ICDL-ACCESS questions - ICDL the access Updated: 2023

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CNN  — 

A newly approved medication to treat postpartum depression will cost $15,900 per 14-day course, before insurance, when it reaches the market later this year, raising concerns among doctors and researchers that some patients may have trouble paying for the drug.

The medicine, Zurzuvae, was approved by the US Food and Drug Administration in August and is the first medicine cleared for postpartum depression that’s taken as a pill. Drugmaker Sage Therapeutics said Tuesday that the drug is expected to become available in December and that it and partner Biogen are talking with insurers about coverage plans.

The companies’ goal is “to enable broad and equitable access for women with PPD who are prescribed this drug,” Sage Chief Executive Officer Barry Greene said in a news release. The hope is for patients to be able to get the medicine, “where possible, with little to no co-pay regardless of financial means,” and the companies will provide financial assistance to help cover costs or provide the drug free for certain patients.

Postpartum depression affects as many as 1 in 8 people who have babies, according to research from the US Centers for Disease Control and Prevention. It typically happens after childbirth but can also set in during the later stages of pregnancy, and it can cause sadness, a loss of energy and thoughts of self-harm.

Mental health specialists welcomed the approval of Zurzuvae this summer, not just because it presents a new way to treat postpartum depression but also specifically because it “appears to be fast-acting,” said Dr. Catherine Monk, chief of the Division of Women’s Mental Health in the Department of Obstetrics and Gynecology at the Columbia University Vagelos College of Physicians and Surgeons.

The drug was shown in one clinical trial to Improve depressive symptoms in as little as three days, according to Sage and Biogen. It was approved based on two trials showing significant improvements after two weeks on a 17-item scale of depression, compared with placebo.

Zurzuvae mimics the function of natural brain steroids that work on the GABA signaling pathway, helping to regulate brain function. Because it can have a depressant effect on the central nervous system, the drug’s label contains a prominent warning that patients shouldn’t drive or do other “potentially hazardous activities” for at least 12 hours after they take the medicine.

“Expedited recovery obviously is a huge plus in helping individuals with PPD feel back to themselves,” Monk wrote in an email. That can be key for bonding in the earliest days of a baby’s life, she said.

The current options to treat postpartum depression orally are selective serotonin reuptake inhibitors or SSRIs, antidepressants that “take weeks to kick in and must continue being taken on a daily basis for at least six to 12 months,” said Dr. Katrina Furey, a psychiatrist in private practice specializing in women’s mental health and reproductive psychiatry, and a clinical instructor at Yale University.

The price of Zurzuvae seems especially high in comparison with those medicines, Furey said. SSRIs, which include the generic versions of drugs like Prozac and Zoloft, typically cost less than $20 a month, according to data from GoodRx.

“It remains to be seen how much insurance companies will cover it or if they will require women to ‘fail’ treatment with less-expensive SSRIs before paying for this new treatment,” Furey said. “I hope that is not the case and that its price will not be a barrier to accessing this treatment.”

She noted, though, that the $15,900 price tag is less than half that of an earlier postpartum depression drug from Sage called Zulresso. Priced at about $35,000, that drug is given via IV infusion over the course of 60 hours in a hospital.

Some financial analysts following Sage had predicted that Zurzuvae’s price could approach Zulresso’s after the FDA declined to grant Zurzuvae broader approval in major depressive disorder. The expectation had been that the broader approval would have led the companies to set the price below $10,000, an important threshold for a specialty drug tier in Medicare coverage; with a smaller patient pool, the analysts, at financial firm Mizuho, forecast the price would be higher. One of those analysts, Uy Ear, confirmed Tuesday that tier doesn’t apply to Medicaid.

A Sage spokesman said in an email Tuesday that the company recognizes “that black and brown women are disproportionally impacted, and we are prioritizing equitable access as well as advocating for policies that better support underrepresented communities,” noting that “those who live in rural areas and those who have Medicaid may be more likely to receive inadequate postpartum care, compared to those who live in urban areas and have private health insurance.”

“As such,” he continued, “Sage and Biogen aim to enable broad and equitable access for all women with PPD who are prescribed Zurzuvae.”

The $15,900 price “raises substantial accessibility concerns, especially when we still don’t know how it’ll be covered by insurance,” said Dr. Lindsay Allen, an assistant professor of emergency medicine and a health economist and health services researcher at the Northwestern University Feinberg School of Medicine.

“Ensuring access to such treatments is imperative, as they may be lifesaving for new mothers during a vulnerable time,” Allen said. “Suicide is a leading cause of death in the first year postpartum.”

She and Columbia’s Monk raised concerns about disparities in access to the medicine, even with insurance coverage, “exacerbating inequities with respect to who has access to what kind of care,” Monk said.

