Abbvie has entered into legal action against NHS England over hepatitis C drug program

Health Service Journal 

NHS England taken to court over 'largest ever medicines procurement' 

By Nick Carding

6 November 2018

NHS England taken to court over 'largest ever medicines procurement'

Pharmaceutical company takes NHS England to court 

Legal challenge over procurement for suppliers of hepatitis C treatment 

Procurement aimed to kick start drive to eliminate disease in England 

A global pharmaceutical company has taken the NHS to court over a procurement process aimed to help England become the first country to eliminate hepatitis C.

American firm Abbvie is claiming NHS England breached procurement rules during a process seeking suppliers for hepatitis C treatment.

The Illinois based company launched proceedings in London’s Technology and Construction Court this summer. NHS England has denied the allegation.

Read More: https://www.hsj.co.uk/service-design/nhs-england-taken-to-court-over-largest-ever-medicines-procurement/7023733.article

Putting lives above profits for Hepatitis C treatment

Asia: The Star Online

Saturday, 7 Apr 2018

Putting lives above profits for Hepatitis C treatment
by loh foon fong
A HIGHLY effective drug which can cure Hepatitis C hit the market in 2013 but five years later, over 70 million people around the world are still not getting the needed treatment.

In Malaysia, that was initially the fate of an estimated 400,000 pa­­tients for this disease, amid intense debates whe­ther the cheaper generic version of drugs should be made available to more people.

Continue reading........

Prescription Drugs : The Costco Kickbacks

Prescription Drugs : The Costco Kickbacks

Secret audio tapes and an exclusive television interview with an industry whistleblower reveal a shady practice that is industry-wide. A Fifth Estate investigation shows how Costco pressed one generic drug company for illegal payments to stock their products -- undermining government attempts to protect consumers.

Watch the program: http://www.cbc.ca/fifth/episodes/2017-2018/prescription-drugs-the-costco-kickbacks

Podcast - Huge pharmaceutical corporations rake in government money

Podcast; Huge pharmaceutical corporations rake in government money

Listen Here
https://www.spreaker.com/user/radiosputnik/huge-pharmaceutical-corporations-rake-in

From
Loud & Clear Interviews

It’s the dirty little secret of Big Pharma. The American taxpayer is funding Big Pharma’s research and development, primarily through the National Institutes of Health. So where do all those pharmaceutical profits go? Straight into the pockets of corporate leaders and investors. There’s a new study out by the Center for Integration of Science and Industry (CISI) that we’ll dive into today. Bryn Gay, the Hepatitis C Virus Project Co-Director at Treatment Action Group who has previous policy and advocacy experience with the United Nations, Doctors of the World and The North-South Institute, joins the show. 

Generic Hepatitis C Drugs Begin to Emerge

Recommended Reading

Efficacy of Generic Oral Directly Acting Agents in Patients with Hepatitis C Virus Infection.

J Viral Hepat. 2018 Jan 28. doi: 10.1111/jvh.12870. [Epub ahead of print]
Full Text - Download Article
Shared by @HenryEChang via Twitter.

Secialty Pharmacy Times
Generic Hepatitis C Drugs Begin to Emerge
Laurie Toich
Associate Editor Publish Date: Wednesday, March 07, 2018

The cost of hepatitis C virus (HCV) antivirals has been at the forefront of health care spending conversations for years. Although it has slowed, spending on the blockbuster drugs remains high. Despite the curative ability of the treatments, it is likely that a significant need for antiviral drugs will remain into the foreseeable future due the prevalence of undiagnosed HCV cases.

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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/India, Egypt and other lower-income countries or through online "buyers clubs"

A Gilead-sponsored journey to patient advocacy: ‘[The drug] I would like to promote now is Harvoni’

Another ‘breach of trust’ at STAT: patient who praised TV drug ads says pharma PR company asked her to write op-ed

Interesting story here folks:

Background
HealthNewsReview.org is a web-based project that evaluates health news for accurate reporting published by US news organizations, here is their criteria. Kevin Lomangino, the managing editor recently wrote two articles about the news site STAT, a site that reports on health and medicine. The first article; ‘A blow to [STAT’s] credibility’: MD listed as author of op-ed praising drug reps didn’t write it, the second ‘breach of trust’ at STAT: patient who praised TV drug ads says pharma PR company asked her to write op-ed

The latter might be of some interest to HCV patients. Although raising HCV awareness both in the public and the health care system is critical to establish risk factors associated with the virus, long-term benefits of early detection, and life saving treatment.

