Peter Wehrwein

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I have to go back to 2019, before the pandemic. At that point, the head of the Center for Innovation at University of Pennsylvania, 

, was talking to our chief medical officer, 

, and wanted to address the issue of health equity. This brought together a group of us at Independence, along with 

 radio, which is the largest African American talk radio station in Philadelphia and the surrounding counties. The idea was: could we find a topic that we could address where health equity is a problem, and work together using the trust that WURD has with the African American community in order to make this successful. 

We discussed various projects that we thought would be worthwhile. We looked at diabetic screening, diabetic treatment, we looked at cancer detection. We settled on colon cancer screening. The FIT test (

), which is a screening test for colon cancer, is a relatively simple test — the logistics of mailing the test to somebody who was interested, getting the test back and getting a result are all relatively simple with regards to what would be required as far as education of what the person should do. So after some planning, we had everything worked out, and then the pandemic hit. That put everything on hold at that moment. So we took some time.

Not that we weren't aware of the health equity issues, because that's what really started this in the first place, but clearly the pandemic even intensified everybody's understanding of the health equity issue. In Philadelphia, we have the 

, who have gained tremendous trust in the Philadelphia area and highlighted the need to have spokespeople in the African American community to accomplish the type of health equity that we are trying to accomplish. So we retooled the program a little bit and worked with University of Pennsylvania so that we could have everything done correctly from a medical and legal aspect and also logistical aspect. And that's really why we started with the FIT program.

The program, which we named “Go to Know,” is being discussed and advertised on WURD. We've had panel discussions featuring African American physicians and more. The program is going to be running for about six months. And we're trying to tie this into other events like Mother's Day, Father's Day. And we'll continue to have speakers on WURD radio, again so that we can build that trust.

The radio station came to us with Roy Rosen, the director of innovation at the University of Pennsylvania. They were a part of the group of people that brought the idea to us. In the future, we may expand the program, but for the first go around we wanted to have somebody who was very invested in it. The CEO of the radio station, Sara Lomax-Reese, is a person who has ties to the medical community. Her father was a physician in the area and had a large practice as an African American physician. There were ties there also with regards to the health equity.

African Americans disproportionately affected by colon cancer

African Americans actually are 40% more likely to get colon cancer than non-Hispanic whites, and actually 20% more likely to die from colon cancer than non-Hispanic whites. So the health equity issue is significant. We hope that this will become a model that we can then use to attack other projects, like screening for breast cancer, screening for diabetes, and diabetes control.

Videos

Brooks, senior medical director of Independence Blue Cross in Philadelphia, was a key member of the team that created a health awareness campaign launched earlier this month in cooperation with local radio station WURD and other partners including the Colorectal Cancer Alliance, the Independence Blue Cross Foundation, Penn Medicine, Labcorp, and the Health Care Improvement Foundation. The campaign, called “Go To Know,” sets out to increase colon cancer screenings among African Americans by providing free Fecal immunochemical, or FIT, tests. 

Ron Brooks of Independence Blue Cross Shares New Campaign Toward Colon Cancer Screening for African Americans

J&J reaches out. Pfizer, Moderna weren’t interested.

You’re on your own. That seems to be the message that Pfizer and Moderna delivered to Johnson & Johnson when it approached the two companies about speaking “with one voice about safety,” according to a story in the 

Citing unnamed sources, the newspaper reported that J & J “sought to build an informal alliance to communicate the benefits and risks of the shots and address any concerns raised among the public by the blood-clot cases.” Six women have developed blood clots after receiving the J & J vaccine and one died. Pfizer and Moderna declined the invite, saying that they didn’t want to duplicate the efforts of regulators, according to the newspaper. AstraZeneca, whose vaccine has also been associated with blood clots, was interested, according to the 

A third shot will probably be necessary, says Pfizer’s Bourla. And annual shots after that.

Bertha Coombs, Karen Lynch, Albert Bourla

It never seemed like the coronavirus was going to be a one-and-done, but now the reality is setting in, especially with the emergent of variants. “The COVID virus looks more like the influenza virus than the polio virus,” Pfizer CEO Albert Bourla said during a

 program produced by CVS Health that was posted on Thursday (April 15). With 

 listening, Bourla went on to talk about the likelihood of the need for a third dose of the two-dose Pfizer vaccine and annual shots thereafter. “A likely scenario is that there will likely be a need for a third dose somewhere between six and 12 months and then from there an annual re-vaccination, he said, adding though that “all of that needs to be confirmed.”

