Latest Drugwonks' Blog
According to the Pink Sheet:
“The Obama administration's proposal to establish an executive branch advisory council on Medicare payment issues may raise the threat of government negotiations for Medicare Part D drug prices. The legislative proposal was forwarded to House Speaker Nancy Pelosi July 17 by Office of Management and Budget Director Peter Orszag, who urged that some form of an Independent Medicare Advisory Commission be included in House health reform legislation.”
“Leaders of the House Energy and Commerce committee have agreed to incorporate the concept in the Tri-Committee health reform bill, committee Chair Henry Waxman, D-Calif., announced July 22. The concept is supported by the fiscally conservative Blue Dog Democratic coalition in the House, which has emerged as a key factor in moving the bill.”
“The White House proposal would establish IMAC to take on some of the Medicare payment and coverage decisions now handled by Congress - mainly payment rates under the Part B physicians' benefit as well as Part A, which pertains to inpatient hospital care. However, the group would also be authorized to recommend other Medicare payment reforms and the Part D prescription drug program is explicitly discussed in the document.”
“For the most part, where specific aspects of Part D are mentioned, they are described as areas where IMAC is not authorized to make recommendations. The document includes a section entitled "exclusions," stating "the council may not recommend any changes to the following aspects of the Medicare program" and listing about a dozen Part D citations. The intent of the exclusions section is to list the sections of the law ‘with which the Council's reform recommendations must remain consistent.’ "
“On closer look, the exclusion list has an interesting exception: "noninterference in 1860D-11(i)" of the Social Security Act.The noninterference clause in 1860D-11(i) has been in the crosshairs for Democratic lawmakers since the Part D program was established. It says the HHS Secretary ‘(1) may not interfere with the negotiations between drug manufacturers and pharmacies and PDP sponsors; and (2) may not require a particular formulary or institute a price structure for the reimbursement of covered part D drugs.’ “
“By excepting the clause from the list of ‘exclusions,’ the proposal can be read as allowing IMAC to reopen the issue, Sidley Austin partner William Sarraille agrees. It also shows that policymakers continue to pursue ways for the government to use its strength at the Part D bargaining table, he pointed out. ‘The Democrats are determined to get government negotiation,’ he said.”
Talk about Part D Deficit Disorder.
Many suggest that allowing the feds to directly negotiate for Part D is no different from the current VA scenario. But suggesting that the Veteran’s Administration “negotiates” prices for prescription drugs is a false premise.
Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.” The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.” The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.
A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.
There’s a big difference between negotiating and mandating – and it’s not a thin line. My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.
(And remember, the Non-Interference Clause was originally authored by Senators Kennedy and Daschle.)
Remember Harry & Louise? Well welcome Harry & Louise 2.0. And this time they’re for healthcare reform.
As Ad Age reports:
Harry and Louise's job description is dramatically different today than it was in the 1990s. During the
Former FDA Associate Commissioner Peter Pitts, now the president for the Center for Medicine in the Public Interest, said he doesn't think the ads are going to do much to help Mr. Obama's cause.
"What's important to remember is that nobody -- not insurance companies, not drugmakers, not doctors, not patients, not politicians -- disagrees that reform is needed," Mr. Pitts said. "That said, 2009 is very different from the initial iteration of Harry and Louise. The average television viewer and YouTube viewer is much more sophisticated and much more aware that these are two paid actors. They were paid 16 years ago to be against health-care reform, and now they're being paid this year to be for health-care reform. If they were paid tomorrow to be New York Yankees fans, you would see a commercial for that."
The complete article can be found here.
And, speaking of the NY Yankees -- Happy Birthday to A-Rod.
http://www.psycho-donuts.com/home/
Will DDMAC’s July 14th warning letter to Abbott send shivers down the spines of MLRers, reinforcing the notion that the FDA doesn’t approve of the use of celebrities?
Let’s look at the facts:
DDMAC cites Abbott’s promotional DVD, titled "I Know What's Important," for clumping the risk information in a dull section of at the end of the video and suggesting that Kaletra (lopinavir/ritonavir) has broader utility in treatment-experienced patients than the label supports. The “I” is non other than Ervin “Magic” Johnson.
In the Kaletra DVD, the first 111/2 minutes are devoted to an "engaging and lively" discussion with Johnson about the benefits he has experienced from the drug. "In contrast," DDMAC writes, "the presentation of serious risks associated with Kaletra is relegated to the end of DVD after the interview is over, where it is unlikely to draw the viewer's attention, and is displayed as a running telescript."