However, one may ask should a patient cured by Gilead's drug Harvoni, take part in training sessions, given by Gilead-affiliated PR experts, to help communicate a clear public message, or Gilead's message about Harvoni?  Kevin Lomangino writes about one of the TV appearances made by the patient turn advocate:

On one of her appearances on NBC 24 in Toledo (click here for video) Dushane kicked off the interview by declaring in no uncertain terms what the take-home message was: “There are a number of drugs you can take in regards to hepatitis C, but the one I would like to promote now is Harvoni because it’s a 12-week treatment, very few side-effects and miraculously I’ve been cured after having the disease for 30-plus years.” [emphasis added]

About the STAT op-ed piece written by the patient:

The author of a STAT op-ed headlined “You can complain about TV drug ads. They may have saved my life” says a PR company with ties to the pharmaceutical industry asked her to write the piece and edited it. 

Although the idea for her STAT piece clearly originated with a PR company, according to Dushane, she says that she wrote the piece herself, wasn’t paid for it, and that her draft received only minor editing from the PR company. However, she said she also had received extensive coaching from Gilead-affiliated PR experts about how to communicate her message.

What do you think about the coaching? I wonder, was this well meaning advocate taken advantage of?

Dushane’s says her journey from retired educator to advocate started with an email from Gilead inviting her to fly out to the company’s headquarters in California. At the company’s expense, she says she joined about 40 other people who’d been treated with Harvoni for a series of presentations on Gilead’s work over the course of two days.

Read the article here.....

Drug Companies Tie Costs to Outcomes

Drug Companies Tie Costs to Outcomes
By Peter Loftus

Sept. 12, 2017 10:07 p.m. ET

But early signs show little evidence that the plans lower prices
In one deal, Gilead Sciences Inc. agreed to pay Cigna additional rebates if its hepatitis C drug Harvoni cured less than 95% of Cigna’s patients who took it, he says. Cure rates have exceeded that threshold and Gilead hasn’t paid additional rebates beyond a base rebate that isn’t tied to the drug’s performance.

Continue reading....

Janssen to Discontinue Hepatitis C Development Program

J&J pulls plug on Medivir-Achillion hep C cocktail to focus on hep B
by Ben Adams
Why? The same reason others have dropped out of the development and sales race: There are too many good treatments and increasingly, those without the need for injection, which has seen domination from Gilead’s curative meds Sovaldi and Harvoni.
These meds, as well as others from Big Pharmas, can effectively cure the vast majority of patients with hep C in a few months; Gilead itself has been a victim of its own success, seeing tens of billions of dollars for its therapies after launch, but this started to quickly dwindle after patients no longer needed them.
Read more.....

Janssen to Discontinue Hepatitis C Development Program

Viral Hepatitis Research and Development to Focus on Addressing Significant Unmet Needs in Chronic Hepatitis B

CORK, Ireland, September 11, 2017 - Janssen Sciences Ireland UC (Janssen), today announced a strategic decision to discontinue further development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals - AL-335, odalasvir and simeprevir. The ongoing phase II studies with JNJ-4178 will be completed as planned, but there will be no additional development thereafter. This decision was made in light of the increasing availability of a number of highly effective therapies addressing the medical need in hepatitis C.

'Going forward, our hepatitis R&D efforts will focus on chronic hepatitis B, where a high unmet medical need still exists. Our scientists are energized by this challenge and our research ambition is to achieve a functional cure of hepatitis B which affects over a quarter of a billion people globally,' said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Infectious Disease Therapeutics, Janssen. 'At Janssen, we focus our research and development on areas of greatest unmet medical need where we can combine our excellent internal science with the best available external innovation to bring optimized solutions and maximum benefit to patients.'

Janssen pioneered the advancement of the first innovations in hepatitis C for nearly a decade when it co-developed telaprevir, a first-in-class protease inhibitor used in combination therapy for the treatment of chronic hepatitis C virus. In collaboration with Medivir AB, Janssen subsequently developed and launched the second generation protease inhibitor OLYSIO(simeprevir),which is approved in countries around the world.

