Real World Health Care Blog

Tag Archives: oncology

Big Data in Health Care: Speaking with Dr. Clifford Hudis

Real World Health Care is pleased to bring you the final interview in our series on Big Data and its impact on health care. Here, we spoke with Dr. Clifford Hudis about how Big Data will impact cancer care. Dr. Hudis is Chief, Breast Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center; Vice President for Government Relations and Chief Advocacy Officer for MSKCC; and Professor of Medicine, Department of Medicine, Weill Cornell Medical College. He also serves on the Board of Governors of the American Society of Clinical Oncology’s CancerLinQ project.

Real World Health Care: In a recent article, you write that big data represents a new opportunity to increase our understanding of cancer care. How is that so?

Clifford A. Hudis, MD Chief, Breast Cancer Medicine Service

Clifford A. Hudis, MD
Chief, Breast Cancer Medicine Service

Clifford Hudis: The ongoing conversion of medical record keeping in oncology from paper-based records to electronic format means that for the first time in history we have potential access to the treatment and outcomes for the vast majority of adults with cancer who are not treated on prospective clinical trials. This means that we can explore treatment effects including both efficacy and toxicity in patients who might not have participated in the usual, tightly controlled, prospective studies that are used to gain regulatory approval. For example, older (or younger) patients, those with co-morbidities, other malignancies, and so on — all of whom are frequently under-represented in prospective drug-development trials — can be studied.

RWHC: What sort of knowledge gaps do you think big data will be able to identify in the area of cancer care?

CH: Key gaps include toxicities and efficacy in special populations, but also use of drugs “off label” based on either classical histopathologic tumor features or newer genomic testing. Another key area is to study drug-drug interactions or drug-genotype interactions.

RWHC: Can you give us an example of how big data has overcome a known limitation of randomized clinical trials in evidence development?

CH:         In other disease areas, such as interventional cardiology, large registries have allowed clinical investigators to refine their understanding of the benefits and harms of specific approaches without the use of conventional prospective randomized trials.

RWHC: What are some of the biggest challenges facing the health care industry in terms of its ability to use big data to improve health care delivery, treatment optimization, and cost containment?

CH:         They key challenges may be outside the realm of big data per se. We have a societal challenge in the uniform definition of benefit, efficacy and ultimately value. This is especially true in oncology where drug development costs are high, many diseases are life-threatening, and the pace of innovation has to continue to accelerate. It is possible that big data will allow us to gain deeper and faster insights into some of these issues as new treatments first permeate the treatment arena. At a more mundane level, we would benefit from even greater interoperability and standardization of data storage and access.

RWHC: Much of the literature published on the use of big data in health care focuses on cancer care. Why is cancer care such a ripe area for implementing big data initiatives?

CH: Among the reasons are the myriad diseases — and therefore complexity — that comprise cancer, the acuity of the illness, the broad reach, and the large price we pay in overall public health. In the face of this massive set of challenges, only three percent of adults participate in clinical research that defines and advances the standards of care. To accelerate progress, we need to innovate in the area of data development. Big data is one key opportunity in that regard as it simultaneously offers to provide new insights, broaden the distribution of evolving knowledge, and improve the efficiency of the entire drug development enterprise.

RWHC: How has the use of big data impacted you personally in your practice?

CH: We increasingly have access to patterns of care, treatment decision-making, and patient outcomes across a large and geographically distributed group of clinicians and investigators working in one traditional disease are.  All of this can be used to improve patient care in an iterative fashion.

 

Categories: Big Data, General

Personalized Medicine & Companion Diagnostics: Speaking with Dr. Joshua Cohen, Tufts Center for the Study of Drug Development

Editor’s Note: In August, the Tufts Center for the Study of Drug Development (CSDD) hosted a roundtable of R&D leaders focused on development of companion diagnostics that can show their use in conjunction with personalized therapeutics that will lead to positive health outcomes. We spoke with Joshua P. Cohen, Ph.D., Research Associate Professor, Tufts CSDD about the promises and challenges in the field of personalized medicine.

Dr. Joshua Cohen

Dr. Joshua Cohen

Real World Healthcare: According to Tufts CSDD, 20 percent of new drugs winning approval in the U.S. last year were considered personalized medicines. What do you think is driving the growth you expect to see?

Joshua Cohen: More investment in the science of biomarker identification and validation, and more investment in the commercialization of personalized medicines and diagnostics.

RWHC: What reimbursement problems, if any, do you see for companion diagnostics?

JC: There are two challenges concerning companion diagnostic pricing and reimbursement. The first is coding. Traditionally, diagnostics have been code-stacked — coded for each individual activity involved in the preparation and use of a diagnostic. Each code is then assigned a price and, when taken together, the prices of individual codes make up the price that diagnostic manufacturers get reimbursed. Code-stacking does not, however, reflect the value of a diagnostic. It only reflects the price of individual components.

