Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data

Gilead Wins 2-Year Battle & Continues to Hide Hep C Drug Clinical Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After a two-year battle, a pair of public health advocacy groups obtained sought-after clinical trial data from regulators for two hepatitis C treatments sold by Gilead Sciences. But they failed to gain access to the most coveted information that would allow researchers to independently verify test results which were originally generated by the company.

 

The Yale Global Health Justice Partnership and Treatment Action Group sought patient-level data in order to better understand the safety and effectiveness of the two medicines. But they encountered a familiar argument from the company — as well as the Food and Drug Administration — that revealing such raw data may compromise trade secrets and patient confidentiality.

 

The FDA redacted certain data, “which would permit analysis, including validating the results that were reported by the company,” Dr. Joseph Ross, an associate professor at the Yale School of Medicine, who worked with the groups, wrote us.

 

The effort began nearly three years ago when the groups asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. As we wrote at the time, they sought this data because the medicines have been widely prescribed, thanks to high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

 

Gilead, however, balked at releasing any data, so the groups then turned to the FDA, since the company had filed all sorts of clinical trial information with the agency in order to win regulatory approval to sell the drugs. But the agency indicated the Freedom of Information request would take up to two years to fulfill, so in June 2015, groups filed a lawsuit to force the FDA to cough up the data.

 

The advocacy groups argued in their lawsuit that doctors “lack(ed) the benefit of any independent assessment of the data.” And given the high cost of the drugs, the groups contended it is “crucial that policymakers be able to evaluate the cost-effectiveness … based on the underlying clinical data. …” The list prices for the drugs were $84,000 and $94,500 for 12-week regimens, before rebates.

 

Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”; http://sco.lt/8R5T7J
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”; http://sco.lt/5FuPeT
Pharma Guy's insight:

I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. There were reported relapses occurring in short clinical trials, so I would expect even more relapses in the real world long-term.

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Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested

Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead's hep C blockbusters are in freefall, and its pool of eligible patients has shrunk dramatically thanks to the success of its meds. If all baby boomers got tested for the virus, though? That could help stem the tide—and it's exactly the move the company is recommending with its latest awareness push.

 

With its second awareness effort—the first began in 2014 before its hep C combo Harvoni hit the market—the Big Biotech reaches out to the almost 75 million people born between 1945 and 1965, following the age range used by the CDC in its recommendation that all baby boomers get tested for hepatitis C.

 

"For millions of baby boomers, there's a virus out there. A virus that's serious, like HIV, but it hasn't been talked about much," a narrator says over images of active boomers looking out over majestic nature scenes. "One in 30 boomers has hep C, yet most don't even know it," the narrator notes, before going over the disease's liver damage and cancer risks and reminding viewers that testing is "the only way to know for sure."

 

While the first awareness campaign sought to re-engage people diagnosed with hep C, the current campaign, dubbed “Forgotten Virus,” goes out more broadly to baby boomers who may not know about the disease, to encourage testing and also to let them know that if they do have it, it can be cured, said David Johnson, Gilead VP, U.S. sales and marketing for liver diseases, in an email interview. Boomers are about five times more likely to have hep C than other adults.

 

The campaign comes at a time when sales of one-time record-breakers Harvoni and component med Sovaldi are slumping; Gilead recently reported that Harvoni sales dropped by 34% in 2016, thanks to competition (read “Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition”; http://sco.lt/8bunVB), payer discounting and the inevitable slowdown of patients, as many people who had hep C when the combo launched have now been treated (read "Will Gilead’s Hep C Sales Implode or Just 'Hit Equilibrium?'"; http://sco.lt/69RQUz).  Targeting unaware baby boomers could unearth new patients that need treatment.

Pharma Guy's insight:

HA HA! The ad shows baby boomers lounging on bent trees and wandering aimless through the landscape as if they are in a trance and have nothing better to do! No doubt millennials are in charge of the storyboards for these ads and it's their way of getting back at their baby boomer parents!

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Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition

Disaster! Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Real fans (of intense fights over drug pricing) don't leave the stands early. The most fascinating pharma battle in recent years has been over new drugs that can rapidly cure hepatitis C (HCV). This fight has everything: Sky-high prices, congressional hearings, concerns about patient access, lawsuits, and a price war. Oh, and a mere $38 billion in combined sales since the first of these drugs launched in late 2013.  

 

In April, Gilead, the leader in this space, reported the first-ever year-over-year sales decline of its lead HCV drug. That prompted some observers to assume the frenzy had peaked -- these drugs are cures, so patient numbers should decline over time. But there are still plenty of patients who need treatment, according to a new analysis by Bloomberg Intelligence analyst Asthika Goonewardene. And a new generation of potentially quicker and more broadly effective drugs means more price wars and market-share brawls may lie ahead for Gilead and competitors such as AbbVie and Merck.

 

This status quo won't last. All three firms are working on more potent drug cocktails that could cut treatment time and work for more types of patients. As these drugs start to arrive over the next few years, things will start to get interesting.

 

BI's model takes a look at how much just one company's pricing decision on one drug -- in this case AbbVie's -- could shift billions in revenue (see chart above).

 

Scenario 1: AbbVie prices its next-generation drug at a big premium to Viekira Pak, keeping prices high across the board.

 

Scenario 2: In a second scenario, it makes that premium a little smaller.

 

Scenario 3: In a third (and probably less-likely) scenario, AbbVie prices the new drug extra-low to grab market share. A big AbbVie price cut could force Gilead to cut its own prices, and its sales could drop to $14 billion by 2018. [DISASTER!]

