Paying up

In addition to tapping the pharmaceutical industry to close the doughnut hole, Congress imposes hefty fees and rebates on the sector. The final tally of $105 billion is higher than the $80 billion industry contribution negotiated earlier by the Pharmaceutical Research and Manufacturers of America (PhRMA), Senate Finance Committee Chairman Max Baucus (D-MT), and the White House. But most companies consider it an acceptable cost for expanding sales and for avoiding more onerous government regulation.

Drug manufacturers will pay fees amounting to $28 billion over 10 years, starting at $2.5 billion in 2011. Total collections will rise to $3 billion in 2014, to $4 billion in 2017, and then drop to $2.8 billion in 2019 and every year thereafter. The fees will be apportioned by the Treasury Department based on a company's relative share of branded prescription drug sales the previous year to Medicare, Medicaid, the Veterans Administration, and Department of Defense healthcare programs. Manufacturers with sales of less than $5 million get a pass, while companies with sales of more than $400 million a year will pay a full share.

Encouraging innovation

Manufacturers are not complaining too loudly about the added fees and rebates because they gain a pathway for the US Food and Drug Administration to authorize follow-on biologics (FOBs), which many consider the "crown jewel" in the bill for drug and biotechnology companies. After years of debate on this issue, innovator firms won an unprecedented 12-year data-exclusivity period for all reference biotechnology products, with the possibility of a six-month extension for sponsors who conduct pediatric studies. The Biotechnology Industry Organization (BIO) focused its lobbying efforts on this "historic provision," which was steered through Congress by Rep. Anna Eshoo (D-CA) despite strong opposition from powerful legislators and the White House.

CBO analysts say the program will save the government $7 billion over 10 years and reduce industry revenue by that amount. BIO President James C. Greenwood praised the measure for providing "incentives necessary to attract the massive investment required to speed the discovery and development of the next generation of breakthrough therapies." But Kathleen Jaeger, president of the Generic Pharmaceutical Association, complained that the bill "locks down indefinite brand product monopolies at a deep cost to patients and taxpayers." Timely access to biopharmaceuticals, claims Jaeger, could have produced savings well over $50 billion during the next 10 years.

All manufacturers, however, stand to benefit from clearer policies on developing and regulating "biosimilars" and "biobetters." That task now falls to FDA, which will issue guidance on what analytical assays and clinical studies will be needed to document FOB safety, purity, and potency, and what criteria could support product interchangeability, a critical issue for marketing and reimbursement. The law requires sponsors to pay FDA user fees and initiates a process for innovators to challenge patent infringement. In addition, Medicare Part B will pay for biosimilars at the average sales price plus 6%—an amount considered high enough to encourage physicians to prescribe less costly FOBs, explains Avalere Health Director Margaret Nowak.

BIO also championed a relatively small provision in the legislation that provides tax credits to small biotechnology companies (i.e., those with less than 250 employees) to cover a portion of research and development expenditures. The bill establishes a two-year program that offers as much as $1 billion in total tax credits to cover expenses related to research on certain critical therapies.

Another plus for industry is language clarifying how the government can use comparative effectiveness research (CER) resulting from a national outcomes study program. The bill establishes a new nonprofit, nongovernmental Patient-Centered Outcomes Research Institute to support comparative studies. Funding for the new entity starts small, but increases to $150 million in 2012 and subsequent years by tapping into the Medicare trust fund and collecting fees from insurance companies. The institute will form a governing board in September 2010 that includes at least one representative from a pharmaceutuical company. Industry will participate in additional advisory boards, including one that will issue CER methodology guidelines next year.

Of particular importance for manufacturers are specifics that distinguish this program from the United Kingdom's National Institute for Health and Clinical Excellence (NICE). The reform legislation rules out using quality-adjusted life years (QALY) as a threshold for establishing cost-effectiveness and limits the use of CER findings in determining coverage or reimbursement decisions by Medicare and other government health programs. Research has to recognize differences in patient populations, and all information has to be made public. The US Health and Human Services' (HHS) Agency for Healthcare Research and Quality will continue to play an important role in disseminating CER results and in distributing grants to research organizations.

More transparency and oversight

At the same time, the legislation includes several challenges for industry. New "Sunshine" provisions require national disclosure of payments and reimbursement by pharmaceutical marketers to physicians. Beginning in 2013, pharmaceutical, biotechnology, and medical-device firms will have to report payments to healthcare providers that exceed $10 or add up to $100 a year. In addition, manufacturers must provide data on drug-sample distribution, including the name of the drug and dosage form, the date of distribution, and the name and address of the receiving physician. The bill instructs HHS to establish a system for disclosing provider payment information to the public and imposes hefty fines for failure to comply. While the federal law pre-empts certain state disclosure rules, the law offers states some leeway on transparency requirements that go beyond federal requirements.

Another transparency provision applies to pharmacy benefit managers, which have to report to HHS on drug rebates and discounts as well as their generic-drug dispensing rates for Medicare drug plans. These reports will be kept confidential, but will be available to Medicare analysts and Congress to help shape payment policies.

As with most major legislation, Congress has ordered a long list of reports assessing the effect of its work. The HHS Inspector General, for example, will compare prescription drug prices under Medicare Part D to those under state Medicaid programs and will examine whether Part-D plan formularies exclude drugs commonly used by low-income dual eligibles. The US Government Accountability Office also will explore how well Part D provides access to vaccines for seniors and what further changes can improve the 340B drug discount program.

Looming on the horizon is a new Independent Medicare Advisory Board (IMAB), formed to propose ways to slow the growth in Medicare spending. PhRMA singled out the broad power of this entity as an area of concern, noting that the panel could institute "sweeping Medicare changes" affecting Part D reimbursement without legislative review. IMAB won't be up and running until 2014, which provides time for industry to press for modifications.

Policymakers may not kill the idea of the Board, however, because they are anxious to gain any and all savings from healthcare providers. The new law looks to "bend the cost curve" on the nation's healthcare system by cutting fraud and waste, establishing electronic medical records, identifying effective medical treatments and bolstering preventive care. These strategies may improve healthcare quality but won't make any real dent in federal expenditures. To pay for expanded coverage, Congress proposes cuts in Medicare provider fees, plus additional taxes on high-income consumers and healthcare companies. The Medicare cuts face an uncertain future. Tax hikes do little to curb healthcare spending overall and may boost outlays even more.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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