From Specialty Pharmacy News

Another Pan-Genomic Hepatitis C Therapy Enters Crowded Class With Lowest WAC (with Chart: Hepatitis C Monthly Wholesale Acquisition Costs)

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, specialty pharmacies, pharma companies, providers and employers contain costs and improve outcomes related to high-cost specialty products. Subscribe today!

By Angela Maas, Managing Editor
August 2017Volume 14Issue 8

When two drugs to treat hepatitis C launched in 2011, they were the first new treatments for that therapeutic class in a decade. And it wasn’t just that they were new products — they were first-in-class treatments that offered tremendous improvements over the existing therapies. But when Sovaldi (sofosbuvir) hit the U.S. market in late 2013 (SPN 12/13, p. 1), it ushered in a newer generation of drugs in what is now a fairly crowded space. And with the Aug. 3 approval of AbbVie Inc.’s Mavyret (glecaprevir and pibrentasvir) — and its class-lowest wholesale acquisition cost (WAC) — payers now have an array of therapeutic choices.

Treatment with ribavirin and interferon had been the standard regimen for a while when the first protease inhibitors, Merck & Co., Inc.’s Victrelis (boceprevir) and Vertex Pharmaceuticals Inc.’s Incivek (telaprevir), gained FDA approval in 2011 (SPN 6/11, p. 8). Since then, the field of therapies has grown considerably more crowded — and more effective. So effective, in fact, that those first two drugs aren’t even available on the U.S. market anymore (SPN 9/14, p. 1; 2/15, p. 6). With the newer drugs all offering high cure rates, that’s allowed payers to prefer products to drive down pricing. It’s also meant that they can drill down in managing the class even further based on nuances of the products and patient populations.

Mavyret is indicated for use in genotypes 1 through 6 in people without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those on dialysis. In addition, it is approved for adults with genotype 1 infection — the most common in the United States, found in about 75% of people with hepatitis C — who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

Specialty Pharmacy News

New Hep C Drug Has Lowest WAC

With its approval, there are eight next-generation therapies available to treat hepatitis C, and they are comparable in efficacy and safety.

“All seem to be able to achieve the high bar of a mid- to higher 90% cure rate,” says Lynn Nishida, area vice president of pharmacy at Solid Benefit Guidance. “Anything short of this efficacy rate will make it hard for the product to compete in the market. By way of safety, all seem to have inherent safety profiles such that patients need to be monitored, but the majority seem to have manageable side effects on the whole.”

But they have their differences:

  • Sovaldi: From Gilead Sciences, Inc., this drug treats genotypes 1, 2, 3 or 4. Regimen durations are 12 or 24 weeks. It is taken with ribavirin always and sometimes with peginterferon alfa. Dosing is one tablet once daily with or without food.

  • Harvoni (sofosbuvir/ledipasvir): From Gilead, this therapy is indicated for genotypes 1, 4, 5 and 6. Regimens are 12 or 24 weeks; the drug is sometimes taken with ribavirin. Dosing is one tablet once daily with or without food.

  • Epclusa (sofosbuvir/velpatasvir): Another Gilead drug, it treats genotypes 1 through 6, and regimens are 12 weeks. The therapy is taken sometimes with ribavirin, and dosing is one tablet once daily with or without food.

  • Vosevi (sofosbuvir/velpatasvir/voxilaprevir): A Gilead product, this drug treats genotypes 1 through 6 in people who are treatment-experienced, and regimens last 12 weeks. Dosing is one tablet once daily with food.

  • Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets): From AbbVie Inc., this treatment is for genotype 1, and regimens last 12 or 24 weeks. Dosing is two combination tablets once daily in the morning and one dasabuvir tablet twice daily, morning and evening, with a meal.

  • Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir): From AbbVie, it treats genotype 1 and has a 12- or 24-week regimen. Dosing is three tablets taken once daily with a meal.

  • Mavyret: An AbbVie therapy, this treats genotypes 1 through 6 for eight, 12 or 16 weeks. Dosing is three tablets taken once daily with food.

  • Zepatier (elbasvir and grazoprevir): From Merck, this drug treats genotypes 1 and 4, and it is taken sometimes with ribavirin. Regimens are 12 or 16 weeks, and dosing is one tablet daily with or without food.

