Legislation Would Create Regulatory Pathway for Generic Biologics 

(Washington, DC)- Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt issued the following statement supporting “The Promoting Innovation and Access to Life-Saving Medicine Act”- bipartisan legislation introduced by Senators Schumer (D-NY), Brown (D-OH), Collins (R-ME), Vitter (R-LA), Stabenow (D-MI), Shaheen (D-NH), and Martinez (R-FL), which would create a regulatory pathway to approve generic versions of biologic products. This legislation has also been introduced in the House by Energy and Commerce Committee Chairman Waxman (D-CA) and Representatives Deal (R-GA), Pallone (D-NJ), and Emerson (R-MO).

“This bipartisan bill will increase access to life-saving medications, save billions and ensure continued innovation for new groundbreaking biologics. It’s one of those rare ‘win-wins’ supported by consumers, ‘budget hawks,’ business, labor and policymakers on both sides of the aisle.

“PCMA applauds Senators Schumer, Brown, Collins, Vitter, Stabenow, Shaheen, and Martinez for their leadership on this issue.”

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PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.

Federal Court Rejects Burdensome Fiduciary-Disclosure Requirement

(Washington, DC)-Late yesterday, the U.S. District Court in D.C. struck down Title II of the D.C. Access Rx Act, which would have imposed burdensome fiduciary-disclosure requirements on pharmacy benefit managers (PBMs) and increased prescription drug costs for consumers and payers, the Pharmaceutical Care Management Association (PCMA) said today.

“This fiduciary-disclosure requirement would have been a recipe for higher drug prices and is exactly what consumers don’t need during these tough economic times,” said PCMA President and CEO Mark Merritt. “The ruling is a clear victory for consumer and payers.”

Since 2004, when PCMA filed this lawsuit, more than 30 states have considered and ultimately rejected similar legislation because it would lead to increased costs without any benefit for consumers.  For these reasons, a broad coalition of consumers, Fortune 500 employers, labor unions, health insurers, and others have worked together to defeat these proposals at the state level.  Maine is the only state that imposes similar fiduciary-disclosure requirements on PBMs.

The savings PBMs provide have been recognized by numerous government and independent analyses.  In recent years, the Federal Trade Commission (FTC), Government Accountability Office (GAO), Congressional Budget Office (CBO), and the Centers for Medicare & Medicaid Services (CMS) have all confirmed that PBMs’ generate substantial savings for public and private payers. 

In reaching its conclusion to nullify Title II, the Court only needed to find that federal law   under ERISA preempted the District’s requirements and did not need to address the other arguments raised by PCMA in its court filings.

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Comparative Effectiveness, Not Protected Classes for ‘Me-Too’ Drugs

(Washington, DC)-The Pharmaceutical Care Management Association (PCMA) released the following statement today on the Medicare Advantage and Prescription Drug Programs (MIPPA) Drug Formulary & Protected Classes Policies:

“PCMA strongly believes that clinical evidence, not political considerations, should guide Medicare formulary decision-making.  While the comparative effectiveness provision in the American Recovery and Reinvestment Act of 2009 (ARRA) relies solely upon clinical evidence, the ‘protected classes’ provision of last year’s MIPPA statute is arbitrary, offers no proven ability to increase access and, according to the Centers for Medicare & Medicaid Services, will increase costs by $4.2 billion over 10 years. 

“As Consumer Reports noted in its research released yesterday, comparative effectiveness improves both patient and physician decision-making.

“History shows that manufacturers of ‘me too’ drugs have no incentive to offer deep discounts unless they face some chance that their competitors will be included on a given formulary instead of themselves.  All other drug benefit coverage including FEHBP, union plans, and private retiree plans address this by making rival manufacturers of ‘me-too’ drugs offer lower prices in order to compete for better formulary placement.  This is accomplished while also maintaining an excellent record of ensuring that patients get the medications they need.  This is particularly true of those in vulnerable populations who suffer from mental illness, HIV/AIDs and other conditions which ‘protected classes’ are meant to address.

