Generic Prices Are Falling, But Seniors Are Paying More

 On average, older Americans take 4.6 prescription drugs every month. Generic drugs have long been a means of helping consumers and third-party payers reduce prescription drug costs. While generic drugs now account for more than 90 percent of all retail prescriptions filled in the United States, they account for only 20 percent of total spending on prescription drugs. This report finds that, on average, retail prices for widely used generic prescription drugs declined between 2006 and 2020. The findings also highlight the unique pricing dynamics in the generic drug market when compared with those in the brand name drug market.

Overview of Findings

• Between 2019 and 2020, retail prices for 503 widely used generic prescription drugs increased by an average of 0.5 percent. The general inflation rate increased by 1.3 percent over the same period.
• The average annual cost for one generic medication used on a chronic basis was $679 in 2020. This represents a dramatic drop since 2016, when the average annual cost of therapy was almost two times higher ($1,336).
• All but two of the 503 generic prescription drug products in the study’s market basket had retail price changes during 2020; 397 drug products (79 percent) had a price decrease, and the remaining 104 (21 percent) had a price increase.
  • Four widely used generic drug products had retail price increases that were greater than 200.0 percent in 2020. One of these widely used generic drug products (hydrochlorothiazide 100-25 mg tablet, used to treat high blood pressure) had a retail price increase of more than 1,100 percent.   
• Between January 2006 and December 2020, retail prices for 56 chronic-use generic drugs that had been on the market since the beginning of the study period decreased cumulatively by an average of 38.7 percent.
  • The cumulative general inflation rate in the US economy was 32 percent during the same 15-year period.
• Thirty-five of the 46 drug manufacturer groups had weighted average generic drug price decreases in 2020. Weighted average annual prices increased for nine drug manufacturer groups—plus the “All Others” category—in 2020. One drug manufacturer group did not experience an average annual price change in 2020.
• Forty-eight of the 59 therapeutic categories of generic drug products—including the “Other Therapeutic Agents” category—had an average annual retail price decrease in 2020, ranging from 0.3 percent to 80.8 percent.
• Eleven therapeutic categories of generic drug products had an average annual retail price increase, nine of which more than tripled the rate of general inflation (1.3 percent).
  • The therapeutic category with the highest generic drug price increase—angiotensin-receptor blocker (ARB)-diuretic combinations used to treat high blood pressure—had an average annual retail price increase of 205.5 percent in 2020.   

The availability of economically competitive and lower-cost generic drugs will take on added importance as more brand name drugs and biologicals enter the market with unusually high prices. Equally important will be determining what is driving substantial retail price increases for some generic prescription drugs, as well as how these factors might be mitigated.

This report is the latest in the AARP Public Policy Institute’s Rx Price Watch series. Separate reports analyze price changes for widely used brand name and specialty drug products. The series also analyzes the price changes for an overall market basket (i.e., brand name, generic, and specialty drug products combined) to reflect the overall market impact of drug price changes.
 

These AARP Public Policy Institute reports are a continuation of our Rx Watchdog report series that has been tracking manufacturer price changes for widely used prescription drugs since 2004.

Suggested citation:
Purvis, Leigh, and Stephen W. Schondelmeyer. Rx Price Watch Reports. Washington, DC: AARP Public Policy Institute, August 24, 2023. https://doi.org/10.26419/ppi.00198.001

https://www.aarp.org/ppi/info-2019/trends-in-retail-prices-of-drugs.htm

CDC Advisory Group Under Fire for Proposed Infection Control Guidelines

 Nurses, patients, and professional groups are pushing for more rigorous infection control standards from the CDC following a preview of proposed changes to its isolation precaution guidelines and an advisory group meeting this week during which a vote on the changes was postponed.

Opponents have said the changes, detailed in a presentationopens in a new tab or window in June, are based on a flawed evidence review and omit key infection control tools. Some have called attention to a CDC approval process that they say is sometimes inscrutable to the public.

The agency last revised the guidelines, "Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings," in 2007, and now the group that advises the CDC on infection control practices -- the Healthcare Infection Control Practices Advisory Committee (HICPAC) -- is drafting proposed 2024 changes for CDC approval.

"While the CDC is updating their language, they're not actually updating their precautions in ways that they should based on the science," Jane Thomason, RN, MSPH, CIH, an industrial hygienist for National Nurses United (NNU), told MedPage Today. NNU has taken a strong stance against the HICPAC recommendations and called for more robust infection protections in healthcare.

