Gilead's Sovaldi -Getting a drug company to cut its price is harder than it sounds

One Of Pharma's Biggest Enemies Goes After The Future's Best-Selling Drug

Matthew Herper 
 Forbes Staff

Getting a drug company to cut its price is harder than it sounds. Haines spoke on a conference call with ISI clients Friday about Waxman’s probable intent of embarrassing regulators. The Food and Drug Administration rushed to approve Sovaldi, the argument goes, and then Gilead goes and charges $84,000 per patient?

 And Gilead, when it’s already going to be bringing in billions of dollars a quarter, would be foolish to simply back down, not matter how intense the criticism....

Except that the stakes here are actually even higher. Sovaldi is a potent drug by itself, but the real excitement is about using it as part of an all-oral single-pill combination that would cure hepatitis C patients without interferon and ribavirin. Analysts have speculated that such a pill could cost $100,000 per patient.

Continue reading @ Forbes

EASL - Merck To Present New Data for MK-8742 and MK-5172

Merck's new PhIII hep C program may help repair a damaged R&D rep

March 25, 2014 | By John Carroll

 In a matter of weeks Merck plans to move a closely-watched combination treatment for hepatitis C into a Phase III trial. The move will boost Merck's late-stage pipeline to 13 programs, giving new R&D chief Roger Perlmutter some additional evidence to back up a case that the leviathan outfit has finally shaken off the lethargy that led to a years-long drought of significant approvals, focusing on pioneering therapies that can carve out badly needed revenue.

Merck announced the move as it prepared to unveil a new round of high cure rates found among genotype 1 patients taking a combination of MK-5172 and MK-8742, a pair of drugs that the FDA picked for its breakthrough drug program, offering a potentially shorter path to the market.
"These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV," said Dr. Eliav Barr, the vice president for infectious disease at Merck Research Laboratories, in a statement. "Based on these data, we are pursuing a Phase III clinical program for these potentially important investigational medicines.........

Read more......

Merck to Present New Data for Investigational Hepatitis C Treatments MK-5172 and MK-8742 at EASL Annual Meeting/The International Liver Congress™ 2014

Company to Initiate Phase 3 Clinical Development Program in Q2 2014

Read more here: http://www.heraldonline.com/2014/03/24/5798673/merck-to-present-new-data-for.html?sp=/100/773/385/#storylink=cpy

WHITEHOUSE STATION, N.J. — Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new Phase 2 data for its two investigational hepatitis C virus (HCV) treatments - MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor – are scheduled to be presented at the 49^th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress™ 2014. The data are from Merck’s overall Phase 2 clinical program. The meeting will take place in London, United Kingdom, April 9 - 13, 2014.

Based on the results of the Phase 2 program, Merck is initiating a Phase 3 clinical trial program, to be named C-EDGE. The C-EDGE program is designed to evaluate these investigational treatments across genotypes and in different HCV subpopulations, including patients with chronic kidney disease, HIV/HCV co-infection, and cirrhosis.

“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV,” said Dr. Eliav Barr, vice president, Infectious Disease, Merck Research Laboratories. “Based on these data, we are pursuing a Phase 3 clinical program for these potentially important investigational medicines.”
In October 2013, Merck announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the investigational combination MK-5172/MK-8742 for treatment of chronic HCV infection.

Selected Presentations for MK-5172/MK-8742:

• Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C Genotype 1 Infected Patients with Cirrhosis or Previous Null-Response: The C-WORTHY Study. Lawitz, E. et al. Oral presentation #O61: April 11, 2014, 4:00-4:15 p.m. BST.
• Efficacy and Safety of the All-Oral Regimen, MK-5172/MK-8742 ± RBV for 12 Weeks in GT1 HCV/HIV Co-infected Patients: The C-WORTHY Study. Sulkowski, M. et al. Oral presentation #O63: April 11, 2014, 4:30-4:45 p.m. BST.
• Safety and Efficacy of the All-Oral Regimen of MK-5172/MK-8742 ± Ribavirin in Treatment-naïve, Non-cirrhotic Patients with Hepatitis C Virus Genotype 1 Infection: The C-WORTHY Study. Hezode, C et al. Oral Presentation #O10: April 10, 2014, 4:45-5:00 p.m. BST.

