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American Hepatitis C drug on the market in September
Dr. Wahid Doss, head of the National Institute for Liver Diseases, said on Monday said the Health Ministry and the registry of the Central Administration of Pharmaceuticals met to complete the registration of the American Hepatitis C drug.
He added that the ministry is buying the drug at 1 percent of its global price.
“Registration will be completed within two months, the fastest period in the history of drug registration in Egypt,” he said. “It will be available on the market in September.”
Egypt is known for having the highest rate of Hepatitis C in the world.
Raymond Schinazi, the developer of the Sovaldi drug, was born in Alexandria in 1950, but was forced to leave Egypt due to his Jewish heritage.
“I spent my childhood there but had to leave because of the political circumstances at the time,” he told talk show host Lamia al-Hadidi via satellite from London in April. “But I’m coming to Egypt for a medical conference in the Red Sea governorate in November.
Edited translation from Al-Masry Al-Youm
http://www.egyptindependent.com//news/american-hepatitis-c-drug-market-september
Published May 20, 2014
Hepatitis C medicine developer: Cure rate is 90-100%
Dr. Raymond Schinazi, developer of the Sovaldi drug for the treatment of Hepatitis C, said the drug works well for early and advanced cases, but is not effective if there is liver cancer.
“The cure rate ranges from 90 percent to 100 percent,” he told talk show host Lamia al-Hadidi via satellite from London.
He added that the drug showed better results than Interferon, which has a cure rate of 40 percent. “Sovaldi is taken for 12 weeks,” he said. “It cures for life if the infection does not occur again.”
Sovaldi is produced by Gilead, which was criticised for selling the drug at high prices. Yet the company offered to sell it to Egypt at a 99-percent discount, as Reuters reported on 21 March.
Meanwhile, the state-run MENA news agency quoted Health Minister Adel al-Adawi as saying Egypt agreed to buy the drug in the second half of 2014 for US$300 for a pack that lasts for a month.
This means that the cost will be US$900 for 12 weeks and more for 24 weeks.
Reuters said the cost of the 12-week treatment in the United States is US$84,000.
Schinazi said there are 12 million patients of Hepatitis C in Egypt. “This is a big problem,” he remarked, pointing out that he is also working on a drug to cure AIDS.
Schinazi was born in Alexandria in 1950. “I spent my childhood there but had to leave because of the political circumstances at the time,” he said. “But I’m coming to Egypt for a medical conference in the Red Sea governorate in November.
The Egyptian-born doctor is of Jewish heritage.
http://www.egyptindependent.com//news/hepatitis-c-medicine-developer-cure-rate-90-100
Published April 15, 2014
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Australia's TGA approves Protalix's ELELYSO for injection to treat Gaucher disease
The Australian Therapeutic Goods Administration (TGA) has approved Israel-based Protalix BioTherapeutics' ELELYSO (taliglucerase alfa) for injection as a long-term enzyme replacement therapy to treat Gaucher disease in both adult and pediatric patients.
The approval of the drug is for patients with a confirmed diagnosis of Type 1 Gaucher disease associated with at least one of the following - splenomegaly, hepatomegaly, anemia and thrombocytopenia.
The company's commercialization partner Pfizer will be responsible for marketing ELELYSO in Australia.
The US Food and Drug Administration (FDA) had already approved taliglucerase alfa for treatment of adults with Type 1 Gaucher disease in May 2012.
With the TGA approval, ELELYSO is now licensed in ten countries and further regulatory filings are underway.
ELELYSO is the first plant cell-expressed enzyme replacement therapy (ERT) derived from ProCellEx, the company's plant cell-based protein manufacturing system, using genetically engineered carrot cells.
The company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx.
Published May 20, 2014
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The Hepatitis C Cascade of Care: Identifying Priorities to Improve Clinical Outcomes
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.00973...
Benjamin P. Linas, Devra M. Barter, Jared A. Leff, Sabrina A. Assoumou, Joshua A. Salomon, Milton C. Weinstein, Arthur Y. Kim,Bruce R. Schackman
Published: May 19, 2014
DOI: 10.1371/journal.pone.0097317
Abstract
Background
As highly effective hepatitis C virus (HCV) therapies emerge, data are needed to inform the development of interventions to improve HCV treatment rates. We used simulation modeling to estimate the impact of loss to follow-up on HCV treatment outcomes and to identify intervention strategies likely to provide good value for the resources invested in them.
Methods
We used a Monte Carlo state-transition model to simulate a hypothetical cohort of chronically HCV-infected individuals recently screened positive for serum HCV antibody. We simulated four hypothetical intervention strategies (linkage to care; treatment initiation; integrated case management; peer navigator) to improve HCV treatment rates, varying efficacies and costs, and identified strategies that would most likely result in the best value for the resources required for implementation.
