More Velcade-Style Risk-Sharing in the UK?

It appears that Janssen-Cilag feels a lot better now about its pay-for-performance scheme around multiple myeloma drug bortezemib (Velcade) than it did when the program was introduced in 2007.

The Velcade Response Scheme (VRS) came about out of desperation: cost-effectiveness watchdog NICE had turned down the drug as too expensive, so Janssen-Cilag, to its credit, said to the UK’s state payer, the Department of Health, ok, well if we promise to charge only when the drug is effective (and refund you if not), then will you give this to patients?

The answer was yes. And now, not only have all of the UK’s Primary Care Trusts have signed up to the VRS, according to a Janssen spokesperson, but this scheme “may now be a good example of how a performance-based scheme could be structured.” That’s not a statement from Janssen; it’s from a position document issued last year by the British Oncology Pharmacy Association on risk-sharing schemes.

Indeed, such schemes have, perhaps inevitably, become a rather more regular feature of the UK drug landscape—making Janssen feel more pioneering than desperate (though Janssen isn’t the first to guarantee performance; Pfizer tried with Lipitor too).

Most of the other recent flavors of risk-sharing programs around expensive cancer drugs emerged, like VRS did, as a result of a negative NICE appraisal. Merck-Serono offered the Cetuximab Cost-Share Program around Erbitux in metastatic colorectal cancer, which involved refunding primary care trusts the cost of any vials of the drug used for patients that fell into a pre-agreed ‘non-responder’ category at up to 6 weeks. Roche instigated the ‘Tarceva Access Program’ for its NSCLC drug erlotinib, offering a rebate, in the form of a credit note against any future Roche purchase, for the amount that the drug cost over and above the cost of the incumbent NSCLC treatment docetaxel (Sanofi-Aventis' Taxotere) for an average patient duration (with an upper limit on the total number of packs).

Now granted, Roche’s program was initially introduced as a means to claw market share off docetaxel, which it was struggling to do ahead of NICE guidance. But when NICE found Tarceva to be un-cost effective—with questions around the lack of comparative data with docetaxel in particular--the scheme was formally proposed to NICE as part of a re-review. In November 2008, NICE issued positive guidance—but only on condition that the overall treatment cost remained in line with that of docetaxel. Roche had to drop the price by about 7.5%.

Critics say such programs are simply a way for industry to coerce NICE into a ‘yes’. Maybe. But there’s no denying that such schemes represent a logical way to improve patient access without breaking the bank. Indeed, the new UK drug pricing contract, the PPRS, formalizes a bunch of patient access schemes, including risk-sharing programs. And NICE, as we heard from CEO Andrew Dillon last week, would prefer such schemes to be proposed up front, before a drug is submitted for review, rather than as a last-resort of the drug fails the cost-test.

Small wonder, then, that in the last three or four months since the PPRS was published, the department of health has been in contact with various companies about schemes around several “high profile” drugs, according to David Thomson, Lead Pharmacist at the Yorkshire Cancer Network and author of the BOPA position statement.

The big problem is administration. As it is, it’s complex to administer rebates and track outcomes. The more different schemes are available, the harder that becomes. “Anecdotal evidence suggests that the VRS [and a similar scheme around Sutent] aren’t necessarily bringing the expected levels of financial benefit to the National Health Service,” Thomson told The IN VIVO Blog.

Add to this the problem of patchy uptake or availability of some of the existing handful of programs across the country, and the possibility of multiple risk-programs across a single drug for different indications, and it’s easy to see why BOPA's pushing for some sort of risk-sharing plan template....and why we may not, after all, see a flood of VRS-followers soon.

image by flickr user fboosman used under a creative commons license

(Final) Deals of the Year Nominee: Lilly/TPG-Axon/NovaQuest

Ah, awards season. Why should film critics have all the fun? And voting! It's not just for presidential elections. This year your IN VIVO Blog team is nominating a handful of alliances, acquisitions, financings, regulatory negotiations and legislative compromises in our First Annual DOTY competition. And then you, dear readers, will vote (early and often, we hope) for the winner. Imaginary federal and international biopharmaceutical statutes prohibit us from awarding a monetary prize. But our winners, when they die, on their deathbeds, they will receive total consciousness. So they've got that going for them, which is nice.

