AMCP session, “Specialty Pharmaceutical in Development,” highlighted critical trends that healthcare executives should be watching
Aimee Tharaldson, PhamD, senior clinical consultant, emerging therapeutics, Express Scripts, set the pace for Wednesday morning, April 21, at the Academy of Managed Care and Specialty Pharmacy Annual Meeting 2016 with the session, “Specialty Pharmaceutical in Development.”
To kick off the discussion, she shared a well-accepted definition of specialty drugs: “High-cost prescription medications used to treat complex, chronic conditions such as cancer, rheumatoid arthritis and multiple sclerosis. They often require special handling (refrigeration during shipping) and administration (such as injection or infusion).
Tharaldson noted three trends affecting specialty pharmacy:
1. Increased competition from a growing number of therapy classes, generic specialty drugs providing (a $16 billion opportunity) and biosimilars worth $43.3 billion
2. Emergence of new orphan and cancer drugs
3. Breakthrough therapies.
Biosimilars hit the radar with the 2010 enactment of the Affordable Care Act and caught steam when the FDA developed a pathway for biosimilars in 2012. Since then, there has been additional FDA guidance focusing on proposed naming and labeling of biosimilars and on their interchangeability.
The emergence of biosimilars has been slow but the industry awaits the market launch of newly approved Inflectra, a non-interchangeable alternative to Remicade that treats most of the same conditions.
Last September, the FDA approved the first biosimilar, Zarxio, a non-interchangeable drug for Neupogen for the treatment of neutropenia with a wholesale price of 15% less than the originator drug.
Tharaldson mentioned other biosimilars in development for originator drugs such as Enbrel, Humira, Neupogen, Epogen, Neulasta and Procrit.
Biosimilars are expected to be 15% to 30% less expensive than the originators drug and expect to offer savings with interchangeability; however, there are legal hurdles to jump, she said
Next: Orphan drugs in development
There are currently 7,000 orphan diseases affecting fewer than 200,000 people. Of the 41 new drugs that were FDA-approved in 2014, 18 were for orphan indications.
Orphan drugs have seen a sales increase from $46.6 billion in 2014 to $54 billion in 2015 in the United States and are projected by drug industry consultant EvaluatePharma to reach more than $60 billion in 2016.
Breakthrough drugs, which receive FDA-expedited review, are generally combinations of drugs and the newest ones are expected to address cancer, hepatitis C and orphan diseases, Tharaldson said.
According to Express Scripts, 2015 saw a 38% spend on specialty pharmacy when compared to traditional drugs that will hit 50% by 2018. The majority of these drugs target inflammatory conditions, multiple sclerosis, cancer, hepatitis C and HIV.
Last year, the FDA approved 45 novel drugs, according to a report by Diplomat Pharmacy. Of the specialty agents approved in 2015, the areas with the most approvals were rare diseases and oncology. A total of 56 drugs were approved last year.
In the specialty pipeline, Tharaldson said there are drugs for inflammatory diseases, MS. HIV, hepatitis C, asthma and allergies, Duchenne muscular dystrophy and nonalcoholic steatohepatitis (NASH).
The inflammatory disease class is anticipating new injectables and expanded uses, although in the pipeline are oral drugs Xeljanz and baricitinib for rheumatoid arthritis and brodalumab administered subcutaneously.
MS foresees immunomodulators, monoclonal antibody and oral and injectable drugs; a generic form of Copaxone (40 mg); and a treatment for progressive MS, in the pipeline. New ones include Zinbryta and Ocrevus.
New chemo, targeted and immunotherapy drugs are in the cancer pipeline, including Atezolizumab and brigatinib for non-small cell lung cancer.
Tharaldson expects that the development of hepatitis drugs will lead to ones that treat all types of the disease and support a shorter duration of treatment. Right now, she said, there is a standard of care evolving.
The trend in HIV drugs is toward ones with new mechanisms of action, a possible vaccine and more injectables. Six are in the pipeline, including Fostemsavir, an oral attachment therapy, and cabotegravir, an integrase strand transfer.
The pipeline for Duchenne muscular dystrophy, for which there is currently no treatment, looks to eteplirsen as a potential drug. Finally, the market for NASH includes an oral drug, Aramchol, to reduce liver fat.
Mari Edlin is a frequent contributor to Managed Healthcare Executive. She is based in Sonoma, California.