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Gilead's "Tone-deaf Pricing" of Sovaldi "Exploits" Our Veterans

Gilead's "Tone-deaf Pricing" of Sovaldi "Exploits" Our Veterans | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The chairman of the House Veterans Affairs Committee is slamming an American pharmaceutical company for "price gouging.


The target of Miller's wrath is Gilead Sciences of Foster City, California, which Miller said earned about $10 billion in the first year its treatment for chronic liver disease hit the market in 2012.


"Gilead's tone-deaf pricing strategy also fails to take into account the fact that without the Department of Veterans Affairs, the drug at the center of this debate would not even exist," Miller wrote. "Sofosbuvir was invented by a team led by a VA doctor, who sold the company that developed the drug to Gilead in 2012."

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Merck's President: Let's Not Compete So We All Can Enjoy High Hep C Drug Prices

Merck's President: Let's Not Compete So We All Can Enjoy High Hep C Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Last month, a game theory expert suggested Merck & Co. ($MRK) focus on winning corners of the hep C market small enough that dominant players Gilead ($GILD) and AbbVie ($ABBV) won't challenge its forthcoming combo treatment. And according to Merck execs, the company is already working to do just that.


The pharma giant is looking to carve out its own piece of the pie by targeting hard-to-treat hep C patients, Bloomberg reports. Translation: It doesn't want to escalate the pricing war that has triggered huge discounts from both Gilead and AbbVie.


Merck's Adam Schechter

"With a competitive product profile, you can be successful potentially without offering significantly more price concessions or discounts," Adam Schechter, Merck's president of global human health, told the news service recently.

Pharma Guy's insight:

Merck is the Hep C drug nazi: "No More price Concessions for you!"

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Specialty Drugs Driving Growth in Rx Spend

Specialty Drugs Driving Growth in Rx Spend | Pharmaguy's Insights Into Drug Industry News | Scoop.it

U.S. prescription-drug spend in 2014 reached $373.9B — a 13 percent increase from the previous year and the largest increase in more than a decade, as more effective and expensive new specialty drugs came to market and existing specialty drugs saw prices rise. The cost increase in specialty drugs makes it ever more difficult for consumers to access needed therapies. It is also squeezing state budgets, constraining employer-provided benefits and consuming resources that could otherwise go toward improving critical areas of healthcare delivery.


Recent analysis of data from Blue Cross Blue Shield (BCBS) companies, the largest commercial claims database in healthcare, confirms this broader trend. BCBS companies’ data reveal that prescription drug (Rx) per-member per-month (PMPM) spend increased by 9.3 percent from 2013 to 2014. This growth outpaced even the substantial rise in outpatient costs, and it far exceeded growth in inpatient and other professional costs. More importantly, this rise in Rx spend also runs counter to other trends, such as greater use of less-expensive generic drugs. For example, in 2014, consumers chose generic drugs two-thirds (67.7 percent) of the time when a branded counterpart was available versus just over half (54.9 percent) of the time in 2012.

Pharma Guy's insight:


The driving factor behind the Rx cost trend is the cost of specialty drugs. Data confirm that in 2014, specialty drug unit costs jumped 20.1 percent, compared to 5.7 percent for non-specialty drugs. Utilization for specialty drugs also rose by 7.3 percent in 2014.


Within the specialty pharmaceutical portfolio, the top 10 drugs contribute to 61 percent of overall spend. New Hepatitis C and Multiple Sclerosis drugs have contributed significantly to the trend (e.g., Sovaldi®, a Hepatitis C treatment introduced in October 2014 priced at $84,000 for 12 week treatment, and Tecfidera® for Multiple Sclerosis priced at $55,000 for 1 year treatment).

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An OTC Allergy Drug May Be an Effective Hep C Treatment, Claims NIH!

An over-the-counter drug indicated to treat allergy symptoms limited hepatitis C virus activity in infected mice, according to a National Institutes of Health study. The results suggest that the drug, chlorcyclizine HCl (CCZ), potentially could be used to treat the virus in people. Results were published April 8 in Science Translational Medicine 


The hepatitis C virus (HCV) causes liver inflammation and often leads to serious complications such as cirrhosis. Early diagnosis and treatment of HCV can prevent liver damage. Drugs are available to treat HCV, but costs can reach tens of thousands of dollars.


“Although hepatitis C is curable, there is an unmet need for effective and affordable medication,” said lead author T. Jake Liang, M.D., senior investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “CCZ is a promising candidate for part of a treatment regimen for this potentially life-threatening disease.”

Conducted at the NIH campus in Bethesda, Maryland, the study found that CCZ blocked the early stage of HCV infection likely by impairing the ability of the virus to enter human liver cells grafted in the mice. The outcome was similar to that of commonly used antiviral drugs but without those drugs’ toxic side effects.


“Using an innovative high-throughput screening process, we identified CCZ as a potent inhibitor of hepatitis C,” said Anton Simeonov, Ph.D., acting scientific director of NIH’s National Center for Advancing Translational Sciences (NCATS), which collaborated in the study. “Identifying already approved drugs from the NCATS Pharmaceutical Collection may offer a faster route to potential discovery of treatments for all diseases.”


The researchers will next study how the drug affects people. CCZ is currently used for the treatment of allergies, not for HCV. “People should not take CCZ to treat their hepatitis C until it has been demonstrated that CCZ can be used safely and effectively for that purpose,” cautions Liang.


“NIH research is vital to finding creative solutions for some of today’s most serious public health issues,” said NIDDK Director Griffin P. Rodgers, M.D. “The CCZ medication may eventually provide an affordable alternative to costly options, especially in low-resource communities where hepatitis C infection is widespread.”


