Showing posts with label Medicaid. Show all posts
Showing posts with label Medicaid. Show all posts

Wednesday, September 19, 2018

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment
September 18, 2018
The Louisiana Department of Health is currently developing a “subscription style” payment plan with pharmaceutical manufacturers to provide state residents with access to hepatitis C treatment.

HCV Next spoke with the department’s chief of staff, Pete Croughan, MD, about the landscape of HCV in the state and the novel payment model designed to expand treatment despite the expensive cost of direct-acting antivirals.

The department estimates that this plan could increase treatment from approximately 3% of people on Medicaid and in correctional facilities up to nearly 60%.

“We’ve actually had conversations with all three hepatitis C manufacturers — AbbVie, Gilead and Merck — and all three have expressed interest in potentially partnering with us,” he said. “The plan is to ultimately select a partner through a request for proposal process, but we’re willing to work with any company that gives us the best deal.”

Continue reading: 

Read the September/October issue of HCV available online here:
https://www.healio.com/hepatology/news/print/hcv-next

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to a collection of research articles addressing the high cost of HCV medications, insurance restrictions; private insurers/Medicaid and availability of generic versions/India, Egypt and other lower-income countries, or through online "buyers clubs".

Tuesday, July 17, 2018

HCV Next: Physicians Diagnosing,Treating HCV Define New Role in Opioid Crisis


Check out the July/August issue of HCV Next, just released online at Healio

Table of Contents
Cover Story 
Physicians Diagnosing,Treating HCV Define New Role in Opioid Crisis
The opioid epidemic in the United States has affected millions, exposing them to health risks that include a range of infectious diseases.

Feature
Point-of-Care HCV Assays: A Turning Point for Decentralized Diagnosis
Compared with traditional hepatitis virological tests, the benefit of point-of-care diagnostics is their use in patient care sites such as outpatient clinics, intensive care units, emergency departments and medical laboratories. Additionally, certain low- and middle-income countries have made use of point-of-care tests in blood banks.

In the Journals Plus
Most iatrogenic HCV cases unidentified until symptom onset
Insurance denials for HCV therapy increase in US

Meeting News
HCV outcomes worse for patients with public insurance, Medicaid
Homeless veterans with HCV diagnosed, treated via PCP outreach

Trend Watch

Begin here.....

On This Blog
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions.

Elsewhere
Efficacy of Generic Oral DAAs in Patients With HCV Infection
Journal of Viral Hepatitis, July 20, 2018

Tuesday, July 10, 2018

N.J. Expands hepatitis C treatments for all Medicaid enrollees

N.J. Expands Vital Hepatitis C Treatments for Medicaid Enrollees 

TRENTON – The New Jersey Department of Human Services announced expanded hepatitis C treatments for all Medicaid enrollees in the state, a policy facilitated by increased funding in the fiscal year 2019 budget.

The improvement comes amid ongoing concern about increased infections due to the opioid epidemic and a growing focus on identifying and treating hepatitis C infection among Baby Boomers.

New Jersey Human Services Commissioner Carole Johnson said that under the new policy, New Jersey Medicaid will cover hepatitis C curative drug treatment once someone is diagnosed with the virus. Previously, individuals in New Jersey were required to wait until their liver had already been damaged before accessing this treatment.

Tuesday, June 19, 2018

Increasing success and evolving barriers in the hepatitis C cascade of care

PLoS ONE 13(6): e0199174

Increasing success and evolving barriers in the hepatitis C cascade of care during the direct acting antiviral era 
Autumn Zuckerman, Andrew Douglas, Sam Nwosu, Leena Choi, Cody Chastain
Published: June 18, 2018
https://doi.org/10.1371/journal.pone.0199174 

With DAA therapy as the new standard of care, the HCV cascade of care (CoC) has transformed, still plagued by challenges in linkage to care yet substantially improved with regards to treatment outcomes. Interventions to emphasize screening, linkage to care, and access to treatment may address some of these challenges. Though DAA agents remain expensive for all groups, efforts to enhance and improve access across payer groups should be pursued. Integration of pharmacy services demonstrated high rates of medication access compared to previous studies, even in those with Medicaid. With new medications and modern tools, HCV treatment can be well-tolerated, effective, and result in high rates of completion.
Full Article

