AbbVie's Viekira Pak was priced at USD83,319 for a 12-week course of treatment; however unprecedented agreement with Express Scripts is set to notably boost market access to the drug in 2015.
IHS Life Sciences perspective | |
Significance | AbbVie (US) has announced the FDA approval of its all-oral triple direct acting antiviral (DAA) regimen, Viekira Pak (ombitasvir + paritaprevir + ritonavir tablets; dasabuvir tablets) as a treatment for chronic genotype 1 hepatitis C virus (HCV) infections with or without ribavirin (RBV), including in patients with compensated cirrhosis. |
Implications | The HCV regimen will cost around USD83,319 for a 12-week course of treatment, however The US's largest pharmacy benefit manager (PBM), Express Scripts, has stated that it will add Viekira Pak to its National Preferred Formulary to be reimbursed at a significant discount starting from 1 January 2015, while excluding other next-generation antiviral therapies such as Gilead's Sovaldi and J&J's (US) Olysio (simeprevir). |
Outlook | Although AbbVie's HCV therapy however was not priced too far below Sovaldi or Harvoni, the firm's negotiated agreement with the US's largest pharmacy benefit provider could greatly facilitate access of the drug through formulary exclusivity, and primary-care prescription. Viekira Pak's approval will notably boost revenues for AbbVie in 2015 and beyond and will serve to reduce its reliance on its best-selling anti-inflammatory drug Humira (adalimumab) moving forward. |
AbbVie (US) has announced the US FDA approval of its all-oral triple direct acting antiviral (DAA) regimen, Viekira Pak (ombitasvir + paritaprevir + ritonavir tablets; dasabuvir tablets) as a treatment for chronic genotype 1 hepatitis C virus (HCV) infections with or without ribavirin (RBV), including in patients with compensated cirrhosis. Regulatory approval was granted based on data from a large multinational clinical programme that enrolled over 2,300 patients in around 25 counties. Results from the six pivotal Phase III trials demonstrated 95-100% cure rates with Viekira Pak in genotype 1a and 1b HCV infected patients, and Phase II trials in patients with liver transplants as well as those co-infected with HIV-1, which demonstrated 97% and 92% cure rates respectively.
Viekira Pak contains three antivirals with distinct mechanisms of action, including a fixed-dose combination of an NS5A inhibitor ombitasvir (25mg), NS3/4A protease inhibitor paritaprevir (150mg) and antiviral booster ritonavir (100mg) dosed once a day, as well as a non-nucleoside NS5B polymerase inhibitor, dasabuvir (250mg), dosed twice a day. The three antivirals target the virus at three different stages of the disease lifecycle to prevent it from multiplying. Treatment duration is typically 12 weeks, except for patients with cirrhosis that need to continue treatment for 24 weeks. RBV should be combined with Viekira Pak for the treatment of all genotype 1a patients, and those with cirrhosis or post-liver transplant.
Viekira Pak priced at USD83,319
According to an AbbVie spokesperson, the HCV regimen will cost around USD83,319 for a 12-week course of treatment, as reported by Reuters. to the price is slightly lower compared to its main competitor on the US market, Gilead Sciences' (US) Sovaldi (sofosbuvir), which is priced at USD84,000 for a 12-week course of treatment (see United States: 9 December 2013: Gilead's HCV drug sofosbuvir priced at USD1,000 per pill granted US FDA approval). However Gilead's all-oral Sovaldi-based combination regimen Harvoni (ledipasvir + sofosbuvir) approved for the treatment of genotype 1 HCV patients would cost notably less for certain patients, about USD63,000 for an eight-week course of treatment (see United States: 13 October 2014: Gilead Sciences garners US FDA approval of all-oral HCV regimen Harvoni, prices it at USD1,125 per pill). Non-cirrhotic, treatment-naïve patients and with a baseline HCV viral load below 6 million international units per millilitre (IU/ml) that are eligible for the eight-week treatment regimen represent nearly 40% of genotype 1 HCV patients. For the remaining patients, a 12-week USD94,000 course of treatment with Harvoni would be required.
