Posts Tagged “Humira”

Both parties want lower drug prices but gridlock prevents reform

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Both parties want lower drug prices but gridlock prevents reform

I went to Walgreens recently to pick up my three-month supply of a prescription I have been using for years. Ho hum. Until I saw what it was going to cost.

All of a sudden the price had gone up by more than 20 percent. I paid it, of course, grumbling. But I decided to do some research into what’s going on with America’s prescription drug prices.

Bloomberg News looked into drug prices last year and found that “255 brand name drugs had increases between Feb.1 and July 13 … the most common increase was for 9 to 10 percent.”

It also tracked the prices for 40 commonly used drugs in six categories — diabetes, cancer, HIV, multiple sclerosis, asthma and chronic pulmonary disease, and autoimmune diseases such as rheumatoid arthritis and psoriasis — over a three-year period from June 2015 to June 2018. During this period the consumer price index went up by 5.6 percent.

“For all six categories of drugs,” Bloomberg found, “list prices rose far faster than inflation.”

They report:

“Prices for 10 commonly used diabetes drugs rose 25.6 percent, on average, while average prices for rheumatoid arthritis and other autoimmune treatments rose 40.1 percent. The latter category…

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NHS England sees off AbbVie’s Hep C legal challenge

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NHS England sees off AbbVie’s Hep C legal challenge

NHS England has claimed a victory after a legal challenge by AbbVie was rejected by the High Court, and says plans to eliminate hepatitis C by 2025 are back on track.

The court victory – and NHS England’s reaction to it – reflect its growing confidence in its use of tough negotiations and procurement to drive down drug prices and strike access deals with pharma.

AbbVie is one of several companies to market the new class of hepatitis C (HCV) treatments known as Maviret (glecaprevir/pibrentasvir), which can cure patients of the serious blood infection. Maviret is in contention with rival treatments such as Gilead’s Sovaldi, Harvoni and Epclusa, to name a few.

NHS England had initially been slow in its uptake of these new curative treatments, but then last year declared it would aim to be the first country in the world to eliminate HCV, with a target date of 2025, and spending £1bn over five years to achieve this goal.

However, in order to make this £1bn stretch to treat millions of HCV patients, NHS England aimed to achieve this via its largest ever procurement process – and called on pharma companies to offer unprecedented discounts to their prices.

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Court backs NHS in hepatitis C procurement row with AbbVie

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Court backs NHS in hepatitis C procurement row with AbbVie

A court has backed NHS England in a case where US pharma giant AbbVie had alleged that its procurement process for hepatitis C drugs was unfair.

NHS England aims to eliminate hepatitis C by 2025 using the ‘largest ever’ drug procurement process, inviting pharma companies to take part in the initiative worth almost a billion pounds over five years. But AbbVie had claimed the NHS breached its duty to treat all bidders fairly and started court proceedings last year.

NHS England said the country’s High Court has dismissed all aspects of the case, claiming that the initiative had been delayed by six months because of the litigation. In the ruling the judge rejected all challenges brought by AbbVie against NHS England’s smart procurement for the supply of curative direct acting antiviral treatments.

The drugs are intended to support a national network of hepatitis C projects that NHS England hopes will eradicate the disease. pharmaphorum understands that contracts have not yet been awarded, and no further details have been announced about which companies are involved.

But only a handful of firms have direct-acting antiviral hepatitis C drugs approved – meaning that as well as AbbVie, pharma companies such as Gilead, Johnson…

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Will big pharma exit the biosimilar market when margins start dropping?

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Will big pharma exit the biosimilar market when margins start dropping?

As prices drop, Big Pharma will exit the biosimilar space over the next five to 10 years, says industry expert Sarfaraz Niazi. Amgen, Novartis and Pfizer refute the claim, saying they are in the sector for the long-term.

