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WASHINGTON -- By Emily P. Walker, Washington Correspondent, MedPage Today

It was quiet on the Hill this week as Congress continued the August holiday but it was business as usual at the FDA and the Centers for Medicare and Medicaid Services.

At the FDA pain -- chronic and pain caused by fibromyalgia -- kept two advisory committees busy while CMS rolled out the estimates for the 2011 Medicare prescription drug premiums. The Part D premiums held fairly steady, but the National Business Group on Health predicted that employer-based insurance plans will take a bigger bit from employees pay checks next year.

Panel Split on Duloxetine for Pain
An FDA advisory committee voted narrowly -- 8 to 6 -- to recommend that the agency expand the indication for the antidepressant duloxetine (Cymbalta) to treat chronic musculoskeletal pain, a condition that may affect as many as 40 million Americans.
An 8 to 6 vote is considered a "null" vote, and provides no clear indication of what the FDA will do. The FDA is not required to follow the advice of its committees, but it often does.
To support its application, Eli Lilly had submitted data from three trials that testing various doses of duloxetine against placebo in chronic low-back pain patients and two trials in arthritis patients. In four of the five trials, duloxetine demonstrated greater pain reduction than placebo (P<0.05 for the four trials).

But one panelist estimated that for every 10 patients treated with duloxetine, just one would experience a 30% reduction in pain. (hY Says! Ka-Ching, Ka-ching!)

Although concerns were raised prior to the meeting about the drug's side effects -- notably hepatoxicity -- the panel seemed to agree the side effects, including the risk for liver damage, were acceptable. The committee voted 9 to 4 that the benefits of duloxetine outweighed the risks.
If approved, duloxetine would be the first non-NSAID, non-opioid analgesic broadly indicated for the treatment of chronic pain.

Separate Panel Rejects CNS Drug for Fibromyalgia
The following day, a separate panel voted 20-2 to recommend that the FDA not grant approval for an expanded indication for sodium oxybate (Xyrem) -- also known as GHB, the "date rape" drug -- to treat fibromyalgia.

A number of members on the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committees felt the potential for widespread abuse of the drug was too great to warrant expanding the indication to a condition that affects an estimated 2% of the U.S. population.
Other panelists weren't as worried over the potential for abuse, but they noted that the drug's maker, Jazz Pharmaceuticals, failed to convincingly prove the drug worked. Others were concerned about the odd dosing mechanism of the drug -- which requires the patient to mix a solution with water and take one dose before bedtime, and set an alarm to wake up four hours later to take the second dose.

The FDA is not required to follow the advice of its advisory committees, but it often does.
Sodium oxybate is currently approved at a 500 mg/ml dose for narcolepsy-associated cataplexy and excessive daytime sleepiness.

Slight Increase for Medicare Drug Premiums Next Year
Medicare beneficiaries enrolled in Part D will pay an average of $30 per month for their prescription drug benefit premiums in 2011, a $1 increase over what they paid this year, according to Centers for Medicare and Medicaid Services (CMS) officials.
Premiums stayed relatively stable because of a discount program in the the healthcare reform law, Jonathan Blum, deputy administrator of CMS' Center for Medicare, told reporters Wednesday.
Cost will remain about steady, and so will benefits, said CMS Administrator Don Berwick, MD.
The low rates will "add stability" to the Medicare Part D program, which has an enrollment of about 27 million seniors, Berwick said.
When Part D first began, the program was projected to cost $634 billion for fiscal 2004 through 2013. Instead, it will cost $373 billion for those same years, Paul Spitalnic, of CMS' Office of the Actuary told reporters.
The main reason for the program coming in $261 billion under projected costs is that the rising costs of prescription drugs slowed in the early 2000s and more people switched to generics, explained Spitalnic.
In addition, Part D plans have been able to negotiate more drug rebates than anticipated, and fewer beneficiaries enrolled than the government originally predicted.

Employees Healthcare Costs to Increase
While seniors won't see a huge hike in their medication premiums next year, one group that might be paying more for healthcare is employees of companies that offer health insurance as a benefit, according to a report from the National Business Group on Health (NBGH).
The group surveyed 72 large employers representing about 3.7 million employees, and asked about medical claims costs for 2010 and projected claims costs for 2011.
The findings showed that about 63% of businesses plan to make employees pay a higher percentage of their premium costs in 2011. In addition, 46% will increase out-of-pocket maximums, while 44% will increase in-network deductibles.
As a result of those higher costs to patients, providers may see patients start asking more questions about the necessity of some procedures, NBGH president Helen Darling told reporters Wednesday.
"What we hope, and we do see evidence of this, is that people will be asking tougher questions of what's being done for or to them," she said. "If the provider says, 'We have to do an MRI,' and the patient asks, 'What will that do for my treatment?' and the provider says, 'Nothing, but we want to have additional information,' then the patient may say, 'Then I don't want it.'"
The companies surveyed projected that the cost of providing healthcare benefits to their employees will rise an average of about 9% in 2011, which is about 2 percentage points higher than the 7% average increase for 2010.
About 1% of next year's increase comes from changes mandated under the Patient Protection and Affordable Care Act (PPACA), according to Darling. 

Next Week

Congress returns to  action on Sept. 13.

No FDA panels will be meeting next week.

Posted in: Washington health news