Wednesday, May 25, 2016

Medicare Rights President Joe Baker Testifies at Congressional Hearing in Support of Part B Drug Payment Model



Washington, DC. May 25, 2016Medicare Rights Center President Joe Baker testified in support of the Centers for Medicare & Medicaid Services (CMS) proposal to test new ways to pay for prescription drugs covered under Medicare Part B, at a hearing held by the Subcommittee on Health of the U.S. House Committee on Energy and Commerce.
“Calls to withdraw the Part B Drug Payment Model fail to acknowledge the very real and unrelenting beneficiary access challenges that exist under the current payment system—not merely hypothetical ones. We applaud CMS for proposing to test solutions that have the potential to alleviate calamitous cost burdens, which cause too many older adults and people with disabilities to forgo necessary care,” said Joe Baker in his testimony.

“We urge members of Congress to support and strengthen the proposal by recommending improvements that put patients at the center of the payment model.”

The Medicare Rights Center’s support for the CMS proposal is informed by the organization’s experience working with people with Medicare and their families for more than two decades.

Medicare Rights answers nearly 17,000 questions on its national helpline and provides educational tools and resources to over two million beneficiaries, family caregivers, and professionals annually. Challenges affording needed health care are a common theme heard on the helpline, affecting nearly one in five callers.

  Sky-high cost sharing for Part B prescription drugs is a notable concern, most often for cancer and immunosuppressant medications.

“People with Medicare and taxpayers deserve a Medicare program that pays for high-value, innovative health care. The Part B Drug Payment Model presents an important opportunity to ensure that the Medicare program meets this high bar,” said Baker.  
The Medicare Rights Center also submitted comments in support of the CMS proposed Part B Drug Payment Model during the public comment period that ended on May 9.
To read Joe Baker’s testimony from the hearing, visit the Medicare Rights Center’s website.

Promise of Nearly a Year of Life on Targeted Drug Not Reality for All Liver Cancer Patients, Study Finds

Targeted Drug Liver Cancer not reality
Drug can have serious side effects and significant out-of-pocket costs for advanced liver cancer patients

Newswise , May 25, 2016- For advanced liver cancer, there’s a single approved drug shown to offer patients a chance at longer life. 

But a new study by University of North Carolina Lineberger Comprehensive Cancer Center researchers found that this drug was notably less effective in a group of Medicare patients who likely had more extensive cancer and serious liver disease than patients included in clinical trials.

In the journal The Oncologist, researchers report today that the median survival for a group of Medicare patients on the drug sorafenib was three months, which was significantly lower than the median survival of nearly 11 months for patients treated with the drug during a phase III clinical trial. 

As the drug comes with significant side effects and a cost to patients and insurers of more than $10,000 a month, researchers are questioning the value of the drug for all patients.

“No drug that results in a three-month survival can be thought to be offering a meaningful life expectancy,” said Hanna K. Sanoff, MD, MPH, a UNC Lineberger member and an associate professor and section chief of the UNC School of Medicine Gastrointestinal Medical Oncology Program. 

“This doesn’t mean that we shouldn’t prescribe it, but we should be mindful that the broader population of liver cancer patients is sicker than the patients in the landmark trial. Our patients deserve to know that the promise of nearly a year of life may not be their reality.”

The U.S. Food and Drug Administration approved sorafenib -- known commercially as Nexavar – for the treatment of advanced hepatocellular carcinoma in 2007. In a phase III clinical trial, patients with advanced liver cancer had a median survival of 10.7 months on the drug, which was 2.8 months more than patients who didn’t get the treatment. 

But patients in that study also were in good physical condition and their level of cirrhosis, which nearly universally accompanies liver cancer, was well controlled, Sanoff said.

“This drug was tested in a clinical trial with patients with mild cirrhosis who were pretty fit,” Sanoff said. 

“Because of concurrent cirrhosis, it may be that the gap between the trial population and the average liver cancer patient may be greater than in some other cancers.”
In the new study, the researchers analyzed survival data for a group of patients insured by Medicare, a government health insurance program for people aged 65 years and older or with disabilities, and who were diagnosed between 2008 and 2011. 

Of the 27 percent of 1,532 patients given sorafenib, median survival from the first prescription was three months, which was not statistically longer than survival of untreated patients.

They concluded that lower survival in the Medicare population was likely due to a generally sicker population. Further analysis suggested that patients in the study with earlier stage disease might be more likely to benefit from taking the drug.

The researchers pointed to issues of cost – both financial and in terms of side effects – as factors that patients and doctors should consider when deciding on a course of treatment.

“We need to question who we prescribe this to, not only because of the cost of the drugs from a side effect perspective, but also the actual financial cost,” Sanoff said.

In previous studies, researchers have found that the median monthly price for the drug across all available Medicare part D plans in 2014 was $10,811 per month, said study co-author Stacie Dusetzina, PhD, a UNC Lineberger member and assistant professor in the UNC Eshelman School of Pharmacy and UNC Gillings School of Global Public Health.

That price tag can mean thousands of dollars in out-of-pocket costs for patients, Dusetzina said, as most plans require cost sharing of at least 25 percent when filling the drug’s prescription. 

Even for patients who have reached the catastrophic spending level in Medicare Part D – when the amount they are expected to pay out-of-pocket decreases - they would still pay $540 per prescription fill each month.

“This is obviously going to present financial challenges for many patients,” Dusetzina said. 

“This underscores the fact that establishing effectiveness of therapies outside of trial settings is complicated but important, if we want to really understand the value of cancer therapies. Translating the benefits of treatments into a ‘real world’ setting isn’t always easy.”

Patient data was drawn from the National Cancer Institute’s Surveillance, Epidemiology and End Results Program Medicare linkage.