NNU and others say the proposed guidelines weaken existing infection control standards, privileging employer and hospital bottom lines over employee and patient safety. "The guidance that they're updating applies to every infectious disease in healthcare settings, from tuberculosis, to measles, to influenza, to MDROs [multidrug-resistant organisms], to COVID. All of it," said Thomason.

"If they take that approach, it enables employers ... to prioritize costs over protections, and that will lead directly to preventable infections amongst healthcare workers and patients," she added.

Notably, at least six of nine currently listedopens in a new tab or window HICPAC voting members are affiliated with major hospitals or healthcare systems, including Ascension, Genesis Healthcare, Mass General Brigham, and Beth Israel Lahey Health.

The Shadow of COVID Crisis Standards

At the height of the pandemic, the CDC adopted a sopens in a new tab or windowet of guidelinesopens in a new tab or window including "contingency" and "crisis capacity" strategies meant to address staffing shortages, which let healthcare facilities and employers implement varying levels of COVID-19 infection precautions based on self-assessment and staffing needs, including "as a last resort," allowing healthcare personnel with active COVID infections to work anyway. The guidelines recognized the use of face masks, including surgical masks, as acceptable even in these cases.

Thomason said this gave hospitals and employers the discretion to provide only the bare minimum of protections. In some instances, she said, nurses caring for COVID-positive patients were told they weren't allowed to access existing N95s.

NNU and other public health professionals have drawn parallels between the CDC's pandemic-era protocols and the new proposed guidelines. A letter sent to CDC

opens in a new tab or window Director Mandy Cohen, MD, MPH, and signed by hundreds of public and occupational health experts, noted that the proposed change "allows healthcare employers undefined broad discretion in creating and implementing their infection control and prevention plans," based in part on staffing levels, patient populations, and a distinction between "pandemic-phase" and "seasonal" pathogens.

The guidelines, experts wrote in the letter, should be "clear and explicit on the precautions that are needed in situations where infectious pathogens are or may be present," since transmission modes are the same regardless of timing.

Evidence Review Opposition

At the heart of the backlash lies a review of evidence on masking and other forms of personal protective equipment (PPE), detailed in part in the June presentation. In the review of 27 studies comparing N95 respirators to surgical masks, the HICPAC work group concluded that there is "no difference between N95s and surgical masks" in protecting against viral respiratory infections. They also conducted a review of "adverse events" of masking with both.

The letter to Cohen stated that the review "omitt[ed] other applicable data and studies," including occupational and lab studies, drew conclusions despite study flaws (like improper mask use), and contrasted it with the CDC's own respirator certification system through the National Institute for Occupational Safety and Health (NIOSH), which they wrote "is based on sound science and research."

And despite new language that delineates both "air" and "touch" transmission, the letter asserted that "the draft recommendations fail to reflect what has been confirmed about aerosol transmission by inhalation during the COVID-19 pandemic" and "continue to recommend use of surgical/medical masks, which do not provide respiratory protection against infectious aerosols." Some of the most effective methods of infection control and prevention were given little to no airtime in HICPAC's June presentation. Ventilation was not addressed, and the use of airborne infection isolation rooms was limited.

The letter asked that aerosol scientists, industrial hygienists, ventilation engineers, and respiratory protection experts be included in discussions about infection control in healthcare settings.

HICPAC's Meeting

In a meeting on August 22 where the guidelines were previously slated for a vote by HICPAC, Sharon Wright, MD, MPH, a HICPAC member and chief infection prevention officer at Beth Israel Lahey Health in Cambridge, Massachusetts, said the vote would be postponed until the next meeting in November because quorum for the meeting was not met. In a public comment portion of the meeting, patients, members of advocacy groups, and researchers voiced strong opposition to the proposed measures.

One public commenter named Liv Grace said that as a physically disabled and immunocompromised patient, they (Grace uses they/them pronouns) caught RSV and COVID at healthcare facilities after medical professionals refused to wear N95 masks during treatment. They called for a new evidence review, and said, "I am literally begging for something to be done."

