Showing posts with label Insurance medicare. Show all posts
Showing posts with label Insurance medicare. Show all posts

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

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"

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.

Wednesday, April 25, 2018

Medicare to require hospitals to post prices online

Medicare to require hospitals to post prices online
Nation
Apr 24, 2018 6:27 PM EDT

WASHINGTON — Medicare will require hospitals to post their standard prices online and make electronic medical records more readily available to patients, officials said Tuesday.

The program is also starting a comprehensive review of how it will pay for costly new forms of immunotherapy to battle cancer.

Monday, March 27, 2017

Hepatitis C - Medicare Part D: High costs put some drugs out of reach

Medicare Part D: High costs put some drugs out of reach
March 27, 2017 12:45 PM
By Katie Wedell / Dayton Daily News
DAYTON, Ohio — High-priced prescription drugs are driving up the cost of Medicare Part D catastrophic coverage, which is bad news for both patients and taxpayers, according to a new report from the Department of Health and Human Services Office of Inspector General.

Patients on specialty drugs for cancer, hepatitis C, multiple sclerosis and other diseases are seeing higher out-of-pocket costs because of inflated list prices that accelerate their move into a coverage gap known as the “doughnut hole,” the report says.

The government’s spending is only going to grow, as 3 out of 4 hepatitis C patients are baby boomers who are aging into eligibility for Medicare Part D.

Drugs like Harvoni are extremely effective, he said, but are beyond reach for many of those afflicted with hepatitis C....
Continue reading... 

Thursday, November 17, 2016

A Growing Group Of Doctors Are Big-Money Prescribers In Medicare

A Growing Group Of Doctors Are Big-Money Prescribers In Medicare

The number of doctors who each prescribe millions of dollars of medications annually in Medicare's drug program has soared, driven by expensive hepatitis C treatments and rising drug prices overall, federal data obtained by ProPublica show.

The number of providers who topped the $5 million mark for prescriptions increased more than tenfold, from 41 in 2011 to 514 in 2015. The number of prescribers — mostly physicians but also nurse practitioners — exceeding $10 million in drug costs jumped from two to 70 over the same time period, according to the data.

Most of the doctors atop the spending list prescribed Harvoni or Sovaldi, relatively new drugs that cure hepatitis C. Other providers on the list prescribed pricey drugs to treat cancer, multiple sclerosis and rheumatoid arthritis.

Thursday, November 3, 2016

The Cost Of A Cure: Revisiting Medicare Part D And Hepatitis C Drugs

The Cost Of A Cure: Revisiting Medicare Part D And Hepatitis C Drugs
Two years ago, soon after the Food & Drug Administration (FDA) approved the first breakthrough treatment for hepatitis C, we wrote about the potential cost of a cure to Medicare Part D and its beneficiaries. For that piece, we used the best available data to estimate the number of people on Medicare who might seek treatment and the impact on Medicare spending. Here we revisit our earlier analysis using new data released by CMS, and consider both the ongoing impact of hepatitis C drugs for Part D and the broader implications for Medicare of new high-priced drugs entering the market.​

Continue reading....

Monday, June 13, 2011

Hepatitis C : Seniors face Medicare cost barrier for cancer meds

Private insurance companies that deliver the Medicare prescription benefit say the problem is that drug makers charge too much for the medications, some of which were developed from taxpayer-funded research. The pharmaceutical industry faults insurers, saying copayments on drugs are higher than cost-sharing for other medical services, such as hospital care.

Others blame the design of the Medicare prescription benefit itself, because it allows insurers to put expensive drugs on a so-called "specialty tier" with copayments equivalent to 25 percent or more of the cost of the medication.

Drugs for multiple sclerosis, rheumatoid arthritis and hepatitis C also wind up on specialty tiers, along with the new anti-cancer pills. Medicare supplemental insurance — Medigap — doesn't cover those copayments. Read More