This work was supported by grants from the National Cancer Institute, NIH Building Interdisciplinary Research Careers in Women’s Health K12 Program, and the North Carolina Translational and Clinical Sciences Institute. 

Additional support was provided by the Integrated Cancer Information and Surveillance System (ICISS), and from the UNC Lineberger Comprehensive Cancer Center with funding provided by the University Cancer Research Fund.
Conflicts of interest: Sanoff has received research grant funding from Bayer and Novartis. Another co-author Bert H. O’Neil of the Indiana University Simon Cancer Center has consulted for Bayer.

In addition to Dusetzina, O’Neil and Sanoff, other authors include YunKyung Chang, PhD, of UNC Lineberger; and Jennifer L. Lund, PhD, of UNC Lineberger and the UNC Gillings School of Global Public Health Department of Epidemiology.

Monday, May 16, 2016

AMERICAN RX BILL OF RIGHTS SITE LAUNCHED; URGES PUBLIC TO ASK SENATORS, REPS WHERE THEY STAND ON RX PRICES, POLICIES


Election 2016 offers once-in-lifetime opportunity to elect Congress to support comprehensive legislation to lower prices

ST. LOUIS, MISSOURI, USA, May 13, 2016 /EINPresswire.com/ -- The newly launched American Rx Bill of Rights(http://americanrxbillofrights.blogspot.com) is urging Americans to ask their Senators and Representatives to take a position on the need for comprehensive, bi-partisan legislation that will guarantee access for Americans to safe, affordable prescription medicines.

Daniel Hines, publisher of the TodaysSeniorsNetwork group of blogs, and Rx for American Health, says the new site is directly aimed at “making a difference” in the 2016 Elections.

“The ‘Articles’ of the Rx Bill of Rights include proposals that can make an immediate impact upon the health and well-being of millions of Americans by ensuring that they are able to afford their vital medicines,” he explains.

“The elections of 2016 offer what may a once-in-a-lifetime opportunity to ensure that millions of Americans are no longer denied the health benefits made possible by access to vital medicines simply because of the predatory pricing practices of Pharma,” he continues. “ Simply put, a medicine that is unaffordable is, in and of itself unavailable, thereby putting the health and well-being of Americans at risk, contributing to rising health costs caused by complications that could have likely been avoided by access to safe, affordable medicines.”

The Articles of the American Rx Bill of Rights are: Article One—A Basic Right to Good Health; Article Two--An Unaffordable Medicine is Unavailable; Article Three--Citizens as Stakeholders in Rx Policy Development; Article Four—Due Process to Protect Unfair Confiscation of Authentic Medicines
Article Five—The Public Interest of an Rx Bill of Rights; Article Six—Reciprocity Agreements to Facilitate Personal Importation of and Access to Safe, Valid Medications

An explanation of the Articles follows:
Article One (A Basic Right to Good Health): The impact of millions of Americans being denied the health benefits of access to a regimen of safe, affordable medicines because of cost is a national health issue that has yet-to-be-recognized consequences. That is why the ability of American Citizens to make health care decisions in concert with their physicians such as the purchase of personally imported safe, affordable prescription medicines should not be hampered by any actions by government or private entities as a policy to restrict Americans' access to authentic medicines.

Article Two (An Unaffordable Medicine is Unavailable): A prescription medicine that is unaffordable is unavailable, thereby meeting the 'rules' of the FDA that such a medicine that is otherwise unavailable is indeed eligible to be personally imported by an American patient, Arbitrary denial by the FDA to such access is detrimental to the health of the patient by denying him or her access to vital maintenance medicines. This is a violation of the purpose of the FDA which is ostensibly designed to protect the health and well-being of American citizens.

Article Three (Citizens as Stakeholders): The relationship between the FDA, elected officials, and Pharma has led to numerous abuses, access by Pharma to legislators and other elected officials based on the contribution of millions of dollars, favored status for Pharma representatives and their front groups as the primary representative at public hearings to determine the health care policy for Federal, State and Local Governments, thereby skewering the decision-making process. That why it is incumbent upon Congress that it acts to ensure that ordinary American citizens whose health and finances are adversely affected by Pharma pricing practices, advocacy groups other than those of Pharma, are given a 'stakeholder' status equal to that of Pharma.

Article Four (Due Process): Americans who purchase safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries whose standards meet or exceed those of the U.S., are the legitimate owners of their authentic medicines and are entitled to exercise their due process rights to have their personal property free from undue and unjustified seizure oar destruction by any governmental agency unless the seizing authority can demonstrate via established judicial processes and to courts that such seizures are of bogus, counterfeit or unsafe prescription medicines.

Article Five (Public Interest): Americans are significant contributors to the development of research and development costs of new medicines through their tax dollars in support of grants to the National Institutes of Health (NIH), and, as such, should be protected from unfair or questionable patent protection granted to Pharma that fails to recognize the rights of American citizens. Abuses in pricing, illegal business activities, or undue influence upon policy-making by the FDA or elected officials should result in a reduction of the patent protection afforded Pharma to the detriment of untold numbers of Americans who must be able to pay what Pharma believes the traffic will bear.

Article Six (Reciprocity): The FDA should extend reciprocity to other Tier One countries in the interests of the health of American citizens. The majority of brand name prescription medicines sold to Americans is manufactured at plants outside the U.S., under FDA supervision, or at plants licensed by Pharma members to produce medicines under a license granted by a particular company, a validation that medicines produced outside the U.S. and sold in this country are indeed capable of being safe. Also, the FDA has entered into agreements with regulatory agencies in many countries to assume the task of overseeing ingredients manufacture of ingredients for brand name medicines. Added to that is that many countries (excluding the U.S and the FDA) have reciprocal agreements (Memorandums of Understanding) that one country will accept the medications produced in another country as safe and authentic.