HCV infection affects an estimated 185 million people worldwide. People with hepatitis C interested in participating in clinical research on CCZ may call 1-866-444-2214 (TTY 1-866-411-1010) or visit www.clinicaltrials.gov (Clinical Trial # NCT02118012) for information. Support for both studies comes from the intramural research programs of the NIDDK and NCATS and from Hiroshima University.

Pharma Guy's insight:


Wow! Sell your Gilead stock now!

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Krishan Maggon 's curator insight, April 9, 2015 2:32 AM
Sci Transl Med 8 April 2015: 
Vol. 7, Issue 282, p. 282ra49 
Sci. Transl. Med. DOI: 10.1126/scitranslmed.3010286RESEARCH ARTICLE

DRUG DISCOVERY

Repurposing of the antihistamine chlorcyclizine and related compounds for treatment of hepatitis C virus infectionShanshan He1, Billy Lin1, Virginia Chu1, Zongyi Hu1, Xin Hu2, Jingbo Xiao2, Amy Q. Wang2,Cameron J. Schweitzer1, Qisheng Li1, Michio Imamura3, Nobuhiko Hiraga3, Noel Southall2, Marc Ferrer2,Wei Zheng2, Kazuaki Chayama3, Juan J. Marugan2 and T. Jake Liang1,*
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Solvaldi Sales Rocket, then Nose Dive. Why? One word: Harvoni. For Gilead, It's All Good

Solvaldi Sales Rocket, then Nose Dive. Why? One word: Harvoni. For Gilead, It's All Good | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Authored by ISI’s Mark Schoenenbaum, and presented here, courtesy of Drug Channels Institute, it tells us that Gilead’s Sovaldi literally ‘blew out the lights’  in U.S. “specialty drug” sales during its first full year on the market. This remarkable prescription drug will come in somewhere between $10 and $11 billion dollars in sales for 2014. And thinking about the first year performances of other first class, heavy weight “specialty drugs” — like Gleevec,  Avastin,and Revlimid, — Sovaldi’s sales numbers are all the more amazing.

Pharma Guy's insight:


Sovaldi scripts are sinking as patients instead opt for Harvoni, Gilead's hep C wonder combo, which boasts cure rates as high as 99.1%. Analysts expect Harvoni to rack up $10 billion a year in sales, becoming the fastest-growing drug of all time on the way there. But if all of that's the case, then why are U.S. scripts lagging behind forecasts? More...

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Gilead's Fake Sovaldi Content Marketing Ploy

Gilead's Fake Sovaldi Content Marketing Ploy | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Pharma Guy's insight:


I subscribed to receive e-mail messages from "Your SOVALDI Team" which is really Gilead. I don't have Hep C, but Gilead doesn't know that.


Today, I received the message "Why should you consider treatment" from my Sovaldi team. I was surprised to see a link to an "arcticle" as shown in the screen grab above.


I expected to be taken to a real article discussing Hep C and treatment with Sovaldi. This, I thought, was an example of "Content Marketing," which relies on useful, unbiased information, perhaps from an independent 3rd-party, to get readers to visit your website or see an associated ad for you product. 


Unfortunately, the link in the Gilead e-mail (i.e., from "In this article") brought me directly to a branded Sovaldi web page that looks just like any other drug.com site. It wasn't an "article" at all!


Oh well. I'm a fake patient, so I guess I deserve a fake content marketing ploy.

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The Hepatitis C Escalation: 1 Million People with Hep C in US May Develop Cirrhosis by 2020

The Hepatitis C Escalation: 1 Million People with Hep C in US May Develop Cirrhosis by 2020 | Pharmaguy's Insights Into Drug Industry News | Scoop.it
There’s never been anything quite like this. The latest ripple effect of the 1945-65 baby boom will be a drug bill so high, that paying it, says Australia’s advisors, “is not possible.”


Hepatitis C virus can clear spontaneously without doing any harm. But most people will develop chronic infection. It’s hard to know how many will go on to develop serious liver damage, called cirrhosis, though. Estimates range from about 10%within 20 years with some more later, to around 30%. Cirrhosis is life-threatening, with liver transplantation to try to prevent early death. Cirrhosis can also lead to liver cancer.


The number of people in the US with cirrhosis from HCV could peak at 1 million in 2020, with the peak for liver cancer coming later.


But the cost for the sofosbuvir alone is around $1,000 a pill – and $84,000 for the course: closer to $95,000 when you count in the drugs used alongside. Forbes reports that is the price set for Harvoni.


Last month, CVS reported that about 10% of people were quitting sofosbuvir treatment without finishing. Restrictions are in place in many parts of the US to contain costs, but more will be needed now. And there’s fierce debate about just how far the manufacturer is willing to go to make the drug even close to affordable in less wealthy countries: that company has a dreadful track record on this for HIV drugs. And whether the costs can be carried in rich countries is debatable, too.

Pharma Guy's insight:


Only 10% non adherence ... sounds reasonable considering, I'd like to know, however, more about thee patients, such as, income. I'm betting  early adopters of Sovaldi have the $ for the co-pay, whereas poorer patients may be waiting for cheaper alternatives to reach the market.

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Krishan Maggon 's curator insight, October 15, 2014 5:55 AM

Image

 

The images of the hepatitis C virus and developing liver fibrosis are from Tarik Asseleh et al, Gene expression and hepatitis C virus infection, Gut 2009, 58(6):846-858.

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AbbVie aims to truck ahead with hep C testing promo campaign

AbbVie aims to truck ahead with hep C testing promo campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AbbVie's  waiting for FDA approval on a hepatitis C combo therapy. OraSure makes a rapid test to detect the virus. And professional truck drivers in the U.S. are more than 5 times as likely as other Americans to have it.


