Amazon Mulls Entering PBM Field, Even As These Middlemen Bear Brunt Of Blame Over High Drug Costs

Stat: Can Amazon Win As A Pharmacy Benefits Manager?
What kind of impact could Amazon have if the ubiquitous company enters the mysterious and complicated world of pharmacy benefit managers? The online retailer is reportedly exploring the pharmacy business and, as part of the plan, may build an internal PBM for its own employees, but later roll this out to the world at large. The possibility is intriguing because it comes at a time when these middlemen — which negotiate with drug makers for favorable insurance coverage — are under varying degrees of financial and political pressure. (Silverman, 5/18)

Stat: US Drug Prices Are So High That Canada Wants Other Countries As Reference Points
How high are drug prices in the US? So high that the Canadian government may remove the US from its long-standing list of countries that are used as a guide for determining whether prices are excessive. In a proposal issued last week, Health Canada said it wants to overhaul the framework used by the Patented Medicine Prices Review Board, which assesses therapeutic benefits and sets ceiling prices. Right now, this is accomplished, in part, by benchmarking prices against what drug makers currently charge in seven other countries — the US, France, Germany, Italy, Sweden, Switzerland, and the UK. (Silverman, 5/22)

The Wall Street Journal: How The FDA Approved A $300,000-A-Year Drug Its Own Experts Didn’t Believe Worked
Jennifer McNary, a stay-at-home mother, was desperate to find a medicine that might spare her two sons an early death from a rare form of muscular dystrophy. Chris Garabedian, the chief executive of a pharmaceutical firm, was desperate to find a profitable drug that would reverse his company’s slow fall. They met in June 2012 at a conference on Duchenne muscular dystrophy and joined forces, often behind the scenes and with little public disclosure, in a yearslong mission to push the government to approve a drug to treat DMD, as it is known. (Pulliam and Mullins, 5/19)

Stat: Generic Hepatitis C Meds Really Are Cost Effective: Study
For the past three years, various governments and patient advocacy groups have clamored for lower-cost hepatitis C medicines, given the high cure rate for these pricey new drugs. Now, a new study finds that upfront treatment with cheaper generic versions can offer a substantial payback. Using a mathematical model for patients in India, researchers found that copycat versions costing around $300 would increase life expectancy by more than eight years and reduce lifetime health care costs by more than $1,300 per person. (Silverman, 5/18)

The Wall Street Journal: FDA Approves Merck’s Keytruda To Treat Cancers With Genetic Defects
The U.S. Food and Drug Administration on Tuesday approved Merck & Co.’s Keytruda drug to treat tumors with a certain genetic defect—the first time the agency has cleared a cancer drug for a use not tied to the site of a tumor. The FDA approved Keytruda to treat tumors with genetic defects known as “microsatellite instability” or “mismatch repair” deficiencies, which are present in an estimated 4% of cancers. Studies showed the drug shrank tumors in a significant number of patients with colorectal and 14 other cancer types that had the genetic defect. (Loftus, 5/23)

The Wall Street Journal: Alexion’s Shakeup Continues As Four Executives Exit
Alexion Pharmaceuticals Inc.’s new chief executive is reshaping the top ranks of the organization following an internal investigation into sales practices prompted by a former employee. (Tweh and Rockoff, 5/23)

CQ Roll Call: House GOP Tries Last-Minute Push For FDA Marketing Change
Republicans are attempting to address a major priority of the drug and medical device industries as part of a bill to fund the Food and Drug Administration, but in so doing risk injecting a controversial issue into what was supposed to be a smooth bipartisan negotiation. The makers of drugs and devices want the FDA to loosen the regulations governing how they can discuss and promote uses of their products that haven’t been explicitly approved. Approved uses are typically identified on a product’s label, but the practice of using drugs or devices in a so-called “off-label” way is common in some areas of medicine where treatment options may be limited, such as for cancer patients or pediatric populations. (Siddons, 5/24)

