Health Care Reform: New Fees are New Factor For Partnerships

When GlaxoSmithKline and Pfizer established the HIV-focused joint venture Viiv in April 2009, it sent a bold statement about the commitment of the new partners to new business models and their commitment to creative business development activities. (See “The GSK/Pfizer HIV Venture: Another Sign of Change?” IN VIVO, April 2009.)

Heck, we liked it so much we nominated it for Deal of the Year.

Now that health care reform has been signed into law, it looks even smarter. Viiv turns out to be a brilliantly timed strategy to blunt some of the impact of the up-front costs of reform for biopharma companies.

Thanks to a new formula for calculating Medicaid rebates and the interaction of that formula on prices paid by State AIDS Drug Assistance Programs that cover HIV therapies, that class of medicine is taking a pretty big hit from reform in 2010. (See “Taking Lumps from Health Care Reform," just published on TheRPMReport.com.)

The impact was felt most acutely by Gilead Sciences, whose product line is very highly concentrated in HIV therapy. The company estimates the impact in 2010 at $200 million, or about 5.7% of its US pharmaceutical sales in 2009.

That ranks as, proportionally, the biggest reported impact from health care reform from any of the publically traded pharmaceutical companies tracked by The RPM Report.

And, naturally, it drew a lot of interest from investors during Gilead’s first quarter conference call April 21. Investors were particularly concerned about the ramp up in the impact on the company through the year; Gilead said the new Medicaid rebate rules reduced sales by $29 million in the first quarter, suggesting a significantly larger liability in the coming quarters.

The reason, Gilead explained, is that the pricing mechanism for drugs purchased by ADAPs lags behind the Medicaid rebate, so the bulk of the impact comes in the last quarter or two of the year.

And the sheer size of the adjustment surprised investors, given that Gilead already provides substantial price concessions to the ADAPs. “In early parts of the healthcare reform discussion, from a distance, we wondered like a lot of companies whether additional rebates would be applied to the payers where we have discounts already in place that are greater than the current 15% now moving to the 23% that have been mandated,” EVP Commercial Operations Kevin Young explained. “It is quite clear from the legislation that irrespective of the discount that you have in place to these federal players, an additional 8% has to be added and I think that’s the clarity that’s now come in the legislation.”

For Pfizer and GSK, on the other hand, the impact on the new Medicaid rebate on antivirals was close to a non-issue. Viiv is about half as large as Gilead in the HIV market, and so might be expected to face an impact of approximately $100 million from reform.

But for Pfizer, which only records income from the joint venture, the impact didn’t merit a mention. GSK records the revenue, but could describe it almost offhandedly in the context of an overall discussion of the manageable size of the reform. CEO Andrew Witty noted in response to a question on the relative exposure of the company to Medicaid and Medicare that “Viiv is a little more exposed than the average.”

Still, the new company did post a sales decline of 7% for the quarter—a result that might have been expected to prompt some comment if it were a $2 billion-plus brand reported by GSK, rather than an innovative HIV therapy joint venture.

That is a nice early return from the joint venture, but it does underscore the likelihood that features of health care reform will start to have an impact on business development.

Take, for instance, Bristol-Myers Squibb’s discussion of the importance of its relationship with Sanofi Aventis for Plavix in considering how the company will be affected in 2011, when a new 50% Part D discount program and market share fee take effect.

“Remember that the sales impact would be relatively higher than earnings due to the accounting treatment for Plavix, where we record 100% of sales, but share profits with Sanofi,” CFO Charles Bancroft noted.

For Viiv, that will not be as challenging an issue. Medicare Part D does cover HIV medicines, but the vast majority of AIDS patients in Medicare are dual eligibles who will not receive the donut hole discount. The market share fee is another matter, however; any sales through Medicare or Medicaid (but not the ADAP sales) will count towards the fee. The rules have yet to be determined, but as the partner recording sales, GSK is likely to be the entity that records the impact of the fee as well.

As the rules of the new Part D program and the calculation of the market share fee are fleshed out, business development executives should pay attention. Treatment of those items is likely to be an important consideration in future partnership agreements.

Glaxo's Witty Tries To Fix An Industry Problem

For the second time in a year, Andrew Witty has succeeded in getting in front of a contentious issue that plagues the pharmaceutical industry – finding ways to provide greater access to medicines to poor countries. Last year, the GlaxoSmithKline ceo trumpted plans to create a patent pool for tropical diseases; reinvest 20 percent of profits from meds sold in the Least Developed Countries, and reduce prices there by 75 percent.

The February 2009 effort (see the pronouncements here) won him kudos for addressing topics that his peers had mostly confronted in fits and starts. Generally pleased with the reaction, Witty this week embarked on what amounted to a 24-hour media blitz – including a widely telegraphed speech this morning before the Council on Foreign Relations in New York – to announce his next steps.

