Illustration: Aïda Amer/Axios

Women at age 30 can start collecting their own vaginal sample for cervical cancer screening at a physician’s office and forego pelvic exams, a federal health advisory committee said on Tuesday.

Why it matters: The draft guidance from the U.S. Preventive Services Task Force marks the first time self-collection for human papillomavirus has been recommended, and it’s expected to increase screening rates.

• Recommendations from the task force not only influence the practice of medicine but also what insurers have to cover.
• “Women who would be more comfortable collecting their HPV test sample themselves can now do so,” task force member Esa Davis said in a statement.

Nearly all cases of cervical cancer are caused by HPV, and studies have shown a test for HPV is optimal for women ages 30 to 65 years old, per the task force.

• Getting a pap smear, doing an HPV test or both still are recommended as good options for women within that age range, the task force said.
• The task force also still recommends pap tests every three years for women in their 20s.

More here

from STAT:

Mantle cell lymphoma patients no longer need stem cell transplant

A new study finds that mantle cell lymphoma patients who go into deep remission from a first therapy may not get any benefit from a follow-up transplant of their stem cells.

The results help shore up a growing consensus that most of these patients simply no longer need to undergo the intense and sometimes dangerous procedure now that there are safer and effective treatments like targeted and immune therapy.

Read more from STAT’s Angus Chen.

GLP-1s

An unexpected partnership between Lilly and Ro

Earlier this year, Eli Lilly launched lower-priced vials of its obesity drug Zepbound, but only made the vials available to patients who were ordering through Lilly’s online portal.

Now, Lilly has partnered with major telehealth company Ro, allowing patients to order the vials through Ro’s app — a sign the pharma company is trying to expand its direct-to-consumer presence and shift more patients onto the vials.

A growing number of pharma companies, including Pfizer and AbbVie, have launched direct-to-consumer platforms, partnering with telehealth providers and online pharmacies. Some experts have voiced concerns that these practices may push patients toward virtual providers that are more favorable to the drug companies and lead to over-prescribing.

In an interview, Ro CEO Zachary Reitano said that Ro and its clinicians are not compensated by Lilly offering the Zepbound vials. “Providers are able to maintain their independent medical decision-making process,” he said.

An interesting facet of the new partnership is that Ro has been offering compounded copies of obesity drugs during shortages of the branded drugs, while Lilly has harshly criticized the cheaper products made by compounding pharmacies — going so far as to petition the FDA to bar pharmacies from making Zepbound copies. (The FDA permits compounders to make copies as long as branded drugs are on the FDA’s shortage list.)

Ro had specifically offered compounded tirzepatide, the ingredient in Zepbound, for several weeks during the fall, but stopped offering it to new patients once FDA pulled Zepbound off its shortage list in October. Although the FDA, in a sudden about-face, said it would reconsider its decision and allow compounders to continue the sale of the copycat drugs, Ro still has not offered compounded tirzepatide to new patients.

When asked whether Lilly asked Ro to stop providing compounded tirzepatide as part of the new partnership, Reitano did not answer directly but maintained that Ro’s clinicians are independent and make their own decisions about prescribing.

“From Ro’s perspective, as it relates to compounding, we will continue to follow applicable laws and continue to fight for our patients to have access to the most effective products at the most affordable prices,” Reitano said.

Meanwhile, Lilly said in a statement that “Ro has assured Lilly that it is committed to following the law and will only offer compounded versions of FDA-approved medicines if the medicine is on the FDA shortage list.”

drug pricingReport: Unsupported drug price hikes cost the U.S. $815 million last yearLast year, drugmakers substantially raised prices on five widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $815 million, according to a new report from ICER.The drug for which spending increased the most due to a price increase was Gilead’s HIV treatment Biktarvy. The company raised the wholesale price by 5.9%, while the net price — after rebates and discounts are calculated — rose by 3.8%, most likely because the company offered more concessions than previously. Consequently, spending for this drug climbed by $359 million, according to the report.Read more from STAT’s Ed Silverman.artificial inteligenceCompanies use AI to fight insurance denialsPeople infrequently challenge health insurance denials even though appeals are often successful. A new batch of startups, like Claimable and FightHealthInsurance.com, is trying to change that, STAT’s Casey Ross reports. These companies use artificial intelligence and other technology to help to analyze coverage requirements and help draft appeal letters for doctors and patients. Nine companies have raised about $36 million from investors in recent years, according to Rock Health.For years, insurance companies have increased their use of algorithms and predictive software in the process of making coverage decisions, often leading to higher rates of denials. The advent of companies to fight denials could be the harbinger of an AI arms race in which two sides use imperfect and ever-changing technology to fight each other.Read more here

from Politico:

