Group says patents have blocked access to life-saving medicine
Pricey hepatitis C treatment has been a top seller for Gilead
Gilead Sciences Inc.’s U.S. patents on the blockbuster $84,000 hepatitis C treatment Sovaldi were challenged by a consumer group that’s battled the drugmaker around the world over the pricing.
The Initiative for Medicines, Access & Knowledge, a nonprofit focused on how patents affect access to medicine, said that it’s filed petitions with the U.S. Patent Trial and Appeal Board seeking to challenge intellectual-property rights that would keep generic versions of Sovaldi from entering the market.
In a decision announced to the parties Wednesday, October 5, the EPO has decided to maintain in amended form European patent EP 2,203,462 granted May 21, 2014 Gilead on Pharmasset treatment of hepatitis C. Médecins du Monde (MDM ) and several other complainants had committed an opposition to the patent with the EPO, whose decisions apply to 38 member states. In practice, the EPO annulled some of the patent including those covering the sofosbuvir. The written decision of the EPO will be sent to interested parties within six weeks.
WASHINGTON, Aug. 18 (UPI) — Democratic presidential nominee Hillary Clinton said Wednesday her administration will go after drug companies that charge exorbitant prices, singling out the company Gilead, whose hepatitis C drugs cost between $900 and $1,000 per pill in the United States.
Gilead’s hepatitis C drug cures what had been a chronic liver condition diagnosed in more than 3 million Americans that can lead to increased risk of cirrhosis and liver cancer. Gilead was recently granted permission to begin sales of its third and most effective drug to treat hepatitis C, Epclusa. It is expected to replace the company’s two previous drugs, Solvadi and Harvoni.
Epclusa will retail for $74,000 for a full treatment, or about $900 per pill, Bloomberg News reported. Solvadi and Harvoni sold for about $10,000 more than that, or $84,000.
After getting beaten up last week over the pricing of its hepatitis C treatments in the United Kingdom, Gilead Sciences is going on the offensive. The drug maker, which has sustained intense criticism over complaints that its prices have strained payer budgets, fired back at a report in an influential medical journal and declared that “we stand behind our pricing.”
Although Gilead has never been entirely mute when confronted with criticism, the drug maker is generally circumspect about addressing specific developments. But the report in BMJ seems to have hit a nerve, since the journal wrote that England’s National Health Service was forced to take several controversial steps to delay coverage of Gilead’s medicines, and it came at the expense of patients.
And so, a Gilead executive wrote a letter to BMJ to defend its pricing decisions, which were also skewered late last year by a US Senate Finance Committee investigation, which spent 18 months reviewing voluminous Gilead documents before concluding that the company placed profits before patients in setting prices for its Sovaldi treatment, the first of three Gilead hepatitis C drugs now available.
After threatening to sue Gilead Sciences over the cost of its hepatitis C treatments, the commonwealth of Massachusetts has reached a deal with the drug maker to receive rebates for most of its residents who are infected with the chronic disease.
The deal, which begins Aug. 1., is expected to save the state a significant amount of money, but projected savings were not disclosed. However, the cost of hepatitis C drugs for about 2,800 people covered by MassHealth, which is the commonwealth’s Medicaid program, has so far totaled about $318 million from late 2014 through early 2016, according to a statement from the agency. A MassHealth spokeswoman, however, said the state expects lower unit costs to be offset by more people being treated, so the state is not forecasting any change in net spending.
Gilead’s Harvoni treatment will be the exclusive therapy for about 80 percent of MassHealth Members, although the agency also negotiated rebates for the older Sovaldi medication and Daklinza, a hepatitis C medicine sold by Bristol-Myers Squibb, which would be used to treat about 20 percent of those who are infected with specific strains of the disease.
They’ve brought hope to millions, drugs so revolutionary that they can cure hepatitis C and so expensive that neither patients nor public health services can afford them — an issue to be raised at this week’s G7.
The pills made by US group Gilead Sciences are just one example of efficient yet costly treatments that have put the delicate question of how much a life is worth on the table of cash-strapped governments which hesitate to fund them.
In Spain, after multiple protests that included the three-month occupation of a Madrid hospital, patients were handed a partial victory last year when the government decided to provide the drugs to those at advanced stages of the disease.
About two and a half years ago, a pharmaceutical company developed a miracle cure with the potential to eradicate a terrible disease from our planet. It was an American pharmaceutical company, so this miracle cure can be seen as a triumph for our using a market system to encourage the development of cures. With this cure we could potentially wipe out a significant disease for the first time since small pox was eradicated almost 40 years ago.
And yet two and a half years later, this disease has remained almost completely untouched.
Why no miracle? Does the cure take a long time? No: From the time the treatment is started, it takes only about 12 weeks. Is it difficult to administer? No: 1-2 pills a day, taken at home, for twelve weeks. Are the pills hard to get, or expensive to make? Well that depends on exactly what you mean.
After concerns were raised that there are some insurance companies that are restricting coverage of the medication of hepatitis C, the New York state attorney general has started an investigation and asked 16 health insurance companies to provide information on their coverage of hepatitis C treatments.
Attorney General Eric Schneiderman’s office has issued subpoenas to the health insurers asking for documents explaining how they decide who should be covered and who should not be covered for specific treatments. Owing to its price, the hepatitis C medications made by Gilead Sciences Inc. and AbbVie Inc. have garnered controversy.
The drug is exceptional, as it cures a patient in 12 weeks, but a single pill costs $1,000 and around $84,000 for a complete course of treatment. Insurers have to negotiate discounts with the manufacturers. Some insurers have limited access to the drugs, which they then restrict to the sickest patients and sometimes, even with discounts, they cannot afford the drug.