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HCV Solution in Egypt / Standoff in USA
  HCV Drug Access Standoff in USA
from Jules: the success in Egypt started with a govt that wanted to provide a solution, thus in other middle & lower income countries the government has to want to do this. This commitment includes a program that has a cost burden & requires an infrastructure. Here in the USA - What is the federal govt doing to solve the problem? Every State Medicaid except for 2 I know of has restrictions preventing access to HCV treatment unless a patient has advanced disease & for those with substance abuse, just the groups most affected by HCV, insurers impose harsh restrictions preventing them from unfettered access. So far the federal govt has been complicit in allowing all Insrurers & Medicaids to impose these restrictions. 2 weeks ago CMS sent a letter to Medicaids apparently telling States to remove restrictions BUT it appears this was a weak publicity stunt to look good, but so far this CMS letter appears to have no teeth and no State has responded. NYS Medicaid refuses to budge citing their rule that they have A Global Medicaid Cap http://www.health.ny.gov/health_care/medicaid/regulations/global_cap/ and so they refuse to remove restrictions until the drug prices are apparently reduced to fit their budget. SO, in the meantime patients are being held hostage. The Federal Law that requires Medicaids to provide access to all FDA approved drugs appears to be in violation, as reflected by the threat of a Law Suit in Connecticut by a letter sent to State officials by Connecticut public/legal-Aid lawyers, but there have yet been further successful lawsuits or threats of a lawsuit, although several additional ones appear to have recently been filed. I do believe the Senate Hearings by Wyden & Grassley are just publicity stunts trying to gain good press by the Senate. Capitalism in the USA has parameters within which corporations act. What about the White House & CMS, its a black hole. What discussions are going on? Value-based pricing has recently been bandied about as a potential solution, but its too early to know if it will be utilize. years ago I suggested a value-based solution, "pay for cure", which J&J utilized in I believe Scotland this past year. "Pay for cure" means if the patient is cured the insurer pays for the drug cost & if the patient is not cured the public or private insurer does not pay. There have been over the past few years several precise deals of various types of value-based pricing that have in fact been made between drug makers & commercial insurers that I think are still in effect and make sense for both parties. But a solution to create unfettered access to HCV therapies remains elusive. The problem is without unfettered access it is virtually impossible to "cure" HCV or eliminate HCV, obviously first you need a system to diagnose & identify who has HCV. Of course the next step is for the Federal and State governments to commit hundreds of millions of dollars to an "Eliminate HCV Program" which includes mass awareness, testing, linkage-to-care services and additional patient and clinic based services for marginalized patient populations particularly those with a history of substance abuse including IDUs, injection drug users. IDUs are clearly the most impacted by HCV in the USA. certainly in recent years IDU is the leading cause for infection. Consider the recent HIV & HCV outbreaks in the "suburbs" like in Ohio, Kentucky, Mass and upstate NY. This is a new epidemic where there has been NO PROGRAMS for screening & care. Last week West Virginia declared needle exchange programs (NEPs) are opening. They haven't changed the law that makes them illegal but the NEPs are being operated with the support of Law Enforcement in WV because they understand the problem & the costs associated with not implementing a solution. In addition West Virgina in the past few weeks removed Restrictions from the drug formulary ! As far as I know they are the only State to do this except Connecticut last year, but that was in response to the aforementioned Law Suit. This brings me back to The White House & CMS, WHERE IS A SOLUTION?, the solution will have to come from them as I see it. If I were CMS & The White House I would be conducting very high level meetings with drug makers & high-level White House/CMS decision makers & I would find a solution. But it has been a long time, 3 years since the advent of these new drugs and the imposed harsh restrictions prevent patients from access to treatment with cure rates of up to 100% with 12 weeks safe/tolerable treatment, and the sad truth is deferring treatment until a patient has advanced disease, cirrhosis means the patient is NOW at increased risk for liver cancer (HCC) and has a vastly reduced chance that the liver disease will regress back towards normal. YES, successful HCV treatment in early disease has a great likelihood that the liver disease will regress & delaying treatment until advanced disease increases risk for liver cancer & that the disease will not regress thusly increased risk for death as well.
Curing Hepatitis C, in an Experiment the Size of Egypt
A new approach tested in Egypt could become the blueprint for providing cutting-edge medicines to the poor.
NY Times By DONALD G. McNEIL Jr.DEC. 15, 2015
Once demonized for withholding lifesaving AIDS drugs from poor countries in Africa, chastened pharmaceutical companies are testing an alternative strategy: a complicated deal to sell hepatitis drugs at a fraction of their usual cost while imposing tight restrictions intended to protect lucrative markets in the West.
The strategy has raised howls of outrage from public health advocates in some quarters. If it succeeds, though, the arrangement in Egypt may serve as a blueprint not just for curing hepatitis around the world, but also for providing other cutting-edge medicines to citizens in poor countries who could never afford them.
The experiment here is about a year old and, while still fragile, appears to be headed for success.
A Worldwide Problem
Hepatitis C is a global crisis: About 150 million people are chronically infected, four times as many as have H.I.V., and about 500,000 die each year of its complications, particularly cirrhosis and liver cancer.