Blockbuster biologic originator companies are, by definition, Big Pharma firms and the target of biosimilar developers. Roche and AbbVie, two of the firms most susceptible to biosimilar erosion, have vocalized the need for a stringent regulatory framework – including calls for appropriate data, individualized labels, and unique identification for all biotherapeutics – while attempting to bat off competition by reformulating products and beefing up both their pipelines and IP.

But at the other end of the Big Pharma spectrum, there are several firms that dominate the biosimilar European and US markets, namely Novartis, Pfizer and Amgen, which all claim to have some of the largest biosimilar pipelines in the industry.

Novartis – through its Sandoz division – has been marketing biosimilars for over a decade in Europe, and was the first to launch a biosimilar in the US after Zarxio, its version of Neupogen (filgrastim), received approval in 2015.

Pfizer, which was the first to launch a version of J&J’s Remicade (infliximab)…

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Leverage, Transparency, and Competition suggested goals for lowering drug prices in the U.S

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Leverage, Transparency, and Competition suggested goals for lowering drug prices in the U.S

The issue isn’t new: Drug prices in the U.S. keep going up. Manufacturers justify these increases based on the high price of R&D, pharmacy benefit managers (PBMs) negotiate rebates while pocketing a large percentage of the savings, and insurers pass down costs to patients via higher deductibles and copays.

As more innovative and expensive therapies enter the market, the issue of affordability vs. value—both on an individual and system-wide level—has taken on a new urgency. While related, they are not the same. A medicine can be “worth it,” in terms of eventual cost-savings and effects on patients, but if a patient or health system can’t afford it, “it doesn’t matter how much it’s worth,” said Gary Pisano, a professor at Harvard Business School.

Pisano was one of five panelists who convened to discuss strategies for “making medicines affordable” at the 2018 Galien Forum, which was held in New York in October.

While the panelists brought a variety of perspectives and suggestions to the table, more than anything else, the discussion highlighted just how far the U.S. is from implementing a solution.

Below are three potential big-picture goals to strive for, nonetheless.

Leverage. There’s been a lot of discussion around why…

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IPHA in Ireland finds it challenging establishing partnerships with key stakeholders and authorities

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IPHA in Ireland finds it challenging establishing partnerships with key stakeholders and authorities

Big Pharma in Ireland has an image problem. At least that’s how it sees it. “I think we are not seen as a trusted partner,” says Aidan Lynch, president of the Irish Pharmaceutical Healthcare Association (Ipha), the body representing the research pharma industry in Ireland. Partnership is a recurring theme for Lynch as he starts his two-year term as head of the group that has spent much of its recent past at loggerheads with government and the health authorities over getting its members paid for the new medicines they develop.

“I want to move us along in terms of how the other side, if I can say that, sees us in terms of partnership,” he says. “I think as a representative body we’re not anywhere close to where we should be in terms of how our stakeholders see us in terms of partnership.”

Little surprise then that the term “partnership” figures prominently in the lobby group’s recent policy document which carries the somewhat grandiose title of Manifesto for Better Health.

Lynch acknowledges that too often the conversation between the parties has been about price rather than the wider benefit of new therapies.

“The perception from the other side is that…

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Biosimilar adalimumab: a landmark for NHS medicines optimisation

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Biosimilar adalimumab: a landmark for NHS medicines optimisation

The implications of adalimumab’s European patent expiry

The NHS’s bid to improve patient outcomes and save money by switching costly biological drugs for cheaper biosimilars reached a major milestone in October when adalimumab – which has the highest global turnover of any medicine – came off patent in Europe.

The NHS has already achieved savings of £210 million through the use of biosimilar medicines, according to recent figures for 2018/19, and it plans to widen the market further as adalimumab, which is used for a range of conditions, is opened up to competition from cheaper rivals.

Regional Medicines Optimisation Committees (RMOCs), which were launched last year, have been playing a pivotal role in working with NHS commissioners and providers on best value biologics and helping them to prepare for adalimumab’s patent expiry.

