Given a paragraph, generate a claim that is supported by the given paragraph. 1) The claim must contain information from within the paragraph. 2) A sentence within the paragraph can be used as a claim. 3) The claim should not have contradictions within the paragraph. 4) The claim should be at most one sentence long.

Q: Teva Pharmaceutical Industries Ltd’s rival migraine headache preventer is excluded on one list and patients can pay more for it in some cases on a second list, the note said. As with rival PBMs Express Scripts and CVS Health Corp, OptumRx’s lists of covered drugs, or formularies, cover tens of millions of consumers who receive their healthcare from employers and health insurers. About 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation, and global migraine drug sales could reach $8.7 billion by 2026, according to analytics firm GlobalData. OptumRx’s decision secures easier access to customers for Lilly’s Emgality at all three of the biggest PBMs - including CVS and Express Scripts - and gives Amgen’s Aimovig a leg up after CVS decided not to include it on its preferred drug list. Teva’s Ajovy only has preferred status at CVS, while Amgen also has it at Express Scripts, part of Cigna Corp.  “We are pleased that all three companies have chosen Emgality to be one of the preferred medications, making it accessible to even more patients suffering from migraine,” Lilly said in an emailed statement. Inclusion on a preferred drugs list by the largest PBMs and health insurers is critically important for sales of new medicines. Increasingly, PBMs are choosing a subset of treatments for their coverage list when there are multiple treatments that are considered equivalent. The three treatments, approved by the U.S. Food and Drug Administration last year, belong to a class of drugs called CGRP inhibitors that have proven effective in helping to prevent migraines. A Teva spokeswoman said the company is committed to increasing access to Ajovy regardless of formulary decisions and is still offering discounts that allow patients to pay nothing in some cases, regardless of insurance. “Since Ajovy injection launched in September, we have experienced strong demand and steady growth, and we continue discussions with payers,” the spokeswoman said. An Amgen spokeswoman said that the company was pleased with the decision and is committed to ensuring affordable access to its drug. Amgen, which shares Aimovig U.S. revenue with Novartis AG, earlier this week reported fourth-quarter sales of $95 million, nearly doubling Wall Street estimates. The OptumRx decision becomes effective Feb. 1. The OptumRx select formulary relegates Teva’s drug to a lower access level that would typically require a higher out-of-pocket cost, it said. PBMs typically extract discounts from drugmakers in return for favorable placement on their preferred list of covered drugs, such as through a low co-payment, or coinsurance payment, for their members. All three migraine drugs have a list price of $575 a month, or $6,900 a year. Those prices do not reflect the rebates and discounts to PBMs, who design and negotiate benefits for employers and insurers. All three drugmakers are providing a limited duration supply of the new drugs at no cost directly to patients in addition to other assistance programs. Amgen’s Aimovig was first-to-market from the new class. But the rivals from Teva and Lilly followed soon after. The three large PBMs together cover the majority of the more than 150 million Americans who receive benefits through their employers. Their clients, including insurers and corporations, may choose not to follow a PBM’s recommendations on coverage, but that typically would cost more. Amgen shares were off 28 cents at $186.63, Lilly was up nearly 1 percent at $120.90 and Teva shares traded in New York  were down nearly 1 percent at $19.69.

A: Exclusive: Top U.S. insurer to cover Amgen, Eli Lilly migraine drugs, exclude Teva.