Main measures
Sustained virologic responses (SVRs), life expectancy, quality-adjusted life expectancy (QALE), costs from health system and program implementation perspectives, and incremental cost-effectiveness ratios (ICERs).
Results
We estimate that imperfect follow-up reduces the real-world effectiveness of HCV therapies by approximately 75%. In the base case, a modestly effective hypothetical peer navigator program maximized the number of SVRs and QALE, with an ICER compared to the next best intervention of $48,700/quality-adjusted life year. Hypothetical interventions that simultaneously addressed multiple points along the cascade provided better outcomes and more value for money than less costly interventions targeting single steps. The 5-year program cost of the hypothetical peer navigator intervention was $14.5 million per 10,000 newly diagnosed individuals.
Conclusions
We estimate that imperfect follow-up during the HCV cascade of care greatly reduces the real-world effectiveness of HCV therapy. Our mathematical model shows that modestly effective interventions to improve follow-up would likely be cost-effective. Priority should be given to developing and evaluating interventions addressing multiple points along the cascade rather than options focusing solely on single points.
=======================
Notoriously tough price regulator disses Gilead's key argument to payers
Gilead Sciences has been trying to soothe payers, unhappy over the price of its HEP C blockbuster Sovaldi, with the argument that it will save them money by preventing them from paying for transplants for patients who develop cancer. But now the U.S. drug maker has run into Germany's Institute for Quality and Efficiency in Health (IQWiG), the toughest among Europe's drug price watchdogs, and it says the evidence for that claim is unclear.
"It is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer, " IQWiG said in a statement Bloomberg reports. "However, it is unclear how many cases of liver cancer can in fact be prevented by Sofosbuvir."
Germany's IQWiG is notorious for its resistance to new high-priced medications, and some drug makers have simply pulled their drugs from the market rather than accept the discounts it insists on. But Germany is a large market and the government will rely on the recommendation to decide whether to approve the €49,000 ($68,000) for a 12-week course that Gilead has put on Sovaldi (Sofosbuvir) there. That is $16,000 less than it charges in the U.S. where demand has been so brisk that in its first full quarter on the market, it racked up $2.3 billion in sales. Sovaldi has been shown to cure about 90% of the patients who take it and Gilead has been using the avoidance of liver transplants as a key selling point in negotiations with payers. Chief Operating Officer John Milligan has said that they understand the big picture. "When you talk to them about the long-term benefits, they recognize they're not going to have to worry as much about liver transplants and other care they're going to have to give," Milligan told Bloomberg as rumbles over price were escalating. A new liver costs about $300,000 in the U.S., and that's before factoring in the price of drugs to make a transplant work. "For most of these plans, the risk/benefit seems to be positive, based on our conversations."
The German regulator is certainly not the first paymaster to balk at the price of the daily pill. Express Scripts ($ESRX) in the U.S. is so unhappy about the cost of the drug needed by millions of people in the U.S., that it has been trying to rally other payers around the idea of cutting Sovaldi out of the picture as soon as a competing drug from AbbVie ($ABBV), Bristol-Myers Squibb ($BMY) or others hit the market.
"What they have done with this particular drug will break the country," Express Scripts CMO Steven Miller told Bloomberg last month. "It will make pharmacy benefits no longer sustainable. Companies just aren't going to be able to handle paying for this drug."
Congressional leaders have also raised concerns about what the cost will mean for Medicaid programs in their states. An expert panel in California that assesses new treatments voted Sovaldi a "low value" treatment, not because isn't effective, just because of its $1,000-a-pill cost. But so far, Gilead has doctors and patients on its side, who have been waiting for a more effective treatment with fewer side effects to deal with the chronic condition.
May 2, 2014 | By Eric Palmer
http://www.fiercepharma.com/story/germany-says-it-unclear-if-gileads-sov...
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Patients with end-stage liver disease caused by hepatitis C to get new drug
NHS will pay for about 500 people to receive Sofosbuvir, which could cure them, without waiting for guidance from the National Institute for Health and Care Excellence (Nice),
The NHS is to pay for around 500 people with end-stage liver disease caused by hepatitis C to receive a new drug which could cure them, without waiting for guidance from the advisory body, Nice.
The new drug, Sofosbuvir, has been shown to cure 90% of people with hepatitis C infection and is causing great excitement in the medical world. But the price tag is very high, at £34,983 for a 12-week course, per patient.
Around 216,000 people in the UK are believed to be infected with hepatitis C, which causes cirrhosis and liver cancer in a large number of cases. The 500 people who will receive the drug as a matter of urgency are in danger of dying and in many cases are on a liver transplant waiting list. Current treatments for hepatitis C do not work in all patients.
