Kentucky passes bill aimed to protect patients, community pharmacies from PBM audit practices
ALEXANDRIA, Va. — Legislation that requires transparency in the pharmacy audit processes conducted by pharmacy benefit managers is being enacted in Kentucky.
H.B. 349, which was signed by Kentucky state governor Steve Beshear last week and sponsored by Senate majority whip Tommy Thompson (D-Ky.), is designed to prohibit PBMs from seeking to recoup payments through pharmacy audits when there is no evidence of fraud.
The signing of the legislation was praised by the National Association of Chain Drug Stores.
"We thank Governor Steve Beshear for signing this important pro-patient, pro-pharmacy legislation to curb tactics used by some PBMs that take away from the important business of improving patient health and making healthcare delivery more efficient and cost-effective," NACDS president and CEO Steve Anderson said. "We thank Rep. Thompson, the Kentucky Retail Federation and the Kentucky Pharmacists Association for their leadership in helping to ensure transparency in the PBM audit process."
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Reports: Humira to become top-selling drug this year
NEW YORK — Move over, Lipitor: There’s a new top drug on the market, according to published reports.
Based on analysis compiled by Thomson Reuters Pharma, Reuters reported Wednesday that Abbott Labs’ arthritis drug Humira (adalimumab) would become the highest-selling drug in the world this year, replacing Pfizer’s cholesterol drug Lipitor (atorvastatin). And, according to Reuters, Lipitor and the No. 2 drug, Bristol-Myers Squibb’s and Sanofi’s blood-thinning drug Plavix (clopidogrel) — also set to face generic competition — might not even make the top 10 list.
The loss of Lipitor’s long-held top spot comes as no surprise as the drug lost patent protection in November 2011 and currently faces competition from Ranbaxy Labs’ cheaper generic version. Other generics are likely to enter the market when Ranbaxy’s own market exclusivity period ends in May, bringing prices for the drug down even further. Lipitor had sales of $7.7 billion in 2011, while Plavix sold $6.8 billion, according to IMS Health. Humira currently is at 10th place, with sales of $3.5 billion in 2011, according to IMS.
The trend is emblematic of drug makers’ gradual shift away from a model of drug development that has relied on small-molecule medicines for such primary care conditions as cardiovascular and respiratory disorders, and toward specialty drugs for such diseases as cancer and autoimmune disorders, especially biotech drugs. While those drugs target smaller patient populations, they sell at prices that allow drug companies to head off loss of patent protection for blockbuster drugs, and are more difficult to duplicate for generic companies that may seek to create biosimilar versions in the future.
Currently, by IMS’ count, Humira is the only specialty drug among the top 10, but among the top 15, all but one of the bottom six are specialty biotech medicines.
Did you know that a small study showed that Humira does cross the placenta and enter the bloodstream of a fetus during the last trimester of pregnancy. Generally, Humira could be found in the infant's bloodstream up to 3 months after birth. It is recommended that babies born to mothers taking Humira be checked closely for infection for the first 6 months of life, and not receive any live-virus vaccinations during that time.
Report: Federal judge hears arguments in ESI-Medco merger case
NEW YORK — A federal judge in Pittsburgh will rule "later" on whether to block or allow a merger between pharmacy benefit managers Medco Health Solutions and Express Scripts, and is considering a request by two trade groups seeking to keep Medco’s operations and assets separate from ESI while the lawsuit is pending, according to published reports.
Bloomberg reported Wednesday that attorneys for the National Association of Chain Drug Stores, the National Community Pharmacists Association and independent pharmacies and ESI argued for three hours before judge Cathy Bissoon of the U.S. District Court for the Western District of Pennsylvania. The pharmacy groups argued that the PBMs’ merger would violate antitrust laws and reduce services to retail pharmacy customers. The groups filed the suit on March 29 following the Federal Trade Commission’s approval of the merger.
ESI’s attorneys countered that stopping the $29.1 billion merger would cause significant harm to the PBM because it already had spent more than $230 million on integration and sharing of information.
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