Nearly 12 years after the FDA approved Zostavax, the first vaccine to prevent shingles in adults 60 and older, the vast majority of seniors still haven’t received it. Only 30.6% of adults age 60 and older reported getting the shingles vaccine, according to the latest CDC (Centers for Disease Control and Prevention) assessment of vaccine coverage.
Since it became available, Zostavax has faced numerous barriers in terms of getting seniors vaccinated, the assessment found. In October, the FDA approved a new shingles vaccine, Shingrix, for people age 50 and older. Less than a week later, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended Shingrix as the CDC’s preferred shingles vaccine for adults age 50 plus due to Shingrix’s better efficacy and fewer side effects compared to Zostavax.
It also recommended anyone who already received Zostavax also get Shingrix, provided at least 8 weeks had passed. Whether Shingrix use will fare any better, particularly among those age 65 plus, depends on whether those barriers remain, says William Schaffner, MD, medical director of the National Foundation for Infectious Diseases.
Barriers to Vaccination
Pharmacist Norman Tomaka, FAPhA, and an American Pharmacists Association spokesperson, has seen firsthand the difficulties with Medicare Part D, but also other issues.
Whether it’s a vaccine or medicine, Tomaka says getting a shot ranks behind taking rectal medications — such as suppositories and enemas — as the major reason for pharmaceutical non-compliance. “Already that it’s a shot, you have to discount a good percentage of seniors,” he says.
Here’s where Shingrix might be an uphill battle, says Tomaka. Vaccination with Shingrix will require 2 shots, an initial shot, and then a second injection 2 to 6 months later. Another worry: Pain, redness and swelling severe enough to prevent normal activity were common side effects after patients received Shingrix. Whether people will remember to go back or want to go back for that second shot remains to be seen, says Tomaka.
Zostavax has some inherent barriers that can dissuade seniors from getting innoculated. As a vaccine with a small amount of live herpes virus present, Zostavax is contraindicated for people with weakened immune systems, which may have limited the number of seniors who could receive it. It also requires freezer storage, another reason most doctors don’t stock it, says Dr. Schaffner. Shingrix, however, is a non-live vaccine made from a protein in the virus, doesn’t require freezer storage, and has fewer limitations on individuals with weakened immune systems.
Why It Matters
The shingles virus (herpes zoster) hits the senior population particularly hard. A blistering skin rash, shingles risk increases with increasing age and so does the related, debilitating nerve pain, known as postherpetic neuralgia (PHN), which can linger long after the rash resolves. In rare cases, shingles can even cause blindness.
Licensed in May 2006, clinical trials showed Merck’s Zostavax reduces the risk of shingles by 51% in adults age 60 and older, and PHN by 67%. But Zostavax has its limitations, says Dr. Schaffner, who is also a professor of preventive medicine in the department of health policy at Vanderbilt University School of Medicine in Nashville.
“What happens is that you get good protection initially, and then it begins to diminish, and by the time you get out to 8 to 10 years, basically the population is close to baseline once again.”
A Kaiser Permanente study of Zostavax’s long-term vaccine effectiveness (VE) found that in persons age 60 to 69, VE dropped to 70.6 % within a year after vaccination and to 32.1% 7 to 8 years out. In 2011, the FDA extended Zostavax approval to individuals 50 and older, but because VE fared even worse among those age 50 to 59, ACIP maintained its 60 and older recommendation.
In comparison, GlaxoSmithKline’s 2-dose Shingrix vaccine was 97% effective at preventing shingles in adults 50 to 69 years old and 91% at preventing PHN. Among adults 70 years and older, Shingrix was still 91% effective in preventing shingles and 89% at preventing PHN. Shingrix’s trial data also showed its VE held strong, with minimal waning, 4 years after administration.
“It looks as though this is going to be long-term protection,” says Dr. Schaffner. “This is really shingles vaccine 2.0. A game changer.”
Medicare Part D Costs…
Where the vaccine resides in Medicare might be the overarching reason most seniors haven’t received Zostavax and might not receive Shingrix, says Dr. Schaffner.
