A look at the politics of the Right-to-Try bill, a state-of-the-art review on preventing cardiovascular disease in diabetes, and the benefits of the FDA’s expedited review programs.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Last week, the so-called Right-to-Try Act of 2017, authorizing the use of unapproved medical products by patients with a terminal illness, unanimously passed the Senate. The bill still has to pass the House and be signed into law by President Donald Trump, but already there is opposition and doubt on whether or not the bill will actually improve patient access to drugs in development.
The FDA already has the Expanded Access program, and its biggest stumbling block to promoting patient access has been the high rate at which drug companies turn down applications for the drugs.
The American Society of Clinical Oncology has also voiced its concern. In a position statement, ASCO’s chief medical officer, Richard Schilsky, MD, FACP, FASCO, said
“We don't support right to try legislation … because these laws ignore key patient protections without actually improving patient access to investigational drugs outside of clinical trials.”
The FDA’s efforts to expedite highly promising drugs to market have been successful so far, according to a study.
New research has found that drugs approved through the FDA’s expedited review programs offer larger health gains than those approved through the traditional process. The study measured health gains by quality-adjusted life-years.
The study results show that the FDA’s expedited review programs appear to be addressing unmet clinical needs and improving current therapy options. The authors wrote,
“Expedited review programs offer the FDA greater discretion for hastening the delivery of highly promising and much-needed treatments to patients and for providing incentives for pharmaceutical innovation.”
Proving the likelihood of improved health outcomes of a treatment is increasingly important as payers start entering into more outcomes-based contracts.
In an interview with The American Journal of Managed Care, Dr Michael Sherman, the chief medical officer of Harvard Pilgrim Health Care, explained the benefits of entering into performance-based risk-sharing arrangements.
Conway Leaves CMS
After 6 years with the agency, Patrick Conway, MD, MSc, is leaving his position with CMS and to join Blue Cross and Blue Shield of North Carolina.
Conway is the current deputy administrator for innovation and quality at CMS and he has taken a leading role in CMS’ transition away from fee-for-service toward value-based payment models. He will start October 1 as the new president and CEO-elect at the insurance company.
Preventing CVD Risk in Diabetes
A review of recent evidence for the prevention of cardiovascular disease in diabetes determined a multifaceted approach gives patients the best chance.
The review condenses guidelines from the American College of Cardiology, the American Diabetes Association, and the American Heart Association, and centers on the core elements of diabetes care: lifestyle management and management of cardiovascular disease risk factors with therapy.
The authors wrote that most patients benefit from a combination of diet, exercise, and medication: “Taken together, these trials suggest that multifactorial interventions targeting several important risk factors simultaneously result in greater CV risk factor control and likely greater reduction in CVD risk compared with single risk factor interventions."
AADE 2017 Coverage
Finally, our coverage from last weekend’s annual meeting of the American Association of Diabetes Educators is now online, including articles on:
State-level partnerships to bring education to people with diabetes
The creation of a new Digital Health Learning Network