National Health Costs (NHE, National Health Expenditures)

While we debate Health Care note that:

• NHE grew 5.8% to $3.2 trillion in 2015, or $9,990 per person, and accounted for 17.8% of Gross Domestic Product (GDP).
• Medicare spending grew 4.5% to $646.2 billion in 2015, or 20 percent of total NHE.
• Medicaid spending grew 9.7% to $545.1 billion in 2015, or 17 percent of total NHE.
• Private health insurance spending grew 7.2% to $1,072.1 billion in 2015, or 33 percent of total NHE.
• Out of pocket spending grew 2.6% to $338.1 billion in 2015, or 11 percent of total NHE.
• Hospital expenditures grew 5.6% to $1,036.1 billion in 2015, faster than the 4.6% growth in 2014.
• Physician and clinical services expenditures grew 6.3% to $634.9 billion in 2015, a faster growth than the 4.8% in 2014.
• Prescription drug spending increased 9.0% to $324.6 billion in 2015, slower than the 12.4% growth in 2014.
• The largest shares of total health spending were sponsored by the federal government (28.7 percent) and the households (27.7 percent).   The private business share of health spending accounted for 19.9 percent of total health care spending, state and local governments accounted for 17.1 percent, and other private revenues accounted for 6.7 percent.

Lymphoma / Aubagio Connection?

https://www.medpagetoday.com/Neurology/MultipleSclerosis/66475?xid=nl_mpt_DHE_2017-07-08&eun=g351680d0r&pos=1

Lymphoma Case Reported in MS Patient on Aubagio

First case in medical literature, more found in global surveillance reports

• SAVESAVED

• by Kristina Fiore, Deputy Managing Editor, MedPage TodayJuly 07, 2017

Researchers have reported the first published case of lymphoma in a multiple sclerosis (MS) patient taking teriflunomide (Aubagio) -- and they also found 10 other cases in an international pharmacovigilance database.

A 54-year-old black woman with MS developed follicular lymphoma after 8 months on teriflunomide -- and the "timing of teriflunomide exposure was consistent with the onset of lymphoma," Anne Landais, MD, of University Hospital of Pointe-a-Pitre in Guadeloupe, France, and colleagues reported online in Multiple Sclerosis and Related Disorders. "So although there is no direct evidence confirming the role of the drug, we believe that it is useful to alert the medical community to this case," they wrote.

When they searched the literature, Landais and colleagues found no reports linking teriflunomide with lymphoma. But when they checked the World Health Organization's VigiBase -- a global database of safety reports -- they found 10 more cases of lymphoma with teriflunomide, and 82 more with leflunomide, of which teriflunomide is the active metabolite.

Although the researchers acknowledged that more than 70,000 patients have been treated with teriflunomide as of April 2017, questions remain, the team noted, about immunosuppressive drugs in MS and cancer risk.

"Ultimately, only the development of registries, databases, and national and international observatories with the combined efforts of all neurologists will help answer the question of the risk of cancer associated with the use of treatment for MS," the researchers wrote.

The woman had no risk factors for lymphoma; indeed, black women in the U.S. have a threefold lower risk of developing the cancer compared with white women in the U.S.,Landais and colleagues noted. The patient did have a history of having a thyroidectomy for multinodular goiter, as well as surgery for a mammary adenofibroma and a uterine fibroid. But the researchers noted that the levothyroxine she was taking for thyroid hormone replacement has never been tied to lymphoma risk.

The patient had developed her first MS symptoms in 2013 and was eventually diagnosed with MS, for which she started teriflunomide in June 2015. In February 2016, she noticed an inguinal ganglion that was about 2 to 3 cm in diameter. By May, she was diagnosed with grade 1-2 follicular B-cell lymphoma. She stopped teriflunomide the next month and started on glatiramer acetate in July.

There was no clear signal from teriflunomide clinical trials regarding cancer risk, although an extension of a phase II trial reported five cancer cases, all of which occurred in patients taking the drug.

The researchers also noted that the 82 globally reported lymphoma cases with leflunomide could be of concern, given that teriflunomide is its active metabolite. With leflunomide, research has shown an increased incidence of malignant lymphoma in male mice given 15 mg/kg of the drug daily.

"An association between teriflunomide and higher risk of lymphoma can't be ruled out," the team concluded.

TAGS: Med Page Today, Kristina Fiore, Anne Landais, MD

Generic Drug Prices Go Up Because-

There is an interesting chart in this article showing the increases of price if there was no competition compared to prescription drugs that were in a competitive market.

• Generic Drugs in non-competitive markets up 100% between 2008 & 2012.
• Generic Drugs in competitive markets had between a 0% increase and a 20% decrease over the same time period.

No Competition... Prescription Drug Prices Rise

Link Between MS Therapy Tysabri and Melanoma Possible

Melanoma a Tysabri Risk?

Link Between MS Therapy Tysabri and Melanoma Possible, an Adverse Reactions Watchdog Group Says

JUNE 30, 2017 

BY MAGDALENA KEGEL

 

IN NEWS.

The multiple sclerosis therapy Tysabri (natalizumab) could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned.

Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said.

Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer.

The organization’s report, published in the journal Cancer Medicine, was titled “Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions (SONAR).”

SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it.

A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years.

Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment.

The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma.

In addition, they looked through the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri’s developer, Biogen,

The research team found 137 cases in the FAERS database through April 1, 2014. The patients’ average age was 45.

Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died.

The researchers said the database contained only about half the information it should have, such as tumor site, patients’ family history of cancer, and earlier immunosuppressive treatment.

Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information.

Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average.

“The existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,” the team wrote.