Put it all together, and you've got the makings for a brand-new marketing campaign, "Truckers Rolling Against Hepatitis C." Together, AbbVie and OraSure--parties to a copromotion agreement focused on testing individuals with the latter's OraQuick HCV Test--have teamed with the Healthy Trucking Association of America to educate drivers about HCV and encourage them to get tested.


The campaign will kick off at--where else?--The Great American Trucking Show, coming up later this week in Dallas. From there, the companies will keep it going with local HCV testing events across the country.

Pharma Guy's insight:


#1: I did not know truckers were 5X as likely to have Hep C. Keep on Truckin' indeed!


#2: Just because there will be competition to Sovaldi doesn't mean that prices for these treatments will drop:


From: Don't worry about a hep C pricing war, analysts tell Gilead-watchers


No price war on hepatitis C drugs? That would be a disappointment to payers worried about the cost of treating millions of patients with super-expensive, yet highly effective drugs. But to investors, that reassurance sounds really good.


As Barron's points out today, Bernstein analysts issued a report to assuage fears of an all-out pricing competition when Gilead Sciences' Sovaldi is joined on the market by new treatments from AbbVie, Bristol-Myers, and Merck.


"One of the near-term bear arguments is the expected approval of a competitive all-oral HCV regimen from AbbVie, and the potential for aggressive pricing tactics by AbbVie," Bernstein's Geoffrey Porges and Wen Shi wrote in a note to investors.


Obviously, major undercutting of Sovaldi's notorious $84,000-per-treatment-course price could either force Gilead to slash the cost of its own meds, or relinquish market share to AbbVie. And as the analysts point out, payers are encouraging AbbVie and its fellows to do just that.


"However, we believe the risk of a price war hurting Gilead's HCV revenue in the next 1-2 years is overblown," they wrote.


For three reasons, basically. Even if AbbVie's regimen is cheaper, payers have "limited tools" to use to restrict access to Gilead's therapy, which will probably include a new combo pill by year's end. AbbVie has said--and recently--that it's not interested in a price war. That sort of competition isn't necessarily a good move in the hep C market, where awareness is growing and diagnosis is expected to increase, which means the entire pie is bigger for everyone.


And besides, if Gilead were to face lower-priced rivals, the company "has counter strategies to mitigate the impact of any potential price war by AbbVie on a payer-by-payer basis," the analysts write. Behind-closed-doors negotiations, maybe?

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Today is World Hepatitis Day: Access to New Treatments for Hep C Difficult, Says WHO

Today is World Hepatitis Day: Access to New Treatments for Hep C Difficult, Says WHO | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Every year on 28 July, WHO and partners mark World Hepatitis Day to increase the awareness and understanding of viral hepatitis and the diseases that it causes.

Viral hepatitis – a group of infectious diseases known as Hepatitis A, B, C, D, and E – affects hundreds of millions of people worldwide, causing acute and chronic liver disease and killing close to 1.4 million people every year. But hepatitis remains largely ignored or unknown.


In April this year, WHO issued new recommendations on treatment of Hepatitis C. In May, World Health Assembly delegates from 194 governments adopted a resolution to improve prevention, diagnosis, and treatment of viral hepatitis.


On World Hepatitis Day, 28 July 2014, WHO and partners will urge policymakers, health workers and the public to 'Think again' about this silent killer.


World Hepatitis Day provides an opportunity to focus on specific actions, such as:


  • strengthening prevention, screening and control of viral hepatitis and its related diseases;
  • increasing hepatitis B vaccine coverage and integration of the vaccine into national immunization programmes;
  • coordinating a global response to viral hepatitis.


The date of 28 July was chosen for World Hepatitis Day in honour of the birthday of Nobel Laureate Professor Baruch Samuel Blumberg, discoverer of the hepatitis B virus.

Pharma Guy's insight:


From the Hep C Fact Sheet:


Scientific advances have led to the development of new antiviral drugs for hepatitis C, which are much more effective, safer and better-tolerated than existing therapies. These therapies, known as oral directly acting antiviral agent (DAAs) therapies simplify hepatitis C treatment by significantly decreasing monitoring requirements and by increasing cure rates. Although the production cost of DAAs is low, the initial prices set by companies are very high and likely to make access to these drugs difficult even in high-income countries.

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Defending Big Pharma [i.e., Gilead] is a Full-Time Job for PhRMA

Defending Big Pharma [i.e., Gilead] is a Full-Time Job for PhRMA | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), 

her job is to develop federal legislative, regulatory and political strategies. She not only fights criticism of the pharmaceutical industry on multiple fronts, but also promotes healthcare reforms that reflect the industry’s interests.


One current fight involves Gilead’s $1,000-a-pill Hepatitis C drug Sovaldi, which lawmakers, insurance companies and pharmacy benefit management companies say could bankrupt families and the healthcare system.


Even though Gilead isn’t a PhRMA client, the lobby group has come to its defense, saying Sovaldi might sound pricey but in the long run it actually saves money.


While Sovaldi may cost $84,000 or more for an individual patient’s 12-week treatment, Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail.

Pharma Guy's insight:


"Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail."


Let's do the math on Sovaldi, using some numbers from the C. Everett Koop Institute, which may or may not receive funding from Gilead and/or PhRMA:


According to the Institute's data (see Hepatitis C: The Facts) the "average lifetime cost for hepatitis C, in the absence of liver transplant, has been estimated to be about $100,000 for individual patients. Assuming that 80% of the 4.5 million Americans believed to be infected develop chronic liver disease, the total lifetime cost for this group (3.6 million) will be a staggering $360 billion in today's dollars. Assuming an estimated survival of 40 years, the annual health care costs for the affected U.S. population with chronic hepatitis C may be as high as $9 billion."


