As the Hepatitis C Marketing Frenzy Continues, a Reminder Not to Ignore the Evidence
The Hepatitis C Spin Cycle Continues Since our last post in July, 2014, about sofosbuvir (Sovaldi, Gilead), the $1000 pill proclaimed to be a wonder drug for the treatment of hepatitis C, the marketing juggernaut for new antiviral drugs for this condition continues to roll along.For example, I just got a notice to look at a Gilead website which proclaims HCV can be curedIn October, Gilead got permission so sell Harvoni, a new combination drug that includes sofosbuvir and ledipasvir, hailed as a once daily pill that can cure hepatitis C, for a mere $94,500 for a typical treatment course. (See this article in the Wall ...
Source: Health Care Renewal - January 5, 2015 Category: Health Management Tags: AbbeVie clinical trials evidence-based medicine Gilead marketing Sovaldi Source Type: blogs
Sovaldi: The drug pricing paradigm has shifted
Sovaldi (sofosbuvir), the new hepatitis drug manufactured and marketed by Gilead Sciences, has garnered considerable media attention over the last several months. The drug was approved by the FDA in December after phase III clinical trials showed it was highly effective in the treatment of chronic hepatitis C (HCV) infection. In fact, with an overall SVR (sustained virologic response) of 90 percent for the genotypes studied, Sovaldi may represent a cure for many of the 3.2 million Americans afflicted with the disease.
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Your patients are rating you online: How to respond. Manage your online re...
Source: Kevin, M.D. - Medical Weblog - December 24, 2014 Category: Journals (General) Authors: Luis Collar, MD Tags: Meds GI Medications Source Type: blogs
Transforming Rural Health Care: High-Quality, Sustainable Access To Specialty Care
Editor’s note: This post is also authored by Kate Samuels, a project manager at Brookings. It is informed by a case study, the fourth in a series made possible through the Merkin Initiative on Physician Payment Reform and Clinical Leadership, a special project to develop clinician leadership in health care delivery and financing reform. The case study will be presented on Monday, December 8 using a “MEDTalk” format featuring live story-telling and knowledge-sharing from patients, providers, and policymakers.
Health care for patients in rural communities across the United States remains a unique challenge. Des...
Source: Health Affairs Blog - December 5, 2014 Category: Health Management Authors: Kavita Patel, Margaret Darling, and Mark McClellan Tags: All Categories Connected Health Disparities Health Care Delivery Health IT Payment Physicians Policy Primary Care Quality Workforce Source Type: blogs
PCORI Board to Consider Hepatitis C & PCORnet Funding at Dec. 8 Meeting
THCBist The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) will consider a plan for funding comparative clinical effectiveness research on hepatitis C virus infection at its day-long meeting on Monday, Dec. 8. In addition, the Board will vote on a plan to fund the second phase of development of PCORnet, PCORI’s initiative to […] (Source: The Health Care Blog)
Source: The Health Care Blog - December 5, 2014 Category: Consumer Health News Tags: Uncategorized PCORI PCORnet Source Type: blogs
"New Chemical Entity Exclusivity Determinations for Fixed-Combination Drug Products": Combo Drugs Now Eligible For 5-Year Exclusivity
The Food and Drug Administration (FDA) recently finalized guidance which allows fixed-combination drugs consisting of at least one new drug product to be eligible for a five-year “New Chemical Entity” (NCE) exclusivity period. FDA’s policy, entitled New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products, changes the Agency's previous interpretation that rendered combination products with even one “previously approved moiety” ineligible for five-year exclusivity. While this policy is good news for manufacturers of combination products going forward, FDA’s new guidance does not...
Source: Policy and Medicine - November 26, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Sovaldi, Harvoni, And Why It’s Different This Time
With the Food and Drug Administration (FDA)’s approval of Harvoni, the successor to Gilead Science’s Sovaldi, the alarm bells have officially rung on breakthrough hepatitis C treatments. One can’t open a newspaper or scan a Twitter feed without stumbling on at least one reference to either of the these two drugs for hepatitis C — an often debilitating viral infection impacting the liver that affects somewhere between 3 to 5 million Americans and several hundred million people worldwide. Hepatitis C infection is often asymptomatic and can have long latency periods. In up to 20 percent of people, chronic infectio...
Source: Health Affairs Blog - November 21, 2014 Category: Health Management Authors: Laura Fegraus and Murray Ross Tags: Access All Categories Bioethics Biotech Business of Health Care Health Care Costs Pharma Spending Source Type: blogs
Governor-elect Charlie Baker on healthcare policy
Charlie Baker (R), Governor-elect of Massachusetts
https://healthbb.files.wordpress.com/2014/02/hbdew0005-david-e-williams-interviews-charlie-baker-republican-for-governor-of-massachusetts.mp3
Early in 2014 I interviewed Massachusetts Governor-elect Charlie Baker (and all the other candidates) about healthcare policy. Now that he’s won the election I have re-posted the interview. I hope to interview him again in the coming months.
Baker has tremendous, relevant experience in healthcare. He was CEO of Harvard Pilgrim Health Care and Secretary of Health and Human Services before that. Healthcare is a huge issue for M...
Source: Health Business Blog - November 12, 2014 Category: Health Managers Authors: dewe67 Tags: Podcast Policy and politics Charlie Baker Harvard Pilgrim Health Care healthcare Massachusetts Source Type: blogs
Top stories in health and medicine, November 12, 2014
From MedPage Today:
Ebola: ‘True Heroes’ in West Africa. Hailed as a hero after recovering from Ebola, Craig Spencer, MD, said the true heroes are those still on the front lines of the epidemic in West Africa.
Closing the Cardiac Care Gender Gap. Heart disease is the No. 1 killer of women in the U.S. In fact, more women than men die from heart disease every year.