Bourla’s prediction got some pushback. “How can Albert Bourla and Pfizer say we will need booster shots when their own vaccine data and Moderna tx’s at 6 months look very solid, and there are no data to how mRNA vaccine’s lack of protection against any variant,” tweeted 

FDA, CDC hit the pause button on J & J. Controversy ensued.

There was whiff of a problem last week the European Medicine Agency said it was reviewing a “safety signal” about the single-dose J & J vaccine and a possible association with blood clots. This week that whiff got a whole lot stronger, although the Twittersphere was full of commentary that the  pause on the vaccine would do more harm (possibly resulting in more COVID-19 cases) than good (maintaining public confidence in vaccine safety regulation and possibly avoiding a very slight risk of blood clots — if the vaccine is, in fact, associated with them).

And this week’s news about a possible link to blood clots came after last week’s quality problems: It’s been a bumpy ride for the J & J vaccine

The story started to unfold on Tuesday (April 13) when the FDA’s 

, M.D., issued a statement said that “out of an abundance of caution” they were recommending a “a pause in the use of this (the J&J) vaccine.” They mentioned six reported U.S. cases of cerebral venous sinus thrombosis occurring among people after they received the J&J vaccine; all six were women between the ages of 18 and 48. Cerebral venous sinus thrombosis is a rare (perhaps about 5,000 cases a year in the U.S.) type of stroke caused by blood clots blocking blood drainage through cerebral veins and 

. Marks and Schuchat also noted the denominator of more than 6.8 million doses of the vaccine that have been administered in the U. S. “Right now, these adverse events appear to be extremely rare,” said their statement. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.

 the same day that it had  “proactively delayed” rollout of its vaccine in Europe and paused clinical trials testing the vaccine.

Then the CDC’s Advisory Committee on Immunization Practices (ACIP) swung into...inaction. The ACIP is a group of outside experts that formulate vaccine recommendations — they are only recommendations, although they are often followed by the CDCand others. The committee held an emergency meeting on Wednesday (April 14) but put off a making a decision. Some more details emerged during that meeting, including the possibility of seventh case. The CDC has scheduled a 

 of the ACIP for this coming Friday, April 23, starting at 11 a.m. to further discuss the J&J vaccine and presumably arrive at some recommendations.

 M.D., M.P.H., dean of Brown University’s School of Public Health, was among those that took to Twitter to criticize the committee for delaying a decision. “ACIP should have recommended continuing pause for women 18-49 but resuming for everyone else. Keeping vaccine paused for everyone makes little sense. Risk-benefit keeping vaccine paused for everyone WAY off,” he said in a thread on Wednesday (April 14). 

As of Friday (April 16) at 6 a.m., vaccine data reported to the CDC showed 202,282,923 vaccine doses administered, an increase of 23,445,142 increase, or 13%, over last Friday (April 9). The CDC’s tally shows that 127,743,096 individuals have received at least one dose of a vaccine, an increase of 13,307,057, or 11.6%, from last Friday. As of yesterday, the CDC’s numbers show 38.5% of the U.S. population has received at least one dose of a vaccine and 24.3% is fully vaccinated.

Not enough vaccine? Soon the problem may be getting enough people to take it.

 on Friday (April 16) in projecting a slacking off in demand for vaccine.

The foundation, which has been tracking public opinion about COVID-19 vaccines since December, said it was too soon to tell what the effect of the pause on the J&J vaccine in an update published on Friday (April 16). Public confidence in the vaccines has increased, the update said, but with a “small but persistent group opposed to getting the vaccine and many others still on the fence, the U.S. may soon hit a point where vaccine supply exceeds demand, a situation that is already the case in certain communities.”

The update took issue with “media narratives” that have focused on certain groups being vaccine hesitant. Yes, a greater share of people who identify as Republicans say they don’t intend to get vaccinated and more Black adults have a “wait and see” attitude. But the foundation says its research shows that a majority across all demographics are “at least somewhat open to getting the vaccine.”

More COVID disproportionality: Low vaccination rate among the incarcerated.

Disproportionality has been a theme of the pandemic, and incarcerated people are among the groups that have been affected more than others. According to the 

, 2,443 incarcerated people in the U.S. have died from COVID-1 as of yesterday (April 16) and 162 members of prison staffs have perished. In a 

 blog post on Thursday (April 15), Lauren Brinkley-Rubinstein, Ph.D., a co-founder of the COVID Prison Project, and her co-authors said project had counted 137, 064 people incarcerated in state or federal prisons who have received at least one vaccination as of April 1, which would work out to be about 6% of the estimated 2.2 million incarcerated people in the country.