His latest moves read like a laundry list of NGO initiatives: creating an ‘open lab’ with $8 million in seed money and space at a Glaxo facility in Spain so that up to 60 scientists from erstwhile locales can research neglected tropical diseases. Glaxo is also contributing 13,500 compounds – including chemical structures and assay data – that will be available on web sites for developing new malaria treatments. There’s more: BIO Ventures for Global Health will run the ‘knowledge’ pool announced last year and collaborations were inked with the Emory Institute for Drug Discovery and South Africa’s iThemba Pharmaceuticals. Finally, in a related development, he promised to limit profits on a malaria vaccine, which is in Phase III testing, to 5 percent and contribute the proceeds to Glaxo’s R&D budget for vaccines to combat neglected tropical diseases (see more in The Pink Sheet).

“The speech I made this morning really tries to build on what I started a year ago,” Witty told a handful of bloggers (including yours truly) at the majestic New York Academy of Sciences offices in lower Manhattan following his morning speech. “We’re really trying to identify a more pluralistic approach to solve very difficult problems rather than constantly use the same approach…and be much more open-minded and be prepared to try new things.”

Certainly, Witty deserves some credit for taking these steps. For years, drug makers have been skewered for failing to do more to make their meds widely available in various countries. Over the past year, the Glaxo ceo has managed to alter many perceptions by conveying a willingness to listen and act. Compare that to the running battles between drug makers and governments that, sometimes, led to brinksmanship over compulsory licensing. Of course, those disputes were generally over very profitable treatments for heart disease, cancer or AIDS. By comparison, malaria treatments are the equivalent of low-hanging fruit, not best sellers that command top dollar in developed countries.

When questioned about the intellectual property and commercialization rights to the 13,500 compounds donated for malaria research, Witty was quite firm in saying that Glaxo wouldn’t benefit from any malaria treatment that may be discovered and developed, unless a company later approached his team for a deal of some sort. “But a cardiovascular medicine,” he added, “that’s a different consideration.”

And he tried hard not to appear defensive when asked about an idea being pushed by Medicines Sans Frontieres and Unitaid, the international drug-purchasing agency based in Geneva, to create a patent pool for HIV medications. Recent reports mention several drug makers that have held talks, but Glaxo wasn’t among those listed. By contrast, Glaxo’s interest in AIDS drugs did make headlines last year, but largely in connection with a joint venture formed with Pfizer, called ViiV. Nonetheless, Witty insisted that Glaxo is, in fact, willing to explore the possibility.

“We actually have eight voluntary licenses for a variety of HIV drugs and each one covers 44 countries…That’s a huge portfolio of openness. These are licensed to both African and Indian manufacturers and they are royalty-free. And we gave permission to generic companies to create combination products. As a result, last year they supplied more than four times the volume than what GSK supplied,” he argued. “So we’re already doing what you’d envision what the pool would generate.

“Where are we with the (Unitaid) pool? Not surprisingly, we’re very aligned with the goal. And we’re engaged in conversation to try to work with them, as are others, in ways that are practical. The ViiV team met (with them) just yesterday or the day before…The meetings are constructive and cordial, and we’re engaged in the spirit of trying to get details hammered out…But the decision lies with the management board of ViiV. As the biggest shareholder, we’re pretty close to knowing what’s going on there. But we’re very aligned with their goals…The devil is in the details and we need to get the details to work.”

Ironically, Witty acknowledged a wee bit of disappointment, but not much surprise, that other large drug makers have yet to embrace the patent pool for neglected tropical diseases he would like to develop. To date, only Alnylam Pharmaceuticals has agreed to join. In explaining the paucity of cooperation, Witty put on a brave face while also trying hard not to deliver a spanking:

“I do hope other companies will join,” he lamented. “…I can completely understand why they take their time. For those other companies, it came a little out of the blue. They’ve had to assess their response after the impact of (the announcement last year). There’s a fair degree of interest among some. But not to overstate, I think there are some (companies) that will never come into it…I hope they will join…But a year’s not a long time…Maybe it is in the blogosphere, but not in the pharmaceutical industry.”

Prodded by another question, Witty then conceded that his idea for a patent pool may one day expand to include prospects to treat other conditions beyond tropical diseases. For now, though, he pointed to the fact that there is little “market stimulation” for discovering meds to treat tropical diseases, unlike so many other illnesses. “But if it works, engages people and inspires people,” he said, “then, absolutely.”

Not everyone is enamored of his efforts, however. Health Action International, an advocacy group that pushes for greater access to medicines, says it’s still waiting for Witty to respond to questions posed last spring about Glaxo’s initiative to lower prices in countries in which this has taken hold. For his part, Witty yesterday preached patience.

“If we sit back as a group and constantly look to design the perfect model to fit the situation, to see what’s working, we’ll never do anything. So let’s see what opportunity we can create and move to the next problem,” he offered. “…This is a step on a journey and journeys have multiple steps.”