Viekira Pak on Express Scripts' National Preferred Formulary
The US's largest pharmacy benefit manager (PBM), Express Scripts, has stated that it will add AbbVie's Viekira Pak to its National Preferred Formulary, its largest plan covering an estimated 25 million beneficiaries, and will reimburse the therapy for the treatment of HCV genotype 1 patients starting from 1 January 2015, while excluding other next-generation antiviral therapies such as Gilead's Sovaldi and J&J's (US) Olysio (simeprevir), as reported by Bloomberg. The exclusive three-year agreement entails AbbVie provide a "significant discount" to the drug's retail price, according to Express Scripts' Chief Medical Officer Steve Miller. This is the first time a drug manufacturer has offered a large discount on its published price in exchange for greater access through formulary exclusivity. Gilead was providing a discount of around 8% to PBMs according to Miller. In addition, prescription of Viekira Pak is not restricted to a specialist, but could also be done by a primary-care provider according to Express Scripts.
Express Scripts' Pharmacy & Therapeutics Committee has determined that Viekira Pak as "at least clinically equivalent" to Harvoni and Sovaldi, and thus would be favoured over all other treatments for genotype 1 HCV patients. Sovaldi will continue to be listed on the formulary for other genotypes and for those patients with advanced liver disease. In addition, patients that have already started treatment with other antivirals will be able to continue to receive coverage until therapy is completed.
Outlook and implications
AbbVie's "breakthrough therapy"-designated Viekira Pak comes with a favourable safety and efficacy profile, even in patients that are more challenging to treat, such as those with advanced liver disease or liver transplants and those patients co-infected with HIV. An estimated 3.2 million individuals in the United States are infected with HCV according to the Centers for Disease Control and Prevention (CDC), with over 70% of those infected carrying the genotype 1 strain. Without medical intervention, nearly 1 million individuals would develop cirrhosis by 2020, and medical costs related to HCV progression could rise to USD85 billion over the next 20 years. The market potential for HCV is significant; Gilead's HCV portfolio is anticipated to generate a cumulative USD10.6 billion at the mid-point range in 2014 (see United States: 24 July 2014: Sales of Gilead's Sovaldi hit USD3.5 bil. in Q2, Zydelig garners US FDA approval for CLL, FL, and SLL).
However, although AbbVie's HCV therapy was not priced too far below Sovaldi or Harvoni, the firm has negotiated an undisclosed price discount with the US's largest pharmacy benefit provider that could greatly facilitate access of the drug through formulary exclusivity, and primary-care prescription. Express Scripts, was one of the fiercest critics of Gilead's pricing strategy for Sovaldi; however it was not the only one: several other payors and legislators voiced concern regarding the cost of treatment for the large infected population (see United States: 24 March 2014: US congressional representatives question cost of HCV drug Sovaldi; United States: 14 July 2014: US senators request detailed pricing information for Gilead's Sovaldi; United States: 23 May 2014: Gilead's Sovaldi comes under greater scrutiny in US; United States: 30 April 2014: US Medicaid group raises concerns over price of Sovaldi; United States: 20 June 2014: Sovaldi anticipated to increase Medicare's spending by USD6.5 bil. in 2015; and United States: 28 October 2014: Express Scripts compares Harvoni's price to orphan drugs, raises concerns over large US patient population). Prescription drug prices are not regulated in the US; however pressure from payors can have a significant impact on access through formulary exclusion, as was the case with Express Scripts.
AbbVie has announced that it will provide its 2015 earnings guidance in January. Viekira Pak's approval will notably boost revenues for AbbVie in 2015 and beyond and will serve to reduce its reliance on its best-selling anti-inflammatory drug Humira (adalimumab) moving forward.