The value of a diagnostic is reflected by the second pricing and reimbursement challenge: clinical utility — the linkage between a companion diagnostic and positive health outcomes. The more clinical utility a diagnostic has the greater the chance it will be reimbursed and the higher price it can command. If a diagnostic differentiates between likely responders and non-responders, the value of that differentiation should be reflected in the diagnostic’s price.

RWHC: What can drug and diagnostic companies do to accelerate the development of biomarker efficacy and remove this key hurdle to the development of personalized medicine?

JC: Identification of biomarkers early in development. Coordination and communication with regulators early in development, as the regulatory processes for diagnostics and therapeutics are different. Also, use of next-generation sequencing to develop diagnostics, in which biomarkers with predictive claims undergo rigorous clinical (cross) validation.

RWHC: When it comes to personalized medicine, even high R&D success rates may not mean much if physicians won’t prescribe it and payers won’t reimburse it. Are you aware of any hesitancy to entering the space by the industry?

JC: There may be some hesitancy on the part of the biopharmaceutical industry because personalized medicine alters the blockbuster model. This said, many newly approved personalized medicines have high price tags. In some cases, these high price tags have made them blockbuster drugs (e.g., Herceptin, Gleevec). Physicians will prescribe personalized therapeutics as long as evidence suggests it does a good job at differentiating between likely responders and non-responders to a particular therapeutic, or indicates which sub-group is at risk for certain adverse effects. Similarly, payers will reimburse personalized therapeutics and companion diagnostics if evidence supports their effectiveness and safety. An issue has come up with respect to awareness on the part of the physicians about personalized medicine, and specifically the role that diagnostics play. In cases in which there is less awareness of the need to employ a certain diagnostic, less clinical adoption will occur.

RWHC: What fields of medicine are furthest along in development of personalized medicines?

JC: Oncology dominates. There is a better understanding of the science behind targeted therapies and the role that biomarkers play.

RWHC: Why do you like this field?

JC: It represents the promise of individualizing treatments, rather than relying on an iterative, trial-and-error method.

 

 

Why Revenue Matters to Patient Care

What approaches can pharmacists embrace to more effectively adapt to the rapidly changing landscape of U.S. health care? It’s exactly this question that Philip E. Johnson, RPh, FASHP, the oncology director for Premier, Inc, a health care improvement company, explores in the December edition of Pharmacy Practice News:

Paul DeMiglio

Paul DeMiglio

“Protecting oncology drug–related revenue is a good place to start, given the huge dollar figures involved and the ease with which that revenue can slip from an institution’s grasp, said Mr. Johnson, who was previously the director of pharmacy at the Moffitt Cancer Center in Tampa, Fla. ‘Revenue is not a four-letter word. It’s important. If the doors close, we’re not providing care to anybody.'”

Click here to read the full article (“Reimbursement and Revenue Integrity”) by Susan Birk and see what tips Mr. Johnson offers to help pharmacists improve efficiencies and communicate their message to leaders, stakeholders and payers alike.

Profiles in Courage: Beating Breast Cancer One Story at a Time

As we recognize Breast Cancer Awareness Month, heroes, organizations and allies nationwide are leveraging creative strategies to empower patients and families, educate communities and mobilize supporters to overcome the disease and live healthier.

Paul DeMiglio

Paul DeMiglio

Are You Dense?

Dedicated to “informing the public about dense breast tissue and its significance for the early detection of breast cancer” Are You Dense? seeks to educate the public and raise awareness around dense breast tissue and the need for early detection through online tools and resources in addition to speaking engagements. This organization helps women diagnosed with breast cancer by highlighting what it’s like to live with the disease, advocating changes to public policy around detection and supporting new and existing research.

Athena® Warriors

From the time she was a little girl, six-time Grammy winner singer/songwriter Amy Grant knew that cancer “was a force to be reckoned with.” Amy was inspired at a young age by the work of her father – an oncologist who spent his entire medical career treating cancer – to join the band of warriors. A tireless advocate, she draws courage from the countless women she helps empower every day to fight breast cancer, along with her fellow warriors: Amanda Beard, Angela Stanford and Karen Gooding.

“I am inspired by every Athena Warrior. If my music can bring women together and make a connection, then I have contributed something. Athena water takes a terrible situation and does something good for many; that’s why I love being an Athena Warrior,” Grant said.

Terror for Ta-Tas

Woods of Terror — a haunted theme park in Greensboro, North Carolina — hosts the annual “Terror for Ta-Tas Night” to benefit breast cancer survivors. A percentage of the proceeds from this year’s event will be donated to Cone Health Cancer Center’s “Finding your New Normal” program for breast cancer survivors.