The role of RMOCs

NHS England’s Medicines Value programme aims to help improve outcomes whilst keeping medicines affordable. A key strand of the programme involves optimising the use of medicines via the four RMOCs, which are based in London, the south, the north, and in the Midlands and east of England. They are designed to operate as a single, strategic medicines optimisation system for the whole country.

Each…

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Professor says Ireland HSE should ‘take seriously’ cheaper medicines

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Professor says Ireland HSE should ‘take seriously’ cheaper medicines

The head of the National Centre for Pharmaeconomics says the HSE “must take seriously” the need to replace expensive branded biological medicines with cheaper alternatives.

Professor Michael Barry, clinical director of the NCP, which conducts the health technology assessment of pharmaceutical products for the HSE, said little has happened since the Department of Health launched a consultation process last year on the use of generic biologics known as biosimilars.

Biologics, medicines made from living cells, have revolutionised the treatment of many chronic conditions like arthritis but they are expensive to produce. Despite this, the uptake of biosimilar medication remains low in Ireland compared to other EU countries.

We have seen a low uptake with generic medicines in the past, and we are seeing it again now with biosimilars. We are almost wedded to branded products,” Prof Barry said on RTÉ radio’s Morning Ireland programme.

Prof Barry said while biosimilars are more complex than generic medicines, they should still be used more by the HSE. “There is no doubt about that. It’s an issue that should be tackled. The HSE needs to take this one seriously and to have a good quality team producing a policy and also implementing it and,…

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Trump Forces Pharma to Face More Medicare Drug-Price Negotiation

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Trump Forces Pharma to Face More Medicare Drug-Price Negotiation

Drugmakers will be required to negotiate on prices for more medications paid for by Medicare, the latest step in the Trump administration’s campaign to rein in prescription costs.

Starting next year, private insurers that provide coverage to about 20 million seniors through Medicare Advantage will get new powers to bargain over drugs administered in doctor’s offices or hospitals, Health and Human Services Secretary Alex Azar said Tuesday in an interview with Bloomberg.

Currently, such drugs are paid for at their cost, plus a percentage fee for doctors, under what’s known as Medicare Part B.

“For the first time ever, we’re going to unleash these plans, which are so good at negotiating, to try to get discounts on Part B drugs,” Azar said in the interview. “This is a very important change in terms of drug pricing as well as just in managing and modernizing how Medicare functions.”

The treatments subject to the change include infusions for rheumatoid arthritis, eye injections to treat certain conditions that cause vision loss as well as some cancer therapies. The government and consumers in the plans spent $25.7 billion on Part B drugs in 2015.

Shared Savings

The change will bring what Medicare pays closer…

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Lukewarm reception to FDA biosimilar plan

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Lukewarm reception to FDA biosimilar plan

Reaction to the FDA’s recently released biosimilar plan is coming in — most of it tepid so far. FDA Commissioner Scott Gottlieb unveiled a wide-ranging, 11-point plan to promote biosimilars earlier this month. Yet approving biosimilars is half the battle in the U.S. market, where FDA lacks full jurisdiction — the rest coming under the FTC and other agencies.

FDA’s plan includes several proposals to speed up approvals and lower barriers for manufacturers to carry out interchangeability studies.

But it has drawn limited support. Leemore Dafny, an economist at Harvard Business School who formerly worked on health care and antitrust issues at the FTC, said Gottlieb could have called for more changes to FDA’s process for approving an interchangeable biosimilar. FDA’s current draft guidance poses such a high hurdle that most brand biologics would be unable to prove two batches of their product were interchangeable, she said.

“Holding the would-be rival to standards that are tougher than you hold the innovator seems like a way to prevent us from getting the benefits of biosimilar competition,” Dafny said at a Brookings Institution event this month where Gottlieb formally released his biosimilar plan.

A public hearing is scheduled for Sept. 4, making…

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