NHS England has announced it will spend £18.7m on the drug for these serious cases in advance of any assessment by the National Institute for Health and Care Excellence (Nice), which advises the NHS on cost effectiveness. Nice will assess the drug this year, but the government has been under pressure to act faster because of the perilous situation of so many people.
The Hepatitis C Trust has been warning that lives will otherwise be lost. Charles Gore, its chief executive, had been complaining that the process of getting effective new drugs to people who need them moved "incredibly slowly".
The UK, he said just prior to the announcement, was often one of the last markets to adopt innovative medicines in Europe. The application to NHS England was submitted in January, he said. "In the meanwhile these patients are getting sicker and sicker and some are going to die entirely preventable deaths."
The Hepatitis C Trust later said it was "delighted" to hear of the decision by NHS England.
The new drugs, said Gore, offered "an extraordinary opportunity not just to reverse the ever rising death toll from hepatitis C but to consign this cancer-causing virus to history as a public health threat".
The clinical director of specialised services at NHS England, James Palmer, said: "This is a major step forward for patients with this debilitating, and often life-threatening, disease and is evidence of NHS England's commitment to widen access to cutting edge drugs, treatments and therapies where both clinically appropriate and cost effective.
"The majority of these patients will already be under the care of a specialist treatment centre, and we will ensure that clinicians are aware of this policy, so that all eligible patients have the opportunity to access this drug".
Hepatitis C is a blood-borne virus that is transmitted between drug users through contaminated needles, but it has also infected many people who had blood transfusions on the NHS before 1991. Some people are thought to have been infected by tattoo needles and piercings.
NHS England anticipates that Nice will find the drug, which is given in combination with some much cheaper, older drugs, is cost-effective.
A patient with chronic hepatitis C is likely to be a continuing cost to the NHS and the price of a liver transplant is in excess of £50,000.
A campaign has already begun to get access to the drug, made by Gilead, for people in parts of the developing world, where hepatitis C is a major problem. The fight is being likened to the struggle to access HIV drugs at prices that poor countries can afford.
http://www.theguardian.com/society/2014/apr/16/patients-end-stage-liver-disease-hepatitis-c-new-drug
$1,000 hepatitis C pill a tough miracle to swallow
Stephanie M. Lee
Scott Barnes holds a pill of Sovaldi in his San Luis Obispo, Calif., home on Wednesday, April 30, 2014. Barnes is a Vietnam War army veteran who suspects he caught hepatitis C (before it was known by that name) toward the end of the war (1973) but wasn't officially diagnosed until the 2000s. He was able to convince his VA doctors to help him get on a regimen of Sovaldi, a drug developed by Gilead Sciences, which is hailed as a cure for hepatitis C. He has stage IV hep C, and sees this treatment as his last chance.
Three decades ago, Scott Barnes needed luck to survive the bullets and bombs of the Vietnam War. Today, his life depends on a beige, $1,000 pill.
Hailed as a breakthrough treatment for hepatitis C, Sovaldi could help more than 130 million people across the globe who suffer from the disease. Barnes believes he became infected during the war, when he received a blood transfusion laced with the virus.
"It's one thing to take a bullet or lose a leg," said Barnes, 59, whose disease is so advanced he's bought a grave and a plaque to go with it. "But it's another thing when you have a disease that's a killer and there's no cure."
To people like Barnes, Sovaldi is a miracle drug. But patients may face a long wait for the miracle, if they get it at all.
Gilead Sciences in Foster City, which makes the drug, sets a 12-week treatment of daily pills at $84,000. The high price means government agencies and insurers must make difficult decisions about whom they can afford to treat first and who will have to wait.
Many hepatitis C patients rely on taxpayer-funded insurance, which puts pressure on state and federal budgets. Exact numbers are unclear, because the liver-attacking disease often goes undetected. But some estimates suggest that more than half of the country's 3 million people with the disease are low-income Medicaid enrollees, prisoners with government-financed care, and veterans treated by the Department of Veterans Affairs.
"You're in a position where you have this whole population of people who are suddenly eligible for treatment all at once," said Dr. Rena Fox, a professor of medicine at UCSF who researches hepatitis C in veterans.
She added, "The industry has set the price at a point which I can't see how it would be affordable for any health insurance or any system to take this on 100 percent."
Unlike traditional treatments for hepatitis C, Sovaldi can cure more than 90 percent of patients in a few months. Barnes, along with millions of others who have been awaiting a cure, cheered when Sovaldi won approval from the Food and Drug Administrationin December.
Gilead's defense
But the drug's high cost muted those cheers. Sovaldi is worth it, Gilead argues, because it is a one-time cure that is cheaper than treatments for serious complications associated with the disease, like liver scarring and cancer. The company also offers discounts and payment assistance programs.
