In this blog post, we consider alternative payment policies that could help to ensure that—despite their potentially high cost—breakthrough treatments are consistently delivering value to patients and that the health care system is addressing inefficiencies in the delivery and total costs of care.
Paying for Value and Outcomes: Alternative Provider Payment Models
Over the last several decades, payers and providers have taken significant steps to move coverage and reimbursement from fee-for-service (FFS) payments that incentivize higher volume and intensity to a focus on achieving better results and lower overall costs for patients. Such payment reforms have important implications for breakthrough treatments, as they allow treatment access while also ensuring care coordination and more efficient total spending.
Paying for Value and Outcomes: Outcomes-based Reimbursement
A further extension of payment reforms that shift from volume and intensity to value is tying payments for the treatment itself to outcomes or other measures of performance. Outcomes-based contracting, in which manufacturers share the risk of a treatment outcome, could help alleviate concerns that high-cost treatments actually lead to patient improvement or cures in practice. At their most basic, outcomes-based reimbursement agreements establish defined payment for defined outcomes: a manufacturer shares in the cost of failure in practice through larger rebates, discounts, or refunds if a product does not achieve the performance or outcomes goals agreed to by the payer.
Read more....
Tuesday, February 3, 2015
HCV Drugs: Triple Drug Regimens, Exclusivity Deals, Merck & Gilead Updates —Alan Franciscus, Editor-in-Chief
At last year’s CROI conference, I wrote about a 6-week study of sofosbuvir, ledipasvir, and GS-9451. This combination was tested against sofosbuvir/ledipasvir alone for 12 weeks and sofosbuvir/ledipasvir plus GS-9669 for 6 weeks. The drugs were combined into one-pill, taken once-daily. There were 20 patients in each arm.
The bottom line is that all 20 patients (100%) achieved a cure in the triple combination of sofosbuvir/ledipasvir and GS-9669 with 6 weeks of treatment. The most common side effects were headache, fatigue and diarrhea.
Comments: This study is a small study and there is currently no information that it has yet entered into phase 3 studies. But given the high cure rates and low side effects hopefully it will be entered into clinical trials with this combination or perhaps Gilead is researching another inhibitor to include.
Study: Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Authors: A Kohli et al.
Exclusivity Deals
Ever since AbbVie’s VIEKIRA PAK’s approval there have been intense negotiations between insurance companies/pharmacies and AbbVie and Gilead to determine who will be the exclusive distributors of the pharmaceutical HCV medications. These deals will help to drive down the costs of the drugs, and this will hopefully translate into more patients having access to HCV medications. The real downside is that the decision as to which medication a patient should be prescribed is now being made by someone other than a patient and medical provider. This is very bad news for patients (see "Predictors" article). The information below is from our blog as of the date that we have put together our newsletter. If you have been denied treatment in the past, you may want to check the list below (or our Blog) to find out if you would now qualify for insurance coverage. The agreements are on-going so keep checking back.
Ever since AbbVie’s VIEKIRA PAK’s approval there have been intense negotiations between insurance companies/pharmacies and AbbVie and Gilead to determine who will be the exclusive distributors of the pharmaceutical HCV medications. These deals will help to drive down the costs of the drugs, and this will hopefully translate into more patients having access to HCV medications. The real downside is that the decision as to which medication a patient should be prescribed is now being made by someone other than a patient and medical provider. This is very bad news for patients (see "Predictors" article). The information below is from our blog as of the date that we have put together our newsletter. If you have been denied treatment in the past, you may want to check the list below (or our Blog) to find out if you would now qualify for insurance coverage. The agreements are on-going so keep checking back.
- AbbVie: Express Scripts, AIDS Drug Assistance Programs (ADAPs)
- Gilead: Aetna, Humana, Anthem, CVS
- Both—AbbVie/Gilead: Prime Therapeutics
Merck
In January, Merck announced that it has been prioritizing portions of its drug development operations including hepatitis C. In this respect, the development of a two-drug single pill (grazoprevir/elbasvir) will be accelerated. Merck hopes to apply for marketing approval in the first half of 2015. The combination is currently in phase 3 studies. Phase 2 studies of the two drug combination with and without ribavirin in multiple arm studies of monoinfected and HIV/HCV coinfected patient populations with and without cirrhosis resulted in cure rates from 90 to 100%. The most common side effects were fatigue, headache and general weakness.