Another public commenter, Shea O'Neil, identified herself as a volunteer for the World Health Network and a parent to a son who is high risk and has "a" omitted intentionally; some prefer this wording and she used it disability. "It is really clear in wildfire smoke messaging that you wear N95 respirator masks -- that surgical cloth and dust masks aren't going to cut it. You'd never, in peak wildfire times ... [say], 'Wear surgicals for now, or actually, wildfires typically aren't all year long, so we will change the guidance to surgical instead,'" she said. "These things do not make sense, do not protect people, not for fires, not for COVID-19 -- both aerosols."

A Murky Approval Process?

Kevin Kavanagh, MD, of Health Watch USA, a patient advocacy and research organization, and co-authors wrote in an article for Infection Control Todayopens in a new tab or window that "the process of recommendation formulation is flawed and lacks transparency," citing HICPAC committee votes held before public comment and meeting presentations not publicly posted.

In a public comment, a representative from the California Division of Occupational Safety and Health said repeated requests for a full draft of the proposed guidelines and previous meeting minutes were denied.

During the meeting, HICPAC detailed their approval process for the guidelines, which included the HICPAC Isolation Precautions work group, two alternating reviews and votes each by HICPAC and the CDC, public comment in the Federal Register, and another "concurrence" clearance process.

Another commenter said her elderly father was left with permanent heart and lung damage from flu, and can't risk getting COVID. "My dad and so many real people ... don't deserve to be abandoned, and their lives or long-term health put in serious risk just because they need a doctor, or a surgery, or are fighting cancer, or are elderly or immunocompromised, or work as a healthcare worker trying to help all of those people," she said. "You are in a position to help all of them -- to help all of us. Please help us."

The Infectious Diseases Society of America declined to comment for this story. The Society for Healthcare Epidemiology of America did not respond by press time, and the Association for Professionals in Infection Control and Epidemiology wrote in an email to MedPage Today, "APIC is supportive of HICPAC's process for updating their infection control guidelines and will await the final draft before commenting further.."

https://www.medpagetoday.com/infectiousdisease/infectioncontrol/106030

'CDC launches new sepsis initiative for US hospitals'

 The Centers for Disease Control and Prevention (CDC) on Thursday announced the launch of a new initiative aimed at supporting sepsis teams at U.S. hospitals in light of new data that found a third of patients who die in hospitals had sepsis while hospitalized.

The CDC’s Hospital Sepsis Program Core Elements will act as a “manager’s guide” on how to organize staff and identify resources needed for bringing sepsis rates down, the agency said.

The initiative listed seven elements of a strong sepsis program: leadership commitment, accountability, multi-professional expertise, action, tracking, reporting, and education.

Sepsis occurs when the body’s immune system responds to an infection in an extreme way, causing damage to tissues and organs. This condition can be caused by almost any type of infection and often occurs in health care settings.

“Sepsis is taking too many lives. 1 in 3 people who dies in a hospital has sepsis during that hospitalization,” CDC Director Mandy Cohen said. “Rapid diagnosis and immediate appropriate treatment, including antibiotics, are essential to saving lives, yet the challenges of awareness about and recognition of sepsis are enormous.”

According to a survey shared by the CDC of more than 5,000 hospitals, while 73 percent of hospitals have sepsis committees, only a little more than half of these locations give sepsis program leaders the time needed for proper management.

About 1.7 million U.S. adults develop sepsis every year, and 350,000 of them either die during hospitalization or are moved to hospice care.

In 2021, former President Clinton was briefly hospitalized in California after an infection led to sepsis. Clinton was discharged a few days later after receiving IV antibiotics and fluids.

The launch of this new program comes shortly before Sepsis Awareness Month in September.

https://thehill.com/policy/healthcare/4169272-cdc-launches-new-sepsis-initiative-for-us-hospitals/

Jordan launches probe into Georgia Trump prosecution

House Judiciary Chairman Jim Jordan (R-Ohio) fired off a sweeping request for documents dealing with former President Trump’s prosecution for election interference in Georgia, asking Fulton County District Attorney Fani Willis (D) to turn over all records relating to the case.

Sent hours before Trump is expected to surrender at the Fulton County Jail, the letter cites “concerns about [Willis’s] motivation” in bringing the case and suggests her sprawling racketeering indictment against the former president and 18 others highlights “the threat that such state prosecutions can pose to the operations of the federal government.”

The letter also asked whether Willis at any point communicated with the team of special counsel Jack Smith, who earlier this month brought federal charges against Trump related to his efforts to overturn the results of the 2020 election.

