- FDA looks at incentives, manufacturing ‘interventions’ to solve drug shortages (fiercepharma.com)
The FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers...FDA Commissioner Scott Gottlieb, M.D...announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it...“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”...The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur...the FDA may want to consider “more significant interventions” than it currently employs. “We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals." One suggestion is to grant the FDA authority to require applicants of certain drugs to conduct a “risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage," and to establish risk mitigation plans in advance to address those weaknesses...
- After the Valeant-Philidor Blowup, PBMs Clamp Down on Network Pharmacies (drugchannels.net)
The initial fallout from the Valeant-Philidor kerfuffle has hit the pharmacy industry. Over the past few weeks, the major pharmacy benefit managers have begun dropping pharmacies from their networks. Some PBMs are also reminding retail pharmacies that they are prohibited from acting as mail pharmacies…I highlight the high-profile network pruning by the top three PBMs—Express Scripts, the Caremark PBM business of CVS Health, and the OptumRx business of UnitedHealthcare. I also speculate on the factors that would lead a PBM to clash with a pharmacy in its network…An as-yet-unanswered question: If PBMs routinely monitor their networks, why did it take a highly publicized pharmacy meltdown before PBMs finally cracked down?
- Medical plans dangle gift cards and cash to get patients to take healthy steps (beta.latimes.com)
Health plans, medical practices and some Medicaid programs are increasingly offering financial incentives to motivate Medicaid patients to engage in more preventive care and make healthier lifestyle choices...They are following the lead of private insurers and employers that have long rewarded people for healthy behavior such as quitting smoking or maintaining weight loss. Such changes in health-related behavior can lower the cost of care in the long run...“We’ve seen incentive programs be quite popular in the insurance market, and now we are seeing those ramp up in the Medicaid space as well,” said Robert Saunders, research director at the Margolis Center for Health Policy at Duke University...Medicaid patients who agree to be screened for cancer, attend health-related classes or complete health risk surveys can get gift cards, cash, gym memberships, pedometers or other rewards. They may also get discounts on their out-of-pocket health care costs or bonus benefits such as dental care.
- Why Do Pets Have Better Web Portals For Medical Records Than Humans? (healthaffairs.org)
..realities of having children is that it is very likely you will also have pets…with pets come responsibilities…such as...taking your cat to the veterinarian…my vet provides access to a health information web portal for my pets,…it was not until the recent release of proposed revisions to Stage 2 Meaningful Use requirements…that I realized perhaps web portal designers for human electronic health records could learn a thing or two from what I know is already available for pets...
- 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...