Gilead
Gilead has announced that it has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.
http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#2
Liver Fibrosis Starts Early After Hepatitis C Infection
MedicalResearch.com Interview with:
Adeel A. Butt, MD, MS, FACP, FIDSA
Adjunct Associate Professor of Medicine and Clinical and Translational Science
University of Pittsburgh School of Medicine
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Butt: Studying clinical consequences of hepatitis C virus (HCV) infection is often limited by the lack of knowledge of actual time of infection. We used the Electronically Retrieved Cohort of HCV-Infected Veterans (ERCHIVES), a well-established national cohort of HCV infected veterans and corresponding HCV-uninfected controls, to identify patients with a known time frame for HCV infection. Our primary aim was to determine the rate of liver fibrosis progression among HCV-infected persons over time, with and to determine factors associated with development of cirrhosis and hepatic decompensation among these persons.
Among 1840 persons who were HCV+ and 1840 HCV− controls, we found that fibrosis progression started early after HCV infection tapered off after 5 years. After 10 years of follow-up, 18.4% of HCV+ and 6.1% of HCV- persons developed liver cirrhosis. Nine years after diagnosis of cirrhosis, only 1.8% of HCV+ and 0.3% of HCV- persons had developed hepatic decompensation.
MedicalResearch: What clinicians and should patients take away from your report?
Read more....
Adeel A. Butt, MD, MS, FACP, FIDSA
Adjunct Associate Professor of Medicine and Clinical and Translational Science
University of Pittsburgh School of Medicine
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Butt: Studying clinical consequences of hepatitis C virus (HCV) infection is often limited by the lack of knowledge of actual time of infection. We used the Electronically Retrieved Cohort of HCV-Infected Veterans (ERCHIVES), a well-established national cohort of HCV infected veterans and corresponding HCV-uninfected controls, to identify patients with a known time frame for HCV infection. Our primary aim was to determine the rate of liver fibrosis progression among HCV-infected persons over time, with and to determine factors associated with development of cirrhosis and hepatic decompensation among these persons.
Among 1840 persons who were HCV+ and 1840 HCV− controls, we found that fibrosis progression started early after HCV infection tapered off after 5 years. After 10 years of follow-up, 18.4% of HCV+ and 6.1% of HCV- persons developed liver cirrhosis. Nine years after diagnosis of cirrhosis, only 1.8% of HCV+ and 0.3% of HCV- persons had developed hepatic decompensation.
MedicalResearch: What clinicians and should patients take away from your report?
Read more....
NAMD Statement on Supplemental Rebates for Hepatitis C Therapies
FOR IMMEDIATE RELEASE
February 2, 2015
Statement of the National Association of Medicaid Directors
Washington, DC - NAMD is pleased to learn that manufacturers of Hepatitis C therapies have finally come to the table to acknowledge and discuss the unsustainable pricing of their products. We believe this is an important first step in achieving the goal of making their products more affordable and accessible for Medicaid consumers and should produce significant savings for federal and state taxpayers.
However, we believe it is important to clarify several aspects of the current status of these discussions. While in some states the price negotiations have been completed, the process is at different stages in most other states. By their nature these agreements often take significant time to finalize. This is due to a variety of factors, including the time that it will take states and their contractors to fully analyze these proposals and then ultimately finalize agreements according to their respective state policies and procedures.
Irrespective of these early rebate agreements emerging for some states, Medicaid Directors remain concerned with regards to the overall sustainability and pricing levels. Directors take very seriously their role as stewards of the both the taxpayer dollar and the public trust. It is therefore important to ensure that these conversations continue in the evolving field of Hepatitis C treatments, as well as when new specialty pharmacy products become publicly available.