RFK IN TROUBLE — Robert F. Kennedy Jr.’s prospects of becoming HHS secretary could be dimming as at least three GOP senators are noncommittal about confirming the vaccine critic, POLITICO’s Ursula Perano reports.Those include swing votes like Sens. Susan Collins of Maine, Lisa Murkowski of Alaska and Bill Cassidy of Louisiana, a gastroenterologist who will chair a committee that could host confirmation hearings for Kennedy.When asked whether Kennedy’s past controversies would bog down his nomination, Cassidy said everyone wants to “predict the future,” but he just wants to “let things play.”Why their votes matter: Kennedy can afford to lose only three Republicans during his confirmation if all Senate Democrats vote against him.Some aren’t timid in sharing their thoughts. Sen. Chris Murphy (D-Conn.), a member of the Senate Health, Education, Labor and Pensions Committee, said he doesn’t want a “denier of science” helming the nation’s top health agency.“I get that there are quid pro quos in politics, but that one’s a pretty naked one,” Murphy said.And a GOP senator, granted anonymity to speak candidly, last week suggested Kennedy might be the next of Trump’s nominees to face problems in the Senate. They noted that goodwill from Democrats toward the nominee may even “hurt” his chances with Republicans.What to watch: Kennedy is expected on Capitol Hill next week with nearly two dozen meetings scheduled, per a spokesperson.“This is a week going after Tulsi Gabbard. Now, I guess they’re gonna skip over Kash [Patel] and then go after RFK next week because he’s coming,” said Sen. Tommy Tuberville (R-Ala.), who said he’s meeting with Kennedy on Tuesday. Tuberville broadly supports Trump’s picks for nominees and said Kennedy has “got a lot of great ideas” and is “outside the box.”

