What led to the abrupt fall of FluMist — the nasal spray version of influenza vaccine — which until recently was considered the preferred alternative to the injectable vaccine for younger children?
No one is quite sure, but there were hints of trouble for the past three flu seasons.
On Wednesday, an advisory panel to the Centers for Disease Control and Prevention voted that — though it continues to be important to be vaccinated against the flu — the spray version was so ineffective that it should not be used by anyone during the 2016-2017 flu season.
Just two years ago, that same Advisory Committee on Immunization Practices recommended FluMist as the preferred alternative for most kids ages 2-8, after reviewing several studies from 2006-2007 that suggested the spray was more effective in kids than the injectable forms of the vaccine.Use Our Content This KHN story can be republished for free (details).
What changed to make the spray so much less effective than studies had shown it to be in the past?
The bottom line is that right now “we don’t understand what it is,” said David Kimberlin, a professor of pediatrics at the University of Alabama, who said academic researchers and those at MedImmune, a subsidiary of Astra Zeneca that makes the vaccine, are working to get answers.
Finding Trouble Spots In The Timeline
FluMist is a live attenuated vaccine, meaning it contains a weakened version of the virus itself but does not give the recipient the flu. Instead, it — like other forms of the vaccine — sparks the body’s immune system to create antibodies to the virus. The injectable forms of the vaccine contain killed versions of the virus.
Among several studies the panel considered when it made its July 2014 preferential recommendation for FluMist was a 2004 randomized controlled trial — considered the best type of study — that found a 55 percent reduction in the number of flu cases among children who received the nasal spray compared with those who got the shot. Results were reported in the New England Journal of Medicine in 2007.
Three months after it made the recommendation, however, the CDC received some troubling data: During the 2013-2014 flu season, the nasal spray showed no measurable effectiveness against the pandemic H1N1 virus in kids aged 2 to 8. That was the predominant type of influenza virus circulating that year.
As a result, the panel in February 2015 did not renew its preference for FluMist for the next flu season, although it was still considered a viable option.
At that meeting, the panel also heard that the spray had performed poorly in the 2014-2015 season.
Because vaccine makers have to guess months ahead of time what the predominant strains of the virus will be, designing the correct combination is always a gamble.
That time, they guessed wrong. More than two-thirds of the H3N2 versions of the virus circulating in the U.S. during the 2014-2015 season were different from the H3N2 versions in both the nasal spray and the injectable vaccines. So all versions of the vaccine — shots and spray — performed poorly.
Now, looking at this winter’s flu season, the CDC says data shows FluMist’s efficacy among children 2-17 was only 3 percent, essentially providing no protective benefit.
For its part, AstraZeneca said the CDC’s data for 2015-2016 are in sharp contrast with its own studies as well as preliminary findings by public health officials abroad.
“These findings demonstrate that FluMist … was 46-58 percent effective overall against the circulating influenza strains during the 2015-2016 season,” the firm said in a release Thursday.
U.S. sales of Flu Mist in 2015 totaled $206 million, about 1 percent of the AstraZeneca’s revenue.
In Search Of An Explanation
In any given flu season, vaccine effectiveness varies. One factor is how well the vaccines match the virus that is actually prevalent. Other factors influencing effectiveness include the age and general health of the recipient. In the overall population, the CDC says studies show vaccines can reduce the risk of flu by about 50 to 60 percent when the vaccines are well matched.
Now, researchers are trying to see what — if any — is the common factor behind FluMist’s recent poor performance.
There’s not a clear answer, said Henry Bernstein, a professor of pediatrics at Hofstra Northwell School of Medicine in New York and an ex-officio member of the committee on infectious diseases for the American Academy of Pediatrics.
“We know that the influenza virus itself is totally unpredictable from one year to the next,” he said.
Among the questions researchers are considering is why the strain of pandemic H1N1 used in the 2013-2014 flu season didn’t perform well. The manufacturer’s attempt to fix it in following seasons also did not work.
Several years ago, the vaccine also went from incorporating three flu virus strains to four. Did that somehow reduce its effectiveness? The earlier studies demonstrating that the spray was more effective than the shots were based on the three-virus vaccine, not the four-virus version.