February 2, 2015
Statement of the National Association of Medicaid Directors
Washington, DC - NAMD is pleased to learn that manufacturers of Hepatitis C therapies have finally come to the table to acknowledge and discuss the unsustainable pricing of their products. We believe this is an important first step in achieving the goal of making their products more affordable and accessible for Medicaid consumers and should produce significant savings for federal and state taxpayers.
However, we believe it is important to clarify several aspects of the current status of these discussions. While in some states the price negotiations have been completed, the process is at different stages in most other states. By their nature these agreements often take significant time to finalize. This is due to a variety of factors, including the time that it will take states and their contractors to fully analyze these proposals and then ultimately finalize agreements according to their respective state policies and procedures.
Irrespective of these early rebate agreements emerging for some states, Medicaid Directors remain concerned with regards to the overall sustainability and pricing levels. Directors take very seriously their role as stewards of the both the taxpayer dollar and the public trust. It is therefore important to ensure that these conversations continue in the evolving field of Hepatitis C treatments, as well as when new specialty pharmacy products become publicly available.
New York Attorney General Targets Supplements at Major Retailers
The New York State attorney general’s office accused four major retailers on Monday of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.
The authorities said they had conducted tests on top-selling store brands of herbal supplements at four national retailers — GNC, Target, Walgreens and Walmart — and found that four out of five of the products did not contain any of the herbs on their labels. The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.
The investigation came as a welcome surprise to health experts who have long complained about the quality and safety of dietary supplements, which are exempt from the strict regulatory oversight applied to prescription drugs.
Monday, February 2, 2015
The White House signals a fight on high drug prices
On Monday, the Obama administration proposed taking a major step towards bringing prices down for expensive specialty medications.
In its budget, the White House calls for Medicare's prescription drug program to negotiate on prices for "high-cost drugs" and biologics, a complex and expensive class of drugs that is just starting to get competition from generics in the United States. "The administration is is deeply concerned with the rapidly growing prices of specialty and brand name drugs," the budget reads.
The Department of Veterans Affairs and state Medicaid programs get mandated discounts on these drugs, but Medicare was forbidden by the 2003 law creating its prescription drug program to negotiate on price. For years, liberals have been pushing to give Medicare that authority, which would make the United States more like the rest of the world.
It's not clear how hard the administration will fight for this idea, but you can add this to the list of budget requests that probably aren't going anywhere. Drug companies and Republican lawmakers have regularly pushed back against the idea of price controls in Medicare Part D.
Read more....
Activist Strategies for Increasing Access to HCV Treatment in Low- and Middle-Income Countries
February 2, 2015Dear Friends,
Drugs that can cure hepatitis C virus (HCV) are on the market in some countries. But these drugs are unaffordable for most of the 150 million people living with hepatitis C globally --90% of whom live in resource-limited settings. Activism to overcome pricing and other barriers to treatment is urgently needed.
TAG is pleased to release Activist Strategies for Increasing Access to HCV Treatment in Low- and Middle-Income Countries. This guide presents key strategies through real-world case studies, and shows how strategies used to combat the AIDS epidemic can be—and have been—adapted to increase HCV treatment access.
We hope you find this document useful in your global treatment advocacy work. Please share widely with relevant stakeholders.
Section One: Laying the Groundwork through Community Organizing
Section Two: Overcoming the Cost Barriers to HCV Treatment Access
Section Three: Collaborating with Researchers to Build Your Case for HCV Treatment Access
Section Two: Overcoming the Cost Barriers to HCV Treatment Access
Section Three: Collaborating with Researchers to Build Your Case for HCV Treatment Access
--
Karyn Kaplan
Director, International Hepatitis/HIV Policy & Advocacy
TAG
karyn.kaplan@treatmentactiongroup.org
ABOUT TAG’S HEPATITIS/HIV PROJECT
TAG’s Hepatitis/HIV Project draws from the core values and history of HIV activism, while incorporating hepatitis C–specific information into strategies targeting different constituencies, regions, and countries. The Hepatitis/HIV Project focuses on optimizing quality of, and broadening access to, HCV care and treatment for communities and individuals by continuing its domestic and international work with other activists, regulatory agencies, pharmaceutical companies, clinicians, and the patient community
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