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Q: The study evaluated the combined effect of six lifestyle habits on prostate cancer mortality. Those six factors were, as described in the journal article: “not currently smoking or quit 10 or more years ago, body mass index under 30 kg/m2, high vigorous physical activity, high intake of tomatoes and fatty fish, and low intake of processed meat.” It’s tough to put a price tag on those lifestyle choices. How much does “high vigorous physical activity” cost? How much does it cost to avoid eating processed meat? It would be easy to say this category doesn’t apply. But the release does address the issue, saying the study findings underscore “the ongoing need for more effective prevention measures and policies to increase exercise, improve diet quality and reduce tobacco use in our population….It takes co-operation and effort from multiple areas, like insurance companies, employers, policy makers and city planners, to figure out how to creatively support and encourage more exercise into most busy adults’ working day.” Recognizing the need for policies that support these lifestyle changes is important — and addresses the cost issue in a meaningful way. This is where things get a little tricky. The research described in this journal article looked at data from two different studies: the Health Professionals Follow-Up Study (HPFS) and the Physicians’ Health Study (PHS). The HPFS tracked 42,701 men from 1986-2010. The PHS tracked 20,324 men from 1982-2010. The release (and journal article) explain that the researchers used the HPFS data to develop a “healthy lifestyle score,” and then applied that score to the men in the PHS to see if it predicted whether someone would contract a lethal form of prostate cancer. The researchers identified the number of lethal cases of prostate cancer in each group to calculate benefits. The release states: “Participants with 5 to 6 points [the highest scores] in the HPFS had a 68 percent decreased risk of lethal prostate cancer[,] and a 38 percent decreased risk was observed in the [PHS] for the same comparison.” Several points to make here. First, the ‘healthy’ group appeared to have been compared to the ‘least healthy’ group (score 0-1) and not all the other groups combined. This was noted in the published results but not mentioned in the release. That’s important. Second, the release does not note (but the journal article does) that the 38 percent decreased risk seen in the PHS was not found to be statistically significant. That’s also an important distinction. Third, this is the relative reduced risk, and doesn’t tell readers what the actual, absolute reduction of risk is. The release doesn’t address harms. But the lifestyle choices at issue here are (for the most part) so broadly defined that it would be difficult to say what the harms would be. What harms are associated with eating tomatoes, avoiding processed meats, or not smoking? We’ll rate this one not applicable. The release does a good job of explaining what is a somewhat complicated study design. The study is basically an analysis of data drawn from two large, previous studies — and the release describes the overall sample size, age range, and length of those two studies. But the language used to describe the results is inappropriate. Since this was an analysis of observational study data that’s unable to prove cause and effect, it’s misleading to use active verbs to describe the results. The release does this in several places: It’s more appropriate to state that these habits were “associated with” reduced risk — not that the habits “save lives” or “cut” risk. Another thing that’s not clearly explained to readers (as noted above) is what it means to develop a lifestyle scoring system based on one study’s data set, and then apply that scoring system to a second data set, when the results section is provided for both data sets. It’s confusing. We’d encourage public affairs specialists preparing news releases and reporters using them as their initial sources to focus more on the limitations of this type of research. Sometimes referred to as “data dredging,” it’s basically finding statistically significant results only by chance. In this case it’s a statistic of a statistic (up to 47% of cancer cases could be prevented with these lifestyle interventions). No disease mongering here. Funding sources were clearly identified, and there are no clear conflicts of interest. Things get tricky again here. As the release notes, most prostate cancers don’t metastasize and aren’t life threatening. But some do metastasize and can be fatal. Are there different types of prostate cancer, just like there are different types of flu? Are there genetic factors that affect risk? Readers would have benefited from that information. And we suppose that the release could have also mentioned other dietary or lifestyle factors that might help reduce risk that were not considered in the paper. However, the range of healthy behaviors discussed here is pretty broad, and it seems excessive to expect the release to address an entire laundry list of possibilities. We’ll give this a Satisfactory rating. The study was limited to a relatively high level income group and the interventions may not be attainable for all men, in all socioeconomic groups. Does partaking of vigorous physical exercise on a regular basis require access to a gym or just a high degree of motivation? Are tomatoes and fish attainable year round for all socioeconomic groups? The study addresses this to some extent when it says, “It takes co-operation and effort from multiple areas, like insurance companies, employers, policy makers and city planners, to figure out how to creatively support and encourage more exercise into most busy adults’ working day.” We’ll award a Satisfactory here. There are a lot — a lot — of papers out there on lifestyle choices and prostate cancer. In fact, the opening sentences in the abstract for the journal article says as much, while articulating what sets this research apart: “Several lifestyle factors have been associated with risk of lethal prostate cancer, but little is known about their combined effect. Our objective was to develop and apply a lifestyle score for prevention of lethal prostate cancer.” However, the release does not acknowledge all of the existing work on lifestyle and prostate cancer, and therefore fails to highlight how this paper fits into that broad body of work. Apart from the cause-and-effect statements addressed above, there is no unjustifiable language used here.