Today, people living with hepatitis C have a much more diverse range of therapies available following a wave of innovative treatments securing approval. For most, the standard of care for hepatitis C therapy has a duration of 8-12 weeks offering a cure to around 92-100% of people treated.
http://www.publicnow.com/view/1FCF810BABD0E322CBD5D388A7B4D40496BD4A00?2017-09-11-13:00:07+01:00-xxx7233

J&J unit ends hepatitis C drug development in crowded market

(Reuters) - Janssen Sciences Ireland UC, a unit of Johnson & Johnson, said it would discontinue further development of its hepatitis C research, citing increased availability of a number of effective hepatitis C therapies.

Janssen said it would not continue the development of the investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct acting antivirals.

Read More -

http://in.reuters.com/article/us-johnson-johnson-hepatitis-c/jj-unit-ends-hepatitis-c-drug-development-in-crowded-market-idINKCN1BM0LL

Hepatitis C - Medivir licenses exclusive rights to MIV-802 for Greater China to Ascletis

Medivir licenses exclusive rights to MIV-802 for Greater China to Ascletis

Stockholm, Sweden and Hangzhou, China— Medivir AB (Nasdaq Stockholm: MVIR) and Ascletis today announce that Ascletis has licensed the exclusive rights to develop, manufacture and commercialize Medivir’s nucleotide polymerase inhibitor for hepatitis C, MIV-802 (Ascletis code: ASC21), in Greater China.

Under the terms of the agreement, Medivir received an upfront payment, and is entitled to receive milestones based on successful development through commercial launch and tiered royalties on net sales of MIV-802 containing products. Ascletis will fund clinical development, manufacturing and commercialization of MIV-802 in Greater China.

“We are pleased to have Ascletis as a partner with their track record in advancing development of pharmaceuticals in Greater China and their portfolio of antivirals with which to create a combination drug against hepatitis C” said Christine Lind, CEO of Medivir.

“Ascletis has filed an NDA in China for its first HCV NS3/4A medicine, danoprevir, at the end of 2016 and has an HCV NS5A inhibitor in the late stage clinical development. By acquiring MIV-802, a nucleotide NS5B inhibitor, Asceltis is committed to treating, eventually eliminating, hepatitis C in greater China with its multiple leading antiviral combinations including MIV-802,” said Dr. Jinzi J. Wu, CEO of Ascletis.

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
Jianjiong Wang, Associate Director, Corporate Affairs, mobile: +86 181 0650 1929. Email: pr@ascletis.com

About MIV-802
MIV-802 is a potent, pangenotypic nucleotide inhibitor of the HCV NS5B polymerase. Hepatitis C treatments comprise combinations of pharmaceuticals with different antiviral mechanisms. Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral agents for the treatment of HCV, including protease inhibitors, non-nucleoside NS5B inhibitors, and NS5A inhibitors.

About Medivir
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

AbbVie’s new, cheaper hepatitis C drug could launch the drug world’s own Hunger Games

AbbVie’s new, cheaper hepatitis C drug could launch the drug world’s own Hunger Games
By Emma Court
Published: Aug 5, 2017 10:25 a.m. ET
Price is a fraught topic in the drug world, but especially so when it comes to hepatitis C, which affects an estimated 3.2 million people and can cause long-term harm or death.

Gilead’s Sovaldi is the disease’s first and best-known treatment. When the therapy came out with an $84,000 price tag, it sent shock waves across the industry and made Sovaldi the poster child for expensive drugs. Critics said the price was too high, but Gilead argued that it was justified by the drug’s value.

Continue reading....

Gilead's campaign boosted HCV diagnosis rates for baby boomers

Healio -  Industry News

Gilead announces continued focus on HBV, HCV, NASH
July 26, 2017
During an earnings conference call today, executives from Gilead Sciences disclosed second quarter earnings and projected pipeline goals with a focus on the company’s hepatitis B, hepatitis C and nonalcoholic steatohepatitis treatments.

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Medical Marketing & Media

Gilead's educational campaign boosted HCV diagnosis rates for baby boomers
Jaimy Lee
Executives at Gilead Sciences told investors Wednesday that an unbranded campaign encouraging baby boomers to get tested for hepatitis C helped boost screening and diagnosis numbers, which in turn upped sales of its HCV therapies.

