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POLICY
FDA Grants EUA for Third COVID-19 Vaccine
February ended in a flurry for the FDA and the Janssen COVID-19 vaccine. In the space of three days, an FDA advisory committee unanimously recommended an emergency use authorization (EUA) for the vaccine, which the agency then granted, followed by the Advisory Committee on Immunization Practices (ACIP) endorsing the safety and effectiveness of the vaccine for people aged 18 years and older.
“This third safe, effective COVID-19 vaccine comes at a potentially pivotal time. CDC’s latest data suggest that recent declines in COVID-19 cases may be stalling and potentially leveling off at still very high numbers. That is why it is so critical that we remain vigilant and consistently take all of the mitigation steps we know work to stop the spread of COVID-19 while we work our way toward mass vaccination,” said CDC Director Rochelle P. Walensky, MD, MPH, on signing the ACIP’s recommendation.
“As vaccination scales up, so too does our nation’s overall protection from serious outcomes due to COVID-19,” she explained.
Calling the vaccine an “important tool in our toolbox,” Walensky said the vaccine has some advantages over the Pfizer/BioNTech and Moderna vaccines. Because it is a one-dose vaccine, “people do not have to return for a second dose to be protected. In addition, this vaccine does not need to be kept in a freezer and can be stored at refrigerated temperatures—so it is easy to transport and store and allows for expanded availability in most community settings and mobile sites, as supply scales up,” she said.
The FDA determined that the Janssen COVID-19 vaccine met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older, the FDA said in a statement.
The Janssen COVID-19 vaccine is manufactured using an adenovirus type 26 (Ad26) to deliver a piece of the DNA that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are relatively common, Ad26, which can cause cold symptoms and pink eye, has been attenuated for the vaccine so that it cannot replicate in the human body to cause illness.
After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
A Pivotal Multicenter Trial
The decision to grant the EUA was based in part on an analysis of 43,783 participants enrolled in the ongoing ENSEMBLE trial, a randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico and the United States. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination.
Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/ critical COVID-19 occurring at least 28 days after vaccination.
There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were five severe/ critical in the vaccine group versus 34 cases in the placebo group.
Data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person, the FDA said.
The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted one to two days. As part of the authorization, Janssen Biotech Inc. and vaccination providers must report serious adverse events following administration to the Vaccine Adverse Event Reporting System (VAERS) for the Janssen COVID-19 vaccine. Those include serious adverse events, cases of multisystem inflammatory syndrome and cases of COVID-19 that result in hospitalization or death.
Strength in Numbers
Public health experts applauded the availability of the new COVID-19 vaccine. “Having different types of vaccines
available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers,” Walensky said. “Getting vaccinated with the first vaccine available to you will help protect all of us from COVID-19.”
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” added acting FDA Commissioner Janet Woodcock, MD.
Johnson & Johnson said it was committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccine and expected to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million Americans.
In March, President Joe Biden called on state, local and tribal governments to enable access to all American adults eligible to sign up for COVID-19 vaccines by May 1.
What About Pharmacists?
In related news, the first public meeting of the COVID-19 Health Equity Task Force was held on Feb. 26, and although several initiatives were announced, including addressing inequities related to COVID-19 vaccination, there was one glaring error: not having pharmacists involved in potential solutions, according to a letter ASHP sent to the Biden administration.
In the letter, ASHP asked the administration to add pharmacists to the group charged with addressing health inequities caused or exacerbated by the COVID-19 pandemic. “I am greatly concerned that despite the role pharmacists are playing in COVID-19 vaccination and treatment, and the relative accessibility of pharmacists in otherwise underserved communities, this task force does not have a single pharmacist among its members,” said ASHP CEO Paul Abramowitz, PharmD, ScD (Hon). “This deprives the task force of insights from medication use experts and the most accessible providers in underserved communities.”
Other sectors of the government seem to better grasp the value pharmacists bring to vaccination efforts. In March, the Department of Health and Human Services expanded its guidance on clinicians who can administer COVID-19 vaccines to include recently inactive pharmacists (active and in good standing within the last five years) and pharmacy interns. —Marie Rosenthal, David Bronstein
The Janssen COVID-19 vaccine is 67% effective
overall in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and 66% effective
at least 28 days after vaccination.
PAPs Flex Muscles
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Call centers shifted from office-based to remote operations, and companies put information about their COVID-19 response on their patient support websites. The GSK program adapted some of its emergency management protocols typically used for fires or floods in certain municipalities, allowing for spouses or legal agents to sign paperwork on behalf of patients who were in quarantine, Gibb said. In some cases, she noted, they looked to alternate therapies, such as an injection patients could self-administer at home with telehealth-based training versus an office-based infusion.