The shingles vaccine falls under Medicare Part D, as a prescription drug, and not as a preventive fully covered under Medicare Part B like the flu and pneumonia vaccines. Being listed in Medicare Part D may create the perception that the shingles vaccine isn’t necessary, unlike the flu or pneumonia vaccines, says Tomaka. Recent vaccination data tells the story: 34.2% of Americans age 65 and older reported getting the shingles vaccine (Zostavax), compared to 73.5% the flu vaccine and 63.6% the pneumonia vaccine.
For seniors on a fixed income, getting any shingles vaccine might be a matter of budget over health. A “fair price” for Zostavax is $206, with some pharmacies charging $245, according to HealthcareBluebook.com. The “fair price” for each Shingrix shot is $151, with some pharmacies charging nearly $300 per shot.
The cost for Part D prescriptions depend on what, if any, stand-alone prescription drug or Medicare Advantage plan seniors purchase.
The good news is that 72% of Medicare recipients are enrolled in a Medicare Part D plan, according to a report by the Kaiser Family Foundation (KFF).
The bad news: Few Medicare Part D plans pay for prescriptions outright. The majority of all Part D enrollees are in plans that use 5 cost-sharing tiers, finds the KFF report. Some plans may charge a flat copay. Others use formularies, with members paying a percentage per drug. Others might require the patient meet their deductible first. For 2018, the deductible for Medicare Advantage plans is capped at $450.
…And Administrative Headaches
Inclusion in Medicare Part D creates barriers to administration. “For people 65 and older, most doctors don’t even stock the vaccine and can’t be bothered to go through all the rigmarole to bill Medicare for it,” says Dr. Schaffner. Doctors who do stock the vaccine may charge patients upfront, requiring them to get reimbursed by their insurance provider.
Most doctors, if they bring up shingles at all, says Dr. Schaffner, refer Medicare patients to their local pharmacy. That, in turn, may create a problem with follow-through. “All those administrative encumbrances are barriers to the use of shingles vaccine in people age 65 and older,” he says.
To remove barriers to vaccinations, in recent years state legislatures have passed regulations allowing pharmacists to administer all ACIP-recommended vaccines based on protocol or prescription, according to the APhA.
Misinformation: Shingles Is Not an STD
“Clinical misinformation is another reason more seniors aren’t getting vaccinated,” says Tomaka. “Some seniors don’t believe they are at risk of getting it.”
Also known as the herpes zoster vaccine, the name itself adds to the confusion. The “herpes” part makes some seniors believe the vaccine is sexually transmitted, says Tomaka. And, if they’re not having sex, or have a monogamous relationship, they think they can’t get shingles. Shingles is not transmitted through either sex or air-borne germs.
How Do You Get Shingles?
The same virus that causes chickenpox (in most people, when they’re children) causes shingles. Once you’ve had chickenpox, the shingles virus lies dormant in your system until it’s reactivated and causes the painful rash.
Some seniors have told Tomaka that because they aren’t around children, they aren’t at risk of getting shingles. While the varicella zoster virus causes both the shingles and chickenpox, being exposed to someone with chickenpox isn’t what causes shingles. The fact that you had chickenpox is what puts you at risk for developing shingles. That trips people up, too. “They say, ‘Well, I’ve had the chickenpox, so I shouldn’t get the shingles,’” says Tomaka.
Which brings us to another problem: Some seniors can’t remember whether they ever had chickenpox. If they can’t remember, they may reason it’s safe to skip the vaccine. But studies have shown that 99% of Americans age 40 and older have had chickenpox, according to the CDC.
Hope for Shingrix
The hope for getting more seniors protected against shingles lies in Shingrix’s lowered vaccination age.
“The great emphasis will be if doctors stock this vaccine because it will be covered by regular medical insurance. You can give it to everyone 50 and older and by the time you reach age 65, you’re already vaccinated. We don’t have to wrestle with all the pain in the neck of Medicare,” explains Dr. Schaffner.
But for seniors who are 65 and older now, the biggest barrier to shingles vaccination — placement in Medicare Part D — remains. “The paradox is that’s where the greatest risk is,” adds Dr. Schaffner.
Efforts to get Congress to move other ACIP-recommended vaccines, including the shingles vaccine, to Medicare Part B, have gone nowhere fast, he says. “No one has any optimism in the current political environment that we’re going to get that. The dominant theme is to tear down the Affordable Care Act, so they’re not going to start expanding preventive health services.”