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's Harvoni Ads Ramp Up the "Cure" Message

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

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


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”;
  • “!
  • “Will Gilead’s Hep C Sales Implode or Just Hit Equilibrium?";
  • “NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C”;
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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Gilead's Investors Shed Croc Tears Despite a 69% Profit Margin for Q1 2016

Gilead's Investors Shed Croc Tears Despite a 69% Profit Margin for Q1 2016 | Pharmaguy's Insights Into Drug Industry News |

The drugmaker Gilead Sciences has seen its fortunes buoyed by its blockbuster hepatitis C drugs in the last two years. But that cash flow is slowing down — and it’s hitting the company’s bottom line.


Combined sales for the powerful drugs, sold as Sovaldi and Harvoni, were $4.3 billion in the first quarter of this year, missing the average analysts’ estimate by nearly $300 million and falling $600 million below the previous quarter, Gilead reported on Thursday. That helped drive a lower-than-expected profit margin for the company.


The company has said it expects its US sales of its hepatitis C drugs to flatten this year.


The high prices of Sovaldi and Harvoni have made the drugs flash points in the public and political uproar over drug prices. The medications are priced at $84,000 and $94,500, respectively, for a full course of treatment, though patients and their insurers generally pay far less thanks to negotiated discounts.


With revenue from the hepatitis C drugs slowing, some investors are clamoring for Gilead to strike new deals. Earlier this month the company said it would pay $400 million for a drug from Nimbus Therapeutics to treat fatty liver disease. CEO John Milligan said it’s open to doing more.


“We are actively assessing options,” he said, “and we will make moves when the right opportunities present themselves.”

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Harvoni TV Commercial Suggests Patients Do Not Want to Wait for Cheaper Competing Drugs

Gilead's "Ready" theme is meant to encourage "diagnosed patients who are ready to seek treatment and ready to be cured" to talk to their doctors, David Johnson, Gilead VP, U.S. sales and marketing for liver diseases, said.


It's also a nod to many hep C patients who've been told by healthcare providers to hang on for new drug developments--or forced by insurers to wait until symptoms worsen.


"We believe we have a responsibility to let people living with HCV know there may be a cure available to them," Johnson said. "The campaign is designed to improve awareness of this advancement, encourage patients with HCV to connect with a qualified health care provider, and support a better conversation between patient and provider to increase patients' understanding of their disease and explore treatment options."

Pharma Guy's insight:

"I don't want to live with the uncertainties of Hep C," says the opening voice over. "I wonder if I should seek treatment," says one patient. "I am ready," says another. The ad ends with the phrase "The ONE you've been waiting for."


The ad mentions "cure" in large font-size text and audio several times, but points out in small type (not audio), "Cure means no virus detected in blood 3 months after treatment ends."


I wonder, however, are there any data about detection AFTER 3 months, or hasn't Harvoni been on the market that long?


Note that the NIH is leading a Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C; Unfortunately, by the time that study is complete, the Harvoni sales cycle will have ended.

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Drug Spending Surged 13% in 2014: Specialty Drugs Accounted for 32% of the Overall Spend

U.S. prescription drug spending shot up 13.1% last year, according to a new report from Express Scripts ($ESRX). And the vocal price critic says it knows just who's to blame.

The pharmacy benefits manager pinned the leap on a new group of ultrapricey hepatitis C meds, led by Gilead's ($GILD) Sovaldi and Harvoni. Those treatments helped specialty drugs--which account for only 1% of all prescriptions countrywide--put up 31.8% of 2014's overall drug spend. They also took hep C spending up by 742.6% from 2013


The numbers apply to commercially insured patients, where spending per member per year amounted to $979.96 in 2014. Of that amount, $668.75 went to pay for traditional meds, while the rest--$311.11--paid for specialty drugs. More patients used specialty meds in 2014 compared with the previous year, the report says, but most of the increase came from higher prices. Price-wise, mainstream drugs went up 6.5%, the PBM says. Specialty drug prices leapt by 25.2%.

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End of Winter Sale: Half Off Sovaldi & Harvoni, Gilead's Hepatitis C Drugs

Gilead Sciences, the maker of Sovaldi® and Harvoni®, two of the highly-effective but expensive new drugs for hepatitis C infection, recently announced that in 2015 it expects to give an average discount of 46% off the original list prices of these drugs.  This discount would produce an average price of approximately $40,000 for a course of treatment with Harvoni, assuming two-thirds of patients can benefit from a shorter 8-week regimen.  At this price, not only does Harvoni (or comparable treatment options) represent a high value in the care of individual patients, but its likely budget impact across broader patient populations will meet the threshold at which the California Technology Assessment Forum (CTAF) would identify it as a "high value" for most health care systems.   

The announcement of steep price discounts follows a brief period of intense negotiations between Gilead and insurance companies following the FDA approval of a rival drug treatment, Viekira Pak®, made by AbbVie.  At its meeting on December 18, 2014, the independent review panel of CTAF [a core program of the Institute for Clinical and Economic Review (ICER)] voted that the evidence was insufficient to distinguish between the clinical effectiveness of the Gilead and AbbVie drug regimens, both of which have demonstrated hepatitis C viral clearance in over 90% of patients treated.  At the time of the CTAF meeting, the AbbVie drug was not yet FDA approved and did not have a list price, but the CTAF panel voted that Harvoni, with a list price of about $95,000 for a 12-week course of treatment, represented a "low" health system value on the basis of its potential to push up state Medicaid costs by over 5% in a single year if all patients with known infections were treated.  


The CTAF panel vote was informed by a drug pricing analysis performed by researchers at the University of California at San Francisco and ICER that suggested that a price range for Harvoni - or any other comparably effective drug regimen - of $34,000-$42,000 for an average course of therapy would serve as a benchmark for keeping health system cost increases below a threshold of 0.5%-1.0%.  The ICER report notes that this threshold budget impact for a single new treatment is viewed by many payers as manageable without resorting to severe treatment delays or cuts in other services.

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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 |

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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Report questions safety of the newest hepatitis C drugs

Report questions safety of the newest hepatitis C drugs | Pharmaguy's Insights Into Drug Industry News |

Over the past few years, billions of dollars have been spent on new hepatitis C medicines because they could eliminate the virus in 90 percent or more of patients. But a new report ( finds that hundreds of cases of liver failure were associated with the drugs, and the authors suggest that regulators may have been too quick to embrace the treatments as a panacea.


Specifically, 524 cases of liver failure were found, along with another 1,058 reports of severe liver injury, according to side effects reports that were filed with the US Food and Drug Administration and reviewed by the Institute for Safe Medicine Practices. The nonprofit group also noted 761 instances in which the reported side effect was a failure of the medicines to combat the virus. The report arrives just three months after the FDA issued a warning that the drugs could reactivate hepatitis B.


…The study authors maintain their findings should be seen as a warning about the “negative consequences” of the drugs. The medicines “should be ranked as a major medical advance, [but] the large number of cases of liver failure and death, as well as antiviral failure, show the need for further investigation of the serious adverse effects of this expensive new class of drugs.”


Indeed, the latest generation of hepatitis C treatments has been revolutionary, offering a desirable combination of high cure rates and manageable side effects. They include the Sovaldi and Harvoni treatments sold by Gilead Sciences. But the drugs come at a cost, literally. List prices range from $54,600 to $94,500, depending upon dosing and regimens, although these do not reflect rebates or discounts.


Spending per patient has ranged from $55,000 to $125,000 per patient, according to the ISMP report, citing data from QuintilesIMS, and about 250,000 patients were treated in 2015. The study authors noted that list-price spending for the drugs exceeded similar spending for antibiotics, and cholesterol and blood pressure drugs, each with patient populations measured in tens of millions.


“These new data raise more questions than they resolve about the adverse effects of direct-acting antiviral drugs…. The FDA and pharmaceutical companies were also overoptimistic in labeling as a ‘cure’ the results of a laboratory assay at 12 weeks indicating undetectable levels” of the virus.


“This is an example of the price we pay for faster drug approval with reduced clinical testing,” said Thomas Moore, a senior scientist at ISMP and one of the study authors. “Don’t we really want to know more than this about a new drug treatment on which we spent more than $10 billion to $20 billion in 2015 alone? We spent more than twice as much on these direct-acting antivirals for about 250,000 patients as the NIH did on all research into all infectious diseases in one year.”


Not everyone is convinced, however, that the report should alter medical practice.


More here…


Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”;
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. Now, in addition, there are serious side effects associated with these drugs.

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Harvoni: Huge Price Tag, Huge DTC Ad Spend, Flat Sales 

Harvoni: Huge Price Tag, Huge DTC Ad Spend, Flat Sales  | Pharmaguy's Insights Into Drug Industry News |

A $100 million ad blitz has whipped up patient demand for Harvoni, the $1,100-a-pill hepatitis C treatment, even as the drug’s price has drawn a barrage of lawsuits, state investigations, and sharp condemnation from members of Congress.


Like most drug advertisers, Gilead last year devoted the majority of its TV ad dollars for Harvoni to the big broadcast networks ABC, NBC, CBS, and FOX — which draw increasingly aging viewers, including baby boomers between the ages of about 50 to 70, who are five times more likely than other adults to have hepatitis C.

Harvoni ads also target more niche audiences. Consider the $600,000 worth of Harvoni ads last year in the magazine of the American Association of Retired Persons. Or the $3 million Gilead spent advertising on Black Entertainment Television and in Ebony magazine — which makes sense given that African-American baby boomers are twice as likely as others in that age group to have hepatitis C.

Men are also disproportionately likely to have hep C, which may explain Gilead’s investment last year in a collective $13 million worth of ads on ESPN and the Golf Channel and in Sports Illustrated and Men’s Journal.

Gilead is wooing patients directly at a time when both private insurers and Medicaid programs are balking at the high price of Harvoni. In some cases, they’re only agreeing to pay for treatment for the sickest patients, leaving those with relatively healthy livers unable to get treated. Other insurers will only pay for a competitor’s lower-priced drug.

Doctors, too, have proved a barrier; some are encouraging patients to hold out for cheaper therapies.

“A lot of physicians are taking a wait-and-see attitude,” said John Mack, who publishes Pharma Marketing News. As a result, he said, Gilead is going directly to patients, trying to “push them” into talking with their doctors and requesting the medication by name.

Dieterich, of Mount Sinai Hospital, said that physicians sometimes have to “do a little fast-talking” to reassure patients that other medications can work just as well as the brand-name drug they’ve seen so often on TV. Competing hepatitis C drugs Viekira Pak and Zepatier aren’t being advertised, so Gilead has the field to itself.

“We’re battling their successful direct-to-consumer advertising,” Dieterich said.

Gilead has said it’s expecting sales from Sovaldi and Harvoni to flatten this year, but the ads may well continue.

Pharma Guy's insight:

Gilead's "Ready" DTC advertising theme is meant to encourage "diagnosed patients who are ready to seek treatment and ready to be cured" to talk to their doctors, David Johnson, Gilead VP, U.S. sales and marketing for liver diseases, said.


The ads feature "cure" in large font-size text and audio several times, but points out in small type (not audio), "Cure means no virus detected in blood 3 months after treatment ends."


I wonder, however, are there any data about detection AFTER 3 months? Note that the NIH is leading a Study to Assess Long-Term (10 years) Outcome of Harvoni for Treatment of Hep-C; Unfortunately, by the time that study is complete, the Harvoni sales cycle will have ended.

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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 |
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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NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C

NIH-led Study to Assess Long-Term Outcome of Harvoni for Treatment of Hep-C | Pharmaguy's Insights Into Drug Industry News |

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.

The study, called ASCEND, is co-sponsored by the NIH’s Clinical Center and National Institute of Allergy and Infectious Diseases (NIAID), with additional support from the NIH Office of AIDS Research. The study is being conducted as part of the D.C. Partnership for HIV/AIDS Progress, a program that aims to reduce the burden of HIV/AIDS and associated diseases, such as hepatitis C, in the District of Columbia.

More than 3 million people in the United States are infected with HCV. If left untreated, the infection can lead to cirrhosis (liver scarring), liver cancer and eventual liver failure. Chronic HCV infections contribute to thousands of deaths each year, and hepatitis C is a leading cause of death for people co-infected with HIV. In the United States, hepatitis C infection is largely centered in urban areas and disproportionately affects minority, low-income and marginalized populations, such as the homeless and people who inject drugs.

In the past, hepatitis C treatment involved long-term use of oral and injectable medications, some of which had unpleasant side effects, including flu-like symptoms and depression. Because of the complexity of these regimens, hepatitis C treatment has largely been provided by specialist physicians, such as infectious disease specialists and hepatologists. New oral direct-acting antiviral drugs may offer more effective, shorter-duration, curative treatments. In October 2014, the U.S. Food and Drug Administration approved a new, once-daily antiviral drug for treatment of hepatitis C infection that combines ledipasvir and sofosbuvir (trade name Harvoni). Gilead Sciences, based in Foster City, California, manufactures the drug and is providing it free-of-charge for use in the ASCEND study.

“The recent advent of direct-acting antiviral medications has offered promising new treatment options for people who are chronically infected with hepatitis C,” said NIAID Director Anthony S. Fauci, M.D. “These therapies have yielded high cure rates in clinical trials led by specialized care teams. The ASCEND study will help determine whether these medications are similarly effective when administered in an urban, community-based setting.”

Pharma Guy's insight:

This study will monitor patients over a 10-year period for short-term and long-term treatment outcomes, including viral response to the drug and evidence of liver damage. That will answer my question about the true effectiveness of these drugs; i.e., whether they actually "cure" Hep C over the long term as implied by the advertising and social media hype. 

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According to @matthewherper "Me Too" Drugs Essential for Lower Drug Prices

According to @matthewherper "Me Too" Drugs Essential for Lower Drug Prices | Pharmaguy's Insights Into Drug Industry News |

 For biotech investors, the news that AbbVie has cut a deal with Express Scripts to sell its new hepatitis C treatment, the Viekira Pak, at a significant and undisclosed discount to its $83,319 seems nothing short of disaster. It means that Gilead Pharmaceuticals will have to compete on price, not just efficacy with its $84,000-per course Sovaldi and $95,000 Harvoni (they are inarguably better drugs). As Adam Feuerstein at The Street points out, that could put limits on the incredible pricing power that is fueling the biotech boom.

But there is another, longer view on this news: this is a reminder of the way the pharmaceutical market has always worked and of the importance of me-too drugs, which have been heavily criticized as proof that drug companies are not innovative, in controlling prices. In areas outside cancer and rare diseases, this is how the pharmaceutical market has always been. It’s not an out-and-out disaster for Gilead, which still has the first and best drug in what could be one of the modern era’s biggest pharmaceutical markets. But it shows that there is price competition pharma, and that is a good thing. Drug prices are too high, and they are rising too fast, and it would be best for everyone if we can find a free-market solution for fixing that problem. This is exactly that.

But today Express Scripts announced that it had made a deal with AbbVie to sell Viekira Pak exclusively [ESRX now says: "Harvoni will be available to those who fail Viekira"]. Twenty-five million patients on its plans will not be able to get Sovaldi at all, and will have to use Viekira. In return, AbbVie is going to pay a huge rebate. The move will probably cause negotiations with other plans, and Gilead may have to offer rebates too.

Patients may protest loudly enough that health plans will opt out of Express Scripts’ decision. For many, taking Viekira instead of Harvoni will mean taking many more pills, taking ribavirin, and being on medicine for another month. Those aren’t minor concerns.

Pharma Guy's insight:

I'm not sure Viekira qualifies as a "Me Too" drug in the classic sense - at least compared to Harvoni. It's difficult to say that one biologic has a nearly identical chemical composition as another, which is typical of me too drugs. Plus, as Herper points out, Viekira must be taken with ribavirin, whereas Harvoni includes that in a single dose. 

The real travesty of "me too" drugs is when a new Rx brand drug is introduced to compete with an older nearly identical cheaper generic version of the drug. A case in point is LOVAZA, which is an Rx drug that is a "me-too" of existing over-the-counter dietary supplements. I am talking about LOVAZA, aka omega-3-acid esters approved by the FDA for the treatment of high triglycerides. Is LOVAZA different than the OTC (over-the-counter) product I have in my kitchen cabinet? (Read more about that here).

At least LOVAZA is more convenient than the cheaper drug. It seems that Viekira does not compete on the convenience level with Harvoni. I expect to see this as a major message in future Harvoni DTC ads.

NOTE: Herper points out an interesting factoid: More relatively healthy patients are getting Sovaldi than very sick ones. "Insurers did very little to restrict Sovaldi to the patients who were most likely to lose liver function as a result of the virus. The severity of a patient’s liver disease is measured by a fibrosis score of between F1 (least severe) and F4 (most severe). As of June 2014, 60% of the patients getting Sovaldi had fibrosis scores of F1 or F2, according to investment bank Evercore ISI."

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