SOURCE: Real Endpoints

October 13, 2014 12:25 ET

Move Over Gilead? AbbVie Could Bring Serious Competition to HCV Market

Gilead's Harvoni Might Be the Top Overall Performer, Says RxScorecard™, but a Discounted Triple Regimen From AbbVie Could Mount Major Challenge

WESTPORT, CT--(Marketwired - Oct 13, 2014) - Gilead's Harvoni (sofosbuvir/ledipasvir combination) is the top overall scorer, according to RxScorecard, a drug-value assessment tool from Real Endpoints LLC. Combining results in the domains of efficacy and safety & use, Harvoni scores 4.8% above the AbbVie Triple regimen. [Click for Chart]

But the AbbVie Triple, with an expected approval by year-end, could easily become the regimen of choice for many payers -- at least until the Merck and Bristol-Myers Squibb (BMS) regimens are approved. AbbVie Triple's efficacy-only scores in the key Genotype 1a and 1b subpopulations are essentially equal to, and in certain subpopulations, 11% better than, Harvoni's.

But because of disadvantages in pill burden, dosing and drug-drug interactions (AbbVie's safety & use domain scores are almost 20% below Harvoni's in Genotype 1a and 11% in Genotype 1b), and because a number of influential payers are looking to choose a single regimen for most of their beneficiaries with HCV, AbbVie will probably have to price its regimen at a weighted discount to Harvoni.

Here's the math: roughly 70% of patients will require 12-weeks of therapy on Harvoni, at cost of $94,500; however, most Genotype 1a naïve patients will only require 8-weeks of therapy, which should cost approximately $63,000. This results in a prevalence-weighted price of roughly $85,000 (i.e., 30% of patients at $63,000, 70% at $94,500). We project that AbbVie will need to price its Triple around $76,000, a discount required to overcome its disadvantages and provide meaningful value to payers. Moreover, plans that are willing to provide significant exclusivity to a single regimen, such as AbbVie Triple, will likely be able to negotiate even better net pricing (including rebates/discounts).

Indeed, it is possible -- if payers limit the therapies' access to sicker patients (cirrhotics, those with liver transplants, and those co-infected with HIV) -- that total HCV therapy costs could drop dramatically from current levels.

RxScorecard allows transparent, objective and apples-to-apples comparisons of marketed and pipeline drugs based on systematic analysis of at least 19 drug characteristics and their performance within key genotypes or subpopulations. So far, RxScorecard has scored drugs/regimens in multiple sclerosis, rheumatoid arthritis, COPD and adjuvant breast cancer in addition to HCV.

Real Endpoints is a healthcare analytics company focusing on drug reimbursement. For more information on RxScorecard click here.

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