Trends That Matter

Trends That Matter for Global Oncology

August 30, 2018

The field of oncology continues to see increasingly innovative treatments and increasingly higher prices, according to IQVIA Institute for Human Data Science’s report Global Oncology Trends: Innovation, Expansion and Disruption.

According to the report, the programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors represent a paradigm shift in the treatment of cancer. Since the therapies first entered the U.S. market in 2014,

The field of oncology continues to see increasingly innovative treatments and increasingly higher prices, according to IQVIA Institute for Human Data Science’s report Global Oncology Trends: Innovation, Expansion and Disruption.

According to the report, the programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors represent a paradigm shift in the treatment of cancer. Since the therapies first entered the U.S. market in 2014, their use has expanded rapidly, and in 2017, they were used to treat patients with 23 tumor types.

Since 2012, 78 new cancer therapies treating 24 tumor types have launched; many of them have been approved for more than one indication. Within that same time period, spending on cancer treatments has doubled within the United States, with 2017 spending reaching almost $50 billion. The costs are expected to double again by 2022.

Trends That Matter for Multiple Myeloma Therapies

August 16, 2018

Although multiple myeloma is a relatively rare cancer, numerous therapies to treat it are available, AIS Health reported. Because of these products’ efficacy, they have made the disease manageable — and, as a result, costly.
“The mainstays of treatment for multiple myeloma are considered specialty medications and therefore placed into a specialty tier,” says Raechele McMahan, vice president and general manager, enterprise specialty pharmacy at Prime Therapeutics. “The therapies are also subject to utilization management,

Although multiple myeloma is a relatively rare cancer, numerous therapies to treat it are available, AIS Health reported. Because of these products’ efficacy, they have made the disease manageable — and, as a result, costly.
“The mainstays of treatment for multiple myeloma are considered specialty medications and therefore placed into a specialty tier,” says Raechele McMahan, vice president and general manager, enterprise specialty pharmacy at Prime Therapeutics. “The therapies are also subject to utilization management, which primarily consists of prior approval.”

“Combination therapy is the standard of care for treating multiple myeloma,” says McMahan. “Due to the use of triple combination therapy in multiple myeloma, the average annual cost of treatment for multiple myeloma can range from $100,000 to more than $250,000.” Contracting for the specialty therapies is not common in the space at this time.

Trends That Matter for Generic Drugs

August 2, 2018

The Trump administration has touted competition as one way to bring down drug prices. With this goal in mind, the FDA recently released a pair of draft guidance documents aimed at helping generics get onto the market sooner while still upholding the focus on safety, AIS Health reported.

One of the documents, titled Development of a Shared System Risk Evaluation and Mitigation Strategy (REMS) (83 Fed. Reg. 25468, June 1, 2018),

The Trump administration has touted competition as one way to bring down drug prices. With this goal in mind, the FDA recently released a pair of draft guidance documents aimed at helping generics get onto the market sooner while still upholding the focus on safety, AIS Health reported.

One of the documents, titled Development of a Shared System Risk Evaluation and Mitigation Strategy (REMS) (83 Fed. Reg. 25468, June 1, 2018), offers recommendations for developing a shared system REMS for multiple drug products.

The other, titled Waivers of the Single, Shared System REMS Requirement (83 Fed. Reg. 25465, June 1, 2018), describes situations in which the agency will waive the requirement that a generic drug and its reference product use a single, shared system (SSS) REMS with Elements to Assure Safe Use.

Since fiscal year 2014, the first full year the Generic Drug User Fee Act was in effect, the FDA has been bringing new generic drugs to the market in the hopes the approvals will help lower drug costs. A recent report from PwC’s Health Research Institute found that in fiscal year 2017, the FDA gave 763 generic drugs full approvals, 86.5% more than in fiscal year 2014.