Researchers will investigate whether the vaccine loses effectiveness for some reason when given to children who have had many previous flu vaccinations.
Uncertainty comes along with the territory for researchers.
But it’s harder for the general public. Kids are bound to be especially disappointed.
“Once they found out about the nasal vaccine instead of the shot, they strongly, strongly preferred the nasal one,” said Elizabeth Howton of Falls Church, Va., who has an 8-year-old and a 10-year-old.
Howton said she fears the uncertainty now surrounding the nasal spray will add to the skepticism some parents have about vaccines in general.
For her kids, there will be no skipping the vaccine. Even though it means a shot. Howton said she expects to offer “copious bribes,” to sweeten the deal.
“I know they will be very disappointed, but I will still get them vaccinated,” said Howton.
The public should be reassured that recommendation not to offer FluMist shows that public health agencies are watching carefully, said Bernstein.
“People need to recognize and applaud the idea that this type of monitoring and evaluation happens continuously,” he said. “The CDC does evaluate the effectiveness of these public health initiatives, including vaccine effectiveness and safety.”
While people who don’t like needles will be disappointed, FluMist’s absence is not likely to lead to an overall shortage, experts say.
The spray made up about 8 percent, according to the CDC, of the total projected supply of 176 million doses of flu vaccine being prepared for the upcoming flu season.
And despite the loss of this form of vaccine, the CDC and other experts continue to strongly recommend that just about everyone 6 months and older get vaccinated because influenza can cause serious illness and is blamed for thousands of deaths each year.
“The importance of preventing flu hasn’t changed,” Kimberlin said. “What has changed is we have one less tool.”
This week at CBPP, we focused on Social Security and Medicare, health care, the federal budget and taxes, housing, and poverty and opportunity.
Two events this week drew new attention to the Independent Payment Advisory Board (IPAB) — a presidentially appointed commission charged with developing ways to slow the growth of Medicare spending. Medicare’s trustees reported that projected Medicare spending growth will likely trigger the IPAB process for the first time in 2017 and require the board to make recommendations in January 2018 for implementation in January 2019. At the same time, House
It’s a predictable passage in life: Hit 50, get lots birthday cards with old-age jokes, a mailbox full of AARP solicitations — and a colonoscopy.
But millions of Americans — about one-third of those in the recommended age range for colon cancer screening — haven’t been tested. Some avoid it because they are squeamish about the procedure, or worried about the rare, but potentially serious, complications that can occur as a result of it.
Now, an influential panel has added some new choices, aiming to get more Americans screened for colorectal cancer, which is the second leading cause of cancer death in the U.S.
Here are five things you need to know:
1. Getting tested — in any of a variety of ways — is a good thing.
Following its review of all the available medical evidence, the U.S. Preventive Services Task Force — an independent blue-ribbon panel of medical experts — updated its colorectal cancer screening guidelines last week. The panel gave an “A” rating to screening all adults between ages 50 to 75 years at average risk of the disease, saying the benefits are “substantial.” People with a family history or other risk factors might want to start earlier — and those older than 75 should talk with their doctors about whether to continue screening.This KHN story also ran on NPR. It can be republished for free (details).
Noting that not enough Americans are getting screened, the panel essentially said the best test is the one that patients will take: “The goal is to maximize the total number of persons who are screened because that will have the largest effect on reducing colorectal cancer deaths.”
2. Two less-invasive tests may qualify for free preventive screening.
The biggest change from prior guidelines is the panel’s inclusion of two more ways to screen for the disease, including “virtual colonoscopies,” like President Barack Obama underwent in 2010. Also called computed tomography (CT) colonography, the test uses special X-ray machines to examine the colon. The panel also added a $650 home test called Cologuard, which checks stool for elevated levels of altered DNA that could indicate cancer. Those tests join several others that were part of the panel’s previous recommendations: the full colon exam called colonoscopy; sigmoidoscopy, which uses a lighted tube and camera to examine just the lower portion of the colon; and two other types of home stool tests, fecal occult-blood tests (gFOBT) and fecal immunochemical tests (FIT). Because of the task force’s “A” rating for colon cancer preventive screening these tests generally must be offered to insured patients without a copayment or deductible under the rules put in place by the Affordable Care Act.