Abstract
Barriers remain in the hepatitis C virus (HCV) cascade of care (CoC), limiting the overall impact of direct acting antivirals. This study examines movement between the stages of the HCV CoC and identifies reasons why patients and specific patient populations fail to advance through care in a real world population. We performed a single-center, ambispective cohort study of patients receiving care in an outpatient infectious diseases clinic between October 2015 and September 2016. Patients were followed from treatment referral through sustained virologic response. Univariate and multivariate analyses were performed to identify factors related to completion of each step of the CoC. Of 187 patients meeting inclusion criteria, 120 (64%) completed an evaluation for HCV treatment, 119 (64%) were prescribed treatment, 114 (61%) were approved for treatment, 113 (60%) initiated treatment, 107 (57%) completed treatment, and 100 (53%) achieved a sustained virologic response. In univariate and multivariate analyses, patients with Medicaid insurance were less likely to complete an evaluation and were less likely to be approved for treatment. Treatment completion and SVR rates are much improved from historical CoC reports. However, linkage to care following referral continues to be a formidable challenge for the HCV CoC in the DAA era. Ongoing efforts should focus on linkage to care to capitalize on DAA treatment advances and improving access for patients with Medicaid insurance.

Thursday, June 7, 2018

Half of hepatitis C patients with private insurance denied life-saving drugs


Open Forum Infectious Diseases
Infectious Diseases Society of America
Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study
Charitha Gowda Stephen Lott Matthew Grigorian Dena M Carbonari M Elle Saine Stacey Trooskin Jason A Roy Jay R Kostman Paul Urick Vincent Lo Re, III
Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy076, https://doi.org/10.1093/ofid/ofy076
Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.
Link - Full Text Online
Download PDF

Half of hepatitis C patients with private insurance denied life-saving drugs

PHILADELPHIA - The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) - once-a-day pills that first became available in the United States in 2014 - are highly effective, with a 95 percent cure rate and few side effects for patients with chronic hepatitis C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit drug use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

"Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector," said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. "It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states."

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It's likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study's 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

"From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer," Lo Re said. "In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the liver, such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others."

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and private insurers remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all chronic hepatitis C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

"Eliminating hepatitis C in the U.S. is a feasible goal," Lo Re said, "but that's going to be hard to achieve if payers are not reimbursing for the treatment."

Today's News
Judge gives early OK to deal to expand Medicaid hep C relief
DETROIT (AP) - A judge has given preliminary approval to a deal that would expand access to hepatitis C treatments for Michigan residents on Medicaid.

On This Blog
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Monday, June 4, 2018

DDW 2018 - Insurance coverage and mortality in patients with hepatitis C

HCV outcomes worse for patients with public insurance, Medicaid
WASHINGTON — In this exclusive video perspective from Digestive Disease Week 2018, Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, discusses insurance coverage and mortality in patients with hepatitis C in the U.S.
Video:https://www.healio.com/hepatology/hepatitis-c/news/online/%7B3714098b-f39c-4e99-86d1-e3a7e9bebb5d%7D/hcv-outcomes-worse-for-patients-with-public-insurance-Medicaid

MedPage Today
WASHINGTON -- Adults with hepatitis C virus (HCV) were more likely to die if they were on Medicaid than other insurance plans, while uninsured HCV-infected …

Digestive Disease Week® (DDW) 2018
Coverage @ Healio
Healio staff will report live on breaking news presented at the meeting and capture video interviews with experts to gain their perspectives on important presentations.

Links
Digestive Disease Week® (DDW) 2018
June 2-5, 2018
Website - Digestive Disease Week® (DDW)
DDW Blog
DDW Daily News
On Twitter - #DDW18

Tuesday, May 29, 2018

Novel Medicaid Strategy Proposed to Increase Access to HCV Treatment

Infectious Disease Advisor
Novel Medicaid Strategy Proposed to Increase Access to HCV Treatment
Zahra Masoud
Implementing a novel drug purchasing strategy may dramatically increase access to drugs for hepatitis C virus (HCV) infection for patients enrolled in Medicaid without increasing state and federal costs, according to a study recently published in the Annals of Internal Medicine.

