Hi
@SapioStrategic
Apologies for the late reply, got distracted by the partnership with Tasly.
Its a great question and I've done some research in the past, but may be slightly out of date .. but hopefully a person who has lived or is a US citizen may be better equipped to give you a better answer, but I'll give it my best shot.
Firstly, once a treatment is approved by the FDA it is given a National Drug Code (NDC) number.
As MSC 100-IV will be administered through a procedure at a clinic/hospital, before Medicare/Medicade, private insurance companies, Veterans Admin or State Pharmacy Assistance Programs (health care providers) are able to make a claim, there must be a Current Procedure Terminology (CPT) code in order to process the claim for administering the drug.
If a CPT doesn't exist, a new CPT must be applied for and approved before a claim can be made. Not sure how long it takes, but it is done with the American Medical Association.
After all this, it doesn't automatically mean MSC 100-IV will be covered by health care providers. There is a process by which each body will decide to cover or not cover MSC 100-IV, this will be up to Mesoblast (or a partner) to push .. and should be initiated as soon as possible after FDA approval is given.
Obviously private insurers will be the hardest to get over the line, the government funded bodies such as Medicare/Medicaid being the first to likely subsidise newly approved treatments such as MSC 100-IV.
As an example I'll talk about Medicare specifically, where there are four parts to it.. Part A for in-hospital treatment, Part B for out-patient treatment, Part D for prescription drugs (drugs you can take at home), and Part C which is a combination Part A, B and D.
Medicare are most likely to Cover drugs administered in Part A, less likely in B, and least likely for Part D.
MSC 100-IV will initially start in Part D, and Mesoblast will need apply to the Center of Medicare and Medicare Services to recategorise it to Part B, which should be a formality as MSC 100-IV will need to be administered at a clinic/hospital (out-patient).
Once in Part B, Mesoblast will need to get it through the Medicare Coverage Determiniation process (
CMS Determination site), which basically registers it as an approved treatment that Medicare will cover.
Being a government funded body, Medicare registering MSC 100-IV will probably be much easier compared to private health providers.
Afterall all that, a patient eligible for Medicare (over the age of 65 or under 65 and disabled or suffering from a specific disorder such as renal diseases or amyotropic lateral sclerosis) will be able to claim approx 80% of the cost, and pay between 10% and 20%; depending on whether the physician accepts assignment or not (kind of like Australia's GAP policy).
And for those who are not covered by any health care providers... they pay 100% out of pocket.
So as you can see its a pretty loaded question you asked, and at the end of the day all this 'red-tape' is the reason why it takes years to fully penetrate a market once a new drug/treatment is approved.
While that sounds like a bad thing, it actually works out quite well because it allows the distributor/supplier to build up their supply and iron out any minor/major issues before the product hits mainstream and becomes widely accessible (financially).
All of this would be factored into the financial models Mesoblast would have had to present to finance providers before these debt facilities were approved, and the business case is significantly enhanced as we will be keeping 100% of proceeds on sales in the US.
The challenge will be to get MSC 100-IV approved by all health care bodies in the US as soon as possible after it is FDA approved, obviously will be slower doing it ourselves... but keeping 100% of proceeds makes up for that slight delay/extra admin/legal cost in getting through the red-tape.
Hope that answers your question .. and happy for anybody with more current/accurate info to contribute.
(20min delay)