Changing Treatment Landscape in CLL. Therapeutic developments in chronic lymphocytic leukemia (CLL) have given rise to new strategies that will continue to evolve with agents in the pipeline.
New HCV Drugs Pass Muster in Real World. Clinical trials f...
Source: Kevin, M.D. - Medical Weblog - November 12, 2014 Category: Journals (General) Authors: MedPage Today Tags: News Cancer GI Heart Infectious disease Source Type: blogs
Top stories in health and medicine, November 11, 2014
From MedPage Today:
Estrogen May Protect Heart by Inhibiting Mineralocorticoid. Estrogen inhibition of a key receptor that helps regulate blood pressure may be a new mechanism by which premenopausal women are protected from cardiovascular disease.
Colorectal Ca Rates on the Rise in Younger People. The incidence of colon and rectal cancer increased significantly in people younger than 50, but decreased overall and among older people.
HCV Combo Effective After Liver Transplant. A two-drug combination for hepatitis C (HCV) appeared to be curative in more than 90% of liver transplant recipients.
Transferring Liver Patients M...
Source: Kevin, M.D. - Medical Weblog - November 11, 2014 Category: Journals (General) Authors: MedPage Today Tags: News Cancer GI Heart Source Type: blogs
Examining State Prison Health Care Spending: Cost Drivers And Policy Approaches
Health care and corrections have emerged as fiscal pressure points for states in recent years as rapid spending growth in each area has competed for finite revenue. Not surprisingly, health care spending for prison inmates—the intersection of these two spheres—also has risen swiftly.
Yet this trend of rising health care costs for prisoners may have been reversed in many states, according to a new report by the State Health Care Spending Project, a collaboration between The Pew Charitable Trusts and the John D. and Catherine T. MacArthur Foundation. Total correctional health care expenditures and per-inmate spending inc...
Source: Health Affairs Blog - November 4, 2014 Category: Health Management Authors: Maria Schiff Tags: Aging All Categories Chronic Care Health Reform Long-Term Care Source Type: blogs
A vision for hepatitis C
This report calls for the government to improve hepatitis C services now to prevent thousands of unnecessary deaths. It highlights concerns from clinicians and patient and professional groups about the rising rate of hepatitis C related deaths and the need for improved screening and diagnosis.
Report
Infographic
Press release (Source: Health Management Specialist Library)
Source: Health Management Specialist Library - November 3, 2014 Category: UK Health Authors: The King's Fund Information & Knowledge Service Tags: Local authorities, public health and health inequalities Source Type: blogs
Adult Conversation On High-Priced Drugs? Don’t Hold Your Breath (But Hang In There) …
Discussion on that occasion also revolved around the conundrum of realizing the value of innovative therapies without imposing disproportionate burdens on any of the system’s many contending parties. It is more likely that we will continue to muddle through, Brennan said, than to reach for a comprehensive, rational policy initiative.
There is no shortage of tactics to be considered, however, and these two Washington briefings were chock full of ideas. Dana Goldman of the Schaeffer Center proposed a “5-percent solution” in which 5 percent of the Hep C population could be treated annually at a socially affordable cost...
Source: Health Affairs Blog - October 27, 2014 Category: Health Management Authors: Rob Cunningham Tags: All Categories Biotech Business of Health Care Chronic Care Consumers Health Care Costs Insurance Pharma Source Type: blogs
Treating hepatitis C with Sovaldi: Is it worth it?
One catch phrase in health care reform is cost-effectiveness. To paraphrase, this label means that a medical treatment is worth the price. For example, influenza vaccine, or flu shot, is effective in reducing the risk of influenza infection. If the price of each vaccine were $1,000, it would still be medically effective, but it would no longer be cost-effective considering that over 100 million Americans need the vaccine.
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Your patients are rating you online: How to respond. Manage your online reputation: A social media guide. Find out how. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - October 22, 2014 Category: Journals (General) Authors: Michael Kirsch, MD Tags: Meds GI Medications Source Type: blogs
The $500 Billion Medicare Slowdown: A Story About Part D
A great deal of analysis has been published on the causes of the health care spending slowdown system-wide — including in the pages of Health Affairs. Much attention in particular has focused on the remarkable slowdown in Medicare spending over the past few years, and rightfully so: Spending per beneficiary actually shrank (!) by one percent this year (or grew only one percent if one removes the effects of temporary policy changes).
Yet the disproportionate role played by prescription drug spending (or Part D) has seemingly escaped notice. Despite constituting barely more than 10 percent of Medicare spending, our an...
Source: Health Affairs Blog - October 21, 2014 Category: Health Management Authors: Loren Adler and Adam Rosenberg Tags: All Categories Hospitals Medicare Payment Pharma Physicians Policy Spending Source Type: blogs
Combination antiviral therapy for hepatitis C
The Food and Drug Administration has approved the use of a single pill containing two different antiviral drugs for the treatment for hepatitis C. It is the first combination pill approved for the disease, and also the first treatment that does not contain interferon or ribavirin.
The new hepatitis C drug, called Harvoni, is a mixture of the antiviral drugs ledipasvir and sofosbuvir. Ledipasvir (pictured) is an inhibitor of the hepatitis C virus protein NS5A, which has multiple roles in the viral replication cycle that include RNA synthesis and virus particle assembly. The mechanism of NS5A inhibition by ledipasvir is n...
Source: virology blog - October 14, 2014 Category: Virology Authors: Vincent Racaniello Tags: Basic virology Information AIDS antiviral drug drug resistance ebola virus Harvoni HCV hepatitis C virus hepatocellular carcinoma HIV-1 ledipasvir liver mutation rate sofosbuvir triple therapy uridine Source Type: blogs