This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the  researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates.

The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time.

These observations do not seem to support a link between Tysabri and melanoma, the team said. “A longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,” the researchers wrote.

But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute’s database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals.

In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued.

While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others.

The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve.

To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri.

While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.

Tags: Multiple Sclerosis News Today, Magdalena Kegel 

The Push to Repeal IPAB

Healthcare Groups Push to Repeal IPAB by August Deadline
Repeal through a joint resolution would need to happen by Aug. 15

by Joyce Frieden, News Editor, MedPage Today
June 30, 2017

WASHINGTON -- A large group of healthcare organizations is pushing for Congress to repeal the law establishing the Affordable Care Act's Independent Payment Advisory Board (IPAB) before Aug. 15, warning that it will get a lot harder after that date.

The IPAB was designed to be a 15-member independent body that would make recommendations on cuts to the Medicare budget; if Congress didn't agree with the IPAB's recommendations, it would have to devise its own plan to cut the Medicare budget by an equivalent amount.

The board has not yet met -- indeed, no one has even been named to it -- and its hypothetical existence has few defenders. Nevertheless, it could become a much bigger focus in the next few weeks if it remains on the books. That's because of the expected release of the Medicare Trustees' Report, an analysis released annually that details the fiscal health of the Medicare program.

The trustees' report will announce whether or not Medicare has met spending targets mandated by the Affordable Care Act (ACA). If the targets are not met -- if Medicare spending is too high -- the ACA's IPAB clause will be triggered. If the IPAB isn't established, or if it meets but fails to devise an acceptable plan, the responsibility of making the cuts would fall to the current Health and Human Services Secretary, Tom Price, MD.

The IPAB's critics -- who span the ideological spectrum -- say it is a far too blunt instrument to use for cutting Medicare spending. "There are more thoughtful ways to improve the efficiency and quality of the Medicare program rather than this meat axe approach," said Mary Grealy, president of the Healthcare Leadership Council, a coalition of drug, medical device, health insurance, and other healthcare organizations that is spearheading the repeal push.

"It takes time to bend the cost curve in Medicare," said Victor Fazio, a former Democratic congressman from California and now a senior advisor to the Washington law firm Akin Gump, which the HLC has hired to help with the repeal effort. The IPAB "is the impatient approach."

In addition, said Grealy -- who, like Fazio, spoke during an interview at which a public relations person was present -- the law creating IPAB "is very restrictive as to who could be on this board" because of conflict-of-interest issues, "so it would be people with no real-world experience in delivering healthcare."

And the cost-cutting recommendations would likely involve reimbursement cuts for physicians and other healthcare providers, according to Grealy.

"The law requires IPAB to achieve scoreable savings within a one-year time period," the HLC, along with several hundred organizations, wrote in a letter to members of Congress. "Thus, instead of pursuing long-term reforms that may not achieve immediate savings, IPAB is more likely to consider short-term savings in the form of payment cuts for healthcare providers. This was, in fact, the conclusion of the Congressional Budget Office, which stated that IPAB is most likely to focus on payment rates or methodologies for services provided by non-exempt providers."

There are better ways to cut Medicare costs than through IPAB, including greater use of accountable care organizations (ACOs), Grealy said. "There is also a big focus now on chronic care and there are a lot of new tools out there [such as] allowing broader use of telehealth." In terms of reducing the cost of prescription drugs -- an issue that affects the drug companies in Grealy's organization -- the solution involves "increasing competition to lower prices -- get more generics to market quickly, and get more brand-name drugs to market quickly too."

Although IPAB could be repealed at any time through the regular law-making process, there is a special provision that would allow it to be repealed through a joint resolution -- a "cleaner" process that allows no amendments to the measure -- as long as it is done by Aug. 15. Hence the group's rush to get the repeal done. "We miss that [deadline] and then it would go to a normal legislative process," which would be much more complicated, Grealy said.
The repeal effort has bipartisan support in Congress, including 49 senators and 219 members of the House, she noted. In the Senate, Ron Wyden (D-Ore.) and John Cornyn (R-Texas) have introduced both a joint resolution and a regular bill to repeal IPAB, as have Reps. Phil Roe, MD, (R-Tenn.) and Raul Ruiz (D-Calif.) in the House. But the biggest problem with Congress has been raising awareness of the issue, Fazio said. "Most members of Congress are surprised to know that the [joint resolution option] is open to them."

Although Democrats have been supportive of the ACA, some are not anxious to trigger the IPAB because if the board fails to cut Medicare costs to Congress's satisfaction, the task will fall to Price, a Republican, he noted.

In general, "IPAB has been operating like a ghost ship -- an empty vessel created by Congress that doesn't have anyone on board," Jonathan Oberlander, PhD, chair of the department of social medicine at the University of North Carolina in Chapel Hill, wrote in an email to MedPage Today.

"Many health services researchers still support IPAB as a device to rationalize healthcare spending and Medicare governance," Oberlander said. "But in Congress, Republicans intensely oppose it and Democratic support is wavering. Some Democrats probably still support IPAB for substantive reasons, others as a symbol of the ACA -- they resist repealing any part of the ACA or giving ground to the GOP on any ACA issue. How strong Democratic support actually is for IPAB in Congress right now I don't know."

"There is a good chance that Congress could repeal IPAB, though given the general uncertainty over healthcare reform and the ACA it is hard to predict and its fate remains uncertain," continued Oberlander, the author of a Perspective article on IPAB in the New England Journal of Medicine. "If it survives, the Trump administration could potentially choose not to enforce its spending cuts -- IPAB in that case would essentially become the institutional equivalent of the living dead."