Although the annual HCV-related death toll in the United States exceeds that of a combination of HIV and 59 other infectious diseases, curative treatments introduced in 2013 resulted in sustained virologic response that has been associated with lower mortality in individuals with chronic HCV infection.

Read More: https://www.infectiousdiseaseadvisor.com/hepatitis/hepatitis-c-virus-treatment-access-may-improve-with-proposed-medicaid-strategy/article/768917/

New At Infectious Disease Advisor
Does Substance Use Disorder Affect Sustained Virologic Response to DAAs?
Infectious Disease Advisor
Although hepatitis C virus (HCV) treatment adherence is worse in patients with comorbid substance use disorders, sustained virologic response (SVR) to …

Thursday, May 24, 2018

With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs

PBS News Hour
May 23, 2018

Watch the program

With highest hepatitis C mortality rate in U.S., Oregon expands access to life-saving drugs
New drugs can cure up to 95 percent of patients with hepatitis C, a virus that can be debilitating or deadly. And there’s been a 20 percent rise in new infections from 2015 to 2016 due to the opioid epidemic. In Oregon, a state hard-hit by the disease, new medicines combined with the big surge in those looking for treatment has led to a unique care model. Special correspondent Cat Wise reports.

Full Transcript 
https://www.pbs.org/newshour/show/with-highest-hepatitis-c-mortality-rate-in-u-s-oregon-expands-access-to-life-saving-drugs

Judy Woodruff: Now the latest on a medical breakthrough that’s starting to have an impact on a hidden, deadly epidemic in this country. New drugs can cure up to 95 percent of patients with hepatitis C, a virus that often leads to debilitating or deadly results. The drugs can save lives, prevent expensive hospitalizations and liver transplants. But some states are feeling the squeeze of the cost of this medicine. Special correspondent Cat Wise has our report for our weekly series on the Leading Edge of science.

Cat Wise: Three-point-five million Americans are living with a potentially deadly virus, and half don’t even know it. It’s hepatitis C, a blood-borne pathogen which attacks the liver and can eventually cause serious liver problems, including cirrhosis and liver cancer. Three-quarters of those with the virus are baby boomers, exposed from unscreened blood transfusions, I.V. drug use, and other blood-to-blood contact prior to the early ’90s. But now the opioid epidemic has led to a 20 percent rise in new infections from 2015 to 2016. One state where the young and the old have been hit hard by the disease is Oregon. Oregon has the highest hepatitis C mortality rate, per capita, in the country. It’s estimated about 100,000 Oregonians have been infected with the virus and more than 500 die every year. It’s been a very difficult disease to treat, but over the last four years, there’s been a revolution in hep C drugs. Many are being cured around the country now, and here in Oregon, many are coming here to the Oregon Clinic for those treatments.

Dr. Kent Benner: We never talked about cure of hep C until the last few years, and now we’re all talking about cure of hep C.

Cat Wise: Dr. Kent Benner is a gastroenterologist and hepatologist at the clinic in Portland. He says people are still dying from the disease, often because they haven’t been tested and aren’t aware they have virus until they are quite sick. But Benner says much has changed since he first started treating patients several decades ago.

Dr. Kent Benner: Treatment at that time was interferon. This required injections, shots several times a week. Quite a few side effects. We felt we were doing well if we could cure 15 or 20 percent of patients. Since late 2013, there’s been a remarkable development from a number of different companies. They have developed drug combinations that provide 95 percent cure rates in patients we treat.

Cat Wise: Costly liver transplants are often the only option when the liver becomes too badly damaged. But at earlier disease stages, the liver often starts to heal once the medicines have cleared virus from the body.

Dr. Kent Benner: Not only are we seeing liver function improve, but patients with more advanced liver disease occasionally can come off the transplant list.

Cat Wise: Sixty-four-year-old Rob Shinney, who recently had knee surgery, is one of those cured by the new hep C drugs known as direct-acting antivirals, or DAAs. Like many others of his generation, he doesn’t really know how he contracted the virus. Under the care of Dr. Benner, Shinney began a three-month treatment in late 2016 after his liver showed signs of moderate scarring known as fibrosis. Tests later confirmed he was virus-free.

Rob Shinney: I had a serious chronic illness hanging over my head that I knew could kill me. And that’s gone now.

