Posts made in May, 2012

The Healthcare Round-Up: May 19-26

Posted on Sunday, May 27, 2012

Real Endpoints would like to congratulate our intern, Halleh Balch, on her graduation from Swarthmore College. We expect great things from Halleh in the years to come; she is one to watch! PSA: To test – or not to test. The big news this week was the United States Preventative Services Task Force’s decision to downgrade the necessity prostate-specific antigen test. After reviewing two large studies, the task force’s working group decided the PSA test, which is designed to flag prostate cancers early, does more harm than good, leading to overdiagnosis and increased treatment risks rather than improved outcomes. According to the USPSTF’s findings, between 1986 and 2005 an estimated one million men received surgery, radiation therapy or both thanks to findings of the PSA test. Of these, at least 5000 died soon after surgery and between 10,000 and 70,000 had serious complications, while another 200,000 to 300,000 suffered impotence. And while the task force is officially recommending against the test, the group seems to have learned something from the mammogram debacle. If patients and doctors feel the test is necessary, it should be performed, as long as there is an “informed “ discussion about the possible benefits and harms. Many, including Matt Farber, the director of the economics and...

Learn More

Are We Really That Different? Transatlantic Lessons In Shopping For Value

Posted on Monday, May 21, 2012

The Americans and the English might think that their health care systems are very different: one, a commercial, private-insurer driven network whose incentives are as mis-aligned as its per-capita spend is high; the other, a state-funded, friendly-yet-inefficient model characterized by rationing. There are plenty of similarities, though. Firstly, the pressures – most obviously, spiraling costs — are the same, whether they’re hitting state-owned or private payers. England’s patchwork of regional, public payers (the Trusts) make local purchasing decisions (and, increasingly, coverage decisions, even though they’re not supposed to.)  That makes them look more like individual US commercial insurers. And like managed care groups or PBMs, most deal directly with drug manufacturers to negotiate local rebates. They have to stay within budget– if not make a profit. The UK may be spared the alphabet soup of MCOs, PBMs and ACOs. But the challenge of coordinating cost-effective care between general practitioners, hospital and home settings remains on both sides of the Atlantic. That’s clear from glancing at the range of initiatives underway in the US and UK to try to address spiraling healthcare costs. They may be called different things, but they’re similar enough to provide reciprocal lessons for both pharma and payers. While various US insurers experiment with cancer pathways,...

Learn More

The Healthcare Round-Up: May 11-18

Posted on Friday, May 18, 2012

Boom time for HCV testing: US health officials released proposed guidelines Friday recommending that all baby boomers should be tested at least once for the hepatitis C virus, which is transmitted through contaminated blood and is often undiagnosed. Infection rates of the silent epidemic have dropped since the 1990s thanks to better blood and organ screening technology, but according to the CDC one in 30 baby boomers (defined as born between 1945 and 1965) are infected with HCV and don’t know it. John Ward, director of the CDC’s viral hepatitis division predict a blood test would identify hundreds of thousands of infections. The proposed guidelines will only fuel the already rampant desires of many biopharmas to become HCV powerhouses. Gilead and Bristol-Myers Squibb are currently duking it out to become the first to offer a non-interferon based regimen, but with new screening guidelines dramatically increasing the treatment pool, expect other companies to look at the space with interest. For payers, meantime, the CDC recs mean more hard choices. With two new hep C drugs on the market – Incivek and Victrelis – payers are already scrutinizing costs in this specialty arena. According to the 2011 Express Scripts Drug report, hep C isn’t in the top 5 costliest specialty trend...

Learn More

Janssen Blinks First: Shrinks Patient Pool, Deepens Discount To Take Zytiga Past NICE

Posted on Wednesday, May 16, 2012

In the regular stand-offs between the UK cost watchdog NICE and drug manufacturers faced with negative reimbursement decisions, it’s usually the pharma that blinks first.  No surprise, then, that Janssen, maker of  Zytiga, was no exception. The prostate cancer drug had been condemned as too expensive in draft guidance issued in February, but late yesterday night NICE changed its mind. Why? Because Janssen offered a deeper discount on the drug’s price and revised downward the estimate of how many patients would be eligible to receive it — effectively shrinking the anticipated cost to the NHS.  And cost was quite clearly the issue: the agency had acknowledged in its earlier guidance not only that Zytiga is “an effective second line treatment,” that’s “generally safe” with “tolerable” adverse reactions, but also that it “may offer a step change [in the treatment of prostate cancer]” because it’s life-extending, not simply palliative.” In making these public declarations, NICE effectively put pressure on the manufacturer to do what it takes to ‘allow’ the agency to make the new drug accessible. In Zytiga’s case, shrinking the proposed patient population is an effective way to do that,  because, it allows the treatment to meet NICE ‘end-of-life’ criteria, which mean the typical £30,000-per-QALY threshold is relaxed slightly. One of...