Saving $360 billion sounds like good news, right? But does the math add up to a savings for payers; e.g., Medicaid, Insurers, States, and patients?

To save that $360 billion, ALL 4.5 million people with Hep C must be treated because doctors can't determine who among the 4.5 million patients will develop chronic liver disease and who won't. At $84,000 "or more" per treatment, the total cost is at least $378 billion! So it's a wash, more or less. Or is it?

On the one hand, Gilead offers discounts to big payers like Medicaid, so the total cost is likely to be much less than $378 billion to treat ALL Hep C patients.

On the other hand, at such a high cost per treatment, it's not likely that ALL Hep C patients will be able to afford treatment and will opt not to take Sovaldi -- especially those patients that do not have and may never have chronic liver disease. Also, we know that even for treatment of life-threatening diseases, patients often (maybe up to 50% of the time) do not comply with the treatment regimen. This may be even more so for drugs like Sovaldi, which are likely to have serious side effects.

So, as far as saving payers money, the Sovaldi math says "maybe." For payers, "maybe" just isn't good enough from a financial, return-on-investment (ROI) standpoint.

Reilly also argues that drugmakers also need a good ROI: "if drugmakers aren’t able to recoup their research and development dollars for diseases like cancer and Alzheimer’s, new drugs won’t come to the market."

Gilead has racked up $5 billion in Sovaldi sales in the first half of 2014. According to a JAMA viewpoint article, it may have cost Gilead $11 billion to "develop" Sovaldi - this is based on the price Gilead paid to acquire Pharmasset, which discovered and initially tested Sovaldi. If all of the approximately 3.6 million Hep C patients with chronic liver disease in the United States were treated with Sovaldi at current prices, Gilead would net more than $300 billion dollars, or better than a 27-to-1 return on its investment, "suggesting that pricing is inappropriately high." 

At the current rate of sales, Gilead will recoup its initial $11 billion investment by the end of the year and Sovaldi will be profitable in 2015. That's about the time that competition may enter the marketplace. So, Gilead decided price not on what the market will bear, but on how quickly it can recoup its investment before it loses market share and is forced to reduce prices.

Why is PhRMA defending Gilead, which isn't even a member organization?

Here's what Reilly says about that: 

"Reilly pushes back against congressional leaders who are challenging the rising cost of specialty drugs and want the Department of Health and Human Services (HHS) to negotiate down the price of treatments like Sovaldi in Medicare Part D plans. 

"Reilly warns the fight isn’t just about one Hepatitis C drug but future drugs that could save the healthcare system billions of dollars by reducing costs such as chronic care and hospital bills. 

"Reilly also says if drugmakers aren’t able to recoup their research and development dollars for diseases like cancer and Alzheimer’s, new drugs won’t come to the market."

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Gilead's Harvoni Ads Ramp Up the "Cure" Message

Gilead's Harvoni Ads Ramp Up the "Cure" Message | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead is adjusting its message in new advertising for hepatitis C drug Harvoni, replacing its two-year-old introductory ad with a spot highlighting patients' relief after treatment. Three key words: "I am cured."

 

“Let Go” replaces “I Am Ready” as the new theme in the marketing effort, which is meant to reach patients who've been diagnosed with hep C, but haven't undergone treatment, a spokeswoman for Gilead said. In a just over one week on the air, the TV ad has tallied more than $6.4 million in national media spending, with the bulk of airings occurring in primetime, according to data from real time TV ad tracker iSpot.tv.

 

In the ad, dozens of people walk through a desert carrying Chinese lanterns, which they light and release skyward as the day turns into night. The voiceover assures viewers: "I no longer live with the uncertainties of hep C, wondering what if? I let go of all those feelings because I am cured, with Harvoni."

 

Further Reading:

  • “Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested”; http://sco.lt/9KSHIn
  • “Scoop.it!
  • “Will Gilead’s Hep C Sales Implode or Just Hit Equilibrium?"; http://sco.lt/69RQUz
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”; http://sco.lt/5FuPeT
Pharma Guy's insight:

This is another arm of the DTC ad campaign to tramp up flagging sales and possibly anticipating that long-term outcome NIH studies may prove that "cure" is an overstatement.

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Will Gilead’s Hep C Sales Implode or Just "Hit Equilibrium?"

Will Gilead’s Hep C Sales Implode or Just "Hit Equilibrium?" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Boom and bust has been a feature of the hepatitis C virus treatment market, but as its own franchise starts to show some weakness, Gilead is hoping to buck that trend.

 

The US pharma company has reaped the benefits of stellar sales for its directly-acting HCV therapies since it first launched Sovaldi (sofosbuvir) in 2013 and two-drug follow-up Harvoni (sofosbuvir/ledipasvir) the following year.

 

However, sales showed a sizeable fall-off in the second quarter of the year – down around a third in the US and Europe and 43% in Japan – and overall fell by around $900m (19%) to $4.0bn.

 

[This is a quarter sales number. Read “Gilead's Investors Shed Croc Tears Despite a 69% Profit Margin for Q1 2016”; http://sco.lt/55ACYL]

 

Gilead attributed the decline in HCV sales to a slowdown in the rate of eligible HCV patients presenting for treatment, in particular sicker patients with liver fibrosis who were among the first to gain access to the new drugs. As these patients are treated with them for longer, shortening treatment durations are also a factor, along with a price cut in Japan and healthcare budget restrictions in countries like the UK.

 

New entrants such as AbbVie's Viekirax (paritaprevir, ombitasvir and ritonavir) and Exviera (dasabuvir) and Merck & Co's Zepatier (elbasvir/grazoprevir) have also played a role, although Gilead maintains that this is happening mainly in the Medicaid market sector in the US where access to the newer therapies remains a little more restricted to less sick patients.