Some PAPs turned to bridge programs to cover therapy for patients with rare diseases whose physician specialists closed their offices for several weeks, halting the prior authorization process, added Emily Phillips, the executive director of reimbursement strategy and patient access for Pharming Healthcare Inc. Several payor partners also extended authorizations as typical follow-up and check-in appointments were canceled, she said. “I was happy to see that patients understood there were struggles all the way around,” Phillips said. “They knew there wasn’t a way for doctors to fight for authorizations if they couldn’t get into the office.”
Gaps Remain
Despite all of these actions, there are some gaps that remain in care, panelists said. One is in the isolationism patients are experiencing, affecting anything from the ability to access social services face to face, to exercising at senior centers, said Meenakshi Datta, JD, a partner with Sidley Austin LLP in Chicago. This could contribute to other problems in the health care system, she said.
“While many of us try to do the best we can, our services always have to have the ‘why’; they have to be needs-based, and have to be medically appropriate within the criteria depending on the program,” Phillips said. “I think we still see, unfortunately, a fear among some patients of being able to access therapies or even get transported to facilities or be seen in a timely manner to make sure they continue to receive therapies.” Her programs and others look to partner with other advocacy organizations where appropriate. (For a listing of more PAP providers, see Table.)
Last year saw a steep drop-off in people undergoing preventative screenings and routine immunizations that has continued, Gibb added. And, even though there was progress in the use of telehealth and being able to reach patients in new digital ways, some gaps remain in electronic health record integration, and new ways to leverage digital technologies to make processes smoother for patients, she said.
Looking forward, Gibb noted two areas for consideration for research and development.
“Last year was historic in its focus on social determinants of health, and health equity, and [it underscored] that different populations are impacted differently by disease,” she said. “Some of the statistics around C COVID-19 and how it has affected minority communities [are] really sobering. As we look toward the R&D pipeline, thinking about considerations for clinical trial diversity and making sure we have the data on different populations is really critical.”
PAPs also need to keep tabs on ongoing development programs for COVID-19 vaccines and therapies, and determine how to remove any access barriers, Gibb said. The government has allocated funds for the uninsured, but as people’s employment status can change even into 2021 and 2022, PAPs may need to evolve programs to meet the needs of uninsured and underinsured persons.
The employment picture even before COVID-19 had not been encouraging. Between March and April 2019, the United States lost 20.6 million jobs, Datta noted, resulting in an unemployment rate of 14.7%—a level not seen since the Great Depression. Certain populations faced rising rates of being uninsured, including Black Americans, 26% of whom were uninsured as of September 2020, and people without a high school diploma, 27% of whom were uninsured as of September 2020.
In addition, 19 rural hospitals closed in 2020, and urban hospitals were squeezed due to economic pressures inflicted by the pandemic, which also affected cities and states that subsidize these providers. All these factors, she stressed, exerted a “tremendous impact on patient access.” —Karen Blum
Table. Top 10 Patient Assistance Programs In the United States
Program Total Giving, $ URL
The AbbVie Patient Assistance 853,356,401 bit.ly/3bvnhWx Foundation
Johnson & Johnson Patient Assistance Foundation Inc. 787,776,687 bit.ly/2PGfjkT
The Bristol Myers Squibb Patient Assistance Foundation Inc. 619,573,888 bit.ly/3rBFA23
Sanofi Foundation for North America 617,927,313 bit.ly/3cgNsQ1 Merck Patient Assistance Program Inc. 566,675,598 bit.ly/2Ol7gJV Novartis Patient Assistance Foundation 542,136,898 bit.ly/2OcWpSy Genentech Access to Care Foundation 495,979,664 bit.ly/3co8X1v Pfizer Patient Assistance Foundation Inc. 446,674,762 bit.ly/3bwIq2y
Lilly Cares Foundation Inc. 408,239,166 bit.ly/3cdNok0
GSK Patient Access Programs Foundation 386,459,002 bit.ly/3ceSFYy
Source: Patients Rising Now.
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tr in v h s
The sources reported no relevant fi nancial disclosures other than their stated employment.
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Waiting for Relief
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lead partner of the law firm McDermott, Will and Emery, in Washington, D.C.
The Year Ahead
There are a few issues to watch this year, Kim said. They include:
International Reference Pricing/
Most Favored Nation Drugs. Court injunctions put the previous administration’s “Most Favored Nation” (MFN) interim final rule aimed at lowering prescription drug prices in limbo, but experts said this probably isn’t the last we’ll see of international drug reference pricing. The rule, which was set to take effect Jan. 1, proposed to restrict costs for the top 50 physician-administered Medicare Part B drugs—which account for almost 80% of Part B spending—to no more than the lowest price that drug manufacturers receive in other similar countries, as reported in Specialty Pharmacy Continuum (bit.ly/ 38LkbMn).
