December 2, 2011 (Washington, DC) — Three US senators are seeking details on corporate agreements that would lead to the preferential prescribing of brand-name Lipitor (Pfizer) over generic atorvastatin [1].
As reported by heartwire , Lipitor, one of the top-selling drugs of all time, lost patent protection this week, and the US FDA approved the first generic version, by Ranbaxy Laboratories (manufactured by Ohm Laboratories). The Ranbaxy generic will hold market exclusivity until May 2012, when other generics will become available. Pfizer, however, has also taken the unusual step of producing an "authorized generic" that is being marketed by Watson Pharmaceuticals and has also signed deals with pharmacy-benefit managers (PBMs) and insurance companies that would allow them to dispense brand-name Lipitor at generic prices, for a limited period of time.
The finer points of these agreements are now being sought by Senate Finance Committee Chair Max Baucus (D-MT), senior Finance Committee member Chuck Grassley (R-IA), and Special Committee on Aging Chair Herb Kohl (D-WI). In particular, the senators are concerned that the discounts built into these agreements will end up profiting certain companies, rather than patients, and that private insurers and Medicare will still end up paying full pop for branded drugs.
In letters sent Wednesday, the senators asked Pfizer, as well as three PBMs and two insurance companies, for reassurances that these dispensing arrangements would not hinder access to generic drugs.
"Patients and their families depend on generic drugs, and they can’t afford to see these generics pushed out of the market," Baucus said in a statement. "By working with manufacturers to push brand-name drugs, drug benefit companies may be abusing Medicare to boost their profits and denying generic alternatives to patients--a practice that needs to end immediately."Grassley, likewise, stated that based on information currently available, it seems as if "just about everyone wins except consumers and taxpayers. That's cause for scrutiny, and these letters reflect a commitment to looking at how to prevent the system from being manipulated so that access to generic drugs is restricted and taxpayers are forced to unnecessarily pay brand-name drug prices."
The letters were prompted by a November news report in the New York Times outlining the arrangement between the companies [2].
In their letter to Pfizer, the senators refer to letters sent from the PBMs to pharmacies that, they say, "will prevent customers enrolled in certain prescription drug plans from receiving generic atorvastatin.
"While letters from PBMs to pharmacies indicate that a plan member’s copay for Lipitor would be discounted and equal to the cost of a generic prescription, we are concerned that the PBMs may charge health plan sponsors, including employers and Medicare Part D, full price for brand-name Lipitor from December 1, 2011 through May 31, 2012 while pocketing the discount from Pfizer."
Arrangements like the one negotiated between Pfizer, the three PBMs (Medco, Express Scripts, and Catalyst RX), and insurance companies Coventry Health Care and UnitedHealth may "hinder access to generic drugs today and in the future," the senators say in their letter.
They've asked for a list of all agreements between Pfizer and the companies named above, including details on whether generic products are excluded; average wholesale prices; and any discounts or payments provided to the PBM or plan. Those details must include any documents, communications, agreements, contracts, or presentations between companies.
Pfizer spokesperson MacKay Jimeson told heartwire in an email, however, that the news item that prompted the senators' questions to Pfizer "contained incomplete and incorrect information" about the company's Lipitor programs.
"We want the public to understand the facts. Our intent is to offer Lipitor to payers and patients at or below the cost of a generic during the 180-day period. As a result, patients receive Lipitor at copays comparable to generics. Participation in Pfizer’s programs by a health plan is entirely voluntary. It is not imposed on any plan either by Pfizer or their PBM. "
Finally, says Jimeson, "We have contracted with PBMs and health plans that serve Medicare Part D patients. The Centers for Medicare & Medicaid Services considers all rebates received directly or indirectly from pharmaceutical manufacturers to be price decreases that reduce the drug costs incurred by Part D plans."
