Industry Trend Analysis - Novartis Will Take Advantage Of Ibrance's Slow Movement In EU - OCT 2017

BMI View: The approval of Kisqali in the EU will aid Novartis ' ambitious growth plans for this drug. It will lag behind the market leader, Pfizer's Ibrance, which has capitalised on first-to-market status. Novartis has an opening to gain market share in Europe, which will be supported by its flexible pricing strategies as Pfizer struggles to gain traction with Ibrance in this region.

Novartis is rapidly expanding the revenue generating potential of Kisqali (ribociclib), building upon the momentum of its first quarter on the US market. The EC has approved Kisqali in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy. Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis.

Swift EU Approval Build s On US Momentum

The EU approval follows a positive opinion granted in June 2017 by the EMA's CHMP, which was based on superior efficacy and demonstrated safety of Kisqali plus letrozole versus letrozole alone in the pivotal Phase III MONALEESA-2 trial. The opinion included a recommendation that allows oncologists the flexibility to prescribe Kisqali with any aromatase inhibitor (letrozole, anastrozole or exemestane) they deem most appropriate for their patient.

In March 2017, the FDA approved Kisqali, in combination with any aromatase inhibitor, as a treatment for metastatic breast cancer. Ribociclib in combination with letrozole was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a category 1 option for HR+/HER2- postmenopausal metastatic breast cancer patients. On May 4 2017, the FDA approved the first-of-its-kind in oncology Kisqali Femara co-pack (ribociclib tablets; letrozole tablets) as initial endocrine-based therapy for the treatment of HR+/HER2- advanced or metastatic breast cancer in postmenopausal women.

Kisqali recorded USD8mn in revenues in its first quarter on the market; however, this is small compared to first quarter revenues of Pfizer's Ibrance (palbociclib), which saw the company's first-to-market status secure USD38mn in revenues. In FY2016, Pfizer recorded Ibrance revenues of USD2.5bn, which will be hard for Novartis to match.

NICE Approval Key To Kisqali Dominating Europe

In February 2017, the UK's National Institute for Health and Care Excellence (NICE) did not recommend Pfizer's Ibrance to treat breast cancer because its cost is too high in relation to its potential benefits in draft guidance out for consultation. Palbociclib is taken with an aromatase inhibitor and works by blocking the production of oestrogen, stopping the hormone's ability to stimulate some breast cancer to grow. Given as a once-daily capsule, palbociclib is the first of a new type of drug that increases the effect of aromatase inhibitors. A full course of treatment with palbociclib costs GBP79,650 (USD99,571.8). It is believed that as Ibrance is classed as an add-on medication, the cost was too high to be covered. Pfizer noted that most of Ibrance's sales were in the US, and this could provide an opportunity for Novartis to claim leadership in Europe.

Novartis has yet to gain NICE approval, but its odds are higher with Kisqali. The company has introduced flexible pricing for the drug, which will aid in gaining coverage. Novartis has stated that at the time of launch in the US, Kisqali will be the CDK4/6 inhibitor with the lowest wholesale acquisition cost. In addition, based on the dosing schedule seen in the trials, the company anticipates it will have an 18-20% lower aggregate cost than Ibrance. Novartis has priced the 28-day supply of the 600mg dose of Kisqali at USD10,950. The same duration supply of the 400mg dose will cost USD8,760, and the 200mg dose will be available at USD4,380. The company noted that the Kisqali Femara co-pack is available at the same cost as Kisqali alone, which will aid in breaking the add-on treatment barrier with NICE. The flexible pricing strategy will serve the company well in its attempts to claim EU market share.