GlaxoSmithKline lupus med Benlysta aims for growth injection with new subcutaneous approval

Benlysta, shown here in vials, will be available soon as an under-the-skin injection for patients with systemic lupus erythematosus (SLE).

GlaxoSmithKline hopes to get its new Benlysta formula under lupus patients’ skin—literally. The company won FDA approval last week for a subcutaneous version of the immunology med, previously delivered only intravenously.

That means patients can inject themselves with Benlysta, rather than travel to a doctor’s office every month for an hourlong infusion.

The new formula is one reason why GSK is betting $139 million on stepped-up production. And it’s one reason why the drugmaker expects its double-digit sales growth to continue, with a forecast of 18% annually over the next several years.

Many lupus patients are women of childbearing age with an active lifestyle, and it can be tough for them to carve out time to receive their monthly infusions, Glaxo’s U.S. VP of immunology and rare diseases, Sheri Mullen, said in an interview. The new subcutaneous option will allow them to inject themselves.

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“What’s great about this new formulation is the option and the choice for patients to be able to get that disease activity control that they saw with IV Benlysta now in the comfort of their own home,” said Tania Gonzalez-Rivera, M.D., the company’s medical director in immuno-inflammation.

For some women, that option could mean sticking to therapy rather than falling off their dosing schedules. “Adherence with any biologic is very patient-dependent,” she said. “Some patients do prefer to come in. Some like self-injection; others don’t like it.”

Benlysta was one of those drugs that didn’t zoom onto the market as expected, but lately, it’s been putting on the gas. It posted 21% year-over-year growth last quarter, with worldwide sales up to $117.7 million (£91 million). For all of 2016, it delivered £277 million, or about $377 million. Approved in 2011, Benlysta has patents stretching to 2023. Its current FDA approval covers systemic lupus erythematosus (SLE), the most common form of the disease.

Mullen said Benlysta’s current salesforce of about 100 reps will handle the subcutaneous version, too. They're in training now on the new FDA labeling and a rollout is planned within four weeks. “There are less than 4,500 rheumatologists, so the target doesn’t necessarily change,” she said.

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One thing that will change is payer coverage. The IV formula is covered as a medical benefit by insurers, while the subcutaneous version is likely to be covered under pharmacy benefits. Now that GSK has the FDA approval in hand, it can step up its talks with those payers to win coverage for the self-injected med.

In preliminary conversations, some payers have said they may allow patients to switch from the IV version to the subcutaneous formula, Mullen said. “Some of the early uptake will be cannibalization of the IV formula,” she noted.

The proportion of patients taking Benlysta’s subcutaneous formula could become quite hefty. Roche has switched up to half of its patients to under-the-skin versions of its cancer drug Herceptin and its rheumatoid arthritis med Actemra. Overall, 40% of Actemra revenue comes from the subcutaneous version, Roche pharma chief Daniel O’Day said during the company’s first-quarter earnings call, and Herceptin’s subcutaneous formula boasts more than half of its sales in some markets.

GSK hasn’t yet released a price for the new Benlysta formula. Mullen said the company is “attempting to provide IV and subcutaneous at a parity—very comparable cost—so we enable this choice for patients,” she said.

The company will offer support programs for the new product—to help women learn how to inject the new formula, for instance—under its new Benlysta Cares umbrella. The company also is actively promoting awareness of the disease, with a new campaign starring retired U.S. soccer star Shannon Boxx.

For the IV formula, the company maintains a zero-copay program worth up to $9,000 per year for patients with commercial insurance or those who have no insurance coverage at all. That doesn’t include the cost of the doctor visit, however.

GSK has more than 10 Benlysta trials going, testing the drug in other forms of lupus and other inflammatory diseases, including Sjören’s syndrome, Gonzalez-Rivera said.

The expanded Benlysta manufacturing, announced at the beginning of this year’s Lupus Awareness Month in May, will increase supply of the drug’s active ingredient by 50% when it’s fully up and running, expected in 2019.