Tami Knutson, Breast Cancer Center Manager for Cone Health, is passionate about helping Terror for Ta-Tas because she believes it will empower more Americans to live healthier and bring us closer to ending breast cancer.

“I teach young women about self-breast awareness,” Knutson said. “There is not another venue that I have access to young people.  Most health fairs attract people in the middle years and older. I find teaching  in such a crazy, unexpected location very rewarding. It catches people off guard and I think my message is really heard.”

The Terror for Ta-Tas event runs from 7:30–11 p.m. Friday, October 11. For event information visit terrorfortatas.com, and to learn more about the “Finding Your New Normal” program e-mail Tami Knutson at Tami.Knutson@conehealth.com.

Tough Enough to Wear Pink

A non-profit marketing campaign sponsored by Wrangler, Tough Enough to Wear Pink (TETWP) began with breast cancer survivor Terry Wheatley who, with Wrangler, challenged cowboys and cowgirls to wear pink at the Wrangler National Finals Rodeo to raise awareness and to honor the women in their lives that had been affected by the disease.  TETWP serves as a springboard for communities to create rodeos and other western events that raise awareness around breast cancer.  By focusing attention on women’s health, this initiative raises money for women’s health education, supports women’s treatment centers and much more.

“The success of the Tough Enough to Wear Pink campaign – which has raised over $14.5 million dollars since its inception in 2004 – is that every community that participates through their rodeo or their western event is encouraged to keep their money locally to do good in their own back yards through contributions to their women’s breast cancer center, the women’s breast cancer wing of the local hospital or whatever breast cancer support group is in need in their community,” Wheatley said. “It is the decision of the local rodeo committee or event on who receives their donation.  The success of the campaign is that it is truly grass-roots, with people raising $5 at a time to support someone in their community.”

For example, Red Bluff Round-Up raises money for breast cancer treatment at the St. Elizabeth Imaging Center in their community of Red Bluff, California, to provide mammograms and other women’s health services directly from the funds generated through their TETWP rodeo event. This is just one of the many examples of how individual rodeos and western events use their funds to help women live healthier lives.

Now tell us how you are touching the lives of women living with breast cancer. What are you doing in your local community, place of worship, school or workplace to spread the word about how we can stop this disease together?

We Need a Little Certainty

When you’ve been diagnosed with cancer like me, you’re faced with an overwhelming amount of uncertainty. Did they catch it in time? Will the treatments work? And for many cancer patients, can I afford good treatment?

Linda Barlow

Linda Barlow

The Emergency Cancer Relief Fund (ECRF) could answer this question, but only if the HealthWell Foundation receives the donations it needs in order to open it.

It’s both sad and frustrating that here, in one of the most highly developed nations in the world, many cancer patients have to wonder if they can afford to save their own lives. Unfortunately, even having health insurance is not always enough of a safety net to avoid personal financial collapse while fighting the fight of your life.

As the bills start to roll in, so too does a new wave of uncertainty: Can you afford what you need to get better?

Providing assistance to people living with cancer has always been a priority for organizations like the HealthWell Foundation. Since 2004, HealthWell has been leading the way in bringing financial relief to more than 70,000 cancer patients with copay assistance through more than 20 oncology funds – yet so many more need help.

That is why I’m turning to you today. HealthWell has made the decision to create the ECRF. It is not yet open, but I want that to change. And for that to happen, HealthWell needs your help today.

Once launched, the ECRF will help people with expenses not covered under traditional current cancer copay funds, expanding services to even more cancer patients who have exhausted all other options and have no one to turn to.

For example, the ECRF can grant as little as $25 to help someone pay for anti-nausea medicine. Larger grants can also help patients overwhelmed by medical expenses accumulated during their treatment, such as medical equipment needs and diagnostic testing.

The ECRF will follow patients every step of the way through their treatment or recovery. It will almost be like having another caregiver watching out for your well-being. And for those of us who have lived through or are living with cancer, we know how important that caregiver network can be.

To that end, I would like to personally recognize and thank all of the health care providers at Abington Memorial Hospital and The Rosenfeld Cancer Center who took such good care of me during my recent treatments for breast cancer. From my initial diagnosis through my follow-up visits, every physician, nurse, therapist and technician I’ve encountered has treated me with both professionalism and the compassion and kindness a cancer patient needs to get through the day.

Compassion and kindness – they’re like life-giving oxygen to a cancer patient. But compassion and kindness aren’t just the hallmark of professional caregivers and loved ones. The ECRF will be proof of that, but HealthWell first has to raise enough money to open the fund so patients can benefit from it.

And that’s where your support comes in. If you want to show compassion and kindness to those with cancer, now is the time. Give to ECRF today so that HealthWell can launch the fund and help cancer patients avoid one more uncertainty in their lives.