Cat Wise: We spoke at a local pub he visits now and again with his choir friends, something he never did when he had the virus.

Rob Shinney: I swear I felt like I was 20 years younger. I had energy. I could do things. It’s great just to be able to sit around and have a beer with everybody and, you know, just enjoy life. Cat Wise: The cost of the drugs used to cure Shinney, who has private insurance, aren’t cheap. Since Gilead Sciences’ Sovaldi first hit the market in late 2013 at a whopping $84,000 for a course of therapy, competitors have steadily lowered the costs. Last year, a new medication called Mavyret was released for around $26,000. Many payers often, though, negotiate even lower prices with the drug company. Still, the drugs are expensive, and they aren’t a vaccine. If someone is cured, they can become reinfected. Access to the drugs varies widely around the country. A report last year by two national advocacy organizations found that many public and private payers choose to limit access to DAAs due to their cost, as well as other concerns. Oregon is among a number of states which have had restrictive Medicaid requirements, including denying coverage to patients in the early stages of disease and those who are abusing drugs and alcohol. But some of those restrictions are beginning to ease.

Dr. Dana Hargunani: In January, we just started covering individuals with lower stages or lower levels of fibrosis.

Cat Wise: Dr. Dana Hargunani is the chief medical officer for the Oregon Health Authority, which oversees the state’s Medicaid program. She says, while the state is starting to expand access, costs are still a significant issue. Oregon has spent more than $94 million on the drugs since 2014, covering about 1,500 people.

Dr. Dana Hargunani: The newer treatments for hepatitis C have a significant budget impact for our state. We had to get additional funding through the legislative process. We’re trying to manage our limited resources to ensure coverage for those who need it immediately for the hepatitis C treatment, as well as all the other individuals in our Medicaid program.

Cat Wise: Hargunani says another reason the state delays coverage until patients have mild liver scarring, not everyone needs the medicines.

Dr. Dana Hargunani: One in five individuals who get infected with hepatitis C will spontaneously clear their infection. Right now, the data doesn’t help us understand how to know which individuals will need to have a high-cost drug to treat and cure their infection.

Dr. Brianna Sustersic: Luckily, he doesn’t have any evidence of cirrhosis.

Cat Wise: Dr. Brianna Sustersic is a medical director at Central City Concern, a federally funded health center in downtown Portland which serves a large number of homeless individuals, many of whom have substance abuse disorders; 25 percent to 50 percent of the patients have hep C.

Dr. Brianna Sustersic: The Medicaid requirements have limited access to treatment for many of our patients. From a public health standpoint, if we are able to treat the population who is contracting this, and spreading it, then we can move toward eradicating the disease.

Cat Wise: To prove that point, and to meet a big need, the clinic and a local syringe exchange program began a small drug company-sponsored study last year to treat patients who otherwise wouldn’t have qualified for the medications; 56-year-old Kim Trano is now virus-free thanks to that trial. She says she’s felt a lot of stigma being a recovering drug user and it was hard to learn she had initially been denied drug coverage. To those who would question giving expensive medicines to someone who might become reinfected, she says:

Kim Trano: Everyone is worthy of a chance. If I were to relapse, I would all precautions not to be reinfected. And that’s pretty easy to do. Most people know how to do that.

Cat Wise: The new medicines combined with the big surge in those looking for treatment has led to a unique care model. Chris Hulstein is not a doctor. He’s a clinical pharmacist and part of a new program at Portland’s Providence Hospital. Over the past year, about 50 patients have been successfully treated by Hulstein and his colleagues. Another 30 are currently in treatment.

Chris Hulstein: A lot of the specialists are very busy managing very complex patients, and that is their role. Having a pharmacist being able to manage the patient gets patients treated faster and more successfully than we ever have been able to do before.

Cat Wise: Hepatitis C advocates are now working with the state and private insurers to open up more access to the drugs. For the “PBS NewsHour,” I’m Cat Wise in Portland, Oregon.

https://www.pbs.org/newshour/show/with-highest-hepatitis-c-mortality-rate-in-u-s-oregon-expands-access-to-life-saving-drugs

Wednesday, May 23, 2018

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions

Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
May 23, 2018
Sydney Lupkin, Kaiser Health News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Harvard Medical School instructor Ameet Sarpatwari. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5 percent to 26.3 percent for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60 percent more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40 percent per unit in just four years, the Medicare data show, and cost $75,200 per beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.