 

The big question is whether the HCV market will implode – as occurred with the HCV protease inhibitors – or experience a slow and managed decline as the pool of infected patients starts to dwindle.

 

Gilead chief executive John Milligan said that increasing diagnosis rates will help prevent a dramatic fall-off, as will a shift towards treatment of less severely ill patients. In the US alone there are an estimated 3m infected people, with just over half of those diagnosed at present, he noted.

 

“I think ... there will continue to be a gradual decline in new patient starts, but an equilibrium will be eventually hit,” he told investors.

Pharma Guy's insight:

This seems to be a worse case than  Bloomberg Intelligence's "Scenario #3": Read “Gilead Sales of Hep C Drugs May Drop to $14 Bn by 2018 Due to Stiff Competition”; http://sco.lt/8bunVB

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Drug Spending Growth Surges Again in 2015

Drug Spending Growth Surges Again in 2015 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Total spending on medicines in the U.S. reached $310 billion in 2015 on an estimated net price basis, up 8.5 percent from the previous year, according to a new report issued today by the IMS Institute for Healthcare Informatics.

Invoice spending is based on IMS Health reported values from wholesaler transactions measured at trade/invoice prices and exclude off-invoice discounts and rebates that reduce net revenue received by manufacturers. Net spending reflects company recognized revenue after off-invoice discounts, rebates and price concessions are applied.


According to IMS, the increase was driven primarily by a wave of "innovative" new medicines. Take a closer look at the data here.

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ThePlanetaryArchives - BlackHorseMedia - San Francisco's curator insight, April 16, 2016 10:53 AM
"Innovative" drugs? There are no drugs that actually cure any disease, and America is sicker and fatter than ever. One day these people will be revealed for the snake-oil salesmen that they are. Except snake-oil actually works.....
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FDA Warning: Hepatitis C Treatments Viekira Pak & Technivie May Cause Serious Liver Injury

FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.


FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.


Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended (see the Drug Safety Communication Data Summary section). FAERS includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.


BACKGROUND: Viekira Pak and Technivie are used to treat chronic hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.


RECOMMENDATION: Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.


Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.

Pharma Guy's insight:

Oh my!

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What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data

What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences’ hepatitis C treatments on a timely basis.


Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.


As far as the health groups are concerned, the accelerated process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”


Specifically, the groups hope to learn about different responses that different patients experienced during clinical trials. Tracy Swan of Treatment Action Group points to relapses in a Harvoni clinical trial that occurred only among African-Americans. The groups also want to perform an independent analysis of poor prognostic factors among people who were not cured in order to identify a patient profile.


In their lawsuit, the groups maintain doctors “lack the benefit of any independent assessment of the data.” And given the high cost of the drugs, the groups argue in their lawsuit that it is “crucial that policymakers be able to evaluate the cost-effectiveness… based on the underlying clinical data…” Sovaldi and Harvoni cost $84,000 and $94,500, respectively, for 12-week regimens, before discounts.


But Gilead never replied to their requests last November for trial data, according to the lawsuit.


So last December, the groups turned to the FDA and submitted a Freedom of Information request for the data, since the drug maker had submitted the information to the agency as part of the drug approval process. However, the groups say the FDA denied their request for “expedited processing” and maintained it would take from 18 to 24 months to fork over the data, according to the lawsuit.


“This delay will leave doctors and patients in the dark for too long,” says Amy Kapczynski, a Yale Law School professor who heads GHJP, in a statement. “Doctors write thousands of prescriptions for these drugs every week, straining budgets of state health care programs. Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more informed treatment choices with real and immediate consequences for public health and spending.”

Pharma Guy's insight:


I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. If there were relapses occurring in short clinical trials, wouldn't you expect even more relapses in the real world following months after treatment?

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Game of Dethrones: Pricey Hep C Drugs Dethrone Pfizer as No. 1 #Pharma Company!

Game of Dethrones: Pricey Hep C Drugs Dethrone Pfizer as No. 1 #Pharma Company! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The runaway success of its hepatitis C pill has seen Gilead overtake Pfizer as the biggest pharma firm in the US when it comes to drug sales.


Sovaldi, which made more than $10bn in sales in its first full year in 2014, has pushed it to the top of the rankings with a 175% growth on 2013.


Meanwhile, Pfizer has now slipped to third place - after being top for the past decade - as sales in the US dropped 7%. This was due predominately from the ongoing generic competition to its once $13bn a year statin Lipitor (atorvastatin), which recorded just $2.8bn in sales last year.


Johnson & Johnson has also made a major leap into second place after being fifth last year as drug revenue grew by an impressive 25% on the year before period to reach more than $17bn.


The firm's drugs unit Janssen was bolstered by an array of new and diverse products, including its new hep C drug Olysio (simeprevir) and prostate cancer pill Zytiga (abiraterone acetate), as well as the type 2 diabetes drug Invokana (canagliflozin) and blood cancer treatment Imbruvica (ibrutinib).

Pharma Guy's insight:


Who ever thought Pfizer would be dethroned as #1!

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Here's What Happens to the Competition When #Pharma Develops Non-"Me Too" Innovative Drugs

Merck will stop selling Victrelis in the U.S. by the end of this year. The company cites "advances in treatment practices"--namely, the new all-oral drug cocktails offered by Gilead and AbbVie--and the shrinking demand they've caused.


Vertex Pharmaceuticals said much the same thing in August, when it announced it would stop selling Victrelis' head-to-head rival, Incivek. That drug went off the U.S. market in October, thanks to diminishing market share--and "available alternative treatments."


