- The ‘cruel joke’ of compassionate use and right to try: Pharma companies don’t have to comply (statnews.com)
...the FDA has a compassionate use program to allow people access to experimental drugs, it can’t compel a company to provide those drugs. The newly signed “right-to-try” law doesn’t either...the Food and Drug Administration calls its expanded access program, also known as compassionate use. It governs the use of an investigational medicine that has not been approved by the FDA outside of a clinical trial...Here’s how it is supposed to work. A physician caring for a patient with a terminal illness who has exhausted all other treatment options and isn’t eligible for a clinical trial appeals to the pharmaceutical company to provide an investigational drug that has undergone at least a Phase 1 trial, which studies the safety of a drug. If the pharmaceutical company agrees, the treating physician applies to the FDA for approval for expanded access to the investigational drug...Large pharmaceutical companies are notoriously risk averse when it comes to expanding access to medications that are still in the testing phase. Many refuse to grant access to investigational drugs outside of clinical trials...One fear they have is that an adverse event, like an injury or death — even if it is not directly due to the medication — will derail a company’s ability to push a drug forward for FDA approval...Pharmaceutical companies also worry that if an experimental medication is given to one patient through compassionate use, it must be given to all patients who request it. In the case of rare diseases...this could mean that a company would have trouble enrolling enough patients when it eventually opens a clinical trial...
- Another antibiotic crisis: fragile supply leads to shortages (reuters.com)
Shortages of some life-saving antibiotics are putting growing numbers of patients at risk and fuelling the evolution of “superbugs” that do not respond to modern medicines...The non-profit Access to Medicine Foundation said there was an emerging crisis in the global anti-infectives market as fragile drug supply chains - reliant on just a few big suppliers - come close to collapse...Global demand for antibiotics has grown by two-thirds since 2000, driven by population growth and the need for medicines to fight infectious diseases in low- and middle-income countries...Most antibiotics are cheap, off-patent generic medicines, which is good for affordability. But that also means they have very low profit margins - particularly compared to modern drugs for diseases like cancer - offering manufacturers little incentive to invest in new production facilities...antibiotic shortages can have especially dire consequences, since doctors have to resort to sub-optimal treatments that are less efficient at killing specific pathogens, leading to the rise of resistant bacteria or so-called superbugs...
- June 1 Pharmacy Week in Review: New Hepatitis C Virus Guidelines and Lyme Disease Prevention (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- EMA post-Brexit: will the UK become a second-tier state? (pharmaceutical-technology.com)The impact of Brexit on the pharmaceutical sector (publications.parliament.uk)
...the Business, Energy and Industrial Strategy Committee released a report detailing the consequences of the UK leaving the EU without a deal for the pharmaceutical industry...UK-headquartered pharma companies generated a total of $87.5bnin global sales...A small reduction in the size of the sector could therefore have significant effects on the UK economy...Findings in the BEIS report suggest that if the UK fails to reach an agreement with the EU for the industry during Brexit negotiations, there is a risk of the UK becoming a second-tier state in pharmaceuticals...The UK’s future role in the European Medicines Agency...is expected to significantly impact the UK’s pharmaceutical sector post-Brexit. If the UK government does not negotiate regulatory parity with the European Economic Area, the UK will no longer have access to the single marketing authorisation for EU and EEA countries, requiring companies to submit a separate UK application for any new drug...This would require duplication of staff and facilities to conduct clinical trials and submit regulatory applications in both the UK and the EU, costing pharmaceutical companies millions of dollars. BEIS warns these consequences will make the UK an unattractive small market and result in complete loss of access to certain drugs, particularly specialised therapies...
- Women’s hormone drug prices have climbed for years, but controversy hasn’t ensued. Why? (fiercepharma.com)
Several drug pricing scandals have grabbed headlines in recent years in cases in which companies hiked the prices of old drugs or jacked up the cost of blockbuster drugs little by little year after year. Another case hasn't garnered the same attention—and maybe that's because people just don't like to talk about vaginas...insurers have shifted more costs to patients through higher deductibles and copays, leaving patients with a higher share of the bill, and that means women are paying more out of pocket...To avoid that, some resort to buying the remedy from overseas outlets...some insurers have placed the drugs on high formulary tiers, so patients must pay more to get them...