The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52 percent from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.

Co-sponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not stepping into this arena and saying that?”

https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Friday, April 27, 2018

There’s A Cure For Hepatitis C, But Oregon Limits Access

There’s A Cure For Hepatitis C, But Oregon Limits Access
By Amelia Templeton / OPB
Oregon’s decision to continue to limit treatment based on a patient’s fibrosis score conflicts with guidelines set by health professional groups.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend that all patients with chronic hepatitis C should be treated.

The groups note that treating patients early, before significant fibrosis has developed in the liver, appears to be a particularly effective way of reducing deaths associated with hepatitis C.

Wednesday, February 21, 2018

Opinion - It's criminal what Illinois is doing to Medicaid patients with hepatitis C

It's criminal what Illinois is doing to Medicaid patients with hepatitis C
By: OLUWATOYIN ADEYEMI, ANDREW ARONSOHN, BASMATTEE BOODRAM, DANIEL JOHNSON and MAI TUYET PHO 

Every day, Illinois Medicaid patients with hepatitis C are denied access to a simple cure to a disease that jeopardizes their life because of outdated and unconscionable restrictions on who can get this proven treatment.

Hepatitis C is a viral infection that causes inflammation and scarring of the liver. People who are infected with hepatitis C usually have no or few symptoms for decades until it reaches the end stages of disease, where patients are at risk of liver failure, liver cancer and death. Hepatitis C is a leading cause of liver-related death and need for liver transplantation in the United States. An estimated 150,000 people are affected by hepatitis C in this state alone, according to the Illinois Department of Public Health.

Monday, February 12, 2018

Medicaid Skimps on Hepatitis C Treatment in Many States

Medicaid Skimps on Hepatitis C Treatment in Many States
by Liz Highleyman
Contributing Writer, MedPage Today
"Hepatitis C: The State of Medicaid Access," issued by the National Viral Hepatitis Roundtable (NVHR) and the Center for Health Law and Policy Innovation (CHLPI) at Harvard Law School, evaluated hepatitis C treatment policies in all 50 states, the District of Columbia, and Puerto Rico.

The report shows that 12 states cover treatment only for people with advanced liver fibrosis, 20 states require at least 6 months of abstinence from drug or alcohol use, and nine require treatment to be prescribed by a liver disease specialist, NVHR executive director Ryan Clary reported at the American Association for the Study of Liver Diseases (AASLD) annual Liver Meeting in October.

Hepatitis C kills more Americans each year than all other infectious diseases combined, yet more than half of U.S. Medicaid programs continue to impose discriminatory and medically unfounded restrictions on hepatitis C cures," Clary told MedPage Today. "

Saturday, December 2, 2017

Colorado lifts restrictions for treating hepatitis C patients; no longer need to have advanced liver damage to receive drugs

Colorado lifts restrictions for treating hepatitis C patients; no longer need to have advanced liver damage to receive drugs
By Jennifer Brown |The Denver Post
December 1, 2017 at 6:43 pm

Friday’s decision by the state Medicaid department comes in the midst of a class-action lawsuit filed by the American Civil Liberties Union of Colorado and after top health officials asked the department to lift restrictions that determined which patients could receive life-altering treatment.

It also comes as the price of the antiviral drugs — which cure up to 90 percent of patients — has dropped from $84,000 per treatment to about $14,000.

Wednesday, November 1, 2017

NC Medicaid Program Removes Hepatitis C Treatment Restrictions

NC Medicaid Program Removes Hepatitis C Treatment Restrictions



Tuesday, October 24, 2017

Hepatitis C: State of Medicaid Access - Half of States/Jurisdictions Receive ‘D’ or ‘F’ for imposing discriminatory restrictions



Today, National Viral Hepatitis Roundtable (NVHR) together with The Center for Health Law & Policy Innovation of Harvard Law School (CHLPI) is launching Hepatitis C: State of Medicaid, an in-depth evaluation of treatment access in each state’s Medicaid program, while highlighting successes in access expansion as well as ongoing challenges. Over half of Medicaid programs received a “D” or an “F” for imposing discriminatory restrictions on hepatitis C cures. 

