The big story of the past week deals with FDA approvals. On the one hand, we have stories about the new, very expensive Alzheimer’s drug that was rapidly (and controversially) approved:
6 BCBS affiliates announce they won't cover Biogen's Alzheimer's drug: “Recently, affiliates in North Carolina, Pennsylvania, Michigan, New York and Kansas all made the announcement, with other plans like Highmark and Care Network of Michigan only allowing its use with prior approval. The announcements largely affect commercial plans.”
Biogen, ICER [Institute for Clinical and Economic Review] experts tussle over Aduhelm as cost watchdogs unanimously slap down new Alzheimer's drug: ”Is there enough evidence to show Biogen’s new Alzheimer’s drug Aduhelm provides a benefit to patients, physicians and society beyond the current standard care? The answer from a group of ICER experts, perhaps unsurprisingly, was "no."
During a daylong meeting Thursday that featured debate over the drug's cost and more, experts voted 15 to 0 that Aduhelm doesn't provide benefits above routine care.”
Cleveland Clinic and Mount Sinai Won’t Administer Aduhelm to Patients: “The rejection by the major medical centers is the latest fallout from the Food and Drug Administration’s approval of the drug on June 7, a decision that has also spurred congressional investigations.
Many Alzheimer’s experts and other scientists have said that it is unclear that the drug works to help slow cognitive decline and that in the best-case scenario, the evidence suggested only a slight slowing while also showing that Aduhelm could cause brain swelling or brain bleeding.”
On the other hand, we have the FDA dragging its feet on approving Covid-19 vaccines that have data on tens of millions of people. The latest update is:
FDA sets January deadline to decide on full approval of Pfizer, BioNTech vaccine: “Pfizer and BioNTech said Friday that the FDA has granted a priority review for an application seeking full approval of their vaccine BNT162b2 to prevent COVID-19 in people 16 years and older. According to the companies, the FDA has set a goal date for a decision in January 2022, although an agency official suggested one is likely to come within two months.”
Covid vaccines for kids under 12 expected midwinter, FDA official says: “Emergency authorization for Covid-19 vaccines in children under 12 could come in early to midwinter, a Food and Drug Administration official said Thursday, a move that could bring relief to many parents who have been unable to vaccinate their children. The agency hopes to then move quickly to full approval of the vaccine for this age group.”
The efficient approval process is important not only for COVID-19, but also for possible emerging pandemics. Here are the latest news items in this regard:
China reports its first death of a human from rare Monkey B virus: “A man in China has died after contracting a rare infectious disease from primates, known as the Monkey B [herpes] virus, Chinese health officials revealed in a report Saturday. The victim, a 53-year-old veterinarian based in Beijing, was the first documented human case of the virus in China.
According to the Chinese Center for Disease Control and Prevention, the man worked in a research institute that specialized in nonhuman primate breeding and dissected two dead monkeys in March.”
Rare case of monkeypox found in Texas resident who had traveled internationally: A case of monkeypox has been confirmed in a Texas resident who had flown to Atlanta from Nigeria on July 8, with a final destination of Dallas Love Field Airport on July 9, the Centers for Disease Control and Prevention said Friday. It is the first case of the virus seen in the United States in nearly two decades…
Monkeypox is related to smallpox, which was eradicated worldwide in 1980, thanks to the smallpox vaccine. Both illnesses cause a distinctive rash that lasts for about a month. Smallpox had a higher fatality rate than monkeypox.”
In other news:
About pharma
FDA allows drugmakers to sell generic Chantix, says cancer risk minimal: “The FDA is allowing drugmakers to distribute varenicline, the generic name for Pfizer's anti-smoking drug Chantix, even if the drug contains low levels of a carcinogen. The health benefits of quitting smoking outweigh the cancer risk from the carcinogen in the drug, the agency said.
In late June, Pfizer halted global distribution of Chantix after finding that some pills contain elevated levels of the carcinogen N-nitroso-varenicline. Pfizer recalled nine lots of the drug, though the FDA said there was no immediate risk from taking the medication, since the increased cancer risk associated with the carcinogen in the drug would only come from long-term use.”
New Merck pneumonia vaccine OK’d in US weeks after Pfizer’s: “Merck said Friday that the Food and Drug Administration approved its shot, called Vaxneuvance, for people aged 18 and up. It protects against 15 of the roughly 100 pneumococcal strains, including those most responsible for severe disease.
Merck hasn’t disclosed its shot’s price or when it will be launched.”
Takeda, AbbVie, BMS, Sanofi, Lilly and others join growing tally of pharma's July price hikes: report: “So far this month, pharma companies large and small have driven up prices on 65 drugs, mostly brand name, by an average of 3.5%, according to GoodRx’s counting. That’s double the count from just two weeks ago and just shy of the July 2020 tally.
While smaller drugmakers dealing in rare disorders dominated the initial price jumps to start the month, a sprinkle of big pharma players such as Pfizer, Eli Lilly, Sanofi, AstraZeneca, Bristol Myers Squibb, Novartis and AbbVie have also gotten involved. Many of the price hikes are in the low single-digit percentages.”
Perhaps the companies are getting in increases before the federal government enacts price controls.
About health insurance
Estimated Plan Enrollment Outcomes After Changes to US Health Insurance Marketplace Automatic Renewal Rules: “The findings of this economic analysis suggest that a smart default policy could avoid defaulting lower-income marketplace enrollees to objectively inferior health care insurance plans and may lead to large reductions in lower-income enrollees’ deductibles, copayments, and maximum out-of-pocket amounts. Implementation of a smart default policy could enable marketplace administrators to reduce the prevalence of underinsurance among lower-income marketplace enrollees.”
About healthcare IT
Anthem study: Telehealth helped address pandemic health disparities, but gaps remain: “Hispanic patients took to telehealth for behavioral health needs in greater numbers than other racial groups last year, according to new data from Anthem.
The analysis includes data on Medicaid members in 14 states and found that while telehealth visits for mental health were in the single digits prior to the pandemic, use rose to account for nearly half (49%) of all Medicaid mental health visits in a six-month window last year…
Amid the pandemic, 40% of Hispanic members in the study had a telehealth visit, compared to 34% of white members.
In addition, 33% of Asian members and 28% of Black members had a telehealth visit for mental health needs, according to the study.”
Elekta software breach hits Advocate Aurora, Intermountain; 96,000 patients affected: “Advocate Aurora Health and Intermountain Healthcare are two of the latest health systems to report having been affected by a cybersecurity breach of cancer care software company Elekta.
Milwaukee-based Advocate Aurora Health reported the breach to HHS July 16 as affecting 68,707 individuals, and Salt Lake City-based Intermountain reported the breach to Maine's attorney general as affecting 28,628 individuals.”