Cancer, Hepatitis C Drugs Loom Large in Specialty Pipeline

Express Scripts Senior Clinical Consultant Aimee Tharaldson, PharmD, discusses specialty pharmacy treatment options for 2014 and beyond.

Advances in the treatment of hepatitis C and various types of cancer could have a dramatic impact on the specialty market as soon as this year, according to a top consultant at the pharmacy benefit manager Express Scripts.

Aimee Tharaldson, PharmD, an Express Scripts senior clinical consultant who analyzes the specialty pharmaceutical pipeline, said in an interview with Specialty Pharmacy Times that new hepatitis C drugs could significantly alter disease management for both patients and health care providers.

In addition to sofosbuvir (Sovaldi), Gilead’s $1000-per day oral medication, pipeline drugs from Abbvie and Enanta Pharmaceuticals, Merck, and Bristol-Meyers Squibb could dramatically reduce the prevalence of hepatitis C, albeit at a very high price.

“I think these will have a significant impact on the market,” Dr. Tharaldson said. “A lot of patients with hepatitis C have been waiting for interferon-free regimens. There is also a significant demand for genotype 1 hepatitis C treatments, because it represents 75% of all hepatitis C cases. But it’s going to be expensive, at the most like $100,000 [per year], so that will have a definite impact on the market.”

Treatments such as sofosbuvir and simeprevir (Olysio) by Janssen Therapeutics currently face little competition. However, Dr. Tharaldson said Abbvie and Enanta’s interferon-free fixed-dose combination regimen could be submitted for FDA approval in the second quarter of 2014, before hitting the market later in the year or early next year.

Pipeline drugs such as Merck’s MK-5172/MK-8742 and Bristol-Meyers Squibb’s daclatasvir and asunaprevir (DCV Dual Regimen), which was granted Breakthrough Therapy designation by the FDA, could increase competition once they hit the hepatitis C drug market. Merck’s regimen may be approved in late 2015 or early 2016. Bristol-Myers Squibb’s regimen is expected to be approved in December 2014 for genotype 1 b chronic hepatitis C, which is easier to treat and less common in the United States.

“As more of these treatments become available, beginning next year it could provide more opportunities for potential cost savings,” she said. “I think it’s going to increase the amount that is spent on patients with hepatitis C, so I think this will create financial challenges for those providing pharmacy benefit coverage for their employees.”

Dr. Tharaldson notes that there are also important new cancer drugs that could soon enter the market, with 30% of specialty drugs currently in the pipeline being developed to treat various forms of the disease.

Ceritinib (LDK378), an ALK inhibitor by Novartis, demonstrated promising results for patients with ALK-positive non-small cell lung cancer during a recent single-arm phase I trial published in The New England Journal of Medicine.

Gilead’s idelalisib, an oral inhibitor of PI3K delta for the treatment of refractory indolent non-Hodgkin’s lymphoma, was submitted to the FDA in January 2014, with approval expected in August, according to Dr. Tharaldson.

Dr. Tharaldson said other pipeline drugs to keep an eye on are Pfizer’s breast cancer therapy palbociclib, which recently completed phase II trials, and Bristol-Meyers Squibb’s lung cancer therapy nivolumab, which is also being developed for the treatment of advanced melanoma and carcinoma.

Dr. Tharaldson points to Merck’s breakthrough anti-PD-1 immunotherapy MK-3475, which shows promising results in multiple tumor types, as another potential blockbuster.

“We’re seeing a lot of development focused on cancer,” she said. “Within 10 years, half of all new cancer drugs will involve immunotherapy. It seems to be relatively safe and effective across a variety of cancer types.”

While significant breakthrough therapies for cancer and hepatitis C loom large on the horizon, there is no such movement on biosimilars, which have still not been approved for use in the United States. Dr. Tharaldson said a number of hurdles still must be overcome before these drugs hit the market and offer consumers cost relief.

“Biosimilars take a lot of money to develop and market,” she said. “Brand manufacturers are going to try to protect their patents for as long as possible. Right now, most manufacturers will file a [biologic license application] rather than go through the abbreviated 351(k) biosimilar pathway. So because there is not a defined path [for approval], I think it’s going to be at least 3 years.”