Portugal: Gov't reaches deal for Hepatitis C drug

The Portuguese government has finally reached an agreement with an American pharmaceutical firm to bring an innovative drug to treat Hepatitis C to Portugal. 

The deal comes one year after the drug from Gilead Sciences reached Europe.

According to reports the Ministry of Health and national drugs watchdog Infarmed managed to negotiated a price that will enable more patients to be treated for less than €25,000 per treatment.

Newspaper Público reports that the plan is to treat between 10,000 and 12,000 patients with the new drug over the next three years.

Source: http://theportugalnews.com/news/govt-reaches-deal-for-hepatitis-c-drug/33932

Pricing wars heat up over hepatitis C drugs

Announcing its first dividend, annual revenue that doubled the prior year's performance and a $15 billion buyback plan wasn't enough to buoy Gilead Sciences' shares when it dropped a bomb during its fourth-quarter earnings conference call: Discounts on the company's hepatitis C drugs this year will be 46 percent, way more than investors and analysts expected.

"That really escalated quickly," Brian Skorney, an analyst with Robert W. Baird, wrote in a note to clients Wednesday. The discount "is meaningfully worse than expectations" in the 25 to 30 percent range, and as a result, Skorney lowered his estimate for Gilead's hepatitis C revenue by 20 percent to $12.9 billion.

Gilead said part of its adjustment reflects a shift toward more patients who are covered by Medicaid and the Veterans Administration receiving the drugs at rebates of more than 50 percent.

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Catamaran Introducing Innovative Clinical Outcomes-Based Program for Hepatitis C Treatment

- Company Selects Gilead Sciences as its Exclusive Hepatitis C Treatment Provider -
- Program Offered Exclusively Through Company's Specialty Pharmacy, BriovaRx^® -

 

SCHAUMBURG, IL, Feb. 3, 2015 /PRNewswire/ - Catamaran Corp. (NASDAQ: CTRX, TSX: CCT), a leading provider of pharmacy benefit management (PBM) services and technology, today announced that it is introducing a new clinical outcomes-based program for hepatitis C treatment through its specialty pharmacy, BriovaRx^®.

This new program will provide clients of Catamaran and BriovaRx an innovative new approach to hepatitis C treatment. Centered on producing positive health outcomes, the program will allow for overall treatment costs to take into account clinical results. Patients will be monitored during their entire treatment regimen through their participation in BriovaRx's Hepatitis C Patient Management Program in order to support full adherence.

"When looking for a hepatitis C partner, our goal was not only to ensure the best possible value for the treatment cost alone, but also to promote the best possible health outcomes for our patients," said Albert Thigpen, SVP, Industry Relations & Supply Chain Management, Catamaran. "This innovative strategy supports Catamaran's view that a smarter approach to medicine has the power to lower overall healthcare costs and promotes optimal outcomes over the long-term."

Gilead Sciences, Inc.'s hepatitis C treatments, Harvoni and Sovaldi, are the exclusive options on Catamaran's National and Value Formularies. Catamaran's commercial clients will be eligible to participate in this clinical outcomes-based program for hepatitis C if they utilize one of these formularies or have a custom formulary and opt-in to the program.

"Catamaran and BriovaRx are rooted in delivering a more integrated healthcare experience for patients through a holistic and personalized approach," said, Sumit Dutta, M.D., M.B.A., Senior Vice President and Chief Medical Officer, Catamaran. "Our clinical outcomes-based program for hepatitis C supports this mission, empowering our nurses and pharmacists to partner with patients in a way that truly drives better health outcomes and ensures these high-cost therapies accomplish what they were designed to do."

To offer patients personalized care and achieve higher persistency and adherence rates, BriovaRx employs a variety of programs to aid patients. BriovaRx's Hepatitis C Patient Management Program features a nursing team that creates an individualized care plan for each patient based on the complexity of their condition and co-morbidities. Offerings like this have helped increase adherence and persistency for patients, contributing to overall cost savings and improved clinical outcomes.