Links
Interactive Map - Click on your state to find out - State of Hepatitis C Medicaid Access - read your states full report, which include: Liver damage restrictions,  Sobriety restrictions, Prescriber restrictions with recommendations.

Download Full Report: 2017 NATIONAL SUMMARY REPORT

CLICK "HERE" FOR THE FULL PRESS RELEASE

Sponsored Segment - Hepatitis C: The State of Medicaid Access
October 25, 2017 | 9:54 AM EDT
A discussion of key finding from the “Hepatitis C: The State of Medicaid Access” report, which details treatment access restrictions in state Medicaid programs, with Ryan Clary, Executive Director of National Viral Hepatitis Roundtable; Robert Greenwald, Clinical Professor of Law and Faculty Director of the Center for Health Law and Policy Innovation at Harvard Law School; and Dr. Robert Zavoski, Medical Director of the Connecticut Department of Social Services.


https://www.washingtonpost.com/video/postlive/sponsored-segment---hepatitis-c-the-state-of-medicaid-access/2017/10/25/22c74b64-b98c-11e7-9b93-b97043e57a22_video.html?utm_term=.e0e7d627cee9

NVHR Press Release: Harvard Law School & NVHR Launch Interactive Project Grading Medicaid Programs for Discriminatory Hepatitis C Treatment Restrictions

‘Hepatitis C: State of Medicaid Access’ Grades Programs & Offers Recommendations to Improve; More than Half of States/Jurisdictions Receive ‘D’ or ‘F’

SAN FRANCISCO, CA & BOSTON, MA (Oct. 23, 2017) – The National Viral Hepatitis Roundtable (NVHR) and the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) today released “Hepatitis C: State of Medicaid Access” – a report and interactive project grading all 50 state Medicaid programs, as well as the District of Columbia and Puerto Rico, according to access to curative treatments for hepatitis C, the nation’s deadliest infectious disease. More than half of Medicaid programs (52 percent) received a “D” or an “F” for imposing discriminatory restrictions on hepatitis C cures.

Hepatitis C: State of Medicaid Access – which is available online in interactive form at http://stateofhepc.org and being unveiled today at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting in Washington, D.C. – grades each state, as well as the District of Columbia and Puerto Rico, according to its overall “state of access.” Each grade is determined by curative treatment restrictions related to three areas: 1) liver disease progression (fibrosis) restrictions, 2) sobriety/substance use requirements, and 3) prescriber limitations – all of which contradict guidance from the Centers for Medicare & Medicaid Services (CMS), as well as recommendations from AASLD and the Infectious Disease Society of America. The report also offers suggestions for each state to reduce its treatment access requirements.

“At least 3.5 million Americans are infected with hepatitis C in an epidemic that has eclipsed all other infectious diseases in the U.S. and has been exacerbated by the opioid crisis,” said Ryan Clary, executive director of NVHR. “Giving Medicaid recipients broad access to curative treatments is critical if we are really serious about ending this country’s deadliest infectious disease. Our hope with this project is to provide a roadmap for states – and the Centers for Medicare and Medicaid Services – in order to get more people treated, cured and ultimately protected from hepatitis C.”

“While more than half of states still received a D or an F in the report for discriminatory restrictions on hepatitis C treatment, we have seen some progress since 2014, when our analysis indicated that 42 state Medicaid programs could be violating federal Medicaid law,” said Robert Greenwald, Clinical Professor of Law at Harvard Law School and the director of CHLPI. “States with the best grades have taken steps to ensure widespread access to hepatitis C treatments. These states should serve as a model for those still rationing access to a hepatitis C cure based on outdated cost concerns, rules that stigmatize those living with hepatitis C, and non-medically indicated treatment criteria.”

States that received an “A” are: Alaska, Connecticut, Massachusetts, Nevada, and Washington. States that received an “F” are: Arkansas, Louisiana, Montana, Oregon, and South Dakota. Most states – 21 and Puerto Rico – received a “D.”

On its interactive site, Hepatitis C: State of Medicaid Access also includes ways to get involved. Users are invited to share their stories, sign a petition calling for better treatment access, and advocate for the issue on social media using the hashtag #stateofhepc.

