Patent extensions upheld and revealed

On Monday, July 17th, a US appeals court ruled that a patent on Takeda Pharmaceutical’s drug Velcade® (bortezomib) was extended to 2022. Generic drug companies had sued to invalidate Takeda’s patents but failed. This means that there will be no generic competition before the 2022 date. This is obviously very good news for Takeda and eliminates hopes that cheaper generics would be available much sooner. Paradoxically, this will also benefit Amgen’s Kyprolis® (carfilzomib), the other major proteasome inhibitor, which would have faced much stiffer competition from a much lower priced generic.

By a strange coincidence, it was noted in a Celgene response to an FDA hearing on Tuesday (see below) that Revlimid® will also be free of any generic, cheaper competition until at least 2022. Thus, both “standard of care” therapies for myeloma will remain at full, patent-protected prices for five more years—at least in the US. In a completely unexpected announcement out of China, the Ministry of Human Resources and Social Security said it had agreed to add 36 drugs to the National Reimbursable Drugs List (NRDL) in return for an average 44% price cut against last year’s retail prices. In a rather astonishing follow-up comment, it was noted that some of the agreed-upon price cuts were as much as 70% -- apparently indicating the drug makers’ strong desire to achieve approval in China. Revlimid was one of the drugs added to the NRDL. Thus, in a bizarre reversal, Revlimid will cost about 50% of what it costs elsewhere. Obviously, the simple math is that by selling at least twice the amount of Revlimid in China (which is highly likely), profits will be recouped. This raises the question: Why not do that in other countries? With this breakthrough negotiation in China, who knows what might be next?

FDA panel seeks to lower drug costs by enhancing generic competition

On Tuesday, July 18, at a US Food and Drug Administration panel meeting, new FDA commissioner Dr. Scott Gottlieb outlined his plans to accelerate generic competition in an effort to reduce drug costs. In a multifaceted approach, he proposed removing hurdles and streamlining the generic drug review process. He characterized some of the hurdles as a “gaming” of the system by pharmaceutical companies to delay generic competition. In letters submitted to the FDA in response to the planned meeting, a spectrum of opinions was expressed. In a letter (as noted above), Celgene referenced a delay of generic competition until 2022 in an agreement with generic competitors. It seems that Scott Gottlieb is targeting these and other strategies in an effort to speed up generic competition. In the current healthcare environment, it is hard to envision progress on any front. However, it seems that the high cost of drugs is in the cross hairs of many groups hoping to reverse what in Maryland is called “unconscionable” drug price increases.

So, for myeloma patients, this week has delivered mixed but interesting news, which, at least, clarifies the landscape for the next five years. What happened in China gives hope that dramatic change can be possible!

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