 

About Catamaran

Catamaran, the industry's fastest-growing pharmacy benefits manager, helps organizations and the communities they serve take control of prescription drug costs. Managing more than 350 million prescriptions each year on behalf of over 32 million members, our flexible, holistic solutions improve patient care and empower individuals to take charge of their health. Processing one in every five prescription claims in the U.S., Catamaran's skill and scale deliver compelling financial results and sustainable improvement in the overall health of members. Catamaran is headquartered in Schaumburg, Ill., with multiple locations in the U.S. and Canada. For more information, please visit CatamaranRx.com, and for industry news and information, follow Catamaran on Twitter, @CatamaranCorp. 

SOURCE Catamaran

Press Release Source: http://www.prnewswire.com/news-releases/catamaran-introducing-innovative-clinical-outcomes-based-program-for-hepatitis-c-treatment-290667831.html 

HCV Drugs: Triple Drug Regimens, Exclusivity Deals, Merck & Gilead Updates —Alan Franciscus, Editor-in-Chief

At last year’s CROI conference, I wrote about a 6-week study of sofosbuvir, ledipasvir, and GS-9451.  This combination was tested against sofosbuvir/ledipasvir alone for 12 weeks and sofosbuvir/ledipasvir plus GS-9669 for 6 weeks.  The drugs were combined into one-pill, taken once-daily.  There were 20 patients in each arm.

The bottom line is that all 20 patients (100%) achieved a cure in the triple combination of sofosbuvir/ledipasvir and GS-9669 with 6 weeks of treatment.  The most common side effects were headache, fatigue and diarrhea. 

Comments:  This study is a small study and there is currently no information that it has yet entered into phase 3 studies.  But given the high cure rates and low side effects hopefully it will be entered into clinical trials with this combination or perhaps Gilead is researching another inhibitor to include. 

Study: Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Authors: A Kohli et al.

Exclusivity Deals
Ever since AbbVie’s VIEKIRA PAK’s approval there have been intense negotiations between insurance companies/pharmacies and AbbVie and Gilead to determine who will be the exclusive distributors of the pharmaceutical HCV medications. These deals will help to drive down the costs of the drugs, and this will hopefully translate into more patients having access to HCV medications.  The real downside is that the decision as to which medication a patient should be prescribed is now being made by someone other than a patient and medical provider. This is very bad news for patients (see "Predictors" article).  The information below is from our blog as of the date that we have put together our newsletter.  If you have been denied treatment in the past, you may want to check the list below (or our Blog) to find out if you would now qualify for insurance coverage.  The agreements are on-going so keep checking back. 

• AbbVie: Express Scripts, AIDS Drug Assistance Programs (ADAPs)
• Gilead: Aetna, Humana, Anthem, CVS
• Both—AbbVie/Gilead:  Prime Therapeutics

Merck
In January, Merck announced that it has been prioritizing portions of its drug development operations including hepatitis C.  In this respect, the development of a two-drug single pill (grazoprevir/elbasvir) will be accelerated.  Merck hopes to apply for marketing approval in the first half of 2015.  The combination is currently in phase 3 studies.  Phase 2 studies of the two drug combination with and without ribavirin in multiple arm studies of monoinfected and HIV/HCV coinfected patient populations with and without cirrhosis resulted in cure rates from 90 to 100%.  The most common side effects were fatigue, headache and general weakness. 

Gilead
Gilead has announced that it has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.

http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#2

Harvard Pilgrim negotiates discount on pricey hepatitis drug

Harvard Pilgrim Health Care has become the first regional health insurer to negotiate a discount on a costly new hepatitis C drug regimen that cures more than 90 percent of people with the virus but inflicts steep financial losses on payers.

Under a one-year contract with Gilead Sciences Inc., maker of the two-drug Harvoni treatment for the liver-ravaging disease, Wellesley-based Harvard Pilgrim expects to save about $10 million on reimbursements to doctors who treat hepatitis C patients. The insurer didn’t disclose how much it will pay for the drug after a rebate from Gilead.

Harvard Pilgrim followed the lead of national pharmacy benefit managers such as CVS/Caremark and Express Scripts, which buy prescription drugs in bulk. Taking advantage of a rival hepatitis C drug combination from AbbVie Inc., those companies recently bargained with both drug makers to secure rebates.

Read more....