About the National Viral Hepatitis Roundtable (NVHR)
The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance. NVHR believes an end to the hepatitis B and C epidemics is within our reach and can be achieved through addressing stigma and health disparities, removing barriers to prevention, care and treatment, and ensuring respect and compassion for all affected communities. For more information, visit www.nvhr.org.

About the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI)
The Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) advocates for legal, regulatory, and policy reforms to improve the health of underserved populations, with a focus on the needs of low-income people living with chronic illnesses and disabilities. CHLPI works with consumers, advocates, community-based organizations, health and social services professionals, government officials, and others to expand access to high-quality healthcare; to reduce health disparities; to develop community advocacy capacity; and to promote more equitable and effective healthcare systems. CHLPI is a clinical teaching program of Harvard Law School and mentors students to become skilled, innovative, and thoughtful practitioners as well as leaders in health and public health law and policy. For more information, visit http://www.chlpi.org

Saturday, October 14, 2017

Native Americans Have Highest HCV Rates Limited funding restricts access to care

AGA Reading Room

Native Americans Have Highest HCV Rates
Limited funding restricts access to care
by Pippa Wysong
Contributing Writer, MedPage Today

HCV infection patterns among Native Americans occur in patterns similar to those found in the rest of North America: younger cohorts who get the infection largely from unsafe injection drug use, and the baby boomer population. But incidence is disproportionately high. For example, American Native veterans born from 1945 to 1965 have an antibody-positive seroprevalence of 10%. All of this demonstrates this is an important cohort to treat.
Native Americans living in cities settings can get care at urban IHS clinics (in those cities that have them), many of which also serve as community health centers -- but these facilities are also struggling with funding issues.
IHS medical providers will apply to state Medicaid programs for DAAs on behalf of their patients, but the accessibility to treatment with DAAs varies between states. Sometimes coverage isn't available unless patients with substance use disorders are abstinent -- "which is not an AASLD [American Association for the Study of Liver Diseases] requirement," Leston said. And states vary in terms of the rules around accessibility to the drugs.
Continue reading - https://www.medpagetoday.com/reading-room/aga/lower-gi/68492

Primary Source
New England Journal of Medicine

Tuesday, October 3, 2017

Hepatitis C Drug’s Lower Cost Paves Way For Medicaid, Prisons To Expand Treatment

Hepatitis C Drug’s Lower Cost Paves Way For Medicaid, Prisons To Expand Treatment
By Michelle Andrews

The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.

In addition, Mavyret’s price tag of $26,400 for a course of treatment is significantly below that of other hepatitis C drugs whose sticker price ranges from about $55,000 to $95,000 to beat the disease. Patients and insurers often pay less, however, through negotiated insurance discounts and rebates.

Read More: https://khn.org/news/hepatitis-c-drugs-lower-cost-paves-way-for-medicaid-prisons-to-expand-treatment/

In The News
Increasing number of individuals spending $50,000+ annually on prescription drugs
A tiny but growing population of individuals with complicated illnesses and special treatment needs are accounting for an increasingly significant amount of the nation’s overall prescription drug costs, according to a report from ExpressScripts, “Super Spending: U.S. Trends in High-Cost Medication Use.”

Related:
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Thursday, July 27, 2017

State Medicaid Programs Should Not Deny Hepatitis C Drugs

Morning Consult
State Medicaid Programs Should Not Deny Hepatitis C Drugs
Michael Ruppal   |  
...

Wednesday, May 17, 2017

Examined - Coverage of all HCV treatment regimens in state Medicaid fee-for-service programs and managed care organizations

"HCV Next" offers information on a range of liver topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, practice management issues, to name a few.

The following articles appeared in the May/June print edition of HCV NEXT, provided online at Healio.

Table of Contents
Call to Action: Physicians Needed to Alleviate HCV Treatment Restrictions
Robert Greenwald, JD
In our report, Hepatitis C: The State of Medicaid Access, co-written and produced by the Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable, we examined coverage of all HCV treatment regimens in state Medicaid fee-for-service programs and managed care organizations. What we found is some improvement in treatment access since 2014, but that many Medicaid programs continue to restrict access to HCV treatments using medically unjustifiable requirements....
Sitting among the sessions at the International Liver Congress in Amsterdam, I had the distinct feeling that we are reaching an end to the era of revolutionary change in hepatitis C, but there remained impressive data, engaging debates and ongoing research given to us to better serve our patients. For those of us long involved in this field, we rejoice with our patients, often on a daily basis, and we intend to remain heavily engaged in addressing the remaining issues even as we heed the clarion call to immerse ourselves ever more deeply in the attempts to conquer other prevalent liver diseases...