It was a big comedown for Incivek, which had been hailed as the fastest drug launch ever, with a quick sprint to blockbuster-level sales. Less so for Victrelis, which peaked at $504 million. Still, it's a turnabout; both meds were big advances in hep C treatment at the time, because they vastly improved the effectiveness of older interferon-based cocktails, and shortened the length of treatment. When the next generation of all-oral treatments neared the market, however, doctors started putting off treating patients to wait for the newer meds.

Pharma Guy's insight:


Considering the high price of Sovaldi and Harvoni, doctors and patients must be convinced that they are much better alternatives than the competition. I only hope they live up to their reputation for "curing" Hep C.

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117,000 Hep C Patients - Out of 130 Million - Received Sovaldi. Gilead Makes $8.5 Billion in 9 Months!

117,000 Hep C Patients - Out of 130 Million -  Received Sovaldi. Gilead Makes $8.5 Billion in 9 Months! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead Sciences' blockbuster hepatitis C drug Sovaldi has been used in around 117,000 people since its launch at the end of last year, said the company in its latest financial report.


Sovaldi (sofosbuvir), which allows patients to be treated without the need for weekly injectable interferon, has been the most lucrative pharma launch of all time, and has recorded revenues of $8.5bn in the first nine months of 2014 and $2.8bn for the three-month period between July and September.


This uptake has been despite criticism from some corners of the US unhappy with the drug's high price – around $84,000 per standard course of treatment – with senators asking Gilead to justify the cost of Sovaldi.


Around 70% of US state Medicaid programmes have implemented controls on Sovaldi prescribing - including prior authorisation requirements based on disease severity  - amid warnings that some healthcare systems may buckle under the strain of providing the drug.


Nevertheless the massive revenues so far put Sovaldi way ahead of Gilead's second biggest selling medicine Atripla, a combination of several HIV treatments. The drug made $2.5bn for the first nine months of the year and just under $900m over the third quarter, both slightly down on the same periods last year.


The huge boost from Sovaldi saw Gilead's total revenues rocket from $8.1bn for the first nine months of 2013 to $17.5bn for the same period in 2014.


Net income was also up, with Gilead taking $8.6bn for the first nine months of 2014 compared to $2.3bn a year previous.

Pharma Guy's insight:


If, say, 100,000 of those patients were in the U.S., that represents just 3% of people with Hep C in U.S. Looks like it will take a generation to treat all of them at this rate! No matter, Gilead is raking it in while the raking is good!

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J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company! Thanks to high-margin, low-cost Olysio for Hep C

J&J #Pharma Earnings Up 18.7% Despite Being Top Fined Drug Company! Thanks to high-margin, low-cost Olysio for Hep C | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For the quarter, Johnson & Johnson announced that it produced $18.47 billion in sales, up 5.1% from the previous year (sales were up 5.8% and affected negatively by currency translation) as its net earnings jumped to $4.3 billion, or roughly 10%, to $1.50 per share.


The big factor for J&J which continues to ignite its results is its pharmaceutical sales. Even though its consumer products and medical device and diagnostic segment combine for more in total sales than its pharmaceutical segment, the margins in its pharma segment absolutely trounce that of the other two, making it by far J&J's cash cow.


For the third quarter, Johnson & Johnson announced an 18.7% increase in pharmaceutical sales, led by a 33.1% increase in the U.S., the world's No. 1 user of pharmaceutical products.

Pharma Guy's insight:

 

For more about J&J settlements, read J&J Is Now Top-Fined Company in the Pharma Criminal & Civil Settlement Planetary System.

 

The sales number is quite an achievement considering the consumer product recalls that J&J had to issue. I guess keeping Rx and consumer health product separated into different subsidiaries is a good strategy for protecting the stock price from wild fluctuations and benefiting more from good news in one division versus bad news in another.

 

J&J's Hepatitis C medication Olysio (simeprevir) boosted Johnson & Johnson's third-quarter pharmaceutical sales (source):

 

The drugmaker announced Tuesday that blood thinner Xarelto (rivaroxaban), diabetes drug Invokana (canagliflozin) and cancer drugs Zytiga (abiraterone) and Imbruvica (ibrutinib) were also behind the growth, somewhat countering the 0.6% drop in consumer sales, to $3.6 billion, compared to the same period the year before. The company said overall third-quarter sales were $18.5 billion, up 5% compared to the same period last year.

 

 

Despite the jump in prescription sales, Olysio's $796-million contribution may not be one the company can depend on. Goldman Sachs analyst Jami Rubin wrote in a Tuesday research note that although Olysio is a high-margin, low-cost product for the drugmaker, Gilead's just-approved Harvoni could mean a “steep decline for Olysio” because of price: Gilead's Harvoni is expected to cost around $94,500 for a 12-week regimen, whereas an Olysio-Sovaldi regimen would cost $150,000 for a three-month treatment. Rubin wrote in a second research note that the Harvoni approval probably means J&J will have to “focus their efforts on certain subsets of the [hepatitis C] population as they will not be able to compete with an 8-week Harvoni regimen for treatment-naïve patients.”

 

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Gilead's (Too?) Clever Deal to Sell Sovaldi in Poor Countries

Gilead's (Too?) Clever Deal to Sell Sovaldi in Poor Countries | Pharmaguy's Insights Into Drug Industry News | Scoop.it
In a bid to forestall criticism over the price of its expensive Sovaldi hepatitis C treatment, Gilead Sciences has reached licensing deals with seven large generic drug makers based in India to sell lower-cost versions in 91 developing countries.