Merck’s Commitment to HCV
For more than 25 years, Merck has been at the forefront of the response to the HCV epidemic, and has helped to make a difference through our proud legacy of commitment to innovation, collaborating with the community, and expanding global access to medicines. Merck is dedicated to applying our scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HCV worldwide.

Read more here: http://www.heraldonline.com/2014/03/24/5798673/merck-to-present-new-data-for.html?sp=/100/773/385/#storylink=cpy

Hepatitis C- Gilead offers Egypt Sofosbuvir at 99 percent discount

Gilead offers Egypt new hepatitis C drug at 99 percent discount

By Maggie Fick and Ben Hirschler

CAIRO/LONDON Sat Mar 22, 2014 1:40am

(Reuters) - Gilead Sciences, facing mounting criticism over the high price of its new hepatitis C pill Sovaldi, has offered to supply the medicine to Egypt at a 99 percent discount to the U.S. price.

While the drug will still cost $900 for a 12-week course of treatment, that is a fraction of the $84,000 charged for a course of treatment in the United States.

The high price tag in America prompted questions from U.S. lawmakers on Friday, after U.S. health insurers said they were seeking help from state health officials to foot the bill.

Gilead said it was "pleased to have finalized an agreement" for the introduction of Sovaldi in Egypt, which has the highest prevalence rate of hepatitis C in the world.

"We believe Sovaldi could have a major impact on public health in Egypt by significantly increasing the number of people who can be cured of hepatitis C," Gregg Alton, head of corporate and medical affairs at Gilead, said in an emailed statement.

Egyptian health minister Adel El-Adawi said Cairo had struck a deal with U.S.-based Gilead for the government to buy Sovaldi for $300 for a one-month box, according to a recent report on the state news agency MENA.

That would imply a cost of $900 if Sovaldi is used as part of a 12-week drug regimen, although the cost would be higher if it was used for 24 weeks, which is also an option based on different drug combinations.

El-Adawi said Gilead's offer would apply to Sovaldi supplies used in government clinics, adding that access programmes would start in the second half of 2014, following completion of registration procedures in Egypt.

Sovaldi is in the vanguard of a wave of pills which could cure the liver-destroying disease in millions of people worldwide, or even eradicate it entirely. But that will only happen if the new therapies are affordable enough to allow widespread use.

Nowhere is the problem more acute than in Egypt, which has the world's highest prevalence of the virus, following the use of poorly sterilized needles in campaigns dating back to the 1970s to stamp out the parasitic disease schistosomiasis.

Like HIV, hepatitis C (HCV) can be spread through blood, often via contaminated needles.

The World Health Organization estimates that more than 150 million people worldwide are chronically infected, most of them in developing countries, putting them at risk of cirrhosis and liver cancer.

Other companies such as Johnson & Johnson, AbbVie, Bristol-Myers Squibb and Merck & Co are also developing oral treatment regimens for HCV that have shown dramatic results in clinical trials, while reducing the need for debilitating interferon injections.

Doctors and industry analysts believe the new drugs will transform HCV treatment - and prove hugely profitable. In the developed world, they are tipped to become major blockbusters, with consensus sales forecasts for Sovaldi alone standing at $9.1 billion in 2017, according to Thomson Reuters Pharma.

But the risk of a gulf in access between patients in the rich and poor parts of the world is causing alarm among health campaigners who warn of a potential re-run of the battle over HIV drugs in Africa more than a decade ago.

Medecins du Monde, a non-profit group that provides medical care around the world, highlighted Egypt as a country in dire need of the new hepatitis C drugs in a report this week.

Gilead has also said it plans to license Sovaldi to a number of Indian generic pharmaceutical manufacturers, which would be able to sell lower-priced copies of the medication.

(Additional reporting by Deena Beasley; Editing by James Dalgleish)

Source - (Reuters)

WellPoint says new hepatitis c drug prices are too high

 WellPoint says new hepatitis c drug prices are too high

(Reuters) - The head of WellPoint Inc's commercial business said on Friday that the price of new hepatitis c drugs, which are made by Gilead Sciences Inc and Johnson and Johnson, are too high.

Ken Goulet, speaking to investors, said the company is working with regulators and drug manufacturers to bring these prices down to a "reasonable" level.