EnvisionRx and Gilead Sciences Sign Exclusive Agreement to Help in the Fight Against Hepatitis C

TWINSBURG, Ohio, Jan 26, 2015 (BUSINESS WIRE) -- EnvisionRx®, a national, full-service pharmacy benefit management (PBM) company, today announced a partnership with Gilead Sciences Inc., a pioneer in the treatment of the Hepatitis C virus (HCV), to provide availability to HCV infection treatments Sovaldi® and Harvoni™ for EnvisionRx patients on an exclusive basis.

“EnvisionRx is committed to helping patients attain the most effective drugs at affordable prices, and we are proud to be able to offer our patients Sovaldi® and Harvoni™, the market leaders in the treatment of HCV, ” said Dawn Sherman, President of EnvisionRx. “The safety and efficacy profile of Gilead’s HCV products, coupled with the most competitive pricing in the drug class, have solidified EnvisionRx’s choice to place Gilead’s HCV products in an exclusive and preferred formulary position. We believe our comprehensive HCV approach will enable our patients to receive the best available care.”

Consistent with PBM industry practice, exceptions for other hepatitis C drugs will be allowed in some cases. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Sovaldi™ (sofosbuvir) 400 mg tablets, is a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Read more...

Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

–Sofosbuvir/GS-5816 Single Tablet Regimen May Provide Important New Option for Patients in Developing Countries –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once approved, for distribution in 91 developing countries, which together account for 54 percent of the total worldwide population of individuals infected with the hepatitis C virus (HCV).

If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.

“Today’s announcement marks an important milestone in Gilead’s effort to make effective hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible,” said Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences. “Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment.”

Professor Abhijit Chowdhury, Head of Hepatology, Institute of Post Graduate Medical Education and Research, Kolkata, commented: “Pan-genotypic hepatitis C treatments have the potential to radically change the treatment landscape in developing countries, removing the need for patients to undergo burdensome laboratory tests. Even if testing facilities are available, their cost is a barrier to treatment access, so a regimen that can be used for any genotype is going to be a real attribute in tackling this disease on a global level.”

The amended agreements expand on Gilead’s existing generic licensing partnerships for hepatitis C, announced in September 2014, under which partners may produce sofosbuvir and the single tablet regimen of ledipasvir/sofosbuvir. Eight Indian-based generic manufacturers now hold licenses to manufacture Gilead’s HCV medicines – Biocon Ltd., Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd.

Sofosbuvir recently received regulatory approval in India (January 2015), and regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.

About GS-5816
The single tablet regimen of sofosbuvir/GS-5816 is an investigational agent and its safety and efficacy have not been established. Phase 3 studies evaluating the combination of GS-5816 and sofosbuvir are currently underway, with data anticipated in the second half of 2015.

Gilead’s Approach to Treatment Access in Developing Countries
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. In developing countries, Gilead’s treatment access strategies include tiered pricing, voluntary generic licensing (often in advance of U.S./EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations. This approach has been successfully applied to Gilead’s humanitarian program in HIV over the past 10 years, where seven million patients are now receiving Gilead-based HIV medicines in developing countries.

For more information on Gilead Sciences, please visit the company’s website at www.Gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

- See more at: http://gilead.com/news/press-releases/2015/1/gilead-expands-hepatitis-c-generic-licensing-agreements-to-include-investigational-pangenotypic-agent#sthash.XNY7QWgP.dpuf

Gilead to appeal India patent ruling on hepatitis C drug

(Reuters) - U.S.-based Gilead Sciences Inc will appeal the Indian patent office's rejection of its application for hepatitis C drug Sovaldi, a move that could allow local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.

The rejection relates to the patent application covering the metabolites, or small molecules, of sofosbuvir, the chemical name of Sovaldi.

Indian drugmaker Natco Pharma and the Initiative for Medicines, Access & Knowledge (I-MAK) had opposed Gilead's application on the grounds that the drug is not inventive enough compared with a previous formulation.

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Aetna backs Gilead's hepatitis C treatment, gets discount

(Reuters) - Aetna Inc, the third-largest U.S. health insurer, said it negotiated a discount with Gilead Sciences Inc for its hepatitis C treatment and will offer it as the preferred choice to nearly 11 million commercial customers.

Aetna, which posted an updated coverage policy on its website on Friday, said it believes the price it received for Gilead's Sovaldi, and a newer combination treatment called Harvoni, is "competitive with other recently announced agreements for this class of therapy." It would not detail the size of the discount.

