Alkermes' Lybalvi launch serves as a new litmus test for mental illness marketing

Marketing drugs for mental illness is a unique challenge in pharma, and Alkermes is navigating COVID, stigma and a major generics market to get its new drug Lybalvi to patients.

Lybalvi is a combination of an old medicine and a new Alkermes drug: olanzapine, originally Eli Lilly’s Zyprexa but now a cheaper generic, and samidorphan, Alkermes’ new addition. Samidorphan works as an opioid antagonist, countering the metabolic effects of olanzapine and helping stave off the weight gain associated with it.

Alkermes won Lybalvi's FDA approval last June for schizophrenia and bipolar disorder 1 and engineered a relatively soft launch four months later in October. The drug brought in $8.2 million in the fourth quarter but Alkermes now predicts net sales of $55 million to $75 million this year.

Getting those sales means relying on olanzapine's well-known effectiveness while fighting its equally well-known side effects—and avoiding one of pharma's most tried-and-true advertising approaches.

A fully branded Lybalvi website has just made its debut, and Alkermes will be fielding some digital advertising, but, “as far as a full-blown, branded and targeted campaign where you see broadcast advertising, well that isn’t happening yet,” said Damon Harrell, Alkermes’ vice president of marketing for psychiatry, in an interview with Fierce Pharma.

'Nobody brings you a casserole'

“There is still a huge amount stigma about mental illness,” Harrell said. “If you are unfortunate enough to get cancer, your neighbors will bring you a casserole; if you are unfortunate enough to get diagnosed with schizophrenia, people often stop talking stop to you. Nobody brings you a casserole.”

What this means for marketing a drug like Lybalvi is that hiring a celebrity spokesperson, like so many other drug brands do, or even doing DTC advertising for schizophrenia simply doesn’t work.

“You just don’t see that,” Harrell said. “And when you think about what advertising is trying to do: It talks to consumers about seeing your doctor and getting them to prescribe you X drug. If you’re in the state of mind to be able to process that information as a patient with schizophrenia, and you can engage with that ad, then you are probably doing OK on your therapy, and don’t need a new one.”

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If people really do need help with a new drug, or need to switch, that means they're already likely experiencing symptoms and will “have a very difficult time processing that information from a commercial,” Harrell said.

He added that, after years of talking with patients, he knows they joke that the “last thing they want is someone talking to them on the TV about their condition, which feels like it is talking to them directly, because it can lead to a paranoid response, and that just adds to the difficulty inherent in this space.”

It is different with bipolar which, Harrell said, has a larger social acceptance in recent years. For that diagnosis,  advertising can work better than in schizophrenia.

Don't alienate doctors

Alkermes understands well how to market for schizophrenia, having sold its injectable Aristada (aripiprazole lauroxil) for the last six years. The therapy brought in $275.4 million last year, up 14% on 2020.

The general rule of thumb in drug marketing, Harrell said, is to “not do campaigns too early.” The key is to “strategically hold off” until doctors are comfortable with your drug and not to push too hard from the start, he said.

“The last thing you want to do is to spend a lot of money to push patients into seeing a new med, having them go to their doctor’s office and ask about it, but then have their doctor turn around and say: ‘I have no idea what drug that is’ and then they will simply not prescribe it.”

That’s a lose-lose situation, and “not money well spent” Harrell said. It can both upset and alienate doctors. And this is one of reasons Alkermes will delay a full DTC push until after doctors are on board.

Efficacy-driven market

While many other drugs could be marketed to patients through a variety of innovative ways, with mental illness, there’s only one way forward: Prove it works, and prove that again and again to doctors.

“It’s an efficacy-driven market,” he explains, “so when it comes marketing, you always have to lead with efficacy.” And with Lybalvi, Alkermes has an ace up its sleeve.

Alkermes is, very simply, showing the data packages from the trials to prove what it hopes will be a winning partnership of efficacy and lesser weight gain.

“The issues around weight gain can effect uptake of these drugs,” said Harrell, “so the logical argument for us is to make the case for Lybalvi by referencing our clinical trials, which combine a highly efficacious drug [olanzapine] with samidorphan.”

A twin-demic of COVID, and generics

But selling isn’t easy: The market is awash with cheap generics (including copycat forms of Zyprexa), and the competition for a new entry is huge. The company is banking on regular switching of drugs, common among patients with these conditions, to be in its favor, with reducing weight gain that key differential.

The launch may, however, be hit by COVID in the short term. Harrell said telehealth has grown massively during the pandemic, especially for mental health, but diagnosis of severe conditions—as well as moving patients either onto meds or onto new meds—isn’t happening as much or as effectively as it was during in-person visits.

“Our concern is that this doesn’t provide the same level of care patients need,” Harrell said, and of course could also hit take-up of Lybalvi.