March 19, 2018

The Most Expensive US Medicine Now Has an Official Sticker Price

12 January 2018, 10:25 | Cesar Cruz

Cost of treating rare genetic blindness: $425000 per eye

Dr. Albert Maguire right checks the eyes of Misa Kaabali 8 at the Children's Hospital of Philadelphia. Misa was 4-years-old when he received his gene therapy treatment

Spark Therapeutics, perhaps aware of the problematic PR that could come its way after announcing the almost $1 million dollar price tag, also delivered a press release outlining a series of new payment models that could establish a novel precedent for how we deal with the financial reality behind these breakthrough, one-off gene therapy treatments. Should the therapy not perform as expected and meet certain undisclosed criteria after the one-time administration at those specified time points, Spark will pay rebates to payers.

"The new payment models announced today are merely a way to disguise a price that is simply too high", David Mitchell, president and founder of Patients For Affordable Drugs, said in a statement.

And on the other side of the Atlantic the Association of the British Pharmaceutical Industry (ABPI) has often suggested that expensive treatments could be funded by instalments, or vary price per patient according to effectiveness.

"New technologies such as gene and cell therapies hold out the potential to transform medicine", FDA Commissioner Dr. Scott Gottlieb-said in a statement announcing the August approval of Kymriah, considered to be the first gene therapy to be approved for the USA market.

Luxturna has the highest list price of any drug, although the ultimate cost for patients and insurers may be less than for other expensive drugs that must be given every year for life.

"We are encouraged by CMS' willingness to engage with us in exploring a new model", Marrazzo said.

Express Scripts has a deal with Spark to distribute Luxturna.

"Luxturna offers hope to hundreds of patients". "But the question that must be asked is this: What is a fair price that will maximize affordability and accessibility and provide a reasonable return for the drug?"

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Anticipating criticism, Spark promised to reimburse patients if the treatment proves not to be effective, and said it expects United States health authorities to authorize payment in stages.

Although Luxturna is intended for a relatively rare type of inherited blindness, several companies are developing similar therapies for more common illnesses. "Our system can not handle unjustified prices like this, and the new payment models announced today are merely a way to disguise a price that is simply too high".

Some critics of Spark are questioning the efficacy and durability of the treatment.

The one-time treatment "helps restore sight for patients with a rare genetic condition", Nisen writes.

Speculation about Spark as a takeover target has been rampant for nearly two years.

These new prospective models are situated inside a greater debate that is now occurring as more of these breakthrough gene therapies become real. With the burgeoning field of gene therapy finally taking hold of medicine, this is something that certainly needs to be managed.

Harvard Pilgrim and Express Scripts, the country's largest pharmacy benefits manager, have also agreed to a new contracting arrangement with Spark that guarantees patient access to Luxturna in exchange for reducing the financial burden and risk for treatment providers and insurers.

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