Category:

Novartis...agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act by making illegal payments to health care providers in China. In doing so, the company becomes the latest drug maker to get punished for paying bribes in order to boost sales in a foreign country...The settlement also comes just one month after South Korean authorities raided Novartis offices in search of evidence the company bribed local doctors...In China, Novartis employees at two different Chinese subsidiaries gave money, gifts, vacations, and entertainment, among other things, to health care professionals between 2009 and 2011, according to an administrative order filed by the US Securities and Exchange Commission...At the same time, the SEC said that Novartis failed to devise and maintain a sufficient system of internal accounting controls and lacked an effective anticorruption compliance program to detect and prevent these schemes. As a result, the improper payments were not accurately reflected in Novartis’s books and records...Novartis spokesman...the issues raised by the SEC largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years. We believe these measures...address the issues raised by the SEC and reflect a broader initiative by Novartis to align and enhance our compliance standards globally...

Canadian stocks retreated for a third day, as disappointing earnings from Concordia Healthcare Corp. dragged drugmakers lower and financial shares slumped...The Standard & Poor’s/TSX Composite Index fell 0.2 percent to 13,358.11 at 4 p.m. in Toronto. The benchmark gauge has lost 1 percent in the holiday-shortened week, capping the longest streak of losses since Feb. 11. The index remains one of the top performers among developed markets this year with a gain of 2.7 percent...Health-care stocks faltered. Concordia plunged as much as 13 percent, the most since October, after the company posted earnings that missed analysts’ estimates. Valeant Pharmaceuticals International Inc. slipped 6.7 percent to halt a three-day rally that added 26 percent to shares in the embattled drugmaker...

The raging dispute between Anthem...and Express Scripts...is winning notice because the companies are battling over billions of dollars in prescription drug costs. Specifically, Anthem contends Express Scripts, which manages prescription drug benefits for health plans, failed to pass along rebates negotiated with drug makers...The battle, which is described in a lawsuit filed in federal court in New York...Anthem claims emphatically that Express Scripts has not been transparent because a third-party consultant conducted an audit and found the insurer was overpaying Express Scripts by about $3 billion annually...Anthem is seeking $15 billion in damages and wants out of its contract with Express Scripts...The outcome "could have far-reaching effects" on pharmacy benefits management..."The lawsuit challenges a fundamental aspect of PBM-insurer relationships: the value of a PBM’s negotiating power" with drug makers. The dispute could "embolden other (Express Scripts) clients to do the same" thing and claim they are not receiving rebates to which they are entitled...Another industry watcher...suggests that Anthem may have an additional motive for its lawsuit beyond recovering money. Anthem plans to merge with Cigna...which happens to have its own pharmacy benefits manager..."Anthem likely wants to bring its PBM function back in house as part of a combined Anthem-Cigna company,"..."Perhaps Anthem’s dispute with Express Scripts is in part a way to convince the FTC to approve the Anthem-Cigna merger because it would increase competition in the PBM market."...

If a drug does a good job of treating lung cancer, but is less effective at combating pancreatic cancer, you might think that the price should be lower for pancreatic cancer patients. But it doesn’t work that way in the convoluted world of pharmaceutical pricing, where a one-size-fits-all approach is generally used...Now, though, a new drug pricing scheme is gaining traction that would base payments on how well a medicine actually works...The concept, which is known as indication-specific pricing, would set different prices for the same drug to reflect the extent to which a medicine is effective for multiple purposes. The goal is to calibrate spending with performance and, in turn, lower overall health care costs.

Investors in Sprout Pharmaceuticals, which makes the first drug to treat low sexual desire in women and was bought by Valeant Pharmaceuticals International Inc last year, say the drug has been priced too high...By overcharging for the drug and neglecting to market it, Valeant has undercut the commercial success of the drug...Valeant priced Addyi (flibanserin)... at $800 a month even though Sprout had established a price point of about $400 a month based on market research...Due to the higher price point, insurance companies refused to cover the drug, helping to make it unaffordable for millions of women...Valeant said it was continuing to work closely with pharmacists, healthcare providers, and patients to educate them about the drug...Valeant intends to comply with all of its obligations under our agreement with the former shareholders of Sprout, including, as they relate to marketing spend, number of sales reps, and post-marketing studies...