Aaand, last but not least: It's not just cash-poor biotech firms that need the occasional helping hand to finance their drug development efforts. Even for the likes of Eli Lilly (and, say, Bristol-Myers, which has blazed this particular trail among larger companies), hedging pre-market risk is part of the game plan when cash is becoming more expensive and clinical development and regulatory affairs more uncertain.

In July, Lilly announced an agreement with TPG-Axon Capital and Quintiles Transnational Corp.'s NovaQuest partnering group under which Lilly's partners will pay up to $325 million in development funding for its two lead Alzheimer's disease compounds, a gamma secretase inhibitor and an A-beta antibody, each ready to begin Phase III testing.

In exchange, TPG (which provides the bulk of the capital) and NovaQuest (10% of the funding and strategic development advice) will receive success-based milestone payments and mid-to-high-single-digit royalties on future sales of the two compounds. Quintiles CRO arm will act under a traditional fee-for-service contract. Finally, to sweeten the deal and hedge the risk shouldered by TPG and NovaQuest, those partners will also receive an additional undisclosed royalty on a third, unidentified product that Lilly has out-licensed to a third party. (See our coverage of the deal here.)

Not to show you how the sausage is made, but there was some internal dispute here at IVB over what this deal signifies within pharma, if not its overall importance.

See, on one hand, the deal is forward-thinking and increasingly necessary in a difficult R&D climate; with the cost of capital increasing even for the likes of Lilly and its Big Pharma brethren it allows Lilly the flexibility to take multiple shots on goal in Alzheimer's or other diseases. It's also the first publicly announced deal (we've heard rumors of deals signed but still private) in which a private equity player takes a big financing role in a Big Pharma's development program -- something they've done in small and mid-sized companies (e.g., Symphony Capital) but which Big Pharma has always shunned.

There will now likely be further variations on this theme: former AstraZeneca CFO, now Goldman-Sachs partner Jon Symonds says he's working on putting together a pool of PE capital for developing Phase I and II Big Pharma (and maybe other) compounds, which could be pulled together as soon as January. That structure, incidentally, addresses one of the big problems for PE players (and probably one of the big sticking points of the Lilly/TPG negotiations, which apparently took about a year and a half): how do you put together a marketbasket of enough develop-able compounds to offset the awful odds facing any single on of them. The drug company wants to put as few as possible in the basket; the PE investor wants as many as it can get.

On the other hand, there is something odd about offering deal-of-the-year honors to a Big Pharma company for creative financing to mitigate risk during the year when a lot of people who are supposed to be the experts in this kind of thing are bankrupt, unemployed--or begging the taxpayers for assistance.

And it is especially odd, given that (as we wrote here) Lilly is a model of a Big Pharma company that is focusing on innovative products--rather than diversifying into OTCs or related business like some of its peers. The logic of focusing--that investors want to diversify for themselves, rather than turn their money over to Novartis management to diversify for them--seems to apply here too. Shouldn't Lilly's investors just hedge for themselves, rather than have Lilly management do it for them?

Still, everyone agrees that the deal allows Lilly to shed risk (in return for a smaller reward) in this notoriously difficult therapeutic space in a creative transaction that could prove to be a model for private equity/pharma deals going forward. It's just that we don't agree about whether that's a GOOD THING.

So there you have it--your last IN VIVO Blog Deals of the Year! Nominee. Got it in just under the wire. Why Lilly/TPG/NovaQuest? For the new-model dealmaking, for the sexy private equity angle. For the Controversy!

We'll see you later, at the ballot box.

image by flickr user jacob.theo used under a creative commons license.