Shingles seen as side effect of the Pfizer vaccine among those with AIIRD

Six patients among 491 with autoimmune inflammatory rheumatic diseases (AIIRD) developed shingles after being vaccinated with the Pfizer vaccine compared to none among 99 controls, 

 on Monday (April 6). Four of the patients who developed shingles had rheumatoid arthritis, one had Sjogren’s syndrome and one, undifferentiated connective disease. The cases of shingles were mild, they reported, except for one that involved 

 in a patient with rheumatoid arthritis that was being treated with Xeljanz (tofacitinib).

“To date there is no data available on the safety of mRNA COVID-19 vaccination in AIIRD (autoimmune inflammatory rheumatic disease) patient as immunosuppressed patients were excluded from the vaccines’ trials,” wrote Victoria Furer, M.D., and her colleagues. "Therefore safety and monitoring of vaccinated patients is especially warranted in this population.”

Antibodies to platelet factor to blame for blood clots after AstraZeneca vaccine? Evidence grows.

accine-induced immune thrombotic thrombocytopenia

 (VITT) after the AstraZeneca vaccine. In this study, 21 of the 23 patients had high levels of antibodies to platelet factor 4 (PF4) a phenomenon seen in the relatively rare instances when people develop blood clots in reaction to heparin, known as 

. Heparin is given to prevent blood clots, so HIT is the exact opposite of the intended effect. Lead author Marie Scully, M.D., and her colleagues said the evidence so far does not show heparin would aggravate the VITT. Even so, they recommend using a nonheparin anticoagulant, such as argatroban, danaparoid, among others.

The other two NEJM studies have also implicated antibodies to PF4 as possibly playing a role in VITT. An 

 warned, though, against jumping the gun and settling on them as culprits. The understanding of the pathogenesis of VITT is incomplete, wrote wrote 

, and the usefulness of measuring pathogenic anti-PF4–related antibodies in vaccine recipients has not been established: “To close the loop, the next step should be a direct demonstration that the anti-PF4 antibodies described here cause thrombosis and thrombocytopenia in an in vivo model.”

And, as many others have, Cines and Bussel also emphasized that VITT is rare and the benefits of vaccination have to be weighed against the risks. At the same time, they also left the door ajar to some vaccines perhaps being more suitable for some populations than others and the need to monitor for rare compliations.

Let’s prevent the next one. Researchers look for “pancoronavirus” vaccine.

SARS-CoV-2 didn’t surprise coronavirus experts. It’s just one variety of a slew of coronavirus, and it’s a safe bet that another will mutate in such a way as to become transmissible among humans. Jon Cohen, an award-winning science journalist for 

, wrote this week about early-days research efforts to develop a “

 that would immunize humans against emerging coronavirus.

“Beyond bats, coronaviruses infect camels, birds, cats, horses, mink, pigs, rabbits, pangolins, and other animals from which they could jump into human populations with little to no immunity, as most researchers suspect SARS-CoV-2 did,” wrote Cohen in a piece published on Thursday (April 15).

Although cool to the idea in the past, the National Institute of Allergy and Infectious Diseases (NIAID) has solicited applications for “emergency awards” to pursue pancoronavirus vaccine development, reported Cohen. An international nonprofit, the 

Coalition for Epidemic Preparedness Innovations

, is also funding research, according to Cohen.

Articles

The Pause on the J&J Vaccine, a 3rd Shot of Pfizer Likely, Research into Causes of the AstraZeneca Blood Clots and Other COVID-19 Vaccine News This Week

Below is a short Q&A excerpt of an interview with Steven Pearson of ICER. Text has been edited for length and clarity.

 Did the pricing of the PCSK9 inhibitors put ICER on the map?

 Well, we have been in existence already for almost seven, eight years at that stage and so if there had already been notice to our work, especially around the time of the new, big budget-buster drug for hepatitis C that was on people's radars, it helped bring more attention. Not too long after the hepatitis C drugs came the PCSK9 inhibitors, and what was unique about them was that they were a completely new paradigm of care for patients with high cholesterol. 

Related: ICER Chief on Bempedoic Acid and Inclisiran: Don’t Repeat the PCSK9 Mistake

There are obviously a lot of patients in the country who have high cholesterol in spite using the available pills. The potential for the budget impact was so high that it raised people's attention. So our approach is not to worry so much about the short-term budget impact but to really try to capture the long-term value in the way that we look at value. Even looking at the PCSK9 data at the time of its launch, we did take the list price that they came out was far too high to match up with what was going to be the likely clinical impact, because remember, by that point we didn't even have the clinical trials that said it did prevent heart attacks and strokes. We just had trials that showed it lowered cholesterol.