She noted that the drug was tested in people with severe – and rarer – forms of depression and said she was concerned that the “heavy media attention and advertising” around Zurzuvae may mean it gets over-prescribed and that patients don’t receive other necessary care, like therapy.”

“The gold standard of mental health care is a combination of psychotherapy and medication when medication is needed,” Monk said. And “often, therapy is enough.”

The “hidden costs” of not treating, or undertreating, postpartum depression and anxiety are important to keep in mind, said Furey, who also co-hosts the “Analyze Scripts” podcast about the depiction of mental health in the media.

“We know that PPD and other postpartum mental health issues can have negative effects on maternal-infant bonding, on the family dynamics as a whole, increase risk of physical health issues [and] pose difficulties returning to work,” she said.

The costs of those effects, she said, are “not easily put into financial terms.”

Gabby Profenno in her home auto shop in Lisbon. Like many independent repair shop owners, Profenno is thinking that the cost to access digital information about vehicles will prove to be too expensive for her to stay in business. Brianna Soukup/Staff Photographer

Gabby Profenno restored her first car in 1977, at 17 years old, working out of her family’s garage in Freeport, and spent her teenage years learning how to fix engines, do bodywork and customize cars.

She then repaired cars as a side business until 1982, when she realized she could do the work for a living and started her own business.

These days, she does repairs, bodywork, restorations, state inspections and customizes old cars as the owner of Girl Pro Customs in Lisbon, an independent shop.

She also is among the many independent repair shop owners and car owners who say vehicle diagnostic and repair data is becoming harder to access. Profenno worries that her ability to work in this industry could be ending.

She hopes, however, that a statewide referendum on accessing vehicle data could reverse that trend.

On the Nov. 7 ballot, voters will decide on Question 4, the Automotive Right to Repair referendum. If the referendum passes, manufacturers would be required to give vehicle owners and independent shops the same access to their diagnostic tools that they give to their authorized repair shops, including software, information, capabilities, tools, parts and miscellaneous components. It also would standardize the digital platform owners and repair shops use to access this information.

Whether it passes or fails, Question 4 will affect car owners and independent car repair shops across the state. But how that impact will be felt is up for debate.

CHANGING TECHNOLOGY

The challenges of advancing vehicle technology have snuck up on Profenno and other indie shop owners over the years.

Those advancements include changing the systems that mechanics use to obtain a car’s diagnostic data. Historically, that was extracted through a port in the car where repair technicians can plug in and pull information on things like the emissions systems, engine and gearbox. Many aftermarket companies have created devices that repair shops and owners can purchase to access to this data for different makes and models. Aside from aftermarket devices, shops can purchase individual subscriptions to access information from each manufacturer.

But now, diagnostics data is gradually advancing and moving to “telematics” – wireless diagnostic information about the vehicle’s performance and systems that is transmitted to the dealer and not stored in the vehicle.

Already, some shop owners say there are a number of specific high-end manufacturers that they aren’t able to get all the information and repair functionalities through the older system. Sukhi Singh, co-owner of Cityside by E&S Auto Repair in Scarborough, struggles getting access to Land Rover’s data. Profenno runs into a lot of issues with Subaru. Many shop owners say they cannot service Teslas.

The automotive manufacturers say they already make that wireless information accessible. In fact, The Alliance for Automotive Innovation, an industry group that represents all of the major auto manufacturers and opposes Question 4, issued a memorandum of understanding in July committing to expand access. The alliance also worked with Maine Rep. Bruce White, D-Waterville, to introduce legislation that includes nearly all of the terms in the referendum question.

But there’s one thing missing in that memorandum and proposed legislation: a standardized diagnostics database.

It’s this requirement that all the data be stored and available in one database that has the manufacturers and opponents of Question 4 worried.

They are concerned about how open access to telematics could pose cybersecurity and consumer privacy threats. They also are concerned that third parties, in bad faith, would unlock anti-theft systems or control modules to bypass federal safety and emission regulations.

Voit Ritch is the owner of Autowerkes, an automobile repair shop in Freeport that specializes in European vehicles. He is opposed to Question 4 over worries that manufacturers might remove or limit access to diagnostic data if there is a legal battle in the event Question 4 passes. Derek Davis/Staff Photographer

Voit Ritch, the owner of Autowerkes Maine, an independent repair shop in Freeport, is urging a ‘no’ vote on Question 4 because he fears it will have a negative impact on his business and on consumers.

Ritch, whom the Press Herald connected with through the Alliance for Automotive Innovation, said he’s concerned that the standardized software database is too large of a task for an independent entity to tackle. He’s concerned that taxpayers will be facing the brunt of what will likely be a legal battle if Question 4 does pass. And he’s concerned that manufacturers will take away access to all data, telematics or not, until the legal battle comes to an end.

Ritch has previously advocated for Right to Repair movements. But this time around, he believes that Question 4 goes too far. He said he currently has no trouble accessing the data he needs to do a full repair and he doesn’t anticipate that changing.

