ReportersNotebook — Chain Pharmacy, 4/2/12
SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.
A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said. The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The FDA approved the drug on Jan. 30.
The companies developed the drug under a partnership started last year that resulted in a dispute between Lilly and Amylin Pharmaceuticals, with which Lilly had developed the injected Type 2 diabetes drugs Byetta (exenatide) and its long-acting version, Bydureon, which the FDA also approved on Jan. 30. Lilly and Amylin terminated their agreement in November.
The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said. Eisai said the FDA delivered a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about a regulatory application that preclude approval.
The drug maker said the FDA’s decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.
Increase in Rx costs surpasses inflation rate
Increases in the prices of prescription drugs have far outpaced the rate of general inflation over the years, as increases in the prices of branded and specialty drugs have offset decreases in the prices of generics, according to a new report by AARP’s research arm.
The study, conducted by AARP’s Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.
The study was based on examinations of retail prices for the 514 drugs most used by Medicare beneficiaries. In 2009, while the rate of general inflation was -0.3%, the drugs increased in price by an average of 4.8%. Branded drugs increased in price by 8.3%, while specialty drugs rose by 8.9% and generic drugs decreased by 7.8%.
“For the people who rely on these drugs, such relentless price increases have serious implications,” AARP SVP public strategy Cheryl Matheis said. “Despite price reductions for generics, it’s evident that the considerable increases in brand-name and specialty drug prices are still leaving Americans with overall costs that are growing far faster than the rate of inflation.”
The report found that the “marked” decreases in prices of generic drugs between 2005 and 2007 dropped the rate of increase to slightly below the rate of general inflation for almost six years, but since 2008, continued growth in specialty and branded drugs have “more than offset” the lower costs of generics. The report called the finding striking because generics already had lower prices and represented slightly more than one-fifth of total drug expenditures by Medicare Part D plans in 2006.
For the 469 drugs on the market since the end of 2004, prices increased by 25.6% from 2005 to 2009, while the general inflation rate was 13.3%. Consumers taking drugs to treat chronic diseases found that their average annual cost increased from $2,160 to $3,168.
The report received praise from the country’s largest trade group representing generic drug manufacturers. “The AARP report offers an important reminder of the vital role generic medicines play in reducing costs throughout the healthcare system, while providing patients access to safe, effective and affordable treatment options,” Generic Pharmaceutical Association president and CEO Ralph Neas said. “With evidence of the dramatic savings generic drugs can achieve becoming more prevalent every day, we urge lawmakers to ensure that efforts to reduce spending do not in any way dampen the availability and use of lifesaving and life-enhancing generic medicines. The future of the U.S. healthcare system and the national economy depend on it.”
Readers’ PBM perspectives
A guest column in the March 12 issue of DSN, “Let me tell you what PBMs do,” by Republican Utah State Rep. Evan Vickers, really set off a firestorm of debate on DrugStoreNews.com and on DSN’s social media sites. Check out this snippet from two online users with VERY different perspectives on all of this. For Rep. Vickers’ complete column and to add your own views to the debate, click here.
This article is hopelessly hypocritical, biased and unfair. It’s not supported by facts in most cases. In cases where accusations are supported by facts, they are half-truths. There are many clever implications that the author does not actually explicitly state. Here’s a point-by-point of the accusations.
Accusation: As proof of these claims, the ad campaign cites conclusions of a study by Visante that was prepared for the PCMA, the trade group for the PBMs, which is a bit like a defendant hiring his own expert witness.
Comment: The author implicitly accused Express Scripts (ESI) of paying Visante, but offered no attempt whatsoever to support that accusation.
Accusation: PBMs profit at the expense of consumers.
Comment: So what? Doesn’t the author like capitalism? By definition, profit comes at the expense of customers. … It seems there’s another implicit message in this accusation — that PBMs profit at the expense of consumers and that amount of profit is unfair and greedy. That’s false. PBMs are aligned in their interest with the interest of plan sponsors.
Accusation: PBMs eliminate competition from smaller pharmacies.
Comment: Um, I’m … flummoxed. … A market-based economy means there will be winners and losers, unfortunately.
Kurtwz, your response is hopelessly hypocritical and biased. I bet you work for PCMA or some PBM.
1) Express Scripts is a member of PCMA, and PCMA would not print anything that was unfavorable to ESI. …
2) PBMs are supposed to make a profit via the plan sponsors, since they’re the ones paying the PBM. But a PBM that takes a rebate from a drug company is costing consumers. Especially consumers that are not aligned with that PBM. …
3) PBMs eliminate competition from smaller pharmacies. It’s one thing to be eliminated competing against another pharmacy — that’s the free market — … [but] the small independents aren’t being allowed to compete. They’re being handed a contract and told [to] take it or we’ll take away your customers. Sounds more like a mafia protection business than health care.