Express Scripts and AbbVie Ink Landmark Formulary Exclusivity Deal

Shortly on the heels of the announcement that AbbVie’s Viekira Pak (ombitasvir, paritaprevir, ritonavir, and dasabuvir) was approved by FDA for the treatment of hepatitis C, Express Scripts announced it negotiated a discount with AbbVie to exclusively offer the new combination treatment to its members. According to Bloomberg, the deal marks the first time a specialty drug maker agreed to a major discount off of its published price in exchange for fewer restrictions on access to the medication.

Pharmacy benefit manager Express Scripts is notorious for rebelling against Gilead’s hepatitis C prices, and has said that Sovaldi’s (sofosbuvir) and Harvoni’s (ledipasvir and sofosbuvir) prices, $84,000 and $94,500 per year, respectively, are too much for payers to bear. Viekira Pak sells for $83,319 before any negotiated discount, according to Bloomberg.

Steve Miller, MD, Express Scripts’ senior vice president and chief medical officer, has said the drugs from Gilead have orphan drug pricing, even though hepatitis C is not an orphan condition. As a result, Sovaldi and Harvoni will be left off the PBM’s formulary starting Jan. 1, 2015, and will not be covered, except in extreme cases, for patients already on the more expensive drug regimens, and for patients with other genotypes of the disease. Janssen’s Olysio (simeprevir), another newer hepatitis C treatment, will also be excluded.

An October 2014 Express Scripts blog post written by Miller alluded to the deal between the PBM and AbbVie: “As new hepatitis C drugs are approved in the coming months, Express Scripts plans to drive more competition among the manufacturers, which will help improve both access and affordability to this important class of medications.”

It appears that the announcement by Express Scripts had an immediate fiduciary impact; Bloomberg reported on Dec. 22. 2014 that shares in Gilead dropped 14% after Express Scripts announced Viekira Pak would be its sole treatment option for genotype 1 hepatitis C.

"For the first time, a pharmaceutical manufacturer and a pharmacy benefit manager have created an agreement to deliver on the promise of a curative therapy for hepatitis C patients,” noted Miller in a press release. “Pharmaceutical innovation must be rewarded based on the value it brings to patients and payers. This agreement marks a fundamental change in how sustainable access and affordability will be delivered to hepatitis C patients."

The multiyear agreement will give AbbVie a guaranteed market for its drug, and the PBM will not require prescribers to submit prior authorizations and patient liver panel data before allowing reimbursement of the drug. The agreement will also allow general practitioners to prescribe Viekira Pak, unlike most hepatitis C prescriptions, which usually require the blessing of a specialist.

The move by Express Scripts, perhaps seen as a positive for many employers, may be viewed as a decision that limits patient options. The decision not to include once-a-day regimens for chronic disease is reminiscent of the PBM’s decision not to include Pfizer’s Xeljanz (tofacitinib) for the treatment of rheumatoid arthritis (RA) on their formulary in 2014. In 2012, Xeljanz was the first oral biologic released for the treatment of RA, and the first oral treatment option for RA in more than a decade. Most of the newer RA biologics, such as tumor necrosis factor inhibitors, are administered subcutaneously or by infusion.

The pill burden on patients is higher for Viekira Pak than for either Harvoni or Sovaldi. While the Gilead treatments are one pill, once a day for 12 weeks, Viekira Pak consists of four pills administered over the course of the day for 12 weeks, and ribavirin is also sometimes required. Although Miller told Bloomberg that the difference in pill burden is “negligible,” critics could argue that one pill versus numerous pills could affect patient adherence, and in turn, cure rates. Matthew Herper of Forbes points out the since some patients on Harvoni can be treated for eight weeks for $63,000, depending on the discount Express Scripts received, Viekira Pak could be more expensive than Gilead’s treatment in some cases.

Like Sovaldi and Harvoni, Viekira Pak is an interferon-free regimen and has a high virologic response rate. According to Express Scripts' independent Pharmacy & Therapeutics Committee, Viekira Pak was determined to be at least clinically equivalent to Harvoni and Sovaldi. "While there haven’t been head-to-head trials between Viekira Pak and Harvoni, the published data show that both products have very high cure rates as well as very high compliance rates," David Whitrap, director of corporate communications at Express Scripts, told BioPharm International in an email.

As part of the agreement with AbbVie, Viekira Pak will be dispensed exclusively through Express Script's specialty pharmacy (Accredo Specialty Pharmacy), so the PBM will make money on distribution of the medication. Although Express Scripts does not publicly disclose pricing figures, Whitrap told us, "the discount we’ve been able to secure for our clients is significant."

"For the first time in this new generation of hepatitis C therapies, plan sponsors can afford to treat all their genotype 1 hep C patients – not just those who have the most advanced stages of disease," Whitrap said. "In total, the announcement opens the door to hepatitis C cures for all patients, at a fair price that payers can sustain."

UPDATE:
Shortly after publishing this article, Diplomat Specialty Pharmacy announced that they will also distribute Viekira, and the drug "will be available for open distribution."

Sources:
Bloomberg
Forbes
Express Scripts