Clinician Insights

Physicians Greet New HCV Drug Zepatier Cautiously

February 29, 2016

The debut of a new drug called elbasvir/grazoprevir (Zepatier, Merck) for adults infected with chronic hepatitis C virus (HCV) genotypes 1 and 4 has not generated much excitement among physicians, at least not yet, according to a Medscape Medical News survey.

Only 11% of physicians said they would prescribe the new drug, touted for cure rates topping 90%, to at least half of their patients who meet the indication in the first year. And although 17% said they felt comfortable with elbasvir/grazoprevir compared with other HCV drugs and would quickly start prescribing it, the majority of physicians expressed a more cautious approach.

These patterns also held true among gastroenterologists, who treat slightly more patients with HCV than their peers and claim to know more about the new drug, although they were slightly more likely (16%) to prescribe it for a majority of their eligible patients in the coming 12 months.

Lack of familiarity with the drug and its cost, as well as the availability of rival therapies, may help explain the quiet reception of elbasvir/grazoprevir, several experts told Medscape Medical News.

The US Food and Drug Administration approved elbasvir/grazoprevir, a once-a-day, single-tablet drug that can be taken with or without ribavirin, on January 28. It joins two other combination drugs for HCV genotype 1 (the most common form of the disease) that do not require concomitant use of interferon, which is notorious for harsh adverse events. The two other drugs are ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and ombitasvir, paritaprevir, ritonavir, plus dasabuvir (Viekira Pak, AbbVie).

Similar to elbasvir/grazoprevir, the two other combination drugs for HCV genotype 1 have very high cure rates, and high prices. However, the newest drug enjoys a relative price advantage. The list price for a 12-week regimen of elbasvir/grazoprevir is $54,600 compared with $94,500 for ledipasvir/sofosbuvir and $83,000 for ombitasvir, paritaprevir, ritonavir, plus dasabuvir. Third-party payers other than Medicare can and do negotiate somewhat lower tabs, however.

The Medscape Medical News survey on elbasvir/grazoprevir, which did not report the list price, asked readers in a Likert scale question how much cost would interfere with their adoption of the drug if the price resembled that for other hepatitis C drugs. Thirty-nine percent of all physicians and 42% of gastroenterologists replied that cost would be a major barrier. For 13% of either group, cost would not pose a barrier at all.

Table 1. A Question of Pricing: If Priced Similarly to Other drugs for Hepatitis C, on a Scale From 1 to 5, How Much of a Barrier Will Cost Be in Your Adoption Approach (1 = not a barrier at all and 5 = a major barrier)?

  All Physicians Gastroenterologists
1 — Not a barrier 13% 13%
2 7% 5%
3 17% 19%
4 17% 17%
5 — A major barrier 39% 42%
Not applicable — no eligible patients with hepatitis C genotype 1 or 4 4% 1%

As of 5 pm EST, February 19.

"The Most Expensive Price Is the Drug That Doesn't Work"

It is not clear how much survey takers knew about the exact price of elbasvir/grazoprevir or whether such knowledge would have influenced their anticipated adoption of the drug.

"It may have," said Paul Martin, MD, a professor of medicine and chief of hepatology at the University of Miami Health System in Florida, in an interview with Medscape Medical News. But even when a drug's list price is known, the cost factor is a wild card.

"Cost is on our radar, but it's difficult when dealing with individual patients to discern what the actual out-of-pocket cost for them will be, because generally when these drugs get on a formulary, they're discounted," said Dr Martin.

It will take some time for elbasvir/grazoprevir to make it on to health plan formularies as a preferred, discounted treatment, and until that happens, the drug could cost a patient more, even though its list price is lower, noted Nancy Reau, MD, hepatology section chief and associate professor of medicine at Rush University Medical Center in Chicago, Illinois.

David Johnson, MD, a professor of medicine and chief of gastroenterology at East Virginia School of Medicine in Norfolk, also said the price of elbasvir/grazoprevir factors into physician prescribing, but with a caveat attached. "The most expensive price is the drug that doesn't work," said Dr Johnson. In other words, efficacy trumps a lot of other considerations.

Bumping Up Against Established Rivals

Not all physicians have the same caseload of patients with hepatitis C genotypes 1 and 4. Only 17% of physicians see 31 or more such patients per month, according to the Medscape Medical News survey. That percentage was a little higher, at 20%, for gastroenterologists, who made up 56% of all 170 physician respondents.

The survey, posted the day after elbasvir/grazoprevir was approved, found that 63% of all physicians and 71% of gastroenterologists claimed to know at least the basic information about the drug, with 35% and 40%, respectively, saying they had an understanding of the clinical trial data.

This level of understanding did not translate into enthusiasm for prescribing the drug. Instead, physicians evinced a go-slow mindset when asked about their anticipated adoption of elbasvir/grazoprevir.

Table 2. Physician Uptake of a New HCV Drug: Which of the Following Statements Most Closely Represents What Your Adoption Approach Toward Elbasvir/Grazoprevir Will Be?

  All Physicians Gastroenterologists
I feel comfortable with elbasvir/grazoprevir in comparison to current products and will quickly start prescribing. 17% 16%
I will investigate the potential for elbasvir/grazoprevir with some of my own patients in comparison to other products, then wait to see their response before accepting it fully. 23% 27%
I will be prudent in my choice of elbasvir/grazoprevir, continually adding one patient at a time in comparison to other agents. 24% 25%
I will need to be convinced of elbasvir/grazoprevir's value then will adopt it for only some patients before I accept fully. 15% 18%
I am unsure about elbasvir/grazoprevir's value and will wait until it becomes well-established and widely used before I accept it fully. 12% 11%
Not applicable — I do not have any eligible patients with hepatitis C 5% 1%

As of 5 pm EST, February 19.

Physician estimates of prescription volume also leaned toward the conservative side.

Table 3. Prescription Predictions: Of Your Patients With Hepatitis C Genotypes 1 or 4 Who Are Eligible for This Particular Treatment, to What Percentage Will You Prescribe Elbasvir/Grazoprevir in the First Year?

  All Physicians Gastroenterologists
Not applicable — I do not have any eligible patients with hepatitis C 8% 4%
0% to 10% 22% 26%
10% to 20% 24% 21%
20% to 30% 17% 19%
30% to 40% 7% 6%
40% to 50% 5% 5%
50% to 60 5% 7%
60% to 70% 1% 3%
70% to 80% 2% 3%
80% to 90% 0% 0%
90% to 100% 3% 3%

As of 5 pm EST, February 19.

Physicians interviewed by Medscape Medical News said they were not surprised by the hesitant embrace of elbasvir/grazoprevir, given its Johnny-come-lately status. "It's bumping up against the success and familiarity of the other drugs" for hepatitis C, said Dr Johnson.

More peer-reviewed studies of the drug's rivals have been published, he noted. There is not as much understanding of elbasvir/grazoprevir's efficacy and safety, "so physicians aren't ready to make the change."

Although "the path is greased" for its competitors, elbasvir/grazoprevir may gain a foothold with patients with renal failure, a small subset that should find the drug easier to use, according to Dr Reau.

The drug's label states that no dosage adjustment is recommended in patients with any degree of renal impairment, including those receiving dialysis. Ombitasvir, paritaprevir, ritonavir, plus dasabuvir comes with the same guidance, except that the drug has not been studied in patients receiving dialysis. With ledipasvir/sofosbuvir, no dosage recommendation can be made for patients with severe renal impairment or end-stage renal disease.

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