Controversy Over The Costliest Drug On The Planet Goes Far Beyond Just The Price Tag
The FDA is poised to approve treatment for a rare disorder that had doomed children to death. But the expected price would make it the most expensive drug on the market. Not only does it raise questions about the cost and value of gene therapies, but it also brings to light fierce bare-knuckle fight between two drugmakers involved. In other pharmaceutical news: Democrats' drug strategy, pharmacy benefits managers, pricing for HIV prevention pills, generics, a kickback case, a nonprofit's first product, and much more.
The Washington Post:
The Costliest Drug On The Planet: New Treatment For Spinal Muscular Atrophy Sparks Rivalry
Until three years ago, infants diagnosed with a rare disease known as spinal muscular atrophy were doomed to death or heartbreaking disability. If babies survived, many parents were forced to build virtual ICUs in their homes. Then gene science brought a drug to market in 2016 that gave afflicted children a strong chance at life, maybe even freedom from a wheelchair. Now, the Food and Drug Administration is poised to approve a second gene treatment for infants with SMA, and with a price tag of $1.5 million to $5 million, it will be the most expensive drug on the planet. (Rowland, 5/15)
Stat:
In Washington, A Partisan Approach To Lowering Drug Costs Leaves Democrats Doubting Their Own Party Leadership
Two top Democratic lawmakers are questioning Speaker Nancy Pelosi’s strategy to couple legislation to lower prescription drug costs with far more contentious Obamacare bills, saying the tactic nixes potential for a bipartisan win. Democratic leadership plans to hold a floor vote Thursday on the combined package of health care bills — effectively rebuking the Trump administration for its attempts to roll back the Affordable Care Act and simultaneously daring Republicans to vote against drug pricing reforms that are increasingly popular. (Facher, 5/16)
CQ:
House Vote Combining Drug, Health Law Bills Irks Republicans
The House is set to vote Thursday on legislation meant to lower prescription drug prices and strengthen the individual health insurance exchanges, setting up a political minefield for Republicans who are torn between the two issues. Democratic leaders’ decision to combine legislation that would make it easier to bring generic drugs to market with bills that would bolster the 2010 health care law (PL 111-148, PL 111-152) does not damage the prospects of passage for the package of bills. But that does make it certain that most Republicans will vote against the bipartisan drug pricing legislation. (McIntire, 5/16)
Stat:
Gilead CEO To Testify Before A House Committee About Pricing For Its HIV Prevention Pill
Gilead Sciences (GILD), which is already the subject of red-hot attention for its business practices, is about to come under still more scrutiny when a House committee holds a hearing on Thursday about pricing for its Truvada HIV prevention pill. And Gilead chief executive Daniel O’Day will be among those testifying. AIDS activists have increasingly lambasted the company for pricing they claim has caused access issues and have implored the federal government to pursue royalties on a key patent that was filed by researchers whose work was funded, in part, with taxpayer dollars. (Silverman, 5/15)
Modern Healthcare:
CMS Seeks To Limit 'Spread Pricing' By PBMs In Managed Care
The CMS is concerned that some Medicaid managed care plans are not accurately reporting "spread pricing," a tactic where pharmacy benefit managers charge a plan more for a drug than it reimburses a pharmacy. The agency released a regulatory guidance on Wednesday intended to help states monitor and audit Medicaid and CHIP managed care plans to identify spread pricing when calculating their medical loss ratio (MLR). The guidance clarified that plans must include a PBM rebate in calculating an MLR if the PBM used a subcontractor. (King, 5/15)
Bloomberg:
Swarms Of Bugs, Missing Data Plague Firms Now Making Heart Drug
A pair of drugmakers in India that the U.S. is counting on to produce generic blood-pressure pills after a far-reaching recall have been faulted by regulators for quality-control issues. Cadila Healthcare Ltd. and Alkem Laboratories Ltd. both won approvals in March from the Food and Drug Administration to make generic versions of valsartan for the U.S. market. Neither company made any of the recalled valsartan, but both companies have recently been cited by agency inspectors for quality-control failures that echo problems at other drugmakers -- renewing questions about the safety of some of the world’s most widely prescribed medicines. (Edney, 5/16)
Modern Healthcare:
Civica Rx Partners With Xellia Pharmaceuticals On First Generic Drugs
Civica Rx teamed up with Xellia Pharmaceuticals to produce the antibiotics vancomycin and daptomycin for Civica's members, the companies announced Wednesday. The drugs used to treat critically ill patients with serious infections are the first that the hospital-led not-for-profit generic drug company have identified. Civica, bolstered by the support of more than 800 U.S. hospitals, plans to deliver 14 generic medications this year as it aims to reinforce the supply of generics prone to shortage and reduce drug costs. (Kacik, 5/15)
Stat:
Novartis May Be Close To Settling Kickback Case On The Eve Of A Trial
After six years of jousting, Novartis (NVS) appears close to settling a lawsuit in which the federal government alleged the drug maker used kickbacks to doctors — including fishing trips and lavish meals — in order to boost prescriptions of several medicines, according to sources familiar with the matter. There is no guarantee that a deal will occur. A trial date was set for this coming Monday in a Lower Manhattan courtroom, although a pretrial conference that was scheduled for last Friday was adjourned the previous day, according to court documents. Details of a settlement could not be learned, but sources indicate the company may agree to pay close to $1 billion to resolve the case. (Silverman, 5/15)
Stat:
Shaped Like A Tennis Ball, This Cancer Protein Was Thought ‘Undruggable.’ Amgen Found A Way To Target It
Scientists have long known that a mutant form of the cell-signaling protein called KRAS causes cancer, but discovering drugs capable of blocking KRAS has proven difficult. The protein is spherical and nearly featureless — its structure has been compared to a tennis ball — leaving potential drugs with few, if any, effective attachment points. On Wednesday, Amgen (AMGN) is reporting early but potential progress in an effort to block mutant KRAS and kill cancer cells. The Amgen drug, a small molecule pill called AMG 510, caused tumors to partially shrink in 30% of patients with lung tumors that tested positive for a particular kind of KRAS mutation. (Feuerstein, 5/15)
Bloomberg:
Sanofi Joins Drugmakers' Bid To Treat Patients With Software
Sanofi is joining other big pharmaceutical companies in expanding beyond pills and injections into a new frontier of tech-based treatments that doctors can prescribe. Working with partner Happify Health, the French drugmaker is studying a potential digital therapy for patients with depression and multiple sclerosis. That follows the launch last year of a similar type of prescription treatment from Novartis AG and Pear Therapeutics Inc. aimed at substance abuse, the first of its kind to win U.S. Food and Drug Administration approval. (Paton, 5/15)
PBS NewsHour:
Conn. Attorney General Calls Generic Drug Makers A ‘Private Sector Cartel’
Affordable health care is a persistent concern for Americans and a topic of great political debate. Typically, generic prescription drugs offer a cheaper alternative to name brands, but a new multi-state lawsuit alleges that their manufacturers have been artificially raising prices. (Yang, 5/15)
Columbus Dispatch:
New Federal Guidelines Target Excessive Profits By Pharmacy Benefit Managers
Citing Ohio’s struggles with rising drug costs, federal regulators on Wednesday announced new reporting guidelines for tax-funded Medicaid managed-care plans aimed at eliminating excessive profits. The Centers for Medicare and Medicaid Services’ directive targets pharmacy middlemen’s use of “spread pricing” and rebates from drug manufacturers to boost earnings. (Candisky, 5/15)