For a poor country, Egypt has a relatively effective health care system, including legions of liver specialists. Committed to repairing the damage done by the schistosomiasis campaign, the health ministry in 2007 developed an ambitious national hepatitis treatment plan using two old drugs: interferon and ribavirin.
But for the past year, Gilead has sold the drug to the Egyptian government for about $10 a pill. The government distributes it to pharmacies across the country, where it is dispensed free to patients.
Gilead also allows 11 Indian and two Egyptian companies to make sofosbuvir under license and to sell it at any price they like, in return for a 7 percent royalty.
In return for selling sofosbuvir cheaply, Gilead asked that Egypt impose strict restrictions on every bottle to prevent the drug from being sold on the black market and undermining its business elsewhere.
All pills must be dispensed by government pharmacies, for example, and all patients must turn in an old bottle to get a fresh one. Those receiving new bottles must immediately unscrew the cap, break the seal and take the first pill in front of the pharmacist - making it nearly impossible to resell the bottle. "I agree with this completely," said Mr. Ellabbad, the air-conditioning repairman. "I'm a poor man. If I did not have to hand in the bottle each time, I might have sold them to buy my son a house."
Egypt's health officials also say that the deal is fair.
"We don't have a problem with the rules," said Dr. Gamal Esmat, a liver specialist at Cairo University Medical School and a co-author of the national hepatitis plan. "They are to prevent the black market from moving it to other countries."
"If you can solve the hepatitis problem in Egypt, you are a hero," he added. "The drug companies know that."
The Egyptian government's ambitious goals are to treat 300,000 hepatitis patients a year starting in 2016 and to drive the national infection rate below 2 percent by 2025.
The first year was successful: A total of 125,000 patients have been treated with sofosbuvir. Now that licensed generic versions are available for as little as $4 a pill, Egypt is even phasing out purchases from Gilead.
Instead, the company's next-generation product, Harvoni, a sofosbuvir-ledipasvir combination that cures with no need for interferon or ribavirin, is being tested for rollout in December at about $14 a day.
Already, the arrangement that Gilead struck with the Egyptian government has been emulated by other pharmaceutical companies.
In August, the government announced that it would import a rival three-drug combination named Viekira from AbbVie. Like Gilead, AbbVie offered the pills at about 1 percent of the price in the United States, or about $13 a day. In a further anti-resale measure, AbbVie renamed it Qurevo for the Egyptian market. In October, the government began importing Daklinza, a hepatitis drug from Bristol-Myers Squibb.
The sudden availability of world-class hepatitis medicines has prompted "great excitement in Egypt," Dr. Doss said, adding, "People are getting cured."
Large-scale diversion of hepatitis drugs onto the black market has not happened in Egypt, and officials do not seem particularly worried that it will.
"Some leakage is a given," said Gregg H. Alton, executive vice president for corporate and medical affairs. "Our goal isn't to stop it 100 percent; if we wanted that, we'd do it the draconian way and not be in the country at all. But we do want to stop large leaks."
Gilead's approach in Egypt is a radical departure, informed by the pharmaceutical industry's disastrous experience with AIDS drugs in Africa.
In 1997 South Africa, which had the world's worst AIDS burden, passed a law allowing it to suspend patents and buy generic versions of H.I.V. drugs. Western manufacturers retaliated, closing some of their South African plants and threatening to stop selling their new drugs there.
They went so far as to sue President Nelson Mandela, starting what former United Nations Secretary General Kofi Annan described as a "worldwide revolt of public opinion." The tactic backfired.
Poor countries forced price cuts in AIDS medications by threatening to revoke patents. The Indian generics industry emerged, and it now makes most of the world's H.I.V. medicines - at less than $100 per patient per year.
Those low generic prices prodded wealthy donor nations to create programs like the Global Fund and the President's Emergency Plan for AIDS Relief. Now 14 million people infected with H.I.V. are receiving treatment.
In 2006, Gilead bucked the industry's longstanding reluctance to cooperate with Indian generics companies and gave several of them licenses to make its best H.I.V. drug, tenofovir, for distribution in Africa in return for a 5 percent royalty.
In the nine years since, millions of Africans have taken generics containing tenofovir, but those pills have not turned up in large amounts in the United States or Europe. "Our worst fears did not come true," Mr. Alton said.
Gilead does not want to take a loss in poor countries but is willing to help at almost no profit, he added.
But critics note that in its arrangement with Indian generics manufacturers, the company reserved not just the richest markets for itself but also middle-income countries like China and Russia, where an estimated 73 million people are infected with hepatitis.
Indian licensees were originally allowed to sell generic versions in only 91 of the poorest countries.
Mr. Alton acknowledged that millions of patients had been excluded from the deal Egyptians received, but said Gilead was negotiating with their governments and "will discount in them at rates that are realistic."
By August, Gilead had added 10 middle-income nations to its access program, including Brazil and Argentina, and was selling all of them Sovaldi at $10 a pill and Harvoni at about $14.

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