Immunotherapy treatment gets FDA breakthrough therapy designation –Daily Rise: Thursday, February 18

Drugs Are Breaking Through All Over

AstraZeneca has been granted the FDA breakthrough therapy designation for durvalumab, an immunotherapy treatment PD-L1–positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.

So has Roche, for their drug treating primary progressive multiple sclerosis (PPMS).

FDA approval is no easy feat. Of course, this is welcome news for patients, who could gain access to a potentially life-saving treatment. If you’re curious about what it all means, check out this article from Brookings, FDA Breakthrough Therapy Designation: A Primer

Critics say many of these drugs are not actually ‘breakthrough’ medicines because they are based on preliminary data.  They say these drugs can be given an unfair marketing advantage making them seem more beneficial than they actually turns out to be.

Certainly a fair point.  But tell that to a patient who needs a new treatment option today. There is not enough consideration given to the patients, like our friend Don Wright, who are living (and in his case running 91 marathons) because of new options waiting when old ones stopped working. This is very common in cancer therapy. Critics cannot overlook the importance of these incremental steps for patients as they shoot down drugs that extend life for ‘months at a time’. It goes without saying that the universal goal is ‘the cure’, but getting the right patient to the right treatment for them today is the best we have forward now.  Embracing incremental steps has the potential to turn survial into years and as a society we should not lose sight of that.

I’ll Show You Mine, If You’ll Show Me Yours

Dr. Robert Goldberg at looks at the issue of drug price transparency. He reiterates a point we’ve been making: transparency must be universal and applied to every aspect of health care.

“I am all for ‘transparency in drug pricing.’ The question transparency proponents have to answer is: why are they only focusing on how drug companies set their prices when the effective price consumers pay is set by PBMs, insurers and hospitals?”

Well said.

And no, a PBM is not the latest sandwich craze, it’s your Pharmacy Benefit Manager.  They contract with the pharmacies, follow the formulary (approved medicines list), negotiate with the drug companies and process claims.

Coming Soon: Rate Your Doctor’s Value

The Washington Post’s Amy Goldstein shares the news that federal health officials and insurers have reached an agreement on how to rate doctors by value.

“Leaders of the federal Centers for Medicare and Medicaid Services and the trade group America’s Health Insurance Plans announced Tuesday that they have reached a consensus on how to measure physician quality in seven medical areas, from primary care to treatment of patients with cancer or AIDS. They will serve as building blocks on which both private health plans and Medicare, the vast public insurance program for older Americans, rely in shifting how doctors are paid.” 

It’s not exactly clear how quickly the ratings will be rolled out. The agreement signals that the focus will be on value.

“Increasingly, both private and public insurance are moving toward payments based on the “value” of care, rather than on how much care a doctor provides. The new measures are designed to help gauge that value.”

From a patient’s perspective, we’re glad to see insurers and the government embrace “value.” We need the same emphasis on the entire value of medicines when it comes to getting insurance companies to cover life-saving treatments. If value is important in rating doctors, value should be equally important in medicines without focusing only on cost.

Would anyone embrace a health care system where patients are required to see the lowest rated doctors first? That’s what we have with fail first or step therapy.

A Tale of Two States: #FailFirstFeb

This month, we’re joining the millions of patients fighting the devastating policies of insurance companies that enforce “fail first” policies.

Indiana working for patients…

Indiana has moved one step closer to ending step therapy. State Senator Michael Crider has introduced legislation that would significantly reduce insurance companies ability to force patients to fail first. “The bill does not ban the process; instead, it gives healthcare providers a course of action to appeal the process.” Senate Bill 41 recently passed the Senate Health and Provider Services Committee.

…Kansas not so much

Meanwhile, things aren’t so sunny for patients in the Sunflower State.

The Kansas State Senate recently approved a bill to “require Medicaid patients to try the least-expensive, most-effective medications first before moving on to higher-cost drugs.”

No one wins with fail first policies. Patients are prevented from obtaining access to potentially life-saving treatments, while taxpayers waste money — first on the less effective treatments, then on the more effective option.

Senate Bill 341 passed on a 23-16 vote and heads to the Kansas House of Representatives.

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