Gilead reported that its HCV franchise generated sales of $1.9 billion in the second quarter of 2017, down 17% from the same quarter in 2016. But sales increased over  the first quarter of the year, driven partly by patient starts (the initiation of an HCV therapy regimen), according to Mizuho Securities analyst Salim Syed.
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Perspective for those who want to dig deeper on prescription drug costs

Perspective for those who want to dig deeper on prescription drug costs
By Scott Scanlon

There are many threads to pull when it comes to determining why prescription drugs cost as much as they do – and how they can be made more affordable for the governments and billions of people who depend on them, at least in part, for their health and wellness. I looked to hit the high points with the main story in this week's Refresh coverage, but found several other stories and sources worth noting for readers who want more context and the opportunity to dig deeper.

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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/India, Egypt and other lower-income countries or through online "buyers clubs"

Bloomberg -The Crazy Math Behind Drug Prices

The Crazy Math Behind Drug Prices
Intermediaries that negotiate to lower prices may cause them to increase, too.
By Paul Barrett and Robert Langreth 

David Hernandez, a 44-year-old restaurant worker and Type 1 diabetic, didn’t have insurance from 2011 through 2014 and often couldn’t afford insulin—a workhorse drug whose list price has risen more than 270 percent over the past decade. As a result of his skimping on dosages, Hernandez in 2011 suffered permanent blindness in his left eye...

In 2014, Gilead Sciences Inc. introduced Harvoni, which cures hepatitis C at a cost of $94,500 for a 12-week treatment. When Gilead offered only a 10 percent rebate, Express Scripts excluded Harvoni and substituted a cheaper drug from rival AbbVie Inc. Gilead got the message. It has said that rebates marketwide on Harvoni exceeded 50 percent in 2016—discounts unavailable to uninsured patients. Gilead declined to comment...

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Hepatitis C - Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs

Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs
by Annie Waldman
ProPublica, Feb. 23, 2017, 8 a.m.

This story was co-published with Consumer Reports.

Over the last three years, pharmaceutical companies have mounted a public relations blitz to tout new cures for the hepatitis C virus and persuade insurers, including government programs such as Medicare and Medicaid, to cover the costs. That isn’t an easy sell, because the price of the treatments ranges from $40,000 to $94,000 — or, because the treatments take three months, as much as $1,000 per day.

To persuade payers and the public, the industry has deployed a potent new ally, a company whose marquee figures are leading economists and health care experts at the nation’s top universities. The company, Precision Health Economics, consults for three leading makers of new hepatitis C treatments: Gilead, Bristol-Myers Squibb, and AbbVie. When AbbVie funded a special issue of the American Journal of Managed Care on hepatitis C research, current or former associates of Precision Health Economics wrote half of the issue. A Stanford professor who had previously consulted for the firm served as guest editor-in-chief.

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With hep C franchises languishing, Merck’s MK-3682 goes from blockbuster to bomb

With hep C franchises languishing, Merck’s MK-3682 goes from blockbuster to bomb
by John Carroll

A little less than three years after acquiring the hepatitis C drug MK-3682 (uprifosbuvir) in its $3.85 billion buyout of Idenix, Merck’s prospects in the field have cooled dramatically, and its once great hopes for the drug have been reduced to nearly nothing.

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Of Interest

Novel emerging treatments for hepatitis C infection: a fast-moving pipeline

MK-3682 + grazoprevir + elbasvir or MK-3682 + grazoprevir + MK-8408 There are two triplet therapies and at least one doublet regimen in development by Merck (Kenilworth, NJ) that include MK-3682 (a novel NS5b nucleotide polymerase inhibitor) with or without grazoprevir and with either elbasvir or MK-8408 (a novel NS5A inhibitor). MK-3682 was tested in 300 mg and 450 mg doses in the CREST 1 (for genotypes 1 and 2) and CREST 2 (for genotype 3) studies. The CREST 1 study showed mITT SVR24 of 91–100% for genotypes 1 (n = 93 with 46 GT1a and 47 GT1b) with either elbasvir or MK-8408 at both doses for MK-3682. However, only the MK-3682 (450 mg)/grazoprevir/MK-8408 regimen showed efficacy >90% in genotype 2 patients (n = 61). For genotype 3 patients, both the 300 mg and 450 mg doses of MK-3682 showed SVR24 rates >90% (n = 86).....