- EU plan to boost off-patent manufacturing, create 25,000 jobs sparks big pharma backlash (in-pharmatechnologist.com)
Officials are considering adding an “export manufacturing waiver” to the Supplementary Protection Certificates that extend patent protection. The waiver would allow companies to manufacture drugs covered by SPCs at sites in Europe, provided the products are destined for export to markets in which patent protection has lapsed or never existed...The Commission is proposing the waiver to enable companies based in the European Union to meet demand for biosimilars and generics in emerging markets and other overseas territories. Currently, SPCs can prevent manufacturers from using their European operations to supply drugs for export, potentially making them less competitive than their foreign peers...This will help create growth and high-skilled jobs in the EU. It could generate €1bn ($1.2bn) net additional sales per year and up to 25,000 new jobs over 10 years...the European Federation of Pharmaceutical Industries and Associations questioned whether the policy will achieve its objectives and said it may create friction between the EU and its trading partners...EFPIA...perceives clear downsides to a policy it sees as devaluing the European intellectual property framework and deterring investment in the region...
- New behavioral institute set to open this fall (kolotv.com)
The Stacie Mathewson Behavioral Health and Addiction Institute will focus on identifying the causes of mental illnesses and addiction at early ages. Thanks to a $6 million donation by Charles and Stacie Mathewson, parents and the medical community will have more resources to help battle addiction and mental health issues..."We don't have enough specialty providers that know how to treat children and adolescents in the community. It's a severe lack; we need more people to specialize in that population and those kids and being able to reach them early," said Kristen Davis-Coelho, psychologist at Renown Regional Medical Center...The Institute will also track babies who are born addicted and help provide individual case management to meet the medical needs of the babies, as well as parents working toward long-term recovery or support for foster and adoptive parents.
- Cost of ER visits in Nevada rising quickly, report says (reviewjournal.com)
...if you get injured or ill in Nevada, you will pay the second-highest price in the nation just to step through the ER doors...The cost of an emergency department visit in the Silver State, not counting the services actually rendered once you’re admitted, is rising at the fastest rate in the country, according to a report published...by the Health Care Cost Institute. The average price per claim in Nevada was $1,281 in 2016, trailing only No. 1 California by $7...From 2009 through 2016, the latest year for which data was available, the price of an emergency department visit increased 147 percent in Nevada...It rose 98 percent nationwide in the same time period...It could be that Nevadans today are sicker than they were a decade ago...Or it could be that Nevada’s ERs are looking to offset the costs incurred by an increasing number of Medicaid patients...A 2014 expansion of the federal program in the state doubled the number of Medicaid patients to more than 600,000, but state health care providers receive one of the lowest reimbursement rates in the nation...
- This Week in Managed Care: June 1, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Alibaba injects pharmacy assets into health-care unit in $1.4 billion deal (cnbc.com)
Alibaba will place some of its online pharmacy business into a listed unit in a deal valued at $1.35 billion....Alibaba Health Information Technology will buy Ali JK Nutritional Products, which controls sales of medical devices, health-care products, adult products, and health-care services on Alibaba's Tmall platform...The deal will see parent Alibaba receive newly issued shares in Ali Health, taking its economic interest in the firm to 56.2 percent from 48.1 percent currently. Alibaba will also have a 67.5 percent voting interest in Ali Health after the deal...The deal should bolster business for Ali Health amid a broader push into a fast-growing health-care technology market...Alibaba CEO Daniel Zhang said in a statement that health care was a "strategically important" business area for the firm and that the deal would help turn Ali Health into the country's "best health-care ecosystem."...Chinese health-care spending is set to hit $1 trillion by 2020, up from $357 billion in 2011...with technology firms increasingly looking to break into a growing private health-care market.