Dive Brief:
- CVS Health Corp.'s pharmacy unit announced March 16 the availability of GlaxoSmithKline plc's shingles vaccine Shingrix across more than 9,800 pharmacies nationwide, roughly five months after an advisory panel for the Centers for Disease Control and Prevention recommended the treatment for prevention of the disease.
- Broad availability of Shingrix should help the British pharma's launch efforts for Shingrix, which was approved in the U.S. in October. The vaccine is one of three new drugs GSK hopes will help offset the impact of its declining Advair business.
- GSK claims Shingrix's 90% efficacy across age groups, coupled with the CDC panel's recommendation, will be a competitive advantage over Merck & Co.'s rival Zostavax, which earned $668 million last year.
Dive Insight:
Shingles, which describes the reactivation of the varicella zoster virus responsible for chickenpox, is more common in older adults and immunocompromised individuals. And although vaccines help to prevent shingles, vaccine effectiveness wanes over time. Overall, vaccines in older adults aren't as effective, as their immune systems cannot be primed as well. Older individuals don't appear to produce as robust an immune response as a younger person after vaccination, for instance.
Merck's Zostavax (zoster vaccine live) currently earns around $700 million a year in sales. But GSK thinks Shingrix (zoster vaccine recombinant, adjuvanted) could stand to earn even more, as the Merck version reached only around 30% of eligible patients.
Results from two GSK studies suggest Shingrix is more effective than Merck's vaccine, which notched a 70% efficacy rate versus placebo in people ages 50 to 59. Zostavax's efficacy also declined in older age groups.
This advantage, coupled with an aggressive marketing and pharmacy contracting strategy for Shingrix, is expected to drive sales and buoy revenue growth for GSK's vaccine unit as a whole.
Broad market
The CDC specified last October that Shingrix can be safely administered to adults who have previously received Zostavax to prevent shingles, meaning GSK can reach the total patient pool with Shingrix. And with the CDC panel's recommendation that everyone over the age of 50 who has previously been exposed to the chickenpox get the vaccine, Shingrix could see strong sales.
Luke Miels, head of GSK's pharmaceuticals division, has indicated the target market for Shingrix is more than 100 million patients in the U.S. Availability of Shingrix through CVS — the nation's largest pharmacy chain — should support that ambition.
"We see a three-phase launch: first, counter-detailing Merck because these guys are still out there, then targeting Zostavax patients for re-vax, and then in the third phase driving market expansion," said Miels on a recent earnings call.
Earlier this month, Walgreens also announced that Shingrix is available at most Walgreens and Duane Reade pharmacies in the U.S.
Two doses
The addition of an adjuvant in Shingrix helps its efficacy profile, and because it is manufactured with a dead rather than living virus, it could also be a safer option than Zostavax, which uses a live virus. But Shingrix may not be a total slam dunk, at least in the eyes of patients.
Proper administration may be a challenge, for example. Shingrix requires two intramuscular doses from 2 to 6 months apart, whereas Zostavax's single-dose regimen could present a more attractive option for patients. Since patients have to visit the pharmacy twice (and get an injection twice) to realize the full benefit of the vaccine, Shingrix's dosage profile could slow uptake, regardless of CDC suggestions.
Some pharmacists agree a two-dose regimen will be an obstacle for some patients. "I could foresee some patients getting the first dose and, for a variety of reasons including normal adverse effects from the first dose, cost, lack of understanding, or inertia, not coming back for the second dose," said Douglas Hoey, CEO of the National Community Pharmacists Association.
"The biggest predictor of medication adherence is the relationship between the patient and their pharmacist, so a key factor in the success of Shingrix will be pharmacists informing their patients about the availability and benefits of the vaccine and helping them understand what to expect from the administrations (adverse effects and that it is two doses)."
Amy Lanctot, senior manager of public relations at CVS, said the wholesale acquisition cost (WAC) of Zostavax is $223.12 per dose, while the WAC of Shingrix is $140.00 per dose.
But because Shingrix requires two doses, the cost would actually be $280.00. She also mentioned that even though CVS will partner with GSK on Shingrix, Zostavax will still be available to patients if they request it.