of prostate cancer. Dr. Beer has been in practice for 15 years and is the author of hundreds of medical publications. He recently co-authored a new book entitled Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials (which will be discussed in tomorrow’s blog post).  Here are his comments on treating prostate cancer:

How long have you been working with prostate cancer?

I have worked with prostate cancer for 15 years and have been actively involved in more than 100 clinical trials for prostate cancer.

What is the most difficult issue(s) for patients with regard to prostate cancer treatment and how does this get addressed?

I don’t think there is a simple answer to this question. For many men, it’s the decision about initial treatment following diagnosis. The choice between surgery, radiation, and observation is very challenging. In advanced disease, it’s often about managing the side effects of treatment to preserve quality of life.

The treatment armamentarium for prostate cancer has recently expanded significantly. How is this changing the actual treatment approach?

There are many more treatment options for advanced disease. When prostate cancer becomes resistant to standard hormonal therapy, we now have a number of life-extending options. That is brand new and very good news.

With all the changes, where do you see a drug like Provenge fitting into the treatment scheme?

Provenge offers a survival advantage for men with metastatic, castration-resistant prostate cancer that are free of symptoms or nearly free of symptoms. The sequence of treatments is in such rapid evolution, that we need to keep paying attention to this question. Because immuno-suppressing drugs may interfere with a response to Provenge, the timing of Provenge treatment needs to consider not only the patient’s condition but also other treatment before and after Provenge. Ideally, patients should not receive steroids or other immuno-suppressive drugs for 3 months before and after Provenge.

In your experience, what percentage of men with prostate cancer agree to enter a clinical trial and does this differ by disease stage? How does this compare to other types of cancer?

I work in a university setting, so the folks I meet may be more inclined to consider trials. In choosing us, they may have expressed an openness to clinical trials, so I don’t know if my experience reflects that of all. Having said that, in our practice more than half of our patients are open to clinical trials and around 25 to 30% end up participating. The level of interest is very high and I think that is true at all stages of the disease.

How do you feel about the proposed changes to the PSA screening recommendations and what do patients generally want to do about annual screenings?

I think men need to understand both the potential benefits and risks of early detection. I don’t think we should be discouraging screening. I think we should be discouraging screening without a balanced and thorough discussion. New data from additional follow-up of the European study are showing more favorable results than initially reported and I would think that the USPSTF should consider these new data and think about these tough issues some more.

What should new drug developers keep in mind as they develop new therapies for prostate cancer?

With so much progress over the last few years, it would be easy to think that prostate cancer is saturated with new drugs. This is not so. Men are still dying of the disease and we need to continue to strive to make progress until that changes. The field is more complicated and new drugs need to be quite a bit better than current drugs to compete, but the need remains.

And last, tell us a bit about your new book?

Co-authored with Larry Axmaker, a cancer survivor and clinical trial participant, the book, Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials, is designed to demystify clinical trials for cancer patients and their families and loved ones. The book provides an easy to read and understandable, yet comprehensive guide to clinical trials and aims to help people develop a foundation of knowledge, make an informed and thoughtful decision about the role of clinical trials in their care, and navigate through the experience of being a participant. For more information, please visit the authors’ blog and to take a look at the book directly, please visit http://tinyurl.com/cancer-clinical-trials-book.

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