Oncology drugs in the pipeline

October 7, 2015

Several new drugs hold promise, but cost is a top concern.

Biopharmaceutical companies are developing 836 medicines and vaccines for cancer, all of which are in clinical trials or awaiting review by FDA, according to the PhRMA (Pharmaceutical Research and Manufacturers of America). While this flurry of activity is positive, executives also need to be prepared for the cost challenges that some of the emerging-and in some cases existing-cancer drugs may present. Here are some of the most noteworthy oncology drugs that should be on your radar.

Lung cancer drugs

Lung cancer is one of the most prevalent cancers in the United States, with non-small cell lung cancer (NSCLC) accounting for about 85% of all lung cancer cases. Emerging therapies will likely change the way NSCLC is treated, according to David Lassen, chief clinical officer, Prime Therapeutics.

FDA is expected to make a decision later this year on the Biologics License Application (BLA) for necitumumab (Lilly Oncology) in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous NSCLC. In a recent study, “Necitumumab in Metastatic Squamous Cell Lung Cancer - Establishing a Value-Based Cost),” published in JAMA Oncology, researchers said that necitumumab should be priced at between $563 and $1,309 per cycle. However, its price is expected to be significantly higher.

In addition, a New Drug Application (NDA) has been filed for rociletinib (Clovis Oncology), an oral cancer drug, for the treatment of patients with mutant epidermal growth factor receptor (EGFR) NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. It is receiving priority review and is expected to be approved March 20, 2016.

The oral drug osimertinib (AstraZeneca) recently produced positive results in patients with mutant EGFR NSCLC, as well.

 

 

PD-1 inhibitors

PD-1 inhibitors, which are a type of immunotherapy, are a relatively new category of oncology drugs that may hold a lot of promise.

“[Immunotherapy treatments] stimulate the patients’ immune system to attack various types of cancer,” Lassen says. “There are two PD-1 inhibitors-Keytruda [pembrolizumab] and Opdivo [nivolumab]-that are FDA approved, and there are other PD-1 inhibitors in the pipeline. In a short period of time, their indications are expanding-allowing them to be used in many different types of cancers ... These are anticipated to be multibillion dollar drugs.”

FDA granted accelerated approval to Merck’s Keytruda to treat patients with advanced (metastatic) NSCLC. Keytruda, previously approved in metastatic melanoma, belongs to this new class of drugs designed to help the immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1. Keytruda is being investigated for two gastrointestinal cancers, advanced anal cancer and advanced biliary tract cancer.

FDA recently approved the first-ever immunotherapy combination Opdivo (Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) for use in patients with metastatic melanoma.

Opdivo, which is already approved for treating metastatic melanoma and lung cancer, has also shown positive results in recent studies to treat kidney cancer and advanced, non-squamous NSCLC, which is a much larger population than squamous cell cancer. New indications anticipated for Opdivo in late 2015 to 2016 include renal cell carcinoma.

 

 

Multiple myeloma

There also has been some development in the treatment of multiple myeloma, which may change the way this cancer is treated, says Lassen.

FDA has accepted for priority review the BLA for elotuzumab (Empliciti, Bristol-Myers Squibb) and daratumumab (Genmab), both intravenous drugs. FDA also granted priority review to the NDA for ixazomib (Takeda), the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.

Additionally, FDA approved a new indication for carfilzomib (Kyprolis, Amgen and its subsidiary Onyx Pharmaceuticals) for combination use in the treatment of patients with relapsed multiple myeloma.

Cost implications

“Generally, as new cancer drugs come to market they are at least as expensive, if not more expensive, than the available alternatives,” Lassen says. “The drugs coming to market will likely increase costs for the treatment of these cancers. Some of these provide alternatives to existing therapies and others provide additional treatment options once first-line drugs have failed.”

Vogenberg

F. Randy Vogenberg, PhD, RPh, cofounder of Access Market Intelligence, Trumbull, Connecticut, shares a similar viewpoint. “Oncology drugs will continue to represent a big driver-in excess of $10,000 per month-for the ‘specialty’ drug segment and medical benefit costs-for cases where drugs are under the medical benefit,” he says. “There will be continued use of limited distribution of these drugs, and continued pressure for minimizing patient out of pocket costs.”

Not all of these drugs are adjudicated through the pharmacy benefit or pharmacy benefit manager, says Nadina Rosier, North America Practice Leader, Pharmacy, Towers Watson. “For example, daratumumab, a multiple myeloma IV drug undergoing FDA review, could be approved as early as 2016 with projected sales of more than $200 million annually.

IV drugs are typically covered through the medical benefit; however, because of the J-code billing system, these drug costs are sometimes ‘hidden’ with other medical costs and thus, can go relatively unnoticed by plan sponsors,” Rosier says. “The historic lack of detailed cost and utilization reporting of specialty drugs covered and paid through the medical benefit, for some health plans, can be a barrier for employers seeking more cost and utilization disclosure specific to their patient population health.”

Prime has closed this gap for its clients and members. “Integrating medical and pharmacy data is inherent in our model with our clients,” added Lassen. “Driving alignment and coordination across the continuum of care to see the big picture of healthcare costs is essential to delivering programs that lead to the best health outcomes.”

 

 

Payer implications

“Today’s rapidly changing oncology environment can make it challenging to manage treatment algorithms or guidelines,” according to Lassen. “Included in this change is legislation, specifically, oral oncology parity laws. These parity laws can assist patients in accessing new innovative therapies, but they prevent payers from helping their member get the best drug that’s right for them and controlling costs for these very expensive therapies.”

Payers will need to determine how to effectively account or model for the members who likely will use these new blockbuster drugs, according to Rosier, who says that Towers Watson works with PBMs to develop appropriate modeling that can help plan sponsors understand their financial and clinical exposure. 

“In some cases, these new drugs are ‘replacements’ to existing therapies and other times, they are viewed as new therapies or ‘better than’ existing products,” she says. “If the data and research are correct and patients are able to improve their response rate and duration of progression-free survival, these therapies could be a win-win for patients and plan sponsors. Plan sponsors will always need to identify comprehensive oncology management solutions that address the overall patient’s health. The drug cost is just one component of total healthcare management.”

The biggest challenge is cost-shifting (copayment) strategies have generally been neutralized to-date by the industry through the use of copay subsidy programs in commercial insurance plans, says Vogenberg.

“Additional challenges include lack of effective communication regarding clinical and cost implications for patients, lack of data identifying providers more likely to use clinically and cost use of evidence based medicine and high out-of-pocket costs,” he says. “The best opportunities will be for vendors that can track, optimize and report oncology drug treatment protocols regardless of benefit design.”