So taking that on, we did a model that said connecting to the likely downstream reduction in heart attacks and strokes, how valuable would these be and what would a fair price be so when we came out with a much lower price, it affirmed what many payers and others were feeling - which was that this seemed like an expensive drug for the for the clinical value, that it was going to provide for the average patient for every patient, but for the average patient.

In this second part of a three-part series, Steven D. Pearson, M.D., M.Sc., founder and president of ICER addresses if pricing of PCSK9 inhibitors put ICER on the map.


The Impact PCSK9 Inhibitor Pricing had on Payers, ICER 

ICER came out with a report a month ago on two cholesterol-reducing agents that may compete with the PCSK9 inhibitors, according to Steven D. Pearson, M.D., M.Sc., founder and president of ICER, said in a recent interview with 

Pearson warned about repeating the mistakes of the past and those early high-priced, low-uptake years of Praluent and Repatha. 

“We all should just be aware that price and access are joined at the hip,” Pearson told 

. “It did feel that the first few years after the PCSK9 inhibitors came out, there was an opportunity squandered because of all the friction and the difficulty that patients and doctors had. And certainly the companies felt like the uptake of the PCSK9 inhibitors — and their revenues — weren’t good.”

The two drugs assessed in the ICER report are bempedoic acid and inclisiran. Bempedoic is sold as Nexletol and, in combination with ezetimibe, as Nexlizet. The FDA held up approval of inclisiran after it found manufacturing problems at a plant in Italy, where the drug is made. ICER says its cost-effectiveness math shows that a fair annual price for the bempedoic acid/ezetimibe combination would be between $1,600 and $2,600, which would be 36% to 60% less than the current wholesale acquisition. ICER’s cost-effectiveness math for inclisiran, which doesn’t have a price yet because it is not the market, put the price tag between $3,600 and $6,000. Pearson said the PCSK9 inhibitors were a hard lesson learned about the dynamics of pricing and squandering the opportunity to bring innovative drugs into clinical use. “If we can get the prices aligned at the front end, that just gets the ball rolling in the right direction.”

Whether inclisiran will be considered to be in the same class as the PCSK9 inhibitors could be a complicating factor in the drug’s uptake. It has a different mechanism of action but does work in the same biochemical pathway, noted Pearson: “A clinician would tell you that it serves the same purpose.” One possible advantage of inclisiran is that it needs to be administered only twice a year, albeit by a healthcare professional, in contrast with the once- or twice-monthly self-administered injections of Praluent and Repatha. A clinician with experience in underserved communities commented at an ICER meeting that the less frequent dosing, administered in a doctor’s office, would be an advantage for many of the patients he cares for, Pearson said.

If and when someone writes the history of drug pricing in the U.S., the cholesterol-lowering PCSK9 inhibitors are likely to be a paradigmatic chapter. When Repatha (evolocumab) and Praluent (alirocumab) came on the market in 2015, their list prices were more than $14,000 a year. But expectations of wide use and big sales crashed and burned. Payers and, to some extent, physicians bridled at the price of the new drugs, which are administered by self-injection. The Institute for Clinical and Economic Review (ICER), the cost-effectiveness research organization in Boston, had already made a name for itself in the controversy about the pricing of the hepatitis C antivirals. It weighed in with a cost-effectiveness assessment that said the prices of the PCSK9 inhibitors should be slashed by 60% or more.

“I think it actually just affirmed what many payers and others were feeling, which was that this seemed like an expensive drug for the clinical value that it was going to provide for the average patient,” Pearson said.

“What was unique about them (the PCSK9 inhibitors) was that they were a completely new paradigm of care for patients with high cholesterol,” Pearson continued

 “There are obviously a lot of patients in the country who had high cholesterol despite using the available pills, so the potential for the budget impact was so high that it caught a lot of people’s attention.”

Starting in 2018, Sanofi and Regeneron, the manufacturers of Praluent, and Amgen, which makes Repatha, started to compete on price, and by 2019, the annual price tags of their PCSK9 inhibitors were below $6,000, still more expensive than the price ranges recommended by ICER (which has revised them since 2015 as new study results have been reported) but still half of the initial price. In a February earnings report, Amgen stated that sales revenue from Repatha increased by 34% in 2020 compared with 2019, with a 67% increase in volume largely responsible for the uptick. At about the same time, Sanofi reported that sales of Praluent increased by 2.3% in 2020.

So arguably a tick in the win column for tying drug prices to cost-effectiveness — and for ICER — right?

In this new episode of MHE Talks: Improving Patient Access podcast, Steven D. Pearson, M.D., M.Sc., warns that high prices can squander an opportunity to bring innovative medications into clinical use. 
