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The pharmaceutical industry’s growing interest in orphan disease shows no sign of diminishing, and for good reason. The increased R&D investment in these indications in recent years has translated into a growing share of overall pharmaceutical sales...The drivers of this change include the favourable regulatory treatment of orphans, as well as market exclusivity and pricing advantages that make such drugs much more profitable than non-orphans. It is notable that the top 25 non-oncology orphan drugs in 2022 are expected to show a compounded growth of 18% over the next six years, almost three times the wider market average...Orphans...remain one of the brightest spots of pharmaceutical development, and the legislation framing them is widely claimed to have been a great success in public policy terms. However, there is a risk that before long orphans could face the same sort of pricing pressure as is common in non-orphan indications...

Spending on prescription drugs for health plans created under the Affordable Care Act increased last year at a rate more than three times that of other commercial plans and most government-run plans managed by Express Scripts Holding Co...year-over-year spending per person for individual insurance plans sold on the Obamacare exchanges where it manages the pharmacy benefit rose 14 percent in 2016, driven by higher drug prices and utilization...Express Scripts said per-capita spending for other commercial plans it manages, mostly for employers, rose just 3.8 percent last year, despite an 11 percent increase in list prices for brand-name drugs...Drug spending for plans the company manages under Medicare...increased 4.1 percent last year while the rise for Medicaid...was 5.5 percent.

Middlemen who manage drug benefits for employers and insurers should be under greater government oversight of their pricing and billing practices to make health care cheaper, an independent pharmacists’ group said (National Community Pharmacists Association)...plans to lower prescription drug costs will only succeed if greater transparency is imposed on pharmacy benefit managers...Benefit managers engage in price negotiations that are often kept secret for competitive reasons, with manufacturers on one end and pharmacies on the other. Pharmacists have criticized these discussions, as well as so-called clawbacks -- extra profit for the PBM after co-pays for cheap, generic medicines exceed the price of the drug itself...PBMs...continue to operate in a virtual black box...As the outcry over drug pricing intensifies, the middlemen have gained more attention...

The next few years are likely to see a major attempt to use market mechanisms to reduce the cost of U. S. healthcare. Healthcare costs are rising again, and Republican campaign promises will put huge pressure on the federal budget. Republicans prefer market based solutions to problems, and they harshly criticize the parts of Obamacare that expand health insurance participation by means of entitlements and sanctions...they feature a shift from defined benefit federal health programs like Medicare and Medicaid, which entitle individuals to the care they need mostly at government expense, to defined payment programs that give individuals a fixed payment based on their life status and leave them responsible for buying the care they need…Since the beginning of the digital health era, entrepreneurs have been interested in creating businesses that enable healthcare consumerism...Healthcare consumerism is very hard to pull off. Price data is still hard to access, understand, and compare...I suggest these guiding principles for entrepreneurs seeking to ride the new wave of healthcare consumerism:

• Choose a sector with favorable characteristics: one in which consumers can judge the value of one offering relative to another and, given choices with different prices, they can choose better value without great risk or inconvenience.
• Consider business models that give healthcare consumers the benefit of professional buyers acting on their behalf.
• ...bear in mind that there are many opportunities in digital healthcare beyond business models that enable healthcare consumerism...businesses focused on making healthcare more efficient by other means, or solving long-standing problems of patient outcomes, comfort, safety, and convenience stand to do well...

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

The World Health Organization warned on Monday that a dozen antibiotic-resistant “superbugs” pose an enormous threat to human health, and urged hospital infection-control experts and pharmaceutical researchers to focus on fighting the most dangerous pathogens first...Many consider the new strains just as dangerous as emerging viruses like Zika or Ebola...the...European Center for Disease Prevention and Control estimated that superbugs kill 25,000 Europeans each year; the C.D.C. has estimated that they kill at least 23,000 Americans a year...New antibiotic candidates are in short supply...because 70 years of research have made it harder to find new ones, and because they are not very profitable for pharmaceutical companies...In the United States, although constant vigilance is crucial, the problem has actually declined in the last decade...

Pfizer Inc. said that it received two subpoenas from the U.S. Attorney’s office in Massachusetts related to charities that help Medicare patients afford co-payments for drugs, the latest company to disclose involvement in the probe...The...subpoenas...requesting documents related to the Patient Access Network Foundation and other organizations that provide financial assistance to Medicare patients. Pfizer donated more than $10 million to the PAN Foundation in 2016...including for funds related to kidney cancer and...acromegaly...A long list of drugmakers have now received subpoenas about their relationships with patient assistance charities, some related to how they help people in the Medicare drug program for the elderly afford the co-payments for drugs...As drug prices have surged, pharmaceutical companies’ large contributions to charities have given them a public-relations foil against backlash and helped keep patients from seeking lower-priced medicines. The seven biggest co-pay charities, which cover scores of diseases, reported combined contributions of $1.1 billion in 2014...

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.

Eric Pusey has to bite his tongue when customers at his pharmacy cough up co-payments far higher than the cost of their low-cost generic drugs, thinking their insurance is getting them a good deal...Pusey’s contracts with drug-benefit managers at his Medicap Pharmacy in Olyphant, Pennsylvania, bar him from volunteering the fact that for many cheap, generic medicines, co-pays sometimes are more expensive than if patients simply pay out of pocket and bypass insurance. The extra money -- what the industry calls a clawback -- ends up with the benefit companies…Clawbacks, which can be as little as $2 a prescription or as much as $30, may boost profits by hundreds of millions for benefit managers and have prompted at least 16 lawsuits since October. The legal cases as well dozens of receipts obtained by Bloomberg and interviews with more than a dozen pharmacists and industry consultants show the growing importance of the clawbacks.

Drug pricing in the U.S. is in need of a fix. Mired in layers of complexity and controversy, experts insist that pharmaceutical manufacturers can take basic steps to navigate the process more smoothly through improved transparency, better communication about products’ clinical value, and tighter internal organization that focuses on the drug’s full revenue life-cycle...many factors should be considered when pricing drugs and biologics, including the clinical value of the drug compared to its competitors, the increased survival and quality of life with the drug, patient affordability, competitors’ prices and the effect of various discount programs…

• ‘Thinking in bits and pieces’...some companies ahead of the curve are managing price, adding analytics and tracking patients’ journeys with the assistance of electronic health records and other technologies...
• Understanding risk and reward...The stakes are high for pharma manufacturers, and they "have to understand what their risk and reward is with pricing," and follow up with analytics to determine the best ways to move forward...what we’re really trying to do [is improve] communicating and understanding the value of these drugs,"...