Links On This Blog
Show posts with label MK3(MK-3682/grazoprevir/ruzasvir1)

Forbes - The U.S. Government Should Buy Gilead For $156 Billion To Save Money On Hepatitis C

The U.S. Government Should Buy Gilead For $156 Billion To Save Money On Hepatitis C

Guest post written by

Peter B. Bach and Mark Trusheim

The U.S. government could cure most Americans suffering from hepatitis C infections if it simply bought drug maker Gilead Sciences on the stock market rather than purchasing its products in the drug market.
Gilead has drawn fire for the high price of its hepatitis C drugs, Sovaldi and Harvoni, which currently cost more than $500 per pill but cure the underlying hepatitis C liver infection. But, counterintuitively, buying Gilead outright on the open market could lower hepatitis C drug costs per patient to one-third their current level. That would make it affordable to rapidly treat the 2.7 million Americans the CDC estimates still have hepatitis C....

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This Army Vet Is Fighting Hep C With Big Pharma’s Help

This Army Vet Is Fighting Hep C With Big Pharma’s Help

by Doni Bloomfield
@DoniBloomfield

More stories by Doni Bloomfield
‎December‎ ‎29‎, ‎2016‎ ‎5‎:‎00‎ ‎AM‎ ‎EST

Burkett specializes in lining up testing and treatment for patients, and most of his work is funded by companies including Gilead Sciences Inc., AbbVie Inc. and Merck & Co. that have sold almost $50 billion of the new antivirals since they began hitting the market in 2013. Stiff competition has driven prices down and discounts up, and many insured patients have already been treated. That’s been bad news for the market leader, Gilead, which must increasingly find patients through the social service networks that target drug users and the poor. Many patients don’t even know they have the infection, which can take years to show symptoms.

“They are seeing patient volume declines even though there are 1 or 2 million patients out there,” said Michael Yee, an analyst with RBC Capital Markets. “They have to go out and find those 1 to 2 million.”
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Settlement reached on state Medicaid denial of pricy hep C drugs

Settlement reached on state Medicaid denial of pricy hep C drugs

By Molly Rosbach

The Health Care Authority on Monday reached a settlement agreement in a class action lawsuit that sought broader coverage of costly hepatitis C drugs for Medicaid patients in Washington state.

The settlement has yet to be approved by a judge but lawyers are hopeful it will be soon.

In the past several years, multiple pharmaceutical companies nationwide have developed direct-acting antiviral drugs that cure hepatitis C in more than 90 percent of patients. But the drugs are extremely expensive - for example, Harvoni, introduced in 2014, has a list price of $1,100 a day, or $94,500 for a 12-week course. (After automatic drug rebates and other discounts, Medicaid pays about half that price for each patient.)

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Gilead's Q3 Bombshell: No More Hepatitis C R&D

Gilead's Q3 Bombshell: No More Hepatitis C R&D
Todd Campbell

Nov 2, 2016 at 4:41PM                    

Gilead Sciences (NASDAQ: GILD) is a Goliath in hepatitis C treatment; however, the company is shifting its research spending in the future away from hepatitis C to other indications, and that decision could have big implications on the hepatitis C market in the long term...  

Gilead Sciences' news could give AbbVie and Merck & Co. an opportunity to gain share if they continue developing new therapies that can compete better. AbbVie's ABT-493 plus ABT-530 mash-up, for example, is in late-stage studies that include an eight-week dosing option. If trials are successful, that therapy could compete more effectively against the short-duration Harvoni regimen in genotype 1...

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Surprise: Gilead's hep C wonder Harvoni costs less in U.S. than in EU, Japan

Surprise: Gilead's hep C wonder Harvoni costs less in U.S. than in EU, Japan
by Tracy Staton

It’s no secret that Gilead Sciences’ ($GILD) slowdown in hepatitis C sales growth has caused consternation among investors, to the point where the company is under intense pressure to make some deals.

It's also no secret that Gilead had to offer some steep discounts to win formulary spots for its blockbuster hep C meds Sovaldi and Harvoni, which initially enjoyed a monopoly on the next-gen hep C market--a key reason for the crimp in their sales growth.

Now, we have some numbers that illustrate just how big Gilead’s discounts are--and how its U.S. hep C prices after those discounts compare with similar figures overseas.

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