HIV Drug Combos Launched with Promise of Lower Costs

Mylan will reduce the wholesale acquisition costs of Smyfi Lo and Cimduo, which are both combination therapies for HIV.

Mylan recently announced it will be launching 2 new fixed-dose HIV combination drugs, which were both approved in February, according to a press release.

Symfi Lo (efavirenz, lamivudine, and tenofovir disoproxil fumarate) is expected to launch in the next few weeks, while Cimduo (lamivudine and tenofovir disoproxil fumarate) is expected in the second quarter of 2018.

Symfi Lo is a once-daily, single-tablet drug indicated as a complete regimen for adult patients with HIV-1 infection and for children who weigh at least 35 kg.

Related Coverage: FDA Approves Two Fixed Dose HIV Treatments

Cimduo is a once-daily combination of nucleo(t)side reverse transcriptase inhibitors and is indicated in combination with other antiretroviral drugs to treat the same population.

"As the world's largest supplier of antiretrovirals by volume, Mylan is deeply committed to expanding access to treatment for people living with HIV," said Heather Bresch, CEO, Mylan. "For a decade, we have helped transform the level of access to high-quality, affordable HIV medications in developing countries. We are excited to bring that same passion to the US with the upcoming launches of Symfi Lo and Cimduo and help deliver significant savings to the health care system."

The launch of these 2 combination therapies is expected to help address the high cost of treating HIV, which surpasses $20 billion annually, according to the release. HIV therapies are also a driver of payer spending, including public health programs.

In 2017, HIV was the drug category that accounted for the most of Medicaid pharmacy spend. HIV drugs were the third highest spend category for health exchange plans and the fifth for commercial plans, according to the release.

In an effort to reduce the high cost of treating HIV, Mylan is discounting Symfi Lo’s list price significantly below the wholesale acquisition cost of any other single-tablet regimen, according to the release. Similarly, Cimduo’s list price will be reduced below the cost of other tenofovir-based products.

More recently, Mylan has sold Symfi Lo overseas since March 2017, when it received tentative approval by FDA under the President's Emergency Plan for AIDS Relief program, according to the release.

"Symfi Lo and Cimduo bring to the US the innovations Mylan has pioneered in the delivery and dosage forms of [antiretrovirals] used by millions of patients in high-burden countries around the world. We are proud of our continued investments in R&D and manufacturing for ARVs, and we are excited to extend the value of these to Americans living with HIV," said Rajiv Malik, president, Mylan. "In particular, we believe the option to take a lower dose of efavirenz in a single-tablet regimen with Symfi Lo will be a welcome addition."