Self-collection for HPV instead of pelvic exams

By Tina Reed

Illustration: Aïda Amer/Axios

Women at age 30 can start collecting their own vaginal sample for cervical cancer screening at a physician’s office and forego pelvic exams, a federal health advisory committee said on Tuesday.Why it matters: The draft guidance from the U.S. Preventive Services Task Force marks the first time self-collection for human papillomavirus has been recommended, and it’s expected to increase screening rates.Recommendations from the task force not only influence the practice of medicine but also what insurers have to cover.”Women who would be more comfortable collecting their HPV test sample themselves can now do so,” task force member Esa Davis said in a statement.Nearly all cases of cervical cancer are caused by HPV, and studies have shown a test for HPV is optimal for women ages 30 to 65 years old, per the task force.Getting a pap smear, doing an HPV test or both still are recommended as good options for women within that age range, the task force said.The task force also still recommends pap tests every three years for women in their 20s.More here from STAT: Mantle cell lymphoma patients no longer need stem cell transplantA new study finds that mantle cell lymphoma patients who go into deep remission from a first therapy may not get any benefit from a follow-up transplant of their stem cells.The results help shore up a growing consensus that most of these patients simply no longer need to undergo the intense and sometimes dangerous procedure now that there are safer and effective treatments like targeted and immune therapy.Read more from STAT’s Angus Chen.GLP-1sAn unexpected partnership between Lilly and RoEarlier this year, Eli Lilly launched lower-priced vials of its obesity drug Zepbound, but only made the vials available to patients who were ordering through Lilly’s online portal.Now, Lilly has partnered with major telehealth company Ro, allowing patients to order the vials through Ro’s app — a sign the pharma company is trying to expand its direct-to-consumer presence and shift more patients onto the vials.A growing number of pharma companies, including Pfizer and AbbVie, have launched direct-to-consumer platforms, partnering with telehealth providers and online pharmacies. Some experts have voiced concerns that these practices may push patients toward virtual providers that are more favorable to the drug companies and lead to over-prescribing.In an interview, Ro CEO Zachary Reitano said that Ro and its clinicians are not compensated by Lilly offering the Zepbound vials. “Providers are able to maintain their independent medical decision-making process,” he said.An interesting facet of the new partnership is that Ro has been offering compounded copies of obesity drugs during shortages of the branded drugs, while Lilly has harshly criticized the cheaper products made by compounding pharmacies — going so far as to petition the FDA to bar pharmacies from making Zepbound copies. (The FDA permits compounders to make copies as long as branded drugs are on the FDA’s shortage list.)Ro had specifically offered compounded tirzepatide, the ingredient in Zepbound, for several weeks during the fall, but stopped offering it to new patients once FDA pulled Zepbound off its shortage list in October. Although the FDA, in a sudden about-face, said it would reconsider its decision and allow compounders to continue the sale of the copycat drugs, Ro still has not offered compounded tirzepatide to new patients.When asked whether Lilly asked Ro to stop providing compounded tirzepatide as part of the new partnership, Reitano did not answer directly but maintained that Ro’s clinicians are independent and make their own decisions about prescribing.“From Ro’s perspective, as it relates to compounding, we will continue to follow applicable laws and continue to fight for our patients to have access to the most effective products at the most affordable prices,” Reitano said.Meanwhile, Lilly said in a statement that “Ro has assured Lilly that it is committed to following the law and will only offer compounded versions of FDA-approved medicines if the medicine is on the FDA shortage list.”drug pricingReport: Unsupported drug price hikes cost the U.S. $815 million last yearLast year, drugmakers substantially raised prices on five widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $815 million, according to a new report from ICER.The drug for which spending increased the most due to a price increase was Gilead’s HIV treatment Biktarvy. The company raised the wholesale price by 5.9%, while the net price — after rebates and discounts are calculated — rose by 3.8%, most likely because the company offered more concessions than previously. Consequently, spending for this drug climbed by $359 million, according to the report.Read more from STAT’s Ed Silverman.artificial inteligenceCompanies use AI to fight insurance denialsPeople infrequently challenge health insurance denials even though appeals are often successful. A new batch of startups, like Claimable and FightHealthInsurance.com, is trying to change that, STAT’s Casey Ross reports. These companies use artificial intelligence and other technology to help to analyze coverage requirements and help draft appeal letters for doctors and patients. Nine companies have raised about $36 million from investors in recent years, according to Rock Health.For years, insurance companies have increased their use of algorithms and predictive software in the process of making coverage decisions, often leading to higher rates of denials. The advent of companies to fight denials could be the harbinger of an AI arms race in which two sides use imperfect and ever-changing technology to fight each other.Read more here from Politico: RFK IN TROUBLE — Robert F. Kennedy Jr.’s prospects of becoming HHS secretary could be dimming as at least three GOP senators are noncommittal about confirming the vaccine critic, POLITICO’s Ursula Perano reports.Those include swing votes like Sens. Susan Collins of Maine, Lisa Murkowski of Alaska and Bill Cassidy of Louisiana, a gastroenterologist who will chair a committee that could host confirmation hearings for Kennedy.When asked whether Kennedy’s past controversies would bog down his nomination, Cassidy said everyone wants to “predict the future,” but he just wants to “let things play.”Why their votes matter: Kennedy can afford to lose only three Republicans during his confirmation if all Senate Democrats vote against him.Some aren’t timid in sharing their thoughts. Sen. Chris Murphy (D-Conn.), a member of the Senate Health, Education, Labor and Pensions Committee, said he doesn’t want a “denier of science” helming the nation’s top health agency.“I get that there are quid pro quos in politics, but that one’s a pretty naked one,” Murphy said.And a GOP senator, granted anonymity to speak candidly, last week suggested Kennedy might be the next of Trump’s nominees to face problems in the Senate. They noted that goodwill from Democrats toward the nominee may even “hurt” his chances with Republicans.What to watch: Kennedy is expected on Capitol Hill next week with nearly two dozen meetings scheduled, per a spokesperson.“This is a week going after Tulsi Gabbard. Now, I guess they’re gonna skip over Kash [Patel] and then go after RFK next week because he’s coming,” said Sen. Tommy Tuberville (R-Ala.), who said he’s meeting with Kennedy on Tuesday. Tuberville broadly supports Trump’s picks for nominees and said Kennedy has “got a lot of great ideas” and is “outside the box.”

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