The Health News USA December 5 2017

  • Amgen Inc. can now promote the ability of its potent but expensive cholesterol drug to reduce the risk of heart attacks and strokes, after U.S. health regulators approved adding those benefits to the medicine’s prescribing label. Amgen has long seen this development as critical to clearing onerous hurdles to patient access and unlocking the value of the drug, Repatha, which has had anemic sales since its August 2015 approval despite its billion-dollar potential.
  • The first birth as a result of a womb transplant in the United States has occurred in Texas, a milestone for the U.S. but one achieved several years ago in Sweden. A woman who had been born without a uterus gave birth to the baby at Baylor University Medical Center in Dallas.
  • U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws. The U.S. FDA approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

News on Health Professional Radio. Today is the 4th of December 2017. Read by Tabetha Moreto.

https://www.reuters.com/article/us-amgen-cholesterol/fda-approves-heart-protection-claims-for-amgen-cholesterol-drug-idUSKBN1DV61D

Amgen Incorporated can now promote the ability of its potent but expensive cholesterol drug to reduce the risk of heart attacks and strokes, after U.S. health regulators approved adding those benefits to the medicine’s prescribing label. Amgen has long seen this development as critical to clearing onerous hurdles to patient access and unlocking the value of the drug, Repatha, which has had anemic sales since its August two thousand fifteen approval despite its billion-dollar potential. The injected biotech drug was approved on the basis of its ability to dramatically lower bad low density lipoprotein or LDL cholesterol.

But health insurers and pharmacy benefit managers have made it extremely difficult for patients to get the medicine, even those whose dangerously high cholesterol met criteria for use in the original label approved by the Food and Drug Administration. As many as seventy five percent of patients prescribed the medicine have been denied coverage despite numerous appeals, severely holding back sales. Repatha sales, while gradually improving, were just eighty nine million dollars in the third quarter. A study released in March of more than twenty seven thousand five hundred patients showed that Repatha cut the risk of heart attacks by twenty seven percent and stroke by twenty one percent compared with a placebo in high-risk patients already on high doses of cholesterol-lowering statins such as Pfizer Incorporated’s Lipitor. In the second year of the study, the benefits were more pronounced, with a combined heart attack and stroke risk reduction of thirty three percent.

But Amgen by law was unable to promote those benefits until the FDA approved adding those claims. The company has repeatedly said having the heart benefits added to the official label was necessary to get insurers to loosen their purse strings.

http://www.nydailynews.com/life-style/health/u-s-baby-born-uterus-transplant-dallas-article-1.3671518

The first birth as a result of a womb transplant in the United States has occurred in Texas, a milestone for the U.S. but one achieved several years ago in Sweden. A woman who had been born without a uterus gave birth to the baby at Baylor University Medical Center in Dallas.
Hospital spokesman Craig Civale confirmed Friday that the birth had taken place, but said no other details are available. The hospital did not identify the woman, citing her privacy.

Baylor has had a study underway for several years to enroll up to ten women for uterus transplants. In October two thousand sixteen, the hospital said four women had received transplants but that three of the wombs had to be removed because of poor blood flow.
The hospital would give no further information on how many transplants have been performed since then. But Time magazine, which first reported the U.S. baby’s birth, says eight have been done in all, and that another woman is currently pregnant as a result. A news conference was scheduled Monday to discuss the Dallas baby’s birth.
….
There have been at least sixteen uterus transplants worldwide, including one in Cleveland from a deceased donor that had to be removed because of complications. Last month, Penn Medicine in Philadelphia announced that it also would start offering womb transplants.
The American Society for Reproductive Medicine issued a statement Friday calling the Dallas birth “another important milestone in the history of reproductive medicine.”

http://abcnews.go.com/Health/wireStory/fda-approves-kind-test-cancer-gene-profiling-51510556

U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws. The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it. The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now, and lead more insurers to cover it.

Doctor Kate Goodrich, chief medical officer for the Medicare oversight agency said: “It’s essentially individualized, precision medicine.” Currently, patients may get tested for individual genes if a drug is available to target those mutations. It’s a hit-and-miss approach that sometimes means multiple biopsies and wasted time. In lung cancer alone, for example, about half a dozen genes can be checked with individual tests to see if a particular drug is a good match. The new FoundationOne CDx test can be used for any solid tumor such as prostate, breast or colon cancer, and surveys three hundred twenty four genes plus other features that can help predict success with treatments that enlist the immune system.

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Foundation Medicine, based in Cambridge, Massachusetts, and others have sold tumor profiling tests for several years under more lax rules governing lab-developed tests. But insurers have balked at paying for the tests, which cost around six thousand dollars. Now, the FDA’s approval gives assurance of quality and the government’s proposed coverage for Medicare and other public insurance programs means private insurers will more likely follow. Public comments on the coverage proposal will be taken for thirty days. A final decision is expected early next year followed by setting a price for reimbursement. Coverage is proposed for patients with recurrent, widely spread or advanced cancers, in people who have decided with their doctors to seek further treatment and who have not previously had a gene sequencing test.

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