Learn More

The Healthcare Round-Up: May 5 – May 12

Posted on Saturday, May 12, 2012

Pharmaceutical Lemonade: Revitalizing “failed” pharmaceuticals isn’t new. Successful medicines like Evista, AZT, Viagra, and thalidomide have all been repurposed. But with pharmaceutical R&D departments under pressure to improve their productivity, the goal of resurrecting drug candidates that may have failed in their first indication is gaining steam—especially if there are ways to do the scientific studies on someone else’s dime. That’s essentially what the National Insitutes of Health is doing with its $20 million grant initiative. Here’s how it works. Three drug companies –Pfizer, AstraZeneca, and Eli Lilly—have donated a total of two dozen molecules previously deprioritized that are known to be safe. Academics interested in studying these compounds further can apply for specific grant funding and have the right to publish non-confidential findings. The academic groups will also retain some intellectual property rights; importantly the company that originally developed the molecule retains rights to the actual compound. The hope is that if researchers find a new use for an old drug, the drug’s originator will see enough promise to license the new intellectual property and fund additional trials. While the consortium includes just three biopharmas now, the NIH hopes other drugmakers will donate additional compounds. It’s hardly surprising to discover Eli Lilly, AstraZeneca, and Pfizer are the initial...

Learn More

“Get The Right Comparator,” Scream Euro Gatekeepers

Posted on Monday, May 7, 2012

Two weeks ago, GSK’s ‘revolutionary’ lupus drug Benlysta got turned down as too expensive by the UK cost-effectiveness watchdog, NICE. Last week, it was Germany’s turn: HTA body IQWiG declared that Benlysta offers “no additional benefit over optimized standard therapy.” The problem in both cases was that there was no ‘reliable’ (NICE) or ‘evaluable’ (IQWiG) data comparing Benlysta to what was deemed the appropriate comparator. IQWiG bemoaned the fact that GSK opted for only limited inclusion of glucocorticoids in the comparative data. NICE, meanwhile, declared Roche’s MabThera (rituximab) the most appropriate comparator in this instance, despite not being licensed for use in lupus. A bit of a rough deal for pharma, perhaps. Before tackling the challenge of providing compelling benefit data, it seems they must second-guess the comparators that the HTA bodies will require. Except that they don’t have to second-guess.  Germany’s higher G-BA body (which commissions IQWiG assessments) clearly states the required comparator. And both !QWiG and NICE offer advisory services to help guide companies towards building up the most appropriate evidence base. Companies must use that. Besides, any drug developer will know the current clinical practice in the therapy area it’s targeting – even if that clinical practice does sometimes vary by country. And it isn’t easy...

Learn More

The Healthcare Round-Up: 4/28 – 5/5

Posted on Saturday, May 5, 2012

Here’s to price transparency: Transparency of procedure and physician costs remains an important initiative as the healthcare industry works to rein in healthcare spending and control the wide price variation seen for similar treatments. On Tuesday May 1, Castlight, which offers a user-friendly tool to compare treatment prices for tests and procedures based on cost and quality, announced it raised $100M in a Series D round­. That’s a huge sum for any privately held life science company. But the figure is especially startling because Castlight falls into the health IT genre, where historically investments have been much, much smaller.  Noted in the Castlight press release, the new round of financing was led by two “major” but unnamed mutual funds, and also included contributions from T. Rowe Price and Redmile Group.  Castlight’s previous investors included standbys like Morgan Stanley, Wellcome Trust, Venrock, Allen & Company and the Cleveland Clinic.  While the financing announcement positions Castlight as the company to beat when it comes to consumer-focused pricing tools, it has plenty of competition, including from payers such as Cigna, WellPoint, and Aetna who are developing tools for their members. —HB Read the Forbes article For an article on changes in consumer behavior, check out this article from the NYT. Read Castlight...

Learn More

Does AZ’s Iressa Single Payment Scheme Point To Risk-Sharing’s Future?

Posted on Thursday, May 3, 2012

We’ve set out our position as far as the future of risk-sharing’s concerned: there is one. And all the more so in the UK, given that cancer funding is about to get a lot tougher. The £600m ($970m) Cancer Drugs Fund, set up as a political quick-win to relieve the restrictions on access to oncologics, is due to end in 2014. The fund helped pharma in negotiations, “because they knew money was available,” says one UK payer. But with the UK National Health Service targeting £20 billion in savings by 2015, a repeat of the CDF is unlikely.  “When the CDF ends, there will be greater demand from a smaller pot. We will have to knock off low-priority drugs,” says the payer. That will soon be the reality in most other European markets, too.  To avoid slashing prices, pharma has to get cleverer. They’ll have to start looking for the winning schemes emerging from the dozen-or-more risk-sharing experiments to date. The problem is that most risk-sharing deals are too managerially complex to work for payers.  That’s why the NHS/AstraZeneca deal on Iressa is so interesting: it’s set up, almost uniquely, to avoid these complexities. And that’s why it’s an important model for payers and pharmas, despite the fact that Iressa is a small...

Learn More