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Trends That Matter

Trends That Matter for Specialty Drug Management

October 11, 2018

Specialty drugs continue to be a concern for large employers, according to The Large Employers’ 2019 Health Care Strategy and Plan Design Survey by the National Business Group on Health (NBGH), AIS Health reported.

NBGH surveyed its corporate members in May and June on what they are doing for 2019. When NBGH asked employers about specialty pharmacy benefit management techniques, respondents selected more aggressive utilization management protocols as the top strategy,

Specialty drugs continue to be a concern for large employers, according to The Large Employers’ 2019 Health Care Strategy and Plan Design Survey by the National Business Group on Health (NBGH), AIS Health reported.

NBGH surveyed its corporate members in May and June on what they are doing for 2019. When NBGH asked employers about specialty pharmacy benefit management techniques, respondents selected more aggressive utilization management protocols as the top strategy, with 64% citing this, followed by having employees get specialty drugs through a specialty pharmacy or the specialty department of the health plan or PBM, cited by 58%. At 44%, site-of-care management notched the third top technique.

Trends That Matter for 2019 PBMs’ Exclusions

September 27, 2018

Leading pharmacy benefit managers (PBMs) recently released updates to their 2019 national formularies. As of Jan. 1, Express Scripts Holding Co. will introduce 48 new formulary exclusions in its 2019 National Preferred Formulary (NPF), which the PBM says will help drive out waste, AIS Health reported.

Adam Fein, Ph.D., president of Pembroke Consulting, Inc. and CEO of Drug Channels Institute, notes that Express Scripts, for the first time, excluded products in two specialty categories: HIV antiretrovirals and Factor VIII recombinant products for hemophilia treatment.

Leading pharmacy benefit managers (PBMs) recently released updates to their 2019 national formularies. As of Jan. 1, Express Scripts Holding Co. will introduce 48 new formulary exclusions in its 2019 National Preferred Formulary (NPF), which the PBM says will help drive out waste, AIS Health reported.

Adam Fein, Ph.D., president of Pembroke Consulting, Inc. and CEO of Drug Channels Institute, notes that Express Scripts, for the first time, excluded products in two specialty categories: HIV antiretrovirals and Factor VIII recombinant products for hemophilia treatment.

Separately, CVS Health’s spokesperson Christine Cramer said, “We are removing 23 drugs from our Standard Control Formulary in 2019 and we will add back four drugs to the formulary. The vast majority of members we serve — 98.76 percent — will be able to stay on their current therapy.”

According to a recent Solid Benefit Guidance white paper, the changes are likely to negatively impact 0.2% to 1.24% of members, as estimated the two largest national PBMs.

Trends That Matter for Epinephrine Medications

September 13, 2018

In August, the FDA approved Teva Pharmaceuticals’ generic version of Mylan N.V.’s EpiPen — a move the FDA says will provide a lower-cost option, though Teva hasn’t released pricing details, AIS Health reported.

In May, after consumers around the country reported difficulties in finding EpiPens to treat severe allergic reactions, the FDA announced shortages of two brands of epinephrine auto-injectors: Mylan Inc.’s EpiPen and Impax Laboratories, LLC’s Adrenaclick.

 

In August, the FDA approved Teva Pharmaceuticals’ generic version of Mylan N.V.’s EpiPen — a move the FDA says will provide a lower-cost option, though Teva hasn’t released pricing details, AIS Health reported.

In May, after consumers around the country reported difficulties in finding EpiPens to treat severe allergic reactions, the FDA announced shortages of two brands of epinephrine auto-injectors: Mylan Inc.’s EpiPen and Impax Laboratories, LLC’s Adrenaclick.

 

 

“The approved ANDA [abbreviated new drug application] generic for EpiPen is a welcomed addition to the market,” says Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “While it is not out yet and we are not certain of the pricing, we are assuming it will be priced at the minimum similar or cheaper than the authorized generic manufactured by Mylan.”

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.