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CVS Health said on Sunday that it had agreed to buy Aetna for about $69 billion in a deal that would combine the drugstore giant with one of the biggest health insurers in the United States and has the potential to reshape the nation’s health care industry...The transaction, one of the largest of the year, reflects the increasingly blurred lines between the traditionally separate spheres of a rapidly changing industry. It represents an effort to make both companies more appealing to consumers as health care that was once delivered in a doctor’s office more often reaches consumers over the phone, at a retail clinic or via an app...A combined CVS-Aetna could position itself as a formidable figure in this changing landscape. Together, the companies touch most of the basic health services that people regularly use, providing an opportunity to benefit consumers. CVS operates a chain of pharmacies and retail clinics that could be used by Aetna to provide care directly to patients, while the merged company could be better able to offer employers one-stop shopping for health insurance for their workers.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

About 11 percent of medicines in developing countries are counterfeit and likely responsible for the deaths of tens of thousands of children from diseases like malaria and pneumonia every year, the World Health Organization said...It's the first attempt by the U.N. health agency to assess the problem. Experts reviewed 100 studies involving more than 48,000 medicines. Drugs for treating malaria and bacterial infections accounted for nearly 65 percent of fake medicines... Between 72,000 and 169,000 children may be dying from pneumonia every year after receiving bad drugs. Counterfeit medications might be responsible for an additional 116,000 deaths from malaria mostly in sub-Saharan Africa...Counterfeit drugs include products that have not been approved by regulators, fail to meet quality standards or deliberately misrepresent an ingredient...In 2013, WHO set up a voluntary global monitoring system for substandard and fake drugs and has received reports of about 1,500 problematic medicines including drugs that claim to treat heart problems, diabetes, fertility problems, mental health issues and cancer. WHO also reported problems of fake vaccines for diseases including yellow fever and meningitis...

When the controversy over the price of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic version available...The answer was complex: while the key ingredient in the anaphylaxis treatment, epinephrine, has been available for decades and is no longer covered by a patent, the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators...the Food and Drug Administration announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others...The FDA guidance says that generic copies with some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended...Dr. Scott Gottlieb, said.."Under this guidance, so long as the generic applicant is able to demonstrate with data, where appropriate, that differences in design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met,"...

The Centers for Medicare and Medicaid Services...offered further insight into how the Meaningful Measures program works...deputy director of CMS' Center for Clinical Standards and Quality, said the initiative to streamline quality reporting was launched in recognition that "there's a fine line between being helpful and being a hindrance."...CMS has heard the feedback from industry stakeholders that there are too many often-overlapping quality measures...Tracking these measures does not always lead to better outcomes for patients...there are two key problems CMS wants to solve with Meaningful Measures...The first is to focus on the highest-priority measures for quality reporting and quality improvement. The second...is to improve the agency's communications with patients, clinicians and stakeholders about what measures they should be paying most attention to...the important concepts we want every measure to be filtered through...Those are: reduce regulatory burden, improve access for rural communities, achieve cost savings, safeguard public health, track to measurable outcomes and impact and eliminate disparities...Those principals...represent the guiding framework for 18 different Meaningful Measure areas that CMS wants health systems to prioritize – they're further grouped under six thematic headings:

1. Make Care Safer by Reducing Harm Caused in the Delivery of Care
2. Strengthen Person and Family Engagement as Partners in their Care
3. Promote Effective Communication and Coordination of Care
4. Promote Effective Prevention and Treatment of Chronic Disease
5. Work with Communities to Promote Best Practices of Healthy Living
6. Make Care Affordable

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Massachusetts' state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value..."This is a serious demonstration proposal,"..."They're not simply using [this idea] as an excuse to cut Medicaid. They're trying to take a step toward efficiency."...If the Department of Health and Human Services approves the...plan, others will likely take similar action...Currently, state Medicaid programs are required to cover almost all drugs that have received Food and Drug Administration approval, including multiple drugs from different manufacturers used for the same purpose and in the same category. In exchange, manufacturers must discount those drugs -- typically based on a set percentage of the list price...The idea is Medicaid's vulnerable beneficiaries get medications they need and the state doesn't go broke paying for them...Massachusetts wants to go a different route, requesting a federal exemption known as a Section 1115 waiver, which is meant to let states test ways of improving Medicaid. It wants to pick which drugs it covers based on most beneficiaries' medical needs and which medicines demonstrate the highest rates of cost effectiveness...It says it will be able to negotiate better prices as a result, saving public dollars while maintaining patients' access to needed therapies...

Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K...The Medicine and Healthcare products Regulatory Agency announced...that it will reclassify the 50 mg dose from prescription only to a pharmacy medicine in the U.K. Viagra Connect is expected to be available for sale in the spring of 2018. Anyone seeking to buy the drug will be required to have a discussion with a pharmacist, who will determine whether the drug is appropriate for their use...It will continue to sell branded versions of other doses of the drug in the U.K...In regard to its U.S. OTC ambitions, Pfizer said, in a statement to FiercePharma, “While we do not have information to share on specific Rx to OTC switch programs in the United States, generally we consider prescription drugs—both within the Pfizer portfolio and outside it—for potential switch to non-prescription status. Our objective is to provide consumers with significantly greater access to medicines with well-established efficacy and safety profiles without a prescription.”

The illegal drug trade on the dark web is growing rapidly, despite authorities shutting down major market sites like AlphaBay, as crime gangs diversify and seek new clients online, a report by two European Union agencies warned...The report, which is the first of its kind to analyze the drug trade in Europe on the dark web, showed that online markets are becoming increasingly sophisticated and offering growing numbers of illegal products to buyers...Users are largely anonymous and untraceable and mainly pay with cryptocurrencies like bitcoin...Two thirds of dark web transactions involve drugs, the report by Europol and EMCDDA (The European Monitoring Centre for Drugs and Drug Addiction) found. The biggest European markets are Germany, Britain and the Netherlands. From 2011-2015, drugs worth more than 170 million euros were sold over the dark web worldwide, including nearly 80 million euros worth in Europe...the dark web is an increasingly attractive market because buyers and sellers are anonymous and there is a perception that drugs bought there are good quality...

New FIP report on the role of pharmacists in reducing harm associated with drugs of abuse includes marijuana...The value of involving pharmacists in reducing harm from drugs of abuse is highlighted in a report released...by the International Pharmaceutical Federation (FIP). The report describes harm reduction services such as needle exchange and opioid substitution in different regions and countries, including Europe, the USA, Canada, central Asia and the Middle East...FIP’s Working Group on Pharmacists’ Role in Harm Reduction...would like pharmacy organisations to engage with policymakers and health authorities to remove barriers to more involvement of pharmacists in harm reduction services...the benefits of harm reduction are many — both to individuals and society — including prevention of infection by HIV and hepatitis C, fewer overdoses and less drug-related criminal activity...The report specifies that a comprehensive service should include: syringe and needle exchange (with the provision of low-dead space syringes where possible); opioid substitution therapy (preferably with pharmacist prescribing or dose adjustment); naloxone supply for overdoses (including pharmacist-initiated supply); and health promotion (including advice on sexual health).