A: Working up a sweat may protect men from lethal prostate cancer
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Q: Excellent job here. The costs of treatment are a core aspect of the story. The opening paragraph describes how the blood test in question could help determine whether patients should receive “costly new-generation drugs or rely on much cheaper traditional chemotherapy,” and the specific costs of different therapies are detailed early in the article. Much less information is given about the cost of the blood test itself, though the writer does make it clear that the price is not yet determined. It would have been useful to note the costs of any comparable tests already in clinical use, and to let the reader know how insurance companies deal with new diagnostic tests. The story says “in a study published last month, patients who tested positive for the anomaly—a variant of the androgen receptor called AR-V7—lived substantially longer if they were treated with chemotherapy than those given the two new drugs.” However, the story doesn’t provide specifics on what that means in number terms. The story does not explain harms. However, diagnostic tests are only as good as their sensitivity and reliability, so it would have been good for readers to get an impression of whether the test catches every case of AR-V7, and the likelihood of false positives or false negatives. Even if that information is not yet available, it is important for readers to be made aware of the issue that a false result could lead to the wrong therapy being given. The story lets us known that this was a relatively small study of 161 patients, and it is described as “retrospective.” We’re also told that the blood test needs validation in large randomized controlled trials. While it may be challenging for readers not well-versed in study design to discern what the limitations of a retrospective study is, and what further information a randomized trial would deliver, these details are sufficient enough to rate Satisfactory. We also appreciated these words of caution: “In the study, a positive test for AR-V7 didn’t assure patients would respond to the chemotherapy, nor did a negative test promise a response to the Xtandi or Zytiga.” Advanced stage prostate cancer is a common, life-threatening disease. The article gives an estimate, albeit from the companies behind the test, that 50,000 U.S. men with advanced prostate cancer would be candidates for the test. No independent expert source is quoted throughout the story. This is problematic not least because representatives of both Epic Sciences and Genomic Health are quoted on the clinical utility of the test, and their claims need to be validated or refuted by experts with no skin in the game. It would also be important to get an independent take on the study itself, the strength of the evidence and whether there were any limitations that should be highlighted. Additionally, next to no information is given about conflicts of interest. While the lead author’s affiliation is given as Memorial Sloan-Kettering Cancer Center, the majority of co-authors of the study are employees of Epic Sciences. This surely warrants a mention so readers are not given the false impression that the company had no role in the study. Moreover, the lead author Howard Scher has received research funding, personal fees and non-financial support from all the companies behind the prostate cancer drugs in question. Despite the fact that the blood test would theoretically identify patients who would be better off not receiving the drugs, Scher has highly relevant conflicts of interest, thus increasing the need for independent expert sources. The article does not explicitly describe whether there are other methods of detecting AR-V7, though it is implicit that AR-V7 has not been used clinically as a biomarker before, and two other companies developing a similar test are mentioned. The story is based around whether using AR-V7 as a biomarker could lead to better outcomes than current clinical standards, so the comparison to the “status-quo” alternative is thoroughly explored. It is made clear that the blood test is not currently available, and the article gives a prospective date for when the test will be launched. Since AR-V7 is not currently used as a biomarker for treatment of advanced prostate cancer, it is clear enough to the reader that this is a new approach. An important point that is only mentioned in passing is that the test is a “liquid biopsy.” Liquid biopsies have often been hyped as a revolutionary new approach to diagnosing cancer without invasive procedures. However, due to questions over sensitivity and reliability, they have been controversial and are yet to become commonplace in clinical practice, so readers might have benefited from a little more context on this point. The writer has clearly interviewed his sources and included substantially more information than available from news releases by either Epic Sciences or Genomic Health.

A:
Test Aids Prostate Cancer Treatment
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