From The Editor | August 16, 2016

What Can Biosimilars Learn From The Hepatitis C Payer Battles?

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By Anna Rose Welch, Editorial & Community Director, Advancing RNA

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In December 2014, Express Scripts announced it had picked AbbVie’s hepatitis C treatment, Viekira Pak, for its 2015 formulary over Gilead’s Harvoni. This move stunned the pharmaceutical industry. Harvoni’s reputation preceded itself, because it was a combination of Gilead’s rock star hep C treatment Sovaldi (sofosbuvir) teamed with ledipasvir. It was also easier for patients to take than Viekira Pak. Patients on Harvoni only take one pill a day, whereas patients on Viekira Pak take four pills. Regardless, the prescription benefit manager (PBM) went with Viekira Pak because AbbVie offered a better price, against which Gilead’s $94,500 Harvoni price tag paled in comparison.

However, as Steve Miller, CMO of Express Scripts, discussed at the World Biosimilar Congress USA, competitive prices are just the beginning of the commercialization journey. I wrote an article recently discussing what biosimilar makers need to bring to the table when striking up a relationship with a payer. One of these takeaways was biosimilar companies must know how they’re going to support their product. The hepatitis C battle serves as a good example for biosimilar makers about how far they likely will have to go to incentivize patients (as well as PBMs).

Harvoni was a tricky drug to turn down. It demonstrated 96 percent cure rates and had the support of physicians. “Gilead owned the Hepatology community,” said Miller. “They did a great job seeding studies, so every hepatologist felt like an investigator because they were able to treat patients pre-launch.”

AbbVie’s Viekira Pak also boasted cure rates of 96 percent, however, its dosage wasn’t convenient. As such, AbbVie and Express Scripts had to work together to come up with services which would guarantee adherence to Viekira Pak and would add value to patients.

“We had predictive models where we knew exactly which patients were likely to be adherent and which would be non-adherent,” Miller explained. “[Together, Express Scripts and AbbVie] developed cell phone apps. We developed nurse outreach platforms. We worked together to develop extended systems so we could attain 95 percent adherence. If you look back a year later, our payers are thrilled because we had 95 percent adherence, as well as a 96 percent cure rate.” In addition, Miller claimed the price difference between Harvoni and Viekira Pak was so great, the PBM had enough money left over it could have hired someone to visit every patient each day to ensure they took their pills.

These value-added services likely sound familiar to many working in the biologics space. As Carol Lynch, global head of biopharmaceuticals for Sandoz, describes in a recent Pharma Times article, patient support services for biologics are becoming more popular, including nurse support — via helpline or home visits. Biosimilars will likely take the same approach as biologics, but the strategy will be what Lynch describes as “branded-lite.” A biosimilar “does away with the bells and whistles” that innovators often bring to the table (e.g., new wearable delivery technologies).  The goal is to offer biosimilar patients the services they would miss the most from the biologic if ever taken away. “That way, we can say the patient is not disadvantaged in any way when taking a biosimilar,” says Lynch.

In fact, just last week we saw Sandoz take a leap and turn a program typically launched by brand name drugs into one for biosimilars. Sandoz has launched a copay assistance program to help patients pay for biosimilar Zarxio. The Sandoz One Source copay program covers the full cost of the patient’s first dose. After that first dose, the patient is only responsible for paying a $10 copay for each monthly dose.

Nearly 400 branded drugs have copay-offset programs, which aim to cover a patient’s out-of-pocket fees. The manufacturer covers any differential between the drug’s wholesale price and what the insurance company will cover plus the pharmacy dispensing fee. This service leads to smaller copays for patients taking costly branded drugs and, in turn, can lead to better adherence or brand loyalty. These programs have sparked criticism that they undermine formulary placement or could lead to declines in the use of generics. (This latter claim has been found slightly inaccurate , according to several different consulting firms.)

However, the use of these copay-offset programs for a biosimilar is an interesting twist. CVS has already jumped willingly onto the biosimilar train by putting Zarxio and Basaglar onto its 2017 formulary. So a copay program would not be going against (at least) CVS’ formulary. This Sandoz program, along with any others launched for biosimilars, would essentially be bolstering biosimilar use, as well as building brand loyalty — a phrase that’s still fairly uncommon for biosimilars. But if there’s one thing that’s becoming more clear, biosimilars are falling more on the innovator side of the generics spectrum.   

It’s going to be an interesting journey for biosimilars as companies begin planning commercialization strategies for a U.S. launch. As more drugmakers jump on board, it’s going to take some creative minds to come up with strategies that truly make a biosimilar stand out — not only from the brand, but also from other biosimilars. The hepatitis C example, in particular, does offer some reassurance to the biosimilar industry, especially as innovators explore new-and-improved, often more convenient versions of existing treatments (for a higher price). Miller’s emphasis on establishing a plan to support a drug — even if that drug might be less convenient to take —  demonstrates there are many ways to bring value to patients. The solutions to reach patients don’t have to be as big as the project undertaken by AbbVie. But the ultimate goal, Miller said, is to make the payer say, “That’s a great solution and is worth the effort to move the patients to the biosimilar sooner.”