India: Natco Pharma ties up with Gilead on hepatitis C drugs

(Reuters) - Natco Pharma Ltd said on Monday it has agreed a deal with Gilead Sciences Inc to supply generic copies of the U.S. drugmaker's chronic hepatitis C medicines, including $1,000-a-pill drug Sovaldi, in 91 developing nations.

Natco, a mid-sized player in India's crowded pharmaceutical industry, is the latest generic drugmaker to team up with Gilead on Sovaldi, having previously attempted to block the U.S. firm from getting a patent for the breakthrough drug in India in the hope of producing a cheaper version on its own. In September, Gilead announced similar licensing deals with seven other generic drugmakers.

Read more...

Pakistan: Waiting for hepatitis drug

AN estimated 10 million hepatitis C patients in the country may hear the good news soon. A life-saving drug to be administered orally to such patients is expected to be cleared for distribution next week, long after it got the approval of the Drug Regulatory Authority of Pakistan. The matter has been pending with the Federal Ministry of Health Services Regulations and Coordination for the last three months, which somehow could not take out the time to give a formal nod to the medicine called Sovaldi. Whereas doctors have prescribed the tablet to a few thousand suffering Pakistanis in anticipation of its availability on the local market, one distribution company has been selected for its supply. The company is going to buy it from the United States. It was initially in competition with many other aspiring distributors, but managed to convince DRAP that it had the right combination of price and quality.

Read more...

Pa. considering moving away from costly Hepatitis C treatment

(Harrisburg) -- Pennsylvania might move away from a stunningly expensive prescription drug treatment for Medicaid patients with Hepatitis C, but the Commonwealth won't save as much as other states.

Missouri is one of the first states to move away from Sovaldi, which costs $1,000 a pill.

Pennsylvania might do the same, but the state's Medicaid program is waiting on final offers from two competitors that provide other drugs recently approved by the FDA for Hepatitis C treatment.

Read more...

Cigna Signs Agreement with Gilead to Improve Affordability of Hepatitis C Treatment for Customers and Clients

• Improving customers' health at the most competitive pricing benefits all stakeholders
• Harvoni is the only Cigna preferred hepatitis C drug treatment for genotype 1

BLOOMFIELD, Conn., February 04, 2015 - Cigna (NYSE: CI) has reached an agreement with Gilead Sciences, Inc. (NASDAQ: GILD) to include Harvoni as the only preferred brand prescription drug treatment for customers with hepatitis C genotype 1, the most common form of the disease in the United States. Cigna clients and customers benefit from obtaining breakthrough clinical cure rates for hepatitis C while significantly lowering the cost of drug treatment.

“Cigna is committed to offering customers and clients the most affordable solutions that deliver improved health while containing both drug and total medical costs. We have selected Gilead’s Harvoni as the preferred drug treatment for hepatitis C genotype 1. Harvoni’s clinical effectiveness, safety and convenience, coupled with our innovative customer counseling, will deliver material health and financial outcomes for our customers and clients,” said Jon Maesner, chief pharmacy officer for Cigna Pharmacy Management.

Clinical studies have shown that 94% to 99% of individuals with genotype 1 hepatitis C treated with Harvoni achieve a sustained virologic response (SVR). Customers who have an SVR when tested 12 weeks after the completion of treatment are considered cured.

“Cigna continues to invest in analyzing real-world SVR outcomes with the leading hepatitis C treatments across the genotypes as we believe creating alignment around clinical and financial outcomes drives more affordable access to essential medications,” added Maesner. The agreement includes development of an innovative outcomes incentive alignment based on actual SVR results across Cigna's customer population.

Cigna is continuing to:

• Offer therapy support management through Cigna Specialty Pharmacy Services to every customer undergoing hepatitis C treatment.
• Conduct real-world outcomes assessments on existing and new hepatitis C drug treatments, including Harvoni, to further develop outcome-based strategies.

Cigna Medicare customers will also now have Harvoni as an additional formulary choice for treatment.

Terms of the agreement are not disclosed.

Read complete press release here
 

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