- 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...
- New York takes drug pricing into its own hands with new clampdown (fiercepharma.com)
New York Governor Andrew Cuomo has...unveiled a first-of-a-kind proposal to curb “exorbitant” prescription prices in the Empire State...New York will create a “review board” to determine the “fair price” for certain expensive drugs under the plan...and then the state will mandate that Medicaid won’t pay more than that amount for its purchases. When a company charges Medicaid more than the board’s set price, it’ll owe a “rebate for any amount” in excess...The proposal would also impact private markets. If a pharma company sells into the state at a price higher than the board’s set amount, that sale will be hit with a surcharge; the government will collect that money and reallocate it “back to the insurance providers to reduce the cost of insurance.”…Lastly, Cuomo's proposal includes new restrictions on pharmacy benefit managers, forcing them to register with the state and disclose “financial incentives or benefits for promoting the use of certain drugs, as well as other financial arrangements affecting customers,”...Then, under the plan, PBMs must have a license beginning in 2019 and the state could revoke those licenses for “deceptive, unfair, or abusive business practices.”...
- NCPA suggests any changes to ACA maintain Rx coverage and pharmacy access (drugstorenews.com)
The National Community Pharmacists Associatio...reached out to Republican congressional leaders to provide the community pharmacist perspective on repeal and replacement of the Affordable Care Act and potential Medicaid changes...Specifically, NCPA recommended any repeal and replacement of ACA include the following provisions:
- Preserve prescription drug coverage as an essential benefit to help reduce overall health costs;
- Require a robust pharmacy network that includes meaningful access to retail pharmacies, including independent pharmacies, for patients to fill their prescriptions and promote proper adherence;
- Maintain current definition for Average Manufacturer Price that is used to determine Medicaid reimbursements;
- Retain sections of the ACA that were dedicated to improving Medicare Part D medication therapy management programs, including an annual comprehensive medications review, and build upon it to further integrate pharmacists into the health care delivery system; and
- Keep transparency provisions requiring pharmacy benefit managers serving exchange plans and Medicare Part D to disclose to HHS the generic dispensing rate for retail and mail order pharmacies, the amount of the rebates collected, the amount passed onto the health plan and the total difference between what the PBM charged the plan and what it paid out to pharmacies
- Federal judge orders state to provide Mumia Abu-Jamal with hepatitis C treatment (philly.com)
A federal judge...ruled that Mumia Abu-Jamal should be provided new medications by the state to treat his hepatitis C infection...U.S. District Judge...ordered that Abu-Jamal, who is serving life in prison for the 1981 killing of Philadelphia Police Officer Daniel Faulkner, must be seen by a doctor within 14 days to determine if there is a medical reason he should not get the expensive drugs...If...is medically cleared, the state must provide him with recently developed direct-acting antiviral medication, also known as DDA (DAA, Direct-Acting Antivirals)... Department of Corrections...has argued in court filings that Abu-Jamal has not met the criteria for treatment...The state has about 7,000 inmates with hepatitis C, and treating them - at a cost of $84,000 to $90,000 per person - would cost $600 million... DOC will no doubt appeal this ruling...
- Former Lincoln County commissioner sentenced in insurance fraud case (reviewjournal.com)
A former Lincoln County commissioner was sentenced Friday to one-to-four years in prison for defrauding insurance companies...Adam Katschke...previously pleaded guilty to felony insurance and Medicaid fraud in the case...Katschke, the head pharmacist and owner of Meadow Valley Pharmacy in Caliente, defrauded insurance companies...by billing for large amounts of pharmaceutical prescriptions that were rarely provided as billed to the patients or prescribed by a physician...The sentencing...ordered Katschke to pay $1.5 million in restitution...The defendant stole a million and a half dollars from taxpayers through Medicaid, a program designed to provide care for those in need, not line the pockets of fraudsters…
- This Week in Managed Care: January 13, 2017 (ajmc.com)
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
- IBM Watson and FDA to develop secure ‘blockchain’ patient data sharing (pharmaphorum.com)
IBM Watson is to work with the FDA to investigate the use of blockchain technology, seen as one of the most secure ways of sharing patient data...(it) allows each separate patient data source to be a ‘block’ part of a complete, unalterable patient data profile which can then be shared securely with healthcare providers or research organisations...Initially focused on oncology-related data, the collaboration will look at how best to exchange data gathered from multiple owner mediated data sources such as Electronic Medical Records, clinical trials, genomic data, mobile devices, wearables, and Internet of Things technologies...The deal aims to overcome the limitations of large scale sharing of health data seen in the past, namely data security and patient privacy concerns during the data exchange process.
- U.S. Supreme Court agrees to hear dispute over biologic drug sales (reuters.com)
The U.S. Supreme Court...agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them...an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the...company from selling its biosimilar version of...Amgen Inc's $1-billion-a-year Neupogen until six months after the Food and Drug Administration approved it. The case could determine how quickly patients have access to biosimilar medicines at potentially cheaper prices...The dispute arose when Amgen sued Sandoz...alleging patent infringement and violations of the law governing biosimilars. The companies disagreed on how to apply the law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version...The justices...also agreed to resolve Amgen's appeal in the same case over whether biosimilar makers must give brand-name manufacturers a copy of their application to make a copycat drug after it is submitted to the FDA.
- Pharmacy Week in Review: January 13, 2017 (pharmacytimes.com)
Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance (raps.org)
In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration...finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name...The decision to finalize this guidance follows...but large opposition to the idea of using meaningless rather than meaningful suffixes that could make it easier to distinguish the manufacturers of the products...For example...Sandoz’s Zarxio, which includes a non-proprietary name with a meaningful suffix (Sndz for Sandoz): filgrastim-sndz...But FDA has said it will change Zarxio’s nonproprietary name from filgrastim-sndz to “filgrastim-bflm." And Amgen's Neupogen (filgrastim) would be changed to "filgrastim-jcwp."...But these suffix rules do not necessarily apply to all related biologics...some instances it has designated a proper name that includes an identifier attached as a prefix to distinguish the products from previously licensed biologics. For example, with ado-trastuzumab emtansine, FDA includes a unique prefix, which it says was necessary to minimize certain medication errors and to facilitate pharmacovigilance.