He said that as of mid-February the company had filled 100 prescriptions for commercial members.

On the Medicaid side of the business, WellPoint said that it is working with states on trying to determine how to proceed with either figuring out a managed care cost for the drug or excluding the drug from the managed care plans.

 (Reporting by Caroline Humer, Editing by Franklin Paul)

Related: 
Gilead offers Egypt new hepatitis C drug at 99 percent discount

By Maggie Fick and Ben Hirschler

CAIRO/LONDON Sat Mar 22, 2014 1:40am

(Reuters) - Gilead Sciences, facing mounting criticism over the high price of its new hepatitis C pill Sovaldi, has offered to supply the medicine to Egypt at a 99 percent discount to the U.S. price.
Continue reading.......

Gilead-Democratic Leaders Request Briefing on Hepatitis C Drug Pricing
Today Ranking Member Henry A. Waxman, Health Subcommittee Ranking Member Frank Pallone, Jr., and Oversight and Investigations Subcommittee Ranking Member Diana DeGette sent a letter to Gilead Sciences Inc. Chief Executive Officer John C. Martin to request a briefing on pricing of the company's recently approved Hepatitis C drug, Sovaldi.

Gilead-Democratic Leaders Request Briefing on Hepatitis C Drug Pricing

Democratic Leaders Request Briefing by Gilead on Hepatitis C Drug Pricing

Today Ranking Member Henry A. Waxman, Health Subcommittee Ranking Member Frank Pallone, Jr., and Oversight and Investigations Subcommittee Ranking Member Diana DeGette sent a letter to Gilead Sciences Inc. Chief Executive Officer John C. Martin to request a briefing on pricing of the company's recently approved Hepatitis C drug, Sovaldi.

WASHINGTON, March 20 -- The Ranking Democratic Member of the House Energy and Commerce Committee issued the following news release:

Today Ranking Member Henry A. Waxman, Health Subcommittee Ranking Member Frank Pallone, Jr., and Oversight and Investigations Subcommittee Ranking Member Diana DeGette sent a letter to Gilead Sciences Inc. Chief Executive Officer John C. Martin to request a briefing on pricing of the company's recently approved Hepatitis C drug, Sovaldi. Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment, which will affect coverage for patients with public or private insurance.

FDA approved Sovaldi in December 2013 after the drug received an FDA Priority Review and Breakthrough Therapy designation, which is intended to expedite review of drugs for serious or life-threatening conditions.

March 20, 2014
The full text of the letter is available online here
(http://democrats.energycommerce.house.gov/sites/default/files/documents/Martin-Gilead-Sciences-Hepatitis-C-Drug-Sovaldi-Pricing-2014-3-20.pdf). 

Investment Commentary 

Elsewhere - Seeking Alpha

Gilead Is An Avoid

Mar. 21, 2014 2:04 PM ET  |  About: GILD, Includes: IBB 

By Thomas H. kee Jr. 

Summary

• Biotech was in play on Friday.
• Political Pricing Pressure in GILD was the cause.
• There are no reasons to buy GILD here.

Of course, political pressures are the heavy hand in this sector, The House sent Gilead a letter to that effect on Thursday, and when the government pays the bills the benefit of capitalism, innovation, often gets hampered, but that cannot and must not distract investors from what makes them money. As far as I am concerned, price makes us money, not news, Government decisions, or anything else. In this case, the government is making a very obvious decision.

 In summary, the letter sent to Gilead from the House of Representatives on Thursday suggests the $84,000 per treatment proposed cost of its Hepatitis C vaccine, Sovaldi, and the more probable $150,000 per treatment cost imposed by combination therapies offered by physicians, would not be affordable by most of the persons diagnosed with Hep-C because those are typically lower income demographics. In addition, and what was not as direct, the letter suggested that the Government, who would ultimately have to pay that bill, was not willing to pay what Gilead was asking. In no uncertain terms, the Government is doing everything in their power to reduce the cost per treatment, and if they are successful as they probably will be, the revenues from this seemingly successful vaccine will come down considerably from that $84,000 estimate. We do not yet know by how much.....
Continue..... 