3. Don’t expect all insurers to drop co-pays on the new tests right away.
While Medicare already covers Cologuard as a preventive screening tool, many private insurers do not. Of people with private insurance who are in the target age range, about one in four currently have coverage for the test, said Kevin Conroy, president and CEO of Exact Sciences, which makes the test. “That’s going to change,” he said, “because health plans have told us that they will follow the task force’s guidelines.”
When it comes to virtual colonoscopies, some insurers — including Cigna — cover them, but Medicare does not. In 2009, Medicare said there was insufficient medical evidence to determine if such tests should be covered nationally.
Now Medicare will likely be asked by proponents of virtual colonoscopy to revisit that decision.
Under the ACA, insurers have up to a year to incorporate “A”- or “B”-rated screening tests into their benefit packages without a copayment. Many experts believe insurers must offer all the types of tests, although they do not have to cover each manufacturer’s product if several competitors exist in a category.
4. The task force didn’t pick favorites.
The panel did not rank the tests, noting a lack of head-to-head comparisons showing any one method has the most net benefit. All tests have pros and cons. For example, getting a colonoscopy every 10 years has the advantage that, if potentially cancerous polyps are detected, they can be removed during the procedure. But it also carries a small risk of harmful complications, such as anesthesia-related cardiac problems, bowel perforations or abdominal pain. Sigmoidoscopy at 5-year intervals has a lower rate of complications, but can miss some cancers because it doesn’t reach the entire colon. Annual stool tests, which don’t themselves carry any risk, reduce colorectal cancer deaths, the panel noted. The newer FIT immunochemical stool tests are a bit better at spotting cancers than FOBT, which studies show can correctly identify cancers 62 percent to 79 percent of the time. Cologuard — recommended every one to three years — detects existing cancers 92 percent of the time, but has a higher false-positive rate than FIT. Virtual colonoscopies, which expose patients to X-ray radiation, spot existing cancers of 10 millimeters or larger 67 percent to 94 percent of the time. The exam can also lead to additional, sometimes unnecessary testing because it flags potential problems outside the colon 40 percent to 70 percent of the time, with only about 3 percent of those concerns ultimately needing some form of treatment, the panel noted.
5. You might still get hit with a copayment.
Although preventive screening is covered without copayments or deductibles, some patients still end up with a bill. Medicare, most notably, requires a 20 percent copayment if a polyp is found during a screening colonoscopy and removed. That payment averages $272, although advocates say they have seen far higher bills. Most private insurers do not charge patients if a polyp is found during a preventive screening, following Obama administration clarifications on the topic.
Another way consumers can get hit with a copayment is if a stool test, sigmoidoscopy or other exam indicates cancer might exist. A colonoscopy is then performed and some insurers consider that test a “diagnostic” exam, rather than a preventive screening. The American Cancer Society Cancer Action Network says it has asked the administration to clarify what happens in such a case. “If a patient has a positive test, the next step is colonoscopy, and therefore should be covered without cost-sharing,” said Caroline Powers, director of federal relations with ACSCAN. “We’re trying to get more people screened.”
Some consumers who use health insurance copays to buy prescription drugs are paying far more than they should be and would be better off paying with cash, especially for generics.
The added cost runs as high as $30 or more per prescription, say pharmacists, and the money is largely being pocketed by middlemen who collect the added profit from local pharmacies.
Cash prices started to dip below copays a decade ago when several big box stores started offering dozens of generics for as little as $4 per prescription. But as copays have risen and high-deductible insurance plans become more common, more consumers are now affected.
The phenomenon illustrates the complexity of how drugs are priced in the U.S. and has led to finger-pointing about who is benefitting or who’s to blame.This KHN story also ran on CNN.com. It can be republished for free (details).
Pharmacists say large pharmacy benefit management (PBM) firms that handle benefit clams for millions of Americans are pocketing the difference, while those firms say pharmacists themselves are being greedy.