The letter mirrors those the committee has sent related to other criminal cases against Trump and echoes the former president’s frequent complaints that all of the charges leveled against him are motivated by politics rather than any wrongdoing.

“The timing of this prosecution reinforces concerns about your motivation,” Jordan wrote.

“You did not bring charges until two-and-a-half years later, at a time when the campaign for the Republican presidential nomination is in full swing,” he continued. “Moreover, you have requested that the trial in this matter begin on March 4, 2024, the day before Super Tuesday and eight days before the Georgia presidential primary.”

Willis’s office did not immediately respond to a request for comment.

Jordan’s panel has frequently sought information on criminal probes into Trump at key junctures.

He sent a letter to Manhattan District Attorney Alvin Bragg (D) before he had even brought charges against Trump, writing that he was “reportedly about to engage in an unprecedented abuse of prosecutorial authority.”

He’s also sent two letters to Attorney General Merrick Garland concerning Smith’s investigation.

Thursday’s letter lays out a case for Trump, arguing the actions he took in Georgia — asking the secretary of state to “find” enough votes for him to win and assembling a slate of fake electors — could be considered official actions taken by a president.

“When states rely on acts like these—apparently taken in connection with official duties—to criminally prosecute federal officers, it raises serious concerns under the Supremacy Clause of the Constitution and poses a threat to the operations of the federal government,” Jordan writes. 

“The threat of future state prosecution for official acts may dissuade federal officers from effectively performing their official duties and responsibilities.”

He also posits that such prosecutions could have a chilling effect on presidents while in office.

“To the extent that presidents fear that they may be subject to politically motivated prosecutions after they leave office, this could impact the policies they choose to pursue while in office,” Jordan said.

“And because this former President is a current candidate for that office, the indictment implicates another core federal interest: a presidential election.”

For her part, Willis has denied having any contact with Smith.

“I don’t know what Jack Smith is doing, Jack Smith doesn’t know what I’m doing. In all honesty, if Jack Smith was standing next to me, I’m not sure I would know who he was. My guess is he probably can’t pronounce my name correctly,” Willis told local media ahead of filing charges.

https://thehill.com/regulation/court-battles/4169099-jim-jordan-launches-probe-into-georgia-trump-prosecution/

Amgen fights FTC's request for injunction against $28B Horizon merger

 As the Federal Trade Commission tries to block Amgen’s $28 billion acquisition of Horizon Therapeutics with an injunction, Amgen has a lot to say in court filings.

The FTC’s case is “far too removed from reality and unmoored from decades of legal precedent,” Amgen’s lawyers wrote in a response to FTC’s request for a preliminary injunction. The company filed the note to a federal court in Illinois on Tuesday.

The trade of barbs comes a month after the FTC said it had ended settlement talks with Amgen. At the time, an FTC lawyer said the agency remained “open to hearing proposals,” according to Bloomberg.

The U.S. antitrust watchdog and several states are challenging the Amgen-Horizon transaction out of concerns that Amgen might one day bundle its products with Horizon’s drugs during reimbursement negotiations.

Amgen argues the FTC’s case is “far too speculative” to warrant an injunction at this stage.

For starters, Amgen has already promised—including in sworn testimony of its execs—that it’s “not going to bundle any of its products, for any reason or at any time, with Tepezza or Krystexxa,” the company’s response shows.

Tepezza and Krystexxa are Horizon’s rare disease drugs for thyroid eye disease and gout, respectively. 

The FTC was uneased by the possibility that Amgen might use some of its blockbuster drugs such as TNF inhibitor Enbrel and psoriasis pill Otezla to reach favorable deals for Tepezza and Krystexxa against potential rivals. But as Amgen noted, the company’s top-selling drugs and the Horizon assets belong to different reimbursement categories, making bundling “extremely difficult (if not impossible)."

Amgen’s own products are self-administered by patients and are covered under pharmacy benefit plans. Tepezza and Krystexxa are infusions administered by healthcare professionals and primarily managed under medical benefit plans, the company pointed out.

“These are vastly different reimbursement mechanisms,” Amgen said, adding that it has never done cross-benefit bundling before.

Even if this type of bundling is doable, Amgen said, existing medical benefit regulations means the two Horizon drugs’ prices would have to come down sharply, “eventually rendering them unprofitable and destroying the rationale for the transaction.”

In addition, Amgen argues the FTC hasn’t provided any proof that rivals to Tepezza and Krystexxa could reach the market in the near term.