Related: Costly New Hepatitis C Drug Raises Questions About Who Will Pay
New hepatitis C medication presents a dilemma for Medicaid and other insurers, who must balance the cost against the large numbers of people who might benefit. The $84,000 cost for the cure over 12 weeks, the most expensive medicine for the disease, has states from Pennsylvania to Colorado limiting its use to only the sickest patients, according to health officials and private insurers that manage care for Medicaid programs.

Hepatitis C-Two-Drug Combo Sovaldi Plus Olysio: Free for Needy Travis County Residents

TEXAS: Getting Free Hepatitis C Drugs a Boon for Needy Travis County Residents
By Mary Ann Roser

The companies that make expensive but highly effective hepatitis C drugs are offering the new treatments for free or nearly free to eligible patients who need help.

The usual 12-week course of treatment costs $84,000 for Sovaldi and $66,000 for Olysio, a total of $150,000. Patient advocates, private insurers and organizations that provide drugs through publicly funded programs, such as Medicaid and the Veterans Health Administration, have raised concerns about those costs.

But officials with the two companies, Sovaldi maker Gilead Sciences and Olysio maker Janssen Therapeutics, said they have assistance programs for people with insurance - and without - who need the drugs, which can be taken together or with other drugs. Sovaldi said it provides the drug for free to eligible patients who lack health insurance and have annual incomes below $100,000 for a family of up to three or earnings that are at or below 500 percent of the federal poverty level.

Among the organizations helping patients tap into the companies' patient assistance programs is Travis County's taxpayer-supported CommUnityCare, which operates a network of 23 health centers.

A new clinic for hepatitis C patients that relies on the drug assistance programs opened March 3 at the system's North Central Health Center at 1210 W. Braker Lane. That clinic is using the two-drug combination treatment and expects to initially help "hundreds" of uninsured patients obtain the drugs, said Sarah Cook, Central Health's Medicaid waiver director. The clinic saw 38 patients in its first seven days.

"It's an incredible game-changer," Cook said.

For this year, Central Health, which oversees CommUnityCare, is contributing $370,000 to pay for clinic staff led by Dr. Imtiaz Alam, medical director of the Austin Hepatitis Center, Cook said. Alam is at the clinic on Mondays and Tuesdays and works with nurses and other providers who take care of patients throughout the week. Eventually, hepatitis C clinic services are expected to also be offered at the Southeast Health & Wellness Center, which CommUnityCare expects to open at 2901 Montopolis Drive in October.

Before the hepatitis C clinic opened at North Central, some patients had to wait a year to see a CommUnityCare doctor, says a document Cook provided. About 6,500 CommUnityCare patients are affected by hepatitis C, Alam said.

More than 3 million Americans have chronic hepatitis C infection, which can cause cirrhosis and liver cancer. It is generally transmitted through blood and can be deadly. Many people don't know they're infected, prompting the U.S. Centers for Disease Control and Prevention to recommend screening for anyone born between 1945 and 1965.

Alam said he is asking the state of Texas Medicaid to put Sovaldi and Olysio on its formulary. "I believe these new medications are well worth their cost and their utilization will have a positive impact in reduction of future health care costs with fewer long-term liver disease complications," he wrote in an email. Dr. William Lee, a professor of internal medicine who is doing clinical trials on new hepatitis C drugs at the University of Texas Southwestern Medical Center in Dallas, expects a single-dose pill to come out later this year. He does not yet know how much it will cost but hopes that the marketplace eventually brings down the costs of new hepatitis drugs.

He believes the drugs he is testing have potential to be as effective or more effective than Sovaldi and Olysio. "I think what's coming around the corner is competition," Lee said.

Hepatitis C "takes a big chunk out of your life and out of your wallet," said Annalyn Earley, 62, of Austin. She is one of Alam's patients and is covered by an insurance program in Texas for people with costly pre-existing illnesses. Earley, who is transitioning to Obamacare, said she was infected by a blood transfusion after a car accident at age 25.

She takes a single dose of Sovaldi and of Olysio daily and says the change from her old drug regimen, known for its debilitating side effects, is "like day and night."

"I feel wonderful," Earley said. "I feel like I lost everything to this disease and now I'm going to get my life back."
 
http://www.aegis.org/DisplayContent/?sectionID=381011
http://www.mystatesman.com

Hepatitis C - Sovaldi-Based Regimens Will Capture More than Half of the Genotype 1 Treatment

Early Uptake by Physicians Establishes Gilead's Sovaldi as a Defining Hepatitis C Virus Therapy in an Increasingly Competitive Market

Information contained on this page is provided by an independent third-party content provider.