However, there are indications that the Biden administration is interested in looking to foreign pricing of certain products in the pharmaceutical sector as a way to negotiate lower prices for U.S. beneficiaries, Kim said. But the use of such a pricing model has significant legal and policy considerations, he stressed, and drugs elsewhere are regulated under different environments. Adoption of MFN-like pricing in the United States also may have unintended consequences for the overall global community—something that has to be examined carefully, Kim said. 340B Drug Pricing. Significant debates abound in the legal community regarding 340B drug pricing. One contentious issue is the use of third-party contract pharmacies by institutions that qualify for 340B drug pricing but do not have in-house pharmacies. The use of contract pharmacies can yield significant cost savings for these hospitals, but the practice has drawn the ire of drug manufacturers, many of which have sought to block these arrangements over the past year. The conflict has resulted in an administrative ruling by the Department of Health and Human Services to uphold the rights of contract pharmacies to access 340B prices.
The HHS summarized its ruling in a Dec. 30, 2020, statement: “HHS has become aware of drug manufacturers refusing to provide 340B discounts to covered entities when covered entities order the drugs themselves but then have the drug physically delivered to patients through contract pharmacies.” Based on its advisory opinion, “HHS has clarified that drug manufacturers must provide 340B discounts when a contract pharmacy is acting as an agent of a covered entity, providing services on behalf of the covered entity.”
“There does need to be a resolution of this issue,” Kim said, because it is now affecting beneficiaries. Xavier Becerra, the attorney general of California and one of those lawyers leading the charge against manufacturers’ refusal to allow contract pharmacy access to 340B
drugs, is President Joe Biden’s pick to head HHS. If he takes over leadership, there is likely to be a resolution of this issue sooner than later, Kim said. But he stressed that it will require an enormous amount of effort and discussion among providers, distributors and pharmacies.
Medicare Drug Price Negotiation.
A big part of Biden’s plan to control drug prices and access to drugs is to authorize Medicare to negotiate the prices of its reimbursed drugs. The factors that will go into the negotiations are extraordinarily complex, Kim said. “It will not be an easy question to answer, but this is a very serious lever on control of drug prices and access that the Biden administration intends to utilize as much as possible.”
Prescription Drug Importa-
tion. Several states and the FDA have authorized rules examining importing prescription drugs, particularly from Canada, but none have seen major success, Kim said. The FDA is concerned with safety and efficacy of those products as well as appropriate regulation, but the Canadian government already has created legislative actions to prohibit such programs from moving forward. Like international reference pricing, any changes have to account for impacts to the global economy, he said.
Title X Federal Family
Planning Program. In response to the Trump administration’s 2019 issued rules banning providers that receive Title X funds from referring people for abortions, on Jan. 28, the Biden administration issued a memorandum on protecting women’s health at home and abroad. It states the secretary of HHS shall review the Title X Rule and any other regulations governing the Title X program that impose “undue restrictions on the use of federal funds or women’s access to complete medical information,” and will consider whether to suspend, revise or rescind them. The memorandum does not change the rule, Kim said, but it does make clear of an intent to modify the Title X program rulings substantially, if not rescind them entirely. The Supreme Court announced in February it would hear a case brought by the American Medical Association, Planned Parenthood and others arguing that former President Trump’s changes violate federal law and harm patient care.
Meanwhile, division among political parties “limits the ability for real substantive changes to occur,” Kim said. “I am hopeful over the course of the year that some issues that have bipartisan support, such as drug pricing issues, can have some sort of effective change. The key question is how we are going to come to a single model that all parties can at least agree to disagree on. No one’s going to be happy with the result from all perspectives, but there is common ground to be met on these issues.”
Dave MacLeod, a co-chair of the conference and the head of patient services and specialty pharmacy operations for Amylyx Pharmaceuticals, said Kim’s presentation was informative and timely with the administration crossover. “I think it’s important for our industry to listen to what’s going on with legislation and the government, and how things are moving forward,” he said.
One issue that MacLeod said keeps him up at night is drug importation. “We do see patients who may not have coverage under insurance for a particular product, so they may go out of their way to become cash-paying patients in Canada, Europe or somewhere else to get their hands on that drug, and that’s hard to regulate,” he said. “It’s tough because if they’re getting their drug outside the country, as a manufacturer there’s not much you can to do to support that because it’s considered offlabel. That’s a key concern.”
—James Kim, JD, MPH
—Karen Blum