“In some cases, consumers are blaming high drug prices on manufacturers, but really the cause of their costs may be the insurance company or the pharmacy or the pharmacy benefit manager,” said Adam J. Fein, who follows the drug industry for management advisory firm Pembroke Consulting in Philadelphia. “It’s very hard to figure this information out.”
‘A Bewildering Array Of Factors’
How much consumers pay at the pharmacy counter depends on a bewildering array of factors, including health insurance policies that set copayments and deductibles, the pharmacies they choose, and which behind-the-scenes PBM their employer or insurer hires to manage claims and negotiate prices with pharmacies and drugmakers.
The back-and-forth between pharmacists and PBMs is part of a long-running feud between the two groups. Not every PBM negotiates prices that allow for these overpayments, the pharmacists say, and not all drugs are affected.
Still, here’s how pharmacists say consumers are getting squeezed. At the pharmacy counter, patients pay their share of the cost — the copay — as set by their PBM and insurance plan.
Days or weeks later, the PBM firm takes back a portion of that patient payment from the pharmacy after the PBM determines what it will actually pay for the drug — a practice sometimes called a “clawback.” That money does not go to the consumer but is generally kept by the PBM.
“It’s a fraudulent misrepresentation to the patient of what is the cost of the drug,” said Susan Hayes, principal with Pharmacy Outcomes Specialists, which audits pharmacy programs on behalf of insurers.
In a survey by the National Community Pharmacists Association taken in early June, members provided examples. None of the pharmacists would talk on the record for fear of being kicked out of the PBM networks, so their responses could not be independently verified.
One told surveyors that a major PBM required the pharmacy to collect a $35 copay for a generic allergy spray, then took $30 back from the pharmacy. Another said a PBM charged a $15 copay for insomnia drug Zolpidem, then took back $13.05. Patients were charged $30 above the cash price for a generic cholesterol medication at another pharmacy.
In effect, the customer has paid more for the drug than the PBM ultimately pays even though “they assume what they are paying is the cost of the drug,” said Susan Pilch, vice president for policy and regulatory affairs with the pharmacists’ group.
In response, the CEO of the benefit managers’ trade association blames pharmacists, whom he says should simply offer customers the cash price of the drugs — if cheaper — bypassing their insurance plans altogether.
“Not everything has to go through the plan,” said Mark Merritt, president and CEO of Pharmaceutical Care Management Association. “The only reason [for pharmacies] to process the claim is to keep the copay for themselves.”
While agreeing that in some cases consumers could get their drugs for less if they paid cash, Pilch said pharmacists are specifically barred from discussing the cash price under terms set by contracts between them and the PBMs. Its June survey of 650 pharmacists found that more than 38 percent said they were unable to tell patients about cheaper cash prices 10 to 50 times in the previous month.
“We are required to run it through insurance and we do not have the option of advising the patient regarding matters of the terms of their plan or their options, or we run the risk of being cut from the network,” she said.
For their part, PBMs say patients pay the amounts specified by their insurance plan benefit design. And the amounts they take back, they say, can help hold down cost and slow future premium increases to the insurers and employers who hire them.
Still, Louisiana lawmakers this month passed legislation to rein in the practice by directing pharmacists to tell patients about all their options — including less expensive alternatives.
Arkansas lawmakers last year passed a law that bars PBMs and pharmacies from collecting more from customers for medications than the pharmacy will ultimately be paid.
The laws “should eliminate these consumer clawbacks, which I believe are rare, but are an example of bad behavior by a PBM making a drug more expensive than it should be,” said Pembroke’s Fein.
OptumRX, a PBM that is part of UnitedHealth Group, was cited as a firm engaged in such efforts by the national pharmacy association and its affiliates in Arkansas and Louisiana.
UnitedHealth spokesman Matt Wiggin said only a small portion of claims were affected, although he could not give a specific percentage. The firm, he said, is moving to change its contracts to avoid the situation in the future.
At Cigna, another firm called out by the pharmacists, spokeswoman Karen Eldred would not say if it takes back a portion of the customer’s payments from pharmacists. But she said customers “would not pay more than the retail price (cash price) reported to Cigna by the pharmacy.”