In the latest attempt to curb the spiraling opioid epidemic, generic companies will face new drug development requirements before they can sell copycat versions of abuse-deterrent opioids, according to a draft guidance released today by the Food and Drug Administration...the agency is recommending that generic drug makers run a variety of studies and provide data analyses to demonstrate that their medicines are no less abuse-deterrent than the brand-name products on which they base their own medications...We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse...encouraging generic alternatives can achieve that goal, especially since these are generally lower-cost alternatives to brand-name medicines...The draft guidance, however, won’t be finalized until after a 60-day comment period and the agency digests the reactions...The greater concern is whether the tamper resistance and abuse deterrence of the original formulation is sufficient. Many people abuse and misuse opioids orally, in which case tamper resistance will be essentially ineffective...

Has Obamacare Reduced Costs?...Those family cost savings, of course, have not materialized...the health care cost curve is still on an upwardly mobile trajectory...Centers for Medicare and Medicaid Services data show that total per capita health insurance spending will rise from $7,786 in 2016 to $11,681 in 2024. Looking at the future of employer-based health insurance costs, the Congressional Budget Office (CBO) projects that job-based premiums are poised to increase by almost 60 percent between now and 2025...the Affordable Care Act...calls for sustained payment cuts to the popular Medicare Advantage program. It also has scheduled some big Medicare payment reductions over the next ten years for hospitals, nursing homes, home health agencies and even hospice care programs...Medicare trustees report that, if policymakers really go through with these Affordable Care Act provisions, 50 percent of America’s hospitals, 70 percent of the nation’s nursing homes and 90 percent of the nation’s home health agencies will be operating in the red in the next 24 years...This...will jeopardize seniors’ access and quality of care.

U.S. doctors and hospitals throw out almost $3 billion in unused cancer drugs each year because the medicines come in supersized single-use packages and excess medicine must be discarded for safety reasons, a recent paper suggests...Researchers focused on 20 expensive medicines that are given by injection or intravenous drip and require doses adjusted based on the patient’s body size. Often, the packages contain much more medicine than patients need, and the leftovers wind up in the trash...The waste is driving up the cost of their care and it is money that they are spending that provides them no benefit...It also drives up the cost for their insurance, which leads to higher premiums, which costs them more money too...Patients and insurers pay drug manufacturers about $1.8 billion a year for medicines that are thrown away...Biologic medicines often lack preservatives and have a higher risk of contamination than other drugs, and leftovers from single-use vials are thrown out because using them could give patients infections...One of the clearest solutions to this waste is to have more dosing options available...That would require drug makers to sell the medicines in a variety of package sizes.

Aprecia Pharmaceuticals announced the U.S. availability of its Spritam (levetiracetam) tablets...The epilepsy medication is the first tablet made using the company’s ZipDose 3D printing technology to be approved by the Food and Drug Administration. It is designed to dissolve with a sip of liquid, easing the process of taking medication for patients with difficulty swallowing...

India has defended its right to grant licenses allowing local firms to override patents and make cheaper copies of drugs discovered by big Western drugmakers, and said reports to the contrary were "factually incorrect"...The Commerce Ministry statement comes weeks after...media in India quoted the...U.S.-India Business Council, as saying India had given private assurances that it would not grant such "compulsory licenses"..."In this regard, it may be noted that India has a well-established TRIPS (Trade-Related Aspects of Intellectual Property Rights) compliant legislative, administrative and judicial framework to safeguard IPRs (intellectual property rights). Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."...The USTR (U.S. Trade Representative) has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favor local drug makers. A legal provision that allows granting of "compulsory licenses" has been a key bone of contention.