But he does anticipate that the referendum question would negatively impact independent repair shops and consumers. He’s thinking about those who would use personal data in bad faith. And he believes the consumer will end up at the dealership, no matter what.

“I have everything I need, now. Why would I take the chance of losing? I’d rather not have a question mark,” Ritch said. “I’d rather live my life the way I’m living it today – my customer calls me on the phone, their car comes in, I am able to get the information I need to fix that car, get it back to them and get them back on the road. My job is to fix the transportation problem.”

But the Right to Repair Coalition says the standardized database is the key for creating more affordable aftermarket devices. And many owners say that purchasing subscriptions from all the different manufacturers is not a financially sustainable option.

At BMW, for example, the current software to access service information costs $3,813 a year, according to its website. The integrated software for all General Motors diagnostic tools costs $4,328.

“It’s not a sustainable business model,” said Tommy Hickey, the executive director of the Right to Repair Coalition running the ‘Yes’ campaign.

It’s not sustainable for Singh or Profenno, either, who both rely on aftermarket devices.

“Are there things that I would pay for? Absolutely. Could I afford everything? No, my shop is too small,” Profenno said.

The indie shop owners say they’re not overwhelmed by issues with the data access just yet. They all feel certain, though, that it’s just a matter of time.

Consumers who own 2023 models with the latest iteration of telematics are likely still taking their vehicles to the dealers while their cars are under warranty.

Erik Lowell, owner of Duval’s Service Center in South Portland, said when warranties begin expiring in a couple of years, he expects to start seeing those customers more. Whether he is actually able to access the data and fix those advanced cars remains to be seen.

“It’s going to change the way I operate, but ultimately the burden is going to fall onto you as the vehicle owner and customer,” Lowell said. “Things are going to be drawn out longer, going to take longer to get repairs done, it’s going to be more expensive – whether I (do the repairs myself) or you have to bring your car to the dealer yourself.”

And there’s one more group of consumers who could be affected: the do-it-yourself car owners.

Jake Cyr, a Bridgton resident, restored his first car as a teenager – like Profenno, he also learned how to repair his own cars; how to do the bodywork, engine work, change the brakes, the suspensions, and customize the radios and speakers.

At the time, Cyr did that work himself because he couldn’t afford to bring it to a repair shop or purchase a new car. Over the years, that DIY spirit has developed from a necessity to a passion. Cyr has built up a fleet of cars that he’s learned to work on himself.

He hopes that Question 4 will pass so that DIY spirit can continue in Maine.

“I love that I can provide for myself – be able to take care of myself, have my hands in everything and know all the information about what I own,” Cyr said. “People think of Mainers like that – that they work hard, take care of their family and do the best with what they have.”

BUSINESS CHALLENGES

Jason Beaulieu has a sign to vote ‘Yes’ on the Automotive Right to Repair referendum in the window at the Hollis location for his business, Jason’s Auto Service. He’s focused on spreading the word to the customers who stop by his repair shops.

Jacob Sirois works on a Ford F150 at Jason’s Auto Service in Hollis. Owner Jason Beaulieu supports Question 4, but believes he’ll find a way no matter what to keep his business going and passing it on to his son, Nick. Brianna Soukup/Staff Photographer

Like Lowell, he believes that this issue will have the most profound impact on consumers.

“The customer will be hit the hardest,” Beaulieu said.

Beaulieu has been in the field since he was 15 and started taking industrial arts classes. He worked his way up from an independent repair technician to a shop owner when he started his business in 2000.

In that time, he’s learned just how important a local repair shop is to the local community.

“We’re here for the consumer, we’re here to help them, we’re here to give them a service that the dealership necessarily doesn’t always give them – personal experience and someone that you come in and they know you by name,” he said.

Beaulieu’s favorite customer feedback is about how customers appreciated seeing his dog, Charlotte, run around; always seeing the same technicians at work; how well he and his employees know a customer and the history of their car.

Beaulieu believes that the Automotive Right to Repair industry will give consumers their right to choice – even if it’s choosing to get work done at the dealer.

A 2020 study from Lang Marketing found that repair costs were on average 36.2% higher at dealerships than at independent repair shops in Massachusetts, based on interviews with over 100 dealerships and indie shops.

In Maine, authorized car dealerships seem ambivalent about the ballot measure. Adam Lee, owner of Lee Auto Malls, and Tom Brown, the president of the Maine Automobile Dealers Association, both feel the referendum paints dealerships in a slightly unfair light, since dealers also have to purchase the software and can’t use the independent devices. But both say they can’t see passage of this referendum hurting dealership business.

Beaulieu believes that no matter the outcome, his business will endure. Nick, his 18-year-old son, believes that the business will still be around at the time that he might take over.

“I think we can evolve, we can do other things as independent shop owners,” Beaulieu said.

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