FDA plan seeks payers input on clinical trial design, evidence — Daily Rise: Tuesday, March 1

Collaboration Yields Results

Michael Mezher of Regulatory Affairs Professionals Society raps on the FDA’s plan to “bring payers to the table” in discussing their clinical trial design and evidence gathering before trials begin.

“The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence gathering with sponsors before clinical trials begin.”

Right now, medical device development is sequential and often means that “FDA approval of a device doesn’t always match the data that a payer needs to make coverage decisions.”

This story is positive news for patients. Here at Patients Rising, we are calling for all parties to come to the table to put patients first.

Provided that payers are reasonable in their demands for the clinical trial design, this collaboration has the potential to speed up the approval process for devices, giving patients faster access to new innovations.

Health Care: Think Different

Dr. Damon Ramsey, a practicing physician and co-founder of InputHealth, argues that “health care needs a Steve Jobs-style disruptor.”

“Few industries yearn for a Jobs-style disruption as much as health care does today,” Ramsey writes in a thoughtful opinion piece published at StatNews. “With its labyrinths of regulation, deeply entrenched and antiquated information systems, and monopolies built upon thrones of indifference to the consumer experience, the health care industry has chained itself to archaic and inefficient processes while resisting its own rescue”

We agree with Ramsey’s assessment that “the health care industry has largely resisted consumer-centric change” and that patients “aren’t as docile as the traditional forces of health care once viewed.”

While we understand providers’ frustration with patients who use WebMD to self-diagnose, more engaged and better informed patients will help drive down the cost of health care. Patient-focused apps and tools can help us make our appointments and remember to take medications on time and in the right dose as well as better monitor our symptoms.

Right to Try: It’s Complicated

Carter Coyle of North Carolina’s Fox 8 News explains why “Right to Try” legislation has its own set of complications. Two-dozen states, including North Carolina, allow terminally ill patients to try experimental treatments that “have completed Phase 1 testing but have not been approved by the Food and Drug Administration.”

As Kurt Altman with the Goldwater Institute explains, “What right to try laws do is if a doctor of a terminally ill patient says this is the very best chance you have right now — and that patient is unable to get into a clinical trial- these laws allow that patient to access those medications.”

But, while “right to try” empowers patients, it’s important to realize that they’re not a perfect solution. Many companies are reluctant to provide access to unapproved treatments for liability and safety reasons.

Fox 8 News notes: “The risk includes the potential scenario of a patient at the end of his life receiving a company’s drug and then dying. It could look like their drug doesn’t work, or worse, that the drug caused the death. In actuality the patient may have been too sick.”

The above-mentioned scenario underscores why we need to expedite the FDA’s drug approval process. If treatments weren’t bogged down in a lengthy bureaucratic process, patients would gain access without compromising safety.

Cancer-Partnership Talks

German-based Boehringer Ingelheim GmbH and Illinois-based AbbVie Inc. according to Bloomberg News, are in major talks about a partnership over their cancer treatment businesses.

“Boehringer focuses on treatments for lung cancer, one of the most common forms of the disease. The company sells the drug Giotrif for non small-cell lung cancer and Vargatef for patients at a later stage when other treatments, such as chemotherapy, have failed. The German company is also researching new treatments for lung and bowel cancer.”

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