The company’s lawyers are asking the court to deny the FTC’s motion for a preliminary injunction.

Industry watchers are following the case closely because it’s the first major pharma M&A deal that the FTC has challenged in court since 2009. The lawsuit comes as the agency adopts a more holistic approach of reviewing pharma M&A deals beyond looking at specific product overlaps. As Amgen’s lawyers put it, the FTC is trying to create a legal precedent based on a theory never before adopted by a court.

Amgen seems unfazed by the FTC challenge. During the company’s second-quarter earnings call earlier this month, CEO Bob Bradway said Amgen still aimed to close the deal mid-December.

https://www.fiercepharma.com/pharma/far-too-speculative-amgen-fights-ftcs-ask-injunction-28b-horizon-merger

Collegium: Extension of Nucynta Regulatory Exclusivity through July 2026

 Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted New Patient Population exclusivity for Nucynta®, an immediate release formulation of tapentadol. This grant extends the period of U.S. exclusivity for Nucynta from June 27, 2025 to July 3, 2026.

The exclusivity determination is based on data from pediatric trials which were submitted in response to the FDA's Pediatric Written Request to evaluate the use of Nucynta as a treatment for pain in pediatric patients aged 6 years and older.

Nucynta is currently approved in the U.S. for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.

https://finance.yahoo.com/news/collegium-announces-extension-nucynta-regulatory-120000406.html

Vindication of transgender whistleblower exposes media bias yet again

 After months of reckless gaslighting, the national media is backpedaling and finally exonerating Jamie Reed, the whistleblower who exposed the sloppy, rushed treatment of children suffering gender dysphoria. It’s too little, too late.

Reed, a self-described gay woman who is married to a transgender man, for nearly four years managed cases at a gender dysphoria clinic at St. Louis Children’s Hospital.

The national media slammed Reed after she bravely came forward in February in a Free Press essay exposing the mistreatment and botched handling of children with gender dysphoria, including children who regretted getting surgeries or hormone injections.

Reed told of a child with schizophrenia who stopped their meds while receiving hormonal injections, which is extremely dangerous, according to physicians.

Reed also reported a 17-year-old girl’s birth canal allegedly being ripping open during sex, unaware that taking testosterone (as part of a female-to-male transition) would cause her to bleed extensively.

Despite Reed’s horrifying report, taken seriously by Missouri lawmakers and resulting in needed legislative changes, the national media turned a blind eye.

MSNBC anchor Chris Hayes wrote a lengthy thread on Twitter, now called X, excoriating Reed, claiming “multiple other outlets have conducted dozens and dozens of interviews with parents, employees, and patients and found no corroboration.”

New York magazine ran an early March article slamming Reed’s claims and highlighting negative articles from the St. Louis Post Dispatch and the Missouri Independent.

Jamie Reed exposed the treatment of children suffering gender dysphoria.

The Free Press

It’s only now some six months later that The New York Times does the responsible thing and actually verifies the horrific claims that Reed exposed.

The Times noted that even secular Europe is backing away from minor medical transgenderism due to reported health dangers.

But don’t expect the Times to be too fair.

Even though the article is among its reporting pages, it editorializes and labels as “draconian” the commonsense moves by lawmakers in more than 20 states to ban or severely restrict gender treatments for minors.

Free Press founder Bari Weiss rightfully called out Hayes for his irresponsibility, noting the Times largely confirmed Reed’s account.

This woke approach to gender dysphoria is hurting lives.

The media gave scant attention when last year, the FDA slapped a warning on puberty blockers because several minors on the drugs experienced tumor-like masses in the brain, including visual disturbances, headache or vomiting, swelling of the optic nerve, increased blood pressure, and eye paralysis.

Hayes and his compatriots omit reporting that the UK National Health Service lists the following potential side effects of cross-sex hormones: blood clots, gallstones, weight gain, acne, abnormal levels of fat in the blood, elevated liver enzymes, and hair loss.

In their rush to condemn Reed, national reporting also left out the risks of reassignment surgery, including surgical complications and infections.

Americans deserve the truth, but we’re holding our breath to sort out the next pack of lies.

Carrie Sheffield is a senior policy analyst at Independent Women’s Voice.

https://nypost.com/2023/08/24/vindication-of-transgender-whistleblower-exposes-media-bias-yet-again/