- Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds: report
There’s no denying that financial incentives for orphan drug development spawned meds that have saved hundreds of thousands of lives. But they’ve also helped mass-market drugmakers rack up millions in incentives, tax breaks and patent-protected profits—in some cases through monopoly pricing...About one-third of the orphan drug approvals the FDA doled out since the program began more than 30 years ago have been for repurposed, large-market products or drugs with multiple orphan green lights...Best-sellers such as Crestor…,Abilify…,Herceptin…,and Humira...fall into the category of big sellers whose makers snagged millions in government incentives—not to mention seven years of exclusive rights on the market—when they resubmitted their therapies as treatments for smaller populations...What we are seeing is a system that was created with good intent being hijacked…Repurposing a drug isn’t necessarily a bad thing, of course, if it can help get a treatment to additional patients...But when the orphan incentives allow competition-free drugmakers to charge whatever prices they want for their meds?...Now...it seems like...this practice may be driving up prices...Industry lobby groups...are unsurprisingly in favor of maintaining the status quo. With rare diseases “tragically killing and brutalizing mostly children,” incentives for orphan drugmakers should be kept in place...the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar...
- Bipartisan thinktank offers FDA fixes (healthcareitnews.com)Advancing Medical Innovation for a Healthier America (bipartisanpolicy.org)
"Americans cannot afford to rely on 20th century methodologies for treatments when the world is on the cutting edge of new medical technologies. Federal agencies must be equipped to keep the U.S. at the forefront of medical innovation."… much of the report focuses on improving the FDA’s ability to work more quickly to evaluate and approve new devices and therapies.
- Retail Pharmacist MTM Roles Supported by US House (pharmacytimes.com)
More than 40 members of the House of Representatives have expressed support for greater pharmacist roles in improvements made to Medicare Part D’s medication therapy management program...CMS announced plans to improve MTM with its Part D Enhanced MTM model in September 2015. The enhanced model aims to look at additional incentives and flexibilities to achieve the goals of the program...Some of those goals include increased communication with pharmacists, prescribers, and patients; improved patient knowledge; reduced medication problems; and improved compliance with medication protocols...The enhanced MTM model test will launch in January 2017...Some of the medication adherence concerns that the Congressional members noted were:
- Nonadherence costs the United States $290 billion annually and makes up 13% of total health care expenditures.
- Patients with several chronic conditions comprise two-thirds of all hospital admissions and are 100 times more likely to have a preventable admission.
- These patients with several chronic conditions visit many different physicians in a year and receive around 50 prescriptions annually on average.
- MTM is currently poorly integrated into health systems.
Congressional leaders called for retail pharmacists to be included in the enhanced MTM models that will be tested, citing how pharmacists have been shown to improve patient health, reduce costs through fewer hospitalizations and readmissions, and increase patient involvement in their own medication management...Our seniors deserve the most robust and effective MTM program possible—one that includes the utilization of the most trained and highly skilled providers medication management services: local retail community pharmacists...
- When Does Workplace Wellness Become Coercive? (khn.org)
….health coverage through an employer that uses financial rewards and penalties to get workers to sign up for wellness programs…today, a small but growing number of employers tie those financial rewards to losing weight, exercising or dropping cholesterol or blood-sugar levels…The incentives….can add up to hundreds, or even thousands, of dollars a year.
- AbbVie buys special review voucher for $350 million (reuters.com)
AbbVie Inc has bought a (FDA) priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs…pediatric disease priority review voucher…eligible to have one of its drugs reviewed in six months, compared to the standard 10 months...AbbVie did not disclose its plans for the voucher...