Saturday, April 7, 2018

Very Brief Blog: Nerd Note, Pricing of KYMRIAH and YESCARTA - Behind the Headlines

BioPharmaDive and other sources reported this week that CMS had set payments for Gilead's YESCARTA at $400,000 and Novartis' KYMRIAH at $500,000.    See BioPharmaDive here, Reuters here.

These are outpatient prices; inpatient drugs are bundled unless and until they achieve "new technology add on payments" or NTAP payments in the hospital DRG system.

Here are some brief research notes.  I'm calling this, Kymriah and Yescarta: Behind the Headlines, but what is behind the headlines is mostly Excel spreadsheets, links, and footnotes.

Are These Prices Posted on the CMS ASP Webpage?
First, I assumed this prices were probably represented in the April 2018 (2Q2018) drug fee schedules from CMS.  These price spreadsheets are found here, under "HCPCS" codes when there are specific codes, or under a spreadsheet of prices as "NOC" codes when there is no HCPCS code. 

Medicare doesn't "set" or "negotiate" biotech drugs or other injectable drugs; it assigns prices based on ASP, or average quarterly US sales price, net of discounts, reported quarterly to CMS by the manufacturer. 

However, I didn't find either KYMRIAH or YESCARTA on these ASP tables.    Maybe next quarter?  Sipuleucil (Provenge) is there with a price around $45,000 per dose.  (CMS CY2016 public data showed Part B payments for Q2043, Provenge, at 3700 doses at $140M).

Do These CART Drugs Have HCPCS Codes?
The two CART drugs have Q-codes.  Kymriah (tisagenlecleucel, up to 250M car positive T cells, including leukapheresis and preparation, Q2040), and Yescarta (axicabtagene, up to 200M Anti CD19 CART cells, including leukapheresis and preparation, Q2041); see code listing here.


Both drugs had presentations at the public NTAP meeting on February 18, 2018; the agenda is still online hereThe full webpage for the February NTAP meeting is here and it is archived on Youtube at 4h53m hereQuite a few Youtube videos have auto-transcripts (by clicking the little three horizontal dot button) but this one doesn't.

Will New Special Policies for KYMRIAH and YESCARTA Appear?

CMS will release inpatient rulemaking regarding the NTAP decisions about April 15-20, 2018.   For most products, NTAP is hard to get, requiring first to be a "new product" (including as "new" that it is not too similar to a prior product).  Second, the medical product must have substantial clinical impact.  And third, the cost must be more than 50% of the DRG.   All three criteria are an easy hurdle for these two CART drugs.  However, the add-on payment atop the DRG is only 50% of the added cost of the new product under existing rules.

Any new outpatient policy for these drugs would appear about July 1 in OPPS rulemaking (unless there's any CMMI action that appears separately).


I pointed out in some blogs last September that there was a lot of sudden excitement and frankly, "hype," about CMS having set special pricing agreements with Novartis --- but there was no detail or facts at all about what that was, or how it was being doing administratively.  Here.

There still isn't.   My point at the time was, that there are laws governing the flow of funds for drugs at Medicare, and the Administrator of CMS can't just create new deals and shake on it and sign the line with a biopharma CEO.   (However, when some lead time, CMMI could craft creative deals as a "demo drug pricing project.")

It remains to be seen if any creative dealmaking - other than the regular rules for NTAP and ASP - will occur in April 2018 Inpatient rulemaking or June 2018 outpatient rulemaking, or in a CART-specific innovation program from CMMI.