“The ‘protected classes’ concept presents a step backward and, unfortunately, only ‘protects’ the pricing policies of drug manufacturers.” 

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PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.

$22 Billion Savings from E-Prescribing Under New Law Will Pay For

Modernizing the Nation’s Entire Health IT Infrastructure

(Washington, DC)- Financial incentives for physicians to adopt health information technology (HIT) included in the recent economic stimulus bill will increase the number of prescribers using electronic prescribing (e-prescribing) to more than 75 percent over the next five years-nearly double the rate of use anticipated after passage of last year’s e-prescribing legislation- according to a new study from Visante, the Pharmaceutical Care Management Association (PCMA) said today. 

The study also found that e-prescribing will help prevent 3.5 million harmful medication errors and save the federal government $22 billion in drug and medical costs over the next 10 years, which more than offsets the projected $19 billion in federal outlays to modernize the nation’s HIT infrastructure under the American Recovery and Reinvestment Act (ARRA).

“E-prescribing saves lives, lowers costs and will substantially finance the government’s overall HIT investment in the new stimulus law,” said PCMA President and CEO Mark Merritt.

Visante modeled the impact on the adoption of e-prescribing of approximately $19 billion in HIT investments by the federal government, including incentives being paid to physicians and other providers by Medicare and Medicaid, with penalties for non-adopters starting in 2015. Their findings include:

• With increasing adoption under ARRA, e-prescribing alone will save the federal government $22 billion in drug and medical costs during the next 10 years, which more than offsets the government’s anticipated $19 billion investment to modernize the nation’s entire health information technology infrastructure.
• ARRA will increase e-prescribing adoption to more than 75 percent of prescribers in just five years, a more than four-fold increase from the usage rate today, and nearly double the rate anticipated after the passage of MIPPA.
• Under ARRA, e-prescribing will help prevent some 3.5 million serious medication errors known as adverse drug events (ADEs) that would have otherwise sickened, hospitalized, or killed patients over the next ten years.

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Study: New Stimulus Law will Save Billions and Reduce Errors by Accelerating E-Prescribing

Legislation Would Create Regulatory Pathway for Generic Biologics

(Washington, DC)- Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt issued the following statement supporting HR 1427, “The Promoting Innovation and Access to Life-Saving Medicine Act”- bipartisan legislation introduced by US House Energy and Commerce Committee Chairman Henry Waxman (D-CA), Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO)-which would create a regulatory pathway to approve generic versions of biologic products. 

“This bipartisan legislation will increase access to life-saving medications and save billions for consumers, employers, and taxpayers.

“PCMA applauds Chairman Waxman, Representatives Deal, Pallone, and Emerson in leading the effort on Capitol Hill to create a clear regulatory pathway for biogenerics.  This bill is the right approach to generate increased competition and lower costs for consumers and payers, while ensuring continued innovation for new, life-saving biologics.  

“Policymakers from both sides of the aisle, employers, unions, consumer groups, and others all realize that allowing generics to compete with biologics in the same way they already do with conventional drugs will improve access to quality care and reduce overall costs.” 

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 PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.

(Washington, DC)-Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt released the following statement today on a new report from AARP examining the high prices of various specialty products and the need for generic biologics to lower costs for consumers.

PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use of electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.

“This study is the latest sign of momentum surrounding biogenerics as an important health reform issue.  The President’s budget also included a provision that would create a regulatory pathway to approve generic biologics as a way to save billions of dollars for both the public and private sector.

“For over a quarter century, generic medicines have increased access and affordability for consumers, employers, labor unions, government agencies, and others.  However, expensive biologics have not faced generic competition, straining public and private payers’ ability to provide affordable drug benefits for these necessary and often life-changing products.

“Generic competition lowers costs because it gives patients the power to choose and gives manufacturers an incentive to reduce prices.  We need legislation which allows generics to compete with biologics in the same way they already do with conventional drugs.”