Reform Update: Medicaid programs crafting limits on Harvoni usage

Reform Update: Medicaid programs crafting limits on Harvoni usage


By Virgil Dickson
Posted: October 21, 2014 - 4:15 pm ET

Which Medicaid beneficiaries will have access to Gilead Sciences' newest high-cost hepatitis C treatment, Harvoni, and when they'll get that access, now depends on prior-authorization criteria being hammered out by various state agencies.
Most will likely limit Harvoni use to patients dealing with liver failure, as 35 states now do for Gilead's Sovaldi. Some may adopt restrictions such as banning those dealing with drug and alcohol addiction from getting the specialty drug, or limiting who may prescribe it to only board-certified gastroenterologists, hepatologists or infectious disease physicians. Another option is implementing the so-called “once in a lifetime” rule, which allows Medicaid patients only one chance at treatment.
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Harvoni will keep Gilead atop Hepatitis C virus treatment landscape, says GlobalData Analyst


Harvoni will keep Gilead atop Hepatitis C virus treatment landscape, says GlobalData Analyst

The recent US Food and Drug Administration (FDA) approval of Harvoni (ledipasvir/sofosbuvir), Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus (HCV) genotype 1 (GT1) infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.

Christopher J. Pace, Ph.D., GlobalData’s Senior Analyst covering Infectious Diseases, expects Harvoni to quickly usurp other Sovaldi-based regimens as the preferred treatment option for GT1 patients, who comprise over 70% of all US adults with HCV. This is due to the drug’s stellar clinical profile and reduced pill burden relative to approved and off-label options.

Furthermore, by attributing the bulk of Harvoni’s wholesale acquisition cost (WAC) to Sovaldi, Gilead will also discourage the off-label use of more expensive Sovaldi-based, direct-acting antiviral (DAA) regimens, strengthening its position against competitors Bristol-Myers Squibb, Johnson & Johnson, AbbVie, and Merck.

Pace comments: “Gilead’s shrewd pricing strategy for the fixed-dose combination pill, with an anticipated WAC of $94,500 for a 12-week course, will help to facilitate its rapid uptake, particularly in the US.

“This approach will easily position Harvoni as the more cost-effective option for most GT1 patients, compared with the interferon-sparing Sovaldi regimens, which have an estimated WAC of $94,726 for a 12-week course of Sovaldi combined with Pegasys [peginterferon alfa-2a] and ribavirin. This pricing strategy will be especially effective for patients who can be cured with an eight-week course of Harvoni, which carries an expected WAC of $63,000.”

However, the analyst notes that while Gilead has a clear lead over competitors in the US, its position in other major markets is less tenable.

Pace explains: “Compared to the US, Gilead has faced a delayed uptake of Sovaldi-based regimens in the five European countries of Germany, Italy, Spain, France and the UK due to cost-effectiveness concerns, particularly in the latter two countries.

“Nevertheless, Harvoni’s convenient once-daily, single-tablet dosing will be hard for clinicians and eligible patients to ignore when it launches in these and the Japanese markets, especially if Gilead emulates its US pricing strategy.”

ACG 2014 - New and upcoming therapies for the treatment of HCV



See more from Highlights from ACG 2014


PHILADELPHIA — In this exclusive video interview, Paul Y. Kwo, MD, professor of medicine, Indiana University, discusses the new and upcoming therapies, including the recently approved combination regimen of ledipasvir and sofosbuvir, to treat patients with hepatitis C virus infection. He further discusses how the new therapies will impact patients within this specific population in the future.

“With a lot of hard work, we should be able to successfully treat and eradicate this disease within the next several decades,” Kwo said.

Disclosure: Kwo holds multiple advisory roles and has received grant support from multiple pharmaceutical companies

Highlights from ACG 2014 resource page @ Healio 
This is your central portal for information presented at the American College of Gastroenterology's Annual Scientific Meeting, including the latest data on novel treatment options and results from important clinical trials. In addition to breaking news, this resource page features onsite video interviews with leading experts to get their reactions to some of the clinical updates and news presented at the conference, and what implications this research may have for the future.

Enanta update on collaboration agreement with AbbVie

Enanta Pharmaceuticals provides update on its collaboration agreement with AbbVie

Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, has announced that it has decided not to exercise its co-development option for ABT-493, Enanta’s next-generation protease inhibitor for hepatitis C virus (HCV) being developed in Enanta’s collaboration with AbbVie.


Per the original collaboration agreement signed in December 2006, Enanta will be eligible for certain regulatory approval milestones as well as royalties on net sales allocable to ABT-493 from worldwide sales of any ABT-493-containing regimens.

Enanta also announced that it has reached agreement with AbbVie regarding the net sales allocations for royalty calculations for ABT-450-containing regimens, as well as any regimens containing ABT-493. ABT-450 is the first clinical-stage protease inhibitor candidate developed within the Enanta-AbbVie collaboration, and ABT-493 is the second.

"We believe that the development and commercialization of our HCV protease assets, ABT-450 and ABT-493, are in good hands with the expertise and resources of a global biopharmaceutical company such as AbbVie," stated Jay R. Luly, Ph.D., President and CEO.

"At this time, we have decided it is better to use our financial resources generated by these partnered assets to advance our other internal proprietary candidates for HCV, including our newly reacquired NS5A program, and to pursue the growth of our pipeline beyond HCV with additional candidates in infectious disease and other indications."

Under the original agreement with AbbVie, Enanta is entitled to receive payments for regulatory and reimbursement approval milestones, as well as annually tiered royalties per product, ranging from the low double digits up to twenty percent, on AbbVie's worldwide net sales allocable to the collaboration's protease inhibitor product.

With the amended agreement, the following percentages of worldwide net sales of ABT-450-containing regimens will be the net sales then used to calculate annual royalties payable to Enanta:

In addition, although ABT-493 is not currently being developed for sale in combination with any active ingredient other than a DAA, if it were, then there would be a further adjustment to net sales of the regimen for royalty purposes based on the relative value of any non-DAA in the regimen sold by AbbVie.

In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV- protease-inhibitor-containing drug combinations. ABT-450 and ABT-493 are protease inhibitors identified through the collaboration.

Under the agreement, AbbVie is responsible for all development and commercialization activities for ABT-450, the collaboration's lead compound that has been submitted for approval in the United States and the European Union as part of a multi-drug regimen.

Enanta received $57 million in connection with signing the collaboration agreement and $95 million in subsequent clinical and regulatory milestone payments, and is eligible to receive up to an additional $155 million in payments for regulatory and reimbursement approval milestones, as well as annually tiered, double-digit royalties per product on AbbVie's worldwide net sales allocable to the collaboration's protease inhibitors.