Stat: FDA Leaps Into Precision Medicine — With Caveats
The many proponents of precision medicine have long promised a world where terms like “lung cancer” and “melanoma” are rendered quaint by the awesome power of genomics. And the FDA, with its latest approval, just endorsed that vision of the future. The agency cleared Merck’s blockbuster cancer drug Keytruda to treat any solid tumor with one of two genetic abnormalities, marking the first time the FDA has granted such an agnostic approval. There are, of course, caveats — the mutations are rare, and Keytruda can be used only after a prior treatment has failed — but it’s a milestone approval nonetheless, and one that will be heartening to some forward-thinking biotech companies. (Garde, 5/23)

Stat: UK Regulator Says Merck Broke Competition Laws Over Biosimilars
The UK antitrust regulator accused Merck of illegally offering discounts for the Remicade biologic medicine in order to block lower-cost biosimilar versions. In a brief statement, the Competition and Markets Authority said it found that the drug maker “provisionally” broke the competition law and was “abusing its dominant position” in the market with its discount scheme. Remicade is used to treat chronic inflammatory diseases such as rheumatoid arthritis. (Silverman, 5/23)

Reuters: India's Drug Pricing Regulator Clamps Down On Drug Cocktails
India's drug pricing regulator has demanded explanations from 65 domestic and global drugmakers for selling new forms of essential diabetes and antibiotic drugs without its approval. The move could bring penalties for the drugmakers, among them Abbott Laboratories, Sanofi, Novartis and Indian firms such as Sun Pharmaceutical Industries and Lupin, the National Pharmaceutical Pricing Authority (NPPA) said on its website. (Siddiqui, 5/18)

Reuters: UK Competition Watchdog Accuses Merck Of Obstructing Biosimilars
Britain's competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade that it said was designed to restrict competition from so-called biosimilar copies. The Competition and Markets Authority (CMA) said on Tuesday it had provisionally found the U.S. company's European unit, Merck Sharp & Dohme, had abused its dominant position through the scheme, opening it up to potential financial penalties. (Hirschler, 5/23)

Stat: Former Lilly Employee Wins An Ironic Lawsuit Over Disability Benefits
A federal appeals court ruled last week that Eli Lilly should not have ended disability benefits to a former human resources director who claimed she was unable to continue working because she suffered from fibromyalgia, a chronic neurologic condition. Yet at the same time the former employee was fighting in court to have those benefits restored, the drug maker was marketing a medicine in the US to treat the condition, which one of its own consultants had described as “very disabling,” according to court documents. (Silverman, 5/22)

Stat: How A Drug Ad Made Its Way Into 'General Hospital'
[Anna] Devane is a soap opera character, as you might have guessed, appearing for the last 32 years on “General Hospital.” And her dramatic diagnosis is brought to you by Incyte Corp., a biotech company that happens to market a drug for her on-screen disease, the rare blood disorder polycythemia vera. The scene, which aired in February, is a novel twist on what’s called unbranded advertising, in which drug companies detail the symptoms of a disease but refrain from mentioning the names of any drugs. (Garde, 5/18)

FiercePharma: Drama And Diagnosis On Soap Opera Set Troubles Cancer Doctors, Puts Incyte In Hot Seat
Soap operas often include medical mysteries and miracles, but a couple of real-life doctors are concerned about Incyte's connection to the latest drama on General Hospital. Writing in JAMA, oncologists Sham Mailankody and Vinay Prasad question the ABC soap opera's rare-disease plot enabled by a partnership with the biopharma company Incyte. In the General Hospital storyline begun in February, leading character Anna Devane is diagnosed with a rare blood cancer called polycythemia vera (PV). The show doctors explain to the character, who is played by Incyte spokesperson Finola Hughes, that PV is part of a group of rare blood cancers called myeloproliferative neoplasms, and that there are treatments, but no cure. (Bulik, 5/22)

Stat: This Company Admitted Failure — And The Stock Market Rewarded It
Rather than shunning the company, investors embraced it. Only a small number of them cashed out their shares. (The coauthor of the paper who took responsibility for the error returned the stock, but made the shares a donation.) The IPO, delayed by a few weeks, went forward. And within a few years WntResearch stock went on a surge that to date has left it up nearly 500 percent over 6 1/2 years. In other words: Openness was a risk in the short run but a long-term boon for the company. (Oransky and Marcus, 5/23)