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Interesting read . . .
Months After Approval, Breakthrough Cancer Drug Given to Just Five Patients

By Michelle Cortez , Caroline Chen , and Natasha Rausch

December 14, 2017, 4:00 AM CST Updated on December 14, 2017, 8:47 AM CST
- Delays in getting novel therapy put sales estimates at risk
- No Medicare coverage, one-by-one rulings by private insurers

Photographer: David Paul Morris/Bloomberg

Two months after Gilead Sciences Inc.’s breakthrough treatment was approved in the U.S. to treat a deadly form of blood cancer, only a tiny handful of patients have actually gotten the costly therapy, while others linger on waiting lists.

Five people have received the treatment, called Yescarta, at the 15 cancer hospitals authorized to administer it in the U.S., the hospitals told Bloomberg. Waiting lists for the $373,000 treatment have grown to at least 200 people, shrinking only as some very sick patients have died.

Doctors at the cancer centers blame holdups in getting the treatment paid for by Medicare and Medicaid, the two giant U.S. government health programs, as well as some of the U.S.’s largest insurers.

“The biggest issue has been insurance, particularly with Medicare and Medicaid,” said Michael Bishop, director of the cellular therapy program at the University of Chicago Medicine, one of the advanced hospitals that were cleared to administer the complicated treatment. “There’s no billing codes for this. It’s been difficult, to be very blunt.”

Those payment delays -- which may not be resolved for months -- have forced the hospitals to choose between putting millions of dollars at risk, or asking dying patients to keep waiting despite the availability of a potential cure.

Estimates at Risk
The delays also mean Gilead is likely to miss Wall Street’s estimates of early sales for Yescarta. Analysts have predicted the therapy will bring in $9.4 million in 2017, implying about 20 more patients would need to be treated in the next two weeks. Based on reports by the medical centers doing the billing procedures, that figure seems unrealistically high.

Gilead is “confident that Yescarta will be covered by payers,” spokeswoman Sonia Choi said in an email. The drugmaker expects about a third of patients to be on Medicare and will continue to “engage actively with Medicare to ensure we are doing all we can to support access.”

Gilead shares declined 1.8 percent to $75.20 at 9:44 a.m. in New York on Thursday. The stock had gained 6.9 percent this year through Wednesday, trailing the Nasdaq Biotechnology Index, which rose 21 percent.


Representatives for the Centers for Medicare and Medicaid Services, the federal agency that oversees the programs, didn’t immediately respond to requests for comment.

Yescarta is part of a new class of cancer therapies called CAR-T that involve a complicated process of extracting immune-system cells from a patient, modifying them in Gilead’s manufacturing plants to make them capable of attacking tumors, and re-infusing them into the person.

Yescarta and Novartis AG’s Kymriah were only approved in the last several months. Because CAR-Ts are so new -- and because the one-time, bespoke therapies involve a blend of hospital care, boutique biological manufacturing and supplemental drugs to guide patients through the treatments -- insurers and government plans have found themselves in uncharted territory.

The clock is ticking for Gilead. The company currently has the market to itself for hard-to-treat lymphoma, a deadly cancer of the blood. As it gets the infrastructure in place to treat patients and get paid, it’s rivals are drawing closer. Novartis has filed for U.S. Food and Drug Administration approval of Kymriah for that form of blood cancer, and Juno Therapeutics Inc. plans to follow next year.

Read More: Cancer Immunotherapy Offers New Promise but Peril Too

Private insurance companies are making coverage decisions for Yescarta on a case-by-case basis, while the Medicare program for the elderly hasn’t created a reimbursement code for the treatment -- meaning hospitals don’t have any guarantee they’ll be paid.

Medicare coverage is critical for the 10,000 people with the form of relapsed non-Hodgkin lymphoma the therapy was approved to treat, since more than half of patients are already over age 65 -- when the program’s eligibility starts -- at the time they’re first diagnosed, according to the National Cancer Institute.

Anthem Inc. said it will cover the procedure. None of the other big insurers provided information about coverage in response to questions from Bloomberg. Choi, the Gilead spokeswoman, said the “vast majority” of commercial payers have confirmed coverage.

Never Seen Before
The 15 centers that responded to Bloomberg included MD Anderson Cancer Center in Houston; Stanford University in California; and Mayo Clinic in Rochester, Minnesota. On top of the five patients who got treated, about a dozen additional patients who have started a weeks-long process to get Yescarta, that begins with having their immune-system cells collected and sent to Gilead.

Insurance hurdles often emerge for novel therapies, especially if they’re as complex and costly as Yescarta. Yet Sattva Neelapu, a professor of lymphoma and director of translational research at MD Anderson, said he’s never seen anything like this.

“We have to work out a spot agreement for each patient,” Neelapu said. “Once we do enough patients there is a template in place, and it’s easier for future patients.”

The total cost per Yescarta patient, when including hospital and doctors fees, will be well in excess of $575,000 and could reach $1 million, doctors said. Since hospitals have to buy the treatment at full cost from Gilead, most places are waiting to have insurer guarantees of reimbursement before moving ahead.

Waiting List of 100

MD Anderson, which has more than 100 patients on a waiting list, has started treatment for a few, after getting them to sign waivers that they will be responsible for the costs if insurance doesn’t pay. Bishop, of the University of Chicago Medicine, said he doesn’t want to turn down any patients, but the prospect of losing $1 million per patient is unsustainable. The hospital has 10 people on its waiting list.

Stanford has decided to take patients regardless of insurance provider.

“My institution is bearing that risk because it’s the right thing to do,” said David Miklos, an associate professor of medicine at the university. “But it’s a huge risk and it’s keeping me awake at night.”

The new therapy is an essential part of the drugmaker’s big bet on the oncology market. Gilead, based in Foster City, California, spent $11.9 billion two months ago to buy Yescarta’s maker, Kite Pharma Inc., in its biggest-ever deal.

— With assistance by Zachary Tracer

https://www.bloomberg.com/news/articles/2017-12-14/cancer-patients-with-little-time-left-wait-for-gilead-s-new-drug