The only risk information included during the interview is a brief acknowledgement by Johnson that he experiences "fatigue sometimes" and disclosures in SUPERs that Kaletra "is not a cure for HIV infection," that "the most commonly reported side effects of moderate severity that are thought to be drug-related are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea, " and that "children taking KALETRA may sometimes get a skin rash."
DDMAC argues that while Johnson's claims may be an accurate reflection of his own experience, "inclusion of the SUPER stating 'Individual results may vary' ... does not mitigate the misleading impression created by the promotional DVD that all or most treatment-experienced patients taking Kaletra can expect to survive and be healthy for at least five years."
"FDA is not aware of substantial evidence or substantial clinical experience to support effectiveness for five or more years of treatment with Kaletra in treatment-experienced adults," DDMAC wrote, and the "personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence."
"These claims misleadingly overstate the efficacy of Kaletra by suggesting that the usual outcome of treatment with Kaletra is the preservation and continuance of a 'normal life,' including activities of daily living, work productivity, and social, emotional, and physical functioning," DDMAC wrote.
Note: No claims were made to infer that use of Kaletra helps to enhance one’s baby sky hook.
"This morning on MSNBC, Igor Volsky, the Wonk Room’s health care blogger and co-author of Howard Dean’s Prescription for Real Health Care Reform, defended President Obama’s health care proposal. When host Chris Jansing argued that the Congressional Budget Office is predicting that health care reform would “increase long-term costs facing the government,” Igor noted that the CBO released a statement last night stating that the House bill would be deficit-neutral.
Igor debated Robert Goldberg, the president of the industry-funded Center for Medicine in the Public Interest. Towards the end of the segment, Goldberg attacked Igor, saying, “I can’t believe I’m hearing a liberal think tank support systematically restricting minorities from access to quality care.” Igor noted that “no one is restricting minorities, Robert — what are you talking about?” Goldberg revealed that his real problem is that he hates Medicaid:
GOLDBERG: If you’re a Medicaid recipient, you are not allowed to take a voucher and go to a plan that you think is good for you. You are forced to stay into Medicaid. Do you think that’s right or wrong? Yes or no?
IGOR: I think Medicaid provides essential services for many Americans that the private market simply can’t provide, which is why we’re expanding Medicaid. … It’s not putting people into Medicaid against their will."
Right, the "private market" can't provide... maybe because the rules and price controls make it impossible for a private market to exist let alone response to unique patterns of care? Another reason I hate Medicaid, along with the fact that under Obamacare it will subsidize rich and healthy people...
Igor also noted that the motive behind including a public health insurance option for all Americans is to ensure everyone is given access to a solid benefits plan regardless of their income or class.
Watch it:
I provide the link since the site has so many intelligent comments that follow the original post...
Read more here
"He praised the pharmaceutical industry for making a hard commitment, but added, We might be able to get $100 billion out of them, or more. Mr. Obama offered no specific plans to increase the companies’ contributions to health care savings."
Folks -- 10% of our national healthcare spend cannot finance the other 90%.
Hullo?
Hence, this in Health Affairs...
Bethesda, MD -- Are drugs known as "second-generation antipsychotics" (SGAs) being overused and misused? What steps can be taken to make sure that medications are used correctly? Those questions are addressed in a trio of articles published today on the Health Affairs Web site.
Read article here
SGAs, also known as "atypical antipsychotics," have largely replaced older, less expensive first-generation (or typical) antipsychotics in the treatment of schizophrenia. SGAs are increasingly being used for a wide range of other clinical conditions as well.
The cost of SGAs is typically from ten to 100 times the cost of "first-generation" antipsychotics, and domestic U.S. sales of SGAs have reached $13 billion a year. However, based on recent research, some experts believe that the overall risk-benefit profiles of SGAs may be no better than those of some of the older and cheaper medications they have displaced, although important questions remain to be addressed through further research, and considerable variation exists in treatment response across individual antipsychotic drugs. While SGAs appear to cause fewer "extrapyramidal" side effects, including serious movement disorders, they bring increased risk of weight gain and blood-lipid abnormalities that may increase the risk of heart disease and diabetes.
Other researchers believe that SGAs can offer important new benefits for patients with schizophrenia and other serious mental conditions, but that the broadened use of these drugs for a more clinically diverse population of patients may have outstripped the evidence base for such use.