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Humana opts for Gilead in hepatitis C drug battle

Humana acknowledged late Tuesday it has an exclusive deal to offer Gilead Sciences' hepatitis C drugs to its members.

Humana CEO Bruce Broussard told investors in a breakout session that it has a pricing arrangement with Gilead, but he did not disclose what kind of discount the health insurer received for the pricey drugs. High specialty drug costs were part of the reason why Humana's profit was lower in the third quarter.

The company's announcement is the latest in a string of bargaining battles between health insurers and pharmacy benefits managers and pharmaceutical companies. Anthem was the first payer to announce an agreement, saying last week it would use Gilead's drugs for its hepatitis C patients. Gilead makes Sovaldi and Harvoni, which cost $84,000 and $94,500 respectively for the usual 12 weeks of treatment.

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UPDATE: Gilead (GILD), AbbVie (ABBV) Hep. C Drugs Both Given Prefered Status at Prime

Gilead (Nasdaq: GILD) and AbbVie (NYSE: ABBV) Hep. C drugs were both given prefered status at Prime. A press release is below.

People with Hepatitis C who are served by pharmacy benefit manager Prime Therapeutics LLC (Prime) will now have greater support for the treatment recommended by their physician. This is a result of new agreements between Prime and pharmaceutical companies Gilead Sciences and AbbVie. Beginning immediately, the agreements place both Gilead's Harvoni® and AbbVie's Viekira Pak® on Prime's preferred drug list (formulary), meaning members can more easily get the medicine they need to feel better and live well.

"There has been a substantial reduction in the net price of both of these drugs just in the past few weeks, so sometimes it pays not to go first," said Peter Wickersham, senior vice president of Integrated Care and Specialty, Prime. "It was clear that neither Gilead nor AbbVie wanted to be left off our formulary and the result proved to be significantly better than taking an exclusive position."

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At $594 Per Dose Gilead Sciences, Inc. (GILD) Hepatitis Drug Is Too Costly For Veterans Affairs Department

Gilead Sciences, Inc. (NASDAQ:GILD)‘s hepatitis C drug Sovaldi, which comes at a cost of $1,000 a pill, has proved to be a breakthrough that reduces treatment time to 12 weeks and at reduced risk compared to a year-long treatment option available. However, this heavily-priced therapy has raised concerns and criticisms across the U.S. by payers and consumer support groups.

To consider the impact of Sovaldi’s $84,000 12-week treatment cost, the Veterans Affairs Department provides this therapy only to the sickest patients who need it. The Department is the largest single provider of hepatitis C care in the U.S., which enabled it to negotiate more than 40% discount to the $594 per-dose price with Gilead.

VA and Hepatitis C Care

The Veterans Affairs Department added Sovaldi to its formulary in April 2014. It treated around 5,400 veterans at a cost of $370 million with Sovaldi in fiscal 2014, and has asked Congress for $1.3 billion to treat another 30,000 patients with Sovaldi and other new hepatitis C drugs.

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Anthem selects Gilead as primary supplier of hepatitis C drugs

Jan 8 (Reuters) - Health insurer Anthem Inc on Thursday said it reached a deal under which Gilead Sciences Inc's hepatitis C drug Harvoni will be the primary treatment for patients infected with the most common strain of the liver-destroying virus.

Anthem said the deal effectively lowers its hepatitis C treatment costs. "We were able to achieve a very competitive rate and a freeze on retail pricing for 2015," the insurer said in an emailed statement. "That does favorably impact plan costs for 2015."

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CVS will cover Gilead hepatitis C treatment over new AbbVie drug

CVS Health Corp., one of the largest U.S. managers of drug benefits, said it would give the hepatitis C treatment from Gilead Sciences Inc. preferred status and cover a new competing treatment from AbbVie Inc. only as an exception, CNBC reported on Monday.

Shares in Gilead rose nearly 3 percent after the report that CVS would favor the treatment, which can cost about $84,000, or $1,000 per pill. Its cost has spurred a national debate about whether drug prices had soared too high.

Two weeks ago, the nation's largest drug benefits manager, north St. Louis County-based Express Scripts Holding Co., said it would cover a competing, newly approved treatment from AbbVie rather than Gilead, and Gilead shares fell sharply.

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