AMSTERDAM — Achieving global elimination of hepatitis C requires actionable plans and changes on many levels of society from allowance of non-specialist prescribing to universal access, a group of experts explained at the International Liver Congress.
AMSTERDAM — Adherence to treatment and subsequent sustained virologic response were unaffected by drug use in a study of patients enrolled in an opioid agonist treatment program, according to a presenter at the International Liver Congress...

The Big Picture
Peer-to-Peer: Take Small Steps to Everyday Advocacy
Stacey Trooskin, MD, PhD
When we started using interferon-free regimens for the first time — for us, it was off-label with simeprevir/sofosbuvir (Olysio, Janssen/Sovaldi, Gilead Sciences) — to treat our many patients with HIV coinfection, we found ourselves restricted by insurance companies...

Tuesday, May 16, 2017

In major shift, Pa. to expand hepatitis C treatment for Medicaid patients

In major shift, Pa. to expand hepatitis C treatment for Medicaid patients
by
The Wolf administration said Tuesday that it would expand Medicaid coverage for treatment of hepatitis C, a major shift that has long been supported by medical organizations but delayed because of potentially high costs to the state.

“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” Department of Human Services Secretary Ted Dallas said in a statement. “Moving forward, the severity of this disease can no longer prevent all [Medicaid] beneficiaries from getting access to treatment if they need it.”
Continue reading....

Wolf Administration Announces Medicaid Policy Change for Individuals Suffering from Hepatitis C Virus Department of Human Services continues to expand access to high-quality services Harrisburg, PA – Today, the Department of Human Services (DHS) is announcing changes to the state’s Medicaid (MA) policy to expand coverage of life-saving drugs to treat Hepatitis C (HCV) virus. Beginning on July 1, the Department will begin phasing in coverage for individuals who have liver function test scores of “F1” or “F0”.

HCV test scores are categorized by the severity of the disease from F0 through F4, with F0 being the least severe form of the disease and F4 being the most severe. Prior to this announcement, the department provided health care coverage through Medicaid for individuals whose scores ranged from F2 through F4 unless they also had other clinical complications.  

“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” said DHS Secretary Ted Dallas. “Moving forward, the severity of this disease can no longer prevent all MA beneficiaries from getting access to treatment if they need it.”

The policy change follows the clinical recommendations presented by the department’s Pharmacy & Therapeutics Committee.

Under the new policy, the department will authorize the drugs for beneficiaries with test scores of F1 starting on July 1, 2017 and will authorize treatment for beneficiaries with scores of F0 starting on January 1, 2018. Adding F0 and F1 will ensure that all qualified individuals with HCV will have access to pharmaceuticals that can now cure this disease. 

HCV is a communicable disease that causes chronic inflammation throughout the body and can lead to serious liver damage, cancer, and death. At least 20,000 people in the United States die each year due to liver disease caused by HCV, making it the deadliest communicable disease in the country. Individuals with HCV can suffer from diabetes, lymphoma, fatigue, joint pain, depression, and other diseases even before reaching the advanced state of the disease.

“Pennsylvania’s new approach will directly improve the lives of many of our clients – some of Pennsylvania’s most vulnerable citizens,” said Laval Miller Wilson, Executive Director of the Pennsylvania Health Law Project (PHLP).

“I would like to thank Laval, Amy Hirsch, Kevin Costello and everyone at PHLP, Community Legal Services, Kairys Rudovsky, Messing & Feinberg, and Center for Health Law & Policy Innovation of Harvard Law School who worked with the department on finding a path forward,” said Secretary Dallas. “Their help has been invaluable throughout the process and been a critical component of being able to make today’s announcement.”

Media Contact: Rachel Kostelac, DHS, 717-425-7606 
http://www.chlpi.org/wp-content/uploads/2017/05/PA_HCV_press-release_05_16_17.pdf