Examining The Use Of SGAs Among Youth and Elderly. In "Broadened Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy Challenges" Stephen Crystal and coauthors document the increased use of SGAs on the two ends of the age spectrum, the nation’s youth and the elderly in nursing homes. When the researchers examined youth in seven state Medicaid programs, they found that 4.2 percent of enrollees ages 6-17 filled at least one prescription for an antipsychotic medication in 2004, up from 2.7 percent in 2001. Virtually all of the antipsychotics used were SGAs.
Read article here
Clinical indications approved by the Food and Drug Administration for antipsychotics in young people are limited to schizophrenia, behavioral symptoms in autism, Tourette’s disorder, and mixed or manic bipolar episodes. But in 2004, one-third of the youth in the seven Medicaid programs studied were being treated for attention deficit hyperactivity disorder without diagnostic codes for more-serious diagnoses such as schizophrenia, autism or bipolar disorder, according to Crystal, director of the Center for Education and Research on Mental Health Therapeutics in the Center for Pharmacotherapy at Rutgers University, and colleagues. Overall, almost three-quarters of Medicaid youth receiving antipsychotics were being treated only for conditions for which no FDA clinical indication existed. The results were similar among privately insured youth.
Likewise, among elderly nursing home residents, most use was for residents without an FDA diagnostic indication, and use increased from 1999 to 2006 despite new safety concerns including FDA warnings of increased mortality associated with use among elderly with dementia. Among nursing home residents in 2006, 27.6 percent were receiving antipsychotics, up from 20.2 percent in 1999.
Increasing Information To Ease Resistance To Practice Changes. In "Developing A Policy For Second-Generation Antipsychotic Drugs," Robert Rosenheck and Michael Sernyak report that many SGAs were prescribed for questionable reasons at one university-affiliated Veterans Affairs health center caring for veterans with serious mental illness. "The most frequent reasons given for prescribing SGAs … were greater efficacy, followed by patient preference and sedation/sleep, none of which is well-supported by current research. In contrast, prevention of neurological side effects – the reason for using SGAs with the strongest research support – was the least frequently cited reason for starting a new SGA," say Rosenheck, codirector of the New England Mental Illness Research, Education, and Clinical Center at the VA Connecticut Health Care System, and Sernyak, chief of the Mental Health Service at the VA Connecticut Health Care System.
Read article here
Rosenheck and Sernyak suggest that the most appropriate policy would be "stepped therapy," in which patients would have to start on first-generation antipsychotics and would only be allowed to try the SGAs with the most risk of side effects if other drugs had failed to help them. However, this policy would be likely to meet resistance, the authors acknowledge. They suggest that "counter-detailing, with its emphasis on individualized education and direct feedback, may be crucial in garnering the understanding and needed support for successful implementation of meaningful practice change."
Notice, no measure of individual response or outcomes..
Whereas David Meltzer and co. note what happens when individual responses to individual drugs are counted...
The Need For More Comparative Effectiveness Research. In "Comparative Effectiveness Research for Antipsychotic Medications: How Much Is Enough?" David Meltzer and coauthors examine a high-profile study funded by the National Institutes of Health that has been used to argue for restricting coverage of SGAs. In 2006, a cost-effectiveness analysis based on this study – known as the Clinical Antipsychotic Trials of Intervention Effectiveness study, or CATIE – found that "treatment with perphenazine [a first-generation antipsychotic] was less costly than treatment with second-generation antipsychotics with no significant differences in measures of effectiveness."
Read more here
However, there are a number of concerns about CATIE’s design that create "great uncertainty about the extent to which CATIE findings should be used to make coverage policy," write Meltzer, Director of the Center for Health and the Social Sciences at the University of Chicago, and colleagues. The authors present a model that they say indicates that additional comparative effective research involving SGAs would be of immense value – exceeding $300 billion – to those who have schizophrenia today and to those who will develop it over the next 20 years. The model also suggests that it would be worthwhile to perform studies of the effectiveness of SGAs with much larger sample sizes than CATIE, on the order of 8,300 patients in each treatment group as opposed to the 400 patients per group in CATIE. The model indicates that studies of cost-effectiveness should be even larger and would offer the greatest value.
Larger? I don't think so. I think spending money developing/testing predictive and biomarker based tools in observational settings would be a lot cheaper.
What are people thinking?
After the embargo lifts, you can read the article by Crystal and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w770
After the embargo lifts, you can read the article by Rosenheck and Sernyak at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w782
After the embargo lifts, you can read the article by Meltzer and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w794
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