The 91 countries covered by the deal – including Egypt, Vietnam, India and many countries in Africa – have a per capita income of nearly $1,900 and account for about 54 percent of those with hepatitis C, according to Knowledge Ecology International, a non-profit that tracks drug access and patents.


Nonetheless, more than three dozen patient advocacy groups say the licensing deals do not go far enough, because the deals excludes many middle-income countries – such as Brazil, China, Turkey, Thailand and Ukraine – where governments and individuals may not be able to afford the Gilead drug.


The patient groups are concerned the licenses will preclude the generic drug makers from selling lower-cost versions to those countries and potentially excluding millions of patients with hepatitis C from gaining access to treatment. For this reason, Doctors Without Borders says the deal “falls short.”


Tamir Ahin of the Initiative for Medicines, Access & Knowledge says this is designed to thwart generic competition in middle-income countries, since the deal involves some of the largest generic suppliers in the world. “In one fell swoop, Gilead has locked up the main competition” for generics.


Pharma Guy's insight:


These are the type of deals that sound good on the surface, but when you dig deeper you discover they tend to benefit the drug company more than patients.

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How Much? Gilead Will Charge $900 for Sovaldi in India

How Much? Gilead Will Charge $900 for Sovaldi in India | Pharmaguy's Insights Into Drug Industry News | Scoop.it
India has become the latest country where the Sovaldi hepatitis C treatment will be offered for $900 per patient. The move, which was reported by The Times of India, comes a few weeks after the manufacturer, Gilead Sciences, is making the medication available for the same price in Egypt.


The pricing reflects an effort by Gilead to forestall the sort of criticism the pharmaceutical industry has often encountered when selling life-saving medicines in poorer countries, which have often complained bitterly that many of its citizens have been unable to afford some treatments.

Pharma Guy's insight:


Some interesting comments to this post are reproduced below,


Commenter #1 believes drug companies charge more for drugs in the U.S. to offset the losses of selling the same drugs for MUCH less money in  foreign countries. It's an interesting twist on pharma's rationale that they charge high prices to recoup research investment (see commenters #2 & #3):


Commenter #1: "In fact the price you pay for drugs in the US is to cover the subsidizing of these other countries (which include the poor countries of Canada, the UK, Netherlands, Denmark). Only way they can do this is someone has to pay and it is us….. I do not blame the drug companies (like most of you do). They have to make money and if they lose money selling it in these other countries, they have to make money somewhere."


Commenter #2: "New chemical entities are enormously expensive to develop and innovation is expensive. R&D must be paid back and more. Otherwise, the is little reason to invest the great sums needed.
That said, Gilead seems to be shooting itself in the foot with great expertise. While this drug, in particular, really is cost-effective at the US price, the PR has been badly done."


Commenter #3: " Gilead did NO RESEARCH, bought Sovaldi maker company for $11B instead of spending money to develop their own. Acquired PHARMASSET patent and is holding up patients in highway robbery to pay ransom for the drug made with John Hopkins research mostly at taxpayer expense"


Here's my analysis of recouping the costs of bringing Sovaldi to market: Gilead has racked up $5 billion in Sovaldi sales in the first half of 2014. According to a JAMA viewpoint article, it may have cost Gilead $11 billion to "develop" Sovaldi - this is based on the price Gilead paid to acquire Pharmasset, which discovered and initially tested Sovaldi. If all of the approximately 3.6 million Hep C patients with chronic liver disease in the United States were treated with Sovaldi at current prices, Gilead would net more than $300 billion dollars, or better than a 27-to-1 return on its investment, "suggesting that pricing is inappropriately high."

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Many Hep C Patients Who Really Need Sovaldi Are Not Getting It

Many Hep C Patients Who Really Need Sovaldi Are Not Getting It | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While Congress and payors have been quick to sermonize Gilead on the price of Sovaldi, the Foster City, CA, drugmaker's earnings report suggests those lectures have fallen on deaf ears, and have done little to keep the drug off formularies or slow down its sales.


For the second quarter of 2014, Gilead's total product sales in the US were slightly over $4.8 billion—Sovaldi total sales reached $3.4 billion with $3 billion in the US alone—meaning nearly three-quarters of the drugmaker's domestic revenue comes from that one, thousand-dollar pill. Gilead estimates that 9,000 Sovaldi patients have been cured of hepatitis C—a total they believe will grow rapidly as the drug gains traction.


Physician penetration, too, proved strong. Seventy percent of targeted doctors have written a script for Sovaldi, according to the drugmaker. As a comparison, Biogen's blockbuster MS pill Tecfidera saw 62% penetration after launch.


Despite AHIP (American Health Insurance Plans) calling for the drugmaker to lower the price, and Kaiser Permanente calling the price “outrageous,” only three states are currently not covering Sovaldi, and of those remaining 47 states half require prior authorization and half require a certain level of fibrosis (i.e. liver damage).


However, of the patients treated so far, 60% had “low fibrosis scores,” Schoenebaum wrote, which could signal that the hard-to-treat patient is still a pressing unmet need.


Also of note was how, and to whom, the drug has been prescribed. Sixty percent of patients treated had genotype 1 (the most common subset of the disease), and 70% of usage was for interferon-free regimens, including combination with J&J's Olysio.

Pharma Guy's insight:


Aside from who gets Sovaldi and who doesn't, Gilead is claiming that 9,000 patients have been "cured," which means "a fully suppressed viral load." Remember the baby who was supposedly "cured" of HIV because no viruses could be detected? What if the same thing happens for Hep C patients who are "cured" by Sovaldi? Will they have to undergo another $84,000 round of treatment with the drug? I don't think the clinical trail was designed to detect that scenario. Only use in the real world will answer my question.

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