Pharma Deal With White House On Course To Net Industry Billions

Pharma Deal With White House On Course To Net Industry Billions

[UPDATED with response from PhRMA below.]

The deal struck between the pharmaceutical lobby, the White House and Senate Democrats has drastically improved Big Pharma's expected profits, a private industry report finds.

IMS Health, a company that supplies the pharmaceutical companies with sales data, predicts that new health reform legislation -- combined with a projected upswing in the economy and other changes in the pharmaceutical industry -- will result in a net gain of more than $137 billion in total market sales over the next four years. The new assessment was contained in document obtained by the Huffington Post.

Back in March, that same firm projected a compound annual growth rate of -0.1 percent in the period of 2008 through 2013. In October, with the general outlines of health care reform clearly in place, it revised that number to a positive 3.5 percent for over the same period.

What happened in those seven months? The economy started looking up, for one, as did the overall prospects of health care reform. But the industry also won a major lobbying victory.

PhRMA, the lobby entity for the industry's heavy hitters, reached a secret deal with the White House and the Senate Finance Committee in June. As detailed in a memo first published by The Huffington Post, the Obama administration agreed to oppose congressional efforts to use government leverage to bargain for lower drug prices. The White House also agreed not to shift some drugs from Medicare Part B to Medicare Part D, which would have cost the industry billions in reduced reimbursements. All this in exchange for $80 billion over ten years to help push for reform.

The Senate version of the healthcare bill still conforms to the deal (that the White House has still never officially confirmed). The House bill is in the same ballpark, although it would cost Big Pharma an extra $14 billion.

The IMS, in its revised October findings, did not reference the deal specifically, but rather made note of what it called a "NEW EVENT" -- mainly that health care reform "could lead to higher priced branded products and increased healthcare coverage across the USA."

"Branded drug price increases are expected to continue," the firm concluded, before citing the specific reforms of the PhRMA deal.

America's Affordable Health Choices Act of 2009 (HR 3200) has proposed several changes to the Medicare Part D program that would impact federal spending. Firstly, it would create a new rebate program that would require manufacturers of brand-name drugs to pay the federal government a rebate equaling 15% of the average manufacturer price. The finer details of the rebate will be determined as the reform legislation develops. Secondly, it would phase out the doughnut hole by simultaneously extending the benefits initial coverage limit and lowering the catastrophe threshold at specified rates leading to removal of the doughnut hole by 2022. Thirdly, as the doughnut hole is being phased out drug makers would be required to provide beneficiaries who are not eligible for the low-income subsidiary programme with a 50% discount on their spending in the doughnut hole for covered branded drugs. This initiative could create new business for pharmaceutical companies and also give seniors a price break, but only if they were paying full price on the brand product in the first instance. For pharmaceutical companies the agreement will lead to a loss if the senior was paying full price, but a win if the senior was not buying brand products at all. By making branded drugs in the doughnut hole more affordable patients may be able to afford to continue with treatment.

As explained by The New Republic's Jonathan Cohn (who got the IMS document first):

Health reform, as currently envisioned, wouldn't merely bring coverage to the uninsured. It would also fill in the "donut hole" in Medicare Part D--the gap in coverage that leaves beneficiaries with serious health problems paying for hundred if not thousands of dollars in out-of-pocket prescription costs.

In addition, because it will take several years to close the donut hole, reform relies on voluntary discounts from the pharmaceutical industry to make drugs more affordable in the intervening years. But those discounts would apply only to name-brand drugs, not generics.

Put it all together, and you have more demand for name-brand drugs.

The structure of health care reform, as IMS goes on to note, will have benefits for the federal government, which could save an estimated $30 billion from 2010 through 2019. Patients, meanwhile, would be paying higher premiums -- roughly five percent more by 2011 -- in return for what the report calls greater "protection against incurring higher drug costs." The real beneficiaries of reform, however, would evidently be the pharmaceutical industry.

IMS's conclusions are one of the clearest affirmations yet of various media reports that PhRMA is coming out of its negotiations with the White House and the Senate as a big winner -- though, as Cohn notes, the numbers IMS uses are simply projections and they may not necessarily bear out.

In a twist of sorts, it was the March IMS study that served as a small pillar in PhRMA's push to get a deal with the White House and Senate Democrats in the first place. In the press release touting its $80 billion commitment, the lobbying entity, along with affiliated institutions, warned that, "Medicines have already begun to play a key role in bending the cost curve in the U.S,"

"In 2009, IMS projects that the U.S. market for prescription medicines will contract, declining 1-2% below 2008 levels. Going forward till 2014, IMS projects annual growth rate for prescription medicines to remain essentially flat."

At the time, PhRMA was making the case that the $80 billion it was offering for reform was a major concession to the White House and Senate Dems. Compared to the new numbers, however, it doesn't look like such a big concession anymore.

UPDATE: PhRMA responded on Wednesday to reports about the IMS study by arguing that the data is inconclusive and misleading. The pharmaceutical industry, the lobby states, is "not expected to generate a material upside" because of coverage expansions in the health care system. Moreover, they note that attempts at even projecting prescription drug sales "is notoriously tricky, evident by the fact that IMS Health has released three different forecasts for 2009."

The statement, from Senior Vice President Ken Johnson, argues that IMS missed key portions of the reform legislation, including the eight percent rebates that brand manufacturers will be paying to Medicaid or the expansion of Medicaid eligibility.

Johnson also argues that because coverage expansions won't be in place until 2013, additional profits would only be materialized down the road.

But the IMS report, according to an industry source, doesn't look only at coverage expansions, but also at the deal made to close the prescription drug loophole in the Medicare Part D program. The firm wrote that its findings were based on Congressional Budget Office data that anticipates that after premiums for beneficiaries rise by about five percent in 2011, pharmaceutical manufactures "will respond by charging higher prices for new drugs as they will be constrained from increasing prices for existing drugs." When coverage is expanded down the road, these profits could very well go higher.

Johnson's statement also makes the point of noting that by covering a major portion of the so-called 'donut hole' in Medicare Part D, beneficiaries are expected to save "as much as $1,800 in 2011."

PhRMA's eagerness to downplay IMS's data in this case contrasts with its previous embrace of the company when its data bolstered the industry's arguments.

FURTHER UPDATE: In a statement provided to the Huffington Post, IMS states that the pharma deal is only a small portion of why it made the $137 billion adjustment in projected market sales.

"[The $137 billion] takes into account a large number of factors impacting the pharmaceutical and healthcare industries," the firm writes. "These include the macroeconomy, the changing mix of innovative and mature products, generics, the rising influence of healthcare access and funding on market demand, along with the effect of any potential legislation. The direct impact of current U.S. healthcare reform measures embedded in the IMS forecast is less than one percent of projected total industry sales through 2013."

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