Among the products, there are additional “nuances,” says April Kunze, senior director, clinical formulary development & trend management strategy at Prime Therapeutics LLC. For example, “Epclusa and Harvoni can cover the majority of treatment-naïve and treatment-experienced hep C patients (i.e., HIV co-infected, cirrhotic patients, etc.) with one pill, once daily. Epclusa requires 12 weeks of therapy for all patients in whom it is indicated. Harvoni can be used for eight weeks in genotype 1 patients within a recommended viral load. Because they contain sofosbuvir, they cannot be used in patients in severe renal failure or on dialysis. Both Harvoni and Sovaldi are approved in patients aged 12-17 years.”

In addition, Kunze says, “Viekira and Viekira Pak require multiple tablets and dosing per day. Vosevi is only indicated in treatment-experienced patients at this time. It is likely that Gilead will submit for a broader label in the future.” And while both Mavyret and Epclusa are pan-genomic, Mavyret “can be used in patients with renal failure or on dialysis and is an eight-week regimen. It can be used in some treatment-experienced patients. It is dosed as three tablets once daily compared to one tablet once daily for Epclusa.”

Much of the media coverage around Mavyret’s approval focused on its shorter treatment duration. Length of regimen “is one of the factors that payers/clinicians may consider important due to compliance/adherence,” says Nishida.

That said, “The treatment of hep C has been reduced from a year or more of therapy down to eight to 12 weeks for most patients, and the regimens are much more tolerable than the older regimens,” Kunze says. “Given these drugs are well-tolerated and highly effective, the difference between eight weeks and 12 weeks is pretty minimal for most patients.”

Mavyret also differentiated itself by coming to market with the lowest WAC: $13,200 for one month (see table below).

“It’s the least costly of all the hep C products (before rebates, discounts), at about $26,400 per eight-week course (about $471 a pill),” Nishida tells AIS Health. “That’s quite a drop — approximately 58% to 65% less expensive — vs. other products like Harvoni that hit the market at $1,125 a pill, or even another new hep C product just approved on July 18 of this year, Vosevi.” That drug “is also a pan-genotypic product that costs about $74,760 for a required 12-week course (about $890 a pill).”

“AbbVie has competitively priced their product in the hep C market,” echoes Kunze.

Contracting within the class through exclusive or preferred arrangements, though, has resulted in similar net costs (SPN 2/16, p. 1). As Umer Raffat, senior analyst, equity research for Evercore ISI, pointed out in an Aug. 3 research note, in 2015 Gilead said Harvoni’s net price was about 46% of its WAC. “Thus, the key would be what gross:net” AbbVie offers, he wrote.

“As more drugs are entering the market, and manufacturers try to maintain market share, contract negotiations are becoming more aggressive,” Kunze says. “This should help hold down costs for health plans and members.”

Contracting, agrees Nishida, is “very competitive due to the enhanced competition. Mavyret has set the tone, and it will be interesting how it weathers against contracting of other product manufacturers. Also, some payers (not all) have seen some favorable declines in their hep C utilization,” as there “seems to be a shrinking population as patients are treated and due to what we would like to hope is high cure rates.”

Prime prefers Harvoni and Epclusa, says Kunze, noting that the company will evaluate Mavyret and Vosevi at its next pharmacy & therapeutics (P&T) meeting. When Kunze was asked whether Gilead and AbbVie offer any kind of package contracting for multiple drugs, she replied, “Prime negotiates contracts based on the individual merits of each drug.”

Asked how payers generally are managing the class and on what they are basing formulary decisions, Nishida says, “For some payers you do see some that are making switches in their formulary year to year, as the market become more competitive, the number of products increase, and price competition is enhanced for additional discounts and rebates. Changes in formulary typically apply to new starts to ease the formulary transition, with most, if not all, payers ensuring that…members are able to finish out their treatment courses on existing products.”

She points out that “Several PBMs aren’t announcing their next year’s (2018) formulary for hep C products until September due to P&T review, followed by manufacturer contracting to secure the best price.”

Indeed, when Express Scripts Holding Co. unveiled changes to its 2018 National Preferred Formulary on July 31, it said, “Please note that product placement for Hepatitis C and treatment for Inflammatory Conditions are under consideration and changes may occur based upon changes in market dynamics and new product launches. The full list of excluded products will be available on or before September 15, 2017.”

And CVS Health explained Aug. 1 when it announced its Standard Control Formulary for 2018, “consistent with our policy, as a new specialty product launches all existing products in the class will be re-evaluated to determine appropriate formulary placement and potentially removed or added to formulary. New entrants are expected in the hepatitis C class. We are in the process of finalizing changes for autoimmune and hepatitis C categories, which will be communicated mid-September.”

Hepatitis C Monthly Wholesale Acquisition Costs


SOURCE: Umer Raffat, senior analyst, equity research, Evercore ISI.

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