Reimbursement issues for Sustol

Heron was unable to convince Food and Drug Administration to include some important Sustol clinical data in the label which would have helped the company ease insurance reimbursement hurdles.
Heron submitted to the FDA results from a phase III study dubbed "MAGIC" which showed Sustol to be superior to standard of care for the prevention of nausea and vomiting after highly emetogenic chemotherapy. Heron submitted these Sustol data from the MAGIC study to the FDA and wanted them included in the drug's approved label.
FDA rejected Heron's request. The Sustol label approved Wednesday omits the MAGIC study data, including any superiority claim over standard of care. What's left in the label is a Sustol statistical non-inferiority (equivalence) claim compared against Aloxi.

Heron dpes not have superiority data in the FDA-approved label give insurers a reason to place reimbursement restrictions on Sustol. This may not matter for the next year or so because Sustol will be priced at parity with Aloxi, but it will become more important in 2018 when a generic (and cheaper) version of Aloxi is launched on the U.S. market.

 

Sandoz Inc. will be permitted to market a generic version of Aloxi® in the United States on September 30, 2018, that is just around the corner. By the time the sales reps get Sustol on formulary Sandoz will be breathing down the necks of customers and at the end of the day why pay more to give a patient and 18 g needle injection when you can hang a piggyback for less money and pain to the patient who already suffers.

 

HATERS HATE...
ITS WHAT THEY DO...

 

NOT IF WHAT IS BEING SAID IS TRUE!

 

HILARIOUS

 

Since Sustol does not have superiority data in the FDA-approved label it gives ALL insurers a reason to place reimbursement restrictions on Sustol.

 

It is going to be a hard sell with what is left in the label for Sustol statistical non-inferiority (equivalence) claim compared against Aloxi.

 

Bingo this means sustol = dog

 

So let me get this straight. This company spends oodles of money and delays getting approval by doing the MAGIC trial. Then the label comes out and the only reference to MAGIC is the ISR chart showing just how painful and uncomfortable this drug is vs. either Aloxi or oral Zofran? OMG, this is classic.

Good luck selling with that PI. You're going to need one heck of a GPO contract to get anyone to use this in real life.

 

Keep away from my patients with that 18 gauge needle! I care about the suffering cancer patient not a GPO contract.

 

Has anyone sold any yet?

 

Puhleaze

 

I'd take a large needle over nausea, any day!

 

This assumes you have a drug which the FDA had deemed is better to Aloxi. Which you don't.

You chickened out of doing MAGIC with Aloxi, and chose an easier mark in IV ondansetron. But even here you couldn't get full HEC.

So how exactly is that harpoon of an 18g needle going to help you avoid CINV any better than the non-painful, gold standard 5-HT3, Aloxi?