Gilead also wants to recoup the more than $11 billion it spent developing the technology. The company is off to a fast start. Sovaldi became the best-selling new drug of all time, generating $2.3 billion over the first three months of the year. But Express-Scripts Holding Co., the nation's largest pharmacy benefit manager, warned that it will boycott the drug unless Gilead lowers the price. And last week, Medicaid-managed care plans said they are having trouble covering the treatment.
Sovaldi is a vexing problem for prisons. One-third of the 2.2 million people in jails and prisons in the U.S. have hepatitis C, according to the Centers for Disease Control and Prevention.
The Federal Bureau of Prisons gets a discount on Sovaldi and another hepatitis C drug, Olysio. But state prisons generally don't receive the same discounts. Although California's prison system has yet to prescribe Sovaldi, a spokeswoman said the state is seeking approval. Now, 260 inmates statewide are being treated for the disease.
"Small jails in particular have big problems with this," said Dr. Michael Puerini, a former president of the Society of Correctional Physicians. "They don't have any funding structure for this kind of treatment."
VA is top provider
In addition to prisoners, veterans represent one of Sovaldi's biggest markets. Almost 190,000 veterans are chronically infected, making the VA the biggest single provider of hepatitis C care in the country, according to a 2010 agency report.
Gilead CEO John Martin told investors in late April that he expected heavy business from the agency. Neither the company nor the federal agency disclosed prices or sales data about Sovaldi for veterans or prisoners.
The VA boasts one of the most robust budgets of any federal department: a proposed $60 billion in 2015 for medical care, up nearly $2 billion from this year.
Since the drug just hit the market, Sovaldi's cost is not yet a problem, said Dr. Matthew Goetz, chief of infectious diseases at the VA Greater Los Angeles Healthcare System, which treats 4,000 veterans with hepatitis C.
Long-term costs a concern
But "there are long-term concerns because ... with 4,000 patients and the wholesale cost of $84,000, that's a large sum of money," he said, "which exceeds the total budget of this facility on a yearly basis."
Last month, a VA expert panel recommended that doctors consider new hepatitis C drugs like Sovaldi only for patients with advanced liver disease. The panel, which didn't take finances into account, said patients with less serious conditions should wait for alternative, potentially superior drugs that may hit the market within a year or two.
A California panel made similar recommendations, saying it may be necessary to limit the number of patients treated in part because costs can run from $70,000 to $170,000 per person.
The rationale: Hepatitis C is a slow-working disease that does not have immediate consequences if untreated. "This is not an urgent situation for every patient," said Fox, who was an expert on the VA panel.
Hepatitis C didn't have a name when Barnes volunteered for the Army at age 18.
After a skirmish in Laos, he woke up in a hospital with gashes across his arms, stomach and back. He received a blood transfusion, two decades before hospitals screened blood donations for hepatitis C. Other veterans, along with many Baby Boomers, likely contracted the virus from the intravenous drugs and tattoos that were so popular in the 1960s and 1970s.
Diagnosed in 2003
Doctors diagnosed Barnes with hepatitis C in 2003, medical records show. Since then, Barnes has undergone surgeries and tried interferon injections and ribavirin pills, the traditional hepatitis C treatments. Finally, after four months of waiting - and a little complaining - Barnes began taking Sovaldi with ribavirin last week.
He is among a select few. Doctors at the veterans’ hospital in Los Angeles said 50 of 4,000 hepatitis C patients are getting Sovaldi.
In San Francisco, about 15 of 2,100 hepatitis C patients are undergoing the treatment, a spokeswoman for the veterans hospital said. And in the Palo Alto system, 26 of the 1,295 hepatitis C patients the hospital treated over the past year received the drug.
Doctors cautious
Doctors say they adopt a cautious approach because they must accurately prescribe the drug and monitor patients for signs of improvement.
"We don't want any patients falling through the cracks because of too much haste just to start the medication," Goetz said. "Not surprisingly, some of our patients have been waiting several years for new medications and want it to start instantly. I can understand their frustration when things don't exactly turn on a dime."
Barnes, though, said he thinks the situation is relatively simple.
"This should be given to those who need it and that it may work in," he said, clutching his $15,000 bottle of pills. "Give it."
Who's taking Sovaldi?
Veterans hospitals in California are treating some hepatitis C patients with Sovaldi, but few of their patients are getting the expensive drug. The figures below are approximate as of late April and show how many hepatitis C patients are taking the drug.
Los Angeles: 50 (out of 4,000)
San Francisco: 15 (out of 2,100)
Palo Alto: 26 (out of 1,295)
Sources: VA Greater Los Angeles Healthcare System, San Francisco VA Medical Center, VA Palo Alto Health Care System
Stephanie M. Lee is a San Francisco Chronicle staff writer.
E-mail: slee@sfchronicle.comTwitter: @stephaniemlee
http://www.sfgate.com/health/article/1-000-hepatitis-C-pill-a-tough-miracle-to-swallow-5455230.php
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