A spokesman for Express Scripts, one of the nation’s largest PBMs, said the firm does not engage in the practices which “are not in the best interest of patients or the country,” said spokesman David Whitrap.
Market experts agree that shopping around and doing some legwork are tactics that will help consumers avoid paying too much because of the clawback.
Cigna, Express Scripts and other insurers also have apps and websites where members can check drug prices at multiple pharmacies and decide for themselves how best to proceed. But if a health plan or PBM doesn’t offer an app, consumers can check the cash price for prescriptions through one of the online websites like GoodRX or Blink health before heading to the pharmacy.
In some cases, it might be less expensive to pay cash. But experts caution that such cash payments don’t always count toward annual drug deductibles. Consumers who expect a lot of drug costs might want to think twice about paying cash. But others may still find it saves them money, even if they never hit their deductible.
“The safest thing to do is always know what the pricing is in the marketplace,” said Mike Miele, an area president who advises employers on benefits for consulting firm Arthur J. Gallagher. “There are literally thousands of generics that are below $10.”
California’s insurance commissioner on Thursday recommended that federal officials block Aetna Inc.’s proposed $37 billion acquisition of Humana Inc., saying the deal would suppress market competition and harm consumers.
The official opinion of Dave Jones came just three days after California’s other health insurance regulator, the Department of Managed Care, approved the planned transaction. Just a week ago, Jones urged the federal government to block another mega-merger, Anthem Inc.’s $54 billion offer for Cigna Corp, also on competitive grounds.
Jones said an Aetna-Humana tie-up would reduce competition in commercial health insurance markets that are already highly concentrated.
“The Aetna and Humana merger has anticompetitive impacts that will likely result in increased prices, decreased availability of health insurance products, and decreased quality and access to healthcare,” Jones said.
He said the merger would combine the nation’s third and fifth largest health insurance companies, by market value.
Aetna officials downplayed the recommendation by Jones.Use Our Content This story can be republished for free (details).
“We received approval earlier this week from the Department of Managed Health Care, the only regulatory agency in the state with official oversight of our acquisition,” said Anjie Coplin, an Aetna spokeswoman.
Jones does not have the authority to block the national insurance merger, but his recommendation could influence the U.S. Department of Justice, which has the final say.
When the Department of Managed Health Care signed off on the Aetna-Humana merger Monday, it noted Aetna’s agreement to keep rate increases to a minimum and improve the quality of patient care.
As a condition of the DMHC’s approval, Aetna also promised to spend nearly $50 million on community investment projects, which include expansion of its Fresno-based service center and support of dental services for low-income communities.
“But these undertakings do not eliminate the anti-competitive effects of the merger,” said Jones, who is a candidate for state attorney general in 2018.
He noted that the DMHC‘s merger reviews do not weigh anti-trust concerns and are limited to managed care policies in California.
Jones said the deal would also have a serious negative impact on millions of seniors who rely on commercially-administered Medicare insurance policies, known as Medicare Advantage plans. Combined, Aetna-Humana would have 26 percent of all Medicare Advantage enrollees in the country. That’s more than any other insurer, Jones said.
The commissioner also cited his concern that Aetna and Humana officials have not guaranteed consumers will see any of the $1.25 billion the companies expect to save annually as a result of the merger.
Consumer advocates, who have actively spoken out against the mergers, are urging the U.S. Department of Justice to accept the commissioner’s recommendations and reject the transaction.
“There is no upside for consumers from this deal,” said Carmen Balber, executive director of Santa Monica-based Consumer Watchdog. “Aetna has overcharged policyholders millions, just in the last few years,” she said, pointing to the company’s 11 rate hikes since 2012. “Yet Aetna and Humana won’t commit that future rates would be justified.”
Aetna officials expect the deal, if approved by federal regulators, to close in the second of half of this year.
When Speaker Paul Ryan releases the House GOP tax plan tomorrow, a key question is whether it’s closer to the plan from presumptive GOP presidential nominee Donald Trump or to a very different one from then-Ways and Means Chairman Dave Camp in 2014, the last time the House GOP presented a comprehensive tax reform plan.