SOURCE - www.DecisionResourcesGroup.com.

Sovaldi-Based Regimens Will Capture More than Half of the Genotype 1 Treatment Share

In the Next Six Months, According to Findings from Decision Resources Group BURLINGTON, Mass., March 19, 2014 /PRNewswire/ --

Decision Resources Group finds that, for the treatment of hepatitis C virus (HCV) infections, regimens containing Gilead's Sovaldi account for approximately 30 percent of the patient treatment share across key genotypes at one month after launch.

Regimens containing Janssen's Olysio capture less than 10 percent of the genotype 1 patient treatment share two months following its launch. Surveyed HCV specialists are also expecting to further increase their uptake of Sovaldi among their genotype 1, 2 and 3 patients, with Sovaldi regimens accounting for the majority of the patient treatment share, while the genotype 1 treatment share for Olysio is expected to be nearly 20 percent in the next six months.

Additionally, survey data show that gains for Sovaldi and Olysio are at the expense of Vertex's Incivek and Merck's Victrelis – a finding underscored by interviewed specialists indicating discontinuing future use of first-generation protease inhibitors.

Other key findings from the report entitled LaunchTrends: Sovaldi and Olysio US Wave 1:

• Sovaldi and Olysio combination: Over 10 percent of surveyed HCV specialists reported prescribing the off-label Sovaldi and Olysio combination regimen.
• Olysio non-prescribers: Nearly 10 percent of surveyed Olysio non-prescribers do not plan to ever prescribe Olysio, while none of the surveyed specialists indicated they would not prescribe Sovaldi.
• Patient warehousing: Surveyed specialists reported increases in both the number of HCV patients under their care and number of patients on active treatment, suggestive of de-warehousing of patients for new regimens.
• Patient influence on uptake: HCV specialists reported recently receiving general inquires and/or prescription requests for Olysio and Sovaldi; prescribers were more likely to report receiving patient requests for the new agents as opposed to non-prescribers, suggestive of possible patient influence on uptake.

Comments from Decision Resources Group Director Brenda Perez-Cheeks, Ph.D.:

• "Although Olysio performs well in our benchmarking analysis when compared with the launches of Incivek and Victrelis, its launch has been largely overshadowed by the market entry of Sovaldi, a drug with key advantages over Olysio. Sovaldi prevails in every key metric evaluated in this study, including frequency of sales representative contact. Olysio is going to face an uphill battle in capturing market share in the genotype 1 space. Marketing efforts and message targeting of HCV specialists is an area where Janssen will have to be competitive with Gilead in order to promote Olysio' s uptake in this key market segment."
• "Cost is the leading prescribing barrier for both Olysio and Sovaldi. Although most surveyed prescribers did not indicate major payer obstacles, many non-prescribers reported experiencing reimbursement obstacles, suggesting that reimbursement is a barrier to prescribing. With the impending availability of several safe and highly efficacious all-oral interferon-free regimens, especially for genotype 1 infections, cost will emerge as an important differentiator, and follow-on therapies will have to offer competitive pricing to penetrate this highly dynamic space."

About Decision Resources Group
Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:Decision Resources GroupChristopher Comfort
781-993-2597
ccomfort@dresourcesgroup.com

March Newsletter: American Liver Foundation

Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

March Newsletter

On February 20, 2014, teams of young clinicians representing leading Chicago and Michigan academic medical centers, debated the ethics of organ transplantation, impact of new hepatitis C treatments and cancer screening benefits at the 11th annual Academic Debates.

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ALF programs extend from the runways of the Daytona 500 to the halls of Congress. Here is what we have been up to this month.

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The American Liver Foundation is making national news on topics including liver wellness, disease prevention, screening and treatment. 

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When a loved one receives a diagnosis of hepatitis C, it affects the whole family. Meet James McGuffey whose love for his wife soars to the heights of the greatest mountain peaks and beyond.

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Ready to roll? Try these forkless salad rolls